This information is intended for use by health professionals

1. Name of the medicinal product

Nalcrom 100mg Capsules

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.

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.

4. Clinical particulars
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.

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.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

None stated

4.5 Interaction with other medicinal products and other forms of interaction

None known.

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.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

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

5. Pharmacological properties
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.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

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

6. Pharmaceutical particulars
6.1 List of excipients

Purified Water

No 2 hard gelatin capsules

Black ink containing:

Water

Ethyl alcohol

Iso-propyl alcohol

Propylene alcohol

N-butyl alcohol

Shellac

Ammonium hydroxide

Potassium hydroxide

Iron oxide black (E172)

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store below 25°C. Store in a dry place. Keep the bottle tightly closed in order to protect from moisture.

6.5 Nature and contents of container

An aluminium can with aluminium screw cap containing 100 capsules or an HDPE bottle with screw cap containing 100 capsules.

6.6 Special precautions for disposal and other handling

Instructions for use are supplied with each pack.

7. Marketing authorisation holder

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

or trading as:-

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing authorisation number(s)

PL 04425/0370

9. Date of first authorisation/renewal of the authorisation

1st May 2005

10. Date of revision of the text

8 October 2015

Legal category

POM