Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CROMOGLICATE SODIUM
Italchimici S.p.A.
100 Milligram
Capsule
2005-07-22
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nalcrom 100 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Sodium Cromoglicate 100.0 mg For excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsule, hard No. 2 clear hard gelatin capsule printed “Sodium Cromoglicate 100 mg” 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 gradually 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. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE (A) General summary of the most important side effects: Side effects include nausea, vomiting, diarrhoea, abdominal discomfort, rashes and joint pains. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/10/2006_ _CRN 2029207_ _page number: 1_ (B) Special precautions for use. 1. There is insufficient experience to assess safety of long term use ov Read the complete document