PATIENT INFORMATION LEAFLET

ALDOCUMAR 5 mg tablets

Warfarin sodium

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult 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 starting to takeALDOCUMAR

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 has ended.

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 death from recurrent myocardial infarction as well as episodes of thromboembolism such as stroke or systemic embolization.

Do not takeALDOCUMAR

• 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, ophthalmological operations, 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 damage.
• In increased fibrinolytic activity (for example, after lung, prostate, etc. operations).
• If you are taking high doses of NSAIDs, miconazole (oral and topical), phenylbutazone (oral), high doses of acetylsalicylic acid, and by extrapolation, other salicylates at high doses.

Warnings and precautionsConsult 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 alterations of the intestinal flora.
• 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 your doctor's indication.

Taking ALDOCUMAR with other medications

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

Inform your doctor or pharmacist if you are taking or have recently taken 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), antiulcerants (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.

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those acquired without a prescription.

Taking ALDOCUMAR with food and beverages

Alcohol consumption should be avoided during treatment with ALDOCUMAR.

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 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 machinery

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.

Follow exactly the administration instructions forALDOCUMARprescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

Before taking the medication, check the expiration date.

TheALDOCUMARtablets should not be removed from their packaging until the time of administration.

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

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

Your doctor will indicate 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 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

• Cardiac mechanical and bioprosthetic valves: INR of 2.5-3.5.

• 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 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. Generally, anticoagulant therapy should continue until the risk of thrombosis and embolism has passed.

If you take more ALDOCUMAR 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, depending on whether there are or are not severe bleeding 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 recent frozen plasma transfusion or whole blood or a commercial Factor IX complex.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 915620420 indicating the medication and the amount ingested.

If you forgot to take ALDOCUMAR

The anticoagulant effect ofALDOCUMARpersists for more than 24 hours. If you forgot to take the prescribed dose ofALDOCUMARat the designated time, you should take the dose as soon as possible on the same day.

Do not take a double dose to compensate for the missed doses, but rather consult your doctor.

If you have any other doubts about the use of this medication, 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 bleeding complications, as a result 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://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of ALDOCUMAR.

Keep ALDOCUMAR out of sight and reach of children.

Store in the outer packaging to protect it from light.

Expiration Date

Do not useALDOCUMARafter the expiration date that appears on the bottle after Cad:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at your local SIGRE collection point at your usual pharmacy. If in doubt, please ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of ALDOCUMAR 5 mg tablets

The active ingredient is warfarin sodium.

The other components (excipients) are: lactose monohydrate (59.50 mg/tablet), microcrystalline cellulose, carboxymethyl sodium starch, colloidal silicon dioxide, magnesium stearate, and yellow quinoline colorant (E-104).

Appearance of the product and contents of the packaging

ALDOCUMAR 5 mgis presented in a box containing 2 blister packs with 20 tablets each, yellow in color, odorless, with a groove on one face and the anagram 5 on the other face.

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/