Carbolevure Adult 30 capsules

In this manual :

1. WHAT IS CARBOLEVURE ADULT, capsule AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE TAKING CARBOLEVURE ADULT, capsule?

3. HOW DO I TAKE CARBOLEVURE ADULT, capsule?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE CARBOLEVURE ADULT, capsule?

6. ADDITIONAL INFORMATION

1. WHAT IS CARBOLEVURE ADULT, capsule and WHAT IS IT USED FOR?

INTESTINAL ADSORBENT/SUBSTITUTE FLORA

(A: digestive system and metabolism).

This medicine is indicated in adults:

- in cases of difficult digestion, particularly with intestinal bloating

- in addition to rehydration and/or dietary measures, in the symptomatic treatment of diarrhoea

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING CARBOLEVURE ADULT, capsule?

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Never use CARBOLEVURE ADULT, capsule:

- If you are allergic (hypersensitive) to any of the ingredients

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

Be careful with CARBOLEVURE ADULT, capsule:

Special warnings

In case of diarrhoea, you should consult your doctor promptly in the following cases:

- if there is no improvement after 2 days of treatment,

- if you develop a fever or vomiting,

- in case of blood or mucus in the stools,

- in case of intense thirst, dry tongue sensation. In fact, these signs indicate the beginning of dehydration, i.e. a significant loss of liquid due to diarrhoea. Your doctor will then judge the need to prescribe rehydration, which may be oral or intravenous.

Precautions for use

- In case of bloating, flatulence, avoid dried vegetables (lentils, flageolets, peas...) as well as certain green vegetables (cabbage, Brussels sprouts, chard...).

- In case of diarrhea, it is necessary to:

o rehydrate with abundant drinks, salty or sweet, in order to compensate for the loss of liquid due to diarrhea (the average daily water intake of an adult is 2 liters)

o eat during the time of the diarrhea,

§ by excluding certain foods, especially raw vegetables, fruits, green vegetables, spicy dishes, and iced foods or drinks.

by favouring grilled meats and rice.

IF IN DOUBT, DO NOT HESITATE TO CONSULT YOUR DOCTOR OR PHARMACIST.

Taking or using other medicines

As this medicine may reduce the absorption of other medicines, they should be administered at a distance from it (more than 2 hours, if possible).

IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL DRUGS, YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS.

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Pregnancy and breastfeeding

It is preferable not to use this medicine during pregnancy.

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

In general, during pregnancy and breastfeeding, always ask your doctor or pharmacist for advice before taking any medication.

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3. HOW TO TAKE CARBOLEVURE ADULT, capsule?

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Dosage

For adults only

Oral use.

3 capsules per day.

Swallow the capsules as is with a glass of water.

Mode and route of administration

Oral use.

Frequency of administration

The capsules should be swallowed unopened with a glass of water, preferably outside of mealtimes.

If you have taken more CARBOLEVURE ADULT, capsule than you should have:

Taking high doses of Carbolevure may result in mild constipation. Treatment will be symptomatic. Ask your doctor or pharmacist for advice.

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Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, CARBOLEVURE ADULT, capsule is likely to have undesirable effects, although not everyone is subject to them.

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 CARBOLEVURE ADULT, capsule

Keep out of the reach and sight of children.

Do not use CARBOLEVURE ADULT capsules after the expiry date stated on the outer packaging.

Store at a temperature not exceeding 30°C.

Medicines should not be disposed of down the drain or in the household garbage. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

What does CARBOLEVURE ADULT capsules contain?

The active ingredients are:

Live dried yeast containing at least¹⁰⁸ Saccharomyces cerevisiae cells per gram 108.5 mg

Activated carbon .............................................................................................................................. 109.0 mg

For one capsule.

Other components are:

Polyvidone K30, colloidal silica.

Capsule shell composition:

- head: black iron oxide - titanium dioxide - gelatin.

- body: erythrosine - red iron oxide - titanium dioxide - gelatine.

What is CARBOLEVURE ADULT, capsule and what does it contain?

This medicine is presented in capsule form. Box of 20, 30, 40 or 60 capsules.

Holder

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE-BILLANCOURT

Operator

PIERRE FABRE MEDICAMENT

29, AVENUE DU SIDOBRE

81106 CASTRES CEDEX

Manufacturer

NEXTPHARMA S.A.S

17, ROUTE DE MEULAN

78520 LIMAY

or

PIERRE FABRE MEDICAMENT PRODUCTION

ETABLISSEMENT PROGIPHARM

RUE DU LYCEE

45500 GIEN

Not applicable.

The last date of approval of this package insert was {date}.

Not applicable.

Detailed information on this medicinal product is available on the website of Afssaps (France).

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Not applicable.