Rivaroxaban Polpharma

Package Leaflet: Information for the User

Rivaroxaban Polpharma, 10 mg, Hard Capsules

Rivaroxaban
Read carefully the entire contents of this leaflet before taking this medicine, as 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

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 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 after surgery, the risk of blood clots is increased.
• 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 blood vessels of the legs and/or lungs.

Rivaroxaban Polpharma 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 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 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),
• 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 Polpharma, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting to take 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, in conditions such as:
• moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in your body,
• taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see section "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 (stomach acid flowing back into the esophagus) or tumors located in the stomach or intestines or the genital or urinary system,
• vascular disease of the back of the eyeball (retinopathy),
• pulmonary disease in which the bronchi are enlarged and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if you have a disorder 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 suspect that you have any of the above conditions, inform your doctor

before taking Rivaroxaban Polpharma. Your doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• you must strictly follow your doctor's instructions regarding the intake of Rivaroxaban Polpharma at a precisely specified time before or after surgery.
• if spinal or epidural anesthesia is planned (e.g., for pain relief):
• it is very important to take Rivaroxaban Polpharma at the times indicated by your doctor,
• you should immediately inform your doctor if, after the anesthesia, you experience numbness or weakness in your legs, bowel or bladder disorders, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Polpharma 10 mg capsules are not recommended for persons under 18 years of age. There is a lack of sufficient data on the use of the medicine in children and adolescents.

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 for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines for 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 noradrenaline reuptake inhibitors (SNRIs)).

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

before taking Rivaroxaban Polpharma, as the action of Rivaroxaban Polpharma may be enhanced. Your doctor will decide whether to use this medicine and whether you should be under close observation.
If your doctor considers that you are at increased risk of developing stomach or duodenal ulcers, he may use a treatment to prevent ulcers.

• If you are taking
• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression,
• rifampicin, which belongs to a group of antibiotics.

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

before taking Rivaroxaban Polpharma, as the action of Rivaroxaban Polpharma may be reduced. Your doctor will decide whether to use Rivaroxaban Polpharma and whether you should be under close observation.

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 this medicine, you should immediately inform your doctor, 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"). Patients who experience these side effects should not drive, ride a bicycle, or operate tools or machines.

Rivaroxaban Polpharma 10 mg contains lactose monohydrate (a type of sugar) and sodium

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

3. How to take Rivaroxaban Polpharma

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

How many capsules to take

• To prevent blood clots in the veins after hip or knee replacement surgeryThe recommended dose is one capsule of Rivaroxaban Polpharma 10 mg taken once a day.
• For the treatment of 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 capsule of 10 mg once a day or one capsule of 20 mg once a day. Your doctor has prescribed Rivaroxaban Polpharma 10 mg once a day for you.

Swallow the capsule whole, preferably with water.
Rivaroxaban Polpharma can be taken with or without food.
If you have difficulty swallowing the whole capsule, 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 it.
If necessary, your doctor may administer the contents of the Rivaroxaban Polpharma capsule through a gastric tube.

When to take Rivaroxaban Polpharma

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

Take the first capsule 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 Polpharma

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

Missing a dose of Rivaroxaban Polpharma

If you have forgotten to take a dose, take the capsule as soon as you remember.
Take the next capsule the next day, and then take the capsules as usual, once a day.
Do not take a double dose to make up for the missed capsule.

Stopping treatment with Rivaroxaban Polpharma

Do not stop taking Rivaroxaban Polpharma without first talking to your doctor, as Rivaroxaban Polpharma prevents a serious disease.
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.
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.

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, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide to closely monitor you or change the treatment.
• Signs of severe skin reactions:
• widespread, acute skin rash, blistering, or changes in the mucous membranes, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, inflammation of internal organs, hematological 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; 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

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

• reduction in red blood cell count, which may 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 sclera),
• bleeding into tissues or body cavities (hematoma, bruising),
• appearance of blood in sputum (hemoptysis) 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 disorders (can be observed in tests performed by your doctor),
• fever,
• stomach pain, nausea (nausea), 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 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 the joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver disorders (can be observed in tests performed by your doctor),
• blood test results may show increased bilirubin levels, activity of certain 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),
• local swelling,
• accumulation 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(occur in less than 1 in 10,000 patients)

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

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

• renal failure after severe bleeding,
• bleeding in the kidneys, 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).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please 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:
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 stated on the blister and carton after: EXP. The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
There are no special precautions for storing the medicine.
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 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 the medicine is rivaroxaban. Each capsule contains 10 mg of rivaroxaban.
• The other ingredients are: capsule contents: sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose type 2910, magnesium stearate; capsule shell: gelatin, yellow iron oxide (E 172), 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

Hard gelatin capsules with an orange body and a red cap with the imprint 10 mg, capsule size 1; the capsule contents are a white or almost white powder or slightly compressed agglomerates.
The hard capsules are in blisters of aluminum/PVC/PVDC foil, in a cardboard box.
Rivaroxaban Polpharma 10 mg is available in packs of 10 hard capsules.

Marketing authorization holder and manufacturer

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 10 mg твърди капсули
LV: Rivaroxaban Polpharma 10 mg cietās kapsulas
LT: Rivaroxaban Polpharma 10 mg kietosios kapsulės
PL: Rivaroxaban Polpharma

Date of the last revision of the leaflet: