Rivaroxaban Farmak

Leaflet attached to the packaging: patient information

Rivaroxaban Farmak, 15 mg, film-coated tablets

Rivaroxaban Farmak, 20 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 you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects 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 pack and other information

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

Rivaroxaban Farmak contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the patient's body, if the patient has a type of irregular heartbeat called atrial fibrillation not caused by a heart valve problem;
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels in the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs. Rivaroxaban Farmak is used in children and adolescents under 18 years of age and weighing 30 kg or more to:
• treat and prevent blood clots in the veins or blood vessels in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban Farmak belongs to a group of medicines called anticoagulants. Its action is based on 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 liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

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

Warnings and precautions

Before starting to take Rivaroxaban Farmak, discuss it with your doctor or pharmacist.

Be particularly careful when taking Rivaroxaban Farmak:

• if the patient has an increased risk of bleeding, such as:
• severe kidney disease in adults and moderate or severe kidney disease in children and adolescents, 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,
• vascular disease of the back of the eyeball (retinopathy),
• pulmonary disease in which the bronchi are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• 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 has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

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

their doctorbefore 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 have surgery:

• they should carefully follow their doctor's instructions regarding the intake of Rivaroxaban Farmak at a strictly specified time before and after surgery,
• if spinal or epidural puncture is planned during surgery (e.g. for spinal or epidural anesthesia or pain relief):
• it is very important to take Rivaroxaban Farmak before and after the puncture or removal of the catheter, as instructed by the doctor
• 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 the anesthesia has ended.

Children and adolescents

Rivaroxaban Farmak tablets are not recommended for children with a body weight below 30 kg. There is a lack of sufficient data on the use of Rivaroxaban Farmak in children and adolescents for indications in adults.

Rivaroxaban Farmak and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• If you are takingcertain medicines used to treat 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 used to treat bacterial infections (e.g. clarithromycin, erythromycin), certain antiviral medicines used to treat HIV or AIDS (e.g. ritonavir), other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists, such as warfarin or acenocoumarol), anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid), 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 enhanced. The doctor will decide whether to use this medicine and whether the patient should be closely monitored. If the doctor believes that the patient is at increased risk of developing stomach or intestinal ulcers, they may use preventive treatment to prevent ulcers.

• If you are takingcertain medicines used to treat 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 doctorbefore 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, you should use effective contraception while taking Rivaroxaban Farmak. If you become pregnant while taking this medicine, you should 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 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

• Adults
• In preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body: The recommended dose is one Rivaroxaban Farmak 20 mg tablet once a day. If the patient has kidney disease, the dose may be reduced to one Rivaroxaban Farmak 15 mg tablet once a day.

If the patient needs a procedure to open up the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent implantation), there is limited evidence to support a dose reduction to one Rivaroxaban Farmak 15 mg tablet once a day (or one Rivaroxaban Farmak 10 mg tablet once a day in case of kidney disease) in combination with an antiplatelet medicine such as clopidogrel.

• In treating blood clots in the veins of the legs, blood clots in the lungs, and preventing the recurrence of blood clots: The recommended dose is one Rivaroxaban Farmak 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Farmak 20 mg tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day. If the patient has kidney disease and is taking one Rivaroxaban Farmak 20 mg tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Farmak 15 mg tablet once a day, if the risk of bleeding is greater than the risk of further blood clots.
• Children and adolescentsThe dose of Rivaroxaban Farmak depends on body weight and will be calculated by the doctor.
• The recommended dose for children and adolescents with a body weight of 30 kg to less than 50 kgis one Rivaroxaban Farmak 15 mgtablet once a day.
• The recommended dose for children and adolescents with a body weight of 50 kgor more is one Rivaroxaban Farmak 20 mgtablet once a day. Each dose of Rivaroxaban Farmak should be taken with food, washed down with a drink (e.g. water or juice). The tablets should be taken every day at about the same time. It is a good idea to set an alarm to remind you. For parents or caregivers: you should watch the child to make sure they take the whole dose.

The dose of Rivaroxaban Farmak is based on body weight, so it is important to come to scheduled doctor's appointments, as the dose may need to be adjusted due to changes in weight. Never adjust the dose yourself.If necessary, the doctor will adjust the dose. Do not divide the tablet to get a partial dose of the tablet. If a smaller dose is needed, you should use other medicines in the form of granules for oral suspension. For children and adolescents who are unable to swallow whole tablets, you should use other medicines in the form of granules for oral suspension. If an oral suspension is not available, you can crush the Rivaroxaban Farmak tablet and mix it with water or apple sauce just before taking it. After this mixture, you should eat a meal. If necessary, the doctor may also give the crushed tablet through a gastric tube. The tablet(s) should be swallowed, preferably with water. Rivaroxaban Farmak should be taken with food. If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways to take Rivaroxaban Farmak. The tablet can be crushed and mixed with water or apple sauce, just before taking it. After this mixture, you should eat a meal immediately. If necessary, the doctor may give the crushed Rivaroxaban Farmak tablet through a gastric tube.

If a dose is spat out or vomited

• less than 30 minutes after taking Rivaroxaban Farmak, a new dose should be taken.
• more than 30 minutes after taking Rivaroxaban Farmak, do nottake a new dose. In this case, the next dose of Rivaroxaban Farmak should be taken at the usual time.

Contact your doctor if you spit out or vomit a dose or vomit after taking Rivaroxaban Farmak.

When to take Rivaroxaban Farmak

The tablet(s) should be taken every day until the doctor decides to stop the treatment. It is best to take the tablet(s) at the same time every day, as it will be easier to remember. The doctor will decide how long to continue the treatment. Preventing the formation of blood clots in the brain (stroke) and other blood vessels in the body: If the heart rhythm needs to be restored to normal using a procedure called cardioversion, Rivaroxaban Farmak should be taken as instructed by the doctor.

Taking a higher dose of Rivaroxaban Farmak than recommended

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

Missing a dose of Rivaroxaban Farmak

• If you are taking one 20 mg or one 15 mg tablet once a day and you miss a dose, take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet at the usual time the next day, and then take one tablet once a day.
• If you are taking one 15 mg tablet twice a day and you miss a dose, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) in one day. The next day, continue taking one 15 mg tablet twice a day.

Stopping treatment with Rivaroxaban Farmak

Do not stop taking Rivaroxaban Farmak without first talking to your doctor, as Rivaroxaban Farmak prevents a serious condition. If you have any further questions about taking this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Rivaroxaban Farmak can cause side effects, although not everybody gets them. Like other medicines with a similar effect of reducing blood clot formation, Rivaroxaban Farmak may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). The signs of bleeding may not always be obvious or visible.

Possible side effects that may be signs 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. This is a serious medical emergency. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina. The doctor may decide to monitor the patient closely or change the treatment.

Possible side effects that may be signs of a severe skin reaction

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

• widespread, severe skin rash, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of this side effect is very rare (up to 1 in 10,000 people),
• drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic disorders (DRESS syndrome). The frequency of this side effect is very rare (up to 1 in 10,000 people).

Possible side effects that may be signs 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; 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).

General list of possible side effects:

Common(may affect up to 1 in 10 people)

• decrease in red blood cell count, which may cause paleness and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestine, bleeding from the urinary and reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding into the eye (including bleeding from the conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• appearance of blood in sputum (hemoptysis) when coughing
• bleeding from the skin or bleeding under the skin
• bleeding after surgery
• oozing of blood or fluid from the 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 (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 some 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 some liver or pancreatic enzymes, or platelet count
• fainting
• malaise
• rapid heartbeat
• dry mouth
• hives

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

• bleeding into the muscles
• cholestasis (bile stasis), hepatitis, including liver cell damage
• jaundice (yellowing of the skin and eyes)
• local swelling
• collection of blood (hematoma) 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 the available data)

• kidney 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of 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 this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Farmak contains

• The active substance is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, croscarmellose sodium, magnesium stearate. See section 2 "Rivaroxaban Farmak contains lactose and sodium". Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

What Rivaroxaban Farmak looks like and contents of the pack

Rivaroxaban Farmak 15 mg is a red, round, biconvex film-coated tablet (with a diameter of 5.6 mm), with the inscription "15" on one side and smooth on the other side. Transparent blisters of PVC/PVDC/Aluminum in cardboard boxes containing 14 or 28 film-coated tablets. Rivaroxaban Farmak 20 mg is a dark red, round, biconvex film-coated tablet (with a diameter of 6.5 mm), with the inscription "20" on one side and smooth on the other side. Transparent blisters of PVC/PVDC/Aluminum in cardboard boxes containing 14 or 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 15 mg film-coated tablets/Rivaroxaban Farmak 20 mg film-coated tablets Poland Rivaroxaban Farmak

Date of last revision of the leaflet: