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.
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
60 months
6.4 Special Precautions For Storage
Store in a dry place.
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
Sanofi-aventis
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
29 November 2010
11. LEGAL CATEGORY
POM
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