Rivaroxaban Lek-am

Leaflet accompanying the packaging: information for the user

Rivaroxaban LEK-AM, 15 mg, film-coated tablets

Rivaroxaban LEK-AM, 20 mg, film-coated tablets

Rivaroxaban

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

• 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 you. 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, you should tell your doctor or pharmacist. See section 4.

Contents of the pack:

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

Rivaroxaban LEK-AM contains the active substance rivaroxaban.
Rivaroxaban LEK-AM 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 form 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 of the lungs (pulmonary embolism) and prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

Rivaroxaban LEK-AM is used in children and adolescents under 18 years of age and weighing 30 kg or more to:

• treat and prevent the recurrence of blood clots in the veins or blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban LEK-AM belongs to a group of medicines called anticoagulants. Its action is based on blocking the blood clotting factor (factor Xa) and thereby 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 of an organ that increases the 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 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 you have liver disease that increases the 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

Before taking Rivaroxaban LEK-AM, you should discuss it with your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban LEK-AM

• if you have 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,
• 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 "Other medicines and Rivaroxaban LEK-AM"),
• very high blood pressure that does not decrease despite treatment,
• 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) 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 prosthetic heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment,
• if you have been diagnosed with abnormal blood pressure or if a surgical procedure or other treatment is planned to remove a blood clot from the lungs.

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

your doctorbefore taking Rivaroxaban LEK-AM. The doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• you should strictly follow your doctor's instructions regarding the intake of Rivaroxaban LEK-AM 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 LEK-AM before and after the puncture or catheter removal, as instructed by your doctor,
• due to the need for special caution, you should immediately inform your doctor if you experience symptoms such as numbness or weakness of the legs, bowel or bladder disorders after anesthesia.

Children and adolescents

Rivaroxaban LEK-AM tablets are not recommended for children weighing less than 30 kg.
There is a lack of sufficient data on the use of Rivaroxaban LEK-AM in children and adolescents for indications in adults.

Rivaroxaban LEK-AM and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If you are taking:
• certain medicines used to treat fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically 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 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, you should inform

your doctorbefore taking Rivaroxaban LEK-AM, as the effect of Rivaroxaban LEK-AM may be enhanced. The doctor will decide whether to use this medicine and whether you should be closely monitored.
If the doctor believes that you have an 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, you should inform

your doctorbefore taking Rivaroxaban LEK-AM, as the effect of Rivaroxaban LEK-AM may be reduced. The doctor will decide whether to use Rivaroxaban LEK-AM and whether you should 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, you should use effective contraception while taking Rivaroxaban LEK-AM. If you become pregnant while taking Rivaroxaban LEK-AM, you should immediately inform your doctor, who will decide on further treatment.

Driving and using machines

Rivaroxaban LEK-AM may cause dizziness (frequent side effects) and 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 LEK-AM contains lactose and sodium.

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

3. How to take Rivaroxaban LEK-AM

This medicine should always be taken exactly as instructed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Rivaroxaban LEK-AM should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If you have difficulty swallowing whole tablets, you should discuss other ways of taking Rivaroxaban LEK-AM with your doctor. The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before taking. After taking this mixture, you should eat a meal immediately. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

How many tablets to take

• Adults
• To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the bodyThe recommended dose is one Rivaroxaban LEK-AM 20 mg tablet once a day. If you have kidney problems, the dose may be reduced to one Rivaroxaban LEK-AM 15 mg tablet once a day.

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

• To treat blood clots in the veins of the legs, blood clots in the blood vessels of the lungs and to prevent the recurrence of blood clotsThe recommended dose is one Rivaroxaban LEK-AM 15 mg tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban LEK-AM 20 mg tablet once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once a day or one 20 mg tablet once a day. If you have kidney problems and are taking one Rivaroxaban LEK-AM 20 mg tablet once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban LEK-AM 15 mg tablet once a day, if the risk of bleeding is greater than the risk of recurrent blood clots.
• Children and adolescents

The dose of Rivaroxaban LEK-AM depends on body weight and will be calculated by your doctor.

• The recommended dose for children and adolescents weighing from 30 kg to less than 50 kgis one Rivaroxaban LEK-AM 15 mgtablet once a day.
• The recommended dose for children and adolescents weighing 50 kg or moreis one Rivaroxaban LEK-AM 20 mgtablet once a day.

Each dose of Rivaroxaban LEK-AM should be taken with food, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you.
For parents or caregivers: you should observe the child to make sure they have taken the entire dose.
The dose of Rivaroxaban LEK-AM is dependent on body weight, so it is important to attend scheduled doctor's appointments, as it may be necessary to adjust the dose depending on changes in weight.
Never adjust the dose yourself. If necessary, your doctor will adjust the dose.
Do not divide the tablet. If a smaller dose is necessary, you should use a different form of the medicine containing rivaroxaban (granules for oral suspension). For children and adolescents who are unable to swallow whole tablets, you should use a medicine containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the Rivaroxaban LEK-AM tablet and mix it with water or apple puree immediately before taking. After taking this mixture, you should eat a meal immediately. If necessary, your doctor may also administer the crushed tablet through a gastric tube.

If you spit out the dose or vomit

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

You should contact your doctor if you spit out the dose or vomit repeatedly after taking Rivaroxaban LEK-AM.

When to take Rivaroxaban LEK-AM

The tablet(s) should be taken every day until your doctor decides to stop the treatment.
It is best to take the tablet(s) at the same time every day, as this will help you remember.
Your doctor will decide how long you should continue the treatment.
To prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored with a procedure called cardioversion, you should take Rivaroxaban LEK-AM as instructed by your doctor.

Missing a dose of Rivaroxaban LEK-AM

• Adults, children and adolescents: If you take one 20 mg or one 15 mg tablet once a day and you miss a dose, you should take it 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.
• Adults: If you take one 15 mg tablet twice a day and you miss a dose, you should take it 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) taken in one day. The next day, you should continue taking one 15 mg tablet twice a day.

If you take Rivaroxaban LEK-AM twice a day and miss a dose, you should take it as soon as possible. If it is less than 6 hours before the next dose, you should take the missed dose. If it is more than 6 hours before the next dose, you should not take the missed dose and should take the next dose at the usual time.

Taking more than the recommended dose of Rivaroxaban LEK-AM

If you take too many Rivaroxaban LEK-AM tablets, you should contact your doctor immediately. Taking too much Rivaroxaban LEK-AM increases the risk of bleeding.

Stopping the treatment with Rivaroxaban LEK-AM

You should not stop taking Rivaroxaban LEK-AM without first consulting your doctor, as Rivaroxaban LEK-AM treats and prevents serious diseases.
If you have any further questions about the use of this medicine, you should ask 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 with a similar effect of reducing blood clot formation, Rivaroxaban LEK-AM may cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.
You should immediately inform your doctorif 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. A serious medical emergency. You should immediately seek medical help!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide to monitor you closely or change the treatment.
• Signs of severe skin reactions
• widespread, acute skin rash, blistering or changes to the mucous membranes, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction causing rash, fever, inflammation of internal organs, hematological and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).
• Signs of severe allergic reactions
• 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).

General list of possible side effects in adults, children and adolescents:

Common(may affect up to 1 in 10 people)

• reduction in red blood cell count, which can 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 conjunctiva of the eye),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum when coughing (hemoptysis),
• 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 your doctor),
• fever,
• stomach pain, nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing),
• 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 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 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).

Very rare(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).

Frequency not known(frequency cannot be estimated from the 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, occurring after bleeding, which can lead to pain, swelling, changes in sensation, numbness or paralysis (compartment syndrome after bleeding).

Side effects in children and adolescents

Overall, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mainly mild to moderate.

Side effects observed more frequently in children and adolescents:

Very common(may affect more than 1 in 10 people)

• headache,
• fever,
• nosebleeds,
• vomiting.

Common(may affect up to 1 in 10 people)

• rapid heartbeat,
• blood test results may show increased bilirubin levels,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• excessive menstrual bleeding.

Uncommon(may affect up to 1 in 100 people)

• blood test results may show increased levels of a bilirubin subtype (direct bilirubin, bile pigment).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rivaroxaban LEK-AM

The medicine should be stored out of 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.
There are no special precautions for storage of the medicinal product.
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 Rivaroxaban LEK-AM 15 mg, film-coated tablets contain

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 15 mg of rivaroxaban.
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (type 2910), sodium lauryl sulfate, magnesium stearate. Coating:hypromellose (type 2910), titanium dioxide (E 171), macrogol (type MW400).

What Rivaroxaban LEK-AM 20 mg, film-coated tablets contain

• The active substance of the medicine is rivaroxaban. Each film-coated tablet contains 20 mg of rivaroxaban.
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose (type 2910), sodium lauryl sulfate, magnesium stearate. Coating:hypromellose (type 2910), macrogol (type MW3350), red iron oxide (E 172), titanium dioxide (E 171).

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

Rivaroxaban LEK-AM 15 mg film-coated tablets are white, round, biconvex, with the number "15" embossed on one side.
The tablets are packaged in blisters, which are placed in cardboard boxes, containing 14, 28, 98 or 100 film-coated tablets.
Rivaroxaban LEK-AM 20 mg film-coated tablets are red, round, biconvex, with the number "20" embossed on one side.
The tablets are packaged in blisters, which are placed in cardboard boxes, containing 14, 28, 42, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

Date of last revision of the leaflet: