Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Advanced search

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

Procter & Gamble (Health & Beauty Care) Ltd.

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

Telephone: +44 (0)191 297 5000
Fax: +44 (0)191 297 6295
WWW: http://www.uk.pg.com
Customer Care direct line: +44 (0) 8000 850367 (UK)

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?

Summary of Product Characteristics last updated on the eMC: 04/08/2010

SPC	Vicks Sinex Micromist

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Vicks Sinex Micromist

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Go to top of the page

3. PHARMACEUTICAL FORM

Nasal spray, solution

Non pressurised, metered dose, aqueous nasal spray solution.

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

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

Go to top of the page

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.

Go to top of the page

4.3 Contraindications

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

Go to top of the page

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.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

None known.

Go to top of the page

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.

Go to top of the page

4.7 Effects on ability to drive and use machines

None known

Go to top of the page

4.8 Undesirable effects

None known

Go to top of the page

4.9 Overdose

No information.

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

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

Go to top of the page

5.2 Pharmacokinetic properties

Not applicable. This product provides purely local action.

Go to top of the page

5.3 Preclinical safety data

Not applicable

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

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

Go to top of the page

6.2 Incompatibilities

None known.

Go to top of the page

6.3 Shelf life

4 years.

Go to top of the page

6.4 Special precautions for storage

Do not store above 25°C.

Go to top of the page

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.

Go to top of the page

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.

Go to top of the page

7. MARKETING AUTHORISATION HOLDER

Procter & Gamble (Health & Beauty Care) Limited

The Heights

Brooklands

Weybridge

Surrey

KT13 0XP

United Kingdom

Go to top of the page

8. MARKETING AUTHORISATION NUMBER(S)

PL 00129/0133