Rynacrom 4% Nasal Spray

1. Name Of The Medicinal Product

Rynacrom 4% Nasal Spray

2. Qualitative And Quantitative Composition

Sodium Cromoglicate BP 4% w/v

3. Pharmaceutical Form

Rynacrom 4% Nasal Spray is presented as an aqueous solution, containing 4% w/v sodium cromoglicate in a metered dose spray pack, for nasal administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Rynacrom 4% Nasal Spray is indicated for the preventative treatment of allergic rhinitis (seasonal and perennial).

4.2 Posology And Method Of Administration

For nasal administration

Adults (including the Elderly) and Children:

One spray into each nostril two to four times daily.

Each actuation of the pump unit delivers approximately 5.2mg of sodium cromoglicate.

Since therapy is essentially preventative, regular doses, distinct from using the drug intermittently to relieve symptoms, should be observed.

4.3 Contraindications

Rynacrom 4% Nasal Spray is contraindicated in patients with known sensitivity to sodium cromoglicate, or any of the ingredients.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interactions between sodium cromoglicate and other drugs. A reduction in concomitant antihistamine therapy will often be possible during treatment with Rynacrom 4% Nasal Spray.

4.6 Pregnancy And Lactation

Cumulative experience with sodium cromoglicate suggests that it has no effect on foetal development. It should only be used in pregnancy if there is a clear need.

On the basis of animal studies and its physico-chemical properties, sodium cromoglicate is unlikely to pass into human breast milk. There is no evidence to suggest that the use of sodium cromoglicate by nursing mothers has any undesirable effects on the baby.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Occasional irritation of the nasal mucosa may occur during the first days of use. In rare cases wheezing or tightness of the chest have been reported by patients.

4.9 Overdose

No action other than medical supervision should be necessary.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Sodium cromoglicate inhibits the release of mediators of the allergic reaction from sensitised mast cells. In the nose, the inhibition of mediator release prevents the symptoms of rhinitis.

5.2 Pharmacokinetic Properties

After instillation of Rynacrom 4% Nasal Spray into the nose, less than 7% of the total dose administered is absorbed via the nasal mucosa. This fraction is excreted unchanged in the bile and urine. The remainder of the dose is expelled from the nose, or swallowed and excreted via the alimentary tract.

5.3 Preclinical Safety Data

There are no pre-clinical safety data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Disodium edetate

Benzalkonium chloride

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C. Protect from direct sunlight.

6.5 Nature And Contents Of Container

Rynacrom 4% Nasal Spray is presented as a transparent, colourless to pale yellow liquid in a 22ml high density polyethylene bottle, fitted with a metered dose pump unit, protected by a polypropylene cover.

6.6 Special Precautions For Disposal And Other Handling

A patient information leaflet is included in each pack.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

PL 04425/0371

9. Date Of First Authorisation/Renewal Of The Authorisation

1st May 2005

10. Date Of Revision Of The Text

December 2006

11. LEGAL CATEGORY

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