Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
CROMOGLICATE SODIUM
Sanofi-Aventis Ireland Limited
20 Milligram
Inhalation Powder, Capsule
2010-03-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Intal Spincaps 20mg Inhalation Powder Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20mg Sodium Cromoglicate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder, hard capsule Hard capsule with transparent yellow cap and clear body printed in black “Sodium Cromoglicate 20 mg” and intended for use with the SPINHALER inhalation device. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intal is indicated for the preventative treatment of bronchial asthma in adults and children, including the prevention of exercise-induced asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intal Spincaps must be administered via a SPINHALER. The capsules are not effective if swallowed. Since Intal therapy is essentially preventative, it is important that the patient is instructed to maintain regular dosage, as distinct from inhaling the drug intermittently to relieve symptoms. Adults (including the elderly) and children: The recommended dosage is one capsule night and morning and at regular intervals of 3 to 6 hours during the day. The dose may be increased to one capsule 6 or 8 times daily in more severe cases or during periods of severe antigen challenge. Additional doses may be taken before exertion to prevent exercise- induced asthma or before exposure to other trigger factors. When the asthmatic condition is stabilised it may be possible to reduce the dosage provided that adequate control of the asthma is maintained. Concomitant bronchodilator therapy: Where a concomitant aerosol bronchodilator is prescribed it is recommended that this be administered prior to the Intal Spincaps. If bronchodilators are used concomitantly, patients may find that the freq read_full_document