Aldocumar 10 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

ALDOCUMAR 10 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, consult 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 side 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) through competition 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 discontinuation of treatment.

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 outweighs the possible clinical benefit, for example: hemorrhagic diatheses 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 (for example, after lung or prostate surgery, etc.).
• If you are using high doses of NSAIDs, miconazole (systemic route and oral gel), phenylbutazone (systemic route), 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 impairment.
• If you have infectious diseases or disturbances of intestinal flora.
• If you have trauma that may result in internal bleeding.
• If you undergo surgery or trauma involving large exposed tissue surfaces.
• If you use catheters.
• 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 debilitated 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 medications—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 the use of an anticoagulant.
• Contact your doctor if you develop any illness, such as diarrhea, infection, or fever, or if you experience unusual bleeding.
• If treatment with ALDOCUMAR 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, interferon alpha and beta, itraconazole, metronidazole, tamoxifen, inactivated influenza virus vaccines, etacrynic acid, nalidixic acid, non-steroidal 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.

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 product 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 effects on fetal development 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, the use of 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 wish 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 reported.

Important information about some of the components of ALDOCUMAR

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take ALDOCUMAR

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

Follow your doctor's instructions carefully, as they 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 should be initiated with 2 to 5 mg of warfarin daily, with dose adjustments based on INR test results.

Maintenance:

Most patients are adequately 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 tablets than you should

Consult your doctor or pharmacist regarding the biological monitoring of an overdose without clinical consequences, as it may require 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 absence of bleeding: temporarily discontinue the anticoagulant and restart therapy with a lower dose, based on the INR value.
• In case of overdose with INR > 6 and absence of 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 the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take ALDOCUMAR

Do not take a double dose to make up for the missed dose.

The anticoagulant effect of ALDOCUMAR lasts for more than 24 hours. If you miss a dose, take the medication as soon as possible and continue treatment as prescribed. However, if the next scheduled dose is approaching, it is better not to take the missed dose and wait for the next scheduled dose.

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

4. Possible adverse effects

Like all medicines, ALDOCUMAR may cause 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.

Renal function impairment 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 through the Spanish Pharmacovigilance System for Human Medicines: https://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 original outer packaging to protect from light.

Expiry

Do not use ALDOCUMAR after the expiry date (EXP) stated on the package. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ALDOCUMAR 10 mg tablets

The active substance is warfarin sodium.

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

Appearance of the product and contents of the pack

ALDOCUMAR 10 mg is presented in a carton containing 2 blister packs with 20 tablets each, white, double-scored tablets.

Marketing Authorization Holder and Manufacturer

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - SPAIN

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

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