Rivaroxaban aurovitas

Package leaflet: 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.
Rivaroxaban
Please 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• 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 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:

• 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 recurrence of blood clots in the blood vessels of the legs and (or) lungs.

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 has active bleeding,
• if the patient has a disease or condition affecting an organ that increases the risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding in the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain the patency of a venous or arterial catheter,
• 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 that any of the above circumstances apply.

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

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • severe kidney disease, as kidney function may affect the amount of medicine acting 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 if heparin is administered to maintain the patency of a venous or arterial catheter (see section "Rivaroxaban Aurovitas with other medicines");
  • blood clotting disorders;
  • very high blood pressure that does not decrease despite treatment with medicines;
  • 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), 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 genital or urinary system;
  • blood vessel disease in the back of the eye (retinopathy);
  • lung 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 condition called antiphospholipid syndrome (an immune system disorder increasing the risk of blood clots), inform the doctor, who will decide whether treatment needs to be changed;
• if the patient has been diagnosed with abnormal blood pressure or is scheduled for surgery or other treatment aimed at removing a blood clot from the lungs.

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

Children and adolescents
The starter pack for treatment with Rivaroxaban Aurovitas is not recommended for patients under
18 years of age, as it is specifically designed for initiating treatment in adult patients and is not suitable for use 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 the patient is taking:
  • certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin;
  • oral ketoconazole (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol);
  • certain antibacterial medicines (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 (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs)).

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 used together 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 that the patient has an increased risk of developing stomach or duodenal ulcers, treatment to prevent 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 taking 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 inform the doctor immediately, who will decide on further management.
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 a bicycle, or operate tools or machinery.
Rivaroxaban Aurovitas 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.
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 as directed by the doctor. If in doubt, consult the doctor or pharmacist.

Rivaroxaban Aurovitas should be taken with food.

The tablet(s) should be swallowed whole, preferably with water.

If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivaroxaban Aurovitas with the doctor.

The tablet may be crushed and mixed with water or soft food such as apple puree immediately before administration. After administering this mixture, a meal should be taken immediately.

If necessary, the doctor may administer crushed Rivaroxaban Aurovitas tablets via a gastric tube.

How many tablets to take

• The recommended dose is one 15 mg Rivaroxaban Aurovitas tablet twice daily for the first 3 weeks. For treatment after 3 weeks, the recommended dose is one 20 mg Rivaroxaban Aurovitas tablet once daily. The starter pack of Rivaroxaban Aurovitas 15 mg and 20 mg is used only during the first 4 weeks of treatment. After completing this pack, treatment will continue with Rivaroxaban Aurovitas 20 mg once daily 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 daily, 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 each day, as this makes it easier to remember.

The doctor will decide how long the patient should continue treatment.

Taking more Rivaroxaban Aurovitas than prescribed

If a patient has taken more than the prescribed dose of Rivaroxaban Aurovitas, contact the doctor immediately. Taking too high a dose of Rivaroxaban Aurovitas increases the risk of bleeding.

Missed dose of Rivaroxaban Aurovitas

• If the patient is taking one 15 mg tablet twice daily and a dose has been missed, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If the patient forgot to take a dose, they 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.
• If the patient is taking one 20 mg tablet once daily and a dose has been missed, 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.

Stopping Rivaroxaban Aurovitas

Do not stop taking Rivaroxaban Aurovitas without first talking to the doctor, as Rivaroxaban Aurovitas helps prevent a serious medical condition.

If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
As with other medicines of similar action that reduce blood clot formation, Rivaroxaban
Aurovitas may cause bleeding, which potentially could 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 effects occur:

• 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 neck stiffness. 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 or a change in treatment is necessary.
• Signs of severe skin reactions:
  • widespread, acute skin rash, blistering or mucosal lesions, e.g. on the tongue 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 adverse 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 adverse 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 adverse effects:
Common (may occur in up to 1 in 10 people):

• decrease in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath;
• bleeding from the stomach or intestine, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding;
• bleeding into the eye (including bleeding from the white of the eye);
• bleeding into tissues or body cavities (haematoma, bruising);
• presence of blood in sputum (haemoptysis) during coughing;
• bleeding from the skin or under the skin;
• bleeding after surgery;
• oozing of blood or fluid from a surgical wound;
• swelling of limbs;
• limb pain;
• kidney function disorders (may be observed in tests performed by the doctor);
• fever;
• stomach pain, indigestion, feeling of nausea (nausea) or vomiting, constipation, diarrhoea;
• low blood pressure (symptoms may include dizziness or fainting upon standing);
• general loss of strength and energy (weakness, fatigue), headache, dizziness;
• rash, itching of the skin;
• increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon (may occur in 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, activity of certain pancreatic or liver enzymes, or number of platelets;
• fainting;
• malaise;
• rapid heartbeat;
• dryness in the mouth;
• urticaria.

Rare (may occur in 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);
• localised swelling;
• accumulation of blood (haematoma) in the groin as a complication of cardiac catheterisation when the catheter is inserted into an artery in the leg (pseudoaneurysm).

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

• accumulation of eosinophils, a type of granular white blood cells, causing inflammation in the lungs (eosinophilic pneumonia).

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

• kidney failure following severe bleeding;

bleeding in the kidneys, sometimes with blood in the urine, leading to kidneys being unable
to function properly (nephropathy associated with anticoagulant drug use);

• increased pressure in the muscles of arms and legs following bleeding, which may lead to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps 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 stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Crushed tablets
Crushed tablets are stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, monohydrate lactose, 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 (diameter: 6.1 mm), biconvex film-coated tablets with an engraved mark “M” on one side and “15” on the other side.
Rivaroxaban Aurovitas, 20 mg:
Dark red to brownish-red, oval, biconvex film-coated tablets with an engraved mark “M” on one side and “20” on the other side. Size: 8.1 x 4.6 mm.
Initial 4-week starter pack:
Each 49-tablet pack for the first 4 weeks of treatment contains:
42 film-coated tablets containing 15 mg rivaroxaban and 7 film-coated tablets containing 20 mg rivaroxaban.

Marketing Authorisation Holder and Manufacturer
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 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