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Pepsane Stomach Ache is an anti-flatulent and antacid medication in the form of an oral gel, containing dimethicone and gaiazulene. It is indicated for the treatment of stomach aches and should be taken when pain occurs. Read the package insert carefully before use.
Pepsane for Stomach Aches is an anti-flatulent and antacid medication that comes in the form of a mint-flavored oral gel, packaged in single-dose sachets. Each 10-gram single-dose packet contains two active ingredients: 3 grams of dimethicone and 4 milligrams of gaiazulene.
Pepsane is indicated for the treatment of stomachaches, like other over-the-counter stomach medications. Its summary of product characteristics specifies this indication: the symptomatic treatment of gastralgia, or stomach pain, and that of intestinal meteorism, or excess gas in the intestines.
As an over-the-counter self-medication, Pepsane is taken as needed, when pain occurs.
Dosage
Oral use. Swallow the contents of 1 or 2 single-dose packets directly, 2 to 3 times a day, when pain occurs.
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Precautions
Precautions, contraindications, interactions, and side effects are detailed in the medication guide; read it carefully before use.
Active Ingredients
| Active ingredient | Amount per 10-g single-dose packet |
|---|---|
| Dimethicone | 3.000 g |
| Gaiazulene | 0.004 g |
Excipients with known effects
70% sorbitol (crystallizable), methyl parahydroxybenzoate, sodium.
Other excipients
Carrageenans, Sodium cyclamate, Peppermint essential oil, Purified water.
Form
Oral gel. Box of 12 single-dose packets.
What we check at the counter is for duplicate ingredients. The dimethicone in Pepsane is found in other medications for stomach issues and bloating, either on its own or in the form of simethicone, a type of dimethicone. Someone who is already taking a gel or capsules for gas may, without realizing it, be taking the same substance twice: before adding Pepsane to another digestive treatment, show both boxes to your pharmacist.
The second point to watch out for is sorbitol. At the maximum dose listed in the package insert—2 packets 3 times a day—the daily intake reaches approximately 8.6 g of sorbitol. This is insignificant for most patients, but critical in cases of hereditary fructose intolerance.
Finally, the package insert does not specify a treatment duration, which does not mean that Pepsane can be taken indefinitely. Stomach pain that recurs daily, wakes you up at night, or is accompanied by weight loss, vomiting, or black stools is no longer a matter for self-medication: it’s time to see a doctor rather than buying another box.
Can I take Pepsane for Stomach Aches while I’m pregnant or breastfeeding?
Yes. The Pepsane package insert states that this medication may, under normal conditions of use, be taken during pregnancy and while breastfeeding. The dosage remains the same: 1 or 2 single-dose packets, 2 to 3 times a day, as needed.
Should I take Pepsane Stomach Ache before or after a meal?
The Pepsane package insert recommends taking the sachet when pain occurs. Its summary of product characteristics specifies that it can be taken before meals or when pain occurs. Neither document recommends taking it systematically after a meal: the contents of the packet are absorbed directly as soon as pain occurs.
Can I give Pepsane Stomach Ache to my child?
The Pepsane package insert does not provide any dosage instructions for children and does not specify a minimum age for use of this medication. If a child is complaining of stomach pain, consult a doctor or pharmacist before administering the medication to ensure the treatment is appropriate for the child’s age and symptoms.
Can I take Pepsane Stomach Ache if I’m watching my sugar intake?
According to its summary of product characteristics, Pepsane does not contain sugar. It is sweetened with sorbitol—at a dose of 1,429 mg per single-dose packet—and sodium cyclamate. Since sorbitol is a source of fructose, anyone with hereditary fructose intolerance should consult their doctor before taking it.
Pharmacovigilance Report an adverse drug reaction(s)
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.
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.
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PEPSANE: oral gel (mint flavoring); box of 12 sachets of 10 g.
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PEPSANE: oral gel (mint flavoring); box of 30 sachets of 10 g.
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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.
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