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THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone: +44 (0)1159 595 165
Fax: +44 (0)1159 592 565

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Summary of Product Characteristics last updated on the eMC: 12/11/2002
SPC Distilled Witch Hazel BPC (Boots Company plc)


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1. NAME OF THE MEDICINAL PRODUCT

Distilled Witch Hazel BPC


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient

% V/V

Hamamelis Water

100


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3. PHARMACEUTICAL FORM

Topical Solution.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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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.


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4.3 Contraindications

Hypersensitivity to hamamelis water.


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4.4 Special warnings and precautions for use

For external use only on unbroken skin.

Keep all medicines out of the reach of children.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions known.


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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.


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4.7 Effects on ability to drive and use machines

No adverse effects known.


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4.8 Undesirable effects

Occasional hypersensitivity reactions.


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4.9 Overdose

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


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Hamamelis water has cooling, astringent and haemostatic properties.


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5.2 Pharmacokinetic properties

None stated.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

None.


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

36 months.


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6.4 Special precautions for storage

None.


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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


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00014/5645R


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation:

2 August 1983

Date of Last Renewal:

23 February 1996


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10. DATE OF REVISION OF THE TEXT

June 2002



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/11158/SPC/


Active Ingredients/Generics

 
  hamamelis