Warfarin PMCS 2 mg, Warfarin PMCS 5 mg

Basic information

Composition

2.17 mg of warfarin sodium clathrate is equivalent to 2.00 mg of warfarin sodium in each tablet. 5.40 mg of warfarin sodium clathrate is equivalent to 5.00 mg of warfarin sodium in each tablet.

Pharmacotherapeutic group

Anticoagulants, antithrombotics, vitamin K antagonists (ATC code: B01AA03)

Therapeutic indications

Treatment and prevention of deep vein thrombosis and pulmonary embolism. Secondary prevention of myocardial infarction and prevention of thromboembolic complications (ictus or systemic embolism) following myocardial infarction. Prevention of thromboembolic complications (ictus or systemic embolism) in patients with atrial fibrillation, heart valve disease or heart valve replacement.

Treatment and prevention of transient ischemic attacks (TIA) and ictus.

Pharmacological properties

Warfarin is a dicumarol derivative antagonising the synthesis of vitamin K dependent coagulation factors (VII, IX, X, II). After oral administration, warfarin is well absorbed from the gastrointestinal tract, bioavailability is greater than 90%, biological half-life is around 36 hours. Warfarin has no direct effect on a formed thrombus, but it prevents its spread and secondarily prevents complications from thromboembolism.

Pharmaceutical form

Tablets

More information

Posology and method of administration

The target INR therapeutic range is 2.5–3.5 in prophylaxis of thromboembolic complications in patients with heart valve replacement. For other indications it is 2.0–3.0.

Hospitalised adult patients with normal weight and spontaneous INR values under 1.2 are administered 10 mg of warfarin for 3 successive days. Adult patients discharged from hospital and in patients with a hereditary C or S protein deficiency are recommended to take a starting dose of 5 mg of warfarin over 3 successive days. Dosage continues based on INR values measured on the 4th day according to the table provided in the SPC. In children the starting dose is 0.2 mg/kg PO if the baseline INR value is 1.0 to 1.3.

Contraindications

Administration of anticoagulant therapy. Hypersensitivity to the active substance or any of the excipients, pregnancy, bleeding (Von Willebrand disease, haemophilia, thrombocytopaenia), serious hepatic insufficiency or cirrhosis of the liver, untreated or uncontrolled hypertension, recent intracranial bleeding, predisposition to intracranial bleeding (such as cerebral artery aneurysm), tendency to frequent collapses due to neurological or other medical conditions, CNS or eye surgery, predisposition to bleeding in the GIT or bleeding in the urinary tract (such as earlier complications in the form of gastrointestinal bleeding, diverticulosis or malignancies), infective endocarditis or bleeding into the pericardium, dementia, psychosis, alcoholism and other situations in which satisfactory adherence to treatment is impossible.

Interactions

The effect of warfarin is potentiated by acetylsalicylic acid, allopurinol, amiodarone, propafenone, quinidine, digoxin, amoxicillin, azithromycin, clarithromycin, erythromycin, doxycycline, tetracycline, cefuroxime, norfloxacin, ciprofloxacin, ofloxacin, anabolic steroids, chloral hydrate, omeprazole, paracetamol, tramadol, disulfiram, indomethacin, piroxicam, phenylbutazone, methotrexate, valproic acid, quinine, metronidazole, sulfamethoxazole-trimethoprim, (dextro)thyroxine, ketoconazole, itraconazole, fluconazole, clofibrate, fenofibrate, simvastatin, lovastatin, fluvastatin, flu vaccines, interferon-alpha and -beta, trastuzumab, tamoxifen, ginkgo, garlic, angelica sinensis, papaya, sage. The effect of warfarin is reduced by azathioprine, barbiturates, carbamazepine, chlordiazepoxide, chlorthalidone, cloxacillin, cyclosporin, dicloxacillin, disopyramide, griseofulvin, mercaptopurine, mesalazine, mitotane, nafcillin, nevirapine, phenobarbital, primidone, rifampicin, spironolactone, trazodone, vitamin C, St. John’s wort, ginseng, foods rich in vitamin K.

Undesirable effects

Bleeding, nausea, vomiting, diarrhoea, coumarin necrosis, purple toes syndrome, reversible alopecia, urticaria, reversible increase in liver enzyme levels, cholestatic hepatitis, allergic reactions.

Special warnings and precautions for use

Caution is required in patients with renal or hepatic insufficiency. Hyperthyroidism, fever and uncompensated cardiac insufficiency may potentiate the effect of warfarin. The product contains lactose.

For more detailed product information, see the Summary of Product Characteristics

Availability

The product can only be obtained with a prescription. The package of 5 mg tablets is fully covered, and 2 mg tablets is partly covered by health insurance.

Contents of container

50 or 100 tablets of 2 mg and 5 mg each

Package available in the Czech Republic

100 tablets of 2 mg and 5 mg each

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

3 March 2021

Product images