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DISTILLED WITCH HAZEL BPC

Active substance(s): HAMAMELIS WATER / HAMAMELIS WATER

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Distilled Witch Hazel BPC

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Hamamelis water % V/V 100

3

PHARMACEUTICAL FORM
Topical Solution.

4
4.1

CLINICAL PARTICULARS
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.

4.9

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

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Hamamelis water has cooling, astringent and haemostatic properties.

5.2

Pharmacokinetic properties None stated.

5.3

Preclinical safety data Not applicable.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
None.

6.2

Incompatibilities Not applicable.

6.3

Shelf life 36 months.

6.4

Special precautions for storage
None.

6.5

Nature and contents of container A white flint glass bottle with an aluminium roll-on pilfer-proof cap with a flowed-in liner or a triseal (LDPE/EPE/LDPE) liner. An amber flint glass bottle with an aluminium roll-on pilfer-proof cap with a flowed-in liner or a triseal (LDPE/EPE/LDPE) liner. Alternative cap: a polypropylene wadless tamper evident cap. Pack size: 100ml, 200ml.

6.6

Special precautions for disposal Not applicable.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/5645R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/09/2006

10

DATE OF REVISION OF THE TEXT
20/09/2006

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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