NOTICE
ANSM - Updated on : 23/10/2023
Product name
OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule
Omeprazole
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 OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule, and what is it used for?
2. What do I need to know before taking OMEPRAZOLE BIOGARAN CONSEIL 20 mg gastro-resistant capsule?
3. How do I take OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule?
4. What are the possible side effects?
5. How to store OMEPRAZOLE BIOGARAN CONSEIL 20 mg gastro-resistant capsule?
6. Package contents and other information.
1. WHAT IS OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: drugs for acid-related disorders, proton pump inhibitors - ATC code: A02BC01.
OMEPRAZOLE BIOGARAN CONSEIL contains the active substance omeprazole. It belongs to the class of drugs known as proton pump inhibitors. It reduces the amount of acid produced by your stomach.
It is indicated for the short-term treatment of symptoms of gastro-sophageal reflux disease (e.g. heartburn, acid regurgitation) in adults (18 years and older).
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 burning sensation in the chest extending up to the throat (pyrosis) and a sour taste in the mouth (acid regurgitation).
Acid reflux and heartburn may disappear after one day's treatment with OMEPRAZOLE BIOGARAN CONSEIL. However, OMEPRAZOLE BIOGARAN CONSEIL is not intended to provide immediate relief. It may be necessary to continue treatment for 2 or 3 consecutive days for symptoms to improve.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule?
Never take OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule
- if you are allergic to lomeprazole or any of the other ingredients of this medicine, as listed in section 6;
- if you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
- if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking OMEPRAZOLE BIOGARAN CONSEIL.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment with lomeprazole. Stop taking lomeprazole and consult a doctor immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4.
OMEPRAZOLE BIOGARAN CONSEIL may mask symptoms of other diseases. Therefore, before you start taking OMEPRAZOLE BIOGARAN CONSEIL, or while you are on treatment, you should inform your doctor immediately if any of the following occur:
- you lose weight for no reason or have trouble swallowing;
- you experience stomach pain or indigestion;
- you vomit food or blood;
- you have black (blood-tinged) stools;
- you suffer from severe or persistent diarrhea, as lomeprazole has been associated with a slight increase in infectious diarrhea;
- you have severe liver problems or jaundice (jaundice, yellowing of the skin and eyes);
- you are suffering from stomach pains for the first time or these pains have recently worsened;
- you have previously suffered from a gastric ulcer or undergone stomach surgery;
- you have been on continuous symptomatic treatment for indigestion or heartburn for 4 weeks or more;
- you are over 55 years of age and are taking over-the-counter indigestion medication on a daily basis;
- you are over 55 and have symptoms that are appearing for the first time or have recently changed;
- you have already developed a skin reaction after treatment with a drug similar to OMEPRAZOLE BIOGARAN CONSEIL which reduces stomach acidity;
- you should have a specific blood test (Chromogranin A).
If you develop a rash on your skin, particularly in sun-exposed areas, consult your doctor as soon as possible, as you may have to stop taking OMEPRAZOLE BIOGARAN CONSEIL. Remember to mention any other side effects, such as joint pain.
When taking domeprazole, inflammation of the kidneys may occur. Signs and symptoms may include a decrease in urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should report these symptoms to your doctor.
This medicine may affect the way your body absorbs vitamin B12, particularly if you have to take it for a long time. Please contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:
- extreme fatigue or lack of energy;
- sensation of pins and needles;
- red or sore tongue, mouth ulcers;
- muscle weakness;
- vision problems;
- memory problems, confusion, depression.
OMEPRAZOLE BIOGARAN CONSEIL should not be used as a preventive treatment.
In the event of recurrence of symptoms after treatment with OMEPRAZOLE BIOGARAN CONSEIL, consult your doctor, who is the only person able to judge whether further tests are necessary.
Children and adolescents
OMEPRAZOLE BIOGARAN CONSEIL is not indicated for children and adolescents under 18 years of age.
Other medicines and OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
OMEPRAZOLE BIOGARAN CONSEIL may affect the way other medicines work and some medicines may affect OMEPRAZOLE BIOGARAN CONSEIL.
Do not take OMEPRAZOLE BIOGARAN CONSEIL if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections);
- digoxin (used to treat heart problems);
- diazepam (used to treat anxiety, epilepsy or as a muscle relaxant);
- phenytoin (used to treat epilepsy). If you are taking phenytoin, you should be supervised by your doctor when you start and stop taking OMEPRAZOLE BIOGARAN CONSEIL;
- blood-thinning anticoagulants such as warfarin or other anti-vitamin K drugs. Your doctor will need to monitor you when you start and stop taking OMEPRAZOLE BIOGARAN CONSEIL;
- rifampicin (used to treat tuberculosis);
- atazanavir (used to treat HIV infection);
- tacrolimus (used for organ transplants);
- St. John's wort(Hypericum perforatum) (used to treat moderate depression);
- cilostazol (used to treat intermittent claudication);
- saquinavir (used to treat HIV infection);
- clopidogrel (used to prevent blood clots (thrombus));
- erlotinib (used to treat cancer);
methotrexate (used in high-dose cancer chemotherapy). If you are taking a high dose of methotrexate, your doctor may temporarily stop your treatment with OMEPRAZOLE BIOGARAN CONSEIL.
OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule with food and drink
OMEPRAZOLE BIOGARAN CONSEIL does not interact with food or beverages.
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.
Your doctor will decide whether you can take OMEPRAZOLE BIOGARAN CONSEIL during this period.
Driving and use of machinery
OMEPRAZOLE BIOGARAN CONSEIL is unlikely to affect your ability to drive and use machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If this occurs, you should not drive or operate machinery.
OMEPRAZOLE BIOGARAN CONSEIL 20 mg gastro-resistant capsule contains sucrose and sodium.
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant 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.
For adults only (18 years and over).
To be taken orally.
The recommended dose is 1 capsule per day.
It is recommended to take OMEPRAZOLE BIOGARAN CONSEIL before meals:
- in the morning if symptoms predominate during the day,
- in the evening if symptoms predominate during the night.
It may be necessary to take the treatment for 2 or 3 consecutive days for symptoms to improve.
Swallow the capsule whole with a sufficient quantity of liquid (e.g. a glass of non-carbonated water), before the morning or evening meal.
Capsules should not be chewed or crunched, as they contain granules whose coating prevents the drug from being destroyed by stomach acid. It is important not to damage the granules contained in the capsules.
If you have difficulty swallowing the capsules :
- open the capsule and swallow the contents directly with half a glass of water, or put the contents in a glass of non-carbonated water, slightly acidic fruit juice (orange, apple or pineapple juice) or applesauce;
- always stir just before drinking (the mixture will not be homogeneous). Then drink the mixture immediately or within 30 minutes;
- to make sure you've drunk all the medicine, rinse the glass well with half a glass of water and drink it. Do not use milk or sparkling water. Do not chew or crunch solid pieces containing the drug.
Treatment with OMEPRAZOLE BIOGARAN CONSEIL should not exceed 14 days. If your pain persists or worsens after 14 days, consult your doctor.
Use in children and adolescents
This medicine should not be taken by children or adolescents under 18 years of age.
If you have taken more OMEPRAZOLE BIOGARAN CONSEIL 20 mg gastro-resistant capsule than you should have
Consult your doctor or pharmacist immediately.
If you forget to take OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule
Do not take a double dose to make up for the one you forgot to take.
If you stop taking OMEPRAZOLE BIOGARAN CONSEIL 20 mg, Gastro-resistant 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 occur systematically in everyone.
If you notice any of the following side effects, which are rare (may affect up to 1 in 1000 people) or very rare (may affect up to 1 in 10,000 people) but serious, stop taking OMEPRAZOLE BIOGARAN CONSEIL and contact a doctor immediately:
- sudden onset of wheezing, swelling of the lips, tongue, throat or body, rash, loss of consciousness or difficulty swallowing (severe allergic reactions) (rare);
- reddening of the skin with bullae or peeling. Sometimes, the bullae may be large and accompanied by bleeding from the lips, eyes, mouth, nose and genitals. This may correspond to Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare);
- generalized rash, elevated body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare);
- red, scaly, generalized rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) (rare);
- jaundice, dark urine and fatigue may be symptoms of liver disease (rare).
Other adverse reactions include
Common adverse reactions (may affect up to 1 in 10 people)
- Headache;
- effects on the stomach or intestine: diarrhea, stomach pain, constipation, flatulence;
- nausea or vomiting;
- benign stomach polyps.
Uncommon adverse reactions (may affect up to 1 in 100 people)
- Swelling of feet and ankles;
- sleep disorders (insomnia);
- dizziness, tingling, drowsiness;
- dizziness;
- changes in the results of blood tests monitoring your liver function;
- skin rashes, hives and itching;
- general malaise, lack of energy.
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 the onset of infections;
- Decreased sodium levels in the blood. This can lead to weakness, vomiting and cramps;
- agitation, confusion or depression;
- taste disorders;
- visual disturbances, such as blurred vision;
- wheezing or shortness of breath (bronchospasm);
- dry mouth;
- inflammation of the inside of the mouth;
- infection called "thrush", which can affect the intestine and is caused by a fungus;
- hair loss (alopecia);
- rash on exposure to the sun;
- joint pain (arthralgia) or muscle pain (myalgia);
- severe kidney problems (interstitial nephritis);
- increased sweating.
Very rare adverse reactions (may affect up to 1 in 10,000 people)
- Change in blood cell count, including granulocytosis (white blood cell deficiency);
- aggressiveness;
- visual, sensory or auditory hallucinations;
- severe liver disorders leading to liver failure and inflammation of the brain;
- erythema multiforme;
- muscle weakness;
- breast swelling in men.
Undesirable effects of undetermined frequency (cannot be estimated on the basis of available data)
- Inflammation of the intestine (leading to diarrhoea);
- If you take OMEPRAZOLE BIOGARAN CONSEIL for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and rapid heartbeat. If you experience any of these symptoms, please inform your doctor immediately. Low magnesium levels may also lead to a drop in potassium or calcium levels in the blood. Your doctor may decide to carry out regular blood tests to monitor your magnesium levels;
- rash, possibly with joint pain.
In very rare cases, OMEPRAZOLE BIOGARAN CONSEIL may affect white blood cells, leading to an immune deficiency. You should consult your doctor as soon as possible 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, mouth or difficulty in urinating. If you have these symptoms, a white blood cell deficiency (agranulocytosis) can be ruled out by a blood test. It is important that you provide information about your medication in this case.
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 are helping to provide more information on drug safety.
5. HOW TO CONSERVE OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant 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.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
Bottle
No special storage precautions are required.
After1st opening, keep capsules in the well-sealed pillbox.
Blister (Aluminium/Aluminium)
Store at temperatures not exceeding 30°C.
Blister (PVC-PVDC/Aluminium)
Store at a temperature not exceeding 25°C.
6. CONTENTS AND OTHER INFORMATION
What OMEPRAZOLE BIOGARAN CONSEIL 20 mg gastro-resistant capsule contains
- The active substance is :
Omeprazole.................................................................................................................... 20 mg
For one gastro-resistant capsule.
- The other components are :
Sugar spheres (sucrose + corn starch), copolymer of methacrylic acid and ethyl acrylate (1:1), sodium hydrogen phosphate dihydrate, hypromellose (E464), talc, triethyl citrate, titanium dioxide (E171).
Capsule shell Capsule shell : gelatin, titanium dioxide (E171), black printing ink.
What is OMEPRAZOLE BIOGARAN CONSEIL 20 mg, gastro-resistant capsule and what does it contain?
This medicine comes in gastro-resistant capsules.
Box of 7 or 14 capsules in blister packs or bottle (HDPE).
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLES
92700 COLOMBES
Manufacturer
TOWA PHARMACEUTICAL EUROPE, S.L.
C/ DE SANT MARTI, 75-97
MARTORELLES, 08107 BARCELONA
SPAIN
Product 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.
HEALTH DEDUCATION ADVICE
This medicine is intended to relieve heartburn and acid reflux. Heartburn and acid reflux can be caused by changes in diet (acidic or spicy foods, alcoholic beverages) or by certain medications (aspirin, anti-inflammatory drugs). Talk to your doctor or pharmacist.
To limit the onset of symptoms, observe the following hygiene rules wherever possible:
- avoid heavy, high-fat meals,
- eat slowly,
- avoid certain foods such as chocolate, mint, spices, peppers, citrus juices, soft drinks and coffee,
- vary your diet,
- normalize your weight (if overweight) and exercise,
- avoid wearing tight-fitting clothes or belts,
- elevate the head of your bed in case of heartburn or nocturnal acid reflux,
- avoid strenuous exercise immediately after a meal,
- do not smoke and limit alcohol consumption.
YOUR PHARMACIST AND YOUR DOCTOR KNOW ALL ABOUT MEDICATIONS.
DON'T HESITATE TO ASK THEIR ADVICE.
NEVER LEAVE MEDICATION WITHIN THE REACH OF CHILDREN.