Vicks Sinex Decongestant Nasal Spray

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

See your doctor for advice before taking this medicine if you suffer from high blood pressure, any heart complaint, diabetes, thyroid disease, hepatic or renal disorders.

4.4 Special Warnings And Precautions For Use

See your doctor if you feel worse or do not feel better after 7 days. Inform your doctor if you develop new symptoms.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

If you are taking other medicines, you should see your doctor for advice before taking this medicine.

4.6 Pregnancy And Lactation

Before using this medicine, obtain advice from your doctor if you intend to become pregnant, are pregnant or are breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

4.9.1 Symptoms

No information.

4.9.2 Treatment of overdose

No information.

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

June 2009