Rivaroxaban Polpharma

Package Leaflet: Information for the User

Rivaroxaban Polpharma, 15 mg, hard capsules

Rivaroxaban Polpharma, 20 mg, hard capsules

Rivaroxaban

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package 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 blood clots in the brain (stroke) and other blood vessels in the body, if you have a form of irregular heart rhythm called atrial fibrillation not caused by heart valve problems.
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent blood clots from forming again 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 blood clots in the veins or 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 to block the blood clotting factor (factor Xa) and thus reduce the tendency to form blood clots.

2. Important information before taking Rivaroxaban Polpharma

When not to take Rivaroxaban Polpharma

• 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 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.

You must not take Rivaroxaban Polpharma, and you should inform your doctor if you think any of the above conditions apply to you.

Warnings and precautions

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

When to be particularly careful when taking Rivaroxaban Polpharma

• 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 body,
• taking other medicines that prevent blood clots (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 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,
• disease of the blood vessels in the back of the eye (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 found to have unstable blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you think you have any of the above conditions, you should inform your doctor

before taking Rivaroxaban Polpharma. Your doctor will decide whether to use this medicine and whether you should be closely monitored.

If you need to have surgery:

• you must follow your doctor's instructions exactly regarding when to take Rivaroxaban Polpharma before or after surgery,
• if spinal or epidural anesthesia is planned (e.g. for pain relief):
• it is very important to take Rivaroxaban Polpharma before and after the procedure, exactly as instructed by your doctor,
• you should immediately inform your doctor if you experience numbness or weakness in your legs, bowel or bladder problems after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Polpharma capsules are not recommended for children weighing less than 30 kg.There is a lack of sufficient data on the use of rivaroxaban 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 might take, including those obtained without a prescription.

• If you are taking:
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically 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 noradrenaline reuptake inhibitors (SNRIs)).

If you think you have any of the above conditions, you should inform

your doctorbefore taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be increased. Your doctor will decide whether to use this medicine and whether you should be closely monitored.
If your doctor thinks you are at increased risk of developing 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 think you have any of the above conditions, you should inform

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

Driving and using machines

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

Rivaroxaban Polpharma contains lactose monohydrate and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that 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.
The capsule(s) should be swallowed, preferably with water.
If you have difficulty swallowing the capsule whole, you should talk to your doctor about other ways of taking Rivaroxaban Polpharma. The contents of the capsule can be mixed with water or apple sauce, immediately before taking. After taking this mixture, you should eat a meal.
If necessary, your doctor may also give the contents of the Rivaroxaban Polpharma capsule through a nasogastric tube.

How many capsules to take

Adults

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

If you need a procedure to open up the 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 Polpharma 15 mg capsule once a day (or one Rivaroxaban Polpharma 10 mg capsule once a day in case of kidney disease) in combination with an antiplatelet medicine such as clopidogrel.

• To treat blood clots in the veins of the legs, blood clots in the lungs and to prevent blood clots from forming againThe recommended dose is one Rivaroxaban Polpharma 15 mg capsule twice a day for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one Rivaroxaban Polpharma 20 mg capsule once a day. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg capsule once a day or one 20 mg capsule once a day. If you have kidney disease and are taking one Rivaroxaban Polpharma 20 mg capsule once a day, your doctor may decide to reduce the dose to one Rivaroxaban Polpharma 15 mg capsule once a day after 3 weeks of treatment if the risk of bleeding is higher than the risk of further blood clots.

Children and adolescents

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

• The recommended dose for children and adolescents weighing 30 kg to less than 50 kgis one Rivaroxaban Polpharma 15 mgcapsule once a day.
• The recommended dose for children and adolescents weighing 50 kg or moreis one Rivaroxaban Polpharma 20 mgcapsule once a day. Each dose of Rivaroxaban Polpharma should be taken with food, with a drink (e.g. water or juice). The capsules should be taken daily at approximately the same time. It is recommended to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the entire dose.

The dose of Rivaroxaban Polpharma is based on body weight, so it is important to come to scheduled doctor's appointments, as the dose may need to be adjusted depending on changes in weight.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not divide the contents of the capsule to get a partial dose of the capsule. If a smaller dose is needed, you should use an alternative medicine containing rivaroxaban in the form of granules for oral suspension.
For children and adolescents who are unable to swallow the capsule whole, you should use a medicine containing rivaroxaban in the form of granules for oral suspension.
If the oral suspension is not available, you can empty the contents of the Rivaroxaban Polpharma capsule and mix it with water or apple sauce, immediately before taking. After taking this mixture, you should eat a meal. If necessary, your doctor may also give the contents of the Rivaroxaban Polpharma capsule through a nasogastric tube.

If you spit out the dose or vomit

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

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

When to take Rivaroxaban Polpharma

The capsule(s) should be taken every day until your doctor decides to stop the treatment.
It is best to take the capsule(s) 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 brain (stroke) and other blood vessels in the body:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, Rivaroxaban Polpharma should be taken as instructed by your doctor.

Taking more than the recommended dose of Rivaroxaban Polpharma

If you have taken more Rivaroxaban Polpharma capsules than recommended, you should contact your doctor immediately. Taking more Rivaroxaban Polpharma capsules than recommended may increase the risk of bleeding.

Forgetting to take Rivaroxaban Polpharma

• Adults, children and adolescents: If you take one 20 mg or one 15 mg capsule oncea day and you miss a dose, you should take it as soon as possible. Do not take more than one capsule in a day to make up for a missed dose. The next capsule should be taken the next day, and then one capsule should be taken once a day.
• Adults: If you take one 15 mg capsule twicea day and you miss a dose, you should take it as soon as possible. Do not take more than two 15 mg capsules in a day. If you miss a dose, you can take two 15 mg capsules at the same time to get a total of two capsules (30 mg) taken in a day. The next day, you should continue taking one 15 mg capsule twice a day.

Stopping treatment with Rivaroxaban Polpharma

You should not stop taking Rivaroxaban Polpharma without first talking to your doctor, as Rivaroxaban Polpharma treats and prevents serious diseases.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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 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.

You should immediately inform your doctor if 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. 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 that you need to be closely monitored or change the treatment.
• Signs of severe skin reactions:
• widespread, severe skin rash, blistering or peeling of the skin, 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 symptoms (DRESS syndrome). The frequency of these side effects is very rare (they occur in less than 1 in 10,000 patients).
• Signs of severe allergic reactions:
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema occur in less than 1 in 100 patients).

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

Common side effects(occur in less than 1 in 10 patients)

• reduced red blood cell count, which can cause paleness and be the cause of weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the urinary or genital 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),
• presence 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 problems (which can be seen 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 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 side effects(occur in less than 1 in 100 patients)

• 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 problems (which can be seen in tests performed by your doctor),
• blood test results may show increased bilirubin levels, increased activity of some pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• hives.

Rare side effects(occur in less than 1 in 1,000 patients)

• bleeding into the muscles,
• cholestasis (bile stasis), hepatitis, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• localized 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 side effects(occur in less than 1 in 10,000 patients)

• accumulation of eosinophils, a type of white granulocytic blood cells, which can cause lung inflammation (eosinophilic pneumonia).

Side effects with unknown 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 seen in children and adolescents treated with Rivaroxaban Polpharma were similar in type to those seen in adults and were mainly mild to moderate in severity.
Side effects seen more frequently in children and adolescents:
Very common side effects(occur in more than 1 in 10 patients)

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

Common side effects(occur in less than 1 in 10 patients)

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

Uncommon side effects(occur in less than 1 in 100 patients)

• blood test results may show increased bilirubin levels (direct bilirubin).

Reporting side effects

If you experience any side effects, talk to 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:
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 Polpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that 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 storage.
The contents of the capsules are stable in water and apple sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Polpharma contains

• The active substance is rivaroxaban. Each capsule contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: capsule contents: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose type 102, croscarmellose sodium, hypromellose type 2910, magnesium stearate; capsule shell: gelatin, yellow iron oxide (E 172) (only in 15 mg capsules), red iron oxide (E 172); ink: shellac, black iron oxide (E 172), propylene glycol (E 1520), ammonia, concentrated.

What Rivaroxaban Polpharma looks like and contents of the pack

Rivaroxaban Polpharma 15 mg: hard gelatin capsules with a yellow body and orange cap with the inscription 15 mg, capsule size 4; the capsule filling is a white or almost white powder or slightly compacted agglomerates.
The hard capsules are in blisters of aluminum/PVC/PVDC, in a cardboard box.
Rivaroxaban Polpharma 15 mg is available in packs of 14, 28, 84 or 98 hard capsules.
Rivaroxaban Polpharma 20 mg is hard gelatin capsules with a red body and cap, with the inscription 20 mg on the cap, capsule size 3; the capsule filling is a white or almost white powder or slightly compacted agglomerates.
The hard capsules are in blisters of aluminum/PVC/PVDC, in a cardboard box.
Rivaroxaban Polpharma 20 mg is available in packs of 14, 28, 84 or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

This medicine is authorized in the Member States of the European Economic Area under the following names:

BG: Ривароксабан Полфарма 15 mg твърди капсули, Ривароксабан Полфарма 20 mg твърди капсули
LV: Rivaroxaban Polpharma 15 mg cietās kapsulas, Rivaroxaban Polpharma 20 mg cietās kapsulas
LT: Rivaroxaban Polpharma 15 mg kietosios kapsulės, Rivaroxaban Polpharma 20 mg kietosios kapsulės
PL: Rivaroxaban Polpharma

Date of last revision of the package leaflet: