Summary of Product Characteristics (SmPC) - J.L. Braggs Medicinal Charcoal tablets BPC 1934 300 mg
1 NAME OF THE MEDICINAL PRODUCT
JL Braggs Medicinal Charcoal Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Activated charcoal, 300mg
Excipient with known effect, sucrose.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Tablet
Black, biconvex tablet (about 11 mm in diameter).
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The symptomatic relief of indigestion, wind, heartburn, dyspepsia, and flatulence.
4.2 Posology and method of administration
Dosage: Adults, including elderly and children over 12 years:
2-4 tablets taken 3 times a day. The tablets may be swallowed whole with water or may be chewed.
Take before or after meals.
Children under 12 years: Not recommended.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1..
4.4 Special warnings and precautions for use
If taking other medication, consult a pharmacist or doctor before taking JL Braggs Medicinal Charcoal Tablets.
JL Braggs Medicinal Charcoal Tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
If taking other medication, consult a pharmacist or doctor before taking JL Braggs Medicinal Charcoal Powder. Activated charcoal is a powerful adsorbent and may reduce the effect of other medicines.
4.6 Fertility, pregnancy and lactation
JL Braggs Medicinal Charcoal Tablets may be taken during pregnancy or breast-feeding.
4.7 Effects on ability to drive and use machines
JL Braggs Medicinal Charcoal Tablets have no influence on the ability to drive and use machines.
4.8 Undesirable effects
Regular use may cause a darkening 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 reactions via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
With overdose discontinue medication.
5 PHARMACOLOGICAL PROPERTIES
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Alimentary Tract and Metabolism, ATC code: A07BA01
Traditionally used to adsorb gastro-intestinal gases, thus relieving the discomfort caused by indigestion, flatulence, dyspepsia, wind and heartburn.
5.2 Pharmacokinetic properties
None available.
5.3 Preclinical safety data
None available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Starch
Tragacanth
Magnesium stearate.
6.2 Incompatibilities
None Known.
6.3 Shelf life
36 months.
6.4. Special Precautions for Storage
Store below 25°C.
Keep the bottle tightly closed to protect from moisture.
Store in the original packaging.
6.5 Nature and contents of container
HDPE bottle with LDPE lid containing 50, 100 or 250 tablets.
Blister packs of 250 μm PVC with 25μm hard temper aluminium foil packed in a carton. Pack sizes of 30, 60 and 105 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
J L Bragg (Ipswich) Limited (trading as JL Bragg) 33-35 Boss Hall Road
Ipswich
Suffolk
IP1 5BN
8. MARKETING AUTHORISATION NUMBER
PL 00726/5000R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 19 April 1989
Date of latest renewal: 09 March 2005
10 DATE OF REVISION OF THE TEXT
02/10/2023