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sanofi-aventis

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK

Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

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Summary of Product Characteristics last updated on the eMC: 04/01/2011

SPC

Nalcrom

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
11. LEGAL CATEGORY

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1. NAME OF THE MEDICINAL PRODUCT

Nalcrom 100mg Capsules

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

The active component per capsule is:

Sodium Cromoglicate 100.0mg

For a full list of excipients, see section 6.1.

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3. PHARMACEUTICAL FORM

Capsule

Hard gelatin capsule with a clear cap and body, marked 'SODIUM CROMOGLICATE 100 mg' in black and containing a white powder.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Nalcrom is indicated for food allergy (where adequate investigations have been performed to determine sensitivity to one or more ingested allergens) in conjunction with restriction of main causative allergens.

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4.2 Posology and method of administration

Nalcrom must be administered orally

Adults (including the elderly)

Initial dose: 2 capsules four times daily before meals

Children (2 - 14 years)

Initial dose: 1 capsule four times daily before meals

For adults (including the elderly) and children, if satisfactory control is not achieved within two to three weeks, the dosage may be doubled but should not exceed 40 mg/Kg/day.

Maintenance dose: Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient free from symptoms.

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4.3 Contraindications

Nalcrom is contraindicated in patients with a known hypersensitivity to sodium cromoglicate or to any of the excipients.

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4.4 Special warnings and precautions for use

None stated

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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4.6 Pregnancy and lactation

As with all medication caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. It should only be used in pregnancy where there is a clear need.

It is not known whether sodium cromoglicate is excreted in the breast milk but on the basis of its physico-chemical properties this is considered unlikely. There is no information to suggest that the use of sodium cromoglicate has any undesirable effects on the baby.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

Nausea, skin rashes and joint pains have been reported in a few cases.

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4.9 Overdose

As Nalcrom is only absorbed to a minimum extent, no action other than medical supervision should be necessary.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiallergic agents, excluding corticosteroids, ATC Code: A07EB01

Sodium cromoglicate inhibits the release from mast cells of mediators of the allergic reaction. In gastrointestinal allergy the release of mediators can result in gastrointestinal symptoms or may allow absorption of antigenic material leading to systemic allergic reactions.

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5.2 Pharmacokinetic properties

Not applicable

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5.3 Preclinical safety data

Animal studies have shown that sodium cromoglicate has a very low order of local or systemic toxicity.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Purified Water

No 2 hard gelatin capsules