SINTROM UNO 1 MG TABLETS, SINTHROME 1 MG TABLETS, ACENOCOUMAROL 1 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - SINTROM UNO 1 MG TABLETS, SINTHROME 1 MG TABLETS, ACENOCOUMAROL 1 MG TABLETS

jHWhat Sintrom Uno is and what it is used for

Sintrom Uno 1 mg Tablets (acenocoumarol) 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.

^■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, or similar medicines to thin the blood called coumarin derivatives (e.g. warfarin, phenprocoumon), or to any of the ingredients in Sintrom Uno (see Section 6, Contents of the pack and other information)
are pregnant, planning to become pregnant or breast-feeding (see Pregnancy, breast-feeding and fertility).
are an alcoholic
have any mental illness for example, schizophrenia or dementia
have recently had, or are about to have an operation on your spine, brain, eyes or any major surgery
had a stroke caused by bleeding into your brain
suffer from very high blood pressure
have stomach ulcer or any intestinal bleeding
pass blood in your water or cough up blood
suffer from any bleeding disorders, bleeding problems or unexplained bruising
feel sharp pain in the centre or left side of the chest which may be accompanied by shortness of breath (these may be signs of a fluid buildup or inflammation around the heart called pericarditis) or if you experience flu-like symptoms, heart murmurs, rash and chest pain (these may be signs of infection of the inner lining of the heart called endocarditis)
have severe liver or kidney disease.

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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sintrom Uno Tablets. Before you take Sintrom Uno tell your doctor or pharmacist if you:

have cancer
have an infection or inflammation (swelling)
have a disorder affecting the absorption of food from the stomach and/or intestine
have heart failure (which causes swelling and shortness of breath) – this might reduce blood flow in the liver which in turn would reduce blood clotting
have liver problems – this might reduce blood clotting
have kidney problems – this could lead to the build up of the breakdown products of Sintrom Uno
have an overactive thyroid
are elderly
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
have a higher risk of bleeding for example if you have:
– a history of variable blood test results for the international normalised ratio (INR)
– a stomach or duodenal ulcer or have ever had one
– high blood pressure
– problems with circulation of blood to the brain (cerebrovascular disease)
– anaemia
– recent wound or injury
– been taking any of the drugs mentioned below or have been taking Sinthrom Uno for a long period of time

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).

Calciphylaxis, a condition in which calcium builds up in blood vessels in the skin, sometimes happens when patients are taking blood thinning medicines including Sintrom Uno. This is rare, but it causes painful skin lumps or ulcers which can lead to serious infection and death. It usually only happens if a person has serious kidney disease, or if they already have something wrong with the levels of calcium, albumin, phosphate, or certain proteins, in their blood.

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.

Other medicines and Sintrom Uno

Tell your doctor or pharmacist if you are taking or have recently taken or might take 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 (including a man-made form called low-molecular-weight 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)
medicines that stop platelets (these are particles in the blood that are involved in blood clotting) from clumping together (e.g. dipyridamole, clopidogrel, ticlopidine)
phenylbutazone or other pyrazolone derivatives (e.g. sulfinpyrazone), other non-steroidal anti-inflammatory medicines (these are used to reduce pain, fever and inflammation), including the ones that target a specific molecule called COX-2, e.g., celecoxib, methylprednisolone (this is sometimes injected into a vein at a high dose to treat various inflammatory or allergic conditions).

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, clarithromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, co-amoxiclav, some cephalosporins, some fluoroquinolones such as ciprofloxacin, norfloxacin and ofloxacin) -medicines used against infections
viloxazine and selective serotonin re-uptake inhibitors such as citalopram, fluoxetine, sertraline 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 or dextrothyroxine – used to treat an underactive thyroid
statins such as atorvastatin, fluvastatin and simvastatin – used to lower blood cholesterol levels
antineoplastics such as 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 (e.g. fenofibrate, gemfibrozil) – medicines used against high cholesterol
disulfiram – for alcohol dependence
etacrynic acid – 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, like econazole, fluconazole, ketoconazole and miconazole) – a medicine used against infection
tramadol – a strong pain killer
tamoxifen – for breast cancer and fertility
proton pump inhibitors (e.g. omeprazole) – used to treat acid reflux, stomach or intestinal ulcers
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 to speed up gastric emptying
antacids (e.g. magnesium hydroxide) – medicines used against stomach acidity.
glucosamine (for osteoarthritis) may increase the effect of Sintrom Uno.
aminoglutethimide – used to treat cancer or Cushing’s syndrome
mercaptopurine – used to treat cancer or autoimmune diseases (a type of diseases when your immune system attacks your own cells)
protease inhibitors such as ritonavir or nelfinavir – used to treat HIV
azathioprine – used after organ transplantation or for chronic inflammatory and autoimmune diseases
barbiturates such as sodium amytal or phenobarbital and carbamazepine – for epilepsy or to help you sleep
vitamin E
medicines known to increase the activity of some liver enzymes (i.e., CYP2C9, CYP2C19 or CYP3A4) – ask your doctor or pharmacist if you are not sure if any of your medicines has such effect.
oral contraceptives such as femodene, logynon and cilest – for birth control
rifampicin – medicine used against infection
thiazide diuretics (e.g., bendroflumethiazide or metolazone) – medicines used to treat water retention and high blood pressure
corticosteroids such as prednisolone – steroids used to treat inflammatory bowel disease, arthritis and certain skin conditions
St John’s Wort – for depression
cholestyramine – medicine used against high cholesterol levels
griseofulvin – used to treat fungal infections.
antineoplastic drugs (e.g. azathioprine, 6– mercaptopurine)
vitamin K (an increase in the amount of your vitamin K intake could reduce the effect of acenocoumarol
protease inhibitors (e.g. indinavir, nelfinavir, ritonavir, saquinavir)
– medicines used to treat HIV infection.

methylprednisolone, a corticosteroid used to treat various inflammatory conditions.

Sintrom Uno 1mg Tablets

(acenocoumarol)

Patient Information Leaflet (continued)

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.
Sintrom Uno may enhance the blood sugar lowering effect of antidiabetic medicines such as glibenclamide or glimepiride.

Sintrom Uno with food, drink and alcohol

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.

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 checkups (see Section 3).

Pregnancy, breast-feeding and fertility

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.

It is not known whether Sintrom Uno can affect your fertility.

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 should use birth control while taking Sintrom Uno.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Sintrom Uno has no influence on the ability to drive or use machines. However, you are advised to keep your anticoagulant card with you.

Sintrom Uno 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^BHow to take Sintrom Uno

Always take Sintrom Uno exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

Sintrom Uno 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 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 (which slows blood flow in the liver and may cause its injury) or malnourished patients may need lower doses.

Use in children and adolescents:

Experience with blood thinning medicines including Sintrom Uno in children and adolescents is limited. If Sintrom Uno is used in children or adolescents, blood should be tested more often, to see how well the medicine is working.

Tell your doctor or dentist or pharmacist at every visit that you are using Sintrom Uno.

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. The symptoms of overdose differ between people. They may appear 1 to 5 days after taking the medicine and include nosebleeds, bleeding from the gums, vomiting or coughing blood, blood in the urine, bloody or black tarry stools, genital bleeding, abundant menstrual bleeding, large bruises, or bleeding into the joints which causes tightness, swelling, and pain. Your heartbeat may speed up, your blood pressure may drop making you feel dizzy, and your skin may seem pale, cold and sweaty. You may experience sickness, vomiting, diarrhoea and abdominal pains. 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 stop taking Sintrom Uno

If you have any questions on the use of this medicine, ask your doctor or pharmacist.

^■Possible side effects

Like all medicines, Sintrom Uno can cause side effects, although not everyone gets them.

Tell your doctor straight away if you have any of the following side effects:

Common (may affect up to 1 in 10 people):

bleeding:

– bleeding from the gums, unexplained bruising or nosebleeds, heavy periods, heavy bleeding from cuts or wounds

– bleeding from various organs: stomach, intestines, gallbladder (abdominal pain, vomiting blood, bloody or black tarry stools), urinary tract (backache, blood in the urine), brain (dizziness, severe headache, weakness in an arm or leg, blurred vision), and eyes (visible pool of blood)

Rare (may affect up to 1 in 1000 people):

allergic (hypersensitivity) reaction in the form of hives, skin rash, inflammation, itching, and fever
loss of appetite
feeling or being sick
vomiting
unusual hair loss

Very rare (may affect up to 1 in 10,000 people):

inflammation of blood vessels (vasculitis) which may cause bruising or bleeding under the skin
skin necrosis (tissue death) with blistering of the skin with or without scars, usually in areas of thighs, buttocks or breasts. This condition is usually associated with congenital deficiency of some proteins in blood
liver injury which may cause jaundice, stomach pain, swelling, and fatigue

Frequency not known: A painful skin rash. Sintrom Uno can cause a serious rare skin condition called calciphylaxis that can start with a painful skin rash but can lead to serious complications. This adverse reaction occurs most often in patients with chronic kidney disease or something wrong with the levels of calcium, albumin, phosphate, or certain proteins, in their blood. Condition of having a lower-than -normal number of red blood cells or reduced

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

$ How to store Sintrom Uno

Keep out of the sight and reach of children.

Store in the original container.

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.

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 Pharma Industrial Services, SA., Via Complutense, 140, Alcala de Henares, Madrid, 28805, Spain and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

The information in this leaflet applies only to Sintrom Uno. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

|POM | PL: 15184/1940

Leaflet revision date: 16/04/21

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Acenocoumarol 1mg tablets but will be reffered to as Acenocoumarol throughout the leaflet.

What is in this leaflet

What Acenocoumarol is and what it is used for

^2| what you need to know before you take acenocoumarol

\3^ How to take Acenocoumarol

^4| Possible side effects

How to store Acenocoumarol

Contents of the pack and other information

jHWhat Acenocoumarol is and what it is used for

Acenocoumarol 1 mg Tablets (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.

22M

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, or similar medicines to thin the blood called coumarin derivatives (e.g. warfarin, phenprocoumon), or to any of the ingredients in Acenocoumarol (see Section 6, Contents of the pack and other information)
are pregnant, planning to become pregnant or breast-feeding (see Pregnancy, breast-feeding and fertility).
are an alcoholic
have any mental illness for example, schizophrenia or dementia
have recently had, or are about to have an operation on your spine, brain, eyes or any major surgery
had a stroke caused by bleeding into your brain
suffer from very high blood pressure
have stomach ulcer or any intestinal bleeding
pass blood in your water or cough up blood
suffer from any bleeding disorders, bleeding problems or unexplained bruising
feel sharp pain in the centre or left side of the chest which may be accompanied by shortness of breath (these may be signs of a fluid buildup or inflammation around the heart called pericarditis) or if you experience flu-like symptoms, heart murmurs, rash and chest pain (these may be signs of infection of the inner lining of the heart called endocarditis)
have severe liver or kidney disease.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Acenocoumarol Tablets. Before you take Acenocoumarol tell your doctor or pharmacist if you:

have cancer
have an infection or inflammation (swelling)
have a disorder affecting the absorption of food from the stomach and/or intestine
have heart failure (which causes swelling and shortness of breath) – this might reduce blood flow in the liver which in turn would reduce blood clotting
have liver problems – this might reduce blood clotting
have kidney problems – this could lead to the build up of the breakdown products of Acenocoumarol
have an overactive thyroid
are elderly
have a higher risk of bleeding for example if you have:
– a history of variable blood test results for the international normalised ratio (INR)
– a stomach or duodenal ulcer or have ever had one
– high blood pressure
– problems with circulation of blood to the brain (cerebrovascular disease)
– anaemia
– recent wound or injury
– been taking any of the drugs mentioned below or have been taking Acenocoumarol for a long period of time

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).

Calciphylaxis, a condition in which calcium builds up in blood vessels in the skin, sometimes happens when patients are taking blood thinning medicines including Acenocoumarol. This is rare, but it causes painful skin lumps or ulcers which can lead to serious infection and death. It usually only happens if a person has serious kidney disease, or if they already have something wrong with the levels of calcium, albumin, phosphate, or certain proteins, in their blood.

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

Other medicines and Acenocoumarol

Medicines that increase the activity of Acenocoumarol such as:

heparin (including a man-made form called low-molecular-weight 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)
medicines that stop platelets (these are particles in the blood that are involved in blood clotting) from clumping together (e.g. dipyridamole, clopidogrel, ticlopidine)
phenylbutazone or other pyrazolone derivatives (e.g. sulfinpyrazone), other non-steroidal anti-inflammatory medicines (these are used to reduce pain, fever and inflammation), including the ones that target a specific molecule called COX-2, e.g., celecoxib, methylprednisolone (this is sometimes injected into a vein at a high dose to treat various inflammatory or allergic conditions).

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, clarithromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, co-amoxiclav, some cephalosporins, some fluoroquinolones such as ciprofloxacin, norfloxacin and ofloxacin) -medicines used against infections
viloxazine and selective serotonin re-uptake inhibitors such as citalopram, fluoxetine, sertraline 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 or dextrothyroxine – used to treat an underactive thyroid
statins such as atorvastatin, fluvastatin and simvastatin – used to lower blood cholesterol levels
antineoplastics such as 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 (e.g. fenofibrate, gemfibrozil) – medicines used against high cholesterol
disulfiram – for alcohol dependence
etacrynic acid – 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, like econazole, fluconazole, ketoconazole and miconazole) – a medicine used against infection
tramadol – a strong pain killer
tamoxifen – for breast cancer and fertility
proton pump inhibitors (e.g. omeprazole) – used to treat acid reflux, stomach or intestinal ulcers
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 to speed up gastric emptying
antacids (e.g. magnesium hydroxide) – medicines used against stomach acidity.
glucosamine (for osteoarthritis) may increase the effect of Acenocoumarol.
aminoglutethimide – used to treat cancer or Cushing’s syndrome
mercaptopurine – used to treat cancer or autoimmune diseases (a type of diseases when your immune system attacks your own cells)
protease inhibitors such as ritonavir or nelfinavir – used to treat HIV
azathioprine – used after organ transplantation or for chronic inflammatory and autoimmune diseases
barbiturates such as sodium amytal or phenobarbital and carbamazepine – for epilepsy or to help you sleep
vitamin E
medicines known to increase the activity of some liver enzymes (i.e., CYP2C9, CYP2C19 or CYP3A4) – ask your doctor or pharmacist if you are not sure if any of your medicines has such effect.
oral contraceptives such as femodene, logynon and cilest – for birth control rifampicin – medicine used against infection
thiazide diuretics (e.g., bendroflumethiazide or metolazone) – medicines used to treat water retention and high blood pressure
corticosteroids such as prednisolone – steroids used to treat inflammatory bowel disease, arthritis and certain skin conditions
St John’s Wort – for depression
cholestyramine – medicine used against high cholesterol levels
griseofulvin – used to treat fungal infections
antineoplastic drugs (e.g. azathioprine, 6– mercaptopurine)
vitamin K (an increase in the amount of your vitamin K intake could reduce the effect of acenocoumarol
protease inhibitors (e.g. indinavir, nelfinavir, ritonavir, saquinavir)

– medicines used to treat HIV infection.

methylprednisolone, a corticosteroid used to treat various inflammatory conditions.
Acenocoumarol may increase the risk of toxicity by hydantoin derivatives such as phenytoin – medicines used to treat epilepsy.
Acenocoumarol may enhance the blood sugar lowering effect of antidiabetic medicines such as glibenclamide or glimepiride.

Acenocoumarol with food, drink and alcohol

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.

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 checkups (see Section 3).

Pregnancy, breast-feeding and fertility

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 Sintrom. However, as a precaution, your doctor should prescribe vitamin K to your child to prevent their blood from being thinned.

It is not known whether Acenocoumarol can affect your fertility.

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 should use birth control while taking Acenocoumarol.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Acenocoumarol has no influence on the ability to drive or use machines. However, you are advised to keep your anticoagulant card with you.

Acenocoumarol 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^BHow to take Acenocoumarol

Always take Acenocoumarol exactly as your doctor has told you to. 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:

Elderly patients, patients with liver disease or severe heart failure (which slows blood flow in the liver and may cause its injury) or malnourished patients may need lower doses.

Use in children and adolescents:

Experience with blood thinning medicines including Acenocoumarol in children and adolescents is limited. If Acenocoumarol is used in children or adolescents, blood should be tested more often, to see how well the medicine is working.

Tell your doctor or dentist or pharmacist at every visit that you are using Acenocoumarol.

If you take more Acenocoumarol than you should

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.

^■Possible side effects

Like all medicines, Acenocoumarol can cause side effects, although not everyone gets them.

Tell your doctor straight away if you have any of the following side effects:

Common (may affect up to 1 in 10 people):

bleeding:
– bleeding from the gums, unexplained bruising or nosebleeds, heavy periods, heavy bleeding from cuts or wounds
– bleeding from various organs: stomach, intestines, gallbladder (abdominal pain, vomiting blood, bloody or black tarry stools), urinary tract (backache, blood in the urine), brain (dizziness, severe headache, weakness in an arm or leg, blurred vision), and eyes (visible pool of blood)

Rare (may affect up to 1 in 1000 people):

allergic (hypersensitivity) reaction in the form of hives, skin rash, inflammation, itching, and fever
loss of appetite
feeling or being sick
vomiting
unusual hair loss

Very rare (may affect up to 1 in 10,000 people):

inflammation of blood vessels (vasculitis) which may cause bruising or bleeding under the skin
skin necrosis (tissue death) with blistering of the skin with or without scars, usually in areas of thighs, buttocks or breasts. This condition is usually associated with congenital deficiency of some proteins in blood
liver injury which may cause jaundice, stomach pain, swelling, and fatigue

Frequency not known: A painful skin rash. Acenocoumarol can cause a serious rare skin condition called calciphylaxis that can start with a painful skin rash but can lead to serious complications. This adverse reaction occurs most often in patients with chronic kidney disease or something wrong with the levels of calcium, albumin, phosphate, or certain proteins, in their blood. Condition of having a lower-than-normal number of red blood cells or reduced haemoglobin (Anaemia).

Reporting of side effects

^5^H

How to store Acenocoumarol

Keep out of the sight and reach of children.

Store in the original container.

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.

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

The information in this leaflet applies only to Acenocoumarol. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

|POM | PL: 15184/1940

Leaflet revision date: 16/04/21

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

(acenocoumarol)

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Sinthrome 1mg tablets but will be reffered to as Sinthrome throughout the leaflet.

What is in this leaflet

Mi What Sinthrome is and what it is used for

What you need to know before you take Sinthrome

m) how to take sinthrome

Possible side effects

J5^ How to store Sinthrome
^6 Contents of the pack and other information

jHwhat Sinthrome is and what it is used for

Sinthrome 1 mg Tablets (acenocoumarol) 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.

^■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, or similar medicines to thin the blood called coumarin derivatives (e.g. warfarin, phenprocoumon), or to any of the ingredients in Sinthrome (see Section 6, Contents of the pack and other information)
are pregnant, planning to become pregnant or breast-feeding

(see Pregnancy, breast-feeding and fertility).

are an alcoholic
have any mental illness for example, schizophrenia or dementia
have recently had, or are about to have an operation on your spine, brain, eyes or any major surgery
had a stroke caused by bleeding into your brain
suffer from very high blood pressure
have stomach ulcer or any intestinal bleeding
pass blood in your water or cough up blood
suffer from any bleeding disorders, bleeding problems or unexplained bruising
feel sharp pain in the centre or left side of the chest which may be accompanied by shortness of breath (these may be signs of a fluid buildup or inflammation around the heart called pericarditis) or if you experience flu-like symptoms, heart murmurs, rash and chest pain (these may be signs of infection of the inner lining of the heart called endocarditis)
have severe liver or kidney disease.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Sinthrome Tablets.

Before you take Sinthrome tell your doctor or pharmacist if you:

have cancer
have an infection or inflammation (swelling)
have a disorder affecting the absorption of food from the stomach and/or intestine
have heart failure (which causes swelling and shortness of breath) – this might reduce blood flow in the liver which in turn would reduce blood clotting
have liver problems – this might reduce blood clotting
have kidney problems – this could lead to the build up of the breakdown products of Sinthrome
have an overactive thyroid
are elderly
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
have a higher risk of bleeding for example if you have:
– a history of variable blood test results for the international normalised ratio (INR)
– a stomach or duodenal ulcer or have ever had one
– high blood pressure
– problems with circulation of blood to the brain (cerebrovascular disease)
– anaemia
– recent wound or injury
– been taking any of the drugs mentioned below or have been taking Sinthrome for a long period of time

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).

Calciphylaxis, a condition in which calcium builds up in blood vessels in the skin, sometimes happens when patients are taking blood thinning medicines including Sinthrome. This is rare, but it causes painful skin lumps or ulcers which can lead to serious infection and death. It usually only happens if a person has serious kidney disease, or if they already have something wrong with the levels of calcium, albumin, phosphate, or certain proteins, in their blood.

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

Other medicines and Sinthrome

Medicines that increase the activity of Sinthrome such as:

heparin (including a man-made form called low-molecular-weight 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)
medicines that stop platelets (these are particles in the blood that are involved in blood clotting) from clumping together (e.g. dipyridamole, clopidogrel, ticlopidine)
phenylbutazone or other pyrazolone derivatives (e.g. sulfinpyrazone), other non-steroidal anti-inflammatory medicines (these are used to reduce pain, fever and inflammation), including the ones that target a specific molecule called COX-2, e.g., celecoxib, methylprednisolone (this is sometimes injected into a vein at a high dose to treat various inflammatory or allergic conditions).

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, clarithromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, co-amoxiclav, some cephalosporins, some fluoroquinolones such as ciprofloxacin, norfloxacin and ofloxacin) -medicines used against infections
viloxazine and selective serotonin re-uptake inhibitors such as citalopram, fluoxetine, sertraline 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 or dextrothyroxine – used to treat an underactive thyroid
statins such as atorvastatin, fluvastatin and simvastatin – used to lower blood cholesterol levels
antineoplastics such as 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 (e.g. fenofibrate, gemfibrozil) – medicines used against high cholesterol
disulfiram – for alcohol dependence
etacrynic acid – 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, like econazole, fluconazole, ketoconazole and miconazole) – a medicine used against infection
tramadol – a strong pain killer
tamoxifen – for breast cancer and fertility
proton pump inhibitors (e.g. omeprazole) – used to treat acid reflux, stomach or intestinal ulcers
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 to speed up gastric emptying
antacids (e.g. magnesium hydroxide) – medicines used against stomach acidity.
glucosamine (for osteoarthritis) may increase the effect of Sinthrome.
aminoglutethimide – used to treat cancer or Cushing’s syndrome
mercaptopurine – used to treat cancer or autoimmune diseases (a type of diseases when your immune system attacks your own cells)
protease inhibitors such as ritonavir or nelfinavir – used to treat HIV
azathioprine – used after organ transplantation or for chronic inflammatory and autoimmune diseases
barbiturates such as sodium amytal or phenobarbital and carbamazepine – for epilepsy or to help you sleep
vitamin E
medicines known to increase the activity of some liver enzymes (i.e., CYP2C9, CYP2C19 or CYP3A4) – ask your doctor or pharmacist if you are not sure if any of your medicines has such effect.
oral contraceptives such as femodene, logynon and cilest – for birth control
rifampicin – medicine used against infection
thiazide diuretics (e.g., bendroflumethiazide or metolazone) – medicines used to treat water retention and high blood pressure
corticosteroids such as prednisolone – steroids used to treat inflammatory bowel disease, arthritis and certain skin conditions
St John’s Wort – for depression
cholestyramine – medicine used against high cholesterol levels
griseofulvin – used to treat fungal infections
antineoplastic drugs (e.g. azathioprine, 6– mercaptopurine)
vitamin K (an increase in the amount of your vitamin K intake could reduce the effect of acenocoumarol.
protease inhibitors (e.g. indinavir, nelfinavir, ritonavir, saquinavir)
– medicines used to treat HIV infection.

methylprednisolone, a corticosteroid used to treat various inflammatory conditions.

Sinthrome

(acenocoumarol)

Patient Information Leaflet (continued)

Effects of Sinthrome on other medicines

Sinthrome may increase the risk of toxicity by hydantoin derivatives such as phenytoin – medicines used to treat epilepsy.
Sinthrome may enhance the blood sugar lowering effect of antidiabetic medicines such as glibenclamide or glimepiride.

Sinthrome with food, drink and alcohol

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 checkups (see Section 3).

Pregnancy, breast-feeding and fertility

Do NOT take Sinthrome if you are pregnant. Sinthrome, like other anticoagulants can cause serious harm to your baby. Tell your doctor if you are pregnant or trying to become pregnant. Your doctor will discuss with you the potential risk of taking Sinthrome during pregnancy.

The decision to breast-feed while taking Sinthrome should be carefully considered with your doctor. You and your child may require blood tests if you are breast-feeding while you are taking Sintrome. However, as a precaution, your doctor should prescribe vitamin K to your child to prevent their blood from being thinned.

It is not known whether Sinthrome can affect your fertility.

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 should use birth control while taking Sinthrome.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Sinthrome has no influence on the ability to drive or use machines. However, you are advised to keep your anticoagulant card with you.

Sinthrome 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^B

How to take Sinthrome

Always take Sinthrome exactly as your doctor has told you to. 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:

Elderly patients, patients with liver disease or severe heart failure (which slows blood flow in the liver and may cause its injury) or malnourished patients may need lower doses.

Use in children and adolescents:

Experience with blood thinning medicines including Sinthrome in children and adolescents is limited. If Sinthrome is used in children or adolescents, blood should be tested more often, to see how well the medicine is working.

Tell your doctor or dentist or pharmacist at every visit that you are using Sinthrome.

If you take more Sinthrome than you should

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 stop taking Sinthrome

If you have any questions on the use of this medicine, ask your doctor or pharmacist.

^■Possible side effects

Like all medicines, Sinthrome can cause side effects, although not everyone gets them.

Tell your doctor straight away if you have any of the following side effects:

Common (may affect up to 1 in 10 people):

bleeding:
– bleeding from the gums, unexplained bruising or nosebleeds, heavy periods, heavy bleeding from cuts or wounds
– bleeding from various organs: stomach, intestines, gallbladder (abdominal pain, vomiting blood, bloody or black tarry stools), urinary tract (backache, blood in the urine), brain (dizziness, severe headache, weakness in an arm or leg, blurred vision), and eyes (visible pool of blood)

Rare (may affect up to 1 in 1000 people):

allergic (hypersensitivity) reaction in the form of hives, skin rash, inflammation, itching, and fever
loss of appetite
feeling or being sick
vomiting
unusual hair loss

Very rare (may affect up to 1 in 10,000 people):

inflammation of blood vessels (vasculitis) which may cause bruising or bleeding under the skin
skin necrosis (tissue death) with blistering of the skin with or without scars, usually in areas of thighs, buttocks or breasts. This condition is usually associated with congenital deficiency of some proteins in blood
liver injury which may cause jaundice, stomach pain, swelling, and fatigue

3 How to store Sinthrome

Keep out of the sight and reach of children.

Store in the original container.

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.

3 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

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.

|POM | PL: 15184/1940

Sinthrome is a registered trademark of Novartis AG

Leaflet revision date: 16/04/21

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

SINTROM UNO 1 MG TABLETS, SINTHROME 1 MG TABLETS, ACENOCOUMAROL 1 MG TABLETS - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - SINTROM UNO 1 MG TABLETS, SINTHROME 1 MG TABLETS, ACENOCOUMAROL 1 MG TABLETS

(acenocoumarol)

Patient Information Leaflet (continued)

^3^BHow to take Sintrom Uno

Patient Information Leaflet

^2| what you need to know before you take acenocoumarol

22M

^3^BHow to take Acenocoumarol

^5^H

(acenocoumarol)

Patient Information Leaflet

(acenocoumarol)

Patient Information Leaflet (continued)

^3^B

3 How to store Sinthrome

3 Contents of the pack and other information