Rivaroxaban aurovitas

Poland
Brand name Rivaroxaban aurovitas
Form tablets, film-coated
Active substance / Dosage
rivaroxaban · 15 mg
Prescription type Prescription only
ATC code
B01AF01
Registration number 100383297
Manufacturer APL Swift Services (Malta) Ltd.

Table of Contents

Package leaflet: Information for the user

Rivaroxaban Aurovitas, 15 mg, film-coated tablets
Rivaroxaban Aurovitas, 20 mg, film-coated tablets
Rivaroxabanum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, please 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 effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

  1. What Rivaroxaban Aurovitas is and what it is 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 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 an irregular heart rhythm called non-valvular atrial fibrillation;
  • treat blood clots in the deep veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent recurrence of blood clots in the veins and/or lungs.

Rivaroxaban Aurovitas is used in children and adolescents under 18 years of age and weighing 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 anticoagulant medicines.

Rivaroxaban Aurovitas 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 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 is experiencing excessive bleeding,
  • if the patient has a disease or condition affecting any organ that increases the risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
  • if the patient is taking other anticoagulant medicines (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. Rivaroxaban Aurovitas must not be used and the doctor must be informed if the patient suspects any of the above conditions apply.

Warnings and precautions
Before starting treatment with Rivaroxaban Aurovitas, talk to your doctor or
pharmacist.
When to exercise special caution when using Rivaroxaban Aurovitas

  • 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, as kidney function may affect the amount of medicine acting in the patient's body;
    • if the patient is taking other anticoagulant medicines (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 Aurovitas with other medicines");
    • coagulation disorders;
    • very high blood pressure that does not decrease despite medication;
    • stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the intestine and stomach or 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 at the back of the eye (retinopathy);
    • lung disease with dilated and pus-filled bronchi (bronchiectasis) or previous lung bleeding;
  • in patients with heart valve prostheses;
  • if the patient has a condition called antiphospholipid syndrome (an immune system disorder increasing the risk of blood clots), inform the doctor, who will decide whether treatment adjustments are needed;
  • if the patient has abnormal blood pressure or if surgery or another treatment to remove a pulmonary clot is planned.

If any of the above points apply to the patient, inform the doctor
before taking Rivaroxaban Aurovitas. The doctor will decide whether to use this medicine and
whether the patient requires close monitoring.
If the patient is to undergo surgery:

  • It is very important to take Rivaroxaban Aurovitas exactly as scheduled by the treating doctor before and after surgery.
  • If during surgery a catheter is to be inserted or an injection given into the spinal canal (e.g. for epidural or spinal anaesthesia or for pain relief):
    • it is very important to take Rivaroxaban Aurovitas exactly as scheduled by the treating doctor before and after the injection or removal of the catheter;
  • immediately inform the doctor if after the anaesthesia wears off the patient experiences numbness or weakness in the legs, or bowel or bladder problems, as immediate treatment may be required.

Children and adolescents
Rivaroxaban Aurovitas is not recommended for children weighing less than 30 kg. There are
insufficient data on the use of this medicine in children and adolescents for indications approved in
adults.
Rivaroxaban Aurovitas with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

  • If the patient is 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 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 any of the above points apply to the patient, inform the doctor before
taking Rivaroxaban Aurovitas, as the effect of this medicine may be enhanced when taken
concurrently with the above-mentioned medicines. The doctor will decide whether to use this
medicine and whether the patient requires close monitoring.
If the doctor considers the patient to be at increased risk of developing stomach or duodenal ulcers, preventive treatment for peptic ulcer disease may be prescribed.

  • If the patient is 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 any of the above points apply to the patient, inform the doctor
before taking Rivaroxaban Aurovitas, as the effect of this medicine may be
reduced when taken together with the above-mentioned medicines. The doctor will decide whether
to use Rivaroxaban Aurovitas and whether the patient requires close monitoring.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use Rivaroxaban Aurovitas 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 Rivaroxaban Aurovitas. If the patient becomes pregnant while taking this medicine, she must immediately inform her doctor, 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 experiencing these side effects should not drive, ride bicycles, or operate tools or machinery.
Rivaroxaban Aurovitas contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaroxaban Aurovitas

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Rivaroxaban Aurovitas should be taken with food.
Swallow the tablet(s) whole, preferably with water.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivaroxaban Aurovitas with your doctor.
The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration. After taking this mixture, the patient should eat a meal promptly.
If necessary, your doctor may administer crushed Rivaroxaban Aurovitas tablets through a gastric tube.

How many tablets to take

  • Adults

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

    If a patient requires a procedure to open blocked blood vessels in the heart (called percutaneous coronary intervention – PCI with stent placement), there is limited evidence supporting dose reduction to one 15 mg Rivaroxaban Aurovitas tablet once daily (or one 10 mg Rivaroxaban Aurovitas tablet once daily in case of kidney impairment), in combination with an antiplatelet medicine such as clopidogrel.

  • For treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and prevention of recurrent blood clots: the recommended dose is one 15 mg Rivaroxaban Aurovitas tablet twice daily for the first 3 weeks. After 3 weeks of treatment, 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 either one 10 mg tablet once daily or one 20 mg tablet once daily.

    If the patient has kidney problems, the 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 greater than the risk of further blood clots.

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

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

Each dose of Rivaroxaban Aurovitas should be taken with a meal and with 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: monitor the child to ensure they have taken the full dose.

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

If a dose is vomited or spat out

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

Contact your doctor if vomiting or spitting out the dose occurs repeatedly after taking Rivaroxaban Aurovitas.

When to take Rivaroxaban Aurovitas
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 treatment should continue.
Prevention of blood clots in the brain (stroke) and other blood vessels in the body:
If a procedure to restore normal heart rhythm (cardioversion) is required, Rivaroxaban Aurovitas should be taken as directed by your doctor.

Taking more Rivaroxaban Aurovitas than prescribed
If a patient takes more Rivaroxaban Aurovitas than prescribed, contact a doctor immediately. Taking too much Rivaroxaban Aurovitas increases the risk of bleeding.

Missing a dose of Rivaroxaban Aurovitas

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

  • Adults
    If a patient takes one 15 mg tablet twice daily and misses a dose, take the tablet as soon as possible. Do not take more than two 15 mg tablets in a single day. If a dose was forgotten, the patient 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, resume taking one 15 mg tablet twice daily.

Stopping Rivaroxaban Aurovitas
Do not stop taking Rivaroxaban Aurovitas without first discussing it with your doctor, as this medicine helps prevent serious illness.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
As with other medicines with a similar action that reduce blood clot formation, Rivaroxaban
Aurovitas 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 immediately inform the doctor if you or the child 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, reduced level of consciousness and neck stiffness. A serious, sudden 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. The 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, internal organ inflammation, blood disorders and systemic illness (DRESS syndrome). The frequency of these side effects is very rare (up to 1 in 10,000 people).
  • Signs of serious allergic reactions:
    • swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and breathing difficulties; 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):

  • reduction in red blood cell count, which may cause paleness of the skin and lead to weakness or shortness of breath;
  • bleeding from the stomach or intestines, 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 white of the eye);
  • bleeding into tissues or body cavities (hematoma, bruising);
  • appearance of blood in sputum (hemoptysis) during coughing;
  • bleeding from the skin or under the skin;
  • postoperative bleeding;
  • oozing of blood or fluid from the surgical wound;
  • swelling of limbs;
  • limb pain;
  • kidney function disorders (may be observed in tests performed by the doctor);
  • fever;
  • stomach pain, indigestion, nausea or vomiting, constipation, diarrhea;
  • low 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 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 number of platelets, blood cells involved in blood clotting);
  • allergic reactions, including allergic skin reactions;
  • liver function disorders (may be observed in tests performed by the doctor);
  • 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;
  • hives.

Rare (may affect up to 1 in 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 when the 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, 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 kidneys being unable to function properly (nephropathy associated with anticoagulant medicines);
  • increased pressure in the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Side effects in children and adolescents
Generally, side effects observed in children and adolescents treated with Rivaroxaban
Aurovitas were similar in type to those observed in adults and were mainly mild to moderate in severity.
Side effects observed 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 tests may show increased levels of bilirubin (a bile pigment);
  • thrombocytopenia (low number of platelets, blood cells that help in blood clotting);
  • excessive menstrual bleeding.

Uncommon (may affect up to 1 in 100 people)

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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, more information on the safety of this medicine can be collected.

5. How to store Rivaroxaban Aurovitas

Keep this medicine out of 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 stated month.
No special storage instructions apply 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 you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Aurovitas contains

  • The active substance is rivaroxaban. One tablet contains 15 mg or 20 mg of rivaroxaban.
  • 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, embossed with the mark "M" on one side and "15" on the other side of the tablet.
Rivaroxaban Aurovitas, 20 mg:
Dark red to brownish-red, oval, biconvex film-coated tablets, embossed with the mark "M" on one side and "20" on the other side of the tablet.
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 Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 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 medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Rivaroxaban AB 15 mg/ 20 mg filmomhulde tabletten
Germany: Rivaroxaban PUREN 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
Spain: Rivaroxaban Aurovitas 15 mg /20 mg comprimidos recubiertos con película EFG