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?
Pharmacotherapeutic class
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?
List of information needed before taking the medicine
Not applicable.
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.
Precautions for use; special warnings
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.
Interactions with other medicines
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.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
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.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO TAKE CARBOLEVURE ADULT, capsule?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
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.
Symptoms and instructions in case of overdose
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.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of 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.
If necessary, warnings against certain visible signs of deterioration
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
Full list of active substances and excipients
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.
Pharmaceutical form and content
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.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
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
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date of approval of this package insert was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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