NOTICE
ANSM - Updated on: 09/09/2015
Name of the medicinal product
POLYSILANE UPSA, oral sachet-dose gel
dimethicone
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Review summary
In this notice :
1. WHAT IS POLYSILANE UPSA, oral sachet-dose oral and WHAT IT IS USED FOR?
2. BEFORE YOU TAKE POLYSILANE UPSA, oral sachet-dose gel?
3. HOW TO TAKE POLYSILANE UPSA, oral gel in a sachet-dose?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE POLYSILANE UPSA, oral gel in sachet-dose?
6. ADDITIONAL INFORMATION
1. WHAT IS POLYSILANE UPSA, oral sachet-dose oral and WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTIFLATULANT.
Therapeutic indications
This medication is indicated in the adjunctive treatment of pain, burns, heartburn and stomach bloating.
2. BEFORE YOU TAKE POLYSILANE UPSA, oral sachet-dose gel?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never take POLYSILANE UPSA oral gel in a sachet-dose:
In case of allergy to any of the ingredients, including propyl parahydroxybenzoate, azorubine (E122) and cochineal red (E124).
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 POLYSILANE UPSA oral sachet-dose gel:
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 4.68 kcal per sachet of POLYSILANE.
This medicine contains azo dyes (cochineal red and azorubine) and may cause allergic reactions.
This medication contains propyl parahydroxybenzoate and may cause allergic reactions.
Interaction with other medicines
Taking or using 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 will only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
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
Important information about some of the ingredients of POLYSILANE UPSA oral gel in sachet-dose:
List of excipients with known effect: Sucrose, azorubine (E122), cochineal red (E124), sorbitol, propyl parahydroxybenzoate (E216).
3. HOW TO TAKE POLYSILANE UPSA, 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
One sachet before the three main meals and, if necessary, at the time of the pain, without exceeding 6 catches per day.
Method and route of administration
Oral use.
The gel should be absorbed as it is (without water).
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
If you forget to take POLYSILANE UPSA oral gel in sachet-dose:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, POLYSILANE UPSA oral sachet-dose oral gel is likely to have side effects, although not everyone is subject to it.
· 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.
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 POLYSILANE UPSA, oral gel in sachet-dose?
Keep out of the reach and sight of children.
Expiration date
Do not use POLYSILANE UPSA oral gel in a sachet-dose after the expiry date which is stated on the carton.
Storage conditions
No special precautions for storage.
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 contains POLYSILANE UPSA oral sachet-dose gel?
The active substance is:
Dimethicone ................................................. .................................................. 2.22500 g
For a sachet-dose.
The other components are:
Artificial aroma raspberry *, azorubine, red cochineal A, guar gum, sucrose palmitate, soda propyl parahydroxybenzoate, sorbic acid, sorbitol, sucrose, purified water.
* Composition of the artificial aroma raspberry: amyl acetate, amyl valerianate, butyric ether, wine leaven essence, formic ether, ethyl vanillin, concrete iris, C 14 aldehyde, C 16 aldehyde, ionone.
Pharmaceutical form and content
What is POLYSILANE UPSA, oral gel in sachet-dose and contents of the pack?
This medication is in the form of an oral gel in a sachet-dose. Box of 12 or 30 sachets-doses.
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
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
exploiting
UPSA SAS
3 RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Maker
UPSA SAS
979, AVENUE DES PYRENEES
47520 THE PASSAGE
or
UPSA SAS
304, AVENUE JEAN BRU
47000 AGEN
or
FARMACLAIR
440 avenue du Général de Gaulle
14200 HEROUVILLE SAINT CLAIR
Names of the medicinal product in the Member States of the European Economic Area
In accordance with the regulations.
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.