Rivaroxaban Lek-am

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Rivaroxaban LEK-AM, 10 mg, film-coated tablets

Rivaroxabanum

Read the leaflet carefully 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.
• Consult a doctor or pharmacist if you have any further questions.
• 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 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 LEK-AM and what is it used for
• 2. Important information before taking Rivaroxaban LEK-AM
• 3. How to take Rivaroxaban LEK-AM
• 4. Possible side effects
• 5. How to store Rivaroxaban LEK-AM
• 6. Contents of the pack and other information

1. What is Rivaroxaban LEK-AM and what is it used for

Rivaroxaban LEK-AM 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 LEK-AM 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 LEK-AM

When not to take Rivaroxaban LEK-AM

• 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 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 switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding.

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

Warnings and precautions

Discuss the use of Rivaroxaban LEK-AM with your doctor or pharmacist before starting treatment.

When to be particularly careful when taking Rivaroxaban LEK-AM

• if you have an increased risk of bleeding, such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see "Other medicines and Rivaroxaban LEK-AM"),
• bleeding disorders,
• very high blood pressure that does not decrease despite treatment,
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) due to reflux disease or tumors in the stomach, intestines, genital, or urinary tract,
• disease of the blood vessels in the back of the eye (retinopathy),
• pulmonary disease with dilated bronchi and pus (bronchiectasis) or previous bleeding from the lungs,
• 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 whether to change your treatment,
• if you have been diagnosed with 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 doctorbefore taking Rivaroxaban LEK-AM. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you need to have surgery:

• follow your doctor's instructions carefully regarding the use of Rivaroxaban LEK-AM at a specific time before or after surgery,
• if you are scheduled to have a lumbar puncture or spinal catheter insertion (e.g., for epidural or spinal anesthesia or pain relief):
• follow your doctor's instructions carefully regarding the use of Rivaroxaban LEK-AM at a specific time,
• inform your doctor immediately if you experience symptoms such as numbness, weakness of the lower limbs, difficulty urinating or defecating, as you may need immediate treatment.

Children and adolescents

Rivaroxaban LEK-AM 10 mg tablets are not recommended for people under 18 years of age. There is limited data on the use of this medicine in children and adolescents.

Rivaroxaban LEK-AM and other medicines

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

• If you are taking:
• certain antifungal medicines (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain antibacterial medicines (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 norepinephrine reuptake inhibitors (SNRIs)).

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

your doctorbefore taking Rivaroxaban LEK-AM, as the effect of Rivaroxaban LEK-AM may be increased. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.
If your doctor thinks that you are at increased risk of stomach or duodenal ulcers, they may use a treatment to prevent stomach ulcers.

• If you are taking
• certain 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 you suspect that you have any of the above conditions, inform

your doctorbefore taking Rivaroxaban LEK-AM, as the effect of Rivaroxaban LEK-AM may be reduced. Your doctor will decide whether to use Rivaroxaban LEK-AM and whether you need to be closely monitored.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban LEK-AM may cause dizziness (common side effect) and fainting (uncommon side effect) (see section 4 "Possible side effects").
Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban LEK-AM contains lactose and sodium.

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

3. How to take Rivaroxaban LEK-AM

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgeryThe recommended dose is one Rivaroxaban LEK-AM 10 mg tablet taken once a day.
• To treat blood clots in the veins of the legs, blood clots in the lungs, and to prevent the recurrence of blood clotsAfter 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.

Swallow the tablet whole, preferably with water.
Rivaroxaban LEK-AM 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 LEK-AM. The tablet can be crushed and mixed with water or soft food, such as apple sauce, immediately before taking it.
If necessary, your doctor may give you a crushed Rivaroxaban LEK-AM tablet through a gastric tube.

When to take Rivaroxaban LEK-AM

Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time every day, as it will be easier to remember.
Your doctor will decide how long you should continue treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.
Treatment usually lasts 5 weeks for patients after major hip surgery.
Treatment usually lasts 2 weeks for patients after major knee surgery.

Taking more than the recommended dose of Rivaroxaban LEK-AM

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

Missing a dose of Rivaroxaban LEK-AM

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 tablet.

Stopping treatment with Rivaroxaban LEK-AM

Do not stop taking Rivaroxaban LEK-AM without consulting your doctor first, as Rivaroxaban LEK-AM prevents a serious disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban LEK-AM can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, Rivaroxaban LEK-AM 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.
Tell your doctor immediatelyif you experience any of the following side effects:

• Signs of bleeding:
• 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. Call for medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to monitor you closely or change your treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering, or changes to the mucous membranes, such as the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction that causes a rash, fever, inflammation of internal organs, hematologic disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 1 in 10,000 people).
• Signs of serious allergic reactionsTell 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 less than 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 side effects( 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 or genital tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• bleeding into the eye (including bleeding into the white of the eye),
• 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,
• pain in the limbs,
• kidney disorders (may be observed in tests performed by your doctor)
• fever,
• stomach pain, nausea, feeling sick (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 may be visible in blood test results.

Uncommon side effects( 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,
• blood test results may show increased bilirubin, activity of certain liver or pancreatic enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives,
• liver disorders (may be observed in tests performed by your doctor).

Rare side effects( 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,
• collection of blood (hematoma) in the groin as a complication of cardiac catheterization, when a catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare side effects( may affect up to 1 in 10,000 people)

• accumulation of eosinophils, a type of white granular blood cells, which can cause inflammation in the lungs (eosinophilic pneumonia).

Side effects of unknown frequency( frequency cannot be estimated from available data)

• kidney failure after severe bleeding,
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant therapy),
• increased pressure in the muscles of the legs and arms after bleeding, which can cause pain, swelling, changes in sensation, numbness, or paralysis ( compartment syndromeafter 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 Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 LEK-AM

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 on each blister after EXP:. The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicinal product.
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 pack and other information

What Rivaroxaban LEK-AM contains

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (type 2910), sodium lauryl sulfate, magnesium stearate. See section 2 "Rivaroxaban LEK-AM contains lactose and sodium". Coating:hypromellose (type 2910), macrogol (type MW3350), titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban LEK-AM looks like and contents of the pack

Rivaroxaban LEK-AM 10 mg film-coated tablets are pink, round, and biconvex.
The tablets are packaged in blisters, which are packed in cardboard boxes containing 10, 30, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ul. Ostrzykowizna 14 A
05-170 Zakroczym
Phone: +48 22 785 27 60

Date of last revision of the leaflet: