DISTILLED WITCH HAZEL BPC - summary of medicine characteristics

Summary of medicine characteristics - DISTILLED WITCH HAZEL BPC

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Distilled Witch Hazel BPC

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient

% V/V 100

Hamamelis water

PHARMACEUTICAL FORM

Topical Solution.

CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of the discomfort of bruises and sprains and minor skin irritations, roughness or soreness.

4.2 Posology and method of administration

Apply undiluted to the affected area and bandage. Keep the bandage moist with Witch Hazel.

For topical application to unbroken skin.

4.3 Contraindications

Hypersensitivity to hamamelis water.

4.4 Special warnings and precautions for use

For external use only on unbroken skin.

Keep all medicines out of the reach of children.

4.5 Interaction with other medicinal products and other forms of interaction No clinically significant drug interactions known.

4.6 Pregnancy and lactation

The safety of Distilled Witch Hazel during pregnancy and lactation has not been established but is unlikely to constitute a hazard.

4.7 Effects on ability to drive and use machines No adverse effects known.

4.8 Undesirable effects

Occasional hypersensitivity reactions.

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

Accidental ingestion of Distilled Witch Hazel may give rise to gastrointestinal discomfort. Treatment should be symptomatic.

PHARMACOLOGICAL PROPERTIESPHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Hamamelis water has cooling, astringent and haemostatic properties.

5.2 Pharmacokinetic properties None stated.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months.

6.4 Special precautions for storage