Package Leaflet: Information for the User

ALDOCUMAR 10 mg tablets

warfarin sodium

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

• Keep this leaflet, as 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isALDOCUMARand what it is used for

2. What you need to know before you start takingALDOCUMAR

3. How to takeALDOCUMAR

4. Possible side effects

5. Storage ofALDOCUMAR

6. Contents of the pack and additional information

ALDOCUMARcontains sodium warfarin as the active ingredient.

Warfarin is an oral anticoagulant that acts by inhibiting the hepatic synthesis of the active forms of coagulation factors (II, VII, IX, X) by competing with vitamin K. When administered orally, warfarin induces hypoprothrombinemia within 36 to 72 hours. The anticoagulant effect can persist for 4 to 5 days after treatment is completed.

It is used for the prophylaxis and/or treatment of venous thrombosis, and pulmonary embolism. Prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation and/or heart valve replacement. It is also indicated for the reduction of the risk of recurrent myocardial infarction death as well as episodes of thromboembolism such as stroke or systemic embolization.

Do not take ALDOCUMAR

• If you are allergic to sodium warfarin or any of the excipients of the preparation.
• If you are pregnant.
• If you are not willing to take the medication correctly.
• In pathological states where the risk of bleeding is greater than the possible clinical benefit, for example: coagulopathy and/or hematological disorders.
• In organic injuries susceptible to bleeding.
• In recent or planned central nervous system surgeries, eye surgeries, and traumatic interventions that expose large areas of tissue.
• In gastric or duodenal ulcers or manifest bleeding in the gastrointestinal, urogenital, or respiratory tracts, cerebral vascular hemorrhages, pericarditis, and pericardial effusions, endocarditis.
• In severe hypertension; severe liver and kidney parenchymal injuries.
• In increased fibrinolytic activity (for example, after lung, prostate, etc. surgeries).
• If you are taking high doses of NSAIDs, miconazole (oral and buccal gel), phenylbutazone (oral), high doses of acetylsalicylic acid, and by extrapolation, other high-dose salicylates.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ALDOCUMAR:

• If you have moderate to severe renal or hepatic insufficiency.
• If you have infectious diseases or intestinal flora alterations.
• If you have trauma that may result in internal bleeding.
• If you have surgery or trauma of exposed large surfaces.
• If you are using catheters.
• If you have moderate to severe hypertension.
• If you have a known or suspected deficiency in protein C-mediated anticoagulant response, which may cause tissue necrosis.
• If you are a debilitated or elderly patient.

ALDOCUMARhas been prescribed for your current illness. Do not take this medication for other conditions without consulting your doctor.

Taking ALDOCUMAR with other medications

Whenever a concomitant treatment withALDOCUMARis initiated or discontinued, repeated INR determinations should be performed until a stable value is obtained.

Consult your doctor before taking any other medication (including those acquired without a prescription).

• Medications and products that may increase the response toALDOCUMAR: allopurinol, analgesics (dextropropoxyphene, tramadol), antiarrhythmics (amiodarone), antibiotics (ciprofloxacin, clarithromycin, erythromycin, norfloxacin, chloramphenicol), antiulcer medications (cimetidine, omeprazole, ranitidine), cisapride, disulfiram, statins (fluvastatin, lovastatin, simvastatin), fluconazole, fluorouracil, fluvoxamine, interferon alpha and beta, itraconazole, metronidazole, tamoxifen, inactivated influenza viruses, etacrynic acid, nalidixic acid, nonsteroidal anti-inflammatory drugs (diclofenac, phenylbutazone, ibuprofen, ketoprofen, mefenamic acid, sulindac), miconazole, carnitine, thyroid hormones, neomycin, paracetamol, quinidine, vitamin E, cephalosporins (cefamandole), clofibrate, stanozolol, piracetam, propranolol, salicylates (acetylsalicylic acid, diflunisal), tetracyclines, ticlopidine, clindamycin.
• Medications and products that may decrease the response toALDOCUMAR: aminoglutethimide, carbamazepine, phenazone, griseofulvin, barbiturates, rifampicin, estrogen-based contraceptives, cholestyramine, corticosteroids, diuretics, mercaptopurine, vitamin K, sucralfate, ginseng, ascorbic acid.

• Other medications and products that may increase or decrease the response toALDOCUMAR: alcohol, chloral hydrate, disopyramide.

Taking ALDOCUMAR with food and beverages

Alcohol consumption should be avoided during ALDOCUMAR treatment.

Foods rich in vitamin K (cereals, broccoli, cabbage, carrots, chicken giblets, etc.) may influence the effect of ALDOCUMAR.

Use in children

There are no sufficient clinical data to support the use of the preparation in children.

Pregnancy and lactation

Pregnancy:

Oral anticoagulants derived from coumarin, such as warfarin, cross the placenta and are not recommended during pregnancy. Congenital malformations and other adverse effects in fetal development have been described in children born to mothers taking this medication during the first trimester. Oral anticoagulants cross the placenta with a risk of fetal or placental hemorrhage when administered weeks before delivery. In cases of essential anticoagulant therapy, the use of heparin, especially during the first trimester, is recommended, as it does not cross the placenta.

Inform your doctor as soon as you suspect you may be pregnant or if you wish to become pregnant. Consult your doctor or pharmacist before taking a medication.

Lactation:

Warfarin is practically undetectable in breast milk, so adverse effects in the infant are not to be feared.

Inform your doctor if you are breastfeeding. Consult your doctor or pharmacist before taking a medication.

Driving and operating machines

Not described.

Important information about some components of ALDOCUMAR

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

The dosing and administration ofALDOCUMARmust be individualized for each patient according to the patient's particular response to the drug.

Follow the doctor's instructions carefully, which may differ from the information contained in this prospectus.

Your doctor will inform you of the duration of treatment withALDOCUMAR; do not exceed the recommended treatment duration.

The dosage should be adjusted based on the INR value, which is generally between INR values of 2.0 and 3.5, depending on the clinical case.

Recommended INR values for different pathologies:

• Deep vein thrombosis (including pulmonary embolism): INR of 2.0-3.0

• Atrial fibrillation: INR of 2.0-3.0

• Post-myocardial infarction treatment: INR of 2.5-3.5

• Mechanical and bioprosthetic heart valves: INR of 2.5-3.5.

• Recurrent systemic embolism: In cases where the risk of thromboembolism is high, a higher INR may be necessary, but not exceeding 4.0.

The doctor will determine the INR review periods.

Initial dosing:

Generally, it is recommended to start therapy with2 to5 mg of warfarin per day, making dose adjustments based on INR test results.

Maintenance:

Most patients are satisfactorily maintained with a dose of2 to10 mg per day. The individual dose and interval should be adjusted according to the patient's response.

Treatment duration:

The treatment duration for each patient should be individualized. In general, anticoagulant therapy should continue until the risk of thrombosis and embolism has passed.

If you take more ALDOCUMAR tablets than you should

Consult your doctor or pharmacist for follow-up on a non-clinically significant overdose, as you need an adequate dose reduction and constant monitoring.

The following steps should be taken, with or without hemorrhagic complications:

• In case of overdose with INR <6
• In case of overdose with INR > 6 and in the absence of severe bleeding: administer 0.5 mg of vitamin K1injectable in continuous infusion of20 to30 minutes. Increase the dosage to 1 mg if the INR?10.
• In case of overdose with severe bleeding: administer10 to20 mg of vitamin K1injectable in slow continuous infusion of 1 hour, along with a transfusion of fresh frozen plasma or whole blood or a commercial Factor IX complex.

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

If you forgot to take ALDOCUMAR

Do not take a double dose to compensate for the missed dose.

The anticoagulant effect ofALDOCUMARpersists for more than 24 hours. In case of a missed dose, you should take the medication as soon as possible and continue treatment as prescribed. However, when the next administration is near, it is better not to take the missed dose and wait for the next administration.

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

Like all medications,ALDOCUMARmay cause adverse effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of these adverse effects. The reported adverse reactions are:

Frequent (in at least 1 in 100 patients)

Bleeding from any tissue or organ and other hemorrhagic complications, as a consequence of the anticoagulant effect. The signs and symptoms will vary according to the location and degree or extent of the bleeding.

Rare (in at least 1 in 1,000 patients)

Liver problems (hepatitis), allergic reactions (hypersensitivity), hair loss, abdominal pain, nausea, vomiting, diarrhea, and fatigue.

Very Rare (less than 1 in 10,000 patients)

Skin necrosis, dermatitis, and itching.

Unknown Frequency

A painful skin rash. In sporadic cases, warfarin may cause severe skin problems, such as calciphylaxis, which may start with a painful skin rash but can lead to other serious complications. This adverse reaction occurs more frequently in patients with chronic kidney disease.

Renal function alteration caused by excessive anticoagulation and presence of blood in the urine (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 not listed in this prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use.https://notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of ALDOCUMAR.

KeepALDOCUMARout of sight and reach of children.

Store in the outer packaging to protect it from light.

Expiration Date

Do not useALDOCUMARafter the expiration date (CAD) indicated on the packaging. The expiration date is the last day of the month indicated.

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

Composition ofALDOCUMAR 10 mg tablets

The active ingredient iswarfarina sódica.

The other components (excipients) are: lactose monohydrate (151.87 mg/tablet),microcrystalline cellulose, carboxymethyl sodium starch, colloidal silicon dioxide, magnesium stearate.

Appearance of the product and contents of the packaging

ALDOCUMAR 10 mgis presented in a box containing 2 blister packs with 20 tablets each, white, with double scoring.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - SPAIN

Date of the last review of this leaflet:November 2021.

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