Distilled Witch Hazel BPC (Boots Company plc)

Summary of Product Characteristics Updated 30-Aug-2023 | THE BOOTS COMPANY PLC

1. Name of the medicinal product

Distilled Witch Hazel BPC

2. Qualitative and quantitative composition

Active Ingredient

% V/V

Hamamelis water

100

3. 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 or search Yellow Card in the Google Play or Apple App Store.

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 and other handling

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

Date of First Authorisation:

2 August 1983

Date of Last Renewal:

23 February 1996

10. Date of revision of the text

24th July 2023

Company Contact Details
THE BOOTS COMPANY PLC
Address

1 Thane Road West, Beeston, Nottingham, NG2 3AA

Fax

+44 (0)1159 592 565

Telephone

+44 (0)1159 595 165