Rivaxar

Package leaflet: Information for the user

Rivaxar, 2.5 mg, 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 give it to others. This medicine 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 Rivaxar is and what it is used for
2. What you need to know 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 Rivaxar is and what it is used for

You have been prescribed Rivaxar because:

• You have been diagnosed with acute coronary syndrome (a condition including heart attack and unstable angina, i.e. acute chest pain), and elevated levels of cardiac biomarkers have been confirmed. Rivaxar reduces the risk of subsequent heart attack and reduces the risk of death due to heart- or blood vessel-related disease in adults. Rivaxar will not be given to you as the only treatment. Your doctor will also prescribe:
  • acetylsalicylic acid, or
  • acetylsalicylic acid and clopidogrel or ticlopidine.
    or
• You have been diagnosed with a high risk of blood clots due to coronary artery disease or peripheral artery disease causing symptoms. Rivaxar reduces the risk of blood clots (atherothrombotic events) in adults. Rivaxar will not be given to you as the only treatment. Your doctor will also prescribe acetylsalicylic acid.

Rivaxar contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (factor Xa), thereby reducing the tendency to form blood clots.

2. Important information before taking Rivaxar

When not to take Rivaxar

• 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 organ condition that increases the risk of serious bleeding (e.g. stomach ulcer, trauma or intracranial hemorrhage, recent brain or eye surgery),
• 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 been diagnosed with acute coronary syndrome and has previously experienced bleeding or blood clot in the brain (stroke),
• if the patient has been diagnosed with coronary artery disease or peripheral artery disease and has previously experienced brain hemorrhage (hemorrhagic stroke), or occlusion of small arteries supplying blood to deep brain structures (lacunar stroke), or if the patient has had a blood clot in the brain (ischemic non-lacunar stroke) within the last month,
• if the patient has liver disease that increases the risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not take Rivaxar and inform your doctor if you suspect that any of the above circumstances apply to you.
Warnings and precautions
Discuss with your doctor or pharmacist before starting Rivaxar.
Rivaxar should not be used in combination with anticoagulant medicines other than acetylsalicylic acid, clopidogrel, or ticlopidine, such as prasugrel or ticagrelor.
When to exercise special caution when taking Rivaxar

• 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 drug active in the patient's body,
• concomitant use of other anticoagulant medicines (e.g. warfarin, dabigatran, apixaban, or heparin) when switching anticoagulant therapy or when heparin is administered to maintain catheter patency in a vein or artery (see section "Rivaxar 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. inflammatory bowel disease or gastritis, or esophagitis (throat and esophagus), e.g. due to gastroesophageal reflux disease (acid reflux into the esophagus),
• vascular disease of the posterior part of the eyeball (retinopathy),
• lung disease with bronchiectasis (dilated bronchi filled with pus) or previous pulmonary hemorrhage,
• if the patient is over 75 years of age,
• if the patient weighs 60 kg or less,
• coronary artery disease with severe symptomatic heart failure,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment adjustment is necessary.

If you suspect that any of the above conditions apply to you, inform your doctor before taking Rivaxar. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If surgery is required:

• strictly follow your doctor's instructions regarding the timing of Rivaxar administration before or after surgery,
• if spinal catheterization or spinal puncture (e.g. for epidural or intrathecal anesthesia or pain relief) is planned during surgery:
  • it is very important to take Rivaxar before and after the puncture or catheter removal, as directed by your doctor,
  • due to the need for special caution, immediately inform your doctor if numbness or weakness in the legs, or bowel or bladder dysfunction occurs after anesthesia.

Children and adolescents
Rivaxar is not recommended for patients under 18 years of age. There is insufficient data on the use of this medicine in children and adolescents.
Rivaxar with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use, 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 excessive 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, prasugrel, and ticagrelor (see section "Warnings and precautions")),
• 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 (SSRI) or serotonin-noradrenaline reuptake inhibitors (SNRI)).

If you suspect that any of the above conditions apply to you, inform your doctor before taking Rivaxar, as the effect of Rivaxar may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If your doctor considers that you have an increased risk of developing stomach or intestinal ulcers, they may prescribe preventive treatment.

• If the patient is taking
• certain antiepileptic medicines (phenytoin, carbamazepine, phenobarbital),
• St. John's wort ( Hypericum perforatum ), a herbal medicine used for depression,
• rifampicin, which belongs to the group of antibiotics.

If you suspect that any of the above conditions apply to you, inform your doctor before taking Rivaxar, as the effect of Rivaxar may be reduced when taken with the above-mentioned medicines. The doctor will decide whether to use Rivaxar and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not take Rivaxar if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, an effective method of contraception should be used during treatment with Rivaxar. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further management.
Driving and operating machinery
Rivaxar may cause dizziness (common side effects) or fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients experiencing these side effects should not drive or operate machinery.
Rivaxar contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Rivaxar

This medicine should always be taken as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.
How many tablets to take
The recommended dose is one 2.5 mg tablet twice daily. Rivaxar should be taken at approximately
the same time each day (for example, one tablet in the morning and one in the evening). This medicine
can be taken with or without food.
If a patient has difficulty swallowing the whole tablet, discuss alternative methods of taking Rivaxar
with your doctor. The tablet may be crushed and mixed with water or soft food, such as apple puree,
immediately before administration.
If necessary, a crushed Rivaxar tablet may be administered via a gastric tube by a physician.
Rivaxar will not be given to the patient as the sole medication.
Your doctor will prescribe acetylsalicylic acid for you. If you are receiving Rivaxar after an acute
coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine.
Your doctor will advise you on the dosage of these medications (usually 75–100 mg acetylsalicylic acid
daily, or 75–100 mg daily acetylsalicylic acid plus 75 mg daily clopidogrel, or the standard daily dose
of ticlopidine).
When to start taking Rivaxar
Treatment with Rivaxar after acute coronary syndrome should be initiated as soon as possible after
stabilization of the acute coronary event, no earlier than 24 hours after hospital admission and at the
time when parenteral (by injection) anticoagulant therapy would normally be discontinued. Your
physician will inform you when to start Rivaxar treatment if you have been diagnosed with coronary
artery disease or peripheral arterial disease.
Your doctor will decide how long treatment should continue.
Taking more than the recommended dose of Rivaxar
If a patient has taken more than the recommended dose of Rivaxar, contact your doctor immediately.
Taking too high a dose of Rivaxar increases the risk of bleeding.
Missed dose of Rivaxar
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose at the
scheduled time.
Stopping Rivaxar treatment
Rivaxar should be taken regularly and for the duration recommended by your doctor.
Do not discontinue Rivaxar without first consulting your doctor. Stopping this medication may
increase the risk of another heart attack, stroke, or death due to heart- or blood vessel-related disease.
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.
Like other medicines with a similar action (anticoagulants), Rivaxar may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.

Possible adverse reactions which may indicate bleeding:
Contact your doctor immediately if any of the following adverse reactions occur:

• prolonged or excessive bleeding,
• unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina, which may be signs of bleeding. Your doctor may decide that close monitoring of the patient or a change in treatment is necessary.

Possible adverse reactions which may indicate skin reactions:
Contact your doctor immediately if the following skin reactions occur:

• widespread, acute skin rash, blistering, or mucosal lesions, e.g. in the mouth or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients),
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) causing rash, fever, internal organ inflammation, hematological disorders and systemic involvement. The frequency of these adverse reactions is very rare (may occur in less than 1 in 10,000 patients).

Possible adverse reactions which may indicate a serious allergic reaction:
Contact your doctor immediately if any of the following adverse reactions occur:

• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing, urticaria (hives), or breathing difficulties; sudden drop in blood pressure. The frequency of these reactions 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 adverse reactions:
Common (may occur in 1 in 10 patients)

• decrease in red blood cells which may cause paleness of the skin and lead to weakness or shortness of breath,
• gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and severe menstrual bleeding), nosebleeds, bleeding from gums,
• bleeding into the eye (including bleeding from the conjunctiva),
• bleeding into tissues or body cavities (hematoma, bruising),
• presence of blood in sputum (hemoptysis) during coughing,
• bleeding from the skin or subcutaneous bleeding,
• bleeding after surgery,
• oozing of blood or fluid from a surgical wound,
• limb swelling,
• 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 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 in 100 patients)

• bleeding into the brain or within the skull,
• bleeding into a joint causing pain and swelling,
• thrombocytopenia (low platelet count, the 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,
• urticaria.

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

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

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

• kidney failure following severe bleeding,
• increased pressure in the muscles of arms and legs after bleeding, which may cause pain, swelling, altered sensation, numbness or paralysis (compartment syndrome following bleeding).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Rivaxar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry and on each blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rivaxar contains

• The active substance is rivaroxaban. One coated tablet contains 2.5 mg of rivaroxaban.
• Other components are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, 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 400, yellow iron oxide (E 172).

What Rivaxar looks like and contents of the pack
Rivaxar 2.5 mg coated tablets are yellow, round, biconvex (6 mm in diameter), with the number "2.5" embossed on one side and smooth on the other.
Tablets are supplied in transparent PVC/PVDC/Aluminum blisters within cardboard boxes.
Pack sizes: 5, 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 90, 98, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the EEA Member States under the following names:
Iceland: Rivaroxaban AdAlvo 2.5 mg filmuhúðaðar töflur
Estonia: Rivaroxaban Auxilia
Finland: Rivaroxaban Avansor 2.5 mg tabletit, kalvopäällysteiset
Latvia: Rivaroxaban Auxilia 2.5 mg apvalkotās tablets
Lithuania: Rivaroxaban Auxilia 2.5 mg plėvele dengtos tabletės
Poland: Rivaxar
Sweden: Rivaroxaban Avansor 2.5 mg filmdragerade tabletter