SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Friars Balsam BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Storax prepared BP 10.0% w/v Benzoin sumatra crushed BP 10.0% w/v

3 PHARMACEUTICAL FORM

Tincture

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

1.    As an inhalant for relief of the symptoms of colds.

2.    As a mild antiseptic dressing.

4.2. Posology and Method of Administration

1.    Through the mouth and nasal passages.

2.    Topical.

1.    As an inhalant

Adults, children over 3 months of age and the elderly: add one 5ml spoonful to a pint of hot, but not boding water.

The dose may be repeated after 4 hours if required.

The product is suitable for use under this clinical indication by adults, children over 3 months and the elderly.

Not suitable for children under 3 months of age.

2.    As an antiseptic

Adults, children and the elderly: apply undiluted to the affected area twice daily. The product is suitable for use under this clinical indication by adults, children and the elderly.

Contraindicated in patients with known sensitivity to Sumatra benzoin or storax.

4.4. Special Warnings and Precautions for Use

Not suitable for children under 3 months when used as an inhalant. For external use only.

Keep all medicines away from children.

Caution: Highly flammable. Keep away from a naked flame.

4.5. Interactions with other Medicaments and other forms of Interaction

None known.

4.6. Pregnancy and Lactation

Use of this product by the indicated routes is not considered likely to cause any undesirable effects in the above conditions.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8. Undesirable effects

Allergic contact dermatitis

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

This product is for external use only. Accidental ingestion is likely to cause a severe burning sensation in the mouth and mucous membranes due to the high alcohol content and the bitter taste of the aloes and balsamic acids. Dilution of the product in the mouth will cause the separation of an unpleasant gummy residue. It is considered unlikely that a significant quantity could be swallowed. However the main effects would be those of alcohol intoxication.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Sumatra benzoin has been used as an ingredient in inhalations used in the treatment of catarrh of the upper respiratory tract for many years. It has also been used topically for its antiseptic and protective properties.

Storax has mild antiseptic action.

5.2.    Pharmacokinetic Properties

No information available.

5.3.    Preclinical Safety Data

None.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Aloes powdered BP,

Purified water BP,

Ethanol (96%) BP.

6.2.    Incompatibilities

None known.

6.3 Shelf life

36 months unopened.

6.4. Special Precautions for Storage

Store below 25°C.

6.5 Nature and contents of container

50ml Glass bottle with a 28mm polypropylene cap with tamper evident band and EPE/Saranex Liner.

6.6.    Instruction for Use/Handling

None.

7    MARKETING AUTHORISATION HOLDER

L.C.M. Limited.,

Linthwaite Laboratories

Huddersfield

HD75QH

England

8    MARKETING AUTHORISATION NUMBER(S)

PL 12965/0002

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/03/2001

10    DATE OF REVISION OF THE TEXT

19/10/2013