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J.L. BRAGGS MEDICINAL CHARCOAL TABLETS BPC 1934 300 MG - summary of medicine characteristics

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Summary of medicine characteristics - J.L. BRAGGS MEDICINAL CHARCOAL TABLETS BPC 1934 300 MG

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

JL Braggs Medicinal Charcoal Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

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

5.3 Preclinical safety data

None available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose (Icing sugar), Potato starch, Gum 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 in order to protect from moisture.

6.5 Nature and contents of container

A cardboard drum with plastic lid containing 50 tablets.

A plastic pot with plastic lid containing 100 or 250 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

6.6 Special precautions for disposal

No special requirements for disposal.

7 MARKETING AUTHORISATION HOLDER

7 MARKETING AUTHORISATION HOLDER

J L Bragg Limited

33–35 Boss Hall Road

Ipswich

Suffolk

IP1 5BN

8. MARKETING AUTHORISATION NUMBER

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