For warnings, precautions for use and contraindications, please consult the instructions for use.
This medication is indicated for the treatment of upset stomach .
An upset stomach is often caused by digestive upset. Among these, we often distinguish:
Directly absorb the content of 1 or 2 sachets, 2 to 3 times a day, when you are in pain.
The active substances are :
Dimethicone. 3,000 g
Guaiazulene. 0.004 g
For a sachet-dose.
The other components are :
Sorbitol at 70% (crystallizable), carrageenans, sodium cyclamate, methyl parahydroxybenzoate, peppermint essential oil, purified water.
This medicine contains parahydroxybenzoate and can cause allergic reactions.
IF IN DOUBT, DON'T HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Never take PEPSANE, oral gel in sachet-dose: if you are allergic (hypersensitive) to one of the constituents.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
This medication can, under normal conditions of use, be taken during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Like all medicines, PEPSANE, oral gel in sachet-dose is capable of having undesirable effects, although not everyone is subject to it.
Hypersensitivity reactions such as rash or pruritus have been exceptionally reported.
If you notice any side effects not listed in this leaflet, or if some side effects become serious, please tell your doctor or pharmacist.
This medication is in the form of an oral gel. Box of 12 or 30 sachets.
Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 23/03/2015
PEPSANE, oral gel in sachet-dose
Gaïazulène, Diméticone
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.
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?
ANTI-FLATULENT - ANTI-ACID
(A: Digestive System and Metabolism)
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.
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.
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?
Not applicable.
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.
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.
Do not use PEPSANE, oral gel in a sachet-dose after the expiry date which is stated on the outer packaging.
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.
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.
ROSA PHYTOPHARMA LABORATORIES
68, RUE JEAN-JACQUES ROUSSEAU
75001 PARIS
Not specified.
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.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
Gastrointestinal tract
diméticone, gaïazulène
. Presentations . Composition . Indications . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
PEPSANE: capsule (blue); box of 30.
-
PEPSANE: oral gel (mint flavoring); box of 12 sachets of 10 g.
-
PEPSANE: oral gel (mint flavoring); box of 30 sachets of 10 g.
-
Rosa-Phytopharma Laboratory
p caps | p sachet | |
dimethicone | 300 mg | 3 g |
Gaïazulène | 4 mg | 4 mg |
sorbitol | + | + |
Methyl parahydroxybenzoate | + |
Usual dosage:
1 capsule at the time of pain or 1 to 2 sachets, 2 or 3 times a day.