IMONOGAS 240mg simethicone 30 SOFT CAPSULES

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NOTICE

ANSM - Last updated: 05/11/2014

Name of the medicinal product

IMONOGAS 240 mg soft capsule

simethicone

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment:

· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms worsen or persist after 10 days, consult a physician.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

Review summary

In this notice :

1. WHAT IS IMONOGAS 240 mg, soft capsule AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE IMONOGAS 240 mg, soft capsule?

3. HOW TO TAKE IMONOGAS 240 mg, soft capsule?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE IMONOGAS 240 mg, soft capsule?

6. ADDITIONAL INFORMATION

1. WHAT IS IMONOGAS 240 mg, soft capsule AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

Antiflatulent.

Therapeutic indications

IMONOGAS acts by modifying the surface tension of the gas bubbles, thus causing them to coalesce. It is used in the symptomatic treatment of abdominal meteorism (flatulence) which gives the sensation of bloating.

2. BEFORE YOU TAKE IMONOGAS 240 mg, soft capsule?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not take IMONOGAS:

· if you are allergic to siméticone or any of the other ingredients of this medication mentioned in section 6.

Precautions for use; special warnings

Warnings and Precautions:

You should consult your doctor:

· if your abdominal meteorism does not improve after 10 days of treatment

· if you have constipation that does not improve.

Interaction with other medicines

Not applicable.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine. IMONOGAS can be used in pregnant and lactating women because systemic exposure to siméticone is negligible

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

IMONOGAS has no known effect on the ability to drive or use machines.

List of excipients with known effect

Not applicable.

3. HOW TO TAKE IMONOGAS 240 mg, soft capsule?

Instructions for proper use

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

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Reserved for adults and teenagers (15 years and over).

The recommended dose is to take one capsule at the end of each of the main meals. Swallow the capsule with a large glass of water.

Do not exceed 3 capsules per day.

Do not exceed 10 days of treatment.

Do not give IMONOGAS to children under 15 years of age.

Symptoms and Instructions for Overdose

If you take more IMONOGAS 240 mg, soft capsule than you should:

Check with your doctor or pharmacist

Instructions for omission of one or more doses

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

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, IMONOGAS 240 mg, soft capsule can cause side effects, although not everybody gets them.

Stop taking Imonogas immediately and see your doctor if you experience symptoms of angioedema such as edema of the face, tongue or pharynx, difficulty swallowing or breathing.

The following undesirable effects have been reported with an unknown frequency:

· abdominal pain, nausea, vomiting and constipation,

· allergic reactions such as skin rash, pruritus, angioedema, edema of the face, lips, throat and tongue or difficulty breathing.

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 IMONOGAS 240 mg, soft capsule?

Keep out of the reach and sight of children.

Expiration date

Do not use IMONOGAS 240 mg soft capsule after the expiry date which is stated on the carton and the blister pack after "EXP". The expiry date refers to the last day of the month.

Storage conditions

No special storage conditions.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does IMONOGAS 240 mg contain, soft capsule?

The active substance is:

Siméticone ................................................. .................................................. .............................. 240.00 mg

For a soft capsule.

The other components are:

Gelatin, glycerol.

Pharmaceutical form and content

What is IMONOGAS 240 mg, soft capsule and contents of the pack?

This medication is in the form of transparent soft capsules. Box of 10, 20 or 30.

Not all pack sizes may be marketed.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, RUE CAMILLE DESMOULINS

92130 ISSY LES MOULINEAUX

exploiting

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, RUE CAMILLE DESMOULINS

92130 ISSY LES MOULINEAUX

Maker

CATALENT FRANCE BEINHEIM SA

74, PRINCIPAL STREET

67930 BEINHEIM

LA FRANCE

Names of the medicinal product in the Member States of the European Economic Area

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

In accordance with the regulations.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the Ansm website (France).

Information for health professionals only

Not applicable.

Other

ADVICE / HEALTH EDUCATION

WHAT TO DO IN THE EVENT OF A DIGESTION DIFFICULTY?

Difficult digestions:

These disorders often occur when feeding:

· too abundant or too rich (cooked fats for example),

· taken too quickly, without chewing,

· accompanied by alcoholic beverages in excessive quantities.

The first step is to identify the error and to avoid it.

Meteorism - flatulence:

Some foods favor the onset of bloating:

· foods containing air (soft drinks, fresh bread),

· foods high in nonabsorbable carbohydrates (dried vegetables, cabbage, raw vegetables, onions).

The first step is to identify the error and to avoid it.

Ask your pharmacist or doctor if you need more advice.

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