NOTICE
ANSM - Last updated: 20/01/2017
Name of the medicinal product
SILIGAZ capsule
simethicone
framed
Please read this leaflet carefully before you start using 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.
· You should contact your doctor if you experience no improvement or feel less well after the recommended treatment period.
Do not use this medication for children.
What is in this leaflet?
1. What is SILIGAZ, capsule and in which cases it is used?
2. What information should be known before taking SILIGAZ, capsule?
3. How to take SILIGAZ capsule?
4. What are the possible side effects?
5. How to store SILIGAZ, capsule?
6. Package contents and other information.
1. WHAT IS SILIGAZ, capsule AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group - ANTIFLATULENT.
This drug is indicated in adults and children over 15 years in case of intestinal bloating and flatulence.
2. WHAT TO DO ABOUT BEFORE TAKING SILIGAZ, capsule?
Do not take SILIGAZ capsules:
· if you are allergic (hypersensitive) to the active substance or to any of the constituents mentioned in section 6.
In case of doubt, it is essential to seek the advice of your doctor and pharmacist.
Warnings and Precautions
If symptoms persist or worsen, or if constipation is prolonged, consult your doctor.
This medicinal product contains two azo dyes: orange yellow S (E110) and azorubine (E122); it can cause allergic reactions.
Other medicines and SILIGAZ capsule
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Pregnancy and breast feeding
Generally, during pregnancy or breast-feeding, you should always seek the advice of your doctor or pharmacist before using any medication.
However, since siméticone is not digestively absorbed, SILIGAZ can be used in pregnant and lactating women
Sport
Not applicable.
Driving and using machines
Not applicable.
SILIGAZ, capsule contains
Yellow orange S (E110), azorubine (E122).
3. HOW TO TAKE SILIGAZ, capsule?
Dosage
Adults and children over 15 years : 2 capsules before or after each of the main meals.
Duration of treatment
The duration of treatment is limited to 10 days.
Administration mode
Oral use.
Take with a glass of water.
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
If you take more SILIGAZ, capsule than you should:
Immediately consult your doctor or pharmacist.
If you forget to take SILIGAZ capsule:
Do not take a double dose to make up for a missed dose.
If you stop taking SILIGAZ, capsule:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, SILIGAZ, capsule is likely to have side effects, although not everyone is subject to it.
Due to the presence of orange yellow S (E110) and azorubine (E122), there is a risk of allergic reactions.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
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 SILIGAZ, 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.
No special storage conditions.
Do not throw any medication into drains or household waste. 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 SILIGAZ contains, capsule
· The active substance is:
Simethicone ................................................. .................................................. 257.50 mg
For a capsule.
· The other components are:
Gelatin, glycerol, azorubine (E122), dimethicone, orange yellow S (E110), titanium dioxide (E171), potassium sorbate.
What is SILIGAZ, capsule and contents of the pack
This medication is in capsule form. Box of 20, 30 or 32 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
ARKOPHARMA LABORATORIES
BP 28
06511 CARROS
Marketing Authorization Operator
ARKOPHARMA LABORATORIES
BP 28
06511 CARROS
Maker
ARKOPHARMA LABORATORY
LID OF CARROS LE BROC
INDUSTRIAL ZONE - 1 E7E AVENUE 2709M
06511 CARROS 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).