ACENOCOUMAROL WZF

Package leaflet: Information for the patient

ACENOCUMAROL WZF, 4 mg, tablets
Acenocoumarolum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Acenocumarol WZF is and what it is used for
2. Important information before taking Acenocumarol WZF
3. How to take Acenocumarol WZF
4. Possible side effects
5. How to store Acenocumarol WZF
6. Contents of the pack and other information

1. What Acenocumarol WZF is and what it is used for

Acenocumarol WZF belongs to a group of medicines called anticoagulants. It reduces the blood's ability to clot, thus preventing the formation of blood clots in blood vessels.
Acenocumarol WZF is used for the prevention and treatment of thromboembolic complications.

2. Important information before using Acenocumarol WZF

When not to use Acenocumarol WZF

• if the patient is allergic to acenocoumarol or other "blood-thinning" drugs, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant (see also section "Pregnancy and breastfeeding");
• if the patient is unable to follow the doctor's instructions regarding taking the medicine (e.g. patients with alcoholism, psychiatric disorders, or elderly patients without supervision or care);
• if the patient has a congenital or acquired bleeding tendency, e.g. haemophilia;
• if the patient has recently undergone surgery or if surgery is planned in the near future (including spine, brain or eye surgery);
• if the patient has gastric ulcers or gastrointestinal bleeding (symptoms: bloody or black tarry stools);
• if the patient has recently had a haemorrhagic stroke (bleeding stroke);
• if there is blood in the urine or sputum;
• if the patient has been diagnosed with pericarditis (inflammation of the outer membrane surrounding the heart) or endocarditis (inflammation of the inner lining of the heart) causing chest pain;
• if the patient has very high blood pressure;
• if the patient has severe liver or kidney dysfunction (severe liver or kidney failure);
• if the patient has blood coagulation disorders or unexplained bleeding, e.g. from gums or bruising.

Warnings and precautions
Before starting treatment with Acenocumarol WZF, discuss the following with your doctor:

• if the patient has cancer;
• if the patient has an infection or inflammation (pain, swelling);
• if the patient has heart failure;
• if the patient has kidney or liver dysfunction;
• if the patient has hyperthyroidism;
• if the patient has blood disorders (called protein C or S deficiency) – this may lead to prolonged bleeding after cuts or injury.

While taking acenocoumarol, the patient should not receive intramuscular injections, as this may lead to haematoma formation.
The patient should always inform the doctor (regardless of specialty) that they are taking acenocoumarol, especially if surgery (including spine, brain or eye surgery) or a dental procedure is planned.
Patients aged 65 years and older may be more sensitive to acenocoumarol; therefore, the doctor may recommend more frequent monitoring and lower doses.
If the patient has an accident or injury while taking acenocoumarol, bleeding may be more severe than usual. It is therefore essential to inform the doctor or medical personnel about the use of this medicine. It is recommended that the patient carries easily accessible information indicating that they are taking acenocoumarol.

Acenocumarol WZF and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Acenocumarol WZF may affect the action of other medicines and vice versa. Do not take any other medicines while using acenocoumarol without first consulting your doctor.
It is essential to inform your doctor about all medicines taken, especially those listed below.

Medicines that may increase the effect of Acenocumarol WZF:

• allopurinol – used to treat gout and to lower uric acid levels;
• testosterone and mesterolone (androgens), anabolic steroids used in replacement therapy to balance hormone levels;
• amiodarone and quinidine – used for irregular heartbeat;
• amoxicillin, erythromycin, clarithromycin, ciprofloxacin, norfloxacin, ofloxacin, tetracyclines, neomycin, chloramphenicol, metronidazole – used to treat infections;
• fenofibrate, simvastatin, atorvastatin, fluvastatin and other statins – used to lower cholesterol levels;
• disulfiram – used in the treatment of alcoholism;
• glucagon – used to treat low blood sugar;
• glucosamine – used for osteoarthritis;
• ranitidine, cimetidine – used to treat stomach or duodenal ulcers;
• co-trimoxazole (sulfamethoxazole and trimethoprim) and other sulfonamide drugs;
• topical miconazole – an antifungal medicine;
• paracetamol – a painkiller and antipyretic;
• glibenclamide and other oral antidiabetic drugs;
• levothyroxine and other thyroid hormones;
• fluoxetine, paroxetine, citalopram – used to treat anxiety and depression;
• tamoxifen – used in the treatment of breast cancer and fertility;
• tramadol – a strong painkiller;
• 5-fluorouracil and its derivatives – used in the treatment of breast, gastrointestinal and skin cancers;
• tolbutamide and chlorpropamide (sulfonylurea derivatives) – used in diabetes;
• ethacrynic acid – a diuretic used for oedema;
• prednisolone, methylprednisolone (corticosteroids) – used to treat inflammatory conditions of the intestine, joints, skin – these may increase or decrease the anticoagulant effect of the medicine.

Medicines affecting haemostasis may increase the anticoagulant effect of Acenocumarol WZF and increase the risk of bleeding:

• heparin – used to "thin the blood" in the treatment of deep vein thrombosis, blood clots, and after surgery;
• dipyridamole, clopidogrel (antiplatelet drugs) – used to prevent clot formation;
• salicylic acid and its derivatives, acetylsalicylic acid, para-aminosalicylic acid, diflunisal, phenylbutazone, sulfinpyrazone and other non-steroidal anti-inflammatory drugs (NSAIDs);
• high-dose methylprednisolone injections.

Medicines that may reduce the effect of Acenocumarol WZF:

• aminoglutethimide – used to treat cancer or Cushing's syndrome;
• azathioprine, 6-mercaptopurine – anticancer drugs;
• phenobarbital (a barbiturate) – used to treat epilepsy or as a sedative;
• carbamazepine, phenytoin – used to treat epilepsy;
• cholestyramine;
• griseofulvin – an antifungal medicine;
• oral contraceptives;
• rifampicin;
• hydrochlorothiazide and other thiazide-type diuretics;
• semaglutide – a medicine used to lower blood sugar;
• herbal products containing St. John's wort extract (Hypericum perforatum);
• ritonavir, indinavir and nelfinavir and other protease inhibitors – used in the treatment of HIV.

Acenocumarol WZF with food, drink and alcohol
Individual sensitivity to acenocoumarol varies and may change if the patient alters their diet, especially if they include foods rich in vitamin K (e.g. spinach, cabbage, cauliflower, turnip, broccoli, Brussels sprouts). Consumption of cruciferous vegetables and other vitamin K-rich foods should be limited to ensure effective treatment with acenocoumarol.
While taking acenocoumarol, cranberry juice and products containing concentrated cranberry juice should not be consumed, as they may enhance the effect of the medicine and lead to bleeding.
Patients taking Acenocumarol WZF, especially those with liver dysfunction, should limit alcohol consumption. Alcohol may alter the way acenocoumarol works.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
This medicine is absolutely contraindicated during pregnancy!
Acenocoumarol may cause severe fetal damage; therefore, inform the doctor if pregnant or planning pregnancy. For women of childbearing age, a pregnancy test is recommended before starting treatment, and effective contraception should be used during treatment. The doctor should discuss the potential risks and benefits of treatment with the patient.
If breastfeeding, consult a doctor. Both mother and child require special medical monitoring, and the child should receive prophylactic vitamin K.

Driving and operating machinery
Acenocumarol WZF does not affect the ability to drive or operate machinery. However, in case of an accident, medical personnel must be informed about acenocoumarol use. Due to the potential risk of injury, e.g. in an accident, it is recommended to carry information about taking Acenocumarol WZF.

Acenocumarol WZF contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Acenocumarol WZF

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.

• The dosage of this medicine is individually determined by the doctor for each patient. Regular blood clotting tests allow the doctor to adjust the dose of Acenocumarol WZF appropriately.
• The dose prescribed by your doctor should be taken orally, regularly at the same time each day (e.g. in the evening with a meal, accompanied by a glass of water).
• Do not exceed the dose prescribed by your doctor.
• While taking this medicine, consumption of certain foods should be limited – see section "Acenocumarol WZF with food, drink and alcohol".
• Acenocumarol WZF 4 mg tablets may be divided into 4 equal doses, each containing 1 mg of acenocoumarol. To divide the tablet, place it on a hard surface and press with your fingers on both edges, on either side of the break line (see figure below).

Dosage
Adults
The usual dose is 2 mg to 4 mg on the first day of treatment, followed by maintenance doses of 1 mg to 8 mg.
Use in children
A doctor will decide whether this medicine should be used in children.
Taking more Acenocumarol WZF than prescribed
Overdose of Acenocumarol WZF may lead to bleeding. In such a case, stop taking the medicine immediately and contact your doctor or go to the nearest hospital without delay.
If you forget to take Acenocumarol WZF
If you miss a dose at the usual time, take it as soon as possible. However, if the next dose is due soon, do not take the missed dose; instead, take the next dose at the usual time. Do not take a double dose.
At your next visit to the doctor, inform them about any missed doses.
Stopping Acenocumarol WZF
Do not stop taking this medicine suddenly. Do not change the dose on your own initiative.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately contact your doctor if any of the following signs of bleeding occur,
as they may indicate that the patient has received more medicine than needed. These symptoms occur frequently (in no more than 1 in 10 people).
These include bleeding of varying severity, such as:

• unexplained nosebleeds or bleeding gums;
• unexplained bruising;
• heavy bleeding or oozing from cuts or wounds;
• heavy menstrual bleeding;
• unexpected bleeding from the urinary or genital tract;
• blood in the urine;
• bloody or black, tarry stools;
• coughing up blood or vomiting blood;
• bleeding into the skin;
• bleeding into the brain;
• bleeding into the eyes.

You should contact your doctor as soon as possible if any of the following symptoms occur. These symptoms occur very rarely (in no more than 1 in 10,000 people).
These include:

• yellowing of the eyes or skin (which may be signs of liver damage);
• red spots progressing to lumpy skin lesions and subsequently to blisters with hemorrhagic discoloration (symptoms suggesting possible development of hemorrhagic skin necrosis);
• vasculitis (blood vessel inflammation) (hemorrhagic discoloration or subcutaneous hematomas may indicate possible vasculitis).

You should inform your doctor if any of the following symptoms occur. These symptoms occur rarely (in no more than 1 in 1,000 people).
These include:

• urticaria, rash (symptoms of allergic reactions);
• loss of appetite, nausea, vomiting;
• hair loss.

If the patient experiences any of the following adverse reactions, you should inform the doctor immediately. Frequency unknown (frequency cannot be determined from available data).
These include:

• painful skin rash. Acenocumarol WZF may cause severe skin disorders, including so-called calciphylaxis, which may initially present as painful skin rash but may lead to other serious complications. This adverse reaction occurs more frequently in patients with chronic kidney disease.
• bleeding in the kidneys, sometimes with blood in the urine, leading to impaired normal kidney function (anticoagulant-related nephropathy).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Acenocumarol WZF

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
The marking on the packaging: EXP indicates the expiry date, and Lot indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Acenocumarol WZF contains

• The active substance is acenocoumarol. Each tablet contains 4 mg of acenocoumarol.
• The other ingredients are: monohydrate lactose, potato starch, copovidone, sodium lauryl sulfate, stearic acid.

What Acenocumarol WZF looks like and contents of the pack
Acenocumarol WZF 4 mg tablets are white, clover-shaped, biconvex tablets with a division line on both sides, dividing the tablet into 4 equal doses.
The medicine is available in a polyethylene container containing 60 tablets, packed in a cardboard box.
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplinska Street 19, 83-200 Starogard Gdanski
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Production Plant in Nowa Dęba
Metalowca Street 2, 39-460 Nowa Dęba