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SINTROM UNO 1MG TABLETS

Active substance(s): ACENOCOUMAROL

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Ref: LTT0053/040516/1/F

Sintrom Uno 1mg Tablets
(acenocoumarol)
Patient Information Leaflet
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.
Your medicine is called Sintrom Uno 1mg tablets but will be reffered to as
Sintrom Uno throughout the leaflet.
The information in this leaflet has been divided into the following sections:
1 What Sintrom uno is and what it is taken for
2 What you need to know before you take Sintrom uno
3

How to take Sintrom uno

4

Possible side effects

5

How to store Sintrom uno

6

Contents of the pack and other information

1

What Sintrom uno is and what it is taken for

Sintrom uno belongs to a group of medicines called anticoagulants
(blood thinning medicines).
Sintrom uno is used to treat and prevent blood clots blocking the blood
vessels e.g. deep vein thrombosis (DVT).
Sintrom uno 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 Sintrom uno

Follow all the doctor’s instructions carefully. They may differ from the general
information contained in this leaflet.
Do not take Sintrom uno:
* 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
Sintrom uno (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 Sintrom uno.
Take special care with Sintrom uno
Before you take Sintrom uno 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
Sintrom uno.
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 Sintrom uno you are likely to
bleed more than normal. The doctor or hospital staff must be informed that
you are taking Sintrom uno 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 Sintrom uno.

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 Sintrom uno:
Medicines that increase the activity of Sintrom uno 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 Sintrom uno is prescribed in combination with these drugs, more
frequent monitoring (including blood tests) will be needed.
Other medicines that may increase the activity of Sintrom uno such as:
* 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
* 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
* 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.
Medicines that may decrease the effect of Sintrom uno 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 Sintrom uno on other medicines
* Sintrom uno 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 Sintrom uno 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.

Ref: LTT0053/040516/1/B

Sintrom Uno 1mg Tablets
(acenocoumarol)
Patient Information Leaflet (continued)
Elderly
If you are 65 years or older you may be more sensitive to the effects of
Sintrom uno and so need more frequent check-ups. You may also need
lower doses.
Children and adolescents
Experience with Sintrom uno in children and adolescents is limited and so
these patients need more frequent check-ups.
Pregnancy and breast-feeding
Do not take Sintrom uno if you are pregnant. Sintrom uno, 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 Sintrom uno
during pregnancy.
The decision to breast-feed while taking Sintrom uno should be carefully
considered with your doctor. You and your child may require
blood tests if you are breast-feeding while you are taking Sintrom uno.
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 Sintrom uno.
You may also be asked to use birth control while taking Sintrom uno.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Sintrom uno has no influence on the ability to drive or use machines.
Sintrom uno 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 Sintrom uno

Always take Sintrom uno exactly as your doctor has told you to. You should
check with your doctor or pharmacist if you are not sure.

* 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 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.

Sintrom uno should be taken as a single dose at the same time every day.
Swallow your tablets whole with a drink of water.

How to store Sintrom uno

5
Your doctor will arrange regular blood tests during treatment with Sintrom
uno to check on how fast your blood is clotting. This will help the doctor
decide on your dose.
The dose of Sintrom uno 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.

Keep out of the sight and reach of children.
Do not take Sintrom uno 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 your tablets show any sign of deterioration or discolouration, consult your
pharmacist for advice.
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.

Children:
Sintrom uno is not recommended for children.
Tell your doctor or dentist or pharmacist at every visit that you are using
Sintrom uno.
What to do if you take more Sintrom uno 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 Sintrom uno
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 Sintrom uno, talk to your doctor.

4

Possible side effects

Like all medicines, Sintrom uno 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

6

Contents of the pack and other information

What Sintrom uno 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, hypromellose, magnesium stearate, maize
starch, talc and silicon dioxide.
What Sintrom uno looks like and contents of the pack
Sintrom uno are white, round, flat tablets, with slightly bevelled edges, with
one side bearing the imprint “CG” and the other imprint “AA”. They come in
cartons of 60 & 100 tablets.
Manufacturer and licence holder
This medicine is manufactured by ROVI Frosst Ibérica, S.A., Via
Complutense, 14028805 Alcalá de Henares, Madrid and is procured from
within the EU. Product licence holder LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything , ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to help you.

POM

PL: 33723/0053

Leaflet revision date: 04/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited, Tel: 01527 505414
for help.

Ref: LTT0053/040516/2/F

Acenocoumarol 1mg Tablets
Patient Information Leaflet
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.
Your medicine is called Acenocoumarol 1mg tablets but will be reffered to as
Acenocoumarol throughout the leaflet.
The information in this leaflet has been divided into the following sections:
1 What Acenocoumarol is and what it is taken for
2

What you need to know before you take Acenocoumarol

3

How to take Acenocoumarol

4

Possible side effects

5

How to store Acenocoumarol

6

Contents of the pack and other information

1

What Acenocoumarol is and what it is taken 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

What you need to know before you take
Acenocoumarol

Follow all the doctor’s instructions carefully. They may differ from the general
information contained in this leaflet.
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 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 Acenocoumarol.
Take special care with Acenocoumarol
Before you take Acenocoumarol 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
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 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 Acenocoumarol:
Medicines that increase the activity of Acenocoumarol 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 Acenocoumarol is prescribed in combination with these drugs, more
frequent monitoring (including blood tests) will be needed.
Other medicines that may increase the activity of Acenocoumarol such
as:
* 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
* 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
* 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.
Medicines that may decrease the effect of Acenocoumarol 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 Acenocoumarol on other medicines
* Acenocoumarol 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 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.

Ref: LTT0053/040516/2/B

Acenocoumarol 1mg Tablets
Patient Information Leaflet (continued)
Elderly
If you are 65 years or older you may be more sensitive to the effects of
Acenocoumarol and so need more frequent check-ups.
You may also need lower doses.
Children and adolescents
Experience with Acenocoumarol in children and adolescents is limited and
so these patients need more frequent check-ups.
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
Acenocoumarol has no influence on the ability to drive or use machines.
Acenocoumarol 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 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:
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:
Acenocoumarol is not recommended for children.
Tell your doctor or dentist or pharmacist at every visit that you are using
Acenocoumarol.
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 left-over 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.
If you have any questions about stopping Acenocoumarol, talk to your
doctor.

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 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 Acenocoumarol:
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 Acenocoumarol

Keep out of the sight and reach of children.
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 your tablets show any sign of deterioration or discolouration, consult your
pharmacist for advice.
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 the pack and other 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, hypromellose, magnesium stearate, maize
starch, talc and silicon dioxide.
What Acenocoumarol looks like and contents of the pack
Acenocoumarol are white, round, flat tablets, with slightly bevelled edges,
with one side bearing the imprint “CG” and the other imprint “AA”. They
come in cartons of 60 & 100 tablets.
Manufacturer and licence holder
This medicine is manufactured by ROVI Frosst Ibérica, S.A., Via
Complutense, 14028805 Alcalá de Henares, Madrid and is procured from
within the EU. Product Licence Holder LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to help you.

POM

PL: 33723/0053

Leaflet revision date: 05/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited, Tel: 01527 505414
for help.

Ref: LTT0053/040516/3/F

®

Sinthrome 1mg Tablets
(acenocoumarol)
Patient Information Leaflet
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.
Your medicine is called Sinthrome 1mg tablets but will be reffered to as
Sinthrome throughout the leaflet.
The information in this leaflet has been divided into the following sections:
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

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.

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:
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 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
* 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
* 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.
Medicines that may decrease the effect of Sintrome 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.

Ref: LTT0053/040516/3/B

®

Sinthrome 1mg Tablets
(acenocoumarol)
Patient Information Leaflet (continued)
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 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 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

– 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 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.

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.

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.
If your tablets show any sign of deterioration or discolouration, consult your
pharmacist for advice.
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.

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

6

Contents of the pack and other 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.
The other ingredients are lactose, hypromellose, magnesium stearate, maize
starch, talc and silicon dioxide.
What Sinthrome looks like and contents of the pack
Sinthrome are white, round, flat tablets, with slightly bevelled edges, with
one side bearing the imprint “CG” and the other imprint “AA”.
They come in cartons of 60 & 100 tablets.
Manufacturer and licence holder
This medicine is manufactured by ROVI Frosst Ibérica, S.A., Via
Complutense, 14028805 Alcalá de Henares, Madrid and is procured from
within the EU. Product licence holder LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to help you.

POM

PL: 33723/0053

Sinthrome is a registered trademark of Novartis Pharmaceuticals Limited.
Leaflet revision date: 04/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited, Tel: 01527 505414
for help.

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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