Reckitt Benckiser Ireland Limited

Karvol Decongestant Capsules

Each capsule contains

For a full list of excipients, see section 6.1

Inhalation vapour, Capsule.

Light brown, flask-shaped capsule containing a slightly yellow oil with a characteristic odour.

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

Babies over three months and young children:

Snip top off capsule and squeeze contents onto a handkerchief tied securely near to, but out of reach of the child.

Older children and adults:

Snip tip off capsule carefully, pointing top downwards and away from the face. Carefully sprinkle the contents onto bedding or material, avoiding the possibility of skin contact.

Alternatively, add to a pint of hot water and inhale vapour freely.

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.

Children under 3 months of age.

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

No clinically significant interactions known.

The safety of Karvol in pregnancy and lactation has not been established, but is not expected to constitute a hazard. Seek doctor or pharmacist's advice when pregnant.

If using hot water to vaporise the product the water should be not boiling. Care should be taken with hot water to avoid spillage and scalds. Children should not be left alone with hot water.

No clinically significant interactions known.

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

Symptoms of overdose 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 thiopentone sodium.

Chlorbutol, 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.

Not applicable.

Not applicable.

Cinnamon Oil

Macrogol- 20 Stearate

Polysorbate 80

Macrogol 400

Triacetin

Capsule Shell

Gelatin

Glycerol

Purified water

Not applicable.

3 years

Do not store above 25°C.

AL / PVC/PVDC blister containing 10, 12, 24 capsules. Not all pack sizes may be marketed.

No special requirements.

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/61/1

1^st April 1983 / 1^st April 2008

April 2011