Zolpimist

Generic Name: zolpidem (Oral route, Oromucosal route, Sublingual route)

zole-PI-dem

Commonly used brand name(s)

In the U.S.

• Ambien


• Ambien CR


• Edluar


• Zolpimist

Available Dosage Forms:

• Tablet


• Tablet, Extended Release


• Spray

Therapeutic Class: Nonbarbiturate Hypnotic

Uses For Zolpimist

Zolpidem belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Zolpidem is used to treat insomnia (trouble in sleeping). Zolpidem helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

This medicine is available only with your doctor's prescription.

Before Using Zolpimist

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Sleep medicines may cause a special type of memory loss or "amnesia". When this occurs, a person does not remember what has happened during the several hours between use of the medicine and the time when its effects wear off. This is usually not a problem since most people fall asleep after taking the medicine. In most instances, memory problems can be avoided by taking zolpidem only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of zolpidem in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zolpidem in the elderly. However, confusion, dizziness, and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zolpidem. Elderly patients may require a lower dose to help reduce unwanted effects.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam


• Buspirone


• Butabarbital


• Chlordiazepoxide


• Chlorpromazine


• Clonazepam


• Clorazepate


• Dexmedetomidine


• Diazepam


• Diphenhydramine


• Doxylamine


• Estazolam


• Eszopiclone


• Ethchlorvynol


• Flumazenil


• Flurazepam


• Fospropofol


• Halazepam


• Hydromorphone


• Hydroxyzine


• Lorazepam


• Meprobamate


• Midazolam


• Oxazepam


• Oxycodone


• Pentobarbital


• Phenobarbital


• Prazepam


• Promethazine


• Propofol


• Quazepam


• Ramelteon


• Secobarbital


• Tapentadol


• Temazepam


• Thioridazine


• Triazolam


• Zaleplon

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion


• Carbamazepine


• Ciprofloxacin


• Desipramine


• Ketoconazole


• Rifampin


• Sertraline


• St John's Wort


• Telaprevir


• Venlafaxine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol


• food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or


• Drug abuse or dependence, history of—Dependence on zolpidem may develop.

• Diseases affecting metabolism or disease involving blood circulation—Caution should be used in patients with these medical problems.

• Emphysema, asthma, bronchitis, or other chronic lung disease or


• Mental depression, history of or


• Mental illness, history of or


• Myasthenia gravis (severe muscle weakness) or


• Sleep apnea (temporary stopping of breathing during sleep)—Use with caution. Zolpidem may make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. Higher blood levels of zolpidem may result, increasing the chance of side effects.

Proper Use of zolpidem

This section provides information on the proper use of a number of products that contain zolpidem. It may not be specific to Zolpimist. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take zolpidem just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

You should swallow the extended-release tablets whole. Do not divide, crush, or chew them.

Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Zolpidem should not be taken with food or right after a meal. It will work faster if you take it on an empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are using the oral spray for the first time, it must be primed by spraying it for 5 times in a safe direction away from your face and other people. If the oral spray has not been used for 14 days, it must be primed again with 1 spray.

To use the oral spray:

• Pull the child-resistant cap to separate it from the base.


• Remove the clear protective cap from the pump.


• Hold the container upright with the black spray opening pointed directly into your mouth.


• Fully press down on the pump to make sure that a full dose (5 mg) of is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed by your doctor, a second spray should be given.


• Put the clear protective cap back over the pump after each use.

To use the sublingual tablets:

• Do not open the blister pack that contains the tablet until you are ready to take it. Do not use the tablet if the seal of the blister pack is broken.


• Remove the tablet from the blister pack by peeling back the top layer of paper, then push the tablet through the foil.


• Place the tablet under your tongue. It should melt quickly. Do not crush, chew, or swallow the tablet. Do not eat or drink anything after using this medicine.


• If you are taking Intermezzo®, check the time before you take this medicine. Intermezzo® should be taken only if at least 4 hours of sleep remain before the planned time of awakening.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the treatment of insomnia (trouble in sleeping):
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—12.5 milligrams (mg) once a day at bedtime.
    
    
    • Older adults—6.25 mg once a day at bedtime.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For oral dosage form (oral spray):
    
    • Adults—10 milligrams (mg) or 2 sprays into the mouth at bedtime.
    
    
    • Older adults—5 mg or 1 spray into the mouth at bedtime.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (sublingual tablets):
    
    • Adults—
      
      • Edluar™: 10 milligrams (mg) placed under the tongue at bedtime.
      
      
      • Intermezzo®: 1.75 mg (for women) and 3.5 mg (for men) placed under the tongue at bedtime.
      
      
    
    
    • Older adults—Intermezzo®: 1.75 mg (for both men and women) placed under the tongue at bedtime.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—10 milligrams (mg) once a day at bedtime.
    
    
    • Older adults—5 mg once a day at bedtime.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw the child-resistant container of the oral spray when the 60 sprays have already been used.

Precautions While Using Zolpimist

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you think you need to take zolpidem for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zolpidem is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to zolpidem before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.

If you will be taking zolpidem for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.

After taking zolpidem for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zolpidem or taking alcohol or other CNS depressants with zolpidem may lead to breathing problems and unconsciousness. Some signs of an overdose are severe drowsiness, severe nausea or vomiting, staggering, and troubled breathing.

Zolpidem may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching; hives; hoarseness; trouble breathing or swallowing; or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Zolpimist Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Clumsiness or unsteadiness


• confusion


• mental depression

Rare

• Dizziness, lightheadedness, or fainting


• falling


• fast heartbeat


• hallucinations (seeing, hearing, or feeling things that are not there)


• skin rash


• swelling of the face


• trouble with sleeping


• unusual excitement, nervousness, or irritability


• wheezing or difficulty with breathing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Clumsiness or unsteadiness (severe)


• dizziness (severe)


• double vision or other vision problems


• drowsiness (severe)


• nausea (severe)


• slow heartbeat


• troubled breathing


• vomiting (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Sleepiness or unusual drowsiness

Less common

• Abdominal or stomach pain


• abnormal or decreased touch sensation


• abnormal sensation of movement


• appetite disorder


• balance disorder


• binge eating


• bladder pain


• bloated


• bloody or cloudy urine


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in hearing


• chest discomfort


• chills


• confusion about identity, place, and time


• constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• daytime drowsiness


• diarrhea


• difficult, burning, or painful urination


• difficulty with moving


• difficulty with swallowing


• discouragement


• double vision or other vision problems


• drugged feelings


• dryness of mouth


• ear drainage


• earache


• excess air or gas in the stomach or intestines


• eye redness


• false or unusual sense of well-being


• fear


• feeling of unreality


• feeling sad or empty


• fever


• frequent bowel movements


• frequent urge to urinate


• full feeling


• general feeling of discomfort or illness


• generalized slowing of mental and physical activity


• headache


• hearing loss


• heartburn


• hives or welts


• itching ears


• joint pain


• lack of appetite


• lack of feeling or emotion


• lack or loss of self-control


• lack or loss of strength


• longer or heavier menstrual periods


• loss of balance


• loss of interest or pleasure


• memory problems


• mood swings


• muscle aches, cramping, pain, or stiffness


• nausea


• nervousness


• nightmares or unusual dreams


• pain in the joints


• passing gas


• redness of the skin


• redness or soreness of the throat


• sense of detachment from self or body


• shortness of breath or troubled breathing


• skin rash


• skin wrinkling


• sneezing


• sore throat


• stress symptoms


• stuffy or runny nose


• swollen joints


• tiredness


• trouble concentrating


• trouble with sleeping


• vision blurred


• visual depth perception altered


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zolpimist side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Zolpimist resources

• Zolpimist Side Effects (in more detail)
• Zolpimist Use in Pregnancy & Breastfeeding
• Zolpimist Drug Interactions
• Zolpimist Support Group
• 2 Reviews for Zolpimist - Add your own review/rating

• Zolpimist Prescribing Information (FDA)


• Zolpimist Oral Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Zolpidem Prescribing Information (FDA)


• Ambien Consumer Overview


• Ambien Monograph (AHFS DI)


• Ambien Prescribing Information (FDA)


• Ambien MedFacts Consumer Leaflet (Wolters Kluwer)


• Ambien CR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ambien CR Prescribing Information (FDA)


• Edluar Prescribing Information (FDA)


• Edluar MedFacts Consumer Leaflet (Wolters Kluwer)


• Edluar Consumer Overview


• Intermezzo Consumer Overview


• ZolpiMist Consumer Overview

Compare Zolpimist with other medications

• Insomnia

E45 Cream (Forum Health Products Limited )

1. Name Of The Medicinal Product

E45 Cream

2. Qualitative And Quantitative Composition

Anhydrous Lanolin		1.0%	w/w
White Soft Paraffin	BP	14.5%	w/w
Light Liquid Paraffin	PhEur	12.6%	w/w

3. Pharmaceutical Form

A cream

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, traumatic dermatitis, sunburn, the dry stage of eczema and certain dry cases of psoriasis.

4.2 Posology And Method Of Administration

For topical application.

Adults, Children, Babies and the Elderly - Apply to the affected part two or three times daily.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The labelling states:

For external use only.

If symptoms persist, consult your doctor.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions known.

4.6 Pregnancy And Lactation

The safety of E45 Cream in pregnancy and lactation has not been assessed but is thought unlikely to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely, but should they occur, may take the form of an allergic rash. Should this occur, use of the product should be discontinued.

4.9 Overdose

E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no pre-clinical safety data of relevance to the consumer.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Empilan GMS, cetyl alcohol, sodium cetostearyl sulphate, carbomer, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, citric acid monohydrate, purified water.

6.2 Incompatibilities

Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.

6.3 Shelf Life

Aluminium tubes and polypropylene tubs: 3 years.

All other containers: 2 years.

6.4 Special Precautions For Storage

Store below 25°C for polyethylene tubes and pump pack, made of polypropylene and polyethylene and consisting of a plastic bottle and a pump system with a dip tube. None for aluminium tubes and polypropylene tubs.

6.5 Nature And Contents Of Container

A collapsible aluminium tube, internally lacquered with a membrane seal and plastic screw cap. Pack sizes: 15, 50 or 100 g.

(The 100 g tube is for dispensing only. One hundred tubes will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)

A polyethylene tube with membrane seal and plastic screw cap. Pack sizes 15 or 50 g.

A polypropylene securipot with a white polythene pilfer-proof screw cap. Pack sizes: 125, 350 or 500 g.

A white polypropylene jar with a white polyethylene push-on, tamper-evident closure. Pack sizes: 250, 300 or 500 g.

((The 500 g jar is for dispensing only. Thirty-six jars will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)

A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or polypropylene dispenser having a polythene covered follower plate.

Pack sizes: 500 or 900 g.

A pump pack made of polypropylene and polyethylene, consisting of a plastic bottle and a pump system with a dip tube. Pack size: 500 g.

A pump pack made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g

Not all pack sizes are necessarily marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Wellcroft Road

Slough,

SL1 4AQ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0404

9. Date Of First Authorisation/Renewal Of The Authorisation

25^th September 1991

10. Date Of Revision Of The Text

07/10/2011

11 DOSIMETRY

IF APPLICABLE

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

IF APPLICABLE

Mezzopram 20 mg Dispersible Gastro-resistant Tablets

1. Name Of The Medicinal Product

Mezzopram 20 mg Dispersible Gastro-resistant Tablets

2. Qualitative And Quantitative Composition

Each gastro-resistant tablet contains 20 mg omeprazole (as omeprazole magnesium).

Excipients: glucose, sucrose

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Gastro-resistant tablet

Pink, oval film-coated tablet with a breaking notch on both sides. The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Mezzopram Dispersible gastro-resistant tablets are indicated for:

Adults

• Treatment of duodenal ulcers

• Prevention of relapse of duodenal ulcers

• Treatment of gastric ulcers

• Prevention of relapse of gastric ulcers

• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease

• Treatment of NSAID-associated gastric and duodenal ulcers

• Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

• Treatment of reflux oesophagitis

• Long-term management of patients with healed reflux oesophagitis

• Treatment of symptomatic gastro-oesophageal reflux disease

• Treatment of Zollinger-Ellison syndrome

Paediatric use

Children over 1 year of age and

• Treatment of reflux oesophagitis

• Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease

Children and adolescents over 4 years of age

• In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori

4.2 Posology And Method Of Administration

Posology in adults

Treatment of duodenal ulcers

The recommended dose in patients with an active duodenal ulcer is Mezzopram 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In patients with poorly responsive duodenal ulcer Mezzopram 40 mg once daily is recommended and healing is usually achieved within four weeks.

Prevention of relapse of duodenal ulcers

For the prevention of relapse of duodenal ulcer in H. pylori negative patients or when H. pylori eradication is not possible the recommended dose is Mezzopram 20 mg once daily. In some patients a daily dose of 10 mg may be sufficient. In case of therapy failure, the dose can be increased to 40 mg.

Treatment of gastric ulcers

The recommended dose is Mezzopram 20 mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period. In patients with poorly responsive gastric ulcer Mezzopram 40 mg once daily is recommended and healing is usually achieved within eight weeks.

Prevention of relapse of gastric ulcers

For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is Mezzopram 20 mg once daily. If needed the dose can be increased to Mezzopram 40 mg once daily.

H. pylori eradication in peptic ulcer disease

For the eradication of H. pylori the selection of antibiotics should consider the individual patient's drug tolerance, and should be undertaken in accordance with national, regional and local resistance patterns and treatment guidelines.

• Mezzopram 20 mg + clarithromycin 500 mg + amoxicillin 1,000 mg, each twice daily for one week, or

• Mezzopram 20 mg + clarithromycin 250 mg (alternatively 500 mg) + metronidazole 400 mg (or 500 mg or tinidazole 500 mg), each twice daily for one week, or

• Mezzopram 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg or tinidazole 500 mg), both three times a day for one week.

In each regimen, if the patient is still H. pylori positive, therapy may be repeated.

Treatment of NSAID-associated gastric and duodenal ulcers

For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is Mezzopram 20 mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.

Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk

For the prevention of NSAID associated gastric ulcers or duodenal ulcers in patients at risk (age> 60, previous history of gastric and duodenal ulcers, previous history of upper GI bleeding) the recommended dose is Mezzopram 20 mg once daily.

Treatment of reflux oesophagitis

The recommended dose is Mezzopram 20 mg once daily. In most patients healing occurs within four weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further four weeks treatment period.

In patients with severe oesophagitis Mezzopram 40 mg once daily is recommended and healing is usually achieved within eight weeks.

Long-term management of patients with healed reflux oesophagitis

For the long-term management of patients with healed reflux oesophagitis the recommended dose is Mezzopram 10 mg once daily. If needed, the dose can be increased to Mezzopram 20-40 mg once daily.

Treatment of symptomatic gastro-esophageal reflux disease

The recommended dose is Mezzopram 20 mg daily. Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.

If symptom control has not been achieved after 4 weeks treatment with Mezzopram 20 mg daily, further investigation is recommended.

Treatment of Zollinger-Ellison syndrome

In patients with Zollinger-Ellison syndrome the dose should be individually adjusted and treatment continued as long as clinically indicated. The recommended initial dose is Mezzopram 60 mg daily. All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of Mezzopram 20–120 mg daily. When dose exceed Mezzopram 80 mg daily, the dose should be divided and given twice daily.

Posology in children

Children over 1 year of age and

Treatment of reflux oesophagitis

Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease

The posology recommendations are as follows:

Age	Weight	Posology
	10-20 kg	10 mg once daily. The dose can be increased to 20 mg once daily if needed
	> 20 kg	20 mg once daily. The dose can be increased to 40 mg once daily if needed

Reflux oesophagitis: The treatment time is 4–8 weeks.

Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease: The treatment time is 2–4 weeks. If symptom control has not been achieved after 2–4 weeks the patient should be investigated further.

Children and adolescents over 4 years of age

Treatment of duodenal ulcer caused by H. pylori

When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.

The treatment should be supervised by a specialist.

The posology recommendations are as follows:

Weight	Posology
15-30 kg	Combination with two antibiotics: Mezzopram 10 mg, amoxicillin 25 mg/kg body weight and clarithromycin 7.5 mg/kg body weight are all administrated together two times daily for one week
31-40 kg	Combination with two antibiotics: Mezzopram 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administrated two times daily for one week
> 40 kg	Combination with two antibiotics: Mezzopram 20 mg, amoxicillin 1 g and clarithromycin 500 mg are all administrated two times daily for one week.

Special populations

Impaired renal function

Dose adjustment is not needed in patients with impaired renal function (see section 5.2).

Impaired hepatic function

In patients with impaired hepatic function a daily dose of 10–20 mg may be sufficient (see section 5.2).

Elderly (> 65 years old)

Dose adjustment is not needed in the elderly (see section 5.2).

Method of administration

It is recommended to take Mezzopram tablets in the morning, swallowed whole with half a glass of water. The tablets must not be chewed or crushed.

For patients with swallowing difficulties and for children who can drink or swallow semi-solid food

Patients can break the tablet and disperse it in a spoonful of non-carbonated water and if so wished, mix with some fruit juices or applesauce. Patients should be advised that the dispersion should be taken immediately (or within 15 minutes)and always be stirred just before drinking and rinsed down with half a glass of water. DO NOT USE milk or carbonated water. The enteric-coated pellets must not be chewed.

4.3 Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients.

Omeprazole like other proton pump inhibitors must not be used concomitantly with nelfinavir (see section 4.5).

4.4 Special Warnings And Precautions For Use

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.

Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5). If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.

Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B₁₂ (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B₁₂ absorption on long-term therapy.

Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole (see section 4.5). The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged.

Some children with chronic illnesses may require long-term treatment although it is not recommended.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter (see section 5.1).

As in all long-term treatments, especially when exceeding a treatment period of 1 year, patients should be kept under regular surveillance.

Mezzopram Dispersible gastro-resistant tablets contain sucrose and glucose. Patients with rare fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Effects of omeprazole on the pharmacokinetics of other active substances

Active substances with pH dependent absorption

The decreased intragastric acidity during treatment with omeprazole might increase or decrease the absorption of active substances with a gastric pH dependent absorption.

Nelfinavir, atazanavir

The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole.

Concomitant administration of omeprazole with nelfinavir is contraindicated (see section 4.3). Co-administration of omeprazole (40 mg once daily) reduced mean nelfinavir exposure by ca. 40% and the mean exposure of the pharmacologically active metabolite M8 was reduced by ca. 75-90%. The interaction may also involve CYP2C19 inhibition.

Concomitant administration of omeprazole with atazanavir is not recommended (see section 4.4). Concomitant administration of omeprazole (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a 75% decrease of the atazanavir exposure. Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration of omeprazole (20 mg once daily) with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30% in the atazanavir exposure as compared to atazanavir 300 mg/ritonavir 100 mg once daily.

Digoxin

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10%. Digoxin toxicity has been rarely reported. However caution should be exercised when omeprazole is given at high doses in elderly patients. Therapeutic drug monitoring of digoxin should be then be reinforced.

Clopidogrel

In a crossover clinical study, clopidogrel (300 mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hours) and 30% (Day 5) when clopidogrel and omeprazole were administered together. In another study it was shown that administering clopidogrel and omeprazole at different times did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19. Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from observational and clinical studies.

Other active substances

The absorption of posaconazole, erlotinib, ketoconazol and itraconazol is significantly reduced and thus clinical efficacy may be impaired. For posaconazol and erlotinib concomitant use should be avoided.

Active substances metabolised by CYP2C19

Omeprazole is a moderate inhibitor of CYP2C19, the major omeprazole metabolising enzyme. Thus, the metabolism of concomitant active substances also metabolised by CYP2C19, may be decreased and the systemic exposure to these substances increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol

Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased C_max and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites by 29% and 69% respectively.

Phenytoin

Monitoring phenytoin plasma concentration is recommended during the first two weeks after initiating omeprazole treatment and, if a phenytoin dose adjustment is made, monitoring and a further dose adjustment should occur upon ending omeprazole treatment.

Unknown mechanism

Saquinavir

Concomitant administration of omeprazole with saquinavir/ritonavir resulted in increased plasma levels up to approximately 70% for saquinavir associated with good tolerability in HIV-infected patients.

Tacrolimus

Concomitant administration of omeprazole has been reported to increase the serum levels of tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be performed, and dosage of tacrolimus adjusted if needed.

Effects of other active substances on the pharmacokinetics of omeprazole

Inhibitors of CYP2C19 and/or CYP3A4

Since omeprazole is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased omeprazole serum levels by decreasing omeprazole's rate of metabolism. Concomitant voriconazole treatment resulted in more than doubling of the omeprazole exposure. As high doses of omeprazole have been well-tolerated adjustment of the omeprazole dose is not generally required. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.

Inducers of CYP2C19 and/or CYP3A4

Active substances known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St John's wort) may lead to decreased omeprazole serum levels by increasing omeprazole's rate of metabolism.

4.6 Pregnancy And Lactation

Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse effects of omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole can be used during pregnancy.

Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

4.7 Effects On Ability To Drive And Use Machines

Mezzopram is not likely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing. None was found to be dose-related. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). Frequency categories are defined according to the following convention: Very common (

SOC/frequency	Adverse reaction
Blood and lymphatic system disorders
Rare:	Leukopenia, thrombocytopenia
Very rare:	Agranulocytosis, pancytopenia
Immune system disorders
Rare:	Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock
Metabolism and nutrition disorders
Rare:	Hyponatraemia
Very rare:	Hypomagnesaemia
Psychiatric disorders
Uncommon:	Insomnia
Rare:	Agitation, confusion, depression
Very rare:	Aggression, hallucinations
Nervous system disorders
Common:	Headache
Uncommon:	Dizziness, paraesthesia, somnolence
Rare:	Taste disturbance
Eye disorders
Rare:	Blurred vision
Ear and labyrinth disorders
Uncommon:	Vertigo
Respiratory, thoracic and mediastinal disorders
Rare:	Bronchospasm
Gastrointestinal disorders
Common:	Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting
Rare:	Dry mouth, stomatitis, gastrointestinal candidiasis
Hepatobiliary disorders
Uncommon:	Increased liver enzymes
Rare:	Hepatitis with or without jaundice
Very rare:	Hepatic failure, encephalopathy in patients with pre-existing liver disease
Skin and subcutaneous tissue disorders
Uncommon:	Dermatitis, pruritus, rash, urticaria
Rare:	Alopecia, photosensitivity
Very rare:	Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)
Musculoskeletal and connective tissue disorders
Rare:	Arthralgia, myalgia
Very rare:	Muscular weakness
Renal and urinary disorders
Rare:	Interstitial nephritis
Reproductive system and breast disorders
Very rare:	Gynaecomastia
General disorders and administration site conditions
Uncommon:	Malaise, peripheral oedema
Rare:	Increased sweating

Paediatric population

The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid-related disease. There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive oesophagitis for up to 749 days. The adverse event profile was generally the same as for adults in short- as well as in long-term treatment. There are no long term data regarding the effects of omeprazole treatment on puberty and growth.

4.9 Overdose

There is limited information available on the effects of overdoses of omeprazole in humans. In the literature, doses of up to 560 mg have been described, and occasional reports have been received when single oral doses have reached up to 2,400 mg omeprazole (120 times the usual recommended clinical dose). Nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache have been reported. Also apathy, depression and confusion have been described in single cases.

The symptoms described in connection to omeprazole overdose have been transient, and no serious outcome has been reported. The rate of elimination was unchanged (first order kinetics) with increased doses. Treatment, if needed, is symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC01

Mechanism of action

Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.

Omeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H⁺ K⁺-ATPase - the acid pump. This effect on the final step of the gastric acid formation process is dose-dependent and provides for highly effective inhibition of both basal acid secretion and stimulated acid secretion, irrespective of stimulus.

Pharmacodynamic effects

All pharmacodynamic effects observed can be explained by the effect of omeprazole on acid secretion.

Effect on gastric acid secretion

Oral dosing with omeprazole once daily provides for rapid and effective inhibition of daytime and night-time gastric acid secretion with maximum effect being achieved within 4 days of treatment. With omeprazole 20 mg, a mean decrease of at least 80% in 24-hour intragastric acidity is then maintained in duodenal ulcer patients, with the mean decrease in peak acid output after pentagastrin stimulation being about 70% 24 hours after dosing.

Oral dosing with omeprazole 20 mg maintains an intragastric pH of

As a consequence of reduced acid secretion and intragastric acidity, omeprazole dose-dependently reduces/normalizes acid exposure of the esophagus in patients with gastro-esophageal reflux disease.

The inhibition of acid secretion is related to the area under the plasma concentration-time curve (AUC) of omeprazole and not to the actual plasma concentration at a given time.

No tachyphylaxis has been observed during treatment with omeprazole.

Effect on H. pylori

H. pylori is associated with peptic ulcer disease, including duodenal and gastric ulcer disease. H. pylori is a major factor in the development of gastritis. H. pylori together with gastric acid are major factors in the development of peptic ulcer disease. H. pylori is a major factor in the development of atrophic gastritis which is associated with an increased risk of developing gastric cancer.

Eradication of H. pylori with omeprazole and antimicrobials is associated with high rates of healing and long-term remission of peptic ulcers

Dual therapies have been tested and found to be less effective than triple therapies. They could, however, be considered in cases where known hypersensitivity precludes use of any triple combination.

Other effects related to acid inhibition

During long-term treatment gastric glandular cysts have been reported in a somewhat increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.

Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

Paediatric use

In a non-controlled study in children (1 to 16 years of age) with severe reflux oesophagitis, omeprazole at doses of 0.7 to 1.4 mg/kg improved oesophagitis level in 90% of the cases and significantly reduced reflux symptoms. In a single-blind study, children aged 0–24 months with clinically diagnosed gastro-esophageal reflux disease were treated with 0.5, 1.0 or 1.5 mg omeprazole/kg. The frequency of vomiting/regurgitation episodes decreased by 50% after 8 weeks of treatment irrespective of the dose.

Eradication of H. pylori in children

A randomised, double blind clinical study (Héliot study) concluded that omeprazole, in combination with two antibiotics (amoxicillin and clarithromycin), was safe and effective in the treatment of H. pylori infection in children age 4 years old and above with gastritis: H. pylori eradication rate: 74.2% (23/31 patients) with omeprazole + amoxicillin + clarithromycin versus 9.4% (3/32 patients) with amoxicillin + clarithromycin. However, there was no evidence of any clinical benefit with respect to dyspeptic symptoms. This study does not support any information for children aged less than 4 years.

5.2 Pharmacokinetic Properties

Absorption

Omeprazole and omeprazole magnesium are acid labile and are therefore administered orally as enteric-coated granules in capsules or tablets. Absorption of omeprazole is rapid, with peak plasma levels occurring approximately 1-2 hours after dose. Absorption of omeprazole takes place in the small intestine and is usually completed within 3-6 hours. Concomitant intake of food has no influence on the bioavailability. The systemic availability (bioavailability) from a single oral dose of omeprazole is approximately 40%. After repeated once-daily administration, the bioavailability increases to about 60%.

Distribution

The apparent volume of distribution in healthy subjects is approximately 0.3 l/kg body weight. Omeprazole is 97% plasma protein bound.

Metabolism

Omeprazole is completely metabolised by the cytochrome P450 system (CYP). The major part of its metabolism is dependent on the polymorphically expressed CYP2C19, responsible for the formation of hydroxyomeprazole, the major metabolite in plasma. The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of omeprazole sulphone. As a consequence of high affinity of omeprazole to CYP2C19, there is a potential for competitive inhibition and metabolic drug-drug interactions with other substrates for CYP2C19. However, due to low affinity to CYP3A4, omeprazole has no potential to inhibit the metabolism of other CYP3A4 substrates. In addition, omeprazole lacks an inhibitory effect on the main CYP enzymes.

Approximately 3% of the Caucasian population and 15-20% of Asian populations lack a functional CYP2C19 enzyme and are called poor metabolisers. In such individuals the metabolism of omeprazole is probably mainly catalysed by CYP3A4. After repeated once-daily administration of 20 mg omeprazole, the mean AUC was 5 to 10 times higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers). Mean peak plasma concentrations were also higher, by 3 to 5 times. These findings have no implications for the posology of omeprazole.

Excretion

The plasma elimination half-life of omeprazole is usually shorter than one hour both after single and repeated oral once-daily dosing. Omeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration. Almost 80% of an oral dose of omeprazole is excreted as metabolites in the urine, the remainder in the faeces, primarily originating from bile secretion.

The AUC of omeprazole increases with repeated administration. This increase is dose-dependent and results in a non-linear dose-AUC relationship after repeated administration. This time- and dose-dependency is due to a decrease of first pass metabolism and systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by omeprazole and/or its metabolites (e.g. the sulphone).

No metabolite has been found to have any effect on gastric acid secretion.

Special populations

Impaired hepatic function

The metabolism of omeprazole in patients with liver dysfunction is impaired, resulting in an increased AUC. Omeprazole has not shown any tendency to accumulate with once-daily dosing.

Impaired renal function

The pharmacokinetics of omeprazole, including systemic bioavailability and elimination rate, are unchanged in patients with reduced renal function.

Elderly

The metabolism rate of omeprazole is somewhat reduced in elderly subjects (75-79 years of age).

Paediatric patients

During treatment with the recommended doses to children from the age of 1 year, similar plasma concentrations were obtained as compared to adults. In children younger than 6 months, clearance of omeprazole is low due to low capacity to metabolise omeprazole.

5.3 Preclinical Safety Data

Gastric ECL-cell hyperplasia and carcinoids, have been observed in life-long studies in rats treated with omeprazole. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition. Similar findings have been made after treatment with H₂-receptor antagonists, proton pump inhibitors and after partial fundectomy. Thus, these changes are not from a direct effect of any individual active substance.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core

Sucrose

Maize starch

Glucose

Copovidone

Povidone

Talc

Titanium dioxide (E 171)

Methacrylic acid-ethyl acrylate copolymer (1:1)

Glycerol monostearate

Propylene glycol

Stearic acid

Polysorbate 80

Simeticone

Cellulose, microcrystalline

Macrogol 6000

Crospovidone

Silica colloidal anhydrous

Magnesium stearate

Tablet coating

Hypromellose

Macrogol 6000

Titanium dioxide (E 171)

Talc

Iron oxide, red (E 172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

HDPE containers:

18 months

shelf life after first opening: 6 months

Do not store above 25 °C after first opening of the container. Keep the container tightly closed, in order to protect from moisture.

Aluminium/aluminium blister:

18 months

Aclar/aluminium blister:

1 year

6.4 Special Precautions For Storage

HDPE containers:

This medicinal product does not require any special storage conditions.

For storage conditions of the medicinal product after first opening of the HDPE container, see section 6.3.

Aluminium/aluminium blister:

This medicinal product does not require any special storage conditions.

Aclar/aluminium blister:

Do not store above 30 °C.

6.5 Nature And Contents Of Container

HDPE container with a polypropylene screw-cap with 7, 14, 15, 28, 30, 56, 98, 100 gastro-resistant tablets

Aluminium/aluminium blister with 5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 90, 98, 100 gastro-resistant tablets.

Aclar/aluminium blister with 5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 90, 98, 100 gastro-resistant tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sandoz Limited

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

8. Marketing Authorisation Number(S)

PL 04416/1078

9. Date Of First Authorisation/Renewal Of The Authorisation

05/07/2010

10. Date Of Revision Of The Text

26/04/2011

Attenuvax

Generic Name: measles virus vaccine, live (Subcutaneous route)

MEE-zuls VYE-rus VAX-een, lyve

Commonly used brand name(s)

In the U.S.

• Attenuvax

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Vaccine

Uses For Attenuvax

Measles Virus Vaccine Live is an immunizing agent used to prevent infection by the measles virus. It works by causing your body to produce its own protection (antibodies) against the virus. This vaccine does not protect you against German measles (Rubella). A separate immunization is needed for that type of measles.

Measles (also known as coughing measles, hard measles, morbilli, red measles, rubeola, and ten-day measles) is an infection that is easily spread from one person to another. Infection with measles can lead to serious problems, such as pneumonia, ear infections, sinus problems, convulsions (seizures), brain damage, and possibly death. The risk of serious complications and death is greater for adults and infants than for children and teenagers.

Immunization against measles is recommended for everyone 12 to 15 months of age and older. In addition, there may be special reasons why children from 6 months of age up to 12 months of age may also require measles vaccine.

Immunization against measles is usually not recommended for infants up to 12 months of age, unless the risk of their getting a measles infection is high. This is because antibodies they received from their mothers before birth may interfere with the effectiveness of the vaccine. Children who were immunized against measles before 12 months of age should be immunized twice again.

You can be considered to be immune to measles only if you received two doses of measles vaccine starting on or after your first birthday and have the medical record to prove it, if you have a doctor's diagnosis of a previous measles infection, or if you have had a blood test showing immunity to measles.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Attenuvax

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Measles vaccine usually is not recommended for infants up to 12 months of age. In special cases, such as children traveling outside the U.S. or children living in high-risk areas, measles vaccine may be given to children as young as 6 months of age.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aclarubicin


• Adalimumab


• Aldesleukin


• Alemtuzumab


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Azathioprine


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Everolimus


• Fingolimod


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Meningococcal Vaccine


• Mercaptopurine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Sirolimus


• Streptozocin


• Tacrolimus


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Ustekinumab


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Leflunomide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Immune deficiency condition (or family history of)—Condition may increase the chance and severity of side effects of the vaccine and/or may decrease the useful effects of the vaccine

• Severe illness with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine

Proper Use of Attenuvax

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For prevention of measles:
    
    • Adults and children 12 months of age and older—One dose injected under the skin, followed by a second dose at least one month later.
    
    
  
  

Precautions While Using Attenuvax

Do not become pregnant for 3 months after receiving measles vaccine without first checking with your doctor.

Tell your doctor that you have received this vaccine:

• If you are to receive a tuberculin skin test within 4 to 6 weeks after receiving this vaccine. The results of the test may be affected by this vaccine.


• If you are to receive this vaccine within 2 weeks before or 3 to 11 months after receiving blood transfusions or other blood products.


• If you are to receive this vaccine 2 weeks before or 3 to 11 months after receiving gamma globulin or other immune globulins.

Attenuvax Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Symptoms of allergic reaction

• Difficulty in breathing or swallowing


• hives


• itching, especially of feet or hands


• reddening of skin, especially around ears


• swelling of eyes, face, or inside of nose


• unusual tiredness or weakness (sudden and severe)

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Fever over 103 °F (39.4 °C)

Rare

• Bruising or purple spots on skin


• confusion


• double vision


• headache (severe or continuing)


• irritability


• stiff neck


• swelling, blistering or pain at place of injection


• swelling of glands in neck


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning or stinging at place of injection


• fever of 100 °F (37.7 °C) or less

Less common

• Fever between 100 and 103 °F (37.7 and 39.4 °C)


• itching, swelling, redness, tenderness, or hard lump at place of injection


• skin rash

Fever or skin rash may occur from 5 to 12 days after vaccination and usually lasts several days.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Attenuvax side effects (in more detail)

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More Attenuvax resources

• Attenuvax Side Effects (in more detail)
• Attenuvax Use in Pregnancy & Breastfeeding
• Attenuvax Drug Interactions
• Attenuvax Support Group
• 0 Reviews for Attenuvax - Add your own review/rating

• Attenuvax Concise Consumer Information (Cerner Multum)


• Attenuvax MedFacts Consumer Leaflet (Wolters Kluwer)

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