Aldocumar 3 mg tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALDOCUMAR 3 mg tablets

warfarin sodium

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What ALDOCUMAR is and what it is used for

ALDOCUMAR contains sodium warfarin as the active substance.

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 may persist for 4 to 5 days after treatment has been discontinued.

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 cardiac valve replacement. It is also indicated for reducing the risk of death from recurrent myocardial infarction, as well as from thromboembolic events such as stroke or systemic embolization.

2. What you need to know before starting ALDOCUMAR

Do not take ALDOCUMAR

• If you are allergic to sodium warfarin or to any of the excipients in the preparation.
• If you are pregnant.
• If you are unwilling to take the medication correctly.
• In pathological conditions where the risk of bleeding is greater than the possible clinical benefit, for example: hemorrhagic diathesis and/or hematological dyscrasia.
• In organic lesions prone to bleeding.
• After recent or planned surgical procedures on the central nervous system, ophthalmological surgeries, or traumatic interventions exposing large tissue surfaces.
• In gastroduodenal ulcer or evident bleeding in the gastrointestinal, urogenital, or respiratory tracts, cerebrovascular hemorrhages, pericarditis and pericardial effusions, subacute endocarditis.
• In severe hypertension; severe hepatic or renal parenchymal damage.
• In increased fibrinolytic activity (e.g., after lung or prostate surgery, etc.).
• If you are taking high doses of NSAIDs, miconazole (systemic and oral gel), phenylbutazone (systemic), high-dose acetylsalicylic acid, and by extrapolation, other salicylates at high doses.

Warnings and precautions
Consult your doctor or pharmacist before starting ALDOCUMAR:

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

ALDOCUMAR has been prescribed for the treatment of your current condition. Do not take this medicine for other conditions unless directed by your doctor.

• Regular monitoring of prothrombin time (INR) is essential. Numerous factors, alone or in combination—such as physical condition or concomitant medication—can alter the patient's response to anticoagulants. It is generally good practice to monitor the patient's response with additional INR measurements immediately after hospital discharge, and when starting, stopping, or irregularly taking other medications.
• It is necessary to strictly follow the dosing regimen prescribed by the physician.
• Avoid alcohol consumption.
• Do not take ALDOCUMAR during pregnancy.
• Avoid any activity or sport that may result in traumatic injury.
• Carry identification indicating that you are taking an anticoagulant.
• Contact your doctor if you develop any illness, such as diarrhea, infection, or fever, or if you experience unusual bleeding.
• If ALDOCUMAR therapy is interrupted, bear in mind that anticoagulant effects may persist for 2 to 5 days.

Taking ALDOCUMAR with other medicines

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

If you are taking any other medication (including those obtained without a prescription), consult your doctor.

• Medications and products that may increase the response to ALDOCUMAR: allopurinol, analgesics (dextropropoxyphene, tramadol), antiarrhythmics (amiodarone), antibacterials (ciprofloxacin, clarithromycin, erythromycin, norfloxacin, chloramphenicol), antiulcer agents (cimetidine, omeprazole, ranitidine), cisapride, disulfiram, statins (fluvastatin, lovastatin, simvastatin), fluconazole, fluorouracil, fluvoxamine, alpha and beta interferon, itraconazole, metronidazole, tamoxifen, inactivated influenza virus vaccines, ethacrynic 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 to ALDOCUMAR: 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 to ALDOCUMAR: alcohol, chloral hydrate, disopyramide.

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

Taking ALDOCUMAR with food and drinks

The consumption of alcoholic beverages should be avoided during treatment with ALDOCUMAR.

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

Use in children

There are insufficient clinical data to support the use of this preparation in children.

Pregnancy and breastfeeding

Pregnancy:

Oral anticoagulants derived from coumarin, such as warfarin, cross the placenta and their use during pregnancy is not recommended. Congenital malformations and other adverse developmental effects have been reported in children born to mothers who received this medication during the first trimester. Oral anticoagulants cross the placenta and pose a risk of fetal or placental hemorrhage when administered in the weeks preceding delivery. If anticoagulant therapy is essential, heparin is recommended, especially during the first trimester, as it does not cross the placenta.

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

Breastfeeding:

Warfarin is practically undetectable in breast milk; therefore, undesirable effects in the nursing infant are unlikely.

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

Driving and use of machines

Not described.

Important information about some of the components of ALDOCUMAR

This medicine 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 ALDOCUMAR

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

Before taking the medicine, check the expiration date.

ALDOCUMAR tablets must not be removed from their packaging until the time of administration.

The dosage and administration of ALDOCUMAR must be individualized for each patient according to the patient's individual response to the drug.

Carefully follow your doctor's instructions, which may differ from the information contained in this leaflet.

Your doctor will determine the duration of treatment with ALDOCUMAR; do not exceed the recommended treatment duration.

Dosage should be adjusted based on the INR value, which generally ranges between 2.0 and 3.5, depending on the clinical condition.

Recommended INR values according to different pathologies:

• Venous thromboembolism (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.

Your doctor will determine the frequency of INR monitoring.

Initial dosage:

In general, therapy is initiated with 2 to 5 mg of warfarin daily, with dose adjustments based on INR test results.

Maintenance:

Most patients are satisfactorily maintained on a daily dose of 2 to 10 mg. The individual dose and dosing interval should be adjusted according to the patient's response.

Duration of therapy:

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

If you take more ALDOCUMAR than you should

Consult your doctor or pharmacist regarding the biological monitoring following an overdose without clinical consequences, as it requires appropriate dose reduction and constant monitoring.

The following steps should be taken, depending on whether or not hemorrhagic complications are present:

• In case of overdose with INR < 6 and no bleeding: temporarily interrupt the anticoagulant and restart therapy with a lower dose, based on the INR value.
• In case of overdose with INR > 6 and no severe bleeding: administer 0.5 mg of injectable vitamin K1 by continuous infusion over 20 to 30 minutes. Increase the dose to 1 mg if INR ≥ 10.
• In case of overdose with severe bleeding: administer 10 to 20 mg of injectable vitamin K1 by slow continuous infusion over 1 hour, together with transfusion of fresh frozen plasma or whole blood, or a commercial Factor IX complex.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915620420, indicating the medication and the amount ingested.

If you forget to take ALDOCUMAR

The anticoagulant effect of ALDOCUMAR lasts more than 24 hours. If you forget to take your prescribed dose of ALDOCUMAR within the scheduled time, you should take the missed dose as soon as possible on the same day.

Do not take a double dose to make up for a missed dose; instead, consult 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, ALDOCUMAR may produce adverse effects, although not everyone experiences them.

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

Frequent (at least 1 in 100 patients)

Bleeding from any tissue or organ and other hemorrhagic complications, as a consequence of the anticoagulant effect. Signs and symptoms will vary depending on the location and severity or extent of the bleeding.

Uncommon (at least 1 in 1,000 patients)

Liver problems (hepatic), allergic reactions (hypersensitivity), alopecia, abdominal pain, nausea, vomiting, diarrhea, and fatigue.

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

Skin necrosis, dermatitis, and pruritus.

Frequency not known

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

Impaired renal function occurring with excessive anticoagulation and presence of blood in the urine (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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of ALDOCUMAR.

5. Storage of ALDOCUMAR

Keep ALDOCUMAR out of the sight and reach of children.

Store in the outer packaging to protect it from light.

Expiry

Do not use ALDOCUMAR after the expiry date stated on the bottle after Exp.: The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your usual pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of ALDOCUMAR 3 mg tablets

The active substance is warfarin sodium.

The other components (excipients) are: monohydrate lactose (61.63 mg/tablet), microcrystalline cellulose, sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate and the colouring agent Patent Blue V (E-131).

Appearance of the medicine and contents of the pack

ALDOCUMAR 3 mg is presented in a carton containing 2 blister packs with 20 tablets each, blue in colour, odourless, with a score line on one side and the symbol "3" on the other.

Marketing Authorisation Holder and Manufacturer

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - SPAIN

Date of the most recent review of this leaflet: November 2021.

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