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Vicks Sinex Decongestant Nasal Spray

Last Updated on eMC 08-Jul-2015 View changes  | Procter & Gamble (Health & Beauty Care) Ltd. Contact details

1. Name of the medicinal product

Vicks Sinex Decongestant Nasal Spray

2. Qualitative and quantitative composition

ACTIVE INGREDIENT

Percentage quantity

Specification

Oxymetazoline hydrochloride

0.050% w/v

Ph. Eur

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 Use during 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.

4.9 Overdose

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Oxymetazoline hydrochloride:

α-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

Camphor

Disodium edetate

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

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.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Procter & Gamble (Health & Beauty Care) Limited

The Heights,

Brooklands,

Weybridge,

Surrey

KT13 0XP

8. Marketing authorisation number(s)

PL 0129/5011R

9. Date of first authorisation/renewal of the authorisation

12th June 1990

10. Date of revision of the text

26/06/2015

Company contact details

Procter & Gamble (Health & Beauty Care) Ltd.

Company image
Address

The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK

Fax

+44 (0)191 297 6295

Customer Care direct line

+44 (0) 8000 850367 (UK)

Telephone

+44 (0)191 297 5000

Customer Care direct line

+353 (1) 800 509 301 (Ireland)

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

oxymetazoline hydrochloride

Legal categories

GSL - General Sales List

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