Trimebutine 100 mg Viatris Mylan Conseil 20 tablets is indicated for the relief of pain caused by digestive or biliary disorders in adults. It corrects associated transit disorders.
For warnings, precautions and contraindications, please see the Viatris Mylan Trimebutine 100 mg leaflet.
This medicine is indicated for the relief of pain caused by digestive or biliary disorders in adults. It corrects associated transit disorders.
Pharmacotherapeutic class: Musculotropic antispasmodics - ATC code: A03AA05.
Antispasmodics are, as their name suggests, drugs designed to regulate contractures, convulsions or spasms, generally of the digestive, genital or urinary tracts. They are not analgesics, but by acting on involuntary muscle contraction, they help to relieve certain types of pain.
Musculotropic antispasmodics have fewer side-effects than cholinergic antispasmodics, as they act directly on the muscles to help them relax.
The active substance is Trimebutine maleate 100 mg
For one tablet.
Other ingredients are: Lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
FOR ADULTS ONLY.
The recommended dose is 1 tablet, 3 times daily.
Method of administration
If you have taken more Trimebutine Viatris Mylan 100 mg, tablet than you should have:
Consult your doctor or pharmacist immediately.
If you forget to take Trimebutine Viatris Mylan 100 mg, tablet:
Do not take a double dose to make up for the one you forgot to take;
If you stop taking Trimebutine Viatris Mylan 100 mg, tablet:
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
Never take Trimebutine Viatris Mylan 100 mg, tablet:
If in doubt, ask your doctor or pharmacist for advice.
Warnings and precautions
Pregnancy and breast-feeding
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 to continue treatment.
It is preferable not to take this medicine if you are 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.
Box of 20 tablets
Warning: Trimebutine 100 mg Viatris Mylan is not a product like others. Read the Trimebutine 100 mg Viatris Mylan leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Be aware of incompatibilities with your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 07/03/2017
TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet
Trimebutine maleate
You should always take this medication exactly as prescribed 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 experience any of the 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 experience no improvement or feel less well after 3 days.
Do not use this medication for children.
1. What is TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet and in which cases it is used?
2. What information should I take before taking TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet?
3. How to 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 COUNCIL 100 mg, tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: A03AA05.
ANTISPASMODICAL MUSCULOTROPE
This medication is indicated in adults for the treatment of spasmodic pain in the intestine and biliary tract.
2. BEFORE YOU TAKE TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet?
Do not take TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet:
· if you are allergic (hypersensitive) to trimebutine maleate or any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet .
If the pain persists for more than 3 days, or if there is insufficient efficacy or other signs, such as:
· high fever;
· pain "stabbing";
· diarrhea and abundant vomiting;
· bloody or black stools;
· fever with burning urination;
· delay of the rules.
Or when the pain follows a trauma such as a fall or a traffic accident, consult your doctor.
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare metabolic diseases).
children
Not applicable.
Other medicines and TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet
Inform your doctor or pharmacist if you are taking , have recently taken or may take any other medicines.
TRIMEBUTINE BIOGARAN TIP 100 mg, tablet with food and beverages
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medication will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
feeding
It is best not to take this medication if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet contains lactose.
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet?
Dosage
RESERVED FOR ADULTS.
The usual dose is 1 tablet, 3 times a day and can be increased exceptionally to 2 tablets 3 times a day.
Administration mode
Oral use.
The tablets should be swallowed with a glass of water.
Frequency of Administration
3 taken per day.
Duration of treatment
The recommended duration of use is 3 days. In the absence of any warning sign, the maximum duration of use will be 7 days.
If you take more than TRIMEBUTINE BIOGARAN TIP 100 mg, tablet you should not have:
Immediately consult your doctor or pharmacist.
If you forget to take TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet:
Do not take a double dose to make up for a missed dose.
If you stop taking TRIMEBUTINE BIOGARAN CONSEIL 100 mg, tablet:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:
Allergic and dermal manifestations
Allergic reactions
· itching
· Urticaria
· Edema of the face (edema of Quincke)
· Anaphylactic shock
Cutaneous manifestations
· Eruption of short duration (rash)
· Eruption in relief (macules, papules)
· Erythema
· Eczema (contact dermatitis)
Severe skin reactions including
· a redness spreading to the whole body with pustules and accompanied by fever (general acute exanthematic pustulosis)
· redness of the skin accompanied by fever (erythema multiforme, toxidermia).
Declaration of side effects
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. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package after {EXP}. The expiry date refers to the last day of that month.
Store at a temperature not exceeding + 30 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What TRIMEBUTINE BIOGARAN CONSEIL 100 mg contains: tablet
· The active substance is:
Trimebutine maleate ............................................... .................................................. ... 100 mg
For a tablet.
· The other components are:
Lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), anhydrous colloidal silica, magnesium stearate.
What is TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet and contents of the pack
This medication is in the form of tablets. Box of 20.
Marketing Authorization Holder
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing Authorization Operator
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
OSTENFELDER STRASSE 51 - 61
59320 ENNIGERLOH
GERMANY
or
DELPHARM EVREUX
5, AVENUE DU GUESCLIN
27000 EVREUX
or
LABORATOIRES SERVIER INDUSTRIE
905 ROUTE DE SARAN
45520 GIDY
Names of the medicinal product 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]
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council
a) What is a stomach ache?
Abdominal pain has many origins and can cause very painful and disturbing disorders, which can translate: a gastrointestinal, renal, hepatic, genital or even cardiac problem.
Pains due to digestive disorders or gastrointestinal infections are usually transient.
Many people regularly suffer from stomach pain with no known cause. This is called intestinal functional disorders. This recurrent disease, sometimes referred to as "colitis", does not usually worsen and does not cause complications.
b) Some practical tips:
If your stomach ache is due to an inadequate diet or too fat, adopt a more digestible diet. In order to limit the onset of symptoms, respect the following hygiene rules as much as possible:
· Eat slowly and calmly, chew well to avoid swallowing too much air.
· If you tend to suffer from bloating, limit the absorption of foods such as onions, cabbage and sauerkraut, beans, lentils, radishes, horseradish, leeks, stone fruits (eg apricots), bran and artificial sweeteners. Try to determine the products that generate the most flatulence in you, to eliminate them systematically or to restrict their proportion.
· Take three meals a day without neglecting breakfast which should take at least 15 minutes;
· Drink regularly at least one liter of water per day, spread throughout the day.
Constipation can induce an unpleasant feeling of heaviness, cramps in the abdomen or pains at defecation. In order to prevent it, respect as much as possible the following hygiene-dietetic rules:
· Drink at least one to two liters of liquid per day (water, fruit juice, soup). Do not abuse coffee, tea or soft drinks;
· Enrich your diet with fiber (fruits, vegetables, whole grains, nuts, prunes ...);
· Exercise, not to mention drinking during and after exercise.
When the pains in the abdomen are due to spasms in the digestive tract, they can be relieved with antispasmodic medication.
In the absence of symptom improvement after 3-4 days of treatment and / or onset of high fever, stabbing pain, stool blood, doctor.
DO NOT HESITATE TO ASK YOUR PHARMACIST FOR ADVICE.
Antispasmodic for digestive aiming
This medication is a generic of DEBRIDAT
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
TRIMÉBUTINE BIOGARAN TIP: tablet (white); box of 20.
-
Biogaran Laboratory
| p cp | |
| Trimébutine maleate | 100 mg |
| Lactose | + |
Usual dosage:
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