COMPOUND THYMOL GLYCERIN B.P 1988

Active substance: THYMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Compound Thymol Glycerin B.P. 1988

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Thymol 0.05% w/v
Glycerol 10.0% v/v
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Gargle

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
As a gargle and mouthwash it is taken orally but not swallowed.

4.2.

Posology and method of administration
Adults, children and the elderly
Dilute one part with three parts of warm water and use immediately as a gargle
or mouthwash; Do not swallow.
Discard any unused diluted solution.

4.3.

Contraindications
Hypersensitivity to any of the ingredients.

4.4.

Special warnings and precautions for use
The product is to be used after dilution of one part with three parts of warm
water; all unused diluted solution should be discarded due to the possible
contamination with resistant micro-organisms. It should not be swallowed.

4.5.

Interactions with other medicinal products and other forms of interaction
None known.

4.6.

Pregnancy and lactation
No adverse problems have been reported. As with all medicines, is should
only be used under medical supervision in pregnant women or nursing
mothers.

4.7.

Effects on ability to drive and use machines
None.

4.8.

Undesirable effects
It can be irritant to the gastric mucosa; rashes may occur. Its prolonged use
should be avoided.

4.9.

Overdose

The product is not intended for ingestion, but, in the case of ingestion (accidental or
otherwise) resulting in overdosage, treatment measures include gastric lavage with
intensive symptomatic supportive therapy.
The symptoms of acute poisoning (mostly due to borax present in the product at the
2% w/v level) are vomiting and diarrhoea; convulsions, changes in body temperature
and renal damage may occur; cumulative toxicity due to slow excretion may lead to
anorexia, debility, confusion, dermatitis, menstrual disorders, anaemia, convulsions
and alopecia.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
The product is used as a mouthwash and as a gargle and as such has a
mechanical cleansing action and freshens the mouth. Thymol has a
disinfectant action which is diminished through combination with protein
though it is less toxic and has a more powerful disinfectant action than phenol.
Its lower solubility in water than phenol and its loss of potency in the presence
of protein reduce its overall effectiveness as a disinfectant.
Glycerol is used mainly as a solvent for the thymol and the various essential
oils and other substances which are used as flavouring agents in the product.

5.2.

Pharmacokinetic properties
Thymol is absorbed from the intestine and excreted in the urine as unchanged
drug and as the glucuronide.
Glycerol is absorbed from the intestine and metabolised as carbon dioxide and
glycogen or it is used in the synthesis of body fats.

5.3.

Preclinical safety data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Carmine
Sodium metabisulphite
Sodium benzoate
Strong ammonia solution
Ethanol 96%
Borax
Sodium bicarbonate
Sodium salicylate
Menthol
Cineole
Pumilio pine oil
Methyl salicylate

Potable Water

6.2.

Incompatibilities
No major incompatibilities have been reported.

6.3.

Shelf life
36 months.

6.4.

Special precautions for storage
Do not store above 25oC.

6.5.

Nature and contents of container
Dispensing packs
500 ml, 1000 ml and 2000 ml amber glass bottles with plastic screw cap and
aluminium foil lined expended polyethylene liner.
Patient or OTC packs as appropriate
200 ml and 300 ml amber glass bottles with plastic ā€œJā€ cap closures.
Not all pack sizes may be marketed.

6.6.

Instructions for use/handling
None.

7.

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park,
Unit 7,
Hardicker Street,

Manchester,
M19 2RB
United Kingdom

8.

MARKETING AUTHORISATION NUMBER(S)
PL 18374/0021

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
9th March 2005

10

DATE OF REVISION OF THE TEXT
09/03/2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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