Rivaroxaban bayer

Package leaflet: Information for the user

Rivaroxaban Bayer, 10 mg, film-coated tablets
Rivaroxabanum
Read the entire leaflet carefully before taking this medicine, because it contains important information for the patient

• Keep this leaflet for future reference.
• If you have any further questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

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

This medicine contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots in veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because the risk of developing blood clots is increased after surgery.
• treat blood clots in the veins of the legs (deep vein thrombosis) and blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the blood vessels of the legs and/or lungs.

This medicine 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 BAYER

When not to take Rivaroxaban Bayer

• 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 in the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clots (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.

Do not use this medicine and inform your doctor if you suspect that any of the above-mentioned circumstances apply to you.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
When to exercise special caution when taking Rivaroxaban Bayer

• 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,
• if the patient is taking other medicines that prevent blood clots (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 (see section "Rivaroxaban Bayer and other medicines"),
• blood clotting disorders,
• very high blood pressure that does not decrease despite medication,
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (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 reproductive or urinary system,
• blood vessel disease of the back of the eye (retinopathy),
• lung 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 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 a change in treatment is necessary,
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

If you suspect that any of the above-mentioned conditions apply to you, inform your doctor
before taking this medicine. The doctor will decide whether to use this medicine or whether the
patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking this medicine before or after surgery,
• if during surgery the patient is scheduled to undergo lumbar puncture or placement of a catheter into the spine (e.g. for epidural or spinal anaesthesia or for pain relief):
• strictly follow the doctor's instructions regarding the timing of taking this medicine,
• immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, disturbances in bowel movements or bladder function, as immediate treatment is required in such cases.

Children and adolescents
Rivaroxaban Bayer 10 mg tablets 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 Bayer and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available 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,
• 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 you suspect that any of the above-mentioned conditions apply to you, inform your doctor
before taking this medicine, as the effect of this medicine may be enhanced.
The doctor will decide whether to use this medicine or whether the patient requires particularly close
monitoring.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcer, he may prescribe treatment to prevent peptic disease.

• If you are 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 you suspect that any of the above-mentioned conditions apply to you, inform your doctor
before taking this medicine, as the effect of this medicine may be reduced.
The doctor will decide whether to use this medicine or whether the patient requires particularly close
monitoring.
Pregnancy and breastfeeding
Do not use this medicine if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with this medicine. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further treatment.
Driving and operating machinery
This medicine 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 Bayer contains lactose and sodium.
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take RIVAROXABAN BAYER

This medicine should always be taken as directed by the physician. If in doubt, consult the
physician or pharmacist.
How many tablets to take

• To prevent blood clots in the veins after hip or knee replacement surgery, the recommended dose is one Rivaroxaban Bayer 10 mg tablet taken once daily.

For the treatment of blood clots in the leg veins, 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 tablet once daily or one 20 mg tablet once daily. The physician has prescribed the patient Rivaroxaban Bayer 10 mg once daily.
The tablet should be swallowed whole, preferably with water.
This medicine may be taken with food or independently of meals.
If the patient has difficulty swallowing the whole tablet, consult the physician about alternative methods of administering this medicine. The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration.
If necessary, the physician may administer crushed Rivaroxaban Bayer tablets via a gastric tube.
When to take Rivaroxaban Bayer
One tablet should be taken every day until the physician decides to discontinue treatment.
It is best to take the tablet at the same time each day, as this makes it easier to remember.
The physician will decide how long treatment should continue.
To prevent blood clots in the leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
In patients undergoing major hip surgery, treatment usually lasts 5 weeks.
In patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more than the recommended dose of Rivaroxaban Bayer
If the patient has taken more than the recommended dose of Rivaroxaban Bayer, contact the physician immediately. Taking too high a dose of Rivaroxaban Bayer increases the risk of bleeding.
Missing a dose of Rivaroxaban Bayer
If the patient forgets to take a dose, take the tablet as soon as remembered. Take the next tablet the following day, then continue taking the tablets as usual, once daily.
Do not take a double dose to make up for a missed tablet.
Stopping Rivaroxaban Bayer treatment
Do not stop taking this medicine without first discussing it with the physician, as this medicine prevents the occurrence of a serious condition.
If there are any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Like other medicines with a similar mechanism of action that reduce blood clot formation, this medicine can cause bleeding, which potentially may 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 contact your doctor immediately 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, decreased level of consciousness and neck stiffness. 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. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, inflammation of internal organs, 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
You should contact your doctor immediately if the following adverse reactions occur:

• swelling of the face, lips, oral cavity, tongue or throat; difficulty swallowing; urticaria and breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse reactions:
Common ( may occur in 1 out of 10 people )

• decreased number of red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding gums,
• 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,
• skin bleeding or subcutaneous bleeding,
• postoperative bleeding,
• 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 arterial blood pressure (symptoms may include dizziness or fainting upon standing),
• general decrease in strength and energy (weakness, fatigue), headache, dizziness,
• rash, itching of the skin,
• increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon ( may occur in 1 out of 100 people )

• 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, the blood cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• 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,
• liver function disorders (may be observed in tests performed by a doctor).

Rare ( may occur in 1 out of 1,000 people )

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

Very rare (may occur in 1 out of 10,000 people)

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

Frequency not known (frequency cannot be estimated from available data)

• kidney failure following severe bleeding,
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to impaired kidney function (drug-induced anticoagulant-related nephropathy),
• increased pressure within the muscles of 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 possible adverse symptoms not listed in this leaflet, consult your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 to provide more information on the safety of the medicine.

5. How to store Rivaroxaban Bayer

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after: EXP and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special precautions for storage are required.
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 no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Bayer contains

• The active substance is rivaroxaban. One coated tablet contains 10 mg of rivaroxaban.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, sodium lauryl sulfate, magnesium stearate. See section 2, "Rivaroxaban Bayer contains lactose and sodium".
  Coating: polyethylene glycol, hypromellose, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban Bayer looks like and contents of the pack
Rivaroxaban Bayer 10 mg coated tablets are light red, round, biconvex, and have the BAYER logo embossed on one side and the number "10" and a triangle on the other side.
The tablets are contained

• in blisters packed in cardboard boxes containing 5, 10, 30 or 98 coated tablets, or
• in perforated blister strips divided into single doses, packed in cardboard boxes containing 100 x 1 tablet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany
Tel: +48 22 572 35 00

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
Bayer HealthCare Manufacturing Srl.
Via delle Groane, 126
20024 Garbagnate Milanese
Italy
Bayer Bitterfeld GmbH
Ortsteil Greppin, Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria, Denmark, Germany, France, Italy, Poland, Sweden: Rivaroxaban Bayer