Acenocoumarol Aurovitas 4 mg tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Acenocumarol Aurovitas contains the active substance acenocumarol. Acenocumarol 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).

Acenocumarol does not dissolve blood clots that have already formed, but it can prevent existing clots from growing larger and causing more serious problems.

2. What you need to know before you start taking Acenocumarol Aurovitas

You may only take this medicine under medical supervision. Acenocumarol is not suitable for all patients.

Carefully follow all instructions provided by your doctor. These may differ from the general information contained in this leaflet.

Do not take Acenocumarol Aurovitas

• If you are allergic to acenocumarol, to any other medicine you have taken to thin the blood, or to any of the other components of this medicine (listed in section 6).
• If you are pregnant, planning to become pregnant, or breastfeeding (see pregnancy, breastfeeding and fertility).
• If you are an alcoholic, or if you are a patient with mental disorders or elderly patients without supervision.
• If you have recently undergone or are about to undergo spinal, brain, or dental surgery, or any major surgery (lungs, prostate, uterus, etc.) involving significant bleeding.
• If you have suffered a stroke caused by bleeding in the brain.
• If you have very high blood pressure.
• If you have a stomach ulcer or gastrointestinal, urogenital, or pulmonary bleeding.
• If you pass blood in your urine or cough up blood.
• If you have a serious bleeding disorder (e.g., haemophilia), bleeding problems, or unexplained bruising.
• If you have pericarditis or endocarditis: inflammation or infection around the heart causing chest pain.
• If you have severe liver or kidney disease.

If you are in any of the above situations, or if you are unsure, speak with your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take acenocumarol.

• If you have cancer.
• If you have an infection, tumours, or inflammation (swelling).
• If you have a disorder affecting food absorption in the stomach and/or intestine. This may interfere with the level of active drug 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.
• If you are elderly.
• If you have a blood disorder such as protein C or protein S deficiency, which could cause you to bleed longer than normal after a cut or injury.
• If you are about to undergo a procedure that may affect your tendency to bleed (e.g., minor surgery, dental extraction, lumbar puncture, or angiography).
• If you have an increased risk of bleeding, for example if you have: blood test results showing an international normalized ratio (INR) above 4.0, are over 65 years old, have a history of variable INR blood test results, gastric or duodenal ulcer or high blood pressure, problems with blood circulation to the brain (cerebrovascular disease), severe heart disease, anaemia, cancer, injury, reduced kidney function, are currently using or have recently used any of the medicines listed below, or have been taking acenocumarol for a prolonged period.

DO NOT receive intramuscular injections while taking acenocumarol.

If you need spinal injections or procedures as part of an X-ray examination or test, or if you require minor surgery including dental surgery, make sure to speak with your doctor about your treatment first.

Calciphylaxis, a condition in which calcium accumulates in blood vessels of the skin, sometimes occurs in patients taking anticoagulant medicines, including acenocumarol. This is rare, but causes painful lumps or ulcers in the skin that may lead to serious infection and death. It usually only occurs if a person has severe kidney disease or already has problems with calcium, albumin, phosphate, or certain protein levels in the blood. If you have been diagnosed with this condition, your doctor will begin treatment and may discontinue your acenocumarol therapy.

If you are in any of the above situations, or if you are unsure, speak with your doctor or pharmacist before taking this medicine.

Other medicines and Acenocumarol Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines. This is especially important for the following medicines, as they may interfere with this medicine.

Medicines that increase the activity of Acenocumarol Aurovitas such as:

• Heparin, used 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) (medicines used for pain).
• Clopidogrel, ticlopidine, phenylbutazone or other pyrazolone derivatives (sulfinpyrazone), other non-steroidal anti-inflammatory agents (medicines affecting platelet function (blood particles involved in blood clotting)).

When acenocumarol is prescribed together with these medicines, more frequent monitoring (including blood tests) will be necessary.

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

• Allopurinol or sulfinpyrazone, used to treat gout and lower uric acid levels.
• Androgens such as testosterone and mesterolone, used in replacement therapy.
• Anabolic steroids (medicines used to increase muscle mass).
• Antiarrhythmic 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 for high cholesterol.
• Corticosteroids such as methylprednisolone, prednisolone steroids, used to treat inflammatory bowel disease, arthritis, and certain skin conditions.
• Disulfiram, used to treat alcohol dependence.
• Ethacrynic acid or thiazide diuretics ("water pills") such as bendroflumethiazide or metolazone—for fluid retention or high blood pressure.
• Glucagon, used to treat low blood sugar.
• Imidazole derivatives (e.g., metronidazole, and even when applied locally, miconazole), medicines used to treat infections.
• Paracetamol, a medicine used for pain.
• Sulphonamides such as cotrimoxazole, used to treat infections.
• Sulphonylureas such as tolbutamide, chlorpropamide, and glibenclamide, oral medicines for diabetes.
• Thyroid hormones such as dextrothyroxine and levothyroxine, used to treat an underactive thyroid.
• Statins and other lipid-lowering agents such as fenofibrate, atorvastatin, fluvastatin, and simvastatin, or colestyramine, used to reduce blood cholesterol levels.
• Tamoxifen, used for breast cancer and fertility.
• Tramadol (a strong painkiller).
• H2 agonists such as cimetidine or ranitidine, used to treat stomach acid, stomach 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 dissolve blood clots during a heart attack.
• Prokinetic agents (e.g., cisapride), medicines used to treat gastrointestinal problems.
• Antacids (e.g., magnesium hydroxide) and viloxazine medicines, used for stomach acid.
• Vitamin E.
• Glucosamine (for osteoarthritis). The effect of some medicines used to prevent blood clotting (e.g., warfarin, dicoumarol, phenprocoumon, acenocumarol, and fluindione) may increase when taken with glucosamine. Therefore, patients treated with these combinations should be carefully monitored from the beginning 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 sodium amytal or phenobarbital and carbamazepine, for epilepsy or to aid sleep.
• Corticosteroids (high intravenous doses of methylprednisolone, prednisolone), medicines used to treat inflammation.
• Colestyramine, used to control high cholesterol levels.
• Griseofulvin, used to treat fungal infections.
• Oral contraceptives, used to prevent pregnancy.
• Rifampicin, a medicine used to treat infections.
• St. John’s wort, used to treat depression.
• Semaglutide, a medicine used to lower blood sugar levels.
• Foods high 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 hypoglycaemic effect of antidiabetic medicines such as sulphonylureas (e.g., glibenclamide or glimepiride).

Acenocumarol Aurovitas with food, drinks, and alcohol

Avoid consuming large amounts of alcohol and foods high in vitamin K, such as green leafy vegetables, spinach, cabbage, and kale. These may alter the effects of acenocumarol in your body. If you have any doubts, consult your doctor.

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

You should avoid consuming cranberry juice and other cranberry products, such as capsules or concentrates, as they may result in you not receiving the correct dose of acenocumarol.

Elderly patients

If you are 65 years of age or older, you may be more sensitive to the effects of acenocumarol and therefore may require more frequent monitoring. You may also require lower doses.

Children and adolescents

Experience with acenocumarol in children and adolescents is limited, so these patients require more frequent monitoring (see Section 3).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

The decision to breastfeed while taking acenocumarol should be carefully discussed with your doctor. You and your baby may require blood tests if you breastfeed while taking acenocumarol. However, as a precaution, your doctor should prescribe vitamin K for your baby to prevent thinning of the blood.

Fertility

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

Driving and use of machines

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

Acenocumarol Aurovitas contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Acenocumarol Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Acenocumarol should be taken as a single daily dose at the same time each 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 monitor your blood clotting time. This will help your doctor adjust your dose appropriately.

Carefully follow your doctor's instructions. Do not exceed the recommended dose.

How much Acenocumarol Aurovitas should you take

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

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

Sensitivity to anticoagulation varies between individuals and may change during treatment or if you alter your diet, especially if you include foods rich in vitamin K (e.g., spinach and other vegetables from the cabbage family). Your doctor will monitor you during regular visits and prescribe the appropriate dose according to your needs. Strictly follow your doctor's instructions. Do not stop taking this medicine suddenly or change the dose on your own initiative.

How long should you take Acenocumarol Aurovitas

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

The dose of acenocumarol may vary from patient to patient and from day to day. 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 initiated with a loading dose regimen, typically 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 medicine is not recommended for use in children.

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

If you take more Acenocumarol Aurovitas than you should

If you accidentally take too many tablets, or if someone else takes any of your medication, you must inform your doctor immediately or contact the nearest emergency service. Symptoms of overdose vary from person to person. They may appear 1 to 5 days after taking the medicine and may include nosebleeds, bleeding gums, vomiting or coughing up blood, blood in the urine, bloody or black tarry stools, genital bleeding, heavy menstrual bleeding, large bruises, or bleeding into joints causing tension, swelling, and pain. If this occurs, treatment with acenocumarol should be stopped and treatment to control bleeding should be started. Your heartbeat may become rapid, your blood pressure may drop causing dizziness, 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 specific treatment may be required.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested. Show the doctor any remaining medicines or the empty packaging.

If you forget to take Acenocumarol Aurovitas

If you forget a dose of this medicine, take it as soon as possible, unless it is almost time for your next dose; then resume your regular dosing schedule. DO NOT take a double dose to make up for a missed dose. Remember to inform your doctor at your next check-up about the number of doses you have missed.

If you stop taking Acenocumarol Aurovitas

If you have any questions about stopping treatment with acenocumarol, speak with your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Do not be alarmed by the list of possible side effects below. You may not experience any of them. However, if you do experience any of the following adverse effects, inform your doctor immediately:

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

• Unusual bleeding such as:

• bleeding from the gums when brushing teeth,

• unexplained bruising or nosebleeds,

• heavy or unexpected menstrual periods,

• unusual heavy bleeding or bleeding from cuts or wounds.

• Signs of internal bleeding such as:

• stomach or abdominal pain,

• back pain,

• blood in the urine,

• bloody or black, tarry stools,

• coughing up or vomiting blood,

• dizziness,

• sudden, severe or persistent headache, joint pain or stiffness,

• blurred vision.

Uncommon (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.

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

• Bruising with blisters on the skin with or without scarring, usually in areas such as:

• thighs,

• buttocks,

• abdomen, breast,

• or sometimes 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, acenocoumarol may cause serious skin disorders, including one called calciphylaxis, which may 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 may lead to the kidneys being unable to function properly (anticoagulant-related nephropathy).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acenocoumarol Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, the carton, or the blister pack after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acenocumarol Aurovitas 4 mg

• The active substance is acenocumarol.

Each tablet contains 4 mg of acenocumarol.

• The other components (excipients) are:

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

Appearance of the medicine and contents of the pack

Acenocumarol Aurovitas 4 mg tablets EFG:

White to off-white, uncoated, round, biconvex tablets, marked with “AR 4” on one side and quadrants on the other. The tablet can be divided into four equal parts.

Acenocumarol Aurovitas tablets are available in blister packs.

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

Only certain pack 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

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the European Economic Area member states under the following names:

Spain: Acenocumarol Aurovitas 4 mg tablets EFG

Portugal: Acenocumarol Generis

Date of the most recent review of this leaflet: July 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)