Rivaxar

Leaflet accompanying the packaging: information for the user

Rivaxar, 15 mg, film-coated tablets

Rivaxar, 20 mg, film-coated tablets

Rivaroxaban

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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 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 Rivaxar and what is it used for
• 2. Important information before taking Rivaxar
• 3. How to take Rivaxar
• 4. Possible side effects
• 5. How to store Rivaxar
• 6. Contents of the pack and other information

1. What is Rivaxar and what is it used for

Rivaxar 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 heart rhythm 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.

Rivaxar 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 Rivaxar

When not to take Rivaxar

• -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 the formation of blood clots (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 Rivaxar, and also inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take Rivaxar, you should discuss it with your doctor or pharmacist.

When to be particularly careful when taking Rivaxar

• if the patient has an increased risk of bleeding, in such conditions as:
• severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
• bleeding disorders,
• taking other medicines that prevent the formation of blood clots (e.g. warfarin, dabigatran etexilate, apixaban or heparin) when changing anticoagulant treatment or when heparin is given to maintain the patency of a vein or artery catheter (see "Rivaxar and other medicines"),
• very high blood pressure that does not decrease despite the use of 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 (backflow of stomach acid into the esophagus),
• 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,
• 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 the doctor, who will decide on possible changes in 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 Rivaxar. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

If the patient needs to undergo surgery:

• they should follow the doctor's instructions regarding the intake of Rivaxar at a strictly specified 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 Rivaxar before and after the puncture or removal of the catheter, in accordance with the doctor's instructions,
• due to the need for particular caution, the doctor should be informed immediately if numbness or weakness of the legs, bowel or bladder disorders occur after the end of anesthesia.

Children and adolescents

Rivaxar is not recommended for people under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

Rivaxar and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

• -If the patient is taking:
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,

ketokonazole in 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 infection 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 doctorbefore taking Rivaxar, as the action of Rivaxar may be enhanced if taken with the above medicines. The doctor will decide whether to use this medicine and whether the patient should be subject to particularly close monitoring.

Pregnancy and breastfeeding

Rivaxar should not be taken if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Rivaxar. If the patient becomes pregnant while taking Rivaxar, they should inform their doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaxar 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 or operate machinery.

Rivaxar contains lactose and sodium.

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

3. How to take Rivaxar

This medicine should always be taken as directed by the doctor. If you have any doubts, you should ask your doctor or pharmacist.

How many tablets to take

• In the prevention of blood clots in the brain (stroke) and other blood vessels

in the patient's body. The recommended dose is one 20 mg Rivaxar tablet once a day.

• If the patient requires a procedure to clear the blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement), there is limited evidence to reduce the dose to one 15 mg Rivaxar tablet once a day (or one 10 mg Rivaxar tablet once a day in case of kidney function impairment) in combination with an antiplatelet agent such as clopidogrel.
• In the treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots. The recommended dose is one 15 mg Rivaxar tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Rivaxar tablet once a day. After at least 6 months of treatment for blood clots, the doctor may decide to continue treatment using one 10 mg tablet once a day or one 20 mg tablet once a day. If the patient has kidney problems and is taking one 20 mg Rivaxar tablet once a day, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaxar tablet once a day, if the risk of bleeding is greater than the risk of recurrent blood clots.

The tablet(s) should be swallowed, preferably with water. Rivaxar should be taken during meals. If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways of taking Rivaxar. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before intake. After such a mixture, the meal should be consumed immediately. If necessary, the doctor may administer the crushed Rivaxar tablet through a gastric tube.

When to take Rivaxar

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 is easier to remember. The doctor will decide how long the patient should continue the treatment. Prevention of blood clots in the brain (stroke) and other blood vessels in the patient's body: If the heart rhythm needs to be restored using a procedure called cardioversion, Rivaxar should be taken at the time specified by the doctor.

Taking a higher dose of Rivaxar than recommended

If the patient has taken a higher dose of Rivaxar than recommended, they should contact their doctor immediately. Taking too high a dose of Rivaxar increases the risk of bleeding.

Missing a dose of Rivaxar

• If the patient is taking one 20 mg or one 15 mg tablet once a day and a dose of Rivaxar has been missed, they should take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. The next tablet should be taken the next day, and then one tablet should be taken once a day.
• If the patient is taking one 15 mg tablet twice a day and a dose of Rivaxar has been missed, they should take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient has forgotten to take a dose, they may take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, they should continue taking one 15 mg tablet twice a day.

Stopping the intake of Rivaxar

Do not stop taking Rivaxar without first consulting your doctor, as Rivaxar prevents the occurrence of serious diseases. If you have any further doubts about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaxar can cause side effects, although not everybody gets them. Like other medicines with similar action (anticoagulants), Rivaxar may cause bleeding, which can potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all of these will be obvious or visible signs of bleeding.

Possible side effects that may be a sign of bleeding:

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

• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina, which may be signs of bleeding. The doctor may decide to monitor the patient very closely or change the treatment.

Possible side effects that may be a sign of a skin reaction

Tell your doctor immediatelyif you experience any of the following skin reactions, such as:

• widespread, severe skin rash, blistering or changes in the mucous membranes, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these side effects is very rare (may occur in less than 1 in 10,000 patients).
• drug reaction causing rash, fever, inflammation of internal organs, hematological and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (may occur in less than 1 in 10,000 patients).

Possible side effects that may be a sign of a severe allergic reaction

Tell your doctor immediatelyif you experience any of the following side effects: swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of these side effects is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General list of possible side effects

Common(may occur in 1 in 10 patients)

• decrease in red blood cell count, which may cause paleness of the skin 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 white of the eye),
• 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 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 occur in 1 in 100 patients)

• bleeding into the brain or within the skull,
• 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 pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare(may occur in 1 in 1,000 patients)

• 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 the 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, occurring 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 the medicine.

5. How to store Rivaxar

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

6. Contents of the pack and other information

What Rivaxar contains

• The active substance of Rivaxar is rivaroxaban. One 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 "Rivaxar contains lactose and sodium". Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

What Rivaxar looks like and contents of the pack

Rivaxar 15 mg film-coated tablets are red, round, biconvex (diameter 5.6 mm), with the number "15" embossed on one side and smooth on the other side. Transparent blisters of PVC/PVDC/Aluminum in cardboard boxes. The pack contains 5, 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 90, 98, 100 film-coated tablets. Not all pack sizes may be marketed. Rivaxar 20 mg film-coated tablets are dark red, round, biconvex (diameter 6.5 mm), with the number "20" embossed on one side and smooth on the other side. Transparent blisters of PVC/PVDC/Aluminum in cardboard boxes. The pack contains 5, 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 90, 98, 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

S-LAB Sp. z o.o. ul. Kiełczowska 2 55-095 Mirków e-mail: [email protected]

Manufacturer:

S.C. Labormed-Pharma S.A. 44B Theodor Pallady Blvd, 3 District 032266 Bucharest Romania Adalvo Ltd Malta Life Sciences Park Building 1, Level 4 Sir Temi Zammit Buildings San Gwann SGN 3000 Malta

This medicinal product is authorized in the Member States of the EEA under the following names:

Iceland: Rivaroxaban AdAlvo 15 mg/20 mg film-coated tablets Estonia: Rivaroxaban Auxilia Finland: Rivaroxaban Avansor 15 mg/20 mg tablets, film-coated Latvia: Rivaroxaban Auxilia 15 mg/20 mg coated tablets Lithuania: Rivaroxaban Auxilia 15 mg/20 mg film-coated tablets Poland: Rivaxar Sweden: Rivaroxaban Avansor 15 mg/20 mg film-coated tablets

Date of last revision of the leaflet: