NOTICE
ANSM - Updated on : 10/06/2022
Name of the medicinal product
TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet
Trimebutine maleate
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 3 days.
What does this leaflet contain?
1. What is TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet and what is it used for?
2. What do I need to know before taking TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet?
3. How do I take TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet?
4. What are the possible side effects?
5. How to store TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet?
6. Package contents and other information.
1. WHAT IS TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: A03AA05.
This medicine is indicated in adults for the treatment of spasmodic intestinal pain.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet?
Never take TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet:
- if you are allergic to trimebutine or to any of the other ingredients of this medicine, as listed in section 6.
This medicine is intended for adults; it must not be given to children under 2 years of age.
Warnings and precautions
Before taking TRIMEBUTINE BIOGARAN CONSEIL 100 mg,contact your doctor, pharmacist or nurse .
If pain persists for more than 3 days, or in the event of insufficient efficacy or any other sign, such as :
- high fever;
- stabbing pain;
- profuse diarrhea and vomiting;
- bloody or black stools;
- fever accompanied by burning on urination;
- delayed menstruation.
Or when the pain follows a trauma such as a fall or traffic accident, consult your doctor.
This medicine is not recommended for patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare metabolic disorders).
Children and adolescents
Not applicable.
Other medicinal products and TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet with food and drink
Not applicable.
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.
This medicine should only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue taking it.
It is preferable not to take this medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Driving and using machines
Not applicable.
TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet contains lactose.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
3. HOW DO I TAKE TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet?
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
FOR ADULTS ONLY.
The usual dose is 1 tablet, 3 times a day. In exceptional cases, the dose may be increased to 2 tablets 3 times a day.
Method of administration
Oral administration.
Tablets should be swallowed with a glass of water.
Frequency of administration
3 doses per day.
Duration of treatment
The recommended duration of use is 3 days. In the absence of any warning signs, the maximum duration of use is 7 days.
If you have taken more TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet than you should have :
Consult your doctor immediately.
You may experience the following symptoms: heart problems, drowsiness, convulsions, loss of consciousness (coma).
Specialized monitoring may be required and symptomatic treatment administered.
If you forget to take TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet :
Do not take a double dose to make up for the one you forgot to take.
If you stop taking TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet :
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 product may cause undesirable effects, but they do not occur systematically in everyone.
The following side effects may occur:
Uncommon (may affect up to one in 100 people):
- rash.
Undetermined frequency (available information does not allow frequency to be evaluated):
- allergic reactions: itching, urticaria, facial swelling (angioedema), anaphylactic shock;
- skin manifestations: raised rash (macules, papules), erythema, eczema (contact dermatitis);
- severe skin reactions: redness spreading to the whole body with pustules and accompanied by fever (acute generalized exanthematous pustulosis), redness of the skin accompanied by fever (erythema multiforme, toxidermia).
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: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet?
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 30°C.
Do not dispose of any medicine 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 TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet contains
- The active substance is :
Trimebutine maleate................................................................................................... 100 mg
For one tablet.
- The other components are :
Lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
What TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablets are and what they contain
This medicine comes in tablet form. Box of 20.
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
DELPHARM EVREUX
5, AVENUE DU GUESCLIN
27000 EVREUX
or
LES LABORATOIRES SERVIER INDUSTRIE
905 ROUTE DE SARAN
45520 GIDY
or
DELHARM LAIGLE
ZONE INDUSTRIELLE N°1
ROUTE DE CRULAI
61300 LAIGLE
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 education advice
a) What is abdominal pain?
Abdominal pain has many different origins, and can cause very painful and disturbing problems. It can be the result of gastrointestinal, renal, hepatic, genital or even cardiac problems.
Pain caused by digestive disorders or gastrointestinal infections is usually temporary.
Many people regularly suffer from stomach pains with no known cause. These are known as functional intestinal disorders. This recurrent condition, sometimes referred to as "colitis", generally does not worsen or lead to complications.
b) Some practical advice:
If your tummy aches are due to an inadequate or excessively fatty diet, adopt a more easily digestible diet. To limit the onset of symptoms, observe the following rules of hygiene wherever possible:
- Eat slowly and calmly, chewing well to avoid swallowing too much air;
- If you tend to suffer from bloating, limit the intake of foods such as onions, cabbage and sauerkraut, beans, lentils, radishes, horseradish, leeks, stone fruits (e.g. apricots), bran and artificial sweeteners. Try to identify the products that cause you the most flatulence, so that you can eliminate them systematically or restrict their proportion;
- Eat three meals a day, without neglecting breakfast, which should take at least 15 minutes;
- Drink at least one liter of water a day, spread throughout the day.
Constipation can lead to an unpleasant feeling of heaviness, stomach cramps or pain when defecating. To prevent constipation, observe the following hygienic and dietary rules wherever possible:
- Drink at least one to two liters of liquid a day (water, fruit juice, soup). Don't drink too much coffee, tea or soft drinks;
- Enrich your diet with fiber (fruit, vegetables, wholegrain cereals, nuts, prunes);
- Exercise, without forgetting to drink during and after exercise.
When pain in the abdomen is due to spasms of the digestive tract, it can be relieved with antispasmodic medication.
If symptoms do not improve after 3-4 days of treatment, and/or if you notice a high fever, stabbing pain or blood in your stools, you should consult a doctor.
ASK YOUR PHARMACIST FOR ADVICE.