Summary of Product Characteristics (SmPC) - J.L. Braggs Medicinal Charcoal powder B.P.C
1 NAME OF THE MEDICINAL PRODUCT
JL Braggs Medicinal Charcoal Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Activated charcoal powder, 100%
3 PHARMACEUTICAL FORM
Powder
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:
A teaspoonful of powder mixed into a glass of water taken 3 times a day. Take before or after meals.
Children under 12 years: Not recommended.
4.3 Contraindications
Hypersensitivity to the active substance, activated charcoal.
4.4 Special warnings and precautions for use
If taking other medication, consult a pharmacist or doctor before taking JL Braggs Medicinal Charcoal Powder.
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 Powder may be used during pregnancy or breast-feeding.
4.7 Effects on ability to drive and use machines
JL Braggs Medicinal Charcoal Powder has 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
None.
6.2 Incompatibilities
None Known.
6.3 Shelf life
1 year
6.4 Special precautions for storage
Store below 25°C. Store in the original container.
6.5 Nature and contents of container
Paper sacks, 20kg.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
J L Bragg Limited
33 Boss Hall Road
Ipswich
Suffolk
IP1 5BN
8. MARKETING AUTHORISATION NUMBER
PL 00726/5003R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 20 April 1989
Date of latest renewal: 16 February 2005
10 DATE OF REVISION OF THE TEXT
09/01/2018