Aldocumar 5 mg tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALDOCUMAR 5 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side 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 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) 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 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 to take ALDOCUMAR

Do not take ALDOCUMAR

• If you are allergic to sodium warfarin or to any of the excipients of the preparation.
• If you are pregnant.
• If you are unwilling to take the medication properly.
• In pathological conditions where the risk of bleeding is greater than the potential 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 the presence of gastroduodenal ulcer or evident bleeding in the gastrointestinal, urogenital, or respiratory tracts, cerebrovascular hemorrhage, pericarditis and pericardial effusions, or 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, systemic or oral gel miconazole, systemic phenylbutazone, high doses of acetylsalicylic acid, and by extrapolation, other salicylates at high doses.

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 disturbances of intestinal flora.
• If you have sustained trauma that could result in internal bleeding.
• If you undergo 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 or elderly patient.

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

• Periodic determination 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 during the period immediately following hospital discharge, and whenever other medications are started, stopped, or taken irregularly.
• It is necessary to strictly follow the dosing regimen prescribed by your doctor.
• Avoid alcohol consumption.
• Do not take ALDOCUMAR during pregnancy.
• Avoid any activity or sport that could 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 treatment with ALDOCUMAR is discontinued, keep 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, ethacrynic 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.

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 offal, 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 treated with these medications during the first trimester. Oral anticoagulants cross the placenta with 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 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 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 should be maintained within an INR range of 2.0 to 3.5, depending on the clinical condition.

Recommended INR values according to different conditions:

• 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 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 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 than you should

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

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

• In case of overdose with INR < 6 and in the absence of bleeding: temporarily interrupt the anticoagulant and restart therapy with a lower dose, based on the INR.
• In case of overdose with INR > 6 and in the absence of severe bleeding: administer 0.5 mg of injectable vitamin K1 as a continuous infusion over 20 to 30 minutes. Increase the dose to 1 mg if the INR ≥ 10.
• In case of overdose with severe bleeding: administer 10 to 20 mg of injectable vitamin K1 as a 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 Poison Information Service at telephone number 915620420, indicating the medicine 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 the prescribed dose of ALDOCUMAR at 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 haemorrhagic 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 1000 patients)

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

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

Skin necrosis, dermatitis, and pruritus.

Frequency not known

A painful skin rash. Occasionally, warfarin may cause serious 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 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://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 original outer packaging to protect from light.

Expiry

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your usual pharmacy. If you have any doubts, ask your pharmacist how to 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 ALDOCUMAR 5 mg tablets

The active substance is sodium warfarin.

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

Appearance of the product and contents of the pack

ALDOCUMAR 5 mg comes in a carton containing 2 blister packs with 20 tablets each, yellow in colour, odourless, with a score line on one side and the symbol "5" on the other side.

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/