Rivaroxaban aurovitas

Package leaflet: Information for the user

Rivaroxaban Aurovitas, 10 mg, film-coated tablets
Rivaroxabanum
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them 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:

• prevent blood clots from forming in the veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing 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 to prevent further blood clots from forming 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 patency of an intravenous 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 particular caution when taking Rivaroxaban Aurovitas

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or 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 patency of an intravenous or arterial catheter (see section "Rivaroxaban Aurovitas with other medicines") or cancers located in the stomach or intestines or in the reproductive or urinary system;
  • coagulation disorders;
  • very high blood pressure that does not decrease despite treatment with medication;
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or oesophagitis (throat and oesophagus), e.g. due to gastroesophageal reflux disease (backflow of stomach acid into the oesophagus);
  • blood vessel disease in the back of the eye (retinopathy);
  • lung disease in which 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), the doctor should be informed so that they can decide whether treatment adjustments are needed,
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If any of the above points apply to the patient, inform the doctor before
using 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 essential to strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Aurovitas before or after surgery.
• If during surgery a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or spinal anaesthesia or for pain relief):
• it is essential to strictly follow the doctor's instructions regarding the timing of taking Rivaroxaban Aurovitas,
• the doctor must be informed immediately if, after the anaesthesia ends, numbness or weakness in the legs or disturbances in bowel or bladder function occur, as immediate treatment may be necessary.

Children and adolescents
Rivaroxaban Aurovitas is not recommended for patients under 18 years of age. There is
insufficient data on the use of this medicine in children and adolescents.
Rivaroxaban Aurovitas and 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, 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
  • 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-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
using Rivaroxaban Aurovitas, as the effect of this medicine may be enhanced when used
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 that the patient has an increased risk of developing gastric or duodenal ulcer, they may prescribe treatment to prevent peptic ulcer disease.

• 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 using 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 particularly close
monitoring.
Pregnancy and breastfeeding
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, inform the doctor immediately, who will decide on further management.
Driving and operating machinery
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 exactly as your doctor has told you. If in doubt, 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 tablet of Rivaroxaban Aurovitas taken once daily.
• For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: After at least 6 months of treatment for blood clots, the recommended dose is one 10 mg tablet once daily or one 20 mg tablet once daily. Your doctor has prescribed Rivaroxaban Aurovitas 10 mg once daily for you.

The tablet should be swallowed whole, preferably with water.
Rivaroxaban Aurovitas may be taken with or without food.
If you have difficulty swallowing the whole tablet, talk to your 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 administration. If necessary, your doctor may administer crushed Rivaroxaban Aurovitas tablets via 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 each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.

To prevent blood clots in the leg veins after hip or knee replacement surgery:
The first tablet should be taken between 6 and 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts for 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts for 2 weeks.

Taking more than the recommended dose of Rivaroxaban Aurovitas
If you have taken more Rivaroxaban Aurovitas than prescribed, contact your doctor immediately. Taking too high a dose of 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 following day and then continue taking the tablets as usual, once daily. Do not take a double dose to make up for a missed tablet.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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 reactions occur:

• 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 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 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. on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis),
  • a drug reaction causing rash, fever, internal organ inflammation, hematological disorders and systemic illness (DRESS syndrome). The frequency of these adverse reactions 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; urticaria and breathing difficulties; 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 adverse reactions:
Common (may occur in 1 out of 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 intestines, bleeding from the urinary or genital system (including blood in the urine and heavy menstrual bleeding), nosebleeds, bleeding gums;
• bleeding into the eye (including bleeding from the conjunctiva of the eye);
• bleeding into tissues or body cavities (hematoma, bruising);
• presence of blood in sputum (hemoptysis) during coughing;
• bleeding from the skin or under the skin;
• bleeding after surgery;
• oozing of blood or fluid from the surgical wound;
• swelling of limbs;
• limb pain;
• kidney function disorders (may be observed in tests performed by a doctor);
• fever;
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea;
• 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 1 out of 100 people):

• bleeding into the brain or within 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 a 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;
• dryness of the mouth;
• urticaria.

Rare (may occur in 1 out of 1,000 people):

• bleeding into muscles;
• cholestasis (bile stasis), hepatitis including liver cell damage;
• yellowing of the skin and eyes (jaundice);
• local swelling;
• collection of blood (hematoma) in the groin as a complication of cardiac catheterization procedure when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in 1 out of 10,000 people):

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

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

• kidney failure following severe bleeding;
• bleeding in the kidneys, sometimes with presence of blood in urine, leading to inability of the kidneys to function properly (anticoagulant-associated nephropathy);
• 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 reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the 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 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. These measures help protect the environment.

6. Contents of the pack and other information

What Rivaroxaban Aurovitas contains

• The active substance 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 contents of the pack
Film-coated tablet.
Light red, round (6.1 mm in diameter), biconvex film-coated tablets,
with "M" debossed on one side and "10" on the other side.
Rivaroxaban Aurovitas film-coated tablets are available in blister packs and HDPE bottles.
Blister packs: 5, 10, 14, 15, 28, 30, 42, 56, 60, 90, 98, 100, 168, 196 and 200 film-coated tablets.
HDPE bottles: 30, 100, 250 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
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 under the following names:
Germany: Rivaroxaban PUREN 10 mg Filmtabletten
France: Rivaroxaban Arrow 10 mg comprimé pelliculé
Netherlands: Rivaroxaban Aurobindo 10 mg, filmomhulde tabletten
Poland: Rivaroxaban Aurovitas
Portugal: Rivaroxabano Aurovitas
Spain: Rivaroxaban Aurovitas 10 mg comprimidos recubiertos con película EFG