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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 Capsules


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1. NAME OF THE MEDICINAL PRODUCT

Karvol Decongestant Capsules


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

mg/capsule

Chlorobutanol

2.25

Levomenthol

35.55

Pine Oil Sylvestris

9.0

Terpineol

66.6

Thymol

3.15

Pumilio Pine Oil

103.05


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3. PHARMACEUTICAL FORM

Capsule


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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4.2 Posology and method of administration

For inhalation.

Snip tip off capsule carefully, pointing top downwards and away from the face.

For Older Children and Adults:

Nightime: Dab contents of one capsule on to bedding or handkerchief nearby but avoiding direct skin contact.

Daytime: Squeeze contents of one capsule on to a tissue or into a pint of hot water and inhale the vapour freely.

For Young Children:

Dab contents of one capsule on to 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 of age.


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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.

Do not take internally.


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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 of Karvol in pregnancy and lactation has not been established, but 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

No side effects would be anticipated.


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4.9 Overdose

Symptoms of overdose may included 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

Menthol, Chlorobutanol, Pine Oil and Terpineol 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

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

PEG – 20 Stearate

Cinnamon Oil

Polysorbate 80 (Tween 80)

Polyethylene Glycol 400 (Macrogol)

Triacetin


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

36 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

A capsule contained in a 200 or 250 Fm PVC or 200 or 250 Fm PVC/40 gsm PVDC blister, heat sealed to aluminium foil. Packs of either 1, 2(stencilled card), 4, 5, 6, 8, 10, 12, 14, 15, 16, 18, 20, 22, 24, 25, 26, 28, 30, 32 or 36 capsules in a printed carton.

An amber glass bottle having a thermoset plastic screw cap containing 500 capsules.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

Crookes Healthcare Limited

1 Thane Road West

Nottingham

NG2 3AA

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 0327/5914R


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16 June 1989 / 24 February 1995


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10. DATE OF REVISION OF THE TEXT

11/09/2007



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/23408/SPC/


Active Ingredients/Generics

 
   chlorobutanol
   levomenthol
   pine oil sylvestris
   terpineol
   thymol
   pumilio pine oil