OFCRAM SR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-12-2016
Summary of Product characteristics
(SPC)
14-07-2018
Active ingredient:
DIPYRIDAMOLE
Available from:
Focus Pharmaceuticals Ltd
ATC code:
B01AC07
INN (International Name):
DIPYRIDAMOLE
Dosage:
200 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
dipyridamole
Authorization status:
Not Marketed
Authorization date:
2013-11-04
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OFCRAM SR 200MG 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.
WHAT IS IN THIS LEAFLET:
1.
What Ofcram Prolonged Release Capsules are and what they are used for
2.
What you need to know before you take Ofcram Prolonged Release
Capsules
3.
How to take Ofcram Prolonged Release Capsules
4.
Possible side effects
5.
How to store Ofcram Prolonged Release Capsules
6.
Contents of the pack and other information
1. WHAT OFCRAM PROLONGED RELEASE CAPSULES ARE
AND WHAT THEY ARE USED FOR
You must talk to your doctor if you do not feel better or if you feel
worse after a few
days.
Ofcram SR 200mg Prolonged Release Capsules (called Ofcram Prolonged
Release
Capsules throughout the rest of this leaflet) contain a medicine
called dipyridamole.
Ofcram belongs to a group of medicines called antithrombotic agents
which are used
to stop blood clots forming.
Ofcram Prolonged Release Capsules are used:
-
After a stroke to prevent blood clots in the brain;
-
To prevent blood clots forming after having a heart valve replaced.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OFCRAM
PROLONGED RELEASE CAPSULES
DO NOT USE OFCRAM PROLONGED RELEASE CAPSULES:
if you are allergic (hypersensitive) to dipyridamole, or any of the
other
ingredients in this medicine (listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ofcram Prolonged
Release
Capsules.
TAKE SPECIAL CARE WITH OFCRAM PROLONGED RELEASE CAPSULES:
Check with your doctor or pharma
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ofcram SR 200mg Prolonged-release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release capsule contains dipyridamole 200 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsules, hard.
_Appearance:_
Hard gelatin capsules consisting of a red cap and an orange body.
Dimension 7,66 mm x 23,1 mm.
The capsule contains yellow coloured slow release pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Secondary prevention of ischaemic stroke and transient ischaemia
attacks either alone or in conjunction with aspirin.
An adjunct to oral anti-coagulation for prophylaxis of thromboembolism
associated with prosthetic heart valves.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Dose
The recommended dose is one capsule twice daily, usually one in the
morning and one in the evening.
The capsules should be taken with food. The capsules should be
swallowed whole without chewing.
_Paediatric population_
Ofcram SR 200mg Prolonged Release Capsules, Hard is not recommended
for children, due to lack of data on safety
and efficacy.
_Elderly_
No dosage adjustment is needed.
_Patients with renal impairment_
No dosage adjustment is needed.
_Patients with hepatic impairment_
No dosage adjustment is needed.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
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