Vicks Sinex Soother Nasal Spray

Oxymetazoline hydrochloride 0.5mg/ml

1 spray (50ìl) contains approximately 25 micrograms oxymetazoline hydrochloride

For a full list of excipients see section 6.1

Nasal Spray, solution

A clear liquid preparation

Local symptomatic relief of nasal congestion, for instance associated with rhinitis and sinusitis

Route of administration: nasal

Adults and children over 12 years: 1-2 sprays up each nostril maximum 2-3 times daily.

Not recommended for use in children under 12yrs.

The preparation should not be used for more than 7 days in a row.

Vicks Sinex Soother should not be used:

• By patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs in the previous two weeks.

• In patients with narrow-angle glaucoma. Vicks Sinex Soother should not be used by patients after trans-sphenoidal hypophysectomy.

• By children under 12 years of age.

• In case of hypersensitivity to the active substance or to any of the excipients.

• Where there is inflammation of the skin and mucosa of the nasal vestibule and encrustation (rhinitis sicca).

• By patients with acute coronary disease or cardiac asthma.

• Do not exceed the recommended dose.

• Vicks Sinex Soother should be used for a maximum of 7 consecutive days to avoid rebound-effect and drug induced rhinitis.

• Caution should be exercised in case of hypertension, severe cardiac diseases, hyperthyroidism, and diabetes mellitus.

• Caution should be exercised by patients taking Bromocriptine.

• If symptoms worsen or do not improve after 3 days, physician should reevaluate clinical situation.

• The preservative (benzalkonium chloride) contained in Vicks Sinex Soother can cause swelling of the nasal mucosa, especially during long-term use. If such a reaction (persistent nasal congestion) is suspected, a product for nasal administration which contains no preservative should be used if possible. If such products for nasal administration are not available without preservative, the use of another dosage form should be considered.

This product should not be used in combination with MAOIs, or for up to 2 weeks after taking MAOIs as there is a risk of hypertension.

This product is known to interact with tricyclic antidepressants.

The effects of Bethanidine, Debrisoquine and Guanethidine may be antagonised.

For oxymetazoline no clinical data on exposed pregnancies are available

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. It is not known if oxymetazoline hydrochloride is excreted into breast milk. The recommended dose should not be exceeded because overdosing can decrease placental blood flow and reduce milk production.

Caution should be exercised during pregnancy and lactation as oxymetazoline may be systemically absorbed.

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

Use for longer than recommended may lead to reduced effect and/or rebound congestion.

Symptoms of moderate or severe overdose can be mydriasis, nausea, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, cardiac arrest, hypertension, oedema of the lungs, dyspnoea, psychic disturbance. The inhibition of functions of the central nervous system such as somnolence, lowering of the body temperature, bradycardia, shocklike hypotension, apnoea and loss of consciousness is also possible. A nonselective alpha-lytic such as phentolamine may be administered to depress the increased blood pressure, Intubation and artificial respiration may be necessary in serious cases.

In the case of moderate or severe inadvertent oral consumption, the administration of activated carbon (absorbent) and sodium sulphate (laxative) or perhaps gastro-lavage in the case of large amounts should be undertaken.

Further treatment is supportive and symptomatic.

Vasopressor drugs are contraindicated.

Pharmacotherapeutic group: Sympathomimetics, plain

ATC code: R01AA05

Oxymetazoline is a direct-acting sympathomimetic amine. It acts on alpha-adrenergic receptors in the vessels of the nasal mucosa producing vasoconstriction and decongestion. Onset of action is within minutes and lasts 6-8 hours.

With local use on the nasal mucosa, there is no clinically relevant absorption of oxymetazoline.

Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity or toxicity to reproduction. Vicks Sinex Soother Nasal Spray has not been tested for genotoxicity or carcinogenicity.

Preclinical data suggest that benzalkonium chloride can produce a concentration- and time-dependant toxic effect on cilia, including irreversible immobility, and can induce histopathological changes in the nasal mucosa.

Sodium citrate dihydrate (for pH-adjustment)

tyloxapol

citric acid anhydrous (for pH-adjustment)

chlorhexidine digluconate solution

menthol (levo)

benzalkonium chloride solution

camphor (racemic)

disodium edetate (dihydrate)

cineole

sodium hydroxide (for pH-adjustment)

purified water.

Not applicable

Glass bottle 10ml: 2 years

Glass bottle 15ml: 3 years

Do not store above 25oC

Brown Type III glass bottle 10ml/15ml with a metering pump (polypropylene).

No special requirement.

PROCTER & GAMBLE (HEALTH & BEAUTY CARE) LIMITED

THE HEIGHTS

BROOKLANDS

WEYBRIDGE

SURREY KT13 0XP

PL 00129/0356

17/05/2010

17/05/2010