Sintrom

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. 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 of the medicine accordingly.
Consult your doctor if you have any questions regarding how Sintrom works or why it has been prescribed.

2. Important information before using Sintrom

Sintrom must only be taken 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 surgery of the eye, central nervous system, dental procedures, or after surgical procedures involving the lungs, prostate gland, uterus, associated with significant blood loss, or shortly before surgery when substantial blood loss is expected.

• If the patient has peptic ulcer of the stomach and/or duodenum, gastrointestinal, genitourinary, cerebral or pulmonary haemorrhage.

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

• If the patient has uncontrolled arterial hypertension.

• If the patient has severe liver or kidney disease.

• If the patient is pregnant or there is suspicion that she may be pregnant.

If any of the above situations apply, contact your doctor before taking Sintrom.
Consult your doctor for advice if you have an allergy.
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 nutrient absorption from 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 taking medicines administered by intramuscular injection. During treatment with Sintrom or similar medicines, intramuscular injections should be avoided as they may cause haematoma formation.
• If the patient has an increased risk of bleeding, for example in patients who previously had variable blood test results for the International Normalized Ratio (INR), have or have had gastric or duodenal ulcers, have 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 taking anticoagulant medicines known as vitamin K antagonists, including Sintrom, rare cases of calciphylaxis have been reported, a condition in which calcium accumulates in blood vessels of the skin. This causes painful nodules or ulcers, which may lead to severe infection often resulting in death. 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 initiate appropriate treatment and may discontinue Sintrom therapy.

Immediately inform your doctor if any of the above situations occur.
Children and adolescents
Data on use in children and adolescents are limited, therefore more frequent monitoring is required.
Elderly patients (over 65 years of age)
Patients over 65 years of age may be more sensitive to acenocoumarol; therefore, more frequent monitoring is necessary and, if required, the dose of the medicine should be reduced.
Sintrom with other medicines
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 affect 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 concomitant use of Sintrom with other medicines is necessary, 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 taken simultaneously with glucosamine. Patients treated with such combinations should be monitored very carefully when starting or stopping glucosamine therapy.

It is recommended that Sintrom not be taken simultaneously with any of the above-mentioned medicines. If during Sintrom treatment 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 infection),
• 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 output),
• glucagon (used to maintain normal blood glucose levels),
• imidazole derivatives (e.g. metronidazole, even topically applied miconazole) (used to treat infection),
• paracetamol (antipyretic medicine),
• sulfonamides including co-trimoxazole (sulfamethoxazole and trimethoprim) (medicines used to treat infection),
• sulfonylurea derivatives (tolbutamide, chlorpropamide) (medicines used to treat diabetes),
• thyroid hormones (including levothyroxine) (used to treat 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) (medicines used to lower cholesterol levels),
• tamoxifen (used in breast cancer treatment),
• tramadol (analgesic medicine),
• proton pump inhibitors (e.g. omeprazole),
• plasminogen activators (e.g. urokinase, streptokinase, alteplase), thrombin inhibitors (e.g. argatroban) (medicines used to dissolve blood clots in angina),
• prokinetic agents (e.g. cisapride) (medicines used to treat gastrointestinal disorders),
• gastric acid neutralizing agents (e.g. magnesium hydroxide),
• viloxazine (antidepressant medicine),
• vitamin E.

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

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

Effect of Sintrom on other medicines:

• Sintrom may increase the risk of toxicity when using hydantoin derivatives, such as phenytoin (used to treat epilepsy).
• 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 have a child, she should consult her doctor or pharmacist before using this medicine.
Use during pregnancy is contraindicated. Sintrom, like other anticoagulants, may cause serious fetal harm.
It is recommended that women of childbearing age undergo a pregnancy test 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.
If breastfeeding, consult your doctor. Both mother and child require special medical monitoring, and the child should receive prophylactic vitamin K.
Driving and operating machinery
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.
Due to the risk of injury, it is recommended to carry an identification card indicating anticoagulant therapy.
Sintrom contains monohydrate lactose
Sintrom contains monohydrate lactose (a milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, he or she should contact the doctor before taking the medicine.

3. How to use Sintrom

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor.
The dosage of this medicine is determined by your doctor. Regular blood clotting tests allow your
doctor to adjust the dose of Sintrom appropriately. Sintrom must be taken every day.
Always follow your doctor's instructions and do not exceed the recommended dose.
Recommended dose
Your doctor will inform you exactly how many Sintrom tablets you should take. Depending on
your response to treatment, your doctor may decide to increase or reduce the dose.
Individual sensitivity to the medicine varies and may change during treatment, or if your diet
changes, particularly if you start eating foods rich in vitamin K (such as spinach, cabbage-family
vegetables). You must strictly follow your doctor's instructions. Your doctor 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 malnourished patients may require a lower dose at the beginning
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, swallowing
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 4 mg Sintrom 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 prescribed
If you accidentally take more Sintrom tablets than prescribed, you must contact your doctor
immediately. Overdose of Sintrom may lead to bleeding. If bleeding occurs, stop taking Sintrom
and begin appropriate treatment for bleeding.
Missed dose of Sintrom
If you forget to take your usual dose at the scheduled time, take the missed dose as soon as
possible. If it is almost time for your next dose, do not take the missed dose. Instead, 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 questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Some side effects may be serious:
Common (less than 1 in 10 people): bleeding (symptoms may include: unexplained
nosebleeds or bleeding gums when brushing teeth; 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 blood in sputum, or vomiting blood; sudden, severe or persistent headache). If any of the above bleeding symptoms occur, this may mean that the patient has received more medicine than needed.
Rare (less than 1 in 1,000 people): allergic reactions such as rash or itching.
Very rare (less than 1 in 10,000 people): skin hemorrhages with blister formation, with or without scarring, usually located on the cheeks, buttocks, abdomen, breasts and sometimes on the toes; skin hemorrhages or subcutaneous hematomas (a sign indicating possible vasculitis); jaundice (symptoms of possible liver damage).
If any of the above side effects occur, you must immediately inform your doctor.
Other side effects:
Rare (less than 1 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 the 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 side effect occurs more frequently in patients with chronic kidney disease.
Lower than normal number of red blood cells or reduced hemoglobin concentration (anemia).
If any side effects not listed in this leaflet occur, you should tell your doctor.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects 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 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Sintrom

No special storage instructions are required.
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. 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. This will help protect the environment.

6. Contents of the pack and other information

What Sintrom contains

• The active substance is acenocoumarol. Each tablet contains 4 mg of acenocoumarol.
• The other ingredients are: monohydrate lactose, 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 embossed with "CG", on the other side there is a cross-shaped score line allowing division into four equal parts, each of which is embossed with the letter "A".
Sintrom is available in packs containing 20 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation 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, The 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Bulgaria, the country of export: 20000293
Parallel Import Licence Number: 49/20