Mylan Viatris Conseil Omeprazole Acid Lift 20mg 14 capsules

NOTICE

ANSM - Updated on: 11/15/2019

Name of the drug

OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule

Omeprazole

Box

Read all of this leaflet carefully before taking this medicine as it contains important information for you.

You should always take this medicine by carefully following the information provided in this leaflet or by your doctor, pharmacist or nurse.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effect that is not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or if you feel worse for 14 days.

What does this booklet contain ?

1. What is OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule and in which cases is it used?

2. What you need to know before you take OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule?

3. How to take OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule?

4. What are the possible side effects?

5. How to store OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule?

6. Contents of the pack and other information.

1. WHAT OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: proton pump inhibitors - ATC code: A02BC01.

The capsules contain an active substance, omeprazole, which is a substance called a 'proton pump inhibitor'. Omeprazole is a powerful inhibitor of acid secretion in your stomach.

This medicine is indicated for the short-term treatment of symptoms of gastroesophageal reflux (e.g. heartburn, acid regurgitation) in adults (from 18 years of age).

Gastroesophageal reflux is the return of acid from the stomach into the esophagus which can become inflammatory and painful. This can cause symptoms such as a burning sensation in the chest up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Acid reflux and heartburn may disappear after a day of treatment with OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule. However, this medication is not intended to provide immediate relief. It may be necessary to continue treatment for 2 or 3 consecutive days to improve symptoms.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule?

Do not take OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule:

· If you are under 18 years of age.

· If you are allergic to omeprazole or any of the other ingredients of this medicine, listed in section 6.

· If you are taking a medicine containing nelfinavir (used to treat HIV infection).

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule .

OMEPRAZOLE MYLAN CONSEIL can mask the symptoms of other diseases; talk to your doctor before taking OMEPRAZOLE MYLAN CONSEIL if:

· you need to have a specific blood test (Chromogranin A), your symptoms are accompanied by an unintentional weight loss (not linked to a diet or exercise program),

· you have swallowing disorders,

· you suffer from persistent stomach pain or digestion problems,

· you vomit food or blood,

· your stools are black,

· you have severe or persistent diarrhea,

· you are experiencing stomach pain for the first time or have experienced recent worsening of this pain,

· you have ever suffered from a gastric ulcer or if you have had a stomach operation,

· you have liver problems or jaundice (jaundice, yellowing of the skin and eyes),

· you have been on continuous symptomatic treatment for indigestion or heartburn for 4 weeks or more,

· you are over 55 years of age and take an over-the-counter indigestion medication daily,

· you are over 55 and have symptoms that appear for the first time or have changed recently,

· if you have ever had a skin reaction after treatment with a medicine similar to OMEPRAZOLE MYLAN CONSEIL that reduces stomach acid.

If you develop a rash, especially in areas exposed to the sun, see your doctor as soon as possible, as you may need to stop your treatment with OMEPRAZOLE MYLAN ADVICE. Remember to also mention any other harmful effects, such as pain in your joints.

OMEPRAZOLE MYLAN CONSEIL should not be used as a preventive treatment.

In case of recurrence of symptoms after treatment with OMEPRAZOLE MYLAN CONSEIL, consult your doctor, because only he can judge if additional examinations are necessary.

If in doubt, ask your doctor for advice.

Children and adolescents

Not applicable.

Other medicines and OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule

Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines.

Do not take OMEPRAZOLE MYLAN ADVICE if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking a medicine containing any of these active substances:

· Clopidogrel (used to prevent blood clots)

· Ketoconazole, itraconazole or voriconazole (used in the treatment of yeast infections);

· Digoxin (used to treat heart disease);

· Diazepam (used to treat anxiety, to relax muscles or for epilepsy);

· Phenytoin (used to treat epilepsy); if you are taking a drug containing phenytoin, your doctor should monitor you when you start or stop OMEPRAZOLE MYLAN TIP;

· Warfarin or other anti-vitamin K (used to thin the blood); your doctor should monitor you when you start or stop OMEPRAZOLE MYLAN ADVICE;

· Rifampicin (used in the treatment of tuberculosis);

· Atazanavir (used to treat HIV infection);

· Tacrolimus (used for organ transplants);

· St. John's Wort (used to treat mild to moderate depression);

· Cilostazol (used to treat intermittent claudication);

· Saquinavir (used to treat HIV infection);

· Methotrexate (chemotherapy drug used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with omeprazole.

OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule with food and drink

Taking OMEPRAZOLE MYLAN CONSEIL does not interact with food or drink.

Pregnancy and breast feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice. or pharmacist before taking this medicine.

Your doctor will decide if you can take OMEPRAZOLE MYLAN CONSEIL during this period.

Your doctor will also decide if you can take OMEPRAZOLE MYLAN CONSEIL while breastfeeding.

Driving and using machines

Taking OMEPRAZOLE MYLAN CONSEIL has no effect on driving and using machines.

However, side effects such as dizziness and / or vision disturbances may occur (see section "4. What are the possible side effects?"). Patients with this type of side effect should not drive or use machines.

OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule contains sucrose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE OMEPRAZOLE MYLAN TIP 20 mg gastro-resistant capsule?

Always take this medication exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

Reserved for adults (from 18 years old).

The recommended dose is 1 capsule per day.

It is recommended to take OMEPRAZOLE MYLAN CONSEIL before the meal:

· in the morning if symptoms predominant during the day

· in the evening in case of predominant symptoms during the night

It may be necessary to take the treatment for 2 or 3 consecutive days for symptom improvement.

Administration mode

Oral use

· Swallow the capsule whole with a sufficient quantity of liquid (for example a glass of non-carbonated water), before the morning or evening meal.

· The capsules should not be chewed or chewed because they contain film-coated granules which prevent the medicine from being destroyed by the acidity of the stomach. It is important not to damage the granules contained in the capsules. These micro-granules contain the active substance omeprazole and are gastro-resistant. This protects them from degradation during their passage through the stomach. The granules release the active substance in the intestine where it is absorbed by your body to produce its effect.

If you have difficulty swallowing the capsules:

· Open them and disperse the contents in a spoon of water or a glass of water (non-carbonated water), slightly acidic fruit juice (orange juice, apple or pineapple) or in apple sauce.

· Always stir before drinking the mixture (the mixture will not be homogeneous). Then drink the mixture immediately or within 30 minutes.

· Make sure you have drunk all the medicine, rinse the glass well with half a glass of water and drink it. Do not use milk or sparkling water. The solid pieces contain the medicine, do not chew or chew them.

Frequency of administration

· One take per day.

Duration of treatment

Treatment with OMEPRAZOLE MYLAN CONSEIL should not exceed 14 days. If after 14 days your pain persists or worsens, consult your doctor.

If you take more OMEPRAZOLE MYLAN TIP 20 mg gastro-resistant capsule than you should:

Immediately consult your doctor or pharmacist.

If you forget to take OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule:

Do not take a double dose to make up for the dose you forgot to take.

If you stop taking OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule:

Not applicable.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following rare but serious side effects:

· Severe allergic reactions, called anaphylactics. Typical symptoms are: swelling of the face, lips, mouth, tongue and / or throat, which may cause difficulty breathing or swallowing, hives.

· Severe skin reactions: sudden redness of the skin with peeling skin or blistering, lesions or bleeding around the eyes, nose, mouth or genitals. These symptoms may evoke Stevens-Johnson syndrome or acute toxic epidermolysis.

· Yellowing of the skin, dark urine and fatigue which can be symptoms of liver problems.

The frequency of side effects is defined as follows:

Frequent:

· headache,

· diarrhea, constipation, bloating (gas), upset stomach,

· nausea, vomiting,

· mild polyps in the stomach.

Occasional:

· accumulation of water in the legs (edema),

· sleep disturbances (insomnia),

· dizziness, tingling sensations, drowsiness,

· dizziness,

· increased levels of liver enzymes,

· itching, rash, skin irritation,

· general feeling of discomfort and lack of energy.

Rare:

· decrease in the number of blood cells (white blood cells, platelets),

· allergic reactions, sometimes very serious, which may cause swelling of the lips, tongue and throat, fever, wheezing,

· decrease in the level of sodium in the blood,

· restlessness, confusion, depression,

· altered taste,

· blurry vision,

· sudden wheezing or difficulty breathing

· dry mouth,

· inflammation of the lining of the mouth,

· an infection in the mouth called "thrush" and caused by a fungus,

· liver problems that can cause jaundice (yellowing of the skin), dark urine, and fatigue,

· hair loss,

· skin rash if exposed to the sun,

· joint pain or muscle pain,

· kidney problems,

· increased sweating.

Very rare:

· change in the number of blood cells, lack of white blood cells,

· aggressiveness,

· hallucinations,

· severe liver problems leading to impaired liver function and brain inflammation,

· sudden redness of the skin with peeling skin or blistering, which may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome or acute toxic epidermolysis),

· muscular weakness,

· swelling of the breasts in men,

· decrease in the level of magnesium in the blood.

Frequency not known:

· microscopic colitis,

· skin rash, potentially accompanied by joint pain.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr .

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OMEPRAZOLE MYLAN TIP 20 mg gastro-resistant capsule?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle, blister or box.

The expiration date refers to the last day of this month .

Vials: No special storage precautions.

Inserts (Aluminum / Aluminum) and inserts (PVC / PVDC / Aluminum) : Store at a temperature not exceeding 30 ° C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What OMEPRAZOLE MYLAN CONSEIL 20 mg contains, gastro-resistant capsule

· The active substance is:

Omeprazole ................................................. .................................................. ...................... 20 mg

For a gastro-resistant capsule.

· The other components are:

Sucrose, corn starch, copolymer of methacrylic acid and ethyl acrylate (1: 1), hypromellose (E464), talc, triethyl citrate, titanium dioxide (E171), disodium phosphate dihydrate.

Capsule shell: gelatin, titanium dioxide (E171), printing ink.

What is OMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule and contents of the pack

This medication is in the form of gastro-resistant capsules.

Boxes of 7 or 14 capsules in bottle.

Boxes of 7 or 14 capsules in blister.

Not all presentations may be marketed.

Marketing authorization holder

MYLAN SAS

117 ALLEE DES PARCS

69800 SAINT-PRIEST

Marketing authorization operator

MYLAN SAS

117 ALLEE DES PARCS

69800 SAINT-PRIEST

Maker

ESTEVE PHARMACEUTICALS, SA

C / DE SAN MARTI 75-97,

MARTORELLES, 08107 - BARCELONA

SPAIN

Names of the drug in the member states of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Health education tips:

This medication is intended to relieve your heartburn and acid reflux. Heartburn and acid reflux can be caused by changes in diet (acidic or spicy foods, alcoholic drinks, etc.) or by taking certain medications (aspirin, anti-inflammatory drugs, etc.). Do not hesitate to talk to your doctor or pharmacist.

To limit the onset of symptoms, observe the following hygienic rules as much as possible:

· avoid abundant and high-fat meals,

· eat slowly,

· avoid certain foods such as chocolate, mint, spices, peppers, citrus juice, soft drinks, coffee,

· vary your diet,

· normalize your weight (in case of overweight) and exercise,

· avoid wearing clothes that are too tight or a belt that is too tight,

· raise the head of your bed in case of heartburn or nighttime acid reflux,

· avoid the practice of a significant effort just after the meal,

· do not smoke and limit alcohol consumption.

YOUR PHARMACIST, YOUR DOCTOR, KNOW THE DRUGS WELL.

DON'T HESITATE TO ASK THEM FOR THEIR OPINION.

NEVER LEAVE A MEDICINE IN THE REACH OF CHILDREN.

FAMILY VIDAL

OMEPRAZOLE MYLAN ADVICE