SINTROM 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Sintrom4 mg Tablets

Acenocoumarol

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet

1. What is Sintrom and what is it used for
2. What you need to know before taking Sintrom
3. How to take Sintrom
4. Possible side effects
5. Storing Sintrom
6. Contents of the pack and further information

1. What is Sintrom and what is it used for

Sintrom is a medication that contains the active substance acenocoumarol. Acenocoumarol belongs to a group of medications called anticoagulants, which reduce the blood's ability to clot and thus help prevent the formation of blood clots in blood vessels.

Sintrom is used for the prevention and treatment of blood clotting.

2. What you need to know before taking Sintrom

You can only take Sintrom under medical supervision. Sintrom is not suitable for all patients.

Do not take Sintrom

• if you are allergic to acenocoumarol or any of the other ingredients of this medication listed in section 6.
• if you may have problems following the treatment (e.g. elderly patients without assistance, with alcoholism or mental disorders).
• if you have blood disorders with a tendency to bleeding or severe hemorrhagic diseases (e.g. hemophilia).
• if you have undergone or are going to undergo major surgical interventions such as eye or brain operations.
• if you have undergone surgical interventions (lung, prostate, uterus, etc.) where there is a lot of bleeding, including dental interventions, due to the increased ability to dissolve blood clots that the medication has.
• if you have stomach ulcers or intestinal, cerebral, or pulmonary hemorrhages.
• if you have a severe infection or inflammation in the heart.
• if you have uncontrolled high blood pressure.
• if you have severe liver or kidney disease.
• if you are pregnant or think you may be pregnant.

Do not take Sintrom if any of these conditions apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Sintrom

• if you have liver disease.
• if you have kidney or thyroid disease, if you have tumors, infections, or inflammations, or any condition that may affect the absorption of food in the stomach and/or intestine.
• if you have severe heart disease.
• if you know you have a deficiency of protein C or S (types of clotting factors).
• if you are going to undergo any intervention that may affect your tendency to bleed, e.g. minor surgery, dental extraction, lumbar puncture, or angiography (a test to obtain an image of the blood vessels).
• if you are using a medication by intramuscular injection. Intramuscular injections can cause hematomas while taking Sintrom or similar medications, so they should be avoided.
• if you have a higher risk of bleeding, for example, if you have: blood test results with an international normalized ratio (INR) above 4.0, more than 65 years, a history of variable blood test results for INR, stomach or duodenal ulcers, or high blood pressure, problems with blood circulation to the brain (cerebrovascular disease), severe heart disease, anemia, cancer, injuries, decreased kidney function, use or have recently used any of the medications listed below, or have been taking Sintrom for a prolonged period.

If you have any of the conditions described above, inform your doctor before taking Sintrom.

Taking Sintrom with other medications:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

The effects of Sintrom may interfere with those of other medications, in particular:

• Medications that may increase the activity of Sintrom:

• Heparin: a medication also used to prevent blood clotting;
• Salicylic acid and related substances such as aspirin, aminosalicylic acid, diflunisal: medications used for pain;
• Clopidogrel, ticlopidine, phenylbutazone, or other pyrazolone derivatives (e.g., sulfinpyrazone);
• Other non-steroidal anti-inflammatory drugs, including those called cyclooxygenase-2 inhibitors (e.g., celecoxib);
• Methylprednisolone (corticosteroid) when injected into a vein in high doses.

Controls (blood tests) will be more frequent if you take these medications with Sintrom.

• Other medications that may increase the activity of Sintrom, such as:

• allopurinol: a medication used for gout;
• anabolic steroids and androgens: medications used for muscle development;
• antiarrhythmic agents such as amiodarone, quinidine: medications used to normalize heart rhythm;
• antibiotics such as erythromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, some cephalosporins, fluoroquinolones, and clindamycin: medications used to treat infections;
• serotonin reuptake inhibitors such as citalopram, fluoxetine, sertraline: a group of antidepressant medications;
• cimetidine: a medication used for heartburn and peptic ulcers;
• clofibrate and other similar medications used to control cholesterol;
• corticosteroids such as methylprednisolone, prednisone: medications used to treat inflammation;
• disulfiram: a medication used for alcoholism;
• etacrynic acid: a medication to increase urine production;
• glucagon: a medication used to maintain blood sugar levels;
• imidazole derivatives such as metronidazole and miconazole (even when applied to the skin): medications used to treat fungal infections;
• paracetamol: a medication used for pain and fever;
• sulfonamides (including co-trimoxazole): medications used to treat infections;
• tolutamide, chlorpropamide: medications used for diabetes;
• thyroid hormones (including dextrothyroxine): medications used to treat thyroid problems;
• statins such as fluvastatin, atorvastatin, simvastatin: medications to lower cholesterol levels;
• tamoxifen: a medication used in breast cancer;
• tramadol: a medication used for pain;
• omeprazole: a medication used to protect the stomach;
• urokinase, streptokinase, alteplase, and argatroban: medications used in heart attacks to dissolve blood clots;
• cisapride: a medication used to treat gastrointestinal problems;
• antacids such as magnesium hydroxide;
• viloxazine: an antidepressant medication;
• noscapine: a medication used for cough;
• vitamin E;
• glucosamine (for osteoarthritis) may increase the effect of Sintrom.

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

• aminoglutethimide, azathioprine, 6-mercaptopurine: medications used in cancer;
• ritonavir, nelfinavir: medications used for AIDS;
• barbiturates, carbamazepine: medications used for epilepsy and convulsions;
• cholestyramine: a medication used to control cholesterol;
• griseofulvin: a medication used for fungal infections;
• oral contraceptives: medications used to prevent pregnancy;
• rifampicin: a medication used to treat infections;
• St. John's Wort: a plant used to treat depression, also called hypericum;
• thiazide diuretics: medications used to increase urine production;
• foods rich in vitamin K;
• semaglutide, a medication used to reduce blood sugar levels;
• hydantoin derivatives such as phenytoin: medications used to treat epilepsy.

• Effect of Sintrom on other medications:

• Sintrom may increase the levels of hydantoin derivatives (e.g., phenytoin, often used to treat epilepsy) in the blood.
• Sintrom may further lower blood sugar levels when combined with antidiabetic medications known as sulfonylureas (e.g., glibenclamide, glimepiride).

Taking Sintrom with food, drinks, and alcohol

You should avoid consuming alcohol or currant juice during treatment, as they may increase the effect of Sintrom and thus the risk of bleeding.

Foods that contain large amounts of vitamin K (e.g., leafy green vegetables, spinach, cabbage) may decrease the effect of Sintrom. Consult your doctor or pharmacist if you have any doubts.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy

Do not use Sintrom if you are pregnant. Sintrom, like other anticoagulants, can cause serious harm to the baby. Therefore, it is essential that you inform your doctor if you are pregnant or plan to become pregnant. If you are of childbearing age, your doctor will perform a pregnancy test to rule it out. You should use contraceptive measures while being treated with Sintrom.

Your doctor will explain the potential risk of Sintrom during pregnancy.

Breastfeeding

The decision to breastfeed while being treated with Sintrom should be discussed in detail with your doctor. If you are breastfeeding while taking Sintrom, you and your child may need additional monitoring. As a precautionary measure, your doctor may prescribe vitamin K for the baby.

Fertility

There is no information available on the possible effect of Sintrom on human fertility.

Driving and using machines

Sintrom does not affect the ability to drive vehicles and operate machines.

However, in the event of an accident or injury, the doctor or medical staff should be informed immediately that you are taking Sintrom. For this purpose, it is recommended to carry the personal anticoagulation card (an identification card that specifies that you are taking this medication) with you.

Sintrom contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Sintrom

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose must be determined by your doctor. You will regularly have a blood test to monitor your blood clotting. This will help your doctor adjust your daily dose of Sintrom better.

Your doctor will tell you how many Sintrom tablets to take. Do not exceed the recommended dose.

Depending on how you respond to the treatment, your doctor will recommend an increase or decrease in the dose.

Sensitivity to anticoagulation varies between people and can change during treatment or if the diet is modified, especially if foods rich in vitamin K (e.g., spinach and cabbage) are included. Your doctor will monitor you in periodic visits and prescribe the most suitable dose in each case. Generally, dose adjustments will be based on the total weekly dose distributed as homogeneously as possible over the seven days. Follow your instructions strictly.

Normally, you should take the tablets at the same time of day, for example, at night with a glass of water and separated from meals.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Remember to tell your doctor, dentist, or pharmacist at each visit that you are taking Sintrom.

Dental treatments and surgery

It is especially important to inform your doctor, dentist, or pharmacist if you are going to undergo any surgery or invasive procedure, such as a dental extraction; consult your doctor as you will need close monitoring of your blood clotting.

Your doctor will decide whether to interrupt or not the medication. Even if it is for a short period, your doctor may prescribe a different medication to stop blood clotting until you are told to start taking Sintrom again.

Use in the elderly

If you are over 65 years old, you may be more sensitive to the effects of Sintrom and therefore may need more monitoring. It may even be necessary to reduce the dose.

Use in children and adolescents

Experience with the use of Sintrom in children and adolescents is limited. If the doctor decides to treat a child or adolescent with Sintrom, they will take blood samples to measure clotting parameters more frequently than in an adult to confirm the functioning of Sintrom and ensure that there are no side effects.

How long to take Sintrom

Your doctor will inform you how long you should take the medication. Do not interrupt the treatment or change the dose on your own initiative; you should always consult your doctor.

If you take more Sintrom than you should

If you accidentally take too many Sintrom tablets, go to your doctor immediately. The symptoms of overdose and their severity depend on individual sensitivity to Sintrom, the number of tablets taken, and the duration of treatment.

If, following the regimen indicated by your doctor, symptoms of overdose appear with continued use of Sintrom, you should go to your doctor to evaluate your treatment.

Overdose with Sintrom can cause bleeding. The most likely symptoms of an overdose are bleeding in the skin, blood in the urine, hematomas, gastrointestinal bleeding, vomiting blood, vaginal bleeding, nosebleeds, gum bleeding, and joint bleeding. If this occurs, treatment should be interrupted and the bleeding treated. Other symptoms include an abnormally fast heartbeat, low blood pressure, alterations in blood circulation to the organs and extremities of the body, feeling unwell, vomiting, diarrhea, and stomach pain.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Tel.: 91 562 04 20.

If you forget to take Sintrom

If you forget a dose of this medication, take it as soon as possible, except if it is almost time for the next dose; then return to your usual administration schedule. Do not take a double dose to make up for forgotten doses. Remember to inform your doctor at your control visit about the number of doses you have forgotten.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Some of these side effects could be serious:

• Frequent (1 or more people out of 10): bleeding (symptoms such as unexplained nosebleeds or gum bleeding when brushing teeth; unexplained hematomas; unusual or heavy bleeding from cuts or wounds; heavy or unexpected menstrual bleeding; blood in urine; stools with blood or black stools; blood when coughing or vomiting; sudden, severe, or persistent headache). If you have any of the bleeding symptoms described, it may mean that you are taking more medication than you need.
• Rare (less than 1 in 1,000 people): allergic reaction in the form of skin rash or itching.
• Very rare (less than 1 in 10,000 people): hematomas with blisters on the skin with or without crusts, usually on the thighs, buttocks, abdomen, chest, or sometimes on the toes; hematomas or bleeding under the skin (possible sign of vasculitis); yellowish color in the eyes or skin (possible sign of liver damage).
• Frequency not known: bleeding in the kidney, sometimes with blood in the urine, which can lead to the inability of the kidneys to function properly (anticoagulant-related nephropathy).

If you experience any of these side effects, go to your doctor immediately.

Other side effects:

• Rare (less than 1 in 1,000 people): unusual hair loss; loss of appetite; vomiting; nausea.
• Frequency not known: painful skin rash. In rare cases, Sintrom can cause serious skin problems, such as calciphylaxis, which can start with a painful skin rash and then lead to more serious complications. This adverse reaction occurs more frequently in patients with chronic kidney disease. Condition characterized by a lower than normal number of red blood cells or reduced hemoglobin (anemia).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications at www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storing Sintrom

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the packaging is damaged or shows signs of tampering.

Keep Sintrom in its original packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Sintrom 4 mg tablets

The active ingredient is acenocoumarol. Each tablet contains 4 mg of acenocoumarol.

The other components are:

Lactose, anhydrous colloidal silica, magnesium stearate, corn starch, pregelatinized corn starch.

Appearance of the product and packaging contents

The 4 mg tablet is round, white in color, with the mark "CG" on one side and a cross with an "A" in each quadrant on the other. The score line is only for fractioning and facilitating swallowing, but not for dividing into equal doses.

Packaging of 20 or 500 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Merus Labs Luxco II S.à.R.L.

208, Val des Bons Malades

L-2121 Luxembourg

Luxembourg

Manufacturer

Rovi Pharma Industrial Services, S.A.

Vía Complutense, 140,

Alcalá de Henares,

Madrid, 28805,

Spain

or

FAMAR A.V.E

Anthoussa Avenue 7,

Anthoussa Attikis,

15349,

Greece

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2ª Planta

28046 Madrid

Spain

Date of the last revision of this leaflet: June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/