Rivaroxaban Farmak

Package Leaflet: Information for the Patient

Rivaroxaban Farmak, 10 mg, Film-Coated Tablets

Rivaroxaban

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 you only. Do not pass it on to others. It 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 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 veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of blood clot formation is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Rivaroxaban Farmak belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thus reducing the tendency to form blood clots.

2. Important information before taking Rivaroxaban Farmak

When not to take Rivaroxaban Farmak:

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have 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 you are 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 you have liver disease that leads to an increased risk of bleeding,
• if you are 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 treatment with Rivaroxaban Farmak, discuss it with your doctor or pharmacist.

Be careful when taking Rivaroxaban Farmak:

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the 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 treatment,
• stomach or intestinal diseases that may cause bleeding, e.g., inflammation of the stomach and intestines or esophageal inflammation (e.g., due to gastroesophageal reflux disease) or tumors in the stomach, intestines, or genitourinary system,
• vascular disease of the back of the eye (retinopathy),
• pulmonary disease with dilated bronchi and filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with artificial heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clot formation), you should inform your doctor, who will decide on possible changes in treatment,
• if you have abnormal blood pressure or are scheduled for surgery to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, inform your doctor

before taking Rivaroxaban Farmak. Your doctor will decide whether to use this medicine and whether you need to be under close observation.

If you need to undergo surgery:

• follow your doctor's instructions carefully regarding the intake of Rivaroxaban Farmak at a strictly specified time before and after surgery,
• if catheterization or spinal puncture is planned during surgery (e.g., for epidural or spinal anesthesia or pain relief):
• follow your doctor's instructions carefully regarding the intake of Rivaroxaban Farmak at a strictly specified time,
• due to the need for special caution, immediately inform your doctor if you experience numbness or weakness of the legs, bowel or bladder disorders after anesthesia.

Children and adolescents

Rivaroxaban Farmak 10 mg is not recommended for persons under 18 years of age. There is insufficient 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 obtained without a prescription.

If you are taking

certain medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically 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 for HIV or AIDS treatment (e.g., ritonavir), other medicines 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 for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, inform your doctor

before taking Rivaroxaban Farmak, as the action of Rivaroxaban Farmak may be enhanced. Your doctor will decide whether to use this medicine and whether you need to be under close observation. If your doctor considers that you have an increased risk of stomach or intestinal ulcers, they may use preventive treatment.

If you are taking

certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital), St. John's Wort (Hypericum perforatum), a herbal medicine used for depression, rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, inform your doctor

before taking Rivaroxaban Farmak, as the action of Rivaroxaban Farmak may be reduced. Your doctor will decide whether to use Rivaroxaban Farmak and whether you need to be under close observation.

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 effective contraception while taking Rivaroxaban Farmak. If you become pregnant while taking this medicine, immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivaroxaban Farmak may cause dizziness (common 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 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

• To prevent blood clots in the veins after hip or knee replacement surgery: The recommended dose is one Rivaroxaban Farmak 10 mg tablet taken once a day.
• For 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: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban Farmak 10 mg once a day for you.

Swallow the tablet with water. Rivaroxaban Farmak 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, your doctor may give you the crushed Rivaroxaban Farmak tablet through a gastric tube.

When to take Rivaroxaban Farmak

Take one tablet every day until your doctor decides to stop the treatment. It is best to take the tablet at the same time every day, as it is easier to remember. Your doctor will decide how long you should continue the treatment. To prevent blood clots in the veins after hip or knee replacement surgery: Take the first tablet 6 to 10 hours after surgery. In patients after major hip surgery, treatment usually lasts 5 weeks. In patients after major knee surgery, treatment usually lasts 2 weeks.

Taking more than the recommended dose of Rivaroxaban Farmak

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

Missing a dose of Rivaroxaban Farmak

If you forget to take a dose, take the tablet as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day. Do not take a double dose to make up for a missed dose.

Stopping treatment with Rivaroxaban Farmak

Do not stop taking Rivaroxaban Farmak without consulting your doctor first, as Rivaroxaban Farmak prevents a serious disease. If you have any further questions about the use of 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 similar action to reduce blood clot formation, Rivaroxaban Farmak may cause bleeding, which can potentially 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.

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, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain, or angina pectoris. Your doctor may decide to monitor you 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, acute skin rash, blistering, or changes in the mucous membrane, 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 these side effects 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 pallor and be the cause of weakness or shortness of breath
• bleeding from the stomach or intestines, bleeding from the urinary tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding
• bleeding into the eye (including bleeding from the conjunctiva)
• bleeding into tissues or body cavities (hematoma, bruising)
• presence 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 disorders (can be observed in tests performed by your doctor)
• fever
• stomach pain, nausea (nausea), 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
• 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 the joint, causing pain and swelling
• thrombocytopenia (low platelet count, cells involved in blood clotting)
• allergic reactions, including allergic skin reactions
• liver disorders (can be observed in tests performed by your 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 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
• blood accumulation (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, 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, 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 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 storage. 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 Rivaroxaban Farmak contains

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.

• 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, 10 mg, is a pink, round, biconvex film-coated tablet (6 mm in diameter), with the inscription "10" on one side and smooth on the other. Transparent blisters of PVC/PVDC/Aluminum in a cardboard box containing 10 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 10 mg film-coated tablets, Poland: Rivaroxaban Farmak

Date of last revision of the leaflet: