Vicks Sinex Decongestant Nasal Spray

ACTIVE INGREDIENT

Non-pressurised, aqueous nasal spray solution.

The symptomatic relief of congestion of the upper respiratory tract due to the common cold, hay fever and sinusitis.

Adults and children over 12 years: 1-2 sprays per nostril every 6-8 hours unless otherwise advised by your doctor.

Topical application as a nasal spray.

Hypersensitivity to oxymetazoline or any of the other ingredients.

Inflammation or lesions of the skin around the nostrils or nasal mucosa.

Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura mater

Concomitant use of other sympathomimetic decongestants

Phaeochromocytoma

Children under 12 years of age.

Consult a doctor before taking this medicine in case of:

• High blood pressure, heart disease including angina, diabetes mellitus, hyperthyroid disease, hepatic and renal disorders and prostatic hypertrophy.

• Patients currently taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs in the last 14 days.

• Use with caution in occlusive vascular disease

• If any of the following occur, Vicks Sinex Micromist should be stopped;

• Patients who have narrow angle glaucoma.

Patients are advised to use for a maximum of 7 consecutive days to avoid rebound effect and drug induced rhinitis.

If symptoms persist consult a doctor

Keep away from eyes

Keep out of the reach and sight of children

Hypertensive interactions may occur between sympathomimetic amines such as oxymetazoline and monoamine oxidase inhibitors (MAOIs) (see Section 4.4) and/or reversible inhibition of monoamine oxidase (RIMA) and Moclobemide.

Oxymetazoline may reduce the efficacy of beta-blocking drugs, methyl dopa or other anti-hypertensive drugs including adrenergic neurone blockers.

There is a possible increased risk of hypertension and arrhythmias when tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants are given with sympathomimetics such as oxymetazoline.

Possible additive cardiovascular toxicity may occur when sympathomimetics are given with antiparkinsonian drugs such as bromocriptine

There is an increased risk of dysrhythmias when cardiac glycosides are given with sympathomimetics such as oxymetazoline.

There is an increased risk of ergotism when ergot alkaloids (ergotamine & methysergide) are given with sympathomimetics such as oxymetazoline.

Due to insufficient evidence on the use of the product in pregnancy and lactation, use of the product should be avoided unless on the advice of a physician.

No effects on ability to drive and use machines have been observed.

.

In general no severe undesirable effects are expected.

Prolonged and/or heavy use of Vicks Sinex may lead to reduced effect and/or rebound congestion (rhinitis medicamentosa), cardiovascular effects and/or CNS effects.

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4.9.1 Symptoms

The symptoms of moderate or acute overdosage can include mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmia, hypertension, dyspnoea, and cardiovascular failure.

CNS depression with symptoms such as decreased body temperature, bradycardia, hypotension, apnoea or loss of consciousness is possible.

4.9.2 Treatment of overdose

Symptomatic treatment of the overdosage is required. In serious cases, intubation and artificial ventilation are required.

Not applicable. The product provides purely local action.

Not applicable.

Menthol

Eucalyptol

Sodium citrate dihydrate

Tyloxapol

Citric acid anhydrous

Chlorhexidine digluconate

Benzalkonium chloride

Camphor

Disodium edetate

Sodium hydroxide

Purified water

None known.

3 years.

None.

15ml or 20ml polyethylene/polypropylene copolymer bottle with L. D polyethylene dip tube to spray orifice. Green polypropylene screw cap.

Not applicable.

Procter & Gamble (Health & Beauty Care) Limited

The Heights,

Brooklands,

Weybridge,

Surrey

KT13 0XP

PL 0129/5011R

12th June 1990

21-Mar-2012