CHARBON DE BELLOC 125 mg soft capsule B/60

Activated charcoal........................................................................................................................................ 125,0 mg

For one soft capsule.

Excipient with known effect: one soft capsule contains 270 mg of soybean oil.

Symptomatic treatment of abdominal bloating (flatulence) in adults and adolescents over 15 years of age, as a complement to hygiene and dietary measures.

Dosage

2 capsules, 2 to 3 times a day.

Method of administration

Oral use.

Swallow the capsule whole with a glass of water.

Duration of treatment

5 to 10 days.

If symptoms persist or worsen, medical advice is required.

Intestinal hypomotility.

Due to the presence of soybean oil, this medicine is contraindicated in cases of allergy to peanut or soy.

BELLOC CHARCOAL 125 mg, soft capsule contains soybean oil and may cause hypersensitivity reactions (urticaria, anaphylactic shock).

In case of associated diarrhoea, the need for rehydration should be assessed.

The extent of rehydration by oral rehydration solution or by intravenous route must be adapted according to the intensity of the diarrhoea, the age and the particularities of the patient (associated diseases…).

Due to the properties of charcoal, the potential reduction in drug absorption means that any other medication should be administered at a distance (more than 2 hours, if possible) from the intake of this medicine.

Associations requiring precautions for use

As a precaution, activated charcoal should be taken at a distance from any other medicine (more than 2 hours, if possible). This concerns in particular acetylsalicylic acid, H2 antihistamines and lansoprazole, bisphosphonates, cation exchange resins, certain classes of antibiotics (fluoroquinolones, cyclines, lincosamides) and certain antituberculosis agents, digitalis glycosides, glucocorticoids, thyroid hormones, phenothiazine neuroleptics, sulpiride, certain beta-blockers, penicillamine, ions (iron, phosphorus, fluoride), chloroquine, dolutegravir, fexofenadine, elvitegravir, rosuvastatin, teriflunomide, ulipristal.

Pregnancy

No teratogenesis study is available in animals.

In clinical use, charcoal use in limited numbers has apparently revealed no teratogenic or fetotoxic effect to date. However, epidemiological studies are needed to verify the absence of risk.

Consequently, given the absence of absorption of charcoal, the use of this medicine should only be considered during pregnancy if necessary.

Breast-feeding

Taking this medicine is possible during breastfeeding.

The use of this medicine at high doses may cause darker discolouration of the stools.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Pharmacotherapeutic class: Intestinal adsorbent (A – alimentary tract and metabolism), ATC code: A07BA01.

3 years.

Metal box : Store at a temperature not exceeding 25°C. Keep the metal box carefully closed, protected from moisture.

Blister packs : 

-          Climatic zones I and II: This medicine does not require any particular storage precautions.

-          Climatic zones III and IV: Store at a temperature not exceeding 25°C and protected from moisture.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.