ACENOCUMAROL AUROVITAS 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Acenocumarol Aurovitas 4 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 pack

1. What is Acenocumarol Aurovitas and what is it used for
2. What you need to know before you take Acenocumarol Aurovitas
3. How to take Acenocumarol Aurovitas
4. Possible side effects
5. Storage of Acenocumarol Aurovitas
6. Contents of the pack and other information

1. What is Acenocumarol Aurovitas and what is it used for

Acenocumarol Aurovitas contains the active substance acenocoumarol. Acenocoumarol belongs to a group of medicines called anticoagulants (medicines that reduce the blood's ability to clot).

This medicine is used to treat and prevent blood clots that block blood vessels, e.g., deep vein thrombosis (DVT).

Acenocoumarol does not dissolve blood clots that have already formed, but it can prevent clots from getting bigger and causing more serious problems.

2. What you need to know before you take Acenocumarol Aurovitas

You can only take this medicine under medical supervision. Acenocoumarol is not suitable for all patients.

Follow your doctor's instructions carefully. They may differ from the general information contained in this leaflet.

Do not takeAcenocumarol Aurovitas

• If you are allergic to acenocoumarol, to any other medicine that you have taken to thin your blood, or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant, plan to become pregnant, or are breast-feeding (see Pregnancy, breast-feeding and fertility).
• If you are an alcoholic or have mental disorders or are an elderly patient without supervision.
• If you have recently had or are about to have an operation on your spine, brain, or teeth, eyes, or any major surgery (e.g., lungs, prostate, uterus, etc.) that involves significant bleeding.
• If you have had a stroke caused by bleeding in the brain.
• If you have very high blood pressure.
• If you have stomach or intestinal ulcers, or bleeding from the urinary or respiratory tracts.
• If you pass blood in your urine or cough up blood.
• If you have a severe bleeding disorder (e.g., hemophilia), bleeding problems, or unexplained bruising.
• If you have pericarditis or endocarditis: inflammation or infection around the heart that causes chest pain.
• If you have severe liver or kidney disease.

If you are in any of the above situations, or if you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Acenocumarol Aurovitas.

• If you have cancer.
• If you have an infection, tumors, or inflammation (swelling).
• If you have a disorder that affects the absorption of food in the stomach and/or intestines. These can interfere with the level of the active substance in the blood.
• If you have heart failure (which causes swelling and difficulty breathing).
• If you have liver or kidney problems.
• If you have an overactive thyroid gland.
• If you are elderly.
• If you have a blood disorder, such as protein C or protein S deficiency, this could cause you to bleed for longer than usual after a cut or injury.
• If you are about to have an operation that may affect your tendency to bleed (e.g., minor surgery, tooth extraction, lumbar puncture, or angiography).
• If you are at a higher risk of bleeding, for example, if you have: blood test results with an international normalized ratio (INR) above 4.0, are over 65 years old, have 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, injury, reduced kidney function, are taking or have recently taken any of the medicines listed below, or have been taking acenocoumarol for a long time.

DO NOT have injections into your muscles while you are taking Acenocumarol Aurovitas.

If you need injections into your spine or as part of an examination or X-ray test, or if you need minor surgery, including dental surgery, make sure you talk to your doctor first about your treatment.

Calciphylaxis, a condition in which calcium builds up in the blood vessels of the skin, sometimes occurs when patients are taking anticoagulant medicines, including acenocoumarol. This is rare but causes painful lumps or ulcers on the skin that can lead to serious infection and death. It usually only happens if a person has severe kidney disease or if they already have problems with calcium, albumin, phosphate, or certain proteins in the blood. If you have been diagnosed with this condition, your doctor will start treating you and may stop your treatment with Acenocumarol Aurovitas.

If you are in any of the above situations, or if you are not sure, talk to your doctor or pharmacist before taking this medicine.

Other medicines and Acenocumarol Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (over-the-counter). This is especially important for the following medicines, as they may interfere with Acenocumarol Aurovitas.

Medicines that increase the effect of Acenocumarol Aurovitas, such as:

• Heparin to thin the blood in the treatment of deep vein thrombosis, blood clots, or after surgery.
• Antibiotics (e.g., clindamycin).
• Salicylic acid and related substances (e.g., acetylsalicylic acid, aminosalicylic acid, diflunisal) (medicine used against pain).
• Clopidogrel, ticlopidine, phenylbutazone, or other pyrazolone derivatives (sulfinpyrazone), other non-steroidal anti-inflammatory agents (medicines that affect the function of platelets (particles in the blood involved in blood clotting)).

When acenocoumarol is prescribed in combination with these medicines, more frequent monitoring (including blood tests) will be necessary.

Other medicines that may increase the effect of Acenocumarol Aurovitas, such as:

• Allopurinol or sulfinpyrazone, for the treatment of gout and to lower uric acid levels.
• Androgens such as testosterone and mesterolone, used as replacement therapy.
• Anabolic steroids (medicines used to increase muscle mass).
• Anti-arrhythmic agents such as amiodarone and quinidine, medicines used to normalize heart rhythm.
• Antibiotics (e.g., erythromycin, tetracyclines, neomycin, chloramphenicol, amoxicillin, some cephalosporins, some fluoroquinolones), medicines used to treat infections.
• Selective serotonin reuptake inhibitors such as fluoxetine, citalopram, sertraline, and paroxetine, used to treat anxiety and depression.
• Clofibrate and related substances, medicines used against high cholesterol.
• Corticosteroids such as methylprednisolone, prednisolone, used to treat inflammatory bowel disease, arthritis, and certain skin conditions.
• Disulfiram, to treat alcohol dependence.
• Etacrynic acid or thiazide diuretics ("water pills") such as bendroflumethiazide or metolazone - for fluid retention or high blood pressure.
• Glucagon, to treat low blood sugar levels.
• Imidazole derivatives (e.g., metronidazole, and even when administered locally, miconazole), medicine used against infections.
• Paracetamol, medicine used for pain.
• Sulfonamides such as cotrimoxazole, used to treat infections.
• Sulfonylureas such as tolbutamide, chlorpropamide, and glibenclamide, oral medicines for diabetes.
• Thyroid hormones such as dextrothyroxine and levothyroxine, used to treat an underactive thyroid gland.
• Statins and other lipid-lowering agents such as fenofibrate, atorvastatin, fluvastatin, and simvastatin, or cholestyramine, used to lower blood cholesterol levels.
• Tamoxifen, used for breast cancer and fertility.
• Tramadol (strong pain reliever).
• H2 agonists such as cimetidine or ranitidine, used to treat stomach acid, stomach ulcers, or intestinal ulcers.
• Proton pump inhibitors (e.g., omeprazole).
• Plasminogen activators (e.g., urokinase; streptokinase and alteplase, thrombin inhibitors (e.g., argatroban), medicines used to break down blood clots during a heart attack).
• Prokinetic agents (e.g., cisapride), medicines used to treat gastrointestinal problems.
• Antacids (e.g., magnesium hydroxide) and viloxazine, used for stomach acid.
• Vitamin E.
• Glucosamine (for osteoarthritis), the effect of some medicines used to prevent blood clotting (e.g., warfarin, dicumarol, phenprocoumon, acenocoumarol, and fluindione) may increase when taken with glucosamine. Therefore, patients treated with these combinations should be monitored with extra care from the start to the end of glucosamine therapy.

Medicines that may decrease the effect of Acenocumarol Aurovitas, such as:

• Aminoglutethimide, azathioprine, 6-mercaptopurine, used in cancer or Cushing's syndrome.
• Protease inhibitors such as ritonavir, nelfinavir, or indinavir, used to treat HIV.
• Barbiturates such as amytal sodium or phenobarbital and carbamazepine, for epilepsy or to help you sleep.
• Corticosteroids (high doses of methylprednisolone intravenously, prednisolone), medicines used to treat inflammation.
• Cholestyramine, used to control high cholesterol levels.
• Griseofulvin, used to treat fungal infections.
• Oral contraceptives, used to prevent pregnancy.
• Rifampicin, medicine used to treat infections.
• St. John's Wort, for the treatment of depression.
• Semaglutide, a medicine used to lower blood sugar levels.
• Foods rich in vitamin K.

Effects of Acenocumarol Aurovitas on other medicines

• This medicine may increase the risk of toxicity from hydantoin derivatives such as phenytoin, medicines used to treat epilepsy.
• This medicine may enhance the hypoglycemic effect of antidiabetic medicines such as sulfonylureas (e.g., glibenclamide or glimepiride).

Acenocumarol Aurovitas with food, drinks, and alcohol

Avoid consuming large amounts of alcohol and foods rich in vitamin K, such as leafy green vegetables, spinach, cabbage, kale. This can change the effects of acenocoumarol in your body. If you have any doubts about this, talk to your doctor.

Since the severity and nature of the interactions between acenocoumarol and alcohol are unpredictable, you should avoid drinking alcohol during treatment with acenocoumarol, especially if you have liver disease.

You should avoid consuming cranberry juice and other cranberry products, such as capsules or concentrates, as this may mean you do not receive the correct dose of acenocoumarol.

Elderly patients

If you are 65 years old or older, you may be more sensitive to the effects of acenocoumarol and may need more frequent checks. You may also need lower doses.

Children and adolescents

Experience with acenocoumarol in children and adolescents is limited, so these patients need more frequent checks (see Section 3).

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

DO NOT take Acenocumarol Aurovitas if you are pregnant. This medicine, like other anticoagulants, can cause serious harm to the unborn baby. It is important that you inform your doctor if you are pregnant or are trying to become pregnant. Your doctor will discuss with you the possible risks of taking Acenocumarol Aurovitas during pregnancy.

Breast-feeding

The decision to breast-feed while taking Acenocumarol Aurovitas should be made carefully with your doctor. You and your child may need blood tests if you are breast-feeding while taking Acenocumarol Aurovitas. However, as a precaution, your doctor should prescribe vitamin K to your child to prevent their blood from thinning.

Fertility

If you are of childbearing age, your doctor may perform a pregnancy test to rule out pregnancy before administering Acenocumarol Aurovitas. You may also be asked to use a contraceptive method while taking Acenocumarol Aurovitas.

Driving and using machines

Acenocumarol Aurovitas has no influence on the ability to drive or use machines. However, if you have an accident while taking Acenocumarol Aurovitas, the doctor or hospital staff must be informed immediately that you are taking Acenocumarol Aurovitas. You are advised to carry your personal anticoagulation card (an identification card from your pharmacist indicating that you are using this medicine) with you.

Acenocumarol Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Acenocumarol Aurovitas

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

Acenocumarol should be taken as a single dose at the same time every day. Swallow the tablets whole with a glass of water.

The dosage must be determined by your doctor. You will have periodic blood tests during treatment with acenocumarol to check the coagulation speed of your blood. This will help your doctor adjust your dose better.

Follow your doctor's instructions carefully. Do not exceed the recommended dose.

How much Acenocumarol Aurovitas to take

Your doctor will tell you exactly how many acenocumarol tablets to take.

Depending on your response to treatment, your doctor may increase or decrease your dose.

Sensitivity to anticoagulation varies between people and can change during treatment or if you modify your diet, especially if it includes foods rich in vitamin K (such as spinach and vegetables of the same family as cabbage). Your doctor will monitor you in periodic visits and prescribe the appropriate doses according to your needs. Follow your doctor's instructions strictly. Do not stop taking this medication suddenly or change the dose on your own initiative.

How long to take Acenocumarol Aurovitas

Your doctor will tell you exactly how long you need to take this medication.

The dose of acenocumarol will vary from one patient to another and from one day to another. The following can be used as a guide:

Adults:

The usual initial dose is 2 mg/day to 4 mg/day without administering a loading dose. Treatment may be started with a loading dose regimen, normally 6 mg on the first day followed by 4 mg on the second day.

Special populations

Elderly patients, patients with liver disease or severe heart failure, or malnourished patients may require lower doses.

Use in children and adolescents

This medication is not recommended for children.

Inform your doctor, dentist, or pharmacist on each visit that you are taking acenocumarol.

If you take more Acenocumarol Aurovitas than you should

If you accidentally take too many tablets, or someone takes some of your medication, you must inform your doctor immediately or contact the nearest emergency service. The symptoms of overdose vary from person to person. They can appear 1 to 5 days after taking the medication and include nosebleeds, bleeding gums, vomiting or coughing up blood, blood in the urine, stools with blood or black tarry stools, genital bleeding, heavy menstrual bleeding, large bruises or bleeding in the joints that causes tension, swelling, and pain. If this occurs, treatment with acenocumarol should be interrupted and treatment to control the bleeding should be started. Your heart rate may accelerate, your blood pressure may drop making you feel dizzy, and your skin may appear pale, cold, and sweaty. You may experience nausea, vomiting, diarrhea, and abdominal pain. You may need blood tests to monitor your condition and treatment may be required.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Tel.: 91 562 04 20, indicating the medication and the amount ingested. Show the doctor the leftover medication or the empty package.

If you forget to take Acenocumarol Aurovitas

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 the usual administration schedule. DO NOT take a double dose to make up for forgotten doses. Remember to inform your doctor at your control visit of the number of doses you have forgotten.

If you interrupt treatment with Acenocumarol Aurovitas

If you have any questions about interrupting treatment with acenocumarol, talk to your doctor.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Do not be alarmed by the list of possible side effects. You may or may not feel any of them. Inform your doctor immediately if you have any of the following adverse effects:

Frequent (may affect up to 1 in 10 people):

• Unusual bleeding such as:

• bleeding gums when brushing teeth,
• unexplained bruises or nosebleeds,
• abundant or unexpected periods,
• abundant unusual bleeding or bleeding from cuts or wounds.

• Signs of bleeding inside the body such as:

• stomach or abdominal pain,
• back pain,
• blood in the urine,
• stools with blood or black tarry stools,
• coughing or vomiting blood,
• dizziness,
• sudden, severe, or persistent headache, pain or stiffness in the joints,
• blurred vision.

Rare (may affect up to 1 in 1,000 people):

• allergic reaction in the form of skin rash or itching,
• skin rashes,
• itching,
• unexplained fever,
• loss of appetite,
• vomiting,
• feeling or being sick,
• unusual hair loss,

Very rare (may affect up to 1 in 10,000 people):

• bruises with blisters on the skin with or without scarring, usually in the areas of:

• thighs,
• buttocks,
• abdomen, breast,
• or sometimes on the toes,
• • bruises or bleeding under the skin (possible sign of vasculitis),
  • jaundice (possible signs of liver damage).

Frequency not known (cannot be estimated from available data):

Painful skin rash. In rare cases, acenocumarol can cause serious skin diseases, including one called calciphylaxis, which can start with a painful skin rash but can lead to serious complications. This adverse reaction occurs more frequently in patients with chronic kidney disease.

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).

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 Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Acenocumarol Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the label, box, or blister after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Acenocumarol Aurovitas 4 mg

• The active ingredient is acenocumarol.

Each tablet contains 4 mg of acenocumarol

• The other components (excipients) are:

Tablet core: lactose monohydrate, pregelatinized starch (cornstarch), talc (E553b), colloidal anhydrous silica (E551), magnesium stearate (E470b).

Product appearance and package contents

Acenocumarol Aurovitas 4 mg tablets EFG:

White to off-white, uncoated, round, biconvex tablets, engraved with "AR 4" on one face and quadrisectioned on the other face. The tablet can be divided into four equal parts.

Acenocumarol Aurovitas tablets are available in blister packs.

Package sizes: 20, 50, 60, 100, 200 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medication is authorized in the member states of the European Economic Area with the following names:

Spain: Acenocumarol Aurovitas 4 mg tablets EFG

Portugal: Acenocumarol Generis

Date of the last revision of this prospectus: July 2025

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