Summary of medicine characteristics - COMPOUND BENZOIN TINCTURE B.P
1. NAME OF THE MEDICINAL PRODUCT
Compound Benzoin Tincture BP or Friars’ Balsam BP.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoin (Ground) 10.0 % w/v
Prepared Storax 10.0% w/v
Aloes 2.0% w/v.
3. PHARMACEUTICAL FORM
Concentrate for inhalation solution.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the relief of colds and laryngitis.
4.2. Posology and method of administration
Adults the elderly and children over 3 months
Add one 5 ml spoonful to a pint of hot, but not boiling, water and inhale the vapour.
Children under 3 months
Not recommended for children under 3 months.
Route of administration
Inhalation of the vapours released by the addition of the product to hot water.
4.3. Contraindications
Apart from the possibility of skin sensitisation (See 4.8 below) in a few persons using the product, no other contraindications have been reported.
4.4. Special warnings and precautions for use
If symptoms persist consult your doctor.
4.5. Interactions with other medicinal products and other forms of interaction
No significant interactions have been reported.
4.6. Pregnancy and lactation
No significant problems have been reported either with pregnant women or with nursing mothers who are breast feeding; However, as with many other medicines, its use, especially in the first three months of pregnancy, is recommended only when the benefits outweigh any risks.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Skin sensitisation has been reported.
4.9. Overdose
Overdosage is unlikely to present a significant risk but if it does occur then the treatment consists of general supportive therapy and may include gastric lavage.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Benzoin
It is reported to have expectorant properties in the relief of catarrh and congestion of the upper respiratory tract.
Storax (Prepared)
It is reported to have a similar action to Benzoin in the relief of catarrh and congestion of the upper respiratory tract.
Aloes
It is uncertain what pharmacological action it plays when used in Compound Benzoin Tincture B.P. as a treatment for the relief of catarrh and congestion of the upper respiratory tract.
5.2. Pharmacokinetic properties
Benzoin / Storax (Prepared) / Aloes
Little information is available in the literature regarding the pharmacokinetic particulars of these three compounds when administered by nasal inhalation of the vapours released when the product is added to hot water.
5.3. Preclinical safety data
No relevant data.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Ethanol 96%
Potable water.
6.2. Incompatibilities
No significant major incompatibilities have been reported other than the fact that solid material is precipitated on addition of water.
6.3. Shelf life
60 months.
6.4. Special precautions for storage
Do not store above 25°C.