VICKS SINEX DECONGESTANT NASAL SPRAY - summary of medicine characteristics

Summary of medicine characteristics - VICKS SINEX DECONGESTANT NASAL SPRAY

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Vicks Sinex Decongestant Nasal Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Oxymetazoline hydrochloride 0.050% w/v

Excipients with known effect

Benzalkonium chloride 0.2 mg/ml

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Nasal spray, solution (Nasal spray)

Solution is a clear liquid with a very slight yellowish colouration.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Indicated for the symptomatic relief of congestion of the upper respiratory tract due to the common cold, hay fever and sinusitis in adults and children aged 12 years and over.

4.2 Posology and method of administration

Posology

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

Paediatric population

Vicks Sinex Decongestant is contraindicated in children aged 12 years and under (see section 4.3).

Method of administration

Nasal use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

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

Patients are advised to consult a doctor before taking this medicine in case of any of the following:

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

Patients who have narrow angle glaucoma.

Use with caution in occlusive vascular disease

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

Hallucinations

Restlessness

Sleep disturbances.

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

Contains benzalkonium chloride. Long-term use may cause oedema of the nasal mucosa.

If symptoms persist consult a doctor

Keep away from eyes

Keep out of the sight and reach 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 Fertility, 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

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

In general no severe undesirable effects are expected.

System Organ Class	Adverse Drug Reaction
Nervous system disorders
Very rare	Insomnia, nervousness, tremor, anxiety, restlessness, irritability, headache

Eye disorders
Rare	Eye irritation, dryness, discomfort or redness
Cardiac disorders and Vascular disorders
Very rare	Tachycardia, palpitations, increased blood pressure
Respiratory, thoracic and mediastinal disorders
Rare	Discomfort or irritation in the nose, mouth or throat, sneezing
Gastrointestinal disorders
Very rare	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 website at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Symptoms of 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.

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

Pharmacotherapeutic group: Sympathomimetics, plain

ATC code: R01AA05

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

Mechanism of action

Oxymetazoline is a direct-acting sympathomimetic amine. It acts on alpha-adrenergic receptors in the vessels of the nasal mucosa producing vasoconstriction and decongestion. The onset of action normally occurs within 2–30 minutes of administration and the duration of action is 6–8 hours.

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

Levomenthol

Eucalyptol

Sodium citrate dihydrate

Tyloxapol

Anhydrous citric acid

Chlorhexidine digluconate solution

Benzalkonium chloride solution

Racemic camphor

Disodium edetate

Sodium hydroxide

Purified water

6.2 Incompatibilities

6.3 Shelf life

3 years.

6.4. Special Precautions for Storage

None.

6.5. Nature and Contents of Container

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