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DISTILLED WITCH HAZEL

Active substance(s): HAMAMELIS WATER / HAMAMELIS WATER / HAMAMELIS WATER

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Distilled Witch Hazel BPC

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Hamamelis water

3

% V/V
100

PHARMACEUTICAL FORM
Topical Solution.

4

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.

5

PHARMACOLOGICAL 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
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
December 2014

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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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