SINTHROME 1MG TABLETS

Active substance: ACENOCOUMAROL

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®

Sinthrome 1mg Tablets

2499
24.06.13[3]

(acenocoumarol)
PATIENT INFORMATION LEAFLET
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.
Your medicine will be referred to as Sinthrome throughout the following
leaflet.
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.
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:
- 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.
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 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.
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
You can drive and use machines as normal while taking Sinthrome.

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

5. HOW TO STORE SINTHROME
Keep out of the sight and reach of children.

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.

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.

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

Store the tablets in the original package.

If your doctor decides to stop your treatment, return any unused medicine
to the pharmacist. Only keep it if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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. FURTHER INFORMATION
What Sinthrome contains
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 acenocoumarol.
The other ingredients are lactose monohydrate, hypromellose, magnesium
stearate, maize starch, talc and silica colloidal anhydrous.
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 60 and 100 tablets.
Manufacturer and Product Licence Holder
Manufactured by Novartis Farmaceutica, S.A., Gran Via de les Corts
Catalanes, 764, 08013, Barcelona, Spain.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2499

Leaflet issue and revision date: (Ref) 24.06.13[3]
Sinthrome is a trademark of Novartis AG.

Acenocoumarol 1mg Tablets

2499
24.06.13[3]

PATIENT INFORMATION LEAFLET
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.
Your medicine will be referred to as Acenocoumarol throughout the
following leaflet.
The information in this leaflet has been divided into the following sections:
1. What Acenocoumarol is and what it is used for
2. Check before you take Acenocoumarol
3. How to take Acenocoumarol
4. Possible side effects
5. How to store Acenocoumarol
6. Further information
1. WHAT ACENOCOUMAROL IS AND WHAT IT IS USED FOR
Acenocoumarol belongs to a group of medicines called anticoagulants
(blood thinning medicines).
Acenocoumarol is used to treat and prevent blood clots blocking the blood
vessels e.g. deep vein thrombosis (DVT).
Acenocoumarol 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 ACENOCOUMAROL
Do not take Acenocoumarol:
- 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 Acenocoumarol (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.
If any of the above applies to you, or if you are not sure, speak to your
doctor or pharmacist before you take Acenocoumarol.
Take special care with Acenocoumarol
Before you take Acenocoumarol 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.
You should not receive any injections into your muscles whilst you are
taking Acenocoumarol.
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 Acenocoumarol you are likely to
bleed more than normal. The doctor or hospital staff must be informed that
you are taking Acenocoumarol 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 Acenocoumarol.

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 Acenocoumarol:
- 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 Acenocoumarol 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.
Pregnancy and breast-feeding
Do not take Acenocoumarol if you are pregnant. Acenocoumarol, 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 Acenocoumarol during pregnancy.
The decision to breast-feed while taking Acenocoumarol should be carefully
considered with your doctor. You and your child may require blood tests if
you are breast-feeding while you are taking Acenocoumarol. 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 Acenocoumarol. You
may also be asked to use birth control while taking Acenocoumarol.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You can drive and use machines as normal while taking Acenocoumarol.

Important information about some of the ingredients of
Acenocoumarol
Acenocoumarol tablets contain lactose monohydrate, if you have been told
by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. HOW TO TAKE ACENOCOUMAROL
Always take Acenocoumarol exactly as your doctor has told you to. You
should check with your doctor or pharmacist if you are not sure.
Acenocoumarol 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
Acenocoumarol to check on how fast your blood is clotting. This will help
the doctor decide on your dose.
The dose of Acenocoumarol 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:
Acenocoumarol is not recommended for children.
What to do if you take more Acenocoumarol 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 leftover medicines or the empty packet to the doctor.
If you forget to take Acenocoumarol
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Acenocoumarol 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.
Tell your doctor or pharmacist if you think you have any of these or other
problems with Acenocoumarol:
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.
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.

5. HOW TO STORE ACENOCOUMAROL
Keep out of the sight and reach of children.
Store the tablets in the original package.
Do not take Acenocoumarol 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.
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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. FURTHER INFORMATION
What Acenocoumarol contains
The active ingredient in this medicine is acenocoumarol. This is the new
name for nicoumalone. The ingredient itself has not changed.
The other ingredients are lactose monohydrate, hypromellose, magnesium
stearate, maize starch, talc and silica colloidal anhydrous.
What Acenocoumarol looks like and contents of the pack
Acenocoumarol tablets are white, round, flat tablets, with “CG” imprinted on
one side and “AA” on the other.
They come in cartons of 60 and 100 tablets.
Manufacturer and Product Licence Holder
Manufactured by Novartis Farmaceutica, S.A., Gran Via de les Corts
Catalanes, 764, 08013, Barcelona, Spain.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2499

Leaflet issue and revision date: (Ref) 24.06.13[3]

Expand view ⇕

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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