SINTHROME TABLETS 1MG

Active substance: ACENOCOUMAROL

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PATIENT INFORMATION LEAFLET
Sinthrome® Tablets 1mg
acenocoumarol

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 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.
The information in this leaflet has been divided into the following sections:
1. What Sinthrome is and what it is taken 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 taken for
Sinthrome 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
 if you are an alcoholic
 if you have any mental illness for example, schizophrenia or dementia
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if you have recently had, or are about to have an operation on your spine,
brain, eyes or any major surgery
if you have had a stroke caused by bleeding into your brain
if you suffer from very high blood pressure
if you have a stomach ulcer or any intestinal bleeding
if you pass blood in your water or cough up blood
if you suffer from any bleeding disorders, bleeding problems or
unexplained bruising
if you have pericarditis or endocarditis – inflammation or infection around
the heart which causes pain in the chest
if you have severe liver or kidney disease
if you regularly drink cranberry juice or take cranberry extracts.

If any of the above applies to you, or if you are not sure, speak to your doctor
or pharmacist before you take Sinthrome.
Take special care with Sinthrome
Before you take Sinthrome tell your doctor or pharmacist:
 if you have cancer
 if you have an infection or inflammation (swelling)
 if you have a disorder affecting the absorption of food from the stomach
and/or intestine
 if you have heart failure (which causes swelling and shortness of breath)
 if you have liver or kidney problems
 if you have an overactive thyroid
 if you are elderly
 if you suffer from a blood disorder such as protein C or protein S
deficiency – this would cause you to bleed for longer than normal after a
cut or injury.
You should not receive any injections into your muscles whilst you are taking
Sinthrome.
If you need any injections into your spine or as part of a scan or X-ray test or if
you need minor surgery, including dental surgery, make sure you discuss your
treatment with your doctor first.
If you are involved in an accident while on Sinthrome you are likely to bleed
more than normal. The doctor or hospital staff must be informed that you are
taking Sinthrome immediately. Always carry your personal anticoagulation
card (an identification card from your pharmacist stating that you are using
this medicine).
If any of the above applies to you, or if you are not sure, speak to your doctor
or pharmacist before you take Sinthrome.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without prescription (over-the2

counter). This applies especially to the following medicines as they may
interfere with Sinthrome:
Medicines that increase the activity of Sinthrome such as:
 heparin - to thin the blood in the treatment of deep vein thrombosis, blood
clots or after surgery
 Salicylic acid and related substances (e.g. Acetyl salicylic acid,
aminosalicylic acid, diflunisal) (medicine used against pain)
 Clopidogrel, ticlopidine, phenylbutazone or other pyrazolone derivatives
(sulfinpyrazone), other non-steroidal anti-inflammatory agents (medicines
affecting the function of platelets (particles in the blood involved in blood
clotting)).
When Sinthrome is prescribed in combination with these drugs, more frequent
monitoring (including blood tests) will be needed.
Other medicines that may increase the activity of Sinthrome such as:













allopurinol or sulfinpyrazone - for
the treatment of gout and to lower
uric acid levels
anabolic steroids - used as
replacement therapy
androgens such as testosterone
and mesterolone - used as
replacement therapy
anti-arrhythmic agents such as
amiodarone and quinidine medicines for an irregular
heartbeat
antibiotics (e.g. erythromycin,
tetracyclines, neomycin,
chloramphenicol, amoxicillin,
some cephalosporins, some
fluoroquinolones)- medicines
used against infections
selective serotonin re-uptake
inhibitors such as fluoxetine and
paroxetine - used to treat anxiety
and depression
paracetamol – a medicine used
for pain
sulfonamides such as cotrimoxazole - used to treat
infections
sulphonylureas such as

 clofibrate and related substances medicines used against high
cholesterol
 corticosteroids such as
prednisolone and
methylprednisolone - steroids used
to treat inflammatory bowel disease,
arthritis and certain skin conditions
 disulfiram - for alcohol dependence
 etacrynic acid or thiazide diuretics
(“water tablets”) such as
bendroflumethiazide or metolazone
- for water retention or high blood
pressure
 glucagon - used to treat low blood
sugar levels
 imidazole derivatives (e.g.
metronidazole, and even when
administered locally, miconazole) a medicine used against infection
 tramadol - a strong pain killer
 tamoxifen - for breast cancer and
fertility
 azathioprine - for organ
transplantation, chronic
inflammatory and autoimmune
diseases
 proton pump inhibitors (e.g.
omeprazole)
 plasminogen activators (e.g.
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tolbutamide, chlorpropamide and
glibenclamide - oral medicines for
diabetes








thyroid hormones such as
levothyroxine - used to treat an
underactive thyroid
statins and other lipid lowering
drugs such as fenofibrate,
simvastatin or colestyramine used to lower blood cholesterol
levels
antineoplastics such as
mercaptopurine and 5-fluorouracil
- for breast, gastrointestinal and
skin cancer
H2-agonists such as cimetidine or
ranitidine - used to treat stomach
or intestinal ulcers




urokinase; streptokinase and
alteplase, thrombin inhibitors (e.g.
argatroben) - medicines used to
breakdown blood clots during
heart stroke
prokinetic agents (e.g. cisapride)
- medicines used against HIV
disease
antacids (e.g. magnesium
hydroxide) and viloxazine medicine used against stomach
acidity

Medicines that may decrease the effect of Sinthrome such as:
 aminoglutethimide - used to treat  oral contraceptives such as
cancer or Cushing’s syndrome
Femodene, Logynon and Cilest - for
birth control
 protease inhibitors such as
ritonavir or indinavir - used to
 rifampicin - medicine used against
treat HIV
infection
 barbiturates such as sodium
 St John’s Wort - for depression
amytal or Phenobarbital and
 cholestyramine - medicine used
carbamazepine - for epilepsy or to
against high cholesterol levels
help you sleep
 corticosteroids (high-dose
 griseofulvin - used to treat fungal
intravenous methylprednisolone,
infections
prednisolone) - medicines used to
treat inflammation

Effects of Sinthrome on other medicines
 Sinthrome may increase the risk of toxicity by hydantoin derivatives
such as phenytoin - medicines used to treat epilepsy
Taking with food and drink
Be careful when drinking alcohol as it may affect how Sinthrome thins your
blood. Check with your doctor first.

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You should avoid drinking cranberry juice or taking other cranberry products,
such as capsules or concentrates as this could mean you do not receive the
correct amount of acenocoumarol.
Elderly
If you are 65 years or older you may be more sensitive to the effects of
Sinthrome and so need more frequent check-ups. You may also need lower
doses.
Children and adolescents
Experience with Sinthrome in children and adolescents is limited and so these
patients need more frequent check-ups.
Pregnancy and breast-feeding
Do not take Sinthrome if you are pregnant. Sinthrome, like other
anticoagulants can cause serious harm to your baby. Tell your doctor if you
are pregnant or trying to become pregnant. Your doctor will discuss with you
the potential risk of taking Sinthrome during pregnancy.
The decision to breast-feed while taking Sinthrome should be carefully
considered with your doctor. You and your child may require blood tests if you
are breast-feeding while you are taking Sinthrome. However, as a precaution,
your doctor should prescribe vitamin K to your child to prevent their blood
from being thinned.
If you are of child bearing age, a pregnancy test may be done by your doctor
to rule out pregnancy before you are given Sinthrome. You may also be asked
to use birth control while taking Sinthrome.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Sinthrome has no influence on the ability to drive or use machines.
Sinthrome tablets contain lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor or pharmacist
before taking this medicinal product.

3. How to take Sinthrome
Always take Sinthrome exactly as your doctor has told you to. You should
check with your doctor or pharmacist if you are not sure.
Sinthrome should be taken as a single dose at the same time every day.
Swallow your tablets whole with a drink of water.
Your doctor will arrange regular blood tests during treatment with Sinthrome
to check on how fast your blood is clotting. This will help the doctor decide on
your dose.
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The dose of Sinthrome will vary from patient to patient and from day to day.
The following can be used as a guide:
Adults and elderly:
The usual starting dose is between 2 mg/day to 4 mg/day without
administration of a loading dose. Treatment can be started with a loading
dose regimen, usually 6 mg on the first day followed by 4 mg on the second
day.
Elderly patients, patients with liver disease or severe heart failure or
malnourished patients may need lower doses.
Children:
Sinthrome is not recommended for children.
Tell your doctor or dentist or pharmacist at every visit that you are using
Sinthrome.
What to do if you take more Sinthrome than you should
If you accidentally take too many tablets, or someone else takes any of your
medicine, you should tell your doctor immediately or contact the nearest
accident and emergency department. You may require blood tests to monitor
your condition and treatment may be required. Show any left-over medicines
or the empty packet to the doctor.
If you forget to take Sinthrome
Do not worry. If you forget to take a dose, take it as soon as possible, unless it
is almost time to take the next dose. Do not take a double dose. Then go on
as before.
If you have any questions about stopping Sinthrome, talk to your doctor.
4. Possible side effects
Like all medicines, Sinthrome can cause side effects, although not everyone
gets them.
If you get any of the following, tell your doctor or pharmacist:
Common (may affect up to 1 in 10 people):
 unusual bleeding such as:
- bleeding from the gums
- unexplained bruising or nosebleeds
- heavy periods
- heavy bleeding from cuts or wounds
 signs of bleeding inside the body such as:
- stomach or abdominal pain
- backache
- blood in the urine
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-

bloody or black tarry stools
coughing or vomiting blood
dizziness
severe headache
joint pain or stiffness
blurred sight.

Rare (may affect up to 1 in 1000):
 allergic reaction in the form of skin rash, or itching
 skin rashes
 itching
 unexplained fever
 loss of appetite
 feeling or being sick
 unusual hair loss.
Very rare (may affect up to 1 in 10,000):
 bruising with blistering of the skin with or without scars, usually in areas of:
- thighs
- buttocks
- abdomen
- breast
- or sometimes in the toes
 bruising or bleeding under the skin (possible sign of vasculitis)
 jaundice (possible signs of liver injury).
Tell your doctor or pharmacist if you think you have any of these or other
problems with Sinthrome:

5. How to store Sinthrome
Keep out of the reach and sight of children.
Do not take Sinthrome after the expiry date which is stated on the carton after
EXP. The expiry date refers to the last day of that month.
If your doctor decides to stop your treatment, return any unused medicine to
the pharmacist. Only keep it if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist on how to dispose of medicines no longer required. These
measures will help protect the environment.

6. Contents of pack and other information
What Sinthrome contains
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The active substance is acenocoumarol 1mg. This is the new name for
nicoumalone. The ingredient itself has not changed.
The other excipients are: aerosol 200 (silica aerogel), lactose, hypromellose,
magnesium stearate, maize starch and talc.
What Sinthrome looks like and contents of the pack
Sinthrome tablets are white, round, flat tablets, with “CG” imprinted on one
side and “AA” on the other. They come in cartons of 100 tablets.
Marketing Authorisation Holder and Manufacturer
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, United Kingdom.
Sinthrome tablet is released onto market by: Novartis Pharmaceutical UK Ltd.,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United
Kingdom.
The information in this leaflet applies only to Sinthrome. If you have any
questions or you are not sure about anything, ask your doctor or a
pharmacist.
This leaflet was last revised in October 2014
Sinthrome is a registered trademark of Novartis Pharmaceuticals Limited.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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