Nalcrom 100mg Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
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 satisfactorily 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 comoglicate 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 comoglicate 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 comoglicate 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.
5.1 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 comoglicate has a very low order of local of systemic toxicity.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified water, No. 2 hard gelatin capsules.
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
Special precautions for storage
6.4
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
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
08/10/2015