SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Potter’s Heartburn Relief Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains: -

160 mg Meadowsweet herb (Filipendula ulmaria ( L.) Maxim)

40 mg Activated Charcoal

For full list of excipients see Section 6.1.

3    PHARMACEUTICAL FORM

Tablet; film coated.

A black round film coated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of indigestion, heartburn and stomach ache, based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly: Two tablets three times a day after meals.

Not recommended for children and adolescents under 18 years of age. (See section 4.4 “Special warnings and precautions for use.”)

If symptoms worsen or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients, salicylates or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or do not improve after one week, a doctor or a qualified healthcare practitioner should be consulted.

Not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used concomitantly with salicylates and other NSAIDs without medical advice.

4.6 Fertility, Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.

Studies on fertility have not been carried out.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

None Known

If other adverse reactions occur, a doctor or a qualified healthcare practitioner should be consulted.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

No cases of overdose have been reported.

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2    Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3    Preclinical safety data

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Calcium Hydrogen Phosphate Microcrystalline Cellulose Stearic Acid

Colloidal Anyhdrous Silica Rhubarb Powder Cinnamon Powder Cardamom Powder Aniseed Oil Caraway Oil Magnesium Stearate

Clear film coating containing hypromellose, glycerol and hydroxypropyl cellulose

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years.

28/09/2015