Sinthrome 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acenocoumarol

Available from:

Norgine Pharmaceuticals Ltd

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; GTIN: 5036631815374

Patient Information leaflet

PAGINA 1
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, or similar medicines to thin the
blood called coumarin derivatives (e.g. warfarin, phenprocoumon), or
to any of the ingredients in Sinthrome (see
Section 6, Contents of the pack and other information)
• are pregnant, planning to become pregnant or breast-feeding (see
PREGNANCY, BREAST-FEEDING AND FERTILITY).
• are an alcoholic
• have any mental illness for example, schizophrenia or dementia
• have recently had, or are about to have an operation on your
spine, brain, eyes or any major surgery
• had a stroke caused by bleeding into your brain
• suffer from very high blood pressure
• have stomach ulcer or any intestinal bleeding
• pass blood in your water or cough up blood
• suffer from any bleeding disorders, bleeding problems or
unexplained bruising
• feel sharp pain in the centre or left side of the chest which may
be accompanied by shortness of breath (these
may be signs of a fluid buildup or inflammation around the heart
called pericarditis) or if you experience flu-like
symptoms, heart murmurs, rash and chest pain (these may be signs of
infection of the inner lining of the heart
called endocarditis)
• have severe liver or kidney disease.
If any of the above applies to you, or if you are not sure, speak to
your doctor or pharmacist before you take
Sinthrome.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacis

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