Sinthrome 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acenocoumarol

Available from:

Waymade Healthcare Plc

ATC code:

B01AA07

INN (International Name):

Acenocoumarol

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080200

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Sinthrome
®
1mg Tablets
acenocoumarol
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you
• Always take this medicine exactly as described in this leaflet or
as your doctor or pharmacist have told 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 Sinthrome is and what it is used for
2. What you need to know before you take Sinthrome
3. How to take Sinthrome
4. Possible side effects
5. How to store Sinthrome
6. Contents of the pack and other information
1. What Sinthrome is and what it is used for
Sinthrome 1 mg Tablets (acenocoumarol) belongs to a group of medicines
called anticoagulants (blood thinning
medicines).
Sinthrome is used to treat and prevent blood clots blocking the blood
vessels e.g. deep vein thrombosis (DVT).
Sinthrome does not dissolve blood clots that have already formed but
it may stop the clots from becoming larger
and causing more serious problems.
2. What you need to know before you take Sinthrome
Follow all the doctor’s instructions carefully. They may differ from
the general information contained in this leaflet.
Do not take Sinthrome:
• if you are allergic (hypersensitive) to acenocoumarol, any other
medicines that you have taken to thin your blood
or to any of the ingredients in Sinthrome (see Section 6, Contents of
the pack and other information)
• if you are pregnant, planning to become pregnant or breast-feeding
(see Pregnancy, breast-feeding and
fertility).
• if you are an alcoholic
• if you have any mental illness for example, schizophrenia or
dementia

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sinthrome 1mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Acenocoumarol BP 1mg.
Excipient(s) with known effect:
Lactose (20mg).
For the full list of excipients see, section 6.1.
3
PHARMACEUTICAL FORM
Tablets for oral administration.
White, round, flat tablets with slightly bevelled edges, with one side
bearing
the imprint “CG”, and the other the imprint “AA”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prevention of thromboembolic diseases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
GENERAL TARGET POPULATION
Sensitivity to anticoagulants varies from patient to patient and may
also fluctuate
during the course of treatment. Therefore, it is essential to perform
regular testing of
prothrombin
time
(PT)/International
Normalised
Ratio
(INR)
and
to
adjust
the
patient’s dosage accordingly. If this is not possible, Sinthrome
should not be used.
Sinthrome should be given in a single oral dose.
INITIAL DOSAGE:
The dosing of Sinthrome must be individualised. If the PT/INR value is
within the
normal
range
before
starting
treatment,
the
following
dosage
schedule
is
recommended:
The usual starting dose is between 2 mg/day to 4 mg/day without
administration of a
loading dose. Treatment may also be initiated with a loading dose
regimen, usually 6
mg on the first day followed by 4 mg on the second day.
If the initial thromboplastin time is abnormal, treatment should be
instituted with
caution.
Elderly patients (
≥
65), patients with liver disease or severe heart failure with hepatic
congestion
or
malnourished
patients
may
require
lower
doses
during
treatment
initiation and maintenance (see section 4.4).
Measurement of the thromboplastin time should be carried out daily in
hospital
starting from second or third dose of Sinthrome and up to the time
when the
coagulation status is stabilized within the target range. The interval
between tests can
later be extended, depending on the stability of PT/INR results. Blood
sam