KARVOL DECONGESTANT DROPS
Active substance: THYMOL
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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Karvol Decongestant Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients Chlorobutanol Hemihydrate Ph Eur Levomenthol Ph Eur Pine Oil Sylvestris Terpineol BP Thymol Ph Eur Pumilo Pine Oil % W/V 0.50 7.90 2.00 14.80 0.70 22.90
3
PHARMACEUTICAL FORM
Inhalation vapour, liquid
4
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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 25C.
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
1
NAME OF THE MEDICINAL PRODUCT
Karvol Decongestant Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients Chlorobutanol Hemihydrate Ph Eur Levomenthol Ph Eur Pine Oil Sylvestris Terpineol BP Thymol Ph Eur Pumilo Pine Oil % W/V 0.50 7.90 2.00 14.80 0.70 22.90
3
PHARMACEUTICAL FORM
Inhalation vapour, liquid
4
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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 25C.
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
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
