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Reckitt Benckiser Healthcare (UK) Ltd
Freepost, RSBU-TEBT-GSTU, Reckitt Benckiser, Kingston Upon Thames, KT2 6LZ, UK
Telephone: +44 (0)500 455 456
WWW: http://www.reckittbenckiser.com
Medical Information Direct Line: +44 (0)500 455 456
Customer Care direct line: +44 (0)500 455 456

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Summary of Product Characteristics last updated on the eMC: 29/07/2010
SPC Karvol Decongestant Drops


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1. NAME OF THE MEDICINAL PRODUCT

Karvol Decongestant Drops


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredients

% W/V

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

Pumilio Pine Oil

22.90


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3. PHARMACEUTICAL FORM

Inhalation vapour, liquid


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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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.


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4.3 Contraindications

Children under 3 months of age


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.


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4.6 Pregnancy and lactation

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


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4.7 Effects on ability to drive and use machines

No adverse effects known.


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4.8 Undesirable effects

None known.


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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.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

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


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Macrogol Stearate,

Cinnamon Oil,

Polysorbate 80,

Polyethylene Glycol 400,

Triacetin.


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

24 months.


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6.4 Special precautions for storage

Do not store above 25°C.


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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.


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6.6 Special precautions for disposal and other handling

Whilst applying drops ensure that the dropper bottle is held vertically.


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7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00063/0406


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08 May 1997


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10. DATE OF REVISION OF THE TEXT

25 January 2008



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/23407/SPC/