Dipyridamol Actavis 200 mg Depotkapsel, hård

Země: Švédsko

Jazyk: švédština

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktivní složka:

dipyridamol

Dostupné s:

Actavis Group PTC ehf.

ATC kód:

B01AC07

INN (Mezinárodní Name):

dipyridamole

Dávkování:

200 mg

Léková forma:

Depotkapsel, hård

Složení:

dipyridamol 200 mg Aktiv substans

Druh předpisu:

Receptbelagt

Přehled produktů:

Förpacknings: Burk, 30 kapslar; Burk, 60 kapslar; Burk, 100 (2 x 50) kapslar

Stav Autorizace:

Avregistrerad

Datum autorizace:

2017-01-19

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIPYRIDAMOL ACTAVIS 200 MG PROLONGED-RELEASE CAPSULES, HARD
dipyridamole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dipyridamol Actavis is and what it is used for
2.
What you need to know before you take Dipyridamol Actavis
3.
How to take Dipyridamol Actavis
4.
Possible side effects
5.
How to store Dipyridamol Actavis
6.
Contents of the pack and other information
1.
WHAT DIPYRIDAMOL ACTAVIS IS AND WHAT IT IS USED FOR
Dipyridamol Actavis contains the active substance dipyridamole. This
belongs to a group of
medicines called ‘anti-thrombotic agents’, which are used to stop
blood clots forming.
Dipyridamol Actavis is used:
-
To reduce the risk of having another stroke in people who have had a
stroke caused by a blood
clot in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIPYRIDAMOL ACTAVIS
DO NOT TAKE DIPYRIDAMOL ACTAVIS:
-
if you are allergic to dipyridamole or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Dipyridamol Actavis:
-
If you have angina or other heart diseases or have had a recent heart
attack
-
If you have myasthenia gravis (muscle weakness)
-
If you have any bleeding problems
IF YOU ARE HAVING HEART TESTS
Dipyridamol Actavis contains dipyridamole. Dipyridamole is also
sometimes given as an injection
during tests to see if the heart is working properly (also called
‘myocardial imaging’). This means that
the test and your medicine

Charakteristika produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dipyridamol Actavis 200 mg prolonged-release capsules, hard.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains dipyridamole 200 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Hard gelatin capsule, 23.5 mm, with a reddish-brown (orange) opaque
body and cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Secondary prevention of ischaemic stroke and transient ischaemic
attacks either alone or in
conjunction with acetylsalicylic acid.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one capsule twice daily, usually one in the
morning and one in the evening,
which can be taken with or without food.
_Paediatric population_
Dipyridamol Actavis is not recommended for children since the safety
and efficacy of dipyridamole in
children has not yet been established.
Method of administration
For oral administration.
The capsules should be swallowed whole without chewing.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Among other properties, dipyridamole acts as a potent vasodilator. It
should therefore be used with
caution in patients with severe coronary artery disease including
unstable angina and/or recent
2
myocardial infarction, left ventricular outflow obstruction or
haemodynamic instability (e.g.
decompensated heart failure).
Patients being treated with regular oral doses of Dipyridamol Actavis
should not receive additional
intravenous dipyridamole. Clinical experience suggests that patients
being treated with oral
dipyridamole who also require pharmacological stress testing with
intravenous dipyridamole should
discontinue drugs containing oral dipyridamole for twenty-four hours
prior to stress testing.
In patients with myasthenia gravis readjustments of therapy may be
necessary after changes in
dipyridamole dosage