Core Safety Profile

Active substance: Nedocromil Pharmaceutical form(s)/strength: Eye drops: 20 mg/ml, Inhalation vapour: 5 mg/ml, Pressurised inhalation: 2 mg/dose, 2mg/0,1 mg, Nebuliser solution: 10 mg/2 ml, Inhalation powder: 10 mg/dose, Nasal spray: 10 mg/ml P-RMS: CZ/H/PSUR/0016/001 Date of FAR: 09.10.2010

EU Core Safety Profile (CSP) For Nedocromil sodium

NB: This CSP is combining safety information from the three existing pharmaceutical forms: Eye drops, Nasal spray and Inhaler. Information that is specific to one form is identified by a subheading. No subheading indicates that information is valid for all pharmaceuticals forms

4.3 Contraindications

For eye drops

eye drops is contraindicated in patients with known hypersensitivity to nedocromil sodium, benzalkonium chloride or other constituents of the formulation.

For Nasal spray and Inhaler

nasal spray or inhaler is contraindicated in patients with known hypersensitivity to any of the constituents.

4.4 Special warnings and precautions for use

For eye drops

Patients should be advised not to wear soft contact lenses during treatment with eye drops. Benzalkonium chloride, a constituent of the formulation, may accumulate in soft contact lenses. This preservative, when slowly released, could possibly irritate the cornea.

In patients who continue to wear hard or gas permeable contact lenses during eye drops treatment, the lenses should be taken out of the eye prior to instillation of the drops. They should be inserted again not earlier than 10 minutes after administration, in order to allow an even conjunctival distribution of the solution.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.

For Nasal spray

The safety and efficacy of nasal spray children under the age of 12 years has not been established.

For Inhaler

CFC- free should not be used for the relief of an acute attack of bronchospasm.

2/5

4.5 Interaction with other medicinal products and other forms of interaction

For eye drop and nasal spray

No harmful interactions with other drugs have been reported in humans or in animals. Specifically, no interactions with other topical ophthalmic or nasal therapies, oral antihistamine therapy or inhaled/oral asthma therapy have been reported.

For Inhaler

Nedocromil sodium has been used in association with numerous other drugs in man, including oral and inhaled β-adrenergic agonists, inhaled and oral corticosteroids, theophylline and other methylxanthines and ipratropium bromide. No harmful interactions have been observed in humans or animals.

4.6 Pregnancy and lactation

Studies in pregnant and lactating animals have failed to reveal a hazard with nedocromil sodium. However, as with all new medicines, caution should be exercised during pregnancy (especially during the first trimester) and while breast feeding. On the basis of animal studies and its physicochemical properties, it is considered that only negligible amounts of nedocromil sodium may pass into human breast milk. There is no information to suggest that use of nedocromil sodium by nursing mothers has any undesirable effects on the baby.

4.7 Effects on ability to drive and use machines

For eye drops and nasal spray

eye drops or nasal spray has no known effect on the ability to drive or operate machinery. Additionally, no sedative effects have been reported following the administration of eye drops or nasal spray.

For Inhaler

CFC- free has no known effect on ability to drive or operate machinery.

4.8 Undesirable effects

The following frequency rating has been used, when applicable:

3/5

Very common (>=1/10); common (>=1/100 to <1/10); uncommon (>=1/1,000 to <1/100); rare (>=1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

For eye drops

In clinical studies conducted in patients treated with nedocromil sodium 2% eye drops, the following adverse events have been reported at the corresponding frequencies:

Eye disorders

Common: burning in eyes, eyes stinging, soreness in eyes Uncommon: eye irritation

Nervous system disorders:

Common: dysgeusia

For Nasal spray

In clinical studies conducted in patients treated with nedocromil sodium 1% nasal solution, the following adverse events have been reported at the corresponding frequencies:

Respiratory, thoracic and mediastinal disorders

Common: nasal burning, nasal irritation Uncommon: nasal stinging, nasal soreness

Nervous system disorders

Common: dysgeusia

For Inhaler

In clinical studies conducted in patients treated with nedocromil sodium metered dose inhaler, the following adverse events have been reported at the corresponding frequencies:

4/5

Gastrointestinal disorders

Very common: abdominal pain, vomiting, nausea Common: dyspepsia

Respiratory, thoracic and mediastinal disorders

Very common: cough, bronchospasm

Nervous system disorders

Very common: headache Common: dysgeusia

4.9 Overdose

Animal studies have not shown evidence of significant toxic effects with nedocromil sodium even at high doses, nor have extended human studies with nedocromil sodium revealed any safety hazard with the drug. Overdosage is, therefore, unlikely to cause problems. However, if overdosage is suspected, treatment should be supportive and directed to control of the relevant symptoms.

5/5