ASASANTIN RETARD 200/25 mg/mg Capsules Modified Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-05-2024
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Active ingredient:
DIPYRIDAMOLE, ACETYLSALICYLIC ACID
Available from:
Primecrown 2010 Ltd
ATC code:
B01AC30
INN (International Name):
DIPYRIDAMOLE, ACETYLSALICYLIC ACID
Dosage:
200/25 mg/mg
Pharmaceutical form:
Capsules Modified Release
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Platelet aggregation inhibitors excl. Heparin
Authorization status:
Authorised
Authorization date:
2012-06-15
Summary of Product characteristics
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 200 mg and acetylsalicylic acid (aspirin) 25 mg.
Excipients with known effect: contains lactose and sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_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 the figure '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.
IRISH
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