Care Decongestant Nasal Spray

1. Name Of The Medicinal Product

Oxymetazoline 0.05% w/v Nasal Spray

Care Decongestant Nasal Spray

2. Qualitative And Quantitative Composition

The nasal solution contains Oxymetazoline (as hydrochloride) 0.05% w/v.

For excipients, see 6.1

3. Pharmaceutical Form

Nasal spray, solution

4. Clinical Particulars

4.1 Therapeutic Indications

Oxymetazoline Nasal Spray or Care Decongestant Nasal Spray is recommended for the relief of nasal congestion in such conditions as the common cold, catarrh and hayfever.

4.2 Posology And Method Of Administration

Adults and Elderly

While holding upright the spray nozzle should be inserted into each nostril in turn and squeezed firmly twice while breathing in. The application may be repeated up to 2 times a day, or used at bedtime to give relief through the night.

Children

Not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to any component of the medicinal product.

Patients who are receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment; patients suffering from porphyria, glaucoma, coronary artery disease, hypertension, hyperthyroidism or diabetes.

4.4 Special Warnings And Precautions For Use

If symptoms persist, consult your doctor. Prolonged use may result in rhinitis medicamentosa and should therefore be avoided. Treatment should be limited to a maximum of seven days. Keep all medicines safely away from children.

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

The safety to use in pregnancy has not been established and administration of oxymetazoline during pregnancy should be avoided.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that it may cause local skin reactions (e.g. contact dermatitis) and discolouration.

Benzalkonium chloride may cause local skin irritation.

4.9 Overdose

No statement.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group (ATC code): S01G A04 Sympathomimetics used as decongestants.

Oxymetazoline is an alpha-adrenoceptor agonist which causes local vasoconstriction when applied to nasal membrane.

5.2 Pharmacokinetic Properties

When applied locally to nasal mucosa, oxymetazoline acts within a few minutes and its effects last for up to 12 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Thiomersal

Sodium chloride

Levomenthol

Cineole

Camphor

Methyl salicylate

Poloxamer 188

Sodium citrate (dihydrate) (E331)

Citric acid (anhydrous) (E330)

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

White, low density polyethylene/polyethylene copolymer 15ml bottle.

White, high density polyethylene 15ml and 20ml bottle.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0343

9. Date Of First Authorisation/Renewal Of The Authorisation

24/01/2007

10. Date Of Revision Of The Text

20/12/2010

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable