NOTICE
ANSM - Last updated: 02/03/2016
Name of the medicinal product
BELLOC CHARCOAL 125 mg, soft capsule
Activated charcoal
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
This is an authorized and controlled medicinal product (see Identification No on the outer packaging)
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist beyond 5 to 10 days, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
Do not use this medication for children.
Review summary
What this leaflet contains:
1. What is BELLOC CHARCOAL 125 mg, soft capsule and in which cases is it used?
2. What should be known before taking BELLOC CHARBON 125 mg, soft capsule?
3. How to take BELLOC CHARCOAL 125 mg, soft capsule?
4. What are the possible side effects?
5. How to store BELLOC CHARCOAL 125 mg, soft capsule?
6. Additional information.
1. WHAT COAL OF BELLOC 125 mg, soft capsule AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
This drug contains charcoal, it is an intestinal adsorbent.
Pharmacotherapeutic group: A07BA01
Therapeutic indications
This medication is indicated in adults and adolescents over 15 years of age in cases of intestinal bloating and flatulence, in addition to hygiene-dietetic measures.
2. BEFORE YOU TAKE CHARCOAL OF BELLOC 125 mg, soft capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take BELLOC CHARCOAL 125 mg, soft capsule:
· if you have a slowing down of intestinal transit,
· if you are allergic to peanut or soy because of the presence of soybean oil, or to any of the other ingredients of this medication mentioned in section 6.
Precautions for use; special warnings
In case of bloating, flatulence, avoid:
· Foods containing air (soft drinks, fresh bread).
· Foods rich in nonabsorbable carbohydrates (pulses, cabbage, raw vegetables, onions).
In case of associated diarrhea, it is necessary to:
· Rehydrate with abundant, salty or sweetened beverages to compensate for fluid losses due to diarrhea (the average adult daily water intake is 2 liters).
· Feeding the time of diarrhea:
- excluding certain intakes and in particular raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks,
- favoring grilled meats, rice.
Interaction with other medicines
As a precautionary measure, activated charcoal should be taken at a distance from any other medicinal product (more than 2 hours if possible). This concerns in particular the administration of acetylsalicylic acid, H2 antihistamines and lansoprazole, bisphosphonates, catioresins, certain classes of antibiotics (fluoroquinolones, cyclines, lincosanides) and certain antituberculosis drugs, digitalis, glucocorticoids, thyroid hormones, phenothiazine neuroleptics, sulpiride, certain beta-blockers, penicillamine, ions (iron, phosphorus, fluorine), chloroquine, dolutegravir, fexofenadine, elvitegravir, rosuvastatin, teriflunomide, 'ulipristal.
Inform your pharmacist if you are taking, have recently taken or may take any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
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.
feeding
It is possible to take this medication while breastfeeding.
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
List of excipients with a known effect: soybean oil.
3. HOW TO TAKE CHARCOAL OF BELLOC 125 mg, soft capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Reserved for adults and adolescents over 15 years of age.
2 capsules, 2 to 3 times a day.
Administration mode
Orally, swallow the capsule as it is with a glass of water.
Frequency of Administration
2 to 3 times a day.
Duration of treatment
5 to 10 days, if symptoms persist or worsen medical advice is required.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
If you forget to take CHARCOAL BELLOC 125 mg, soft capsule, do not take double dose to make up for the dose you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
In some people, this medicine may cause more or less annoying effects, such as dark colouration of the stools.
Declaration of side effects
If you experience any side effects, talk to your pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE CHARCOAL OF BELLOC 125 mg, soft capsule?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Storage conditions
This medicine does not require special precautions for storage.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
· The active substance is activated charcoal.
· The other components are: soybean oil, yellow beeswax, soy lecithin, glycerol and gelatin.
Pharmaceutical form and content
This medication is in the form of soft capsules in platelets of 36 or 60, or in a box of 36.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Marketing Authorization Holder and Manufacturer
Holder
SUPER DIET LABORATORIES
8 RUE CHRISTOPHE COLOMB
75008 PARIS
exploiting
SUPER DIET LABORATORIES
STREET VICTOR HUGO
BP 70010
59721 DENAIN CEDEX
Maker
SUPER DIET LABORATORIES
STREET VICTOR HUGO
BP 70010
59721 DENAIN CEDEX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this notice was revised is <{MM / YYYY}> <{month YYYY}.>
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.