Rivaxar

Package leaflet: Information for the user

Rivaxar, 15 mg, coated tablets
Rivaxar, 20 mg, 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 other people, 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 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

Rivaxar contains the active substance rivaroxaban and is used in adults to:

• prevent blood clots forming in the blood vessels of the body, including in the brain (stroke), in patients who have a type of irregular heartbeat called non-valvular atrial fibrillation.
• 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. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

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 has active bleeding,
• if the patient has a disease or condition of an organ that leads to an increased 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 clots (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.

Do not take Rivaxar and inform your doctor if you suspect that any of the above conditions apply to you.
Warnings and precautions
Before starting Rivaxar, discuss this with your doctor or pharmacist.
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 medicine acting in the patient's body,
• blood clotting disorders,
• taking other medicines that prevent blood clots (e.g. warfarin, edoxaban, 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"),
• 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 inflammation of the oesophagus (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 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 disorder called antiphospholipid syndrome (an immune system disorder causing increased risk of blood clots), the patient should inform the doctor, who will decide whether a change in treatment is needed,
• if the patient has been diagnosed with abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

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 the patient needs to undergo surgery:

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

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
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan 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-relieving medicines (e.g. naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine 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 increased when taken together with the above-mentioned medicines. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing peptic ulcer disease, preventive treatment 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, an antibiotic.

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 together 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 use 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 Rivaxar, 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, they should consult their 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 your doctor. If in doubt, consult your doctor or pharmacist.

How many tablets to take

• For prevention of blood clots in the brain (stroke) and other blood vessels in the body
  The recommended dose is one 20 mg Rivaxar tablet once daily.

• If a procedure to open narrowed blood vessels in the heart (called percutaneous coronary intervention - PCI with stent placement) is required, there is limited evidence supporting dose reduction to one 15 mg Rivaxar tablet once daily (or one 10 mg Rivaxar tablet once daily if the patient has renal impairment), in combination with an antiplatelet medicine such as clopidogrel.

• For treatment of blood clots in the veins of the legs, blood clots in the blood vessels of the lungs, and prevention of recurrence of blood clots
  The recommended dose is one 15 mg Rivaxar tablet twice daily for the first 3 weeks. For treatment beyond 3 weeks, the recommended dose is one 20 mg Rivaxar 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 and is taking one 20 mg Rivaxar tablet once daily, the doctor may decide to reduce the dose after 3 weeks of treatment to one 15 mg Rivaxar tablet once daily if the risk of bleeding is greater than the risk of further blood clots.

Swallow the tablet(s) whole, preferably with water.
Rivaxar should be taken with food.
If you have difficulty swallowing the whole tablet, talk to your doctor about other ways of taking Rivaxar. The tablet may be crushed and mixed with water or soft food such as apple puree, immediately before administration. After mixing, the mixture should be consumed immediately with a meal.
If necessary, your doctor may administer crushed Rivaxar through a gastric tube.

When to take Rivaxar
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 you should continue treatment.

For 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, Rivaxar should be taken as directed by your doctor.

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

Missing a dose of Rivaxar

• If you are taking one 20 mg tablet or one 15 mg tablet once daily and you miss a dose, 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, and then continue taking one tablet once daily.

• If you are taking one 15 mg tablet twice daily and you miss a dose, take the tablet as soon as possible. Do not take more than two 15 mg tablets in one day. If you forget to take a dose, you 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.

Stopping Rivaxar treatment
Do not stop taking Rivaxar without first consulting your doctor, as Rivaxar helps prevent serious medical conditions.
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 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.

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 or a change in treatment is necessary.

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

• Widespread, severe 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), characterized by rash, fever, internal organ inflammation, hematological abnormalities, 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, oral cavity, tongue or throat; difficulty swallowing, urticaria (hives), and breathing difficulties; sudden drop in blood pressure. The frequency of these adverse 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,
• Bleeding from the stomach or intestines, bleeding from the genitourinary system (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding 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,
• 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 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 occur in 1 in 100 patients)

• Bleeding into the brain or intracranial hemorrhage,
• Bleeding into a joint causing pain and swelling,
• Thrombocytopenia (low platelet count, 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 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 procedure, 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 occurring after 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, 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 provide more information on the safety of this medicine.

5. How to store Rivaxar

Keep this medicine out of 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 conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Rivaxar contains

• The active substance is rivaroxaban. One coated tablet contains 15 mg or 20 mg of rivaroxaban.
• The other ingredients 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 3350, iron oxide red (E 172).

What Rivaxar looks like and contents of the pack
Rivaxar 15 mg coated tablets are red, round, biconvex (diameter 5.6 mm), with the number "15" engraved on one side and smooth on the other side.
Transparent blisters made of PVC/PVDC/Aluminum in cardboard boxes.
Pack containing 5, 10, 14, 15, 20, 28, 30, 42, 45, 50, 56, 90, 98, or 100 coated tablets.
Not all pack sizes may be marketed.
Rivaxar 20 mg coated tablets are dark red, round, biconvex (diameter 6.5 mm), with the number "20" engraved on one side and smooth on the other side.
Transparent blisters made of PVC/PVDC/Aluminum in cardboard boxes.
Pack containing 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 for marketing in the EEA countries under the following names:
Iceland: Rivaroxaban AdAlvo 15 mg/20 mg filmuhúðaðar töflur
Estonia: Rivaroxaban Auxilia
Finland: Rivaroxaban Avansor 15 mg/20 mg tabletit, kalvopäällysteiset
Latvia: Rivaroxaban Auxilia 15 mg/20 mg apvalkotās tablets
Lithuania: Rivaroxaban Auxilia 15 mg/20 mg plėvele dengtos tabletės
Poland: Rivaxar
Sweden: Rivaroxaban Avansor 15 mg/20 mg filmdragerade tabletter