ALDOCUMAR 5 mg TABLETS

1. What is ALDOCUMAR and what is it used for

ALDOCUMARcontains warfarin sodium 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 or 5 days after treatment is stopped.

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 you take ALDOCUMAR

Do not takeALDOCUMAR

• If you are allergic to warfarin sodium or any of the excipients of the preparation.
• If you are pregnant.
• If you are not willing to take the medication correctly.
• In pathological conditions where the risk of bleeding is greater than the possible clinical benefit, such as hemorrhagic diathesis and/or blood dyscrasia.
• In organic injuries that may bleed.
• In recent or planned surgical interventions in the central nervous system, ophthalmological operations, and traumatic interventions that expose large tissue surfaces.
• In gastroduodenal ulcer or manifest bleeding in the gastrointestinal, urogenital, or respiratory tracts, cerebrovascular bleeding, pericarditis, and pericardial effusions, slow endocarditis.
• In severe hypertension; severe liver and kidney parenchymal damage.
• In increased fibrinolytic activity (e.g., after lung, prostate, etc. operations).
• If you are using high doses of NSAIDs, miconazole (general and oral gel), phenylbutazone (general), 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 with large exposed 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 cause tissue necrosis.
• If you are a weakened or elderly patient.

ALDOCUMARhas been prescribed for you for the treatment of your current condition. Do not take this medication for other conditions without your doctor's indication.

• Periodic determination of prothrombin time (INR) is essential. Numerous factors, alone or in combination, physical condition, or concomitant medication may modify the patient's response to anticoagulants. It is generally good practice to monitor the patient's response with additional INR determinations in the immediate period after hospital discharge and when other medications are started, interrupted, or taken irregularly.
• It is necessary to follow the dosing schedule proposed by the doctor exactly.
• Avoid consuming alcohol.
• Do not take ALDOCUMARduring pregnancy.
• Avoid any activity or sport that may result in traumatic damage.
• Carry identification indicating the use of an anticoagulant.
• Contact your doctor if any disease appears, such as diarrhea, infection, or fever, or if an unusual bleeding occurs.
• If therapy with ALDOCUMARis interrupted, it should be taken into account that the anticoagulant effects may persist for 2 to 5 days.

Taking ALDOCUMAR with other medicines

Whenever concomitant treatment with ALDOCUMARis started or stopped, repeated prothrombin time determinations should be performed until a stable value is obtained.

If you are going to take any other medication (even those purchased without a prescription), consult your doctor.

• Medicines 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, etacrynic acid, nalidixic acid, non-steroidal anti-inflammatory agents (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.

• Medicines 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 medicines and products that may increase or decrease the response to ALDOCUMAR: alcohol, chloral hydrate, disopyramide.

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those bought without a prescription.

Taking ALDOCUMAR with food and drinks

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 not enough clinical data to support the use of the preparation in children.

Pregnancy and breastfeeding

Pregnancy:

Oral anticoagulants derived from coumarin, such as warfarin, cross the placenta and are not recommended for use during pregnancy. Congenital malformations and other adverse effects on 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 bleeding when administered weeks before delivery. In cases where anticoagulant therapy is essential, the use of heparin is recommended, especially during the first trimester, as it does not cross the placenta.

Tell 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 medicine.

Breastfeeding:

Warfarin is not detected in breast milk, so no adverse effects are expected in the breastfed infant.

Tell your doctor if you are breastfeeding. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Not described.

Important information about some of the ingredients of ALDOCUMAR

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take ALDOCUMAR

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

Before taking the medicine, check the expiration date.

The ALDOCUMARtablets should not be removed from their packaging until the moment of administration.

The dosage and administration of ALDOCUMARmust 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 leaflet.

Your doctor will indicate the duration of treatment with ALDOCUMAR; 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 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.

The doctor will determine the INR review periods.

Initial dosage:

Generally, it is recommended to start therapy with 2 to 5 mg of warfarin per day, making dose adjustments based on the results of INR determinations.

Maintenance:

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

Duration of therapy:

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

If you take more ALDOCUMAR than you should

Consult your doctor or pharmacist for biological follow-up of an overdose without clinical repercussions, as it requires adequate dose reduction and constant monitoring.

The steps to follow are as follows, depending on whether or not there are hemorrhagic complications:

• In case of overdose with INR <6 and in the absence of bleeding: temporarily interrupt anticoagulant restart therapy with a lower dose, based on inr.< li>
• In case of overdose with INR > 6 and in the absence of severe bleeding: administer 0.5 mg of vitamin K1 by injection in continuous perfusion for 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 vitamin K1 by injection in slow continuous perfusion for 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 your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 915620420 indicating the medication and the amount ingested.

If you forget to take ALDOCUMAR

The anticoagulant effect of ALDOCUMARpersists for more than 24 hours. If you forgot to take the prescribed dose of ALDOCUMARat the determined time, you should take the dose as soon as possible on the same day.

Do not take a double dose to make up for forgotten doses, but consult your doctor.

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

4. Possible side effects

Like all medicines, ALDOCUMARcan cause side effects, although not everybody gets them.

Inform your doctor immediately if you experience any of these side effects. The adverse reactions that have been reported 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. The signs and symptoms will vary according to the location and degree or extent of the bleeding.

Uncommon (at least 1 in 1,000 patients)

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

Rare (less than 1 in 10,000 patients)

Skin necrosis, dermatitis, and pruritus.

Frequency not known

A painful skin rash. In sporadic cases, warfarin can cause serious skin problems, such as calciphylaxis, which can 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.

Alteration of renal function that occurs with excessive anticoagulation and presence of blood in the urine (anticoagulant-related nephropathy).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use. https://www.notificaram.es. By reporting side 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 date

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines 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 warfarin sodium.

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

Appearance of the product and packaging content

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

Marketing authorization holder and manufacturer:

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - SPAIN

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

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/