Mylan Viatris Conseil Esomeprazole 20 mg Heartburn 14 capsules

NOTICE

ANSM - Updated on: 07/06/2018

Name of the drug

ESOMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule

Esomeprazole

Box

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

You should always take this medication by carefully following the information provided in this leaflet or by your pharmacist.

· 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 or pharmacist. 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 after 14 days.

What does this booklet contain ?

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

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

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

4. What are the possible side effects?

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

6. Contents of the pack and other information.

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

Pharmacotherapeutic group: drugs for acidity disorders, proton pump inhibitors; ATC code: A02BC05.

ESOMEPRAZOLE MYLAN CONSEIL contains the active substance called esomeprazole. It belongs to a group of medicines called 'proton pump inhibitors'. They work by decreasing the amount of acid produced by the stomach.

This medicine is used in adults for the short-term treatment of symptoms of gastroesophageal reflux (e.g. heartburn and acid regurgitation).

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 painful feeling in the chest going up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

ESOMEPRAZOLE MYLAN CONSEIL is not intended to provide immediate relief. It may be necessary to continue treatment for 2 or 3 consecutive days before you experience any improvement in symptoms. You should talk to your doctor if you do not feel better or if you feel worse after 14 days.

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

Never take ESOMEPRAZOLE MYLAN CONSEIL 20 mg, gastro-resistant capsule:

· if you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6) ,

· if you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole),

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

Do not take this medication if you are in any of the situations described above. If you are not sure, tell your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking ESOMEPRAZOLE MYLAN CONSEIL if:

· have a history of gastric ulcer or have had a stomach operation,

· have been taking continuous reflux or heartburn treatment for 4 weeks or more,

· you have jaundice (yellow discoloration of the skin or eyes) or severe liver problems,

· you have severe kidney problems,

· you are over 55 years of age and you have symptoms of gastroesophageal reflux disease that are new or have changed for the first time, or you need to take daily treatment for indigestion or heartburn without a prescription ,

· you have ever had a skin reaction after treatment with a medicine similar to esomeprazole that reduces stomach acid.

Consult your doctor immediately before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another more serious illness:

· you lose weight for no reason,

· you have problems or pain when you swallow,

· you have stomach pain or signs of indigestion such as nausea, feeling of heaviness, bloating especially after taking food,

· you start vomiting food or blood, which may appear as dark coffee grounds,

· you have black (blood stained) stools,

· you have severe or persistent diarrhea because taking esomeprazole has been associated with a slight increase in the risk of infectious diarrhea,

· 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 esomeprazole. Remember to also mention any other harmful effects, such as pain in your joints.

See a doctor urgently if you suffer from chest pain accompanied by drunkenness, sweating, dizziness, or shoulder pain accompanied by shortness of breath. This can be a serious condition of your heart.

Talk to your doctor before taking this medicine if:

o you must have an endoscopy or urea breath test,

o you must have a specific blood test (Chromogranin A).

If you are in one of the situations described above (or have any doubts), consult your doctor immediately.

Children and adolescents

This medication should not be given to children and adolescents under 18 years of age.

Other medicines and ESOMEPRAZOLE 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. This medicine can affect the way other medicines work, and some medicines can affect it.

Do not take this medicine if you are also taking a medicine containing nelfinavir (used to treat HIV).

You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).

Do not take this medicine with other medicines that limit the level of acid produced by the stomach, such as another proton pump inhibitor (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or an H2 blocker ( e.g. ranitidine or famotidine).

You can take this medicine with an antacid (for example magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate or a combination of these) if necessary.

Tell your doctor or pharmacist if you are taking any of the following medicines:

· ketoconazole and itraconazole (used to treat fungus-induced infections),

· voriconazole (used to treat fungus-induced infections) and clarithromycin (used to treat infections). Your doctor may need to adjust your dose of ESOMEPRAZOLE MYLAN CONSEIL if you also have severe liver problems and are being treated for long periods,

· erlotinib (used to treat cancer),

· methotrexate (used in the treatment of cancer and rheumatological disorders),

· digoxin (used for heart problems),

· atazanavir, saquinavir (used to treat HIV),

· citalopram, imipramine or clomipramine (used to treat depression),

· diazepam (used to treat anxiety, epilepsy or as a muscle relaxant),

· phenytoin (used to treat epilepsy),

· medicines used to thin the blood such as warfarin. Monitoring by your doctor may be necessary when you start or stop taking ESOMEPRAZOLE MYLAN CONSEIL,

· cilostazol (used to treat intermittent claudication - pain in the legs when walking which is caused by insufficient blood supply),

· cisapride (used for indigestion or heartburn),

· rifampicin (used to treat tuberculosis),

· tacrolimus (used for organ transplants),

· St. John's wort (Hypericum perforatum) (used to treat depression).

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

ESOMEPRAZOLE MYLAN CONSEIL can be taken with or without food.

Pregnancy and breast feeding

As a precautionary measure, you should preferably avoid the use of ESOMEPRAZOLE MYLAN CONSEIL during pregnancy. You should not use this medication while breastfeeding.

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

Driving and using machines

ESOMEPRAZOLE MYLAN CONSEIL is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision may occur infrequently (see section 4). If this is the case, you should not drive or use machinery.

ESOMEPRAZOLE MYLAN CONSEIL contains sucrose, which is a type of sugar, propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218):

· if your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases);

· parahydroxybenzoates can cause allergic reactions (possibly delayed).

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

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

Quantity to take

· The recommended dose is one tablet per day.

· Do not take more than the recommended dose of one tablet (20 mg) per day, even if you do not experience immediate improvement.

· You may need to take the tablets for 2 to 3 consecutive days to improve the symptoms of gastroesophageal reflux disease (for example, heartburn and acid regurgitation).

· The duration of treatment can be up to 14 days.

· When your gastroesophageal reflux symptoms have completely disappeared, you should stop taking this medicine.

· If your gastroesophageal reflux symptoms worsen or do not improve after taking this medication for 14 consecutive days, you should see a doctor.

If you have persistent or long-standing symptoms that come back frequently, even after treatment with this medicine, you should contact your doctor.

Administration mode

· You can take your capsules at any time of the day, with or without food.

· Swallow your capsules whole with a glass of water. The capsules, like their contents, must not be chewed or chewed. Indeed, the capsules contain granules whose coating protects the drug from the acidity of the stomach. It is important not to damage the granules.

What to do if you have trouble swallowing the capsules

1) Carefully open the capsules over a glass of water (non-carbonated) and empty the contents of the capsules (granules) into the glass. No other liquid should be used.

2) Stir. Then drink the mixture immediately or within 30 minutes. Always stir the mixture before drinking it.

3) In order to take all of the medicine, then rinse the glass by adding the content of half a glass of water and drink it. All granules should be swallowed without chewing or chewing.

If you take more ESOMEPRAZOLE MYLAN CONSEIL 20 mg gastro-resistant capsule than you should:

If you take more ESOMEPRAZOLE MYLAN ADVICE than recommended, tell your doctor or pharmacist immediately. You may experience symptoms such as diarrhea, upset stomach, constipation, nausea or vomiting, and weakness.

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

If you forget to take a dose, take it as soon as you remember, on the same day. Do not take a double dose to make up for the dose you forgot to take.

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

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

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

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

If you notice any of the following serious side effects, stop taking ESOMEPRAZOLE MYLAN CONSEIL and contact a doctor immediately:

· sudden wheezing, swelling of the lips, tongue, throat, or body, skin rash, unconsciousness, or difficulty swallowing (severe allergic reactions, considered rare);

· redness of the skin with bubbles or flaking. Sometimes the bubbles can be large and be accompanied by bleeding from the lips, eyes, mouth, nose or genitals. This may correspond to Stevens-Johnson syndrome or toxic destruction of the skin (Lyell syndrome), considered to be very rare;

· jaundice, dark urine and fatigue can be symptoms of liver disease, which are considered rare.

Talk to your doctor as soon as possible if you experience any of the following signs of infection:

This drug can in very rare cases affect white blood cells resulting in an immune deficiency. If you have an infection with symptoms such as fever with a very important alteration of general condition, or fever with local infection symptoms such as pain in the neck, throat or mouth, or difficulty urinating, you should see your doctor as soon as possible to rule out the presence of a white blood cell deficit (agranulocytosis) by a blood test. It is important that you give information about your medicines in this case.

The other side effects are:

Common (may affect up to 1 in 10 people)

· headache,

· effects on the stomach or intestine: diarrhea, stomach pain, constipation, flatulence, mild polyps in the stomach,

· nausea, vomiting.

Uncommon (may affect up to 1 in 100 people)

· swelling of the feet and ankles,

· sleep disturbance (insomnia), drowsiness,

· dizziness, tingling like "pin and needle" sensations,

· dizziness,

· dry mouth,

· changes in blood tests to check how well your liver is working,

· rash, hives and itching.

Rare (may affect up to 1 in 1,000 people)

· blood disorders such as a decrease in the number of white blood cells or platelets. These effects can cause weakness, bruising and facilitate the occurrence of infections,

· decrease in the level of sodium in the blood. This can cause weakness, nausea, vomiting and cramps,

· restlessness, confusion or depression,

· taste disturbances,

· vision problems, such as blurred vision,

· sudden wheezing or shortness of breath (bronchospasm).

· inflammation of the inside of the mouth,

· an infection called "thrush" which can affect the intestine caused by a fungus,

· hair loss (alopecia),

· skin rash when exposed to the sun,

· joint (arthralgia) or muscle pain (myalgia),

· general feeling of discomfort and lack of energy,

· increased sweating.

Very rare (may affect up to 1 in 10,000 people)

· low levels of red blood cells, white blood cells and platelets in the blood (a disease called pancytopenia),

· aggressiveness.

· visual, sensory or auditory hallucinations,

· severe liver problems causing liver failure and inflammation of the brain,

· muscular weakness,

· severe kidney problems,

· swelling of the breasts in men.

Not known (frequency cannot be estimated from the available data)

· low levels of magnesium in the blood. This can cause weakness, nausea (vomiting), cramps, tremor and arrhythmia (heart rhythm disturbances). If you have low levels of magnesium, you may also have low levels of calcium and / or potassium in your blood,

· inflammation of the intestine (leading to diarrhea),

· skin rash, potentially accompanied by joint pain.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.ansm.sante.fr

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

5. HOW TO STORE ESOMEPRAZOLE 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 carton, bottle or blister. The expiration date refers to the last day of this month.

Do not store above 25 ° C.

For the bottles :

Keep the bottle tightly closed, protect from moisture.

After first opening the bottle, keep for 3 months.

For platelets :

Store in the original package in order to protect from moisture.

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 ESOMEPRAZOLE MYLAN CONSEIL 20 mg contains, gastro-resistant capsule

· The active substance is: esomeprazole.

Each capsule contains 20 mg of esomeprazole (as esomeprazole magnesium dihydrate).

· The other components are:

Content of the capsule:

sugar spheres (sucrose, corn starch), hypromellose, dimethicone emulsion 35% (dimethicone, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol sorbitan monolaurate, octylphenoxy polyethoxy-ethanol and propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc, 30% dispersion of copolymer of methacrylic acid and ethyl acrylate (1: 1) (copolymer of methacrylic acid and acrylate ethyl, sodium lauryl sulfate and polysorbate 80), triethyl citrate, stearic macrogolglycerides.

Capsule shell:

gelatin, shellac, black iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

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

This medication is in the form of a gastro-resistant capsule. The capsules have an opaque yellow head and an opaque white body. "20 mg" is printed in black on the head and body.

Box of 7 or 14 capsules in blister packs or in a bottle.

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

ETHYPHARM

ZI DE SAINT-ARNOULT

28170 CHATEAUNEUF-EN-THYMERAIS

France

Or

ETHYPHARM

POWDER TRAIL

76120 GRAND-QUEVILLY

France

Or

FAMAR L'AIGLE

INDUSTRIAL ZONE N ° 1, ROUTE DE CRULAI

61300 L'AIGLE

France

Or

LAPHAL INDUSTRIES

248 AVENUE DE VICTOIRE

13106 ROUSSET

France

Or

MYLAN HUNGARY LTD

MYLAN UTCA 1

2900 KOMAROM

HUNGARY

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

[To be completed later by the holder]

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).

FAMILY VIDAL

ESLANPRAZOLE MYLAN ADVICE