ALAIRGIX ALLERGIC RHINITIS SODIUM CROMOGLICATE 2 % Nasal powder spray Bottle/15ml

Sodium cromoglicate.............................................................................................................................................2,00 g

For 100 ml of solution.

It is indicated in the treatment of seasonal allergic rhinitis (hay fever) or non-seasonal allergic rhinitis (animal hair, moulds, mites…).

Adults and childs : 1 spray in each nostril 4 to 6 times a day.

The duration of treatment will depend on the duration of exposure to the allergen.

History of allergy to sodium cromoglicate or to one of the excipients.

Pregnancy

Animal studies have not shown any teratogenic effect.

In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have proven teratogenic in animals in well-conducted studies in two species.

In clinical practice, analysis of a large number of exposed pregnancies has apparently revealed no particular malformative or foetotoxic effect of cromoglicic acid. However, only epidemiological studies would make it possible to verify the absence of risk.

Consequently, cromoglicic acid may be prescribed during pregnancy if needed.

Breast-feeding

There is no data on the passage of sodium cromoglicate into breast milk.

However, given the absence of toxicity, breastfeeding is possible during treatment with this medicine.

• Possibility of occurrence of hypersensitivity reactions to sodium cromoglicate.
• A brief nasal irritation may occur at the start of treatment after spraying.

The symptoms are usually transient.

Rarely, epistaxis may occur.

No overdose incidents have been described with sodium cromoglicate.

In case of suspected overdose, symptomatic treatment and medical monitoring are required.

ANTI-ALLERGIC, ATC code: S01GX01.

(S: Sense organs)

Sodium cromoglicate exerts a direct local action at the level of the mucous membranes (bronchial, nasal, conjunctival, digestive). Its mechanism of action remains poorly elucidated.

It prevents the release of the chemical mediators of anaphylaxis by stabilising the membrane of the mast cell.

Sodium cromoglicate has no direct effect at the level of peripheral receptors.

Sodium cromoglicate is not metabolised. The study of urinary elimination of the product labelled with 14C shows low absorption through the nasal mucosa (of the order of 2 to 5 %). The major part is swallowed, absorption via the digestive route being slow and very limited (approximately 0,5 %).

The absorbed portion is eliminated, as after intravenous administration, in unchanged form in substantially equal proportions via the biliary and urinary routes.

There are no other pre-clinical data available considered relevant from the point of view of clinical safety other than those presented in the other sections of the SmPC.

3 years.

After first opening: 3 months.

No special precautions for storage.

No special requirements.