Polysilane UPSA oral gel 12 sachets/dose

1. WHAT IS POLYSILANE UPSA, oral gel in a sachet and WHAT IS IT USED FOR?

Pharmacotherapeutic class

ANTIFLATULANT.

Therapeutic indications

This medicine is indicated in the adjunctive treatment of pain, burning, heartburn of the stomach and in intestinal bloating.

2. WHAT YOU SHOULD KNOW BEFORE TAKING POLYSILANE UPSA, oral gel in a sachet?

List of information needed before taking the medicine

If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.

Contraindications

Do not take POLYSILANE UPSA, oral gel in a sachet:

In case of allergy to any of the constituents, especially propyl parahydroxybenzoate, azorubin (E122) and cochineal red (E124).

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Precautions for use; special warnings

Be careful with POLYSILANE UPSA, oral gel in sachet:

This medicine should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare metabolic diseases).

This medicine contains 3.5 g of sucrose per dosage unit, which must be taken into account in the daily diet in case of low sugar diet or diabetes.

The use of this medicine is not recommended in patients with fructose intolerance (a rare hereditary disease).

Due to the presence of sorbitol, this medicine may cause mild digestive disorders (diarrhoea).

Caloric value 2.6 kcal/g of sorbitol or 4.68 kcal per sachet of POLYSILANE.

This medicine contains azoic colouring agents (cochineal red and azorubin) and may cause allergic reactions.

This medicine contains propyl parahydroxybenzoate and may cause allergic reactions.

Interactions with other medicines

Taking or using other medicines

Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Interactions with food and drink

Not applicable

Interactions with herbal products or alternative therapies

Not applicable

Use during pregnancy and lactation

Pregnancy and lactation

This medicine should only be used during pregnancy on the advice of your doctor.

If you discover that you are pregnant during treatment, consult your doctor, as only he or she can judge whether it is necessary to continue the treatment.

Ask your doctor or pharmacist for advice before taking any medicine.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Not applicable.

List of excipients with a known effect

Important information about some ingredients of POLYSILANE UPSA, oral gel in sachet:

List of excipients with a known effect: Sucrose, azorubin (E122), cochineal red (E124), sorbitol, propyl parahydroxybenzoate (E216).

3. HOW TO TAKE POLYSILANE UPSA, oral gel in a sachet?

Instructions for proper use

Not applicable.

Dosage, Method 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 pain, without exceeding 6 doses per day.

Method and route of administration

Oral use.

The gel should be taken as is (without water).

Symptoms and instructions in case of overdose

Not applicable.

Instructions in case of missed dose(s)

If you forget to take POLYSILANE UPSA, oral gel in a sachet:

Do not take a double dose to make up for the dose you forgot to take.

Risk of withdrawal syndrome

Not applicable.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, POLYSILANE UPSA, oral gel in a sachet, is likely to have undesirable effects, although not everyone is subject to them.

Possibility ofdigestive disorders and diarrhea;

Risk ofallergic reactions, especially due to the presence of azorubin and cochineal red A;

risk ofcontact eczema;

exceptionally: immediate reactions with urticaria and bronchospasm.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.

5. HOW TO CONSERVE POLYSILANE UPSA, oral gel in sachet?

Keep out of the reach and sight of children.

Expiry date

Do not use POLYSILANE UPSA, oral gel in a sachet after the expiry date stated on the box.

Storage conditions

No special storage precautions.

If necessary, warnings against certain visible signs of deterioration

Do not dispose of the medicine in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

Full list of active ingredients and excipients

What does POLYSILANE UPSA, oral gel in a sachet, contain?

The active substance is:

Dimeticone .................................................................................................................................... 2.2500 g

For one sachet.

The other components are:

Artificial raspberry flavour*, azorubin, cochineal red A, guar gum, sucrose palmitate, sodium propyl parahydroxybenzoate, sorbic acid, sorbitol, sucrose, purified water.

*Composition of the artificial raspberry flavour: amyl acetate, amyl valerianate, butyric ether, essence of wine lees, formic ether, ethyl vanillin, concrete iris, aldehyde C 14, aldehyde C 16, ionone.

Pharmaceutical form and contents

What is POLYSILANE UPSA, oral gel in a sachet and what does it contain?

This medicine is presented as an oral gel in a sachet. Box of 12 or 30 sachets.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

BRISTOL - MYERS SQUIBB

3, RUE JOSEPH MONIER

92500 RUEIL-MALMAISON