מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
DIPYRIDAMOLE ACETYLSALICYLIC ACID
PCO Manufacturing
200/25 Milligram
Capsules Modified Release
2009-07-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asasantin Retard 200mg/25mg Modified Release Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains dipyridamole 200mg and acetylsalicylic acid (aspirin) 25mg Excipients-Contains Lactose monohydrate and sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules _Product imported from _the UK: Hard capsule containing acetylsalicylic acid in standard release form and dipyridamole in modified release form. Capsules consisting of a red cap and an ivory body imprinted with the company logo and figures “01A” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Secondary prevention of ischaemic stroke and transient ischaemic attacks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The recommended dose is one capsule twice daily, usually one in the morning and one in the evening preferably with meals. The capsules should be swallowed whole without chewing together with a glass of water. Asasantin Retard is not indicated for use in children and young people less than 16 years of age (see “Special Warnings and Precautions for Use”). Alternative regimen in case of intolerable headaches In the event of intolerable headaches during treatment initiation, switch to one capsule at bedtime and low-dose acetylsalicylic acid (ASA) in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week. 4.3 CONTRAINDICATIONS Hypersensitivity to any component of the product or salicylates. Patients with active gastric or duodenal ulcers or bleeding disorders. Patients in the last trimester of pregnancy. In certa קרא את המסמך השלם