Rivaroxaban polpharma

Package leaflet: Information for the user

Rivaroxaban Polpharma, 10 mg, hard capsules
Rivaroxabanum
Please read all of this leaflet carefully before taking this medicine , because it contains
important information for you.

• Keep this leaflet, as 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 personally. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet

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 and is used in adults to:

• prevent blood clots from forming in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots after surgery 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 to 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. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

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 active bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Rivaroxaban Polpharma must not be used, and the doctor must be informed if the patient suspects that any of the above circumstances apply.

Warnings and precautions
Before starting to take Rivaroxaban Polpharma, discuss this with your doctor or
pharmacist.
When to exercise particular caution when taking Rivaroxaban Polpharma

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
  • taking other medicines that prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban Polpharma with other medicines"),
  • blood clotting disorders,
  • very high blood pressure that does not decrease despite medication,
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammatory bowel disease or gastritis, or oesophagitis (inflammation of the throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines, or in the genital or urinary system,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease with dilated airways filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with heart valve prostheses,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment needs to be changed,
• if the patient has been diagnosed with unstable blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

If the patient suspects that any of the above conditions apply, the doctor must be informed
before taking Rivaroxaban Polpharma. The doctor will decide whether to use this medicine and whether
the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• it is essential to strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Polpharma before or after surgery.
• if a lumbar puncture or spinal catheter placement is planned during surgery (e.g. for epidural or spinal anaesthesia or for pain relief):
  • it is very important to take Rivaroxaban Polpharma exactly at the times specified by the doctor,
  • the doctor must be informed immediately if, after the anaesthesia, numbness or weakness in the legs, or disturbances in bowel or bladder function occur, as immediate treatment may be required.

Children and adolescents
Rivaroxaban Polpharma 10 mg capsules are not recommended for patients under 18 years of age.
There is insufficient data on the use of this medicine in children and adolescents.
Rivaroxaban Polpharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking
  • certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
  • ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
  • certain antibiotics (e.g. clarithromycin, erythromycin),
  • certain antiviral medicines used in HIV infection or AIDS treatment (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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If the patient suspects that any of the above conditions apply, the doctor must be informed
before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be enhanced.
The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, he may prescribe treatment to prevent peptic ulcer disease.

• If the patient is taking
  • certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
  • St John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
  • rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above conditions apply, the doctor must be informed
before taking Rivaroxaban Polpharma, as the effect of Rivaroxaban Polpharma may be reduced.
The doctor will decide whether to use Rivaroxaban Polpharma and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not use Rivaroxaban Polpharma if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, an effective method of contraception should be used during treatment with Rivaroxaban Polpharma. If the patient becomes pregnant while taking this medicine, she must inform the doctor immediately, who will decide on further treatment.
Driving and operating machinery
Rivaroxaban Polpharma may cause dizziness (common side effects)
and fainting (uncommon side effects) (see section 4 "Possible side effects").
Patients experiencing these side effects should not drive, ride a bicycle or operate tools or machinery.
Rivaroxaban Polpharma 10 mg contains monohydrate lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult the doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Rivaroxaban Polpharma

This medicine should always be taken exactly as your doctor has told you. If you are unsure, you should
consult your doctor or pharmacist.
How many capsules to take

• To prevent blood clots in the veins after hip or knee replacement surgery
  The recommended dose is one 10 mg Rivaroxaban Polpharma capsule taken once daily.
• For the treatment of blood clots in the legs, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots
  After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once daily or one 20 mg capsule once daily. Your doctor has prescribed Rivaroxaban Polpharma 10 mg once daily for you.

Swallow the capsule whole, preferably with water.
Rivaroxaban Polpharma may be taken with or without food.
If you have difficulty swallowing the entire capsule, talk to your doctor about other ways of taking
Rivaroxaban Polpharma. The contents of the capsule may be mixed with water or apple puree immediately before taking.
If necessary, your doctor may administer the emptied contents of the Rivaroxaban Polpharma capsule
through a gastric tube.
When to take Rivaroxaban Polpharma
Take the capsule every day until your doctor decides to stop treatment.
It is best to take the capsule at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
To prevent blood clots in the legs after hip or knee replacement surgery:
Take the first capsule between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.
If you take more Rivaroxaban Polpharma than you should
If you take more than the prescribed dose of Rivaroxaban Polpharma, contact your doctor immediately.
Taking too much Rivaroxaban Polpharma increases the risk of bleeding.
If you forget to take Rivaroxaban Polpharma
If you forget to take a dose, take the capsule as soon as you remember.
Take the next capsule the following day, and then continue taking the capsules as usual, once daily.
Do not take a double dose to make up for a forgotten capsule.
Stopping Rivaroxaban Polpharma
Do not stop taking Rivaroxaban Polpharma without first talking to your doctor, as this medicine helps prevent serious illness.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, Rivaroxaban
Polpharma may cause bleeding, which potentially can be life-threatening. Excessive
bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always
obvious or visible.
You should immediately inform your doctor if any of the following adverse reactions occur:

• Signs of bleeding:
  • bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, reduced level of consciousness and neck stiffness. This is a serious medical emergency. Seek immediate 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 close monitoring of the patient or a change in treatment is necessary.
• Signs of severe skin reactions:
  • widespread, acute skin rash, blistering or mucosal lesions, e.g. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic symptoms (DRESS syndrome). The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).
• Signs of serious allergic reactions:
  • swelling of the face, lips, mouth, tongue or throat, difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe hypersensitivity 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 adverse reactions
Common adverse reactions (occur in less than 1 in 10 patients)

• reduction in red blood cells which may cause skin pallor and lead to weakness or shortness of breath,
• bleeding from the stomach or intestine, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from or under the skin,
• bleeding after surgery,
• oozing of blood or fluid from the surgical wound,
• limb swelling,
• limb pain,
• kidney function disorders (may be observed in tests performed by a doctor),
• fever,
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, skin itching,
• increased activity of certain liver enzymes, which may be evident in blood test results.

Uncommon adverse reactions (occur in less than 1 in 100 patients)

• bleeding into the brain or inside the skull (see signs of bleeding above),
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• liver function disorders (may be observed in tests performed by a doctor),
• blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria.

Rare adverse reactions (occur in less than 1 in 1,000 patients)

• bleeding into muscles,
• cholestasis (bile stasis), hepatitis including liver cell damage,
• yellowing of the skin and eyes (jaundice),
• local swelling,
• collection of blood (hematoma) in the groin as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare adverse reactions (occur in less than 1 in 10,000 patients)

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

Adverse reactions with unknown frequency (frequency cannot be determined from
available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with blood in urine, leading to impaired kidney function (drug-related anticoagulant nephropathy),
• increased pressure in the muscles of the arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 the cardboard
package following the word EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
No special storage instructions apply.
The capsule contents remain stable in water and apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 10 mg of rivaroxaban.
• Other ingredients are: capsule content: sodium lauryl sulfate, monohydrate lactose, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose type 2910, magnesium stearate; capsule shell: gelatin, yellow iron oxide (E 172), red iron oxide (E 172); printing ink: shellac, black iron oxide (E 172), propylene glycol (E 1520), ammonium hydroxide, concentrated.

What Rivaroxaban Polpharma looks like and contents of the pack
Hard gelatin capsules with an orange body and a red cap, printed with "10 mg", capsule size No. 1; the capsule filling is a white or almost white powder or slightly compressed agglomerates.
The hard capsules are contained in blisters made of Aluminium/PVC/PVDC foil, packed in a cardboard box.
Rivaroxaban Polpharma 10 mg is available in packs containing 10 hard capsules.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

This medicinal product is authorised 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