Sintrom

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Sintrom, 4 mg, tablets
(Acenocoumarol)
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Sintrom is and what it is 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 Sintrom is and what it is used for

What Sintrom is
Sintrom contains the active substance acenocoumarol.
Acenocoumarol belongs to a group of anticoagulant substances that reduce the blood's ability to clot and thereby prevent the formation of blood clots in blood vessels.
What Sintrom is used for
Sintrom is indicated for the treatment and prevention of thromboembolic disorders.
How Sintrom works
Sintrom works by inhibiting the formation of blood clots. It does not dissolve existing blood clots, but may prevent clots from growing larger and causing more serious problems.
Control tests during treatment with Sintrom
During treatment with Sintrom, your doctor will order regular blood tests and adjust the dose accordingly. If you have any questions about how Sintrom works or why it has been prescribed, please consult your doctor.

2. Important information before using Sintrom

Sintrom must only be used after consultation with a doctor. Sintrom is not suitable for every patient.
You must strictly follow your doctor's instructions, which may differ from the information contained in this leaflet.
When not to use Sintrom:

• If the patient is allergic (hypersensitive) to acenocoumarol and similar coumarin derivatives or to any of the other ingredients of this medicine (listed in section 6 of the leaflet). In such a case, contact your doctor before using Sintrom. If in doubt about 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 psychiatric disorders).

• If the patient has congenital or acquired bleeding disorders (haemophilia).

• Shortly after eye surgery, central nervous system surgery, dental procedures, or after surgical procedures involving the lungs, prostate gland, uterus, associated with significant blood loss, or shortly before surgery when major blood loss is expected.

• If the patient has peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, urinary or genital tract bleeding, bleeding in the brain or lungs.

• If the patient has acute infection or inflammatory conditions affecting the heart, pericardial effusion.

• If the patient has uncontrolled high blood pressure.

• If the patient has severe liver or kidney disease.

• If the patient is pregnant or if pregnancy is suspected.

If any of the above situations apply, contact your doctor before using Sintrom.
Consult your doctor for advice if you have allergies.
Warnings and precautions
Before starting Sintrom, discuss with your doctor:

• If the patient has liver function disorders.
• If the patient has kidney or thyroid function disorders, tumour diseases, inflammatory conditions, or diseases associated with impaired absorption of nutrients in the gastrointestinal tract. These conditions may lead to abnormal levels of the active substance in the blood.
• If the patient has severe heart failure.
• If the patient has been diagnosed with protein C or protein S deficiency (a type of protein affecting blood clotting).
• If diagnostic or therapeutic procedures are planned, e.g. minor surgery, tooth extraction, lumbar puncture, angiography.
• If the patient is receiving medicines administered by intramuscular injection. During treatment with Sintrom or similar medicines, intramuscular injections should be avoided as they may cause haematomas.
• If the patient has an increased risk of bleeding, for example, in patients with a history of fluctuating international normalized ratio (INR) test results, current or past gastric or duodenal ulcers, high blood pressure, cerebrovascular disease (cerebrovascular disease), anaemia, recent wounds or injuries, or if the patient is currently or recently used any of the medicines listed below, or has been taking Sintrom for a long time.
• In patients treated with anticoagulant medicines known as vitamin K antagonists, including Sintrom, rare cases of calciphylaxis have been reported, a condition in which calcium deposits form in blood vessels of the skin. This leads to painful nodules or ulcers, which may result in severe infection, often fatal. This usually occurs only when a 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 initiate appropriate treatment and may discontinue Sintrom therapy.

Inform your doctor immediately if any of the above situations occur.
Children and adolescents
Data on use in children and adolescents are limited, therefore more frequent monitoring tests are necessary.
Elderly patients (over 65 years of age)
Patients over 65 years of age may be more sensitive to acenocoumarol; therefore, more frequent monitoring tests are required and, if necessary, the dose of the medicine should be reduced.
Other medicines and Sintrom
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The effect of Sintrom may influence the action of other medicines and vice versa.
Concomitant use of Sintrom with the following medicines is not recommended:

• heparin (anticoagulant medicine),
• antibiotics (e.g. clindamycin),
• salicylic acid and its derivatives, e.g. acetylsalicylic acid, aminosalicylic acid, diflunisal (pain-relieving medicine),
• clopidogrel, prasugrel, ticagrelor, ticlopidine, phenylbutazone and other pyrazolone derivatives, non-steroidal anti-inflammatory drugs (including celecoxib),
• pyrazolone (sulfinpyrazone), other non-steroidal anti-inflammatory drugs (medicines affecting platelets, involved in the blood clotting process).

Exercise caution when Sintrom must be used concomitantly with other medicines, particularly with:

• glucosamine (in osteoarthritis) – may enhance the effect of Sintrom,
• certain types of medicines used to prevent blood clotting (e.g. warfarin, dicoumarol, phenprocoumon, acenocoumarol, and fluindione). The effect of these medicines may be stronger when used together with glucosamine. Patients treated with such combinations should be monitored particularly carefully when starting and stopping glucosamine therapy.

It is recommended that Sintrom should not be taken simultaneously with any of the above-mentioned medicines. If during treatment with Sintrom it becomes necessary to take any of these medicines, your doctor will more frequently monitor blood coagulation parameters.
Other medicines that may increase the effect of Sintrom, such as:

• allopurinol (used in the treatment of gout),
• androgens, anabolic steroids,
• antiarrhythmic agents (e.g. amiodarone, quinidine) (medicines preventing abnormal heart rhythm),
• antibiotics (e.g. erythromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, certain cephalosporins, and certain fluoroquinolones) (medicines used to treat infections),
• selected antidepressants (serotonin reuptake inhibitors, SSRIs: e.g. citalopram, fluoxetine, sertraline),
• cimetidine (used in heartburn and gastrointestinal ulcers),
• clofibrate and its derivatives (used to lower cholesterol levels),
• corticosteroids, e.g. methylprednisolone, prednisone (anti-inflammatory medicines),
• disulfiram (used in the treatment of alcoholism),
• ethacrynic acid (used to increase urine production),
• glucagon (used to maintain normal blood glucose levels),
• imidazole derivatives (e.g. metronidazole, even topically applied miconazole) (used to treat infections),
• paracetamol (antipyretic medicine),
• sulfonamides including co-trimoxazole (sulfamethoxazole and trimethoprim) (used to treat infections),
• sulfonylurea derivatives (tolbutamide, chlorpropamide) (used in diabetes treatment),
• thyroid hormones (including dextrothyroxine) (used in hypothyroidism),
• medicines reducing the activity of the liver enzyme called CYP2C9 (e.g. valproic acid) – ask your doctor or pharmacist whether any of the medicines you are taking have this effect,
• statins (e.g. fluvastatin, atorvastatin, simvastatin) (used to lower cholesterol levels),
• tamoxifen (used in breast cancer treatment),
• tramadol (pain-relieving medicine),
• proton pump inhibitors (e.g. omeprazole),
• plasminogen activators (e.g. urokinase, streptokinase, alteplase), thrombin inhibitors (e.g. argatroban) (used to dissolve blood clots in angina pectoris),
• prokinetic agents (e.g. cisapride) (used to treat gastrointestinal disorders),
• gastric acid neutralizing agents (e.g. magnesium hydroxide),
• viloxazine (antidepressant),
• vitamin E.

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

• certain anticancer medicines (aminoglutethimide, azathioprine, 6-mercaptopurine) (used in cancer treatment),
• certain antiviral medicines (ritonavir, nelfinavir) (used in HIV therapy),
• barbiturates, carbamazepine (antiepileptic medicines),
• cholestyramine (used to lower cholesterol levels),
• griseofulvin (used to treat fungal infections),
• oral contraceptives,
• rifampicin (used to treat infections),
• St John's wort (Hypericum perforatum) (herbal medicine used in depression treatment),
• foods rich in vitamin K.

Effect of Sintrom on other medicines:

• Sintrom may increase the risk of toxicity when used with hydantoin derivatives, such as phenytoin (used in epilepsy treatment).
• Sintrom may enhance the blood glucose-lowering effect of antidiabetic medicines known as sulfonylurea derivatives (e.g. glibenclamide, glimepiride).

Sintrom with food, drink, and alcohol
Limit consumption of large amounts of alcohol and foods rich in vitamin K, such as green leafy vegetables, spinach, cabbage, kale, peas, soybean oil, walnuts, broccoli, turnip, alfalfa, avocado, etc. Alcohol may alter the way Sintrom works. If in doubt, consult your doctor.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Use during pregnancy is contraindicated. Sintrom, like other anticoagulant medicines, may cause serious fetal harm.
It is recommended that a pregnancy test be performed in women of childbearing age before starting Sintrom to exclude pregnancy. An effective method of contraception should be used during treatment with Sintrom.
The potential risks and benefits of the therapy should be discussed with the patient by the doctor.
In case of breastfeeding, consult your doctor. Both mother and child require special medical monitoring, and the child should receive prophylactic vitamin K.
Driving and using machines
Sintrom has no effect on the ability to drive or operate machinery. In case of an accident, inform the doctor or hospital staff about taking this medicine.
Given the possibility of injury, e.g. in an accident, it is recommended to carry an identification card indicating anticoagulant therapy.
The medicine contains monohydrate lactose
Sintrom contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to take Sintrom

This medicine must always be taken exactly as prescribed by the doctor. In case of doubts, consult
your doctor.
The dosage of this medicine is determined by the doctor. Regular blood clotting tests allow the
doctor to appropriately adjust the dose of Sintrom, which should be taken daily.
Always follow your doctor's instructions and do not exceed the recommended doses.
Recommended dose
Your doctor will inform you exactly how many Sintrom tablets you should take. Depending on how
you respond to treatment, your doctor may recommend increasing or decreasing the dose.
Individual sensitivity to the drug varies and may change during the course of treatment or if your
diet changes, especially when foods rich in vitamin K (spinach, cruciferous vegetables) are
introduced. Strictly follow your doctor's advice, who will determine the appropriate dose based on
laboratory tests and your individual needs.
Do not suddenly stop taking this medicine or change the dose on your own initiative.
Dosage:
Adults
The usual initial dose is 2 mg/day to 4 mg/day.
The maintenance dose usually ranges between 1 mg/day and 8 mg/day.
Elderly patients, patients with liver disease or severe heart failure (which slows blood flow through
the liver and may damage it), or undernourished patients may require a lower dose at the start of
treatment and during maintenance therapy with Sintrom.
Use in children and adolescents
Your doctor will decide whether Sintrom should be used in children and adolescents.
During every visit to a doctor or dentist, inform them that you are taking this medicine.
How and when to take Sintrom
Take the tablets regularly every day at the same time (e.g. in the evening with a meal, with a glass of
water). Swallow the tablets whole.
The tablet may 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 clearly inform you how long you should continue taking Sintrom.
Taking more Sintrom than recommended
If you accidentally take more Sintrom tablets than recommended, you must immediately
contact your doctor. Overdosing on Sintrom may lead to bleeding. If bleeding occurs, stop taking
Sintrom and begin treatment for bleeding.
Missing a dose of Sintrom
If you forget to take your usual dose, take it as soon as possible. However, if it is almost time for the
next dose, do not take the missed dose—simply take the next dose at the usual time.
Do not take a double dose to make up for a missed dose. At your next visit to the doctor, inform
them about any missed doses.
Stopping Sintrom
If you have any further doubts about using this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious:
Common ( less than 1 case in 10 people ): bleeding (symptoms may include: unexplained
nosebleeds or bleeding from gums during tooth brushing; unexplained bruising; unusual, heavy
bleeding or oozing from cuts or wounds; abnormally heavy or unexpected menstrual bleeding;
blood in urine; bloody or black, tarry stools; coughing up blood or bloody sputum, or vomiting
blood; sudden, severe or persistent headache). If any of the above bleeding symptoms occur,
this may indicate that the patient has received more medicine than needed.
Rare ( less than 1 case in 1,000 people ): allergic reactions such as rash or itching.
Very rare ( less than 1 case in 10,000 people ): bloody skin eruptions forming blisters, with or
without scarring, usually located on cheeks, buttocks, abdomen, breasts and sometimes toes;
bloody eruptions or subcutaneous haematomas (a sign indicating possible vasculitis); jaundice
(symptoms of possible liver damage).
If any of the above adverse symptoms occur, you must immediately inform your doctor.
Other adverse reactions:
Rare ( less than 1 case in 1,000 people ): hair loss, decreased appetite, vomiting, nausea.
If any of the above symptoms occur, you should inform your doctor.
Frequency not known (frequency cannot be estimated from available data): painful skin rash.
Sintrom may cause serious skin disorders, including so-called calciphylaxis, which may initially
present as painful skin rash but can lead to other serious complications. This adverse reaction
occurs more frequently in patients with chronic kidney disease.
Lower than normal number of red blood cells or reduced haemoglobin concentration (anaemia).
If any adverse reactions not listed in this leaflet occur, inform your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your
doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of
Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sintrom

Keep this medicine out of the sight and reach of children.
No special storage instructions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Sintrom contains

• The active substance is acenocoumarol. One tablet contains 4 mg of acenocoumarol.
• The other ingredients are: lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize 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 embossed with "CG", and on the other side there is a cross-shaped score line allowing division into four equal parts, each embossed with the letter "A".
Sintrom is available in packs containing 20 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, the country of export:
Merus Labs Luxco II S.à R.L.
26-28, rue Edward Steichen
L-2540 Luxembourg
Luxembourg
Manufacturer:
FAMAR A.V.E.
Anthousa Avenue 7
Anthousa Attiki, 15349
Greece
Norgine B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands
Rovi Pharma Industrial Services, S.A.
Vía Complutense, 140
Alcalá de Henares, Madrid 28805
Spain
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Bulgaria, the country of export: 20000293
Parallel import authorisation number: 335/18