Rivaroxaban Farmak

Leaflet accompanying the packaging: patient information

Rivaroxaban Farmak, 2.5 mg, film-coated tablets

Rivaroxabanum

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

• Keep this leaflet, so that you can read it again if necessary.
• In case of any further doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Rivaroxaban Farmak and what is it used for

The patient has been given Rivaroxaban Farmak because

• they have been diagnosed with acute coronary syndrome (a condition that includes heart attack and unstable angina, acute chest pain) and have elevated levels of cardiac biomarkers. Rivaroxaban Farmak reduces the risk of another heart attack or reduces the risk of death due to heart or blood vessel disease in adults. Rivaroxaban Farmak will not be given to the patient as the only medicine. The doctor will instruct the patient to also take:
• aspirin or
• aspirin and clopidogrel or ticlopidine.

or

• they have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral arterial disease, which causes symptoms. Rivaroxaban Farmak reduces the risk of blood clots (atherothrombotic events) in adults. Rivaroxaban Farmak will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin. In some cases, if the patient is taking Rivaroxaban Farmak after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin.

Rivaroxaban Farmak contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. Its action involves blocking a blood clotting factor (factor Xa) and thereby reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban Farmak

When not to take Rivaroxaban Farmak:

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of the body that leads to an increased risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter,
• if the patient has been diagnosed with acute coronary syndrome and has had bleeding or a blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral arterial disease and has had bleeding in the brain (stroke) or blockage of small arteries that supply blood to the brain tissues (cerebral sinus thrombosis), or if the patient has had a blood clot in the brain (ischemic stroke) in the last month),
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaroxaban Farmak, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with Rivaroxaban Farmak, discuss it with your doctor or pharmacist. Rivaroxaban Farmak should not be taken with other blood clotting inhibitors, such as prasugrel or ticagrelor, except for aspirin, clopidogrel, or ticlopidine.

Be particularly careful when taking Rivaroxaban Farmak:

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body,
• taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivaroxaban Farmak and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite taking medicines,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) e.g. due to reflux disease of the esophagus (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• disease of the blood vessels in the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if the patient is over 75 years old,
• if the patient weighs less than 60 kg,
• coronary artery disease with severe symptomatic heart failure,
• in patients with artificial heart valves,
• if the patient has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), the patient should inform their doctor, who will decide whether to change the treatment.

If the patient suspects that they have any of the above conditions, they should inform their doctor

before taking Rivaroxaban Farmak. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery:

• they should carefully follow the doctor's instructions regarding the intake of Rivaroxaban Farmak at a specific time before or after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g. for epidural or spinal anesthesia or pain relief):
• it is very important to take Rivaroxaban Farmak before and after the puncture or catheter removal, according to the doctor's instructions;
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after anesthesia.

Children and adolescents

Rivaroxaban Farmak 2.5 mg is not recommended for people under 18 years old. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Rivaroxaban Farmak and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those that are available without a prescription.

• If you are takingcertain medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin, ketoconazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol), certain medicines for bacterial infections (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir), other medicines that prevent blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol, prasugrel and ticagrelor (see "Warnings and precautions")), anti-inflammatory and pain-relieving medicines (e.g. naproxen or aspirin), dronedarone, a medicine used to treat heart rhythm disorders, certain medicines used to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs)).

If the patient suspects that they have any of the above conditions, they should inform their doctor

before taking Rivaroxaban Farmak, as the effect of Rivaroxaban Farmak may be increased. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.

• If you are takingcertain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's wort (Hypericum perforatum), a herbal medicine used to treat depression, rifampicin, which belongs to a group of antibiotics.

If the patient suspects that they have any of the above conditions, they should inform their doctor

before taking Rivaroxaban Farmak, as the effect of Rivaroxaban Farmak may be reduced. The doctor will decide whether to use Rivaroxaban Farmak and whether the patient should be closely monitored.

Pregnancy and breastfeeding

Do not take Rivaroxaban Farmak if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, use an effective method of contraception while taking Rivaroxaban Farmak. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Farmak may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban Farmak contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the product is considered "sodium-free".

3. How to take Rivaroxaban Farmak

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How many tablets to take

The recommended dose is one 2.5 mg tablet twice a day. Rivaroxaban Farmak should be taken at approximately the same time every day (e.g. one tablet in the morning and one in the evening). This medicine can be taken with or without food. If you have difficulty swallowing the whole tablet, talk to your doctor about other ways to take Rivaroxaban Farmak. The tablet can be crushed and mixed with water or apple sauce, just before taking it. If necessary, the doctor may administer the crushed Rivaroxaban Farmak tablet through a gastric tube. Rivaroxaban Farmak will not be given to the patient as the only medicine. The doctor will instruct the patient to also take aspirin. If the patient is taking Rivaroxaban Farmak after an acute coronary syndrome, the doctor may also instruct the patient to take clopidogrel or ticlopidine. If the patient is taking Rivaroxaban Farmak after a procedure to open up a narrowed or blocked artery in the leg to restore blood flow, the doctor may also prescribe clopidogrel for the patient to take for a short time in addition to aspirin. The doctor will tell the patient what dose of these medicines to take (usually 75-100 mg of aspirin per day or a daily dose of 75-100 mg of aspirin plus a daily dose of 75 mg of clopidogrel or a standard daily dose of ticlopidine).

When to start taking Rivaroxaban Farmak

Treatment with Rivaroxaban Farmak after an acute coronary syndrome should be started as soon as possible after stabilization of the acute coronary syndrome, at the earliest 24 hours after hospital admission and when parenteral (by injection) anticoagulant treatment would normally be discontinued. The doctor will tell the patient when to start treatment with Rivaroxaban Farmak if they have been diagnosed with coronary artery disease or peripheral arterial disease. The doctor will decide how long to continue treatment.

Taking a higher dose of Rivaroxaban Farmak than recommended

If you have taken a higher dose of Rivaroxaban Farmak than recommended, contact your doctor immediately. Taking too much Rivaroxaban Farmak increases the risk of bleeding.

Missing a dose of Rivaroxaban Farmak

Do not take a double dose to make up for a missed dose. If you miss a dose, take the next dose at the scheduled time.

Stopping treatment with Rivaroxaban Farmak

Rivaroxaban Farmak should be taken regularly and for the time prescribed by your doctor. Do not stop taking Rivaroxaban Farmak without first consulting your doctor. If you stop taking this medicine, the risk of another heart attack, stroke, or death due to heart or blood vessel disease may increase. If you have any further doubts about taking this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Rivaroxaban Farmak can cause side effects, although not everybody gets them. Like other medicines that reduce blood clotting, Rivaroxaban Farmak may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

Side effects that may be a sign of bleeding

Tell your doctor immediatelyif you experience any of the following side effects:

• bleeding into the brain or inside the skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, and stiffness of the neck. A serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina. The doctor may decide to closely monitor the patient or change the treatment.

Side effects that may be symptoms of a severe skin reaction

Tell your doctor immediatelyif you experience any of the following side effects:

• widespread, acute skin rash, blistering or changes in the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of this side effect is very rare (up to 1 in 10,000 people),
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of this side effect is very rare (up to 1 in 10,000 people).

Side effects that may be symptoms of severe allergic reactions

Tell your doctor immediatelyif you experience any of the following side effects:

• swelling of the face, lips, mouth, tongue, or throat; hives and difficulty breathing; a sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

u maksymalnie 1 na 100 osób) i niezbyt częsta (obrzęk naczynioruchowy i obrzęk alergiczny może wystąpić u 1 na 100 osób).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds
• bleeding into the eye (including bleeding from the conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• appearance of blood in sputum (hemoptysis) while coughing
• bleeding from the skin or subcutaneous bleeding
• bleeding after surgery
• oozing of blood or fluid from a wound after surgery
• swelling of the limbs
• limb pain
• kidney function disorders (can be observed in tests performed by the doctor)
• fever
• stomach pain, nausea, feeling of nausea (nausea) or vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• increased activity of certain liver enzymes, which can be seen in blood test results

Uncommon(may affect up to 1 in 100 people)

• bleeding into the brain or inside the skull (see above signs of bleeding)
• bleeding into a joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver function disorders (can be observed in tests performed by the doctor)
• blood test results may show increased bilirubin levels, activity of certain pancreatic or liver enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives

Rare(may affect up to 1 in 1,000 people)

• bleeding into muscles
• cholestasis (bile stasis), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• hematoma (collection of blood) in the groin as a complication of heart catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm)

Frequency not known(frequency cannot be estimated from available data)

• renal failure after severe bleeding
• increased pressure in the muscles of the legs and arms after bleeding, which can lead to pain, swelling, changes in sensation, numbness, or paralysis (compartment syndrome after bleeding)

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 Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 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 Rivaroxaban Farmak

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Farmak contains

• The active substance of Rivaroxaban Farmak is rivaroxaban. Each film-coated tablet contains 2.5 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2 "Rivaroxaban Farmak contains lactose and sodium". Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172).

What Rivaroxaban Farmak looks like and contents of the pack

Rivaroxaban Farmak 2.5 mg is a light yellow, round, biconvex film-coated tablet (6 mm in diameter), with the inscription "2.5" on one side and smooth on the other. Transparent blisters of PVC/PVDC/Aluminum in a cardboard box containing 28 film-coated tablets.

Marketing authorization holder

Farmak International Sp. z o.o. ul. Koszykowa 65 00-667 Warsaw tel. +48 22 822 93 06

Manufacturer

Saneca Pharmaceuticals a.s. Nitrianska 100 920 27 Hlohovec, Slovakia Alvogen Malta (Out-Licensing) Ltd. / AMOL Ltd. Malta Life Sciences Park, Building 1, Level 4 San Ġwann, SĠN 3000, Malta

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

Lithuania Rivaroxaban Farmak 2.5 mg plėvele dengtos tabletės Poland Rivaroxaban Farmak

Date of last revision of the leaflet: