NOTICE
ANSM - Last updated: 23/11/2016
Name of the medicinal product
DOLOSPASMYL 60 mg / 300 mg soft capsule
Alvérine / siméticone citrate
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.
What is in this leaflet?
1. What is DOLOSPASMYL 60 mg / 300 mg, soft capsule and in which cases it is used?
2. What should I know before taking DOLOSPASMYL 60 mg / 300 mg, soft capsule?
3. How to take DOLOSPASMYL 60 mg / 300 mg, soft capsule?
4. What are the possible side effects?
5. How to store DOLOSPASMYL 60 mg / 300 mg soft capsule?
6. Package contents and other information.
1. WHAT QUEDOLOSPAMYL 60 mg / 300mg, soft capsule AND IN WHAT CASES DO IT USE?
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 DOLOSPASMYL 60 mg / 300 mg, soft capsule?
Do not take DOLOSPASMYL 60 mg / 300 mg, soft capsule:
· If you are allergic (hypersensitive) to the active ingredients or to any of the other ingredients of DOLOSPASMYL. You will find the list of components 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.
IN CASE OF DOUBT DO NOT HESITATE AT REQUEST THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Other medicines and DOLOSPASMYL 60 mg / 300 mg, soft capsule
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
DOLOSPASMYL 60 mg / 300 mg, soft capsule with food and beverages
Not applicable.
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.
Sport
Not applicable.
Driving and using machines
Not applicable.
DOLOSPASMYL 60 mg / 300 mg soft capsule contains
Not applicable.
3. HOW TO TAKE DOLOSPASMYL 60 mg / 300 mg 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 than DOLOSPASMYL 60 mg / 300 mg, soft capsule you should:
Immediately consult your doctor or pharmacist.
If you forget to take DOLOSPASMYL 60 mg / 300 mg, soft capsule:
Do not take a double dose to make up for a missed dose.
If you stop taking DOLOSPASMYL 60 mg / 300 mg, soft capsule:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following uncommon side effects have been reported:
· urticaria;
· laryngeal edema;
· shock;
· regressive liver involvement at cessation of treatment.
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 DOLOSPASMYL 30 mg / 600 mg 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 carton and plate 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
This medicine does not require special precautions for storage.
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 DOLOSPASMYL contains: 60 mg / 300 mg soft capsule
· The active substances are:
Alvérine Citrate .............................................. .................................................. ...................... 60 mg
Simethicone ................................................. .................................................. 300 mg
For a soft capsule
· The other components are:
Soft Capsule Envelope:
Gelatin, glycerol and titanium dioxide (E171).
What is DOLOSPAMYL 60 mg / 300 mg soft capsule and contents of the pack
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 eating certain foods that promote bloating: foods high in nonabsorbable carbohydrates (pulses, cabbage, raw vegetables, onions ...) and soft drinks.
· eat slowly,
· limit alcohol consumption.