Rivaroxaban Aurovitas

Package Leaflet: Information for the User

Rivaroxaban Aurovitas, 15 mg, film-coated tablets

Rivaroxaban Aurovitas, 20 mg, film-coated tablets

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

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

Rivaroxaban Aurovitas contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots in the brain (stroke) and other blood vessels in patients with irregular heart rhythm (atrial fibrillation) not caused by heart valve problems;
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and prevent blood clots from forming again in the veins and/or lungs. Rivaroxaban Aurovitas is used in children and adolescents aged less than 18 years 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 Aurovitas belongs to a group of medicines called anticoagulants. Its action is to block the factor Xa involved in blood clotting and thus reduce the tendency to form blood clots.

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

Do not take Rivaroxaban Aurovitas:

• 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 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 treatment or when heparin is given to maintain catheter patency in a vein or artery.
• if you have liver disease that increases the risk of bleeding,
• if you are pregnant or breast-feeding. Do not take Rivaroxaban Aurovitas and inform your doctorif you think any of the above applies to you.

Warnings and precautions

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

When to be extra careful when taking Rivaroxaban Aurovitas

• 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;
• if you are taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant treatment or when heparin is given to maintain catheter patency in a vein or artery (see "Rivaroxaban Aurovitas with other medicines");
• bleeding disorders;
• very high blood pressure that does not decrease with treatment;
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or inflammation of the esophagus (throat and esophagus) due to reflux disease (backflow of stomach acid into the esophagus) or tumors in the stomach, intestines, genital or urinary system;
• vascular disease in the back of the eye (retinopathy);
• lung disease with dilated bronchi and pus (bronchiectasis) or previous bleeding from the lungs;
• in patients with prosthetic 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 treatment may need to be changed
• if you have abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If any of the above points apply to you, tell your doctor

before taking Rivaroxaban Aurovitas. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.

If you are going to have surgery:

• It is very important to take Rivaroxaban Aurovitas before and after surgery at the times specified by your doctor.
• If a catheter is to be inserted or an injection is to be given into the spinal cord (e.g. for spinal or epidural anesthesia or pain relief):
• it is very important to take Rivaroxaban Aurovitas before and after the injection or removal of the catheter at the times specified by your doctor;
• you should immediately inform your doctor if you experience numbness or weakness in your legs, or bowel or bladder problems after anesthesia, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Aurovitas is not recommended for children weighing less than 30 kg. There is limited data on the use of this medicine in children and adolescents for adult indications.

Rivaroxaban Aurovitas with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• 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 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 norepinephrine reuptake inhibitors (SNRIs)).

If any of the above points apply to you, tell your doctor before taking Rivaroxaban Aurovitas, as the effect of this medicine may be increased if taken with the above medicines. Your doctor will decide whether to use this medicine and whether you need to be closely monitored.
If your doctor thinks you are at risk of developing stomach or duodenal ulcers, they may prescribe treatment to prevent this.

• 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 any of the above points apply to you, tell your doctor

before taking Rivaroxaban Aurovitas, as the effect of this medicine may be reduced if taken with the above medicines. Your doctor will decide whether to use Rivaroxaban Aurovitas and whether you need to be closely monitored.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Rivaroxaban Aurovitas if you are pregnant or breast-feeding. If there is a risk that you may become pregnant, you should use effective contraception during treatment with Rivaroxaban Aurovitas. If you become pregnant while taking this medicine, you should inform your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Aurovitas 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 Aurovitas contains lactose and sodium.

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially "sodium-free".

3. How to take Rivaroxaban Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Rivaroxaban Aurovitas should be taken with food.
Swallow the tablet(s) whole with water.
If you have difficulty swallowing whole tablets, talk to your doctor about other ways to take Rivaroxaban Aurovitas.
The tablet can be crushed and mixed with water or soft food such as apple puree, immediately before taking. After such a mixture, the meal should be eaten immediately. If necessary, your doctor may also give you a crushed tablet through a gastric tube.

How many tablets to take

• Adults
• In the prevention of blood clots in the brain (stroke) and other blood vessels: the recommended dose is one 20 mg Rivaroxaban Aurovitas tablet once daily. If you have kidney problems, the dose may be reduced to one 15 mg Rivaroxaban Aurovitas tablet once daily.

If you need a procedure to open up 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 Aurovitas tablet once daily (or one 10 mg Rivaroxaban Aurovitas tablet once daily in case of kidney problems) in combination with an antiplatelet agent such as clopidogrel.

• In the treatment of blood clots in the veins of the legs, blood clots in the lungs and to prevent blood clots from forming again: the recommended dose is one 15 mg Rivaroxaban Aurovitas tablet twice daily for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg Rivaroxaban Aurovitas tablet once daily. After at least 6 months of treatment for blood clots, your doctor may decide to continue treatment with one 10 mg tablet once daily or one 20 mg tablet once daily.

If you have kidney problems, your doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaroxaban Aurovitas tablet once daily if the risk of bleeding is higher than the risk of further blood clots.

Children and adolescents

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

• Recommended dose for children and adolescents with body weight from 30 kg to less than 50 kgis one Rivaroxaban Aurovitas 15 mgtablet once daily.
• Recommended dose for children and adolescents with body weight of 50 kgor more is one Rivaroxaban Aurovitas 20 mgtablet once daily. Each dose of Rivaroxaban Aurovitas should be taken with food, with a drink (e.g. water or juice). Tablets should be taken daily at approximately the same time. It is a good idea to set an alarm to remind you. For parents or caregivers: you should observe the child to make sure they take the entire dose.

The dose of Rivaroxaban Aurovitas is weight-dependent, so it is important to attend scheduled doctor's appointments, as the dose may need to be adjusted due to weight changes.
Never adjust the dose yourself.If necessary, your doctor will adjust the dose.
Do not divide the tablet to obtain a partial dose of the tablet. If a smaller dose is needed, use a different form of Rivaroxaban Aurovitas, a granule for oral suspension.
For children and adolescents who are unable to swallow whole tablets, use Rivaroxaban Aurovitas in the form of granules for oral suspension.
If the oral suspension is not available, you can crush the Rivaroxaban Aurovitas tablet and mix it with water or apple puree immediately before taking. After such a mixture, the meal should be eaten immediately. If necessary, your doctor may also give you a crushed tablet through a gastric tube.

If you spit out or vomit a dose

• less than 30 minutes after taking Rivaroxaban Aurovitas, you should take a new dose.
• more than 30 minutes after taking Rivaroxaban Aurovitas, do nottake a new dose. In this case, the next dose of Rivaroxaban Aurovitas should be taken at the usual time.

Contact your doctor if you spit out or vomit a dose or have repeated vomiting after taking Rivaroxaban Aurovitas.

When to take Rivaroxaban Aurovitas

Take the tablet(s) daily until your doctor decides to stop treatment.
It is best to take the tablet(s) at the same time every day, as this will help you remember.
Your doctor will decide how long you should continue treatment.
Prevention of blood clots in the brain (stroke) and other blood vessels:
If your heart rhythm needs to be restored to normal using a procedure called cardioversion, you should take Rivaroxaban Aurovitas as directed by your doctor.

If you take more Rivaroxaban Aurovitas than you should

If you take more Rivaroxaban Aurovitas than you should, contact your doctor immediately. Taking too much Rivaroxaban Aurovitas increases the risk of bleeding.

If you forget to take Rivaroxaban Aurovitas

• Adults, children and adolescents If you take one 20 mg or one 15 mg tablet once daily and miss a dose, take it as soon as possible. Do not take more than one tablet in one day to make up for a missed dose. Take the next tablet at the usual time the next day and then take one tablet once daily.
• Adults If you take one 15 mg tablet twice daily and miss a dose, take it as soon as possible. Do not take more than two 15 mg tablets in one day. If you miss a dose, you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) taken in one day. The next day, continue taking one 15 mg tablet twice daily.

If you stop taking Rivaroxaban Aurovitas

Do not stop taking Rivaroxaban Aurovitas without first talking to your doctor, as Rivaroxaban Aurovitas prevents a serious condition.
If you have any further questions on the use of this product, 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 prevent blood clotting, Rivaroxaban Aurovitas can cause bleeding, which can be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These are not always obvious or visible signs of bleeding.

Seek medical help immediately if you or your child experience any of the following side effects:

• Signs of bleeding:
• bleeding into the brain or skull (symptoms may include headache, one-sided weakness, vomiting, seizures, decreased level of consciousness and stiff neck. This is a serious medical emergency. Seek medical help immediately!).
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina. Your doctor may decide that you need to be closely monitored 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),
• a drug reaction that causes a rash, fever, inflammation of internal organs, blood disorders and a systemic disease (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, tongue, throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe side effects is very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic edema; may affect up to 1 in 100 people).

General list of possible side effects in adults, children and adolescents:

Common(may affect up to 1 in 10 people):

• reduced red blood cell count, which can cause pallor and be the cause of weakness or shortness of breath;
• bleeding from the stomach or intestines, bleeding from the urinary or reproductive system (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding;
• bleeding into the eye (including bleeding into the conjunctiva);
• bleeding into tissues or body cavities (hematoma, bruising);
• appearance of blood in sputum 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 problems (can be seen in tests performed by your doctor);
• fever;
• stomach pain, nausea (nausea) or 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;
• increased activity of certain liver enzymes, which can be seen in blood test results.

Uncommon(may affect up to 1 in 100 people):

• bleeding into the brain or skull (see above, signs of bleeding);
• bleeding into a joint, causing pain and swelling;
• low platelet count (low number of platelets, cells involved in blood clotting);
• allergic reactions, including allergic skin reactions;
• liver problems (can be seen in tests performed by your doctor);
• blood test results may show increased bilirubin levels, increased activity of certain liver or pancreatic enzymes, or increased platelet count;
• fainting;
• malaise;
• rapid heartbeat;
• dry mouth;
• hives.

Rare(may affect up to 1 in 1,000 people):

• bleeding into muscles;
• cholestasis (bile stasis), liver inflammation, including liver cell damage;
• jaundice (yellowing of the skin and eyes);
• local swelling;
• pseudoaneurysm (a complication of catheterization of the heart, where the catheter is inserted into an artery in the leg).

Very rare(may affect up to 1 in 10,000 people):

• accumulation of eosinophils, a type of white blood cell, which can cause inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure after severe bleeding;
• kidney bleeding, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with anticoagulant use);
• 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 Aurovitas were similar in type to those seen in adults and were mostly mild to moderate.
Side effects seen more frequently in children and adolescents:
Very common(may affect more than 1 in 10 people)

• headache;
• fever;
• nosebleeds;
• vomiting.

Common(may affect up to 1 in 10 people)

• rapid heartbeat;
• blood test results may show increased bilirubin levels;
• low platelet count (low number of platelets, which are cells that help blood clot);
• excessive menstrual bleeding.

Uncommon(may affect up to 1 in 100 people)

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

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, 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
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 Aurovitas

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 label, blister, carton and bottle after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
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. This will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Aurovitas contains

• The active substance is rivaroxaban. Each tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, hypromellose type 2910 (3 cPs), sodium lauryl sulfate, magnesium stearate; Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide red (E 172).

What Rivaroxaban Aurovitas looks like and contents of the pack

Film-coated tablet.
Rivaroxaban Aurovitas, 15 mg:
Red, round, biconvex film-coated tablets with "M" engraved on one side of the tablet and "15" on the other side.
Rivaroxaban Aurovitas, 20 mg:
Dark red to brown-red, oval, biconvex film-coated tablets with "M" engraved on one side of the tablet and "20" on the other side.
Rivaroxaban Aurovitas film-coated tablets are available in blisters and HDPE bottles.
Blisters: 5, 10, 14, 15, 28, 30, 42, 56, 60, 90, 98, 100, 168, 196 and 200 film-coated tablets.
HDPE bottle: 30, 100, 250 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26 Hal Far Industrial Estate
Birzebbugia, BBG 3000
Malta
Arrow Génériques - Lyon
26 Avenue Tony Garnier
69007 Lyon
France
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Rivaroxaban AB 15 mg/ 20 mg film-coated tablets
Germany:
Rivaroxaban PUREN 15 mg/ 20 mg film-coated tablets
France:
Rivaroxaban Arrow 15 mg /20 mg film-coated tablets
Netherlands:
Rivaroxaban Aurobindo 15 mg /20 mg film-coated tablets
Poland:
Rivaroxaban Aurovitas
Portugal:
Rivaroxaban Aurovitas
Spain:
Rivaroxaban Aurovitas 15 mg /20 mg film-coated tablets EFG

Date of last revision of the leaflet: 02/2024