Trimébutine 100 mg 20 tablets Viatris Mylan COUNCIL

NOTICE

ANSM - Last updated: 07/03/2017

Name of the medicinal product

TRIMEBUTINE BIOGARAN CONSEIL 100 mg tablet

Trimebutine maleate

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Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

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.

What is in this leaflet?

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

Not applicable.

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?

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

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

BIOGARAN

15, BOULEVARD CHARLES DE GAULLE

92700 COLOMBES

Marketing Authorization Operator

BIOGARAN

15, BOULEVARD CHARLES DE GAULLE

92700 COLOMBES

Maker

ROTTENDORF PHARMA GMBH

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]

Other

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.

VIDAL OF THE FAMILY

TRIMÉBUTINE BIOGARAN CONSEIL