Dipyridamole 25mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-07-2019
Summary of Product characteristics
(SPC)
22-08-2019
Active ingredient:
Dipyridamole
Available from:
A A H Pharmaceuticals Ltd
ATC code:
B01AC07
INN (International Name):
Dipyridamole
Dosage:
25mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02090000; GTIN: 5012252102871
Patient Information leaflet
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BSTCutterGuideReq@actavis.com
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Dipyridamole Tablets
25mg, 100mg x 84’s (UK)
130x210 (Reel Fed)
50972449
Leaflet for Bottles
4158
T. Hull
08/07/19
130x210 Leaflet Reel Fed Profile (BST)
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FMD info
NA (not a carton)
No
Yes
Details
DIPYRIDAMOLE ALL STRENGTHS TABLETS PIL - UK
Black
Profile
BBBA5530
G. Worth
17/07/2019
23/07/2019
G.Worth
130 x 210
8 pt
Accord Barnstaple
n/a
n/a
2
Version 2
01.11.2017
DIPYRIDAMOLE 25MG
AND 100MG TABLETS
_Continued top of next column_
_Continued over page_
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.
INDEX
1
WHAT DIPYRIDAMOLE TABLETS ARE
AND WHAT THEY ARE USED FOR
2
BEFORE YOU TAKE
3
HOW TO TAKE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE
6 FURTHER INFORMATION
1 WHAT DIPYRIDAMOLE TABLETS ARE
AND WHAT THEY ARE USED FOR
Dipyridamole tablets belong to the group
of medicines known as “antithrombotic
agents”. They are used to prevent blood
clots which may occur if you have
had your heart valves replaced. You
will normally also be receiving other
medicines to prevent your blood clotting.
2 BEFORE YOU TAKE
DO NOT TAKE Dipyridamole tablets
and TELL your doctor if you:
•
are ALLERGIC (hypersensitive)
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DIPYRIDAMOLE TABLETS BP 25mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg Dipyridamole BP.
3.
PHARMACEUTICAL FORM
Orange film-coated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
1) As an adjunct to oral anticoagulation for prophylaxis of
thromboembolism
associated with prosthetic heart valves.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Dipyridamole should usually be taken before meals.
_Adults:_ 300-600mg daily in three or four divided doses.
_Children:_ The normal total oral daily dose is 5mg/kg bodyweight
daily in
divided doses.
_Elderly:_ No specific information is available.
_ _
_Route of administration_
For oral administration.
4.3
CONTRA-INDICATIONS
Hypersensitivity to dipyridamole or any other ingredients in the
formulation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Dipyridamole is a potent vasodilator. It should be used with caution
in patients
with sub-valvular aortic stenosis, hypotension, severe coronary artery
disease
including unstable angina or haemodynamic instability associated with
recent
myocardial infarction, left ventricular outflow obstruction such as
aortic
stenosis, and in patients with decompensated heart failure.
Dipyridamole should be used with caution in patients with coagulation
disorders.
Oral dipyridamole should be stopped 24 hours before intravenous use
for
stress testing.
In patients with myasthenia gravis readjustment of therapy may be
necessary
after changes in dipyridamole dosage (see Section 4.5).
This product contains lactose and sucrose. Patients with rare
hereditary
problems of fructose intolerance, glucose-galactose malabsorption or
sucrose-
isomaltase insufficiency should not take this medicine.
The tablets contain sunset yellow, E110 which can cause allergic-type
reactions including asthma. Allergy is more common in those people who
are
allergic to aspirin.
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The absorption of dipyridamo
Read the complete document
