Package Insert: Information for the User

Sintrom4 mg Tablets

Acenocumarol

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

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Sintrom is a medication that contains the active ingredient acenocumarol. Acenocumarol belongs to a group of medications called anticoagulants, which reduce the blood's ability to clot and therefore help prevent the formation of clots in blood vessels.

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

Only take Sintrom under medical supervision. Sintrom is not suitable for all patients.

Do not take Sintrom

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

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

Warnings and precautions

Consult 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 inflammation, or any condition that may affect the absorption of food in the stomach and/or intestine.
• if you have a severe heart condition.
• if you know you have a deficiency of protein C or S (types of clotting factors).
• if you are to undergo any intervention that may affect your tendency to bleed, e.g. minor surgery, tooth extraction, lumbar puncture, or angiography (test to obtain an image of blood vessels).
• if you are using an injectable medication. Intramuscular injections may 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: an international normalized ratio (INR) result above 4.0, over 65 years old, a history of variable INR test results, stomach or duodenal ulcers, high blood pressure, cerebrovascular disease, severe heart disease, anemia, cancer, injuries, reduced renal function, have used or are using 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:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Medications that may increase the activity of Sintrom:

• Heparin: a medication also used to prevent blood coagulation;
• 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 nonsteroidal anti-inflammatory drugs (NSAIDs), including those called cyclooxygenase-2 inhibitors (e.g. celecoxib);
• Methylprednisolone (corticosteroid) when injected intravenously in high doses.

Controls (blood tests) will be more frequent when taking these medications with Sintrom.

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

• Alopurinol: a medication used for gout;
• Androgens and anabolic steroids: 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;
• Selective serotonin reuptake inhibitors (SSRIs) such as citalopram, fluoxetine, sertraline: a group of antidepressant medications;
• Cimetidine: a medication used for heartburn and 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;
• Ethacrynic acid: a medication to increase urine production;
• Glucagon: a medication used to maintain blood sugar levels;
• Imidazole derivatives such as metronidazole and miconazole (even 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;
• Tolbutamide, 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 for breast cancer;
• Tramadol: a medication used for pain;
• Omeprazole: a medication to protect the stomach;
• Urokinase, streptokinase, alteplase, and argatroban: medications used in heart attacks to dissolve blood clots;
• Cisapride: a medication 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 for cancer;
• Ritonavir, nelfinavir: medications used for HIV/AIDS;
• Barbiturates, carbamazepine: medications used for epilepsy and seizures;
• Colestiramine: 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 known as hypericum;
• Thiazide diuretics: medications used to increase urine production;
• Foods rich in vitamin K;
• Hydantoin derivatives such as phenytoin: medications used to treat epilepsy.

The 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 blackcurrant juice during treatment, as they may increase the effect of Sintrom and thereby increase 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 damage to the baby. Therefore, 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 will need to take contraceptive measures while taking Sintrom.

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

Breastfeeding

You and your baby may need additional monitoring while breastfeeding while taking Sintrom. As a precaution, your doctor may prescribe vitamin K for the baby.

Fertility

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

Driving and operating machinery

Sintrom does not affect your ability to drive vehicles and operate machinery.

However, in the event of an accident or injury, inform your doctor or medical staff immediately that you are taking Sintrom. For this purpose, it is recommended to carry a personal anticoagulation card (a card that identifies you as taking this medication).

Sintrom contains lactose

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

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

The dose will be determined by your doctor. You will be regularly undergoing blood tests to monitor your coagulation. This will help your doctor to adjust your daily dose of Sintrom better.

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

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

Individual sensitivity to anticoagulation varies and can change during treatment or if your diet is modified, especially if you include foods rich in vitamin K (e.g. spinach and members of the cabbage family). Your doctor will monitor you at regular visits and prescribe the most suitable dose in each case. Generally, dose adjustments will be based on the total weekly dose distributed as evenly as possible over the seven days. Follow your instructions strictly.

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

The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

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

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 tooth extraction; consult with your doctor as you will need to closely monitor your blood coagulation status.

Your doctor will decide whether to interrupt or not the medication. Although it is for a short period of time, your doctor may prescribe a different medication to stop blood coagulation until you are informed 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. You may even need to reduce the dose.

Use in children and adolescents

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

For how long should you take Sintrom

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

If you take more Sintrom than you should

If you accidentally take too many Sintrom tablets, go immediately to your doctor.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 schedule indicated by your doctor, with the continued use of Sintrom, symptoms of overdose appear, you should go to your doctor to evaluate your treatment.

An overdose of Sintrom can cause bleeding. The most likely symptoms of an overdose are skin bleeding, blood in the urine, bruises, gastrointestinal bleeding, vomiting blood, vaginal bleeding, nasal bleeding, gum bleeding, and joint bleeding. If this occurs, treatment should be interrupted and the bleeding treated. Other symptoms include an abnormally fast heart rate, low blood pressure, alterations in blood circulation in organs and limbs, feeling unwell, vomiting, diarrhea, and stomach pain.

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

If you forgot 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 one; then return to your usual administration schedule. Do not take a double dose to compensate for the missed doses. Remember to inform your doctor at your control visit of the number of doses you have forgotten.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Some of these adverse effects could be severe:

• Frequent (1 or more people per 10): Bleeding (symptoms such as: unexplained nasal bleeding or bleeding gums when brushing teeth; unexplained bruises; unusual intense bleeding or 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 you are taking more medication than you need.
• Rare (less than 1 per 1,000 people): Allergic reaction in the form of skin rash or itching.
• Very rare (less than 1 per 10,000 people): Blisters with or without scabs on the skin, usually on thighs, buttocks, abdomen, breasts, or sometimes on the toes; hematomas or bleeding under the skin (possible sign of vasculitis); yellowish discoloration of the eyes or skin (possible sign of liver damage).

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

Other adverse effects:

• Rare (less than 1 per 1,000 people): Unusual hair loss; loss of appetite; vomiting; nausea.
• Unknown frequency: Painful skin rash. In rare cases, Sintrom may cause serious skin problems, such as calcifilaxis, which can start with a painful skin rash, and then lead to more severe complications. This adverse reaction occurs more frequently in patients with chronic kidney disease.Condition by which there is a lower than normal number of red blood cells or reduced hemoglobin (anemia).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use at www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of the sight and reach of children.

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

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

Store Warfarin in its original packaging.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at your local SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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, cornstarch, pregelatinized cornstarch.

Appearance of the product and contents of the packaging

The 4 mg tablet is round, white, with the mark “CG” on one face and a cross with an “A” in each quadrant on the other. The groove serves only to break and facilitate swallowing, but not to divide into equal doses.

Packaging of 20 or 500 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Merus Labs Luxco II S.à.R.L.

208, Val des Bons Malades

L-2121 Luxembourg

Luxembourg

Responsible for manufacturing

Rovi Pharma Industrial Services, S.A.

Vía Complutense, 140,

Alcalá de Henares,

Madrid, 28805,

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046 Madrid

Spain

Last review date of this prospectus: June 2021

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Products (AEMPS)http://www.aemps.gob.es/