Rivaroxaban bayer

Package leaflet: Information for the user

Rivaroxaban Bayer, 15 mg, film-coated tablets
Rivaroxaban Bayer, 20 mg, film-coated tablets
Rivaroxabanum
Read the entire leaflet 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• 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 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.
This medicine is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels in the body in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation.
• 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 veins of the legs and/or lungs. This medicine is used in children and adolescents under 18 years of age and with body weight of 30 kg or more, to:
• treat blood clots and prevent recurrence of blood clots in the veins or in the blood vessels of the lungs, after at least 5 days of initial treatment with injectable medicines used to treat blood clots.

This medicine belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency to form blood clots.

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 surgical procedure 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 you must inform your doctor if you suspect that any of the above circumstances apply to you.

Warnings and precautions
Before starting this medicine, consult your doctor or pharmacist.
When to exercise particular caution when taking Rivaroxaban Bayer

• if the patient has an increased risk of bleeding, such as in the following conditions:
• severe kidney disease in adults, or moderate to severe kidney disease in children and adolescents, because kidney function may affect the amount of medicine acting in the patient's body,
• blood clotting disorders,
• taking other medicines that prevent blood clots (e.g. warfarin, etexilate dabigatran, apixaban or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaroxaban Bayer and other medicines"),
• very high blood pressure that does not decrease despite medication,
• diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), for example 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 at the back of the eye (retinopathy),
• lung disease with bronchiectasis (dilated airways filled with pus) or previous bleeding from the lungs,
• 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 a change in treatment is needed,
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If the patient suspects that any of the above conditions apply, they should inform their doctor
before taking this medicine. The doctor will decide whether to use this medicine or whether the
patient should be placed under particularly close observation.
If the patient needs to undergo surgery:

• it is essential to strictly follow the doctor's instructions regarding the timing of taking this medicine before or after surgery,
• if during surgery catheterisation or spinal puncture (e.g. for epidural or intrathecal anaesthesia or pain relief) is planned:
• it is very important to take this medicine before and after the puncture or catheter removal, as directed by the doctor,
• due to the need for special caution, the doctor should be informed immediately if numbness or weakness of the legs, or bowel or bladder dysfunction occurs after the anaesthesia wears off.

Children and adolescents
Rivaroxaban Bayer tablets are not recommended for children weighing less than 30 kg.
There is insufficient data on the use of this medicine in children and adolescents for the indications approved for adults.
Rivaroxaban Bayer 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 obtained without a prescription.

• If the patient is taking:
• certain medicines used to treat fungal infections (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 used to treat bacterial infections (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, they should inform their 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 should be placed under particularly close observation.
If the doctor considers that the patient has an increased risk of developing stomach or duodenal ulcers, they 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 medicine used for depression,
• rifampicin, which belongs to the group of antibiotics.

If the patient suspects that any of the above conditions apply, they should inform their 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 should be placed under particularly close observation.
Pregnancy and breastfeeding
Do not use this medicine 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 this medicine. If the patient becomes pregnant while taking Rivaroxaban Bayer, they should inform the 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 the patient has previously been diagnosed with intolerance to certain sugars, they should consult their 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 instructed by your doctor. If you have any doubts,
contact your doctor or pharmacist.
This medicine should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking
this medicine. The tablet may be crushed and mixed with water or soft food such as apple puree,
immediately before administration. After taking this mixture, a meal should be consumed promptly.
If necessary, your doctor may administer crushed Rivaroxaban Bayer tablets via a gastric tube.

How many tablets to take

• Adults
  o For prevention of blood clots in the brain (stroke) and other blood vessels in the body:
  The recommended dose is one Rivaroxaban Bayer 20 mg tablet once daily.
  If you have kidney function impairment, the dose may be reduced to one Rivaroxaban Bayer 15 mg tablet once daily.

  If you require a procedure to unblock blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one Rivaroxaban Bayer 15 mg tablet once daily (or one Rivaroxaban Bayer 10 mg tablet once daily if kidney function is impaired), in combination with an antiplatelet medicine such as clopidogrel.

  o For treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots:
  The recommended dose is one Rivaroxaban Bayer 15 mg tablet twice daily for the first 3 weeks.
  After 3 weeks of treatment, the recommended dose is one Rivaroxaban Bayer 20 mg tablet once daily.
  After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with either one 10 mg tablet once daily or one 20 mg tablet once daily.
  If you have kidney function impairment and are taking one Rivaroxaban Bayer 20 mg tablet once daily, your doctor may decide to reduce the dose after 3 weeks of treatment to one Rivaroxaban Bayer 15 mg tablet once daily if the risk of bleeding is greater than the risk of further blood clots.

• Children and adolescents
  The dose of this medicine depends on body weight and will be calculated by your doctor.

  • The recommended dose for children and adolescents with a body weight of 30 kg to below 50 kg is one Rivaroxaban Bayer 15 mg tablet once daily.
  • The recommended dose for children and adolescents with a body weight of 50 kg or more is one Rivaroxaban Bayer 20 mg tablet once daily.

Each dose of Rivaroxaban Bayer should be taken with a meal, accompanied by a drink (e.g. water or juice). Tablets should be taken every day at approximately the same time. Consider setting an alarm as a reminder.
For parents or caregivers: observe the child to ensure the full dose has been taken.

The dose of Rivaroxaban Bayer depends on body weight, so it is important to attend scheduled doctor’s appointments, as dose adjustments may be necessary due to weight changes.
Never adjust the dose on your own. If needed, your doctor will adjust the dose.
Do not split the tablet to achieve a partial dose. If a lower dose is required, another medicine containing rivaroxaban in the form of granules for oral suspension should be used.
For children and adolescents who cannot swallow whole tablets, Rivaroxaban Bayer in the form of granules for oral suspension should be used.
If the oral suspension is not available, the Rivaroxaban Bayer tablet may be crushed and mixed with water or apple puree immediately before administration. After this mixture, a meal should be consumed. If necessary, your doctor may also administer the crushed tablet via a gastric tube.

If a dose is vomited or regurgitated

• Within 30 minutes of taking this medicine, take a new dose.
• More than 30 minutes after taking this medicine, do not take a new dose. In this case, take the next dose of Rivaroxaban Bayer at the usual time.

Contact your doctor if you repeatedly vomit or regurgitate the medicine after taking it.

When to take Rivaroxaban Bayer
Take the tablet(s) every day until your doctor decides to stop treatment.
It is best to take the tablet(s) at the same time each day, as this makes it easier to remember.
Your doctor will decide how long you should continue treatment.
For prevention of 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 cardioversion procedure, this medicine should be taken as directed by your doctor.

Missed dose of Rivaroxaban Bayer

• Adults, children and adolescents: If you are taking one 20 mg tablet or one 15 mg tablet once daily and you miss a dose, take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. Take the next tablet the following day, then continue taking one tablet once daily.

Adults:
If you are taking one 15 mg tablet twice daily and you miss a dose, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If you forgot to take a dose, you may take two 15 mg tablets at the same time to achieve a total of two tablets (30 mg) taken within one day. The next day, continue taking one 15 mg tablet twice daily.

Taking more Rivaroxaban Bayer than recommended
If you have taken too many Rivaroxaban Bayer tablets, contact your doctor immediately. Taking too high a dose of Rivaroxaban Bayer increases the risk of bleeding.

Stopping Rivaroxaban Bayer
Do not stop taking this medicine without first consulting your doctor, as this medicine treats and prevents serious conditions.
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 reducing blood clot formation, this medicine 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 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. 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, formation of blisters or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement (DRESS syndrome). The frequency of these adverse reactions is very rare (up to 1 in 10,000 people).

Signs of severe allergic reactions

• swelling of the face, lips, oral cavity, tongue or throat; 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 in adults, children and adolescents:
Common (may occur in 1 out of 10 people)

• decrease in red blood cell count 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 severe 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,
• bleeding from the skin or subcutaneous bleeding,
• postoperative bleeding,
• oozing of blood or fluid from a 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 evident 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, 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, activity of certain pancreatic or liver enzymes, or platelet count,
• fainting,
• malaise,
• rapid heartbeat,
• dry mouth,
• urticaria.

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

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

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

Adverse reactions in children and adolescents
Overall, adverse reactions observed in children and adolescents treated with this medicine were similar in type to those observed in adults and were mainly mild to moderate in severity.
Adverse reactions observed more frequently in children and adolescents:
Very common (may occur in more than 1 out of 10 people)

• headache
• fever
• nosebleeds, vomiting

Common (may occur in 1 out of 10 people)

• rapid heartbeat
• blood tests may show increased bilirubin levels (a bile pigment)
• thrombocytopenia (low platelet count, platelets being blood cells that help in clotting)
• excessive menstrual bleeding

Uncommon (may occur in 1 out of 100 people)

• blood tests may show increased levels of a subcategory of bilirubin (direct bilirubin, a bile pigment).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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 outer carton following:
Expiry and on each blister following: 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 pack and other information

What Rivaroxaban Bayer contains

• The active substance is rivaroxaban. One coated tablet contains 15 mg or 20 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: macrogol, hypromellose, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban Bayer looks like and contents of the pack
Rivaroxaban Bayer 15 mg coated tablets are red, round, biconvex, with the BAYER logo engraved on one side and the number "15" and a triangle on the other side.
The tablets are contained:

• in blisters packed in cardboard boxes containing 14, 28, 42 or 98 coated tablets, or
• in unit-dose divisible blisters packed in boxes containing 100 x 1.

Rivaroxaban Bayer 20 mg coated tablets are reddish-brown, round, biconvex, with the BAYER logo engraved on one side and the number "20" and a triangle on the other side.
The tablets are contained:

• in blisters packed in cardboard boxes containing 14, 28 or 98 coated tablets, or
• in unit-dose divisible blisters packed in boxes containing 100 x 1.

Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Austria, Denmark, Germany, France, Italy, Poland, Sweden: Rivaroxaban Bayer