SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Vicks Sinex Decongestant Nasal Spray

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

ACTIVE INGREDIENT

Percentage quantity

Oxymetazoline hydrochloride    0.050% w/v

3. PHARMACEUTICAL FORM

Non-pressurised, aqueous nasal spray solution.

4    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

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

4.2 Posology and method of administration

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.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

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;

o Hallucinations o Restlessness o Sleep disturbances

■    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

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6    Pregnancy and lactation

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.

4.7    Effects on ability to drive    and    use machines

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

4.8    Undesirable effects

In general no severe undesirable effects are expected.

Rare:    Eye disorders: Eye irritation, dryness, discomfort or redness

Respiratory : Discomfort or irritation in the nose, mouth or throat; Sneezing

Very rare: Cardiovascular : Tachycardia, palpitations, increased blood pressure

CNS : Insomnia, nervousness, tremor, anxiety, restlessness, irritability, headache

Gastrointestinal: Nausea

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Oxymetazoline hydrochloride: a-Adrenergic imidazoline derivative, providing localised nasal vasoconstriction.

5.2. Pharmacokinetic Properties

Not applicable.

The product provides purely local action.

5.3. Preclinical Safety Data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Menthol

Eucalyptol

Sodium citrate dihydrate Tyloxapol

Citric acid anhydrous Chlorhexidine digluconate Benzalkonium chloride

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/12/2010

DATE OF REVISION OF THE TEXT

26/06/2015