Rivaxar

Package Leaflet: Information for the User

Rivaxar, 10 mg, Film-Coated Tablets

Rivaroxaban
You should read the contents of this leaflet carefully before taking the medicine because it contains important information for you.
Important information for patients

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Rivaxar and what is it used for
• 2. Important information before taking Rivaxar
• 3. How to take Rivaxar
• 4. Possible side effects
• 5. How to store Rivaxar
• 6. Contents of the pack and other information

1. What is Rivaxar and what is it used for

Rivaxar 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. Your 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 to prevent the recurrence of blood clots in the veins of the legs and/or lungs.

Rivaxar 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 Rivaxar

When not to take Rivaxar

• if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if you have excessive bleeding,
• if you have a disease or condition of the body that leads to an increased risk of serious bleeding (e.g., stomach ulcer, injury or bleeding into the brain, recent brain or eye surgery),
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter,
• if you have liver disease that leads to an increased risk of bleeding,
• if you are pregnant or breastfeeding.

Do not take Rivaxar, and inform your doctorif you suspect that you have any of the above conditions.

Warnings and precautions

Before starting treatment with Rivaxar, discuss it with your doctor or pharmacist.

When to be particularly careful when taking Rivaxar

• if you have an increased risk of bleeding, in conditions such as:
• or severe kidney disease, as kidney function may affect the amount of medicine that works in your body,
• if you are taking other medicines that prevent blood clotting (e.g., warfarin, dabigatran, apixaban, or heparin), except when switching anticoagulant therapy or when heparin is given to maintain the patency of a venous or arterial catheter (see section "Rivaxar and other medicines"),
• bleeding disorders,
• very high blood pressure that does not decrease despite medication,
• 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 gastroesophageal reflux disease (backflow of stomach acid into the esophagus),
• vascular disease of the back of the eye (retinopathy),
• pulmonary disease in which the airways are dilated and filled with pus (bronchiectasis) or previous bleeding from the lungs,
• in patients with artificial heart valves,
• if you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), you should inform your doctor, who will decide whether to change the treatment,
• if you have been diagnosed with abnormal blood pressure or are scheduled for surgery or other treatment to remove a blood clot from the lungs.

If you suspect that you have any of the above conditions, inform

your doctorbefore taking Rivaxar .The doctor will decide whether to use this medicine and whether you should be under close observation.

If you need to have surgery:

• you should carefully follow your doctor's instructions regarding the intake of Rivaxar at a strictly defined time before or after surgery,
• If a spinal puncture or catheter insertion into the spine is planned during surgery (e.g., for epidural or spinal anesthesia or to relieve pain):
• you should carefully follow your doctor's instructions regarding the intake of Rivaxar at a strictly defined time,
• you should immediately inform your doctor if you experience symptoms such as numbness, weakness of the lower limbs, disturbances in bowel or bladder function after anesthesia, as immediate treatment may be necessary.

Children and adolescents

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

Rivaxar and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take, including those that are available without a prescription.

• -If you are taking:
• certain medicines for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only locally on the skin,
• ketokonazole tablets (used to treat Cushing's syndrome, in which the body produces too much cortisol),
• certain medicines for bacterial infections (e.g., clarithromycin, erythromycin),
• certain antiviral medicines for HIV or AIDS treatment (e.g., ritonavir),
• other medicines 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 for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)).

If you suspect that you have any of the above conditions, inform

your doctorbefore taking Rivaxar ,as the effect of Rivaxar may be enhanced if taken with the above medicines. The doctor will decide whether to use this medicine and whether you should be under close observation.
If the doctor believes that you have an increased risk of stomach or duodenal ulcers, they may use treatment to prevent ulcers.

• -If you are taking
• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital),
• St. John's Wort ( Hypericum perforatum), a herbal medicine used for depression,
• rifampicin, which belongs to a group of antibiotics.

If you suspect that you have any of the above conditions, inform

your doctorbefore taking Rivaxar ,as the effect of Rivaxar may be reduced if taken with the above medicines. The doctor will decide whether to use Rivaxar and whether you should be under close observation.

Pregnancy and breastfeeding

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

Driving and using machines

Rivaxar may cause dizziness (frequent side effects) or fainting (uncommon side effects) (see section 4 "Possible side effects"). Patients who experience these side effects should not drive or operate machinery.

Rivaxar contains lactose and sodium.

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Rivaxar

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, ask your doctor or pharmacist.

How many tablets to take

• In order to prevent the formation of blood clots in the veins, after hip or knee replacement surgery.

The recommended dose is one Rivaxar 10 mg tablet taken once a day.

• In the treatment of 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 Rivaxar 10 mg once a day for you.

The tablet should be swallowed whole, preferably with water.
Rivaxar can be taken with or without food.
If you have difficulty swallowing the whole tablet, you should talk to your doctor about other ways to take Rivaxar. 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 Rivaxar tablet through a gastric tube.

When to take Rivaxar

You should take one tablet every day until your doctor decides to stop the 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 you should continue the treatment.
In order to prevent blood clots in the veins of the legs after hip or knee replacement surgery:
The first tablet should be taken 6 to 10 hours after surgery.
In patients after major hip replacement surgery, treatment usually lasts 5 weeks. In patients after major knee replacement surgery, treatment usually lasts 2 weeks.

Taking more than the recommended dose of Rivaxar

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

Missing a dose of Rivaxar

If you have forgotten to take a dose, you should take the tablet as soon as you remember. The next tablet should be taken the next day, and then you should take the tablets as usual, once a day.
You should not take a double dose to make up for the missed tablet.

Stopping treatment with Rivaxar

You should not stop taking Rivaxar without first talking to your doctor, as Rivaxar prevents a serious disease.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rivaxar can cause side effects, although not everybody gets them.
Like other medicines with similar effects (anticoagulants), Rivaxar can cause bleeding, which can potentially be life-threatening. Excessive bleeding can lead to a sudden drop in blood pressure (shock). These may not always be obvious or visible signs of bleeding.

Possible side effects that may be a sign of bleeding:

You should immediately inform your doctorif you experience any of the following side effects:

• prolonged or excessive bleeding,
• unusual weakness, fatigue, pallor, dizziness, headache, swelling of unknown cause, shortness of breath, chest pain or angina ,which may be signs of bleeding. Your doctor may decide to closely monitor you or change the treatment.

Possible side effects that may be a sign of skin reaction:

You should immediately inform your doctorif you experience the following skin reactions such as:

• widespread, severe skin rash, blistering, or changes to the mucous membranes, e.g., mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these side effects is very rare (may occur in less than 1 in 10,000 patients),
• drug reaction that causes a rash, fever, inflammation of internal organs, hematological disorders, and systemic disorders (DRESS syndrome). The frequency of these side effects is very rare (may occur in less than 1 in 10,000 patients).

Possible side effects that may be a sign of a severe allergic reaction

You should immediately inform your doctorif you experience the following side effects:

• swelling of the face, lips, mouth, tongue, or throat; difficulty swallowing, hives, and difficulty breathing; sudden drop in blood pressure. The frequency of these side effects is very rare (anaphylactic reactions, including anaphylactic shock, may occur in less than 1 in 10,000 patients) and uncommon (angioedema and allergic edema may occur in less than 1 in 100 patients).

General list of possible side effects:

Common(may occur in up to 1 in 10 patients)

• 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 reproductive system (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, feeling of nausea (nausea) or vomiting, constipation, diarrhea,
• low blood pressure (symptoms may include dizziness or fainting when standing up),
• general decrease in strength and 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 occur in up to 1 in 100 patients)

• bleeding into the brain or within the skull,
• bleeding into a joint, causing pain and swelling,
• thrombocytopenia (low platelet count, cells involved in blood clotting),
• allergic reactions, including allergic skin reactions,
• 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,
• liver function disorders (can be observed in tests performed by your doctor).

Rare(may occur in up to 1 in 1,000 patients)

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

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

• kidney failure after severe bleeding,
• 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 syndromeafter bleeding).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rivaxar

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 after: Expiry date and on each blister after: EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 pack and other information

What Rivaxar contains

• The active substance of Rivaxar is rivaroxaban. One film-coated tablet contains 10 mg of rivaroxaban.
• Other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, hypromellose 2910, sodium croscarmellose, magnesium stearate. See section 2 "Rivaxar contains lactose and sodium". Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 3350, iron oxide red (E 172).

What Rivaxar looks like and contents of the pack

Rivaxar 10 mg film-coated tablets are pink, round, biconvex (diameter 6 mm), with the number "10" embossed on one side and smooth on the other side.
Transparent blisters of PVC/PVDC/Aluminum in cardboard boxes.
Packaging containing 5, 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 90, 98, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
e-mail: [email protected]

Manufacturer:

S.C. Labormed-Pharma S.A.
44B Theodor Pallady Blvd, 3 District
032266 Bucharest
Romania
Adalvo Ltd
Malta Life Sciences Park
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann SGN 3000
Malta

This medicinal product is authorized in the Member States of the EEA under the following names:

Iceland:
Rivaroxaban AdAlvo 10 mg film-coated tablets
Estonia:
Rivaroxaban Auxilia
Finland:
Rivaroxaban Avansor 10 mg tablets, film-coated
Latvia:
Rivaroxaban Auxilia 10 mg coated tablets
Lithuania:
Rivaroxaban Auxilia 10 mg film-coated tablets
Poland:
Rivaxar
Sweden:
Rivaroxaban Avansor 10 mg film-coated tablets

Date of last revision of the leaflet: