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ACENOCOUMAROL 1MG TABLETS

Active substance(s): ACENOCOUMAROL

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PATIENT INFORMATION LEAFLET

Sinthrome® 1mg Tablets / Acenocoumarol 1mg Tablets
(acenocoumarol)
This medicine is available using either of the above names but will be referred to
as Sinthrome throughout the following leaflet.

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-the-counter).
This applies especially to the following medicines as they may interfere with
Sinthrome:

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.

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)).

If you get any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

When Sinthrome is prescribed in combination with these drugs, more frequent
monitoring (including blood tests) will be needed.

The information in this leaflet has been divided into the following sections:

Other medicines that may increase the activity of Sinthrome such as:

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

 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 co-trimoxazole - used to treat infections
 sulfonylureas 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
 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. 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

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.

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
 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.

Medicines that may decrease the effect of Sinthrome such as:
 aminoglutethimide - used to treat cancer or Cushing’s syndrome
 protease inhibitors such as ritonavir or indinavir - used to treat HIV
 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
 oral contraceptives such as Femodene, Logynon and Cilest - for birth control
 rifampicin - medicine used against infection
 St John’s Wort - for depression
 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
Taking 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.
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 breastfeeding 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.
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
− 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the national reporting system 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 out of the sight and reach of children.
 Store in the original package.
 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.
 If your medicine becomes discoloured or show signs of any deterioration,
consult your doctor or pharmacist who will tell you what to do.
6. Contents of pack and other information
What Sinthrome contains
Each tablet contains 1mg of acenocoumarol.
This is the new name for nicoumalone. The ingredient itself has not changed.
The other excipients are: colloidal silicon dioxide, lactose, hypromellose, corn
starch, magnesium stearate and talc.
What Sinthrome looks like and contents of the pack
Sinthrome are white, round, flat tablets with “CG” imprinted on one side and “AA”
on the other side. They are available in blister packs of 100 tablets.
POM

PL: 15814/1200

Sinthrome is manufactured by Merus Labs Netherlands B.V., Herengracht 483,
1017 BT Amsterdam, The Netherlands.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
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.
Leaflet revision and issue date (Ref.): 25.07.2016.
Sinthrome is a registered trademark of Novartis Pharmaceuticals Limited.
To request a copy of this leaflet in Braille, large print or audio please call 01923
332 796.

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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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