NOTICE
ANSM - Last updated: 23/03/2015
Name of the medicinal product
PEPSANE, oral gel in sachet-dose
Gaïazulène, Diméticone
framed
Read this leaflet carefully before you start taking 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 PEPSANE, oral gel in a sachet-dose AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE PEPSANE, oral gel in a sachet-dose?
3. HOW TO TAKE PEPSANE, oral gel in a sachet-dose?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PEPSANE, oral gel in a sachet-dose?
6. ADDITIONAL INFORMATION
1. WHAT IS PEPSANE, oral gel in a sachet-dose AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTI-FLATULENT - ANTI-ACID
(A: Digestive System and Metabolism)
Therapeutic indications
This medication is indicated for the treatment of stomach pain.
2. BEFORE YOU TAKE PEPSANE, oral gel in a sachet-dose?
List of information needed before taking the medication
If your doctor tells you that you are intolerant to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take PEPSANE, oral gel in a sachet-dose:
· if you are allergic (hypersensitive) to any of the constituents.
Precautions for use; special warnings
Take special care with PEPSANE, oral gel in sachet-dose:
Special warnings
This medicine contains parahydroxybenzoate and may cause allergic reactions.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
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
This medication may be taken during pregnancy and lactation under normal conditions of use.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with a known effect : methyl parahydroxybenzoate, sorbitol.
3. HOW TO TAKE PEPSANE, oral gel in a sachet-dose?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Oral use.
Absorb directly the contents of 1 or 2 sachets-dose, 2 to 3 times a day, at the moment of the pains.
Symptoms and Instructions for Overdose
If you take more PEPSANE, oral gel in a sachet-dose than you should:
Consult your doctor or pharmacist.
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, PEPSANE, oral gel in a sachet-dose is likely to have undesirable effects, although not everyone is subject to it.
Hypersensitivity reactions such as cutaneous eruption or pruritus have been exceptionally reported.
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 PEPSANE, oral gel in a sachet-dose?
Keep out of the reach and sight of children.
Expiration date
Do not use PEPSANE, oral gel in a sachet-dose after the expiry date which is stated on the outer packaging.
Storage conditions
This medication should be stored at a temperature not exceeding 25 ° 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 PEPSANE, oral gel in a sachet-dose contain?
The active substances are:
Dimethicone ................................................. .................................................. ................................... 3,000 g
Gaïazulène ................................................. .................................................. ................................... 0.004 g
For a sachet-dose.
The other components are:
70% sorbitol (crystallizable), carrageenans, sodium cyclamate, methyl parahydroxybenzoate, peppermint essential oil, purified water.
Pharmaceutical form and content
What is PEPSANE, oral gel in a sachet-dose and contents of the pack?
This medicine is in the form of a drinkable gel. Box of 12 or 30 sachets-dose.
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
ROSA PHYTOPHARMA LABORATORIES
68, RUE JEAN-JACQUES ROUSSEAU
75001 PARIS
exploiting
Not specified.
Maker
ROSA-PHYTOPHARMA LABORATORIES
2 AVENUE OF THE TREATY OF ROME
BP 51
78401 CHATOU CEDEX
or
PHARMATIS LABORATORIES
AREA OF ACTIVITY IS N ° 1
BP 20
60190 ESTREES SAINT DENIS
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.