METEOSPASMYL PAIN DIGESTIVE 30 CAPSULES

NOTICE

ANSM - Last updated: 10/03/2017

Name of the medicinal product

METEOSPASMYL, soft capsule

Citrate of Alvérine and Simeticone

framed

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 or pharmacist.

· 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 or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

Do not use this medication for children.

What is in this leaflet?

1. What is METEOSPASMYL, soft capsule and in which cases it is used?

2. What information should be known before taking METEOSPASMYL, soft capsule?

3. How to take METEOSPASMYL, soft capsule?

4. What are the possible side effects?

5. How to store METEOSPASMYL, soft capsule?

6. Package contents and other information.

1. WHAT IS METEOSPASMYL, soft capsule AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: ANTISPASMODIQUE MUSCULOTROPE / ANTIFLATULENT - ATC code (A: digestive system and metabolism).

This medication is indicated in the symptomatic treatment of digestive pain with bloating.

2. BEFORE YOU TAKE METEOSPASMYL, soft capsule?

Never take METEOSPASMYL, soft capsule:

· If you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6.

· If you have ever had an adverse reaction after taking this medication.

Warnings and Precautions

· If symptoms persist or worsen or if constipation is prolonged, consult your doctor.

· METEOSPASMYL may increase blood levels of liver enzymes (see section 4). Your doctor may prescribe blood tests during treatment to check the condition of your liver. An elevation of these enzymes may cause your doctor to discontinue treatment.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Other medicines and METEOSPASMYL, soft capsule

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

METEOSPASMYL, soft capsule with food, drink and alcohol

Not applicable.

Pregnancy and breast feeding

Pregnancy

It is best not to use this medication during pregnancy.

If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.

Ask your doctor or pharmacist for advice before taking any medicine.

feeding

You should avoid taking this medicine if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

METEOSPASMYL is unlikely to affect your ability to drive or use machines. However, METEOSPASMYL may cause dizziness and this may affect your ability to drive and use machines.

METEOSPASMYL contains

Not applicable.

3. HOW TO TAKE METEOSPASMYL, soft capsule?

Dosage

RESERVED FOR ADULTS

1 capsule 2 to 3 times a day.

Administration mode

Oral use.

Frequency of Administration

To be taken at the beginning of the meals or at the moment of the pains.

If you take more METEOSPASMYL, soft capsule than you should:

Cases of dizziness have been reported at dosages above the recommended dose. Immediately consult your doctor or pharmacist.

If you forget to take METEOSPASMYL, soft capsule:

Do not take a double dose to make up for a missed dose.

If you stop taking METEOSPASMYL, soft capsule:

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, contact a physician immediately:

· Signs of a severe allergic reaction including swelling of the face, lips, mouth, tongue and / or throat, which can cause difficulty breathing or swallowing, rash, itching, severe dizziness with beating acceleration of the heart and abundant sweating (severe allergic reaction considered very rare, that can affect up to 1 in 10 000 people).

· Signs suggestive of liver dysfunction. Symptoms may include yellowing of the skin or whites of the eyes, dark discolouration of the urine, loss of appetite, nausea or vomiting (liver involvement considered very rare, that is, to 1 in 10,000 people).

The following other undesirable effects have been reported with an indeterminate frequency (the available information does not allow to evaluate the frequency):

· Skin rash,

· Urticaria,

· Itching;

· Fear of heights ;

· Headache ;

· Nausea;

· Increased blood levels of liver enzymes (transaminases, alkaline phosphatases) and bilirubin (see section 2) .

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 METEOSPASMYL, soft capsule?

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.

PVC / Aluminum Plates

Store at a temperature not exceeding 30 ° C.

Plates PVC / PE / PVDC-Aluminum

No special storage conditions.

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 METEOSPASMYL contains, soft capsule

· The active substances are:

Alvérine Citrate .............................................. .................................................. .......... 60.00 mg

Siméticone ................................................. .................................................. 300 mg

For a soft capsule.

· The other components are:

Composition of the shell of the soft capsule: Gelatin, glycerol, titanium dioxide.

What METEOSPASMYL, soft capsule and contents of the outer packaging mean

This medication is in the form of a soft, oblong capsule of bright white opaque color, containing a thick whitish suspension.

Box of 20, 30 or 40 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

MAYOLY SPINDLER LABORATORIES

6, AVENUE OF EUROPE

BP 51

78401 CHATOU CEDEX

Marketing Authorization Operator

MAYOLY SPINDLER LABORATORIES

6, AVENUE OF EUROPE

BP 51

78401 CHATOU CEDEX

Maker

MAYOLY SPINDLER LABORATORIES

6, AVENUE OF EUROPE

BP 51

78401 CHATOU CEDEX

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 councils:

This medication is intended to treat the symptoms of digestive pain with bloating, these disorders may be due to changes in diet or taking certain medications. Do not hesitate to talk to your doctor or pharmacist.

To limit the onset of symptoms, observe the following food hygiene rules:

· avoid abundant and high-fat meals,

· avoid the consumption of certain foods favoring the appearance of bloating: foods rich in carbohydrates not absorbable (pulses, cabbages, raw vegetables, onions ...) and soft drinks,

· eat slowly,

· limit alcohol consumption.

VIDAL OF THE FAMILY

MÉTÉOSPASMYL