Polysilane oral gel is an antiflatulent and digestive dressing silicone, it is used in case of pain or burning in the stomach and intestinal bloating.
For warnings, precautions for use and contraindications, please consult the instructions for use.
Polysilane oral gel is an antiflatulent and a digestive silicone dressing, it is used in case of pain or burning of the stomach and feeling of intestinal bloating .
Dosage
Against indications
Oral use
Read the instructions carefully
Packaging: 170g tube of oral gel (11 tablespoons)
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 - Updated on: 19/07/2017
POLYSILANE UPSA, oral tube gel
dimethicone
You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
1. What is POLYSILANE UPSA, tube oral gel and in which cases it is used?
2. What should I tell you before taking POLYSILANE UPSA oral tube gel?
3. How to take POLYSILANE UPSA oral gel in tube?
4. What are the possible side effects?
5. How to store POLYSILANE UPSA oral gel in tube?
6. Package contents and other information.
1. WHAT IS POLYSILANE UPSA, Tube Oral Gel AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: ANTIFLATULENT, ATC code: A03AX13 .
You should contact your doctor if you experience no improvement or feel less well after 5 days.
2. BEFORE YOU TAKE POLYSILANE UPSA oral tube gel?
Do not take POLYSILANE UPSA, oral tube gel:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
in case of doubt, it is essential to seek the advice of your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before taking POLYSILANE UPSA oral oral gel.
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare metabolic diseases).
This medicinal product contains 3.5 g of sucrose per unit dose, which should be taken into account in the daily diet in the case of a low-sugar diet or diabetes.
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
Due to the presence of sorbitol, this drug may cause mild digestive disorders (diarrhea).
Caloric value 2.6 kcal / g of sorbitol or 1.85 kcal per tablespoon of POLYSILANE UPSA oral tube gel.
This medicine contains azo dyes (4R red cochineal A and E122 azorubine) and may cause allergic reactions.
This medication contains propyl parahydroxybenzoate and may cause allergic reactions.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Children and Youth
Not applicable.
Other medicines and POLYSILANE UPSA oral oral gel
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
POLYSILANE UPSA, oral gel in tube with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medication will only be used during pregnancy on the advice of your doctor.
feeding
Not applicable
Fertility
Not applicable
Driving and using machines
POLYSILANE UPSA oral oral gel has no effect on the ability to drive and use machines.
POLYSILANE UPSA oral tube gel contains sucrose (3.5 g per tablespoon) azorubine (E122), cochineal red A (4R), sorbitol (E420) and propyl parahydroxybenzoate (E216).
3. HOW TO TAKE POLYSILANE UPSA oral tube gel?
Dosage
One tablespoon before each of the three main meals and, if necessary, at the time of the pain, without exceeding 6 catches per day.
If you have the impression that the effect of POLYSILANE UPSA oral oral gel is too strong or too weak, talk to your doctor or pharmacist.
Method and route of administration
Oral use.
The gel should be absorbed as it is (without water).
If you take more POLYSILANE UPSA oral tube gel than you should
In case of overdose or accidental poisoning, notify a doctor immediately.
If you forget to take POLYSILANE UPSA, oral tube gel
Do not take a double dose to make up for a missed dose.
If you stop taking POLYSILANE UPSA, oral tube gel
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· possibility of digestive disorders and diarrhea;
· risk of allergic reactions, in particular due to the presence of azorubin and cochineal red A;
· risk of contact dermatitis;
· exceptionally: immediate reactions with urticaria and bronchospasm.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 POLYSILANE UPSA oral oral gel?
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 package. The expiry date refers to the last day of that month.
After first opening the tube, the shelf life must not exceed 12 months.
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 POLYSILANE UPSA contains, oral tube gel
· The active substance is:
Dimethicone ................................................. .................................................. .................. 15.00 g
For 100 g of gel.
· The other components are:
Artificial flavoring raspberry, azorubine (E122), red cochineal A (4R), guar gum, saccharose palmitate, soda propyl parahydroxybenzoate (E216), sorbic acid, sorbitol (E420), purified water qs 100 g.
What is POLYSILANE UPSA, oral tube gel and contents of the pack
This medication is in the form of an oral gel.
Box of 1 or 500 tubes.
Marketing Authorization Holder
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Marketing Authorization Operator
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
979, AVENUE DES PYRENEES
47520 THE PASSAGE
or
UPSA SAS
304, AVENUE OF DOCTOR JEAN BRU
47000 AGEN
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]
{month YYYY}.
Detailed information on this medicine is available on the ANSM website.
Gastrointestinal tract
dimethicone
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
POLYSILANE UPSA: oral gel (raspberry aroma); box of 12 sachets of 15 g.
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POLYSILANE UPSA: oral gel (raspberry aroma); 170 g (11 tablespoons) tube.
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UPSA Laboratory
| p sachet | pc to s | |
| dimethicone | 2.25 g | 2.25 g |
| Sucrose | 3.5 g | 3.5 g |
| sorbitol | + | + |
| parahydroxybenzoate | + | + |
Usual dosage:
1 sachet or 1 tablespoon before each of the 3 meals and if necessary at the time of the pain, without exceeding 6 catches per day.
