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Active substance(s): ACENOCOUMAROL

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Sinthrome® Tablets 1mg

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. 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 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, breastfeeding and fertility).
• if you are an alcoholic
• if you have any mental illness for example, schizophrenia or dementia
• 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.



Warnings and precautions
Talk to your doctor or pharmacist before taking
• 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.
Other medicines and Sinthrome
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without prescription (over‑the-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
• antibiotics (e.g. clindamycin)
• 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
• androgens such as testosterone and
mesterolone - used as replacement therapy
• anti-arrhythmic agents such as amiodarone
and quinidine - medicines for an irregular
• antibiotics (e.g. erythromycin, tetracyclines,
neomycin, chloramphenicol, amoxicillin, some
cephalosporins, some fluoroquinolones)medicines used against infections

• paracetamol – a medicine used for pain
• sulfonamides such as co-trimoxazole - used
to treat infections
• sulphonylureas such as 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

• 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
• imidazole derivatives (e.g. metronidazole,
and even when administered locally,
miconazole) - a medicine used against
• tramadol - a strong pain killer
• tamoxifen - for breast cancer and fertility
• azathioprine - for organ transplantation,
chronic inflammatory and autoimmune
• proton pump inhibitors (e.g. omeprazole)
• plasminogen activators (e.g. 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

Medicines that may decrease the effect of Sinthrome such as:
• aminoglutethimide - used to treat cancer or
Cushing’s syndrome

• oral contraceptives such as femodene,
logynon and cilest - for birth control

• protease inhibitors such as ritonavir or
indinavir - used to treat HIV

• St John’s Wort - for depression

• barbiturates such as sodium amytal or
phenobarbital and carbamazepine - for
epilepsy or to help you sleep
• corticosteroids (high‑dose intravenous
methylprednisolone, prednisolone) medicines used to treat inflammation

• rifampicin - medicine used against infection
• cholestyramine - medicine used against
high cholesterol levels
• griseofulvin - used to treat fungal infections.

Effects of Sinthrome on other medicines
• Sinthrome may increase the risk of toxicity by hydantoin derivatives such as phenytoin medicines used to treat epilepsy.



• selective serotonin re‑uptake inhibitors such
as fluoxetine and paroxetine - used to treat
anxiety and depression

• 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

Sinthrome with food and drink
Be careful when drinking alcohol as it may affect how Sinthrome thins your blood. Check with
your doctor first.
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.
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. (see Section 3)
Pregnancy, breast-feeding and fertility
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 contains 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.
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.
Sinthrome is not recommended for children.
Tell your doctor or dentist or pharmacist at every visit that you are using Sinthrome.
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
- 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).
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: By reporting side effects you can help provide more
information on the safety of this medicine.
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
6. Contents of pack and other information
What Sinthrome contains
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
Marketing Authorisation Holder
Merus Labs Luxco II S.à.R.L., 26-28, rue Edward Steichen, L-2540, Luxembourg.
Merus Labs Netherlands B.V.
Alexander Battalaan 37
6221 CB Maastricht,
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 July 2016
Sinthrome is a registered trademark of Novartis Pharmaceuticals Limited.


18 Jan 2016

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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.