Bedelix box of 30 sachets

1. WHAT IS BEDELIX, powder for oral suspension in sachet AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

This medicine works by protecting the walls (mucous membranes) of your stomach and intestine.

Therapeutic indications

This medicine is used in the symptomatic treatment of functional colopathy, i.e. to treat the symptoms associated with a functional colon disease (a disease that affects the proper functioning of the intestine).

2. WHAT YOU SHOULD KNOW BEFORE TAKING BEDELIX, powder for drinkable suspension in sachet?

List of information needed before taking the medicine

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

Contraindications

Do not take BEDELIX, powder for drinkable suspension in sachet:

• - If you are allergic to the active substance (beidellitic montmorillonite) or to any of the other components contained in BEDELIX (for a list of components see section 6).
• - If you have a disease that causes a narrowing of your digestive tract.

Precautions for use; special warnings

Be careful with BEDELIX, powder for drinkable suspension in sachet:

If you are on dialysis, this means that your kidneys are not working properly and your kidneys will have difficulty eliminating the aluminium hydroxide contained in this medicine. In this case, you should not take this medicine for a prolonged period without talking to your doctor.

This medicine should not be used in patients with glucose and galactose malabsorption syndrome.

Interactions with other medicines

Taking other medicines

BEDELIX and another medicine should be taken at intervals to avoid reducing the effectiveness of the other treatment.

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

Food and drink

BEDELIX should be taken between meals or slightly before.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and lactation

This medicine should be used with caution during pregnancy and lactation.

In general, if you are pregnant or breastfeeding, always ask your doctor or pharmacist before taking any medication.

Sportsmen

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with a known effect

Important information about some ingredients of BEDELIX, powder for oral suspension in sachet

Glucose.

3. HOW TO TAKE BEDELIX, powder for oral suspension in sachet

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Always follow the dose indicated by your doctor. If in doubt, consult your doctor or pharmacist.

In general, the usual oral dosage is

• - Adults:
  3 sachets per day on average.
• - Children:
  before 2 years: 1/2 sachet once or twice a day;
• - from 2 to 5 years old

The contents of one sachet should be dissolved in half a glass of water or mixed with a semi-liquid food such as porridge, compote, purée, etc.

If your doctor has recommended that you use BEDELIX rectally.

In this case, take 1 to 3 sachets of BEDELIX 1 to 3 times a day.

Dissolve the contents of the sachet(s) in 100 ml of lukewarm water. Then introduce the suspension obtained into the rectum with an enema bulb.

Frequency of administration

BEDELIX should preferably be taken between meals or shortly before.

Duration of treatment

Your doctor will tell you how long you should take this medicine. If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.

Symptoms and instructions in case of overdose

If you have taken more BEDELIX, powder for oral suspension in a sachet than you should have:

Overdose in children may result in vomiting; if you have given more BEDELIX than you should, consult a doctor.

Instructions in case of missed dose(s)

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, BEDELIX, powder for drinkable suspension in sachet is likely to have side effects, although not everyone is subject to them.

Reported side effects include rash, angioedema, itching and hives.

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

5. HOW TO USE BEDELIX, powder for drinkable suspension in sachet?

Keep out of the reach and sight of children.

Expiry date

Do not use BEDELIX, powder for oral suspension in sachet after the expiry date stated on the pack. The expiry date refers to the last day of the month.

Conditions of storage

No special storage precautions.

If necessary, warnings against certain visible signs of deterioration

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

6. ADDITIONAL INFORMATION

Full list of active ingredients and excipients

What does BEDELIX powder for oral suspension in sachet contain?

The active substance is:

Beidellitic montmorillonite ............................................................................................................. 3,000 g

For one sachet of 3.925 g.

The other components are:

Codried magnesium carbonate aluminium hydroxide gel, liquorice extract, vanillin, sodium saccharin, glucose hydrate.

Pharmaceutical form and content

What is BEDELIX, powder for drinkable suspension in sachet and what does it contain?

This medicine comes as a whitish powder in a sachet. Boxes of 30, 60 or 100 sachets.

Not all presentations may be marketed.

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

Holder

IPSEN PHARMA

65, QUAI GEORGES GORSE

92100 BOULOGNE BILLANCOURT