Rivaroxaban Aurovitas

Leaflet attached to the packaging: information for the user

Rivaroxaban Aurovitas, 10 mg, film-coated tablets

Rivaroxabanum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 packaging 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:

• prevent the formation of blood clots in the veins after hip or knee replacement surgery. The doctor has prescribed this medicine because the risk of blood clots is increased after surgery;
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism) and 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 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 therapy or when heparin is used to maintain catheter patency in a vein or artery,
• if the patient has liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding. Do not take Rivaroxaban Aurovitas and inform your doctorif you think you may be in one of these situations.

Warnings and precautions

Before starting treatment with Rivaroxaban Aurovitas, talk to your doctor or pharmacist.

When to be particularly careful when taking Rivaroxaban Aurovitas

• if the patient has an increased risk of bleeding, such as:
• moderate or 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 therapy or when heparin is used to maintain catheter patency in a vein or artery (see "Rivaroxaban Aurovitas and other medicines") or tumors located in the stomach or intestines or genital or urinary tract;
• bleeding disorders;
• very high blood pressure that does not decrease despite treatment;
• stomach or intestinal diseases that may cause bleeding, such as inflammation of the intestines and stomach or esophagitis (throat and esophagus) due to gastroesophageal reflux disease (backflow of stomach acid into the esophagus);
• vascular disease of the back of the eyeball (retinopathy);
• pulmonary disease in which the airways 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 undergo surgery:

• The patient must strictly follow the doctor's instructions regarding the intake of Rivaroxaban Aurovitas at a precisely specified time before or after surgery.
• If, during the surgical procedure, the patient is scheduled to undergo a lumbar puncture or insertion of a catheter into the spine (e.g., for epidural or spinal anesthesia or to relieve pain):
• The patient must strictly follow the doctor's instructions regarding the intake of Rivaroxaban Aurovitas at a precisely specified time,
• The patient should immediately inform their doctor if, after the anesthesia is completed, they experience numbness or weakness in their legs or bowel or bladder disturbances, as immediate treatment may be necessary.

Children and adolescents

Rivaroxaban Aurovitas is not recommended for people under 18 years of age.There is insufficient data on the use of the medicine in children and adolescents.

Rivaroxaban Aurovitas 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 medicines used to treat fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin
• ketokonazole 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 you, tell your doctor before taking Rivaroxaban Aurovitas, as the effect of this medicine may be increased if it is taken with the above medicines. The doctor will decide whether to use this medicine and whether you should be closely monitored.
If the doctor believes that you are at increased risk of developing stomach or duodenal ulcers, they may use a treatment to prevent stomach ulcers.

• If you are 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 you, tell your doctor

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

Pregnancy and breastfeeding

Do not take Rivaroxaban Aurovitas if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use effective contraception while taking Rivaroxaban Aurovitas. If you become pregnant while taking this medicine, tell your doctor immediately, who will decide on further treatment.

Driving and using machines

Rivaroxaban Aurovitas may cause dizziness (common 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 previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to take Rivaroxaban Aurovitas

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor 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 10 mg Rivaroxaban Aurovitas tablet once a day.
• To treat blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and to prevent the recurrence of blood clots. After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once a day or one 20 mg tablet once a day. Your doctor has prescribed Rivaroxaban Aurovitas 10 mg once a day for you.

Swallow the tablet whole, preferably with water.
Rivaroxaban Aurovitas can be taken with or without food.
If you have difficulty swallowing the whole tablet, 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 sauce, immediately before taking it. If necessary, your doctor may administer the crushed Rivaroxaban Aurovitas tablet through a gastric tube.

When to take Rivaroxaban Aurovitas

Take one tablet every day until your doctor decides to stop treatment.
It is best to take the tablet at the same time every day, as it will be easier to remember.
Your doctor will decide how long to continue treatment.
To prevent blood clots in the veins of the legs after hip or knee replacement surgery:

Take the first tablet 6 to 10 hours after surgery.
Treatment usually lasts 5 weeks for patients after major hip surgery.
Treatment usually lasts 2 weeks for patients after major knee surgery.

Taking more than the recommended dose of Rivaroxaban Aurovitas

If you have taken more than the recommended dose of Rivaroxaban Aurovitas, contact your doctor immediately. Taking too much Rivaroxaban Aurovitas increases the risk of bleeding.

Missing a dose of Rivaroxaban Aurovitas

If you forget to take a dose, take the tablet as soon as you remember. Take the next tablet the next day, and then take the tablets as usual, once a day. Do not take a double dose to make up for the missed tablet.

Stopping treatment with Rivaroxaban Aurovitas

Do not stop taking Rivaroxaban Aurovitas without first talking to your doctor, as Rivaroxaban Aurovitas prevents a serious disease.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaroxaban Aurovitas can cause side effects, although not everybody gets them.
Like other medicines with a similar anticoagulant effect, Rivaroxaban Aurovitas may cause bleeding, which can 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.

Tell your doctor immediately if you 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. 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 to closely monitor you or change your treatment.
• Signs of severe skin reactions:
• -widespread, acute skin rash, blistering, or changes to the mucous membranes, such as the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• a drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and 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, or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. The frequency of severe allergic reactions 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):

• decrease in red blood cell count, which may cause pallor and be the cause of weakness or shortness of breath;
• bleeding from the stomach or intestines, bleeding from the urinary or genital tract (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums;
• bleeding into the eye (including bleeding from the conjunctiva);
• bleeding into tissues or body cavities (hematoma, bruising);
• appearance of blood in sputum (hemoptysis) while 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 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 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 a 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 your doctor);
• blood test results may show increased bilirubin levels, activity of some pancreatic or liver enzymes, or 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), hepatitis, including liver cell damage;
• jaundice (yellowing of the skin and eyes);
• localized 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 granular blood cells, 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;
• bleeding in the kidneys, 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).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, blister, carton, and bottle after: EXP. The expiry date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
Crushed tablets
Crushed tablets are stable in water or apple sauce for up to 4 hours.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rivaroxaban Aurovitas contains

• The active substance of Rivaroxaban Aurovitas is rivaroxaban. One tablet contains 10 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.
Light red, round (6.1 mm in diameter), biconvex film-coated tablets with "M" embossed on one side and "10" on the other.
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:

Germany:
Rivaroxaban PUREN 10 mg film-coated tablets
France:
Rivaroxaban Arrow 10 mg film-coated tablets
Netherlands:
Rivaroxaban Aurobindo 10 mg film-coated tablets
Poland:
Rivaroxaban Aurovitas
Portugal:
Rivaroxaban Aurovitas
Spain:
Rivaroxaban Aurovitas 10 mg film-coated tablets EFG

Date of last revision of the leaflet: 02/2024