Rivaroxaban Polpharma

Package Leaflet: Information for the User

Rivaroxaban Polpharma, 15 mg, hard capsules

Rivaroxaban Polpharma, 20 mg, hard capsules

Rivaroxabanum

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness 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.

Contents of the pack and other information

• 1. What Rivaroxaban Polpharma is and what it is used for
• 2. What you need to know before you take 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 Rivaroxaban Polpharma is and what it is 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 blood clots in the lungs (pulmonary embolism) and prevent new blood clots from forming in the veins 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 prevent the formation of blood clots by blocking factor Xa, which is involved in blood clotting.

2. What you need to know before you take Rivaroxaban Polpharma

Do not 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 bleeding that is not under control,
• if you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes),

if you are taking other medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin), except when switching to Rivaroxaban Polpharma or when heparin is given to maintain the patency of a venous or arterial catheter,

• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take Rivaroxaban Polpharma if any of the above applies to you. Tell your doctor if you think any of these conditions apply to you.

Warnings and precautions

Before taking Rivaroxaban Polpharma, talk to your doctor or pharmacist.

When to exercise extra caution 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 in the body,
• taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching to Rivaroxaban Polpharma or when heparin is given to maintain the patency of a venous or arterial catheter (see "Rivaroxaban Polpharma and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease with treatment,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the stomach and intestines or inflammation of the esophagus (throat) e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus) or tumors in the stomach, intestines, genital or urinary tract,
• vascular disease in the back of the eye (retinopathy),
• pulmonary disease with dilated bronchi and bronchi filled with pus (bronchiectasis) or previous bleeding from the lungs,
• if you have artificial 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 your treatment,
• if you have unstable blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you think any of the above conditions apply to you, tell your doctor before taking Rivaroxaban Polpharma

Your doctor will decide whether to prescribe this medicine and whether you need to be closely monitored.

If you need to have surgery:

• you must carefully follow your doctor's instructions regarding when to take Rivaroxaban Polpharma 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):
• 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, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Polpharma capsules are not recommended for children under 30 kg. There is limited 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 locally on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, where 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 any of the above conditions apply to you, tell your doctor before taking Rivaroxaban Polpharma

as the effect of Rivaroxaban Polpharma may be increased. Your doctor will decide whether to prescribe this medicine and whether you need to be closely monitored. If your doctor considers that you are at increased risk of stomach or duodenal ulcers, they may prescribe 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, an antibiotic.

If you think any of the above conditions apply to you, tell your doctor before taking Rivaroxaban Polpharma

as the effect of Rivaroxaban Polpharma may be reduced. Your doctor will decide whether to prescribe Rivaroxaban Polpharma and whether you need to 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 during treatment with Rivaroxaban Polpharma, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Polpharma 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 machinery.

Rivaroxaban Polpharma contains lactose monohydrate and sodium

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

How much to take

Adults

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

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 15 mg Rivaroxaban Polpharma capsule once daily (or one 10 mg Rivaroxaban Polpharma capsule once daily in case of kidney problems) in combination with an anti-platelet medicine such as clopidogrel.

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

Children and adolescents

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

• For children and adolescents with a body weight of 30 kg to less than 50 kgThe recommended dose is one 15 mg Rivaroxaban Polpharma capsule once daily.
• For children and adolescents with a body weight of 50 kg or moreThe recommended dose is one 20 mg Rivaroxaban Polpharma capsule once daily. Each dose of Rivaroxaban Polpharma should be taken with food, with a drink (e.g. water or juice). Capsules should be taken at the same time every day. It is a good idea to set an alarm to remind you. For parents or caregivers: you should check that the child has taken the whole dose.

The dose of Rivaroxaban Polpharma is based on body weight, so it is important to attend scheduled doctor's appointments, as the dose may need to be adjusted if the child's weight changes. 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. If a smaller dose is needed, an alternative rivaroxaban medicine in the form of granules for oral suspension should be used. For children and adolescents who are unable to swallow whole capsules, a rivaroxaban medicine in the form of granules for oral suspension should be used. If the oral suspension is not available, the contents of the Rivaroxaban Polpharma capsule can be mixed with water or apple puree just before taking. After taking this mixture, you should eat a meal. If necessary, your doctor may also give you the contents of the capsule through a gastric 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, take the next dose of Rivaroxaban Polpharma at the usual time.

Contact your doctor if you spit out the dose or vomit after taking Rivaroxaban Polpharma.

When to take Rivaroxaban Polpharma

Take the capsule(s) every day until your doctor decides to stop treatment. It is best to take the capsule(s) at the same time every day, as this will help you to remember to take them. Your doctor will decide how long you should continue 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, take Rivaroxaban Polpharma as instructed by your doctor.

If you take more Rivaroxaban Polpharma than you should

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

If you forget to take Rivaroxaban Polpharma

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

If you stop taking Rivaroxaban Polpharma

Do 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. As with other medicines that prevent blood clots, Rivaroxaban Polpharma may cause bleeding, which can be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Not all bleeding may be obvious or visible.

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. Seek medical help immediately!),
• prolonged or excessive bleeding,
• unusual weakness, tiredness, paleness, 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 peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• 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 (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 oedema 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 pale skin and be the reason for 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, bleeding from the gums,

bleeding into the eye (including bleeding into the white of the eye),

• bleeding into tissues or body cavities (haematoma, bruising),
• coughing up blood while coughing,
• bleeding from the skin or bleeding under the skin,
• 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 (feeling sick), vomiting, constipation, diarrhoea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general weakness and lack of energy (weakness, tiredness), headache, dizziness,
• skin rash, itching,
• increased activity of certain 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,
• low platelet count (thrombocytopenia),
• allergic reactions, including skin allergic reactions,
• liver problems (which can be seen in tests performed by your doctor),
• blood test results may show increased levels of bilirubin, certain liver or pancreatic enzymes, or platelet count,
• fainting,
• feeling unwell,
• rapid heartbeat,
• dry mouth,
• hives.

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

• bleeding into the muscles,
• cholestasis (bile flow obstruction), liver inflammation, including liver cell damage,
• jaundice (yellowing of the skin and eyes),
• localised swelling,
• blood accumulation (haematoma) in the groin as a complication of cardiac catheterisation, 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 blood cell, which can cause inflammation of the lungs (eosinophilic pneumonia).

Side effects with unknown 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

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. 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 levels of bilirubin,
• low platelet count (thrombocytopenia),
• excessive menstrual bleeding.

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

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below. 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 wording 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 storage instructions for this medicine. The contents of the capsules are stable in water and 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 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 imprint 15 mg, capsule size 4; capsule contents are white or almost white powder or slightly compressed agglomerates. The hard capsules are in blisters of aluminium/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: hard gelatin capsules with a red body and cap, with the imprint 20 mg on the cap, capsule size 3; capsule contents are white or almost white powder or slightly compressed agglomerates. The hard capsules are in blisters of aluminium/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 authorisation holder and manufacturer

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

This medicine is authorised 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 leaflet: