Rivaroxaban Aurovitas

Leaflet attached to the packaging: information for the user

Rivaroxaban Aurovitas, 15 mg, film-coated tablets

Rivaroxaban Aurovitas, 20 mg, film-coated tablets

Starter pack

Do not use in children.
Rivaroxabanum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rivaroxaban Aurovitas and what is it used for
• 2. Important information before taking 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 is Rivaroxaban Aurovitas and what is it used for

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

• 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 Aurovitas 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 Aurovitas

When not to take Rivaroxaban Aurovitas:

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient has excessive bleeding,
• if the patient has a disease or condition of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if the patient is 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 the patency of a vein or artery catheter.
• if the patient has liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not take Rivaroxaban Aurovitas and inform your doctorif you suspect that any of the above circumstances apply to you.

Warnings and precautions

Before starting to take Rivaroxaban Aurovitas, you should talk to your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Aurovitas

• if the patient has an increased risk of bleeding, in such conditions as:
• severe kidney disease, as kidney function may affect the amount of medicine that works in the patient's body;
• if the patient is 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 the patency of a vein or artery catheter (see section "Rivaroxaban Aurovitas 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 (backflow of stomach acid into the esophagus) or tumors located in the stomach or intestines or genital or urinary system;
• disease of the blood vessels in the back of the eye (retinopathy);
• pulmonary 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 disease called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), they should inform their doctor, who will decide whether treatment may need to be changed;
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment to remove a blood clot from the lungs.

If any of the above points apply to the patient, they should tell their doctor

before taking Rivaroxaban Aurovitas .The doctor will decide whether to use this medicine and whether the patient should be closely monitored.

If the patient is to be operated on:

• It is very important to take Rivaroxaban Aurovitas before and after surgery at the times specified by the attending physician.
• If during the surgical procedure the patient is scheduled to have a catheter inserted or an injection into the spinal cord (e.g. for spinal or epidural anesthesia or to reduce pain):
• it is very important to take Rivaroxaban Aurovitas before and after the injection or removal of the catheter at the times specified by the attending physician;
• the doctor should be informed immediately if, after the anesthesia is completed, numbness or weakness of the legs occurs, or bowel or bladder disorders, as immediate treatment may be necessary.

Children and adolescents

The starter pack for treatment with Rivaroxaban Aurovitas is not recommended for people under 18 years of age, as it is specifically designed for the initiation of treatment in adult patients and is not suitable for use in children and adolescents.

Rivaroxaban Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available 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 locally on the skin;
• ketokonazole in tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol);
• certain medicines used to treat 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 any of the above points apply to the patient, they should tell their doctor before taking Rivaroxaban Aurovitas ,as the effect of this medicine may be increased if it is used at the same time as the above-mentioned medicines. The doctor will decide whether to use this medicine and whether the patient should be closely monitored.
If the doctor considers that the patient is at increased risk of developing stomach or duodenal ulcers, they may use treatment to prevent stomach ulcers.

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

If any of the above points apply to the patient, they should tell their doctor

before taking Rivaroxaban Aurovitas ,as the effect of this medicine may be reduced if it is given at the same time as the above-mentioned medicines. The doctor will decide whether to use Rivaroxaban Aurovitas and whether the patient should be closely monitored.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Do not take Rivaroxaban Aurovitas if the patient is pregnant or breastfeeding. If there is a risk that the patient may become pregnant, they should use effective contraception while taking Rivaroxaban Aurovitas. If the patient becomes pregnant while taking this medicine, they should inform their 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 the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Rivaroxaban Aurovitas

This medicine should always be taken as directed by the doctor. If you have any doubts, you should consult your doctor or pharmacist.
Rivaroxaban Aurovitas should be taken with food.
The tablet(s) should be swallowed, preferably with water.
If the patient has difficulty swallowing the whole tablet, they should talk to their doctor about other ways of taking Rivaroxaban Aurovitas.
The tablet can be crushed and mixed with water or soft food, such as apple puree, immediately before taking it. The mixture should be taken immediately after preparation.
If necessary, the doctor may administer the crushed tablet of Rivaroxaban Aurovitas through a gastric tube.

How many tablets to take

• The recommended dose is one 15 mg tablet of Rivaroxaban Aurovitas twice a day for the first 3 weeks. After 3 weeks, the recommended dose is one 20 mg tablet of Rivaroxaban Aurovitas once a day. The starter pack of Rivaroxaban Aurovitas 15 mg and 20 mg is used only for the first 4 weeks of treatment. After completing this pack, treatment will be continued with Rivaroxaban Aurovitas 20 mg once a day, as directed by the doctor. If the patient has kidney problems, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg tablet once a day, if the risk of bleeding is greater than the risk of further blood clots.

When to take Rivaroxaban Aurovitas

The tablet(s) should be taken every day until the doctor decides to stop treatment.
It is best to take the tablet(s) at the same time every day, as it is easier to remember.
The doctor will decide how long the patient should continue treatment.

Taking a higher dose of Rivaroxaban Aurovitas than recommended

If the patient has taken a higher dose of Rivaroxaban Aurovitas than recommended, they should contact their doctor immediately. Taking too high a dose of Rivaroxaban Aurovitas increases the risk of bleeding.

Missing a dose of Rivaroxaban Aurovitas

• If the patient is taking one 15 mg tablet twice a day and a dose of the medicine has been missed, they should take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient has forgotten to take a dose, they may 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, they should continue taking one 15 mg tablet twice a day.
• If the patient is taking one 20 mg tablet once a day and a dose of the medicine has been missed, they should take the tablet as soon as possible. Do not take more than one tablet in one day to make up for the missed dose. The next tablet should be taken the next day, and then one tablet should be taken once a day.

Stopping treatment with Rivaroxaban Aurovitas

Do not stop taking Rivaroxaban Aurovitas without first talking to your doctor, as Rivaroxaban Aurovitas prevents the occurrence of a serious disease.
If you have any further doubts about taking this medicine, you should consult 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 with similar anticoagulant action, Rivaroxaban Aurovitas may cause bleeding, which can potentially 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.

The patient should immediately inform their doctor if they 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. A serious medical emergency. Medical help should be sought immediately!).
• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina pectoris. The doctor may decide to closely monitor the patient or change the treatment.
• Signs of severe skin reactions:
• -widespread, acute skin rash, blistering or changes to the mucous membranes, e.g. on the tongue or eyes (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 serious allergic reactions:
• -swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; a sudden drop in blood pressure. The frequency of serious 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:

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

• reduced 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 genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, gum bleeding;
• 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 function disorders (can be observed in tests performed by the 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 of the skin;
• increased activity of some liver enzymes, which can be seen in blood test results.

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

• 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 function disorders (can be observed in tests performed by the doctor);
• blood test results may show increased bilirubin levels, activity of some pancreatic or liver enzymes, or platelet count;
• syncope;
• malaise;
• rapid heartbeat;
• dry mouth;
• hives.

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

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

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

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

• kidney failure after severe bleeding;

bleeding in the kidneys, sometimes with blood in the urine, leading to kidney failure (nephropathy associated with the use of anticoagulant drugs);

• 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 side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Rivaroxaban Aurovitas

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storing the 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. The patient should ask their 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 Aurovitas contains

• The active substance of Rivaroxaban Aurovitas is rivaroxaban. One 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 what the pack contains

Film-coated tablet.
Rivaroxaban Aurovitas, 15 mg:
Red, round (6.1 mm in diameter), biconvex film-coated tablets with the imprint "M" on one side and "15" on the other.
Rivaroxaban Aurovitas, 20 mg:
Dark red to brown-red, oval, biconvex film-coated tablets with the imprint "M" on one side and "20" on the other. Size: 8.1 x 4.6 mm.
First 4 weeks of treatment with the starter pack:
Each pack of 49 film-coated tablets for the first 4 weeks of treatment contains:
42 film-coated tablets of 15 mg rivaroxaban and 7 film-coated tablets of 20 mg rivaroxaban.

Marketing authorization holder and manufacturer

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:

Germany:
Rivaroxaban PUREN Starterpackung 15 mg + 20 mg Filmtabletten
France:
Rivaroxaban Arrow 15 mg + 20 mg comprimé pelliculé
Netherlands:
Rivaroxaban Aurobindo 15 mg /20 mg, filmomhulde tabletten
Poland:
Rivaroxaban Aurovitas
Portugal:
Rivaroxabano Aurovitas

Date of last revision of the leaflet: 09/2023