Sintrom

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Sintrom

4 mg, tablets

Acenocoumarol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 packaging 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 blood clots that have already formed, but it 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 Sintrom accordingly.
You should consult your doctor if you have any questions about the action of Sintrom or the reasons why it was prescribed.

2. Important information before taking Sintrom

Sintrom can only be taken after consulting a doctor. Sintrom is not suitable for every patient.
You should strictly follow the doctor's instructions, which may differ from the information contained 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, you should ask your doctor or pharmacist.

In such a case, you should contact your doctor before taking Sintrom. If you are unsure which medicines to avoid, you should 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 and acquired bleeding disorders (hemophilia).
• Shortly after eye surgery, central nervous system surgery, dental procedures, as well as 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 and/or duodenal ulcer disease, gastrointestinal bleeding, genitourinary tract bleeding, brain or lung 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 if there is a suspicion that the patient may be pregnant.

If any of the above situations occur, you should contact your doctor before taking Sintrom.
You should consult your doctor for advice if you have an allergy.

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 malabsorption syndromes. 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, or angiography.
• If the patient is taking injectable medications. During Sintrom treatment or similar medications, you should avoid injectable medications, as they may cause bruising.
• If the patient has an increased risk of bleeding, for example, in patients who have had variable blood test results for the international normalized ratio (INR), who have or have had stomach or duodenal ulcers, who have high blood pressure, who have cerebrovascular disease, who have anemia, who have recently suffered an injury or trauma, or who are taking or have recently taken any of the medications listed below or have been taking Sintrom for a long time.
• In patients taking anticoagulant medications 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, causing painful nodules or ulcers that can lead to serious infections, often fatal. This usually occurs only when the person has severe kidney disease or abnormal levels of calcium, albumin, phosphorus, or certain proteins in the blood. If this condition is diagnosed, the doctor will start appropriate treatment and may discontinue Sintrom treatment.

You should immediately inform your doctor if any of the above situations occur.

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, if necessary, dose reduction of the administered medication may be required.

Sintrom and other medications

You should inform your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Sintrom may affect the action of other medications, and vice versa.

It is not recommended to take Sintrom with the following medications:

• heparin (an anticoagulant medication),
• 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 medications (including celecoxib),
• pyrazolone (sulfinpyrazone), other nonsteroidal anti-inflammatory medications (medications that affect platelets and participate in the blood clotting process).

Caution should be exercised when taking Sintrom in combination with other medications, particularly:

• glucosamine (for osteoarthritis) - may enhance the effect of Sintrom,
• certain types of medications used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione). The action of these medications may be stronger when taken with glucosamine. Patients treated with such combinations of medications should be closely monitored when starting or stopping glucosamine treatment.

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

• allopurinol (a medication used to treat gout),
• androgens, anabolic steroids,
• antiarrhythmic medications (e.g., amiodarone, quinidine) (medications that prevent irregular heart rhythm),
• antibiotics (e.g., erythromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, some cephalosporins, and some fluoroquinolones) (medications used to treat infections),
• certain antidepressant medications (serotonin reuptake inhibitors, SSRIs: e.g., citalopram, fluoxetine, sertraline),
• cimetidine (a medication used to treat stomach ulcers and gastroesophageal reflux disease),
• clofibrate and its derivatives (a medication used to lower cholesterol levels),
• corticosteroids, such as methylprednisolone, prednisone (anti-inflammatory medications),
• disulfiram (a medication used to treat alcoholism),
• ethacrynic acid (a medication used to increase urine production),
• glucagon (a medication used to maintain normal blood glucose levels),
• imidazole derivatives (e.g., metronidazole, and even miconazole when used topically) (a medication used to treat infections),
• paracetamol (a pain reliever and antipyretic),
• sulfonamides, including co-trimoxazole (sulfamethoxazole and trimethoprim) (medications used to treat infections),
• sulfonylurea derivatives (e.g., tolbutamide, chlorpropamide) (medications used to treat diabetes),
• thyroid hormones (including dextrothyroxine) (a medication used to treat hypothyroidism),
• medications that reduce the activity of the liver enzyme CYP2C9 (e.g., valproic acid) - you should ask your doctor or pharmacist if any of the medications you are taking have this effect.
• statins (e.g., fluvastatin, atorvastatin, simvastatin) (medications used to lower cholesterol levels),
• tamoxifen (a medication 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) (medications used to dissolve blood clots during myocardial infarction),
• prokinetic medications (e.g., cisapride) (medications used to treat gastrointestinal disorders),
• antacids (e.g., magnesium hydroxide),
• viloxazine (an antidepressant medication),
• vitamin E.

Medications that may decrease the effect of Sintrom, such as:

• certain anticancer medications (e.g., aminoglutethimide, azathioprine, 6-mercaptopurine) (medications used to treat cancer),
• certain antiviral medications (e.g., ritonavir, nelfinavir) (medications used in HIV therapy),
• barbiturates, carbamazepine (antiepileptic medications),
• cholestyramine (a medication used to lower cholesterol levels),
• griseofulvin (an antifungal medication),
• oral contraceptives,
• rifampicin (an antibiotic),
• Hypericum perforatum (St. John's Wort) preparations (a herbal medication used to treat depression),
• foods rich in vitamin K.

Effect of Sintrom on other medications:

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

Sintrom with food and 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, and avocados. Alcohol may alter the effect of Sintrom. If you are unsure, you should 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 medication.
Use during pregnancy is contraindicated.Sintrom, like other anticoagulant medications, 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 an effective method of contraception while taking Sintrom.
The potential risks and benefits of the treatment should be discussed with the patient by the doctor.
If you are breastfeeding, you should consult your doctor. Both the mother and the 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, it is recommended to carry a card with information about anticoagulant treatment.

Sintrom contains lactose monohydrate

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

3. How to take Sintrom

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

Recommended dose

The doctor will inform you exactly how many Sintrom tablets to take. Depending on how you respond to the treatment, the doctor may recommend increasing or decreasing the dose.
The sensitivity of individual patients to Sintrom may vary and may change during treatment or when changes are made to the diet, especially when foods rich in vitamin K (spinach, cabbage) are included. You should strictly follow the doctor's instructions, which will be based on laboratory tests and tailored to your needs.

Dosing for 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 beginning and during maintenance treatment with Sintrom.
Use in children and adolescents
The doctor will decide whether to use Sintrom in children and adolescents.

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

How and when to take Sintrom

You should take the tablets regularly, every 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.
The doctor should assess whether the patient is able to divide the Sintrom tablet, 4 mg, into four equal parts.

How long to take Sintrom

The doctor will inform you exactly how long to take Sintrom.

Taking a higher dose of Sintrom than recommended

If you accidentally take more than the recommended amount of Sintrom tablets, you should immediately contact 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 the next dose, you should 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 the missed dose. During your next visit to the doctor, you should inform them about all instances of missed doses.

Stopping Sintrom treatment

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

4. Possible side effects

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

Some side effects may be serious:

Frequent (less than 1 in 10 people):bleeding (symptoms may include: unexplained nosebleeds or bleeding gums when brushing teeth; unexplained bruising; unusual or heavy menstrual bleeding; blood in the 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 medication than you need.
Rare (less than 1 in 1000 people):allergic reactions in the form of a rash or itching.
Very rare (less than 1 in 10,000 people):bleeding into the skin with blistering or scarring, usually located on the cheeks, buttocks, abdomen, chest, and sometimes on the toes; bleeding or bruising under the skin (a sign of possible vasculitis).
If you experience any of the above side effects, you should immediately inform your doctor.

Other side effects:

Rare (less than 1 in 1000 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).
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 this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Sintrom

There are no special storage instructions.
The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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, cornstarch, pregelatinized cornstarch, colloidal anhydrous silica.

What Sintrom looks like and what the packaging contains

Sintrom is a white, round, flat tablet with rounded edges. On one side, it is marked with "CG", and on the other side, there is a cross-shaped score line that allows the tablet to be divided into four equal parts, each marked with the letter "A".
Sintrom is available in packaging containing 20 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Merus Labs Luxco II S.à R.L.
208, Val des Bons Malades
L-2121 Luxembourg
Luxembourg

Manufacturer:

FAMAR A.V.E.
Anthousa Avenue 7
Anthousa Attiki, 15349, Greece
Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
Rovi Pharma Industrial Services, S.A.
Vía Complutense, 140, Alcalá de Henares, Madrid, 28805, Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20000293
Parallel import authorization number:49/20

Date of leaflet approval: 10.01.2025

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