NOTICE
ANSM - Last updated: 30/06/2017
Name of the medicinal product
METEOXANE, capsule
Siméticone, Phloroglucinol hydrate
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· 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, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS METEOXANE, capsule AND IN WHAT CASES IS IT USED?
2. BEFORE YOU TAKE METEOXANE, capsule?
3. HOW TO TAKE METEOXANE, capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE METEOXANE, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS METEOXANE, capsule AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
ANTIFLATULENT associated with a NON-ATROPINIC ANTISPASMODIC
(A: digestive system and metabolism)
Therapeutic indications
This medication is recommended in the relief of stomach pain with bloating and / or emission of gas associated or not with mild diarrhea.
2. BEFORE YOU TAKE METEOXANE, capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take METEOXANE, capsule:
· In case of a history of allergic reaction or intolerance to phloroglucinol, siméticone or any of the excipients.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with METEOXANE, capsule:
Precautions for use
The combination of phloroglucinol with major analgesics such as morphine or its derivatives should be avoided due to their spasmogenic effect.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Bloating, flatulence:
Avoid dried vegetables (lentils, flageolets, peas ...), some green vegetables (cabbage, Brussels sprouts, chard ...).
Diarrhea:
Add sweet drinks, salted broths to compensate for the loss of liquid due to diarrhea.
If diarrhea persists beyond 2 days, CONSULT YOUR DOCTOR.
Interaction with other medicines
Taking other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
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
It is best not to administer this medication during the first three months of pregnancy.
However, no adverse effects were reported during pregnancy.
Precautions should be taken when administering this medication during breast-feeding.
In general, during pregnancy and breast-feeding, always seek the advice of your doctor or pharmacist before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE METEOXANE, capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Swallow with a little water, 2 capsules, 3 times a day, before meals or at the time of the pains.
It is usually useless to exceed 6 capsules per day. If these are not enough to calm you down, CONSULT YOUR DOCTOR.
Method and route of administration
Oral use.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, METEOXANE, capsule is likely to have undesirable effects, although not everyone is subject to it: possibility of allergy.
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.
5. HOW TO STORE METEOXANE, capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use METEOXANE capsule after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 30 ° C.
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 METEOXANE contain, capsule?
The active substances are:
Siméticone ................................................. .................................................. 125 mg
Phloroglucinol hydrate ................................................ .................................................. ...................... 80 mg
For a capsule.
The other components are:
Anhydrous colloidal silica (AEROSIL 200), anhydrous colloidal silica (AEROSIL 380), talc, microcrystalline cellulose, calcium hydrogen phosphate.
Pharmaceutical form and content
What is METEOXANE, capsule and contents of the pack?
This medication is in the form of a capsule. Box of 15, 30 or 60 capsules.
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
ALFASIGMA FRANCE
14 BOULEVARD DES FRERES VOISIN
92130 ISSY-LES-MOULINEAUX
exploiting
ALFASIGMA FRANCE
14 BOULEVARD DES FRERES VOISIN
92130 ISSY-LES-MOULINEAUX
Maker
RODAEL LABORATORIES
1, SOCIAL ROUTE
59380 BIERNE
or
MACORS LABORATORIES
RUE DES CAILLOTTES
ZI PLAINE DES ISLES
89000 AUXERRE
or
ALFA WASSERMANN SPA
Via Enrico Fermi, 1
65020 ALANNO
ITALY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.