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HAMAMELIS WATER B.P.C.

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Hamamelis Water B.P.C.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Double Distilled Extract of Witch Hazel.
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Topical solution

4

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
For the treatment of bruises, sprains and also for minor scalds and burns where
the skin is unbroken.

4.2.

Posology and Method of Administration
Adults, the elderly and children
Apply undiluted to the affected area and bandage; Keep the bandage moist
with witch hazel.
Route of administration
Topical - for external use only.

4.3.

Contra-indications

Hypersensitivity to hamamelis water.

4.4.

Special Warnings and Special Precautions for Use
The product is for external use only and should not be taken by mouth.
It should not be used on inflamed or broken skin.

4.5. Interactions with other Medicinal Products and other Forms of
Interaction
None known.

4.6.

Pregnancy and Lactation
No significant problems have been reported though, as with all medicines, it
should be used under medical supervision in pregnant or lactating women.

4.7.

Effects on Ability to Drive and Use Machines
None known.

4.8.

Undesirable Effects
No significant undesirable effects are known.

4.9.

Overdose
As the product is for external use only the likelihood of overdose due to
ingestion is small; should it occur then treatment includes induction of emesis
followed by supportive therapy accompanied by gastric lavage.

5

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties

Hamamelis Water B.P.C. has been used as a traditional embrocation but
exactly how it functions and to what degree have not been clearly established.
Likewise mild astringent and local anaesthetic properties have also
traditionally been attributed to it.

5.2.

Pharmacokinetic Properties
Little information regarding the pharmacokinetics of the active principle are
available in the literature.

5.3.

Preclinical Safety Data
No relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Ethanol 96%
Purified Water

6.2.

Incompatibilities
No significant incompatibilities have been reported.

6.3.

Shelf Life
36 months.

6.4.

Special Precautions for Storage
Do not store above 25°C.

6.5.

Nature and Contents of Container

2000 ml dispensing pack
White polythene bottle; white plastic screw cap with an aluminium foil lined
EPE liner.
500 ml dispensing pack
White polythene bottle; plastic wadless screw cap.
100/200 ml OTC packs
Amber glass bottle; white plastic "J" cap.
Not all pack sizes may be marketed.

6.6.

Instruction for Use/Handling
None.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom.

8.

MARKETING AUTHORISATION NUMBER
PL 18374/0039

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
14th April 2005

10

DATE OF REVISION OF THE TEXT
14/04/2005

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