ASASANTIN RETARD 200/25 mg/mg Capsules Modified Release

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

DIPYRIDAMOLE, ACETYLSALICYLIC ACID

Disponibil de la:

Boehringer Ingelheim Limited

Codul ATC:

B01AC30

INN (nume internaţional):

DIPYRIDAMOLE, ACETYLSALICYLIC ACID

Dozare:

200/25 mg/mg

Forma farmaceutică:

Capsules Modified Release

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Platelet aggregation inhibitors excl. Heparin

Statutul autorizaţiei:

Authorised

Data de autorizare:

2001-03-09

Prospect

PACKAGE LEAFLET: 
INFORMATION FOR THE USER
ASASANTIN® RETARD
200 MG / 25 MG 
MODIFIED RELEASE 
HARD CAPSULES
dipyridamole and acetylsalicylic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE
• Keep this leaflet. You may need to read it
 again
• If you have any further questions, ask your
 doctor or pharmacist
• This medicine has been prescribed for you.
 Do not pass it on to others. It may harm  
 them, even if their symptoms are the same
 as yours
• If any of the side effects gets troublesome
 or serious, or if you notice any side effects
 not listed in this leaflet, please tell your  
 doctor or pharmacist
IN THIS LEAFLET:
1. What ASASANTIN Retard is and what it is
  used for
2. Before you take ASASANTIN Retard
3. How to take ASASANTIN Retard
4. Possible side effects
5. How to store ASASANTIN Retard
6. Further information
1. WHAT ASASANTIN RETARD IS AND  

    WHAT IT IS USED FOR
WHAT ASASANTIN RETARD IS
The name of your medicine is ASASANTIN
Retard 200 mg / 25 mg Modified Release
Hard Capsules (called ASASANTIN Retard in
this leaflet).
Each capsule of ASASANTIN Retard contains
two different medicines called:
• Dipyridamole
• Aspirin (acetylsalicylic acid)
These belong to a group of medicines called
‘anti-thrombotic agents’. Aspirin is also a
type of medicine called a ‘Non-Steroidal
Anti-inflammatory Drug’ (NSAID).
WHAT ASASANTIN RETARD IS USED FOR
ASASANTIN Retard is used when you have
had a:
• Stroke or
• Transient Ischaemic Attack (TIA, also
 known as ‘mini-stroke’)
which was caused by a blood clot in your
brain. ASASANTIN Retard prevents the blood
clots reforming and so reduces the risk of
either of these happening again.
2. BEFORE YOU TAKE ASASANTIN RETARD
DO NOT TAKE ASASANTIN RETARD IF YOU ARE 
ALLERGIC (HYPERSENSITIVE) TO:
• Dipyridamole
• Aspirin or any other medicines containing
 aspirin (also called ‘salicylates’)
• Any of the other ingredients of ASASAN

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ASASANTIN Retard 200 mg/25 mg Modified Release Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dipyridamole 200 mg and acetylsalicylic acid (aspirin) 25 mg.
Excipients:
Each capsule contains:
Lactose Monohydrate 53 mg and sucrose 11.32 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
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.
In ce