Rivaroxaban Polpharma

Package Leaflet: Information for the Patient

Rivaroxaban Polpharma 15 mg Film-Coated Tablets

Rivaroxaban Polpharma 20 mg Film-Coated Tablets

Rivaroxabanum

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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rivaroxaban Polpharma and what is it used for
• 2. Important information before taking Rivaroxaban Polpharma
• 3. How to take Rivaroxaban Polpharma
• 4. Possible side effects
• 5. How to store Rivaroxaban Polpharma
• 6. Contents of the pack and other information

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

Rivaroxaban Polpharma contains the active substance rivaroxaban.
Rivaroxaban Polpharma 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 heart valve problems;
• 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 Polpharma 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 in the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

Rivaroxaban Polpharma 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 Polpharma

When not to take Rivaroxaban Polpharma:

• 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),

or 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,

Warnings and precautions

Before starting treatment with Rivaroxaban Polpharma, discuss it with your doctor or pharmacist.

Be careful when taking Rivaroxaban Polpharma:

• 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 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 Polpharma 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 (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system,
• disease of the blood vessels in the back of the eyeballs (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with prosthetic heart valves,
• if the patient has a disorder 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 Rivaroxaban Polpharma. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.

If the patient needs to undergo surgery:

• follow the doctor's instructions carefully regarding the intake of Rivaroxaban Polpharma at a 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):
• it is very important to take Rivaroxaban Polpharma before and after the puncture or catheter removal, 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 anesthesia.

Children and adolescents

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

Rivaroxaban Polpharma 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 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 norepinephrine reuptake inhibitors (SNRIs)).

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

their doctorbefore taking Rivaroxaban Polpharma, as the action of Rivaroxaban Polpharma 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 stomach or intestinal ulcers, they may use preventive treatment to prevent 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 the patient suspects that they have any of the above conditions, they should inform

their doctorbefore taking Rivaroxaban Polpharma, as the action of Rivaroxaban Polpharma may be reduced. The doctor will decide whether to use Rivaroxaban Polpharma and whether the patient should be closely monitored.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaroxaban Polpharma may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects").
Patient who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban Polpharma 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 of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Rivaroxaban Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Rivaroxaban Polpharma should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take Rivaroxaban Polpharma. The tablet can be crushed and mixed with water or apple puree, just before taking it. After such a mixture, eat a meal immediately. If necessary, your doctor may also give you a crushed tablet through a gastric tube.

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 20 mg Rivaroxaban Polpharma tablet once a day. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Polpharma 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 15 mg Rivaroxaban Polpharma tablet once a day (or one 10 mg Rivaroxaban Polpharma tablet once a day in case of kidney function disorder) in combination with an antiplatelet agent 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 15 mg Rivaroxaban Polpharma tablet twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Rivaroxaban Polpharma 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 20 mg Rivaroxaban Polpharma tablet once a day, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban Polpharma tablet once a day, if the risk of bleeding is greater than the risk of further blood clots.
• Children and adolescentsThe dose of Rivaroxaban Polpharma depends on body weight and will be calculated by your doctor.
• Recommended dose for children and adolescents weighing 30 kg to less than 50 kgis one Rivaroxaban Polpharma 15 mgtablet once a day.
• Recommended dose for children and adolescents weighing 50 kg or moreis one Rivaroxaban Polpharma 20 mg tablet once a day.

Each Rivaroxaban Polpharma dose should be taken with food, with a drink (e.g., water or juice). Tablets should be taken every day at about the same time. It's a good idea to set an alarm to remind you.
For parents or caregivers: observe the child to make sure they take the entire dose.
The dose of Rivaroxaban Polpharma depends on body weight, so it's essential to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose of Rivaroxaban Polpharma yourself.If necessary, your doctor will adjust the dose.
Do not divide the tablet to get a partial dose. If a smaller dose is needed, use other medicines in the form of granules for oral suspension.
For children and adolescents who are unable to swallow whole tablets, use other medicines in the form of granules for oral suspension.
If an oral suspension is not available, you can crush a Rivaroxaban Polpharma tablet and mix it with water or apple puree just before taking it. After this mixture, eat a meal immediately. If necessary, your doctor may also give you a crushed tablet through a gastric tube.
In case of spitting up a dose or vomiting

• less than 30 minutes after taking Rivaroxaban Polpharma, take a new dose.
• more than 30 minutes after taking Rivaroxaban Polpharma, do not take a new dose. In this case, take the next dose of Rivaroxaban Polpharma at the usual time.

Contact your doctor if you spit up a dose or vomit repeatedly after taking Rivaroxaban Polpharma.

When to take Rivaroxaban Polpharma

Take the tablet(s) every day until your doctor decides to stop treatment.
It's best to take the tablet at the same time every day, as it's easier to remember.
Your doctor will decide how long to continue treatment.
Preventing 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, take the tablet(s) at the time specified by your doctor.

Missing a dose of Rivaroxaban Polpharma

• Adults, children, adolescents: If you take one 20 mg or one 15 mg tablet once a day and miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for a missed dose. Take the next tablet the next day, and then take one tablet once a day.
• Adults: If you take one 15 mg tablet twice a day and miss a dose, 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, continue taking one 15 mg tablet twice a day.

Taking more than the recommended dose of Rivaroxaban Polpharma

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

Stopping treatment with Rivaroxaban Polpharma

Do not stop taking Rivaroxaban Polpharma without first talking to your doctor, as Rivaroxaban Polpharma 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 Polpharma can cause side effects, although not everybody gets them.
Like other medicines that reduce blood clotting, Rivaroxaban Polpharma can 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.
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. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina.
• Signs of severe skin reactions
• widespread, severe skin rash, blistering, or changes in the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (less than 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 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 in adults, children, and adolescents:

Common(may affect up to 1 in 10 people)

• reduced red blood cell count, which can cause pallor and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or 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),
• blood in the sputum when 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 your doctor),
• fever,
• stomach pain, nausea, 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,
• 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, liver or pancreatic enzyme activity, 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). Very rare(may affect less than 1 in 10,000 people)
• eosinophilia, a type of white blood cell that causes inflammation in the lungs (eosinophilic pneumonia).

Frequency not known(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 syndrome after bleeding).

Side effects in children and adolescents

Generally, the side effects observed in children and adolescents treated with rivaroxaban were similar in type to those observed in adults and were mostly 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 (direct bilirubin, a bile pigment)
• 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 subtype of bilirubin (direct bilirubin, a bile pigment)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 Polpharma

Keep this 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.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
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 Polpharma contains

• The active substance of Rivaroxaban Polpharma is rivaroxaban. Each film-coated tablet contains 15 mg or 20 mg of rivaroxaban.
• Other ingredients are: tablet core: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate. See section 2 "Rivaroxaban Polpharma contains lactose and sodium". coating of the 15 mg tablet (Opadry II Pink 33G240024): hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, iron oxide red (E 172), iron oxide black (E 172); coating of the 20 mg tablet (Opadry II Red 33G250007): hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3350, triacetin, iron oxide red (E 172), iron oxide yellow (E 172).

What Rivaroxaban Polpharma looks like and contents of the pack

Rivaroxaban Polpharma 15 mg is a pink, round, biconvex film-coated tablet, with the number "15" embossed on one side.
The tablets are in transparent blisters, packaged in cardboard boxes containing 10, 14, 28, 42, 98, or 100 film-coated tablets.
Rivaroxaban Polpharma 20 mg is a brown-red, round, biconvex film-coated tablet, with the number "20" embossed on one side.
The tablets are in transparent blisters, packaged in cardboard boxes containing 10, 14, 28, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

FARMAPROJECTS S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 i 15
08028 Barcelona
Spain
Date of last revision of the leaflet:October 2023