Dindevan 50mg Tablets; Phenindione 50mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PHENINDIONE

Available from:

Mercury Pharma Group Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, United Kingdom

ATC code:

B01AA02

INN (International Name):

PHENINDIONE 50 mg

Pharmaceutical form:

TABLET

Composition:

PHENINDIONE 50 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2006-08-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DINDEVAN 50MG TABLETS
Phenindione
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet, See section 4.
The name of your medicine is Dindevan 50mg Tablets. It will be
referred to as ‘Dindevan Tablets’ for ease
hereafter.
WHAT IS IN THIS LEAFLET
1.
What Dindevan Tablets are and what they are used for
2.
What you need to know before you take Dindevan Tablets
3.
How to take Dindevan Tablets
4.
Possible side effects
5.
How to store Dindevan Tablets
6.
Contents of the pack and other information
1.
WHAT DINDEVAN TABLETS ARE AND WHAT THEY ARE USED FOR
Phenindione belongs to a group of medicines called anticoagulants.
These medicines increase the time it takes for
your blood to clot.
Phenindione is used to prevent and treat blood clots in the veins and
arteries, for example, clots in the legs, lungs,
brain or heart.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DINDEVAN TABLETS
DO NOT TAKE DINDEVAN TABLETS
•
if you are allergic to Phenindione or any of the other ingredients of
this medicine (listed in section 6)
•
if you have severe liver or kidney problems
•
if you are pregnant or trying for a baby
•
if you within the last 72 hours have had an operation or you have
given birth within the last 48 hours
•
if you suffer from any unusual bruising or bleeding
•
if you are currently breast-feeding
•
if you suffer from uncontrolled high blood pressure
•
if you have an infection of the tissues lining the heart called
bacterial endocarditis
•
if you have a rare problem of sugar intolerance
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dindevan 50mg Tablets
Phenindione 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg phenindione.
Excipient with known effect:
Each tablet contains -
52mg lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Creamy
white,
flat,
bevel-edged
uncoated
tablets,
scored
on
one
side,
engraved D50 on the scored side.
The score line is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dindevan
(Phenindione
BP)
is
a
synthetic
anticoagulant
which
acts
by
interfering with the formation of clotting factors II, VII, IX and X.
It produces
its effect in 36-48 hours after the initial dose; the effect wanes
over a period of
48-72 hours after Dindevan is stopped.
Anticoagulant therapy can be initiated with Heparin and Dindevan
together.
Anticoagulant therapy in the prophylaxis of systemic embolisation in
patients
with rheumatic heart disease and atrial fibrillation.
Prophylaxis after insertion of prosthetic heart valves.
Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Adults: Initial loading dose of 200mg, followed on the second day by a
dose of
100mg. Dosage must be adjusted from the third day, dependent on the
results
of the appropriate coagulation tests such as prothrombin time,
reported as
international normalised ratio (INR).
Note: Concomitant heparin therapy affects the results of INR control
tests and
heparin should be discontinued at least 6 hours before the first INR
control test
is undertaken.
Control tests must be undertaken at regular intervals and the dosage
adjusted
according to the results of the INR tests.
A maintenance dose of 50-150mg/day is satisfactory in most patients,
but a
"resistant" patient may need 200mg/day or more.
A "sensitive" patient may need less than 50mg/day.
Method of administration: Oral
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance o