FRIARS BALSAM BP - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Friars Balsam BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Storax prepared 10.0% w/v

Benzoin sumatra crushed 10.0% w/v

Excipients with known effect

Ethanol 86.2% v/v

For the full list of excipients, see section 6.1.

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.

4.3. Contra-indications

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.

Keep all medicines out of the sight and reach of children.

Caution: Highly flammable. Instruct patients to keep away from naked flames, lit cigarettes and some devices (e.g. hairdryers).

Ingredients of known effect:

This medicine contains 3448mg or 86.2% v/v of alcohol (ethanol) per 5ml dose. The amount in 5ml of this medicine is equivalent to 87ml of beer or 35ml of wine. The amount of alcohol in this medicine is not likely to have an effect on adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy.

A dose of 5ml of this medicine administered to an adult weighing 70kg would result in exposure to 49.2mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 8.62mg/100ml. For comparison, for an adult drinking a glass of wine or 500ml of beer, the BAC is likely to be about 50mg/100ml.

If patients are pregnant, breast-feeding or addicted to alcohol, they should discuss with their doctor or pharmacist before using this product.

This medicine may cause burning sensation on damaged skin.It may cause burning sensation on damaged skin.

4.5. Interactions with other medicinal products and other forms of interaction

Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.

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 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 for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

4.9. Overdose

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.