Dindevan 10mg Tablets; Phenindione 10mg 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 10 mg

Pharmaceutical form:

TABLET

Composition:

PHENINDIONE 10 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2012-07-18

Patient Information leaflet

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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENINDIONE 10 MG TABLETS, PHENINDIONE 25 MG TABLETS, PHENINDIONE 50
MG TABLETS
The name of your medicine is Phenindione 10 mg Tablets, Phenindione 25
mg Tablets, Phenindione 50
mg Tablets. It will be referred to as ‘Phenindione Tablets’ for
ease hereafter.
WHAT IS IN THIS LEAFLET
1.
What Phenindione Tablets are and what they are used for
2.
What you need to know before you take Phenindione Tablets
3.
How to take Phenindione Tablets
4.
Possible side effects
5.
How to store Phenindione Tablets
6.
Contents of the pack and other information
1.
WHAT PHENINDIONE TABLETS ARE AND WHAT THEY ARE USED FOR
Phenindione Tablets (either 10, 25 or 50 mg) belong 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.
The tablets come in three strengths: 10mg (creamy white); 25mg (green)
and 50mg (creamy white).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENINDIONE TABLETS
DO NOT TAKE PHENINDIONE 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 are currently breast-feeding
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dindevan 10mg Tablets
Phenindione 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg phenindione.
Excipient with known effect:
Each tablet contains -30mg 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 D10 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