SINTROM 4 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Sintrom, 4 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Sintrom and what is it used for
   1. What is Sintrom
   2. What is Sintrom used for
   3. How Sintrom works
   4. Control tests during Sintrom treatment
4. Important information before taking Sintrom
   1. When not to take Sintrom:
   2. Children and adolescents
   3. Elderly patients (over 65 years old)
   4. Other medicines and Sintrom
   5. Medicines that should not be taken with Sintrom:
   6. Medicines that require caution when taken with Sintrom:
   7. Medicines that may reduce the effect of Sintrom, such as:
   8. Effect of Sintrom on other medicines:
   9. Sintrom with food, drink, and alcohol
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Sintrom contains lactose
5. How to take Sintrom
   1. Recommended dose
   2. Dosage:
   3. During each visit to your doctor or dentist, you should inform them that you are taking this medicine.
   4. How and when to take Sintrom
   5. How long to take Sintrom
   6. Taking more Sintrom than recommended
   7. Missing a dose of Sintrom
   8. Stopping Sintrom treatment
6. Possible side effects
   1. Some side effects can be serious:
   2. Other side effects:
   3. Reporting side effects
7. How to store Sintrom
8. Contents of the pack and other information
   1. What Sintrom contains
   2. What Sintrom looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: June 2025

Leaflet accompanying the packaging: patient information

Sintrom, 4 mg, tablets

(Acenocoumarol)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sintrom and what is it used for
• 2. Important information before taking Sintrom
• 3. How to take Sintrom
• 4. Possible side effects
• 5. How to store Sintrom
• 6. Contents of the pack and other information

1. What is Sintrom and what is it used for

What is Sintrom

Sintrom contains the active substance acenocoumarol.
Acenocoumarol belongs to a group of anticoagulant substances that reduce the blood's ability to clot and thus prevent the formation of blood clots in blood vessels.

What is Sintrom used for

Sintrom is indicated for the treatment and prevention of thromboembolic diseases.

How Sintrom works

Sintrom works by inhibiting the formation of blood clots. It does not dissolve existing blood clots, but can prevent clots from growing and causing more serious problems.

Control tests during Sintrom treatment

During treatment with Sintrom, the doctor will order regular blood tests and adjust the dose of the medicine accordingly.
If you have any questions about the action of Sintrom or the reasons why it was prescribed, you should consult your doctor.

2. Important information before taking Sintrom

Sintrom should only be taken after consulting a doctor. Sintrom is not suitable for every patient.
You should strictly follow your doctor's instructions, which may differ from the information in this leaflet.

When not to take Sintrom:

• If the patient is allergic (hypersensitive) to acenocoumarol and similar coumarin derivatives or any of the other ingredients of this medicine (listed in section 6 of the leaflet). In this case, you should contact your doctor before taking Sintrom. If you are unsure which medicines to avoid, ask your doctor or pharmacist.
• If the patient is unable to cooperate (e.g., unsupervised elderly patients, alcoholics, and patients with mental disorders).
• If the patient has congenital or acquired bleeding disorders (hemophilia).
• Shortly after eye surgery, central nervous system surgery, dental procedures, and after surgical procedures involving the lungs, prostate, uterus, which are associated with significant blood loss or shortly before surgery when significant blood loss is expected.
• If the patient has gastric or duodenal ulcer disease, gastrointestinal bleeding, genitourinary tract bleeding, cerebral or pulmonary bleeding.
• If the patient has acute infection or inflammatory conditions of the heart, pericardial effusion.
• If the patient has uncontrolled hypertension.
• If the patient has severe liver or kidney disease.
• If the patient is pregnant or suspects they may be pregnant.

If any of the above situations occur, you should contact your doctor before taking Sintrom.
Warnings and precautions:
Before starting Sintrom, you should discuss the following with your doctor:

• If the patient has liver function disorders.
• If the patient has kidney or thyroid function disorders, cancer, inflammatory conditions, or disorders related to impaired absorption of nutrients in the gastrointestinal tract. These conditions may cause abnormal levels of the active substance in the blood.
• If the patient has severe heart failure.
• If the patient has a deficiency of protein C or protein S (a type of protein that affects blood clotting).
• If the patient is scheduled for diagnostic or therapeutic procedures, such as minor surgery, tooth extraction, lumbar puncture, angiography.
• If the patient is taking medicines administered by intramuscular injection. During Sintrom treatment or similar medicines, intramuscular injections should be avoided, as they may cause hematoma formation.
• If the patient has an increased risk of bleeding, for example, in patients who have had variable blood test results for international normalized ratio (INR), have had or currently have gastric or duodenal ulcers, have high blood pressure, cerebrovascular disorders (cerebrovascular disease), anemia, recent injury or trauma, or if the patient is taking or has recently taken any of the medicines listed below or has been taking Sintrom for a long time.
• In patients taking anticoagulant medicines called vitamin K antagonists, including Sintrom, rare cases of calciphylaxis have been reported, a condition in which calcium accumulates in the skin's blood vessels. This causes painful lumps or ulcers that can lead to serious infection, often resulting in death. This usually occurs only when the person has severe kidney disease or abnormal calcium, albumin, phosphorus, or certain protein levels in the blood. If this condition is diagnosed, the doctor will start appropriate treatment and may discontinue Sintrom treatment.

If any of the above situations occur, you should tell your doctor immediately.

Children and adolescents

Data on the use of Sintrom in children and adolescents are limited, and therefore, more frequent control tests are necessary.

Elderly patients (over 65 years old)

Patient over 65 years old may be more sensitive to acenocoumarol, and therefore, more frequent control tests and dose adjustments may be necessary.

Other medicines and Sintrom

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Sintrom may interact with other medicines, and their effects may be enhanced or reduced.

Medicines that should not be taken with Sintrom:

• Heparin (an anticoagulant medicine),
• Antibiotics (e.g., clindamycin),
• Salicylic acid and its derivatives, such as acetylsalicylic acid, aminosalicylic acid, diflunisal (a pain reliever),
• Clopidogrel, prasugrel, ticagrelor, ticlopidine, phenylbutazone, and other pyrazolone derivatives, nonsteroidal anti-inflammatory drugs (including celecoxib),
• Pyrazolone (sulfinpyrazone), other nonsteroidal anti-inflammatory drugs (medicines that affect platelets involved in the blood clotting process).

Medicines that require caution when taken with Sintrom:

• Glucosamine (for osteoarthritis) - may enhance the effect of Sintrom,
• Certain types of anticoagulant medicines (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be stronger when taken with glucosamine. Patients treated with such combinations should be closely monitored when starting or stopping glucosamine treatment.

It is recommended that Sintrom not be taken with any of the above medicines. If it is necessary to take any of these medicines while taking Sintrom, your doctor will monitor your blood clotting parameters more frequently.
Other medicines that may increase the effect of Sintrom, such as:

• Allopurinol (a medicine used to treat gout),
• Androgens, anabolic steroids,
• Antiarrhythmic drugs (e.g., amiodarone, quinidine) (medicines that prevent irregular heart rhythm),
• Antibiotics (e.g., erythromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, some cephalosporins, and some fluoroquinolones) (medicines used to treat infections),
• Selected antidepressant drugs (serotonin reuptake inhibitors, SSRIs: e.g., citalopram, fluoxetine, sertraline),
• Cimetidine (a medicine used to treat stomach ulcers and gastroesophageal reflux disease),
• Clofibrate and its derivatives (a medicine used to lower cholesterol levels),
• Corticosteroids, such as methylprednisolone, prednisone (anti-inflammatory medicines),
• Disulfiram (a medicine used to treat alcoholism),
• Etacrynic acid (a medicine used to increase urine production),
• Glucagon (a medicine used to maintain normal blood glucose levels),
• Imidazole derivatives (e.g., metronidazole, and even topical miconazole) (a medicine used to treat infections),
• Paracetamol (a pain reliever and antipyretic),
• Sulfonamides, including co-trimoxazole (sulfamethoxazole and trimethoprim) (medicines used to treat infections),
• Sulfonylurea derivatives (tolbutamide, chlorpropamide) (medicines used to treat diabetes),
• Thyroid hormones (including dextrothyroxine) (a medicine used to treat hypothyroidism),
• Medicines that reduce the activity of the liver enzyme CYP2C9 (e.g., valproic acid) - you should ask your doctor or pharmacist if any of your medicines have this effect.
• Statins (e.g., fluvastatin, atorvastatin, simvastatin) (medicines used to lower cholesterol levels),
• Tamoxifen (a medicine used to treat breast cancer),
• Tramadol (a pain reliever),
• Proton pump inhibitors (e.g., omeprazole),
• Plasminogen activators (e.g., urokinase, streptokinase, and alteplase), thrombin inhibitors (e.g., argatroban) (medicines used to dissolve blood clots during angina pectoris),
• Prokinetic drugs (e.g., cisapride) (medicines used to treat gastrointestinal disorders),
• Antacids (e.g., magnesium hydroxide),
• Viloxazine (an antidepressant),
• Vitamin E.

Medicines that may reduce the effect of Sintrom, such as:

• Certain anticancer medicines (aminoglutethimide, azathioprine, 6-mercaptopurine) (medicines used to treat cancer),
• Certain antiviral medicines (ritonavir, nelfinavir) (medicines used in HIV therapy),
• Barbiturates, carbamazepine (antiepileptic medicines),
• Cholestyramine (a medicine used to lower cholesterol levels),
• Griseofulvin (a medicine used to treat fungal infections),
• Oral contraceptives,
• Rifampicin (a medicine used to treat infections),
• Hypericum perforatum (St. John's Wort) preparations (a herbal medicine used to treat depression),
• Foods rich in vitamin K,
• Oral antidiabetic medicines, such as semaglutide.

Effect of Sintrom on other medicines:

• Sintrom may increase the risk of toxicity when taken with hydantoin derivatives, such as phenytoin (a medicine used to treat epilepsy).
• Sintrom may enhance the effect of sulfonylurea derivatives (e.g., glibenclamide, glimepiride) used to lower blood glucose levels.

Sintrom with food, drink, and alcohol

You should limit your consumption of large amounts of alcohol and foods rich in vitamin K, such as leafy green vegetables, spinach, cabbage, kale, peas, soybean oil, walnuts, broccoli, turnips, alfalfa, avocados, etc. Alcohol may alter the effect of Sintrom. If you are unsure, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Use during pregnancy is contraindicated. Sintrom, like other anticoagulant medicines, may cause serious harm to the fetus.
It is recommended that women of childbearing age have a pregnancy test before taking Sintrom to rule out pregnancy. You should use effective contraception while taking Sintrom.
The potential risks and benefits of the treatment should be discussed with your doctor.
If you are breastfeeding, you should consult your doctor. Both the mother and child require special medical supervision, and the child should prophylactically receive vitamin K.

Driving and using machines

Sintrom does not affect the ability to drive or use machines. In case of an accident, you should inform your doctor or hospital staff that you are taking Sintrom.
Considering the possibility of injury, e.g., in an accident, it is recommended to carry a card with information about anticoagulant treatment.

Sintrom contains lactose

Sintrom contains lactose (milk sugar). If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Sintrom

This medicine should always be taken according to your doctor's instructions. If you are unsure, consult your doctor.
The dosage of the medicine is determined by your doctor. Regular blood clotting tests allow your doctor to adjust the dose of Sintrom, which should be taken daily.
You should follow your doctor's instructions and not exceed the recommended doses.

Recommended dose

Your doctor will inform you exactly how many Sintrom tablets to take. Depending on how you respond to treatment, your doctor may recommend increasing or decreasing the dose.
Individual sensitivity to the medicine may vary and may change during treatment or when changes are made to your diet, especially when foods rich in vitamin K (spinach, cabbage) are included. You should strictly follow your doctor's instructions, which will be based on laboratory tests and tailored to your needs. You should not suddenly stop taking this medicine or change its dose on your own initiative.

Dosage:

Adults
The usual initial dose is 2 mg/day to 4 mg/day.
The maintenance dose is usually between 1 mg/day and 8 mg/day.
Elderly patients, those with liver disease, or severe heart failure (which slows down blood flow in the liver and may damage it) or malnourished patients may require a lower dose at the start and during maintenance treatment with Sintrom.
Use in children and adolescents
Your doctor will decide whether to use Sintrom in children and adolescents.

During each visit to your doctor or dentist, you should inform them that you are taking this medicine.

How and when to take Sintrom

You should take the tablets regularly, once a day, at the same time (e.g., in the evening with a meal, with a glass of water). The tablets should be swallowed whole.
The tablet can be divided into equal doses.
Your doctor should assess whether you are able to divide the Sintrom 4 mg tablet into four equal parts.

How long to take Sintrom

Your doctor will inform you exactly how long you should take Sintrom.

Taking more Sintrom than recommended

If you have accidentally taken more than the recommended amount of Sintrom tablets, you should immediately inform your doctor.
Overdose of Sintrom may lead to bleeding. If bleeding occurs, you should stop taking Sintrom and start treatment for the bleeding.

Missing a dose of Sintrom

If you miss a dose, you should take the missed dose as soon as possible. If it is almost time for your next dose, do not take the missed dose, just take the next dose at the usual time.
You should not take a double dose to make up for a missed dose. During your next visit to your doctor, you should inform them about all instances of missed doses.

Stopping Sintrom treatment

If you have any further doubts about taking this medicine, you should consult your doctor.

4. Possible side effects

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

Some side effects can be serious:

Frequent (less than 1 in 10 people): bleeding (symptoms may include: unexplained nosebleeds or bleeding gums when brushing teeth; unexplained bruising; unusual, heavy, or unexpected menstrual bleeding; blood in urine; bloody or black, tarry stools; coughing up blood or bloody vomit; sudden, severe, or persistent headache. If you experience any of these bleeding symptoms, it may mean that you have taken more medicine than you need.
Rare (less than 1 in 1,000 people): Allergic reactions in the form of a rash or itching.
Very rare (less than 1 in 10,000 people): Blood spots under the skin with blistering or without blistering, usually located on the cheeks, buttocks, abdomen, chest, and sometimes on the toes; blood spots or hematomas under the skin (a sign of possible vasculitis). Jaundice (symptoms of possible liver damage).
If you experience any of the above side effects, you should immediately inform your doctor.

Other side effects:

Rare (less than 1 in 1,000 people): Hair loss, decreased appetite, vomiting, nausea.
If you experience any of the above symptoms, you should inform your doctor.
Frequency not known (frequency cannot be estimated from the available data): Painful skin rash. Sintrom may cause severe skin disorders, including calciphylaxis, which may initially manifest as a painful skin rash but can lead to other serious complications. This side effect occurs more frequently in patients with chronic kidney disease.
Lower than normal red blood cell count or decreased hemoglobin levels (anemia).
Bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (nephropathy associated with anticoagulant use).
If you experience any side effects not listed in this leaflet, you should tell your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sintrom

There are no special precautions for storing the medicine.
The medicine should be stored in its original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: Expiry date. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sintrom contains

• The active substance of Sintrom is acenocoumarol. Each tablet contains 4 mg of acenocoumarol.
• The other ingredients are: lactose monohydrate, magnesium stearate, corn starch, pregelatinized corn starch, colloidal anhydrous silica.

What Sintrom looks like and contents of the pack

Sintrom is a white, round, flat tablet with rounded edges. On one side, it is marked with "CG", and on the other side, it has a cross-shaped dividing line, allowing it to be divided into four equal parts, with the letter "A" marked on each of the four parts.
Sintrom is available in packs containing 20 tablets.

Marketing authorization holder

Merus Labs Luxco II S.à.R.L.
208, Val des Bons Malades
L-2121 Luxembourg
Luxembourg
Phone: +352 271127044

Manufacturer

FAMAR A.V.E ANTHOUSSA PLANT
Anthousa Avenue 7
Anthousa Attiki, 15349
Greece
Rovi Pharma Industrial Services, S.A.,
Vía Complutense, 140,
Alcalá de Henares,
Madrid, 28805,
Spain

Date of last revision of the leaflet: June 2025