SINTHROME 1MG TABLETS

Active substance: ACENOCOUMAROL

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This product is known as any of the above names but will usually be referred to as Sinthrome throughout
this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

The information in this leaflet has been divided into the following sections:
1. What Sinthrome is and what it is used for
2. Check before you take Sinthrome
3. How to take Sinthrome
4. Possible side effects
5. How to store Sinthrome
6. Further 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. Check before you take Sinthrome
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 Further 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 or 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 regularly drink cranberry juice or take cranberry extracts.

DATE:

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.

22/11/13

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).

REPORTING OF SIDE EFFECTS

UK PIL GRANTED APRIL 2008

CODE:

06464/2683B

TVT CHECKED

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 taken any of the following medicines as they may
interfere with Sinthrome:
• paracetamol and non-steroidal anti-inflammatories (NSAIDs) such as aspirin, ibuprofen and
celecoxib - used for pain relief or to treat rheumatic diseases
• tramadol - a strong pain killer
• antibiotics such as rifampicin, amoxicillin and metronidazole - used to treat infections
• sulfonamides such as co-trimoxazole - used to treat infections
• sulphonylureas such as tolbutamide, chlorpropamide and glibenclamide - oral medicines for
diabetes
• glucagon - used to treat low blood sugar levels
• thyroid hormones such as levothyroxine - used to treat an underactive thyroid
• allopurinol or sulfinpyrazone - for the treatment of gout and to lower uric acid levels
• anti-arrhythmic agents such as amiodarone and quinidine - medicines for an irregular heartbeat
• oral contraceptives such as Femodene, Logynon and Cilest - for birth control
• antiepileptics such as carbamazepine or phenytoin - used to treat epilepsy
• H2-agonists such as cimetidine or ranitidine - used to treat stomach or intestinal ulcers
• aminoglutethimide - used to treat cancer or Cushing’s syndrome
• barbiturates such as sodium amytal or phenobarbital - for epilepsy or to help you sleep
• etacrynic acid or thiazide diuretics (“water tablets”) such as bendroflumethiazide or metolazone for water retention or high blood pressure
• statins and other lipid lowering drugs such as fenofibrate, simvastatin or colestyramine - used to
lower blood cholesterol levels
• imidazoles such as econazole and ketoconazole or griseofulvin - used to treat fungal infections
• antineoplastics such as mercaptopurine and 5-fluorouracil - for breast, gastrointestinal and skin
cancer
• tamoxifen - for breast cancer and fertility
• anti-platelet medicines such as dipyridamole, clopidogrel - to prevent blood clots forming
• selective serotonin re-uptake inhibitors such as fluoxetine and paroxetine - used to treat anxiety
and depression
• St John’s Wort - for depression
• protease inhibitors such as ritonavir or indinavir - used to treat HIV
• anabolic steroids - used as replacement therapy
• androgens such as testosterone and mesterolone - used as replacement therapy
• corticosteroids such as prednisolone and methylprednisolone - steroids used to treat inflammatory
bowel disease, arthritis and certain skin conditions
• azathioprine - for organ transplantation, chronic inflammatory and autoimmune diseases
• disulfiram - for alcohol dependence
• heparin - to thin the blood in the treatment of deep vein thrombosis, blood clots or after surgery.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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.

WARNING!

Take special care with Sinthrome
Before you take Sinthrome tell your doctor:
• if you have cancer
• if you have an infection or inflammation (swelling)
• 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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

DATE:

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take
Sinthrome.

You should not receive any injections into your muscles whilst you are taking Sinthrome.

DATE OF PROOF:

ARTWORKER:

DT

PRE-PRESS NO.:

PRODUCT:

Sinthrome 1mg tabs

CUSTOMER: Waymade

04-1957

Q.A.
APPROVED:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 22/11/13

Leaflet Flat Size = 148 x 432

Read all of this leaflet carefully before you start taking this medicine
• 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your
doctor or pharmacist.

WARNING!

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

SINTHROME® 1mg TABLETS/
ACENOCOUMAROL 1mg TABLETS
(acenocoumarol)
Patient Information Leaflet

Driving and using machines
You can drive and use machines as normal while taking Sinthrome.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Important information about some of the ingredients of Sinthrome
Sinthrome tablets contain lactose, if you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
Leaflet Flat Size = 148 x 432

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.

PROOF HISTORY:
v.1 - waymade - 22/11/13

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:
Most patients will receive doses of between 1 to 8 mg (milligrams) a day. A dose of 4 mg is usual on the first
day of treatment.
Elderly patients, patients with liver disease or severe heart failure or malnourished patients may need lower
doses.
Children:
Sinthrome is not recommended for children.

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.

DATE:
22/11/13

Other rare side effects (that affect less than 1 person in 1000):
• loss of appetite
• feeling or being sick
• skin rashes
• itching
• unexplained fever
• hair loss.
REPORTING OF SIDE EFFECTS

UK PIL GRANTED APRIL 2008

TVT CHECKED

DATE OF PROOF:

06464/2683B

DT

CODE:

Q.A.
APPROVED:
04-1957

Tell your doctor or pharmacist if you think you have any of these or other problems with Sinthrome:

Sinthrome 1mg tabs

ARTWORKER:

DATE:

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:
• 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 up blood
• dizziness
• severe headache
• joint pain or stiffness
• blurred sight.

PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

CUSTOMER
APPROVED:

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.

Very rare side effects (that affect less than 1 person in 10,000):
• red patches on the skin or bruising
• vasculitis (inflammation of the blood vessels)
• liver damage which can cause yellow eyes or skin.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor.
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 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
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 to protect the
environment.

6. Further information
Your medicine is called Sinthrome 1mg tablets/Acenocoumarol 1mg tablets.
The active ingredient in this medicine is acenocoumarol. This is the new name for nicoumalone.
The ingredient itself has not changed.
Each tablet contains 1mg of the active ingredient acenocoumarol.
Sinthrome 1mg tablets/Acenocoumarol 1mg tablets are white, round, flat tablets, with “CG” imprinted on one
side and “AA” on the other.
Sinthrome 1mg tablets/Acenocoumarol 1mg tablets also contain the following:
lactose, hypromellose, magnesium stearate, maize starch, talc and colloidal silica.
Sinthrome 1mg tablets/Acenocoumarol 1mg tablets are available in packs of 60 and 100 tablets.
POM

PL No: 6464/2683

This product is manufactured by Novartis Farmaceutica S.A., Gran Via de les Corts Catalanes, 764, 08013,
Barcelona, Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 22.11.2013
Sinthrome is a registered trademark of Novartis AG

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Ask your doctor or pharmacist for advice before taking any medicine.

WARNING!

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.

WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

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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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