KARVOL DECONGESTANT DROPS

Active substance: THYMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Karvol Decongestant Drops

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Chlorobutanol Hemihydrate Ph Eur

0.50

Levomenthol Ph Eur

7.90

Pine Oil Sylvestris

2.00

Terpineol BP

14.80

Thymol Ph Eur

0.70

Pumilo Pine Oil

3

% W/V

22.90

PHARMACEUTICAL FORM
Inhalation vapour, liquid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of nasal congestion and colds in the head.

4.2

Posology and method of administration
For older children and adults:
For relief throughout the night: sprinkle 6 drops onto bedding or handkerchief
nearby but avoiding direct skin contact.
Daytime: sprinkle 6 drops onto a tissue or into a pint of hot water and inhale
the vapours freely.
For young children:
For daytime use and relief throughout the night: sprinkle 6 drops onto a
handkerchief tied down securely in the vicinity but out of reach of the child..

Elderly: There is no need to modify the administration of this preparation for
use by the elderly.
Children under 3 months: Not recommended for children under 3 months.

4.3

Contraindications
Children under 3 months of age

4.4

Special warnings and precautions for use
Avoid contact with the eyes and prolonged contact with the skin.
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
For inhalation only.
Do not put drops directly in mouth or nose.

4.5

Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.

4.6

Pregnancy and lactation
The safety in pregnancy and lactation has not been established but it is not
expected to constitute a hazard.

4.7

Effects on ability to drive and use machines
No adverse effects known.

4.8

Undesirable effects
None known.

4.9

Overdose
Symptoms of massive overdose by ingestion include nausea, vomiting, colic,
headache, dizziness, a feeling of warmth, delirium, muscle twitching,
epileptiform convulsions, depressed respiration, CNS depression and coma.

Initial treatment consists of emptying the stomach by lavage and aspiration.
Administer a saline laxative such as sodium sulphate and activated charcoal by
mouth. Convulsions may be controlled with diazepam or thiopental sodium.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Chlorobutanol, levomenthol, pine oil, terpineol and thymol are volatile
substances and are thought to produce an irritant effect on the respiratory tract,
possibly via a nasal/pulmonary arc.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
There are no preclinical safety data of relevance to the consumer.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Macrogol Stearate, Cinnamon Oil, Polysorbate 80, Polyethylene Glycol 400,
Triacetin.

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
24 months.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
The liquid is contained in an amber glass bottle fitted with a combined all in
one polyethylene/polypropylene dropper and a tamper evident child resistant
polypropylene cap, or a non child resistant polypropylene cap. The bottle is
presented in a cardboard carton.

6.6

Special precautions for disposal
Whilst applying drops ensure that the dropper bottle is held vertically.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0406

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08 May 1997

10

DATE OF REVISION OF THE TEXT
25 January 2008

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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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