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SINTHROME TABLETS 1MG

Active substance(s): ACENOCOUMAROL / ACENOCOUMAROL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Measurement Bar (mm)

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. (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, breast-feeding 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 precaution
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.
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 surgery
• 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
• sulphonylureas such as tolbutamide, chlorpropamide
gout and to lower uric acid levels
and glibenclamide - oral medicines for diabetes
• clofibrate and related substances -medicines used
• thyroid hormones such as levothyroxine - used to
against high cholesterol
treat an underactive thyroid
• anabolic steroids - used as replacement therapy
• statins and other lipid lowering drugs such as
• androgens such as testosterone and mesterolone fenofibrate, simvastatin or colestyramine - used to
used as replacement therapy
lower blood cholesterol levels
• corticosteroids such as prednisolone and methyl• imidazole derivatives (e.g. metronidazole, and even
prednisolone - steroids used to treat inflammatory
when administered locally, miconazole) - a medicine
bowel disease, arthritis and certain skin conditions
used against infection
• anti-arrhythmic agents such as amiodarone and
• tramadol - a strong pain killer
quinidine - medicines for an irregular heartbeat
• tamoxifen - for breast cancer and fertility
• antibiotics (e.g. erythromycin, tetracyclines, neo• azathioprine - for organ transplantation, chronic
mycin, chloramphenicol, amoxicillin, some cephainflammatory and autoimmune diseases
losporins, some fluoroquinolones)-medicines used
• proton pump inhibitors (e.g. omeprazole)
against infections
• plasminogen activators (e.g. urokinase) strep• disulfiram - for alcohol dependence
tokinase and alteplase, thrombin inhibitors (e.g.
• etacrynic acid or thiazide diuretics (“water tablets”)
argatroben) - medicines used to breakdown blood
such as bendroflumethiazide or metolazone - for
clots during heart stroke
water retention or high blood pressure
• antineoplastics such as mercaptopurine and 5-fluo• glucagon - used to treat low blood sugar levels
rouracil - for breast, gastrointestinal and skin cancer
• selective serotonin re-uptake inhibitors such as
• H2-agonists such as cimetidine or ranitidine - used
fluoxetine and paroxetine - used to treat anxiety and
to treat stomach or intestinal ulcers
depression
• prokinetic agents (e.g. cisapride) - medicines used
• paracetamol – a medicine used for pain
against HIV disease
• sulfonamides such as co-trimoxazole - used to treat
• antacids (e.g. magnesium hydroxide) and viloxazine
infections
- medicine used against stomach acidity.
Medicines that may decrease the effect of Sinthrome such as:
• aminoglutethimide - used to treat cancer or Cush• oral contraceptives such as femodene, logynon and
ing’s syndrome
cilest - for birth control
• protease inhibitors such as ritonavir or indinavir • rifampicin - medicine used against infection
used to treat HIV
• St John’s Wort - for depression
• cholestyramine - medicine used against high cho• barbiturates such as sodium amytal or phenobarbital
lesterol levels
and carbamazepine - for epilepsy or to help you sleep
• griseofulvin - used to treat fungal infections.
• corticosteroids (high-dose intravenous methylprednisolone, 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.
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.
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.
Measurement Bar (mm)

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.
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.
Tell your doctor straight away if you have any of the following side effects:
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
- A painful skin rash. On rare occasions Sinthrome can cause serious skin conditions, including one called
calciphylaxis that can start with a painful skin rash but can lead to serious complications. This adverse
reaction occurs more frequently in patients with chronic disease kidney disease.
• 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sinthrome
Keep this medicine out of the sight and reach 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
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.
Manufacturer
FAMAR A.V.E
Anthousa Avenue 7
Anthousa Attiki, 15344
Greece
Merus Labs Netherlands B.V.
Alexander Battalaan 37
6221 CB Maastricht,
Netherlands
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 June 2017
31039270 UK

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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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