Varfin

Package Leaflet: Information for the User

Warfin, 3 mg, tablets

Warfin, 5 mg, tablets

Warfarin sodium

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Warfin and what is it used for

Warfin in tablet form is a medicine used to prevent blood clots (thrombosis) or to treat thrombosis or its complications. Warfin reduces the tendency to form blood clots. Your doctor will inform you about the treatment or prevention of which diseases this medicine is used for. The medicine is most often used to: prevent and treat deep vein thrombosis of the lower limbs (blood clots in the veins of the lower limbs) and pulmonary embolism (blood clots in the blood vessels of the lungs) prevent the formation of blood clots in patients with atrial fibrillation (heart rhythm disorder) prevent the formation or recurrence of blood clots after a heart attack prevent the formation of blood clots after heart valve replacement.

2. Important information before taking Warfin

When not to take Warfin

if the patient is in the first trimester or in the last four weeks of pregnancy if the patient has a tendency to bleed (hemophilia, von Willebrand disease, thrombocytopenia or platelet function disorders) if there is acute liver failure or liver cirrhosis if there is uncontrolled high blood pressure if the patient has recently had a bleeding stroke if the patient has a tendency to frequent falls due to a neurological condition or other health change if the patient has recently undergone surgical procedures in the central nervous system or eye, or if the patient is going to undergo such procedures in the near future

• if there is endocarditis or pericarditis, or if there is pericardial effusion
• if the patient has a predisposition to bleeding from the gastrointestinal or urinary tract, e.g. previous complications related to bleeding from the stomach or intestines, diverticulitis or tumors
• if the patient is allergic to warfarin sodium or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking St. John's Wort (Hypericum perforatum)
• if the patient has dementia, psychosis, alcoholism or other conditions in which anticoagulant treatment cannot be used safely.

Warnings and precautions

Before starting to take Warfin, discuss it with your doctor or pharmacist if you are pregnant or planning to become pregnant if you have hypothyroidism or hyperthyroidism if you have heart failure associated with acute exacerbation episodes (episodes of increased swelling of the legs and shortness of breath) if you have other liver diseases not mentioned above or hepatitis if you have kidney failure if you are scheduled to have a dental or other surgical procedure, consult your doctor if you are currently taking, have recently taken, or are planning to take other medicines during treatment with Warfin (see "Warfin and other medicines"). You should avoid drastic changes in dietary habits, as the vitamin K content in food may affect warfarin treatment. Factors that may affect therapy include: switching to a vegetarian diet, a very restrictive diet, depression, vomiting, diarrhea, steatorrhea or malabsorption due to other causes.

Warfin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, even those that are available without a prescription. This includes herbal medicines or natural products. Many medicines affect the action of Warfin tablets - both reducing and increasing its action. Do not start taking new medicines or stop taking medicines without consulting your doctor first. All changes in the dosage of concomitantly administered medicines may change the balance of the action of oral anticoagulants, so it may be necessary to perform laboratory tests to determine the INR (International Normalized Ratio) more frequently. If you need to take painkillers, consult your doctor. Most over-the-counter painkillers should not be taken with Warfin. However, medicines containing only paracetamol can be taken for temporary pain or fever relief. Glucosamine (used for osteoarthritis) may increase the action of Warfin. Herbal medicines and natural products If you are already taking some of the herbal medicines listed below, you should consult your doctor before stopping them. Herbal medicines containing ginkgo biloba, garlic, angelica, papaya, and salvia may increase the action of Warfin. On the other hand, St. John's Wort and ginseng reduce the action. Therefore, taking these herbal medicines should not be started or stopped during treatment with Warfin without consulting a doctor.

Warfin with food and drink

Taking vitamin K affects Warfin treatment. Therefore, consuming products containing vitamin K should be as uniform as possible during Warfin treatment. Avoid sudden changes in diet. The richest source of vitamin K is: green vegetables, leaves, and herbs. Some of them are listed below. It is not necessary to avoid eating them, but you should avoid changes in the daily amount of these products consumed. Sources rich in vitamin K include: beet leaves, avocado, broccoli, Brussels sprouts, cabbage, canola oil, chayote leaves, dill, coriander, cucumber skin (but not cucumber without skin), endive, kale, kiwi, lettuce leaves, mint leaves, mustard, olive oil, parsley, peas, pistachios, purple seaweed, spinach leaves, spring onion, soybeans, soybean oil, tea leaves (but not tea), turnip or watercress. Cranberry juice and other cranberry products may increase the action of warfarin, so you should avoid consuming these products during warfarin treatment. Smoking may affect the effectiveness of warfarin. More frequent INR monitoring may be necessary if the patient has been smoking for a long time and quits smoking during Warfin therapy.

Pregnancy and breastfeeding

The doctor should decide whether Warfin can be taken during pregnancy. If you are planning to become pregnant or are pregnant while taking Warfin, you must contact your doctor, as taking Warfin during pregnancy may be harmful to the fetus. Warfin should not be taken during the first trimester and in the last four weeks of pregnancy, and if possible, Warfin should be avoided throughout the entire pregnancy, except in exceptional circumstances under specialist supervision. Warfarin sodium does not pass into breast milk. Therefore, you can breastfeed while being treated with Warfin.

Driving and using machines

Warfarin has no effect on the ability to drive vehicles or operate machines.

Warfin contains lactose

This medicine contains 85 mg of lactose (in the form of lactose monohydrate). If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Other excipients

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Warfin

You will receive detailed instructions for Warfin treatment from your doctor, hospital, or clinic. This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, ask your doctor or pharmacist. It is very important to regularly perform blood tests. The dose of the medicine is individually adjusted for the patient and may change from day to day. It is absolutely necessary to follow the dosage instructions and undergo laboratory tests.

Taking a higher dose of Warfin than recommended

If you or someone else has taken an overdose of Warfin, you should contact your doctor for further instructions. If a large dose of the medicine has been taken, activated charcoal can be given as first aid, but you should still contact your doctor as soon as possible. Inducing vomiting should not be used as a first aid measure.

Missing a dose of Warfin

If you forget to take a dose of the medicine within the first 12 hours, you can take the missed dose as soon as possible. Take the next dose at the usual time. If more than 12 hours have passed since you forgot to take the dose, the missed dose should be divided into two or three parts and taken with the next doses, so that the weekly dose does not change. If you have missed more than one dose, you should contact your doctor for further dosage instructions. Never take a double dose or two doses, one after the other.

Stopping Warfin treatment

The anticoagulant effect of the medicine may persist for 2 to 5 days after stopping Warfin treatment. If you have any further doubts about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Important!

You should immediately contact your doctor if you experience any of the following symptoms during Warfin treatment:

• Increased sensitivity or tendency to bruising, nosebleeds or gum bleeding, blood in urine, black or bloody stools, vomiting blood, increased or prolonged menstrual bleeding.
• Allergic reaction - symptoms may include swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, severe itching of the skin with raised bumps.
• Red or purple swollen or painful spots on the skin, which look like bruises or blood-filled blisters, which turn black.
• Pain in the fingers, which become purple or discolored.
• Painful skin rash. Rarely, warfarin can cause serious skin disorders, including so-called calciphylaxis, which initially may manifest as a painful skin rash, which can lead to other serious complications. This side effect occurs more frequently in patients with chronic kidney disease.

Common (may affect up to 1 in 10 people): moderate bleeding (from the nose, gums, or bruising); also blood in urine, black or bloody stools, heavier or prolonged menstrual bleeding or other bleeding. Nausea, vomiting, diarrhea. Rare (may affect up to 1 in 1,000 people): warfarin-induced skin necrosis, purple toe syndrome (painful, purple skin changes on the toes or soles of the feet). Very rare (may affect up to 1 in 10,000 people): hypersensitivity reactions to the medicine, usually manifesting as a skin rash, reversible elevation of liver enzyme levels, pain related to gallstones, development of vasculitis, transient hair loss, priapism (usually in the initial treatment period), calcification of the trachea, cholesterol embolism. Unknown (frequency cannot be estimated from the available data): calcium deposits in the walls of blood vessels, which can lead to the formation of growing and painful skin ulcers. Renal dysfunction occurring with excessive anticoagulation and hematuria (nephropathy associated with anticoagulant drugs).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Warfin

Store in a temperature below 25°C. Store in the original package. Store the bottle tightly closed in the outer packaging to protect it from light and moisture. The bottle contains a desiccant that protects the tablets from moisture. Do not remove the desiccant capsule from the bottle. Do not swallow the desiccant capsule. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the package after "Expiry date (EXP)". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Warfin contains

• The active substance of the medicine is 3 mg or 5 mg of warfarin sodium per tablet.
• Other ingredients are: lactose monohydrate, cornstarch, magnesium stearate, and dyes:
• indigotine (E 132), gelatin in 3 mg tablets (light blue)
• erythrosine (E 127), povidone in 5 mg tablets (pink)

What Warfin looks like and contents of the pack

Warfin 3 mg: light blue, may contain speckles, round, flat tablets with beveled edges, marked "ORN 17", 7 mm in diameter. Score line on one side. The tablets can be divided into equal doses. Warfin 5 mg: pink, may contain speckles, round, flat tablets with beveled edges, marked "ORN 18", 7 mm in diameter. Score line on one side. The tablets can be divided into equal doses. White, plastic bottle (HDPE), containing a desiccant capsule, closed with a cap (HDPE), with a tamper-evident seal. Pack sizes: 30 or 100 tablets.

Marketing authorization holder

Orion Corporation Orionintie 1 FI-02200 Espoo Finland

Manufacturer

Orion Corporation, Orion Pharma Orionintie 1 FI-02200 Espoo Finland Orion Corporation Orion Pharma Joensuunkatu 7 FI-24100 Salo Finland For more detailed information on this medicine, please contact the local representative of the marketing authorization holder: Orion Pharma Poland Sp. z o. o. [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Hungary: Warfarin Orion Poland: Warfin Slovenia: Marevan Croatia: Martefarin Date of last revision of the leaflet:24.11.2024