Vicks Sinex Micromist

1. Name Of The Medicinal Product

Vicks Sinex Micromist

2. Qualitative And Quantitative Composition

Name of active substance	Quantity	Unit
Oxymetazoline hydrochloride	0.05	%w/v

3. Pharmaceutical Form

Nasal spray, solution

Non pressurised, metered dose, 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, hayfever, and sinusitis.

4.2 Posology And Method Of Administration

Nasal spray: for topical nasal use.

Adults and children over 12 years: 1-2 sprays per nostril every 6-8 hours.

4.3 Contraindications

Patients suffering from high blood pressure, any heart complaint, diabetes, thyroid disease, hepatic or renal disorders.

4.4 Special Warnings And Precautions For Use

Patients should seek medical advice if they feel worse, or do not feel better after 7 days, or if they develop new symptoms.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Although there is no evidence of any risk when this medicine is used in pregnancy, such use is not recommended without medical advice.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

None known

4.9 Overdose

No information.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Oxymetazoline hydrochloride is an α - adrenergic imidazoline derivative, providing localised nasal vasoconstriction.

5.2 Pharmacokinetic Properties

Not applicable. This product provides purely local action.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Menthol (levo)

Sodium citrate dihydrate

Tyloxapol

Citric acid anhydrous

Chlorhexidine gluconate solution (20%)

Benzalkonium chloride solution (50%)

Camphor (racemate)

Disodium edetate (dihydrate)

Eucalyptol

Sodium hydroxide

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

4 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

15ml glass bottle (amber type III glass) mounted with an atomiser/metering unit which delivers 25μg Oxymetazoline Hydrochloride per spray.

The atomiser comprises of a polypropylene body, stainless steel spring, a high-density polyethylene piston, a polyethylene terephthalate dip tube and other plastic components.

6.6 Special Precautions For Disposal And Other Handling

Two actuations of the pump are required before first usage of this medicine. Following periods of storage of greater than one week one actuation is required to prime the pack before use.

7. Marketing Authorisation Holder

Procter & Gamble (Health & Beauty Care) Limited

The Heights

Brooklands

Weybridge

Surrey

KT13 0XP

United Kingdom

8. Marketing Authorisation Number(S)

PL 00129/0133

9. Date Of First Authorisation/Renewal Of The Authorisation

8^th December 2000

10. Date Of Revision Of The Text

March 2010