NOTICE
ANSM - Updated on : 14/04/2025
Product name
ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule
Esomeprazole
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 14 days.
What does this leaflet contain?
1. What is ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule, and what is it used for?
2. What do I need to know before taking ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule?
3. How do I take ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule?
4. What are the possible side effects?
5. How to store ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule?
6. Package contents and other information.
1. WHAT IS ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: proton pump inhibitor - ATC code: A02BC05
ESOMEPRAZOLE BIOGARAN CONSEIL contains the active substance esomeprazole. It belongs to a group of drugs known as proton pump inhibitors. They work by reducing the amount of acid produced by the stomach.
It is used in adults for the short-term treatment of symptoms of gastro-sophageal reflux disease (e.g. heartburn and acid regurgitation).
Gastro-sophageal reflux is the backflow of acid from the stomach into the esophagus, which can become inflamed and painful. This can lead to symptoms such as a painful sensation in the chest rising to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
ESOMEPRAZOLE BIOGARAN CONSEIL is not intended to provide immediate relief. It may be necessary to continue treatment for 2 or 3 consecutive days before symptoms improve. You should contact your doctor if you do not feel better or feel worse after 14 days.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule?
Never take ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule
- If you are allergic to lomeprazole or to any of the other ingredients 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 in the treatment of HIV infection).
- If you have ever developed severe skin rashes or exfoliation, blistering and/or mouth ulcers after taking ESOMEPRAZOLE BIOGARAN CONSEIL or other related medicines.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking ESOMEPRAZOLE BIOGARAN CONSEIL.
- If you have a history of gastric ulcer or have undergone stomach surgery.
- If you have taken continuous treatment for reflux or heartburn for 4 weeks or more.
- If you have jaundice (yellowing of the skin or eyes) or severe liver problems.
- If you have severe kidney problems.
- If you are over 55 and have symptoms of gastro-sophageal reflux disease (GERD) that are new or have recently changed, or if you need to take a non-prescription daily treatment for indigestion or heartburn.
- If you have ever developed a skin reaction after treatment with a drug similar to ESOMEPRAZOLE BIOGARAN CONSEIL that reduces gastric acidity. Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with ESOMEPRAZOLE BIOGARAN CONSEIL. Stop using ESOMEPRAZOLE BIOGARAN CONSEIL and seek medical advice immediately if you experience any of the symptoms associated with these severe skin reactions described in section 4.
- If you have to undergo endoscopy or a lung test.
- If you have to undergo a specific blood test (Chromogranin A).
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 are losing weight for no reason,
- you have problems or pain when swallowing,
- you have stomach pain or signs of indigestion such as nausea, heaviness or bloating, especially after taking food,
- you start vomiting food or blood, which may appear as dark coffee grounds,
- you have black stools tinged with blood,
- you have severe or persistent diarrhoea, as the use of desomeprazole has been associated with a slight increase in the risk of infectious diarrhoea.
If you develop a skin rash, particularly in sun-exposed areas, consult your doctor as soon as possible, as you may need to stop taking ESOMEPRAZOLE BIOGARAN CONSEIL. Don't forget to mention any other adverse effects, such as joint pain.
Seek urgent medical attention if you experience chest pain accompanied by dizziness, sweating, dizziness or shoulder pain accompanied by shortness of breath. This may indicate a serious heart condition.
If you find yourself in any of the above situations (or if you are in any doubt), consult your doctor immediately.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Other medicines and ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine. This medicine may affect the way other medicines work, and some medicines may have an effect on this medicine.
Do not take this medicine if you are also taking a medicine containing nelfinavir (used in the treatment of HIV).
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 amount of acid produced by the stomach, such as other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or H2 blockers (e.g. ranitidine or famotidine).
You may take this medicine with an antacid (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate or a combination of these substances) 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 BIOGARAN CONSEIL if you also have severe liver problems and are receiving long-term treatment.
- Erlotinib (used to treat cancer).
- Methotrexate (used to treat cancer and rheumatological disorders).
- Digoxin (used for heart problems).
- Atazanavir, saquinavir (used in the treatment of 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).
- Blood-thinning drugs such as warfarin. Your doctor may need to monitor you when you start or stop taking ESOMEPRAZOLE BIOGARAN CONSEIL.
- Cilostazol (used in the treatment of intermittent claudication - pain in the legs when walking caused by insufficient blood supply).
- Cisapride (used for indigestion or heartburn).
- Rifampicin (used to treat tuberculosis).
- Tacrolimus (used in organ transplants).
- St John's wort(Hypericum perforatum) (used to treat depression).
ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule with food and drink
ESOMEPRAZOLE BIOGARAN CONSEIL may be taken with or without meals.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
As a precautionary measure, you should avoid using ESOMEPRAZOLE BIOGARAN CONSEIL during pregnancy.
Do not use ESOMEPRAZOLE BIOGARAN CONSEIL while breast-feeding.
Driving and use of machinery
ESOMEPRAZOLE BIOGARAN CONSEIL is unlikely to affect your ability to drive or operate machinery. However, side effects such as dizziness and visual disturbances may occur infrequently (see section 4). If this occurs, you should not drive or operate machinery.
ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule contains sucrose, benzoic acid and sodium.
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 1.78 µg of benzoic acid. Benzoic acid may increase the risk of dicterus (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
This drug contains less than 1 mmol (23 mg) sodium per capsule, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
The recommended dose is 1 capsule per day.
Do not take more than the recommended dose of one capsule (20 mg) per day, even if you do not feel an immediate improvement.
You may need to take the capsules for 2 to 3 consecutive days to achieve improvement in symptoms of gastro-sophageal reflux disease (e.g. heartburn and acid regurgitation).
Treatment can last up to 14 days.
When your gastro-sophageal reflux symptoms have completely disappeared, you should stop taking this medication.
If your reflux symptoms worsen or do not improve after taking this medication for 14 consecutive days, you should consult a physician.
If you have persistent or long-standing symptoms that recur frequently, even after treatment with this medication, you should contact your doctor.
Method of administration
You can take your capsule at any time of day, with or without meals.
Swallow the capsule whole with a glass of water. Do not chew or crunch the capsule. The capsule contains granules whose coating protects the drug from stomach acid. It is important not to damage the granules.
What to do if you have difficulty swallowing the capsules
1) Carefully open the capsules over a glass of water (non-carbonated) and empty the capsule contents (granules) into the glass. No other liquid should be used.
2) Stir. Then drink the mixture immediately, or within 30 minutes. Always stir before drinking.
3) To ensure full absorption, rinse the glass with half a glass of water and drink. All granules must be swallowed without chewing or crunching.
If you have taken more ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule than you should have
Consult 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 BIOGARAN CONSEIL 20 mg, gastroresistant 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 one you forgot to take.
If you stop taking ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not always occur in everyone.
If you notice any of the following serious side effects, stop taking ESOMEPRAZOLE BIOGARAN CONSEIL and contact a doctor immediately:
- Jaundice, dark urine and fatigue may be symptoms of liver disease. These effects are rare and may affect up to 1 in 1000 people.)
- Sudden wheezing, swelling of the lips, tongue, throat or body, rash, loss of consciousness or difficulty swallowing (severe allergic reactions, considered rare). These effects are rare and may affect up to 1 in 1000 people.)
- Reddening of the skin with blistering or peeling. Occasionally, blistering may be severe and accompanied by bleeding from the lips, eyes, mouth, nose or genitals. These severe cutaneous signs may suggest Stevens-Johnson syndrome, a toxic destruction of the skin (or Lyell syndrome). These effects are very rare and may affect 1 in 10,000 people.
- Extensive rash, elevated body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), considered very rare and may affect 1 in 10,000 people.
Talk to your doctor as soon as possible if you experience any of the following signs of infection:
- In very rare cases, this drug may affect white blood cells, leading to an immune deficiency. If you have an infection with symptoms such as fever with very severe general tiredness, or fever with symptoms of local infection such as pain in the neck, throat or mouth, or difficulty in urinating, you should consult your doctor as soon as possible to determine the presence of a white blood cell deficiency (agranulocytosis) by means of a blood test. It is important that you give information about your medication in this case.
Other side effects include
Common side effects (may affect up to 1 in 10 people)
- Headache.
- Effects on the stomach or intestine: diarrhea, stomach pain, constipation, flatulence.
- Nausea, vomiting.
- Benign stomach polyps.
Uncommon adverse reactions (may affect up to 1 in 100 people)
- Swelling of feet and ankles.
- Sleep disorders (insomnia), drowsiness.
- Dizziness, pins-and-needles sensation.
- Dizziness.
- Dry mouth.
- Increased liver enzymes as shown by blood tests monitoring liver function.
- Skin rashes, hives and itching.
- Fracture of the hip, wrist or vertebrae (if ESOMEPRAZOLE BIOGARAN CONSEIL is used in high doses over a long period of time).
Rare adverse reactions (may affect up to 1 in 1000 people)
- Blood disorders such as a reduction in the number of white blood cells or platelets. These effects may lead to weakness, bruising or facilitate infections.
- Decreased sodium levels in the blood. This can cause weakness, nausea, vomiting and cramps.
- Agitation, confusion, depression.
- Taste disorders.
- Visual disturbances, such as blurred vision.
- Sudden onset of wheezing or shortness of breath (bronchospasm).
- Inflammation of the inside of the mouth.
- Infection called "thrush", which can affect the intestine and is caused by a fungus.
- Liver disorders including jaundice, which can cause yellow skin, dark urine and fatigue.
- Hair loss (alopecia).
- Rash on exposure to sunlight.
- Joint pain (arthralgia) or muscle pain (myalgia).
- General feeling of malaise and lack of energy.
- Increased sweating.
Very rare adverse reactions (may affect up to 1 in 10,000 people)
- Low numbers of red blood cells, white blood cells and platelets in the blood (a condition known as pancytopenia).
- Aggressiveness.
- Visual, sensory or auditory hallucinations.
- Severe liver disorders leading to liver failure and inflammation of the brain.
- Sudden onset of severe skin eruptions, blistering or scaling (bullous reactions) which may be associated with fever and joint pain (erythema multiforme), Stevens-Johnson syndrome, Lyell syndrome (or toxic epidermal necrolysis), drug hypersensitivity syndrome with eosinophilia and systemic symptoms (or DRESS).
- Muscle weakness.
- Severe kidney disorders.
- Male breast swelling.
Undesirable effects of undetermined frequency (cannot be estimated on the basis of available data)
- Low blood magnesium levels. This can lead to fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and rapid heartbeat. If you experience any of these symptoms, please inform your doctor immediately.
If you have low magnesium levels, you may also have low levels of calcium and/or potassium in your blood.
- Inflammation of the intestine (leading to diarrhoea).
- Skin rash, potentially accompanied by joint pain.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastroresistant capsule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Store in original outer packaging, protected from moisture.
Do not dispose of any medicines down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg gastroresistant capsule contains
- The active substance is :
Each capsule contains 20 mg of esomeprazole (as esomeprazole magnesium dihydrate).
- The other components are
Capsule contents
Sugar spheres (sucrose, corn starch), hypromellose, mimeticone emulsion 30% (mimeticone, polysorbate 65, methylcellulose, polyethylene glycol stearate, glycerides, xanthan gum, benzoic acid (E210) sorbic acid and sulfuric acid), polysorbate 80, mannitol, diacetylated monoglycerides, talc, 30% methacrylic acid/ethyl acrylate copolymer dispersion (1:1) (copolymer of methacrylic acid and ethyl acrylate, 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 ESOMEPRAZOLE BIOGARAN CONSEIL 20 mg gastroresistant capsule is and what it contains
This medicine comes in the form of a gastroresistant capsule. Capsules have an opaque yellow head and opaque white body. "20 mg" is printed in black on the head and body.
Boxes of 7 or 14 capsules in blister packs.
Not all presentations may be marketed.
Marketing authorization holder
BIOGARAN
15 Boulevard Charles de Gaulle
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15 Boulevard Charles de Gaulle
92700 COLOMBES
Manufacturer
ETHYPHARM
Z.I. de Saint-Arnoult
28170 - Châteauneuf-en-Thymerais - FRANCE
or
ETHYPHARM
Chemin de la Poudrière
76120 - Grand-Quevilly - FRANCE
or
LES LABORATOIRES SERVIER INDUSTRIE
905 ROUTE DE SARAN
45520 GIDY
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.