RIVOKSAR is used in cardiovascular diseases, for the prevention of heart attack and blood clot formation in blood vessels after stent placement.
Active ingredient: 2.5 mg rivaroxaban in each film-coated tablet.
Excipients: microcrystalline cellulose (type 102), lactose granules (lactose monohydrate SD) (derived from cow’s milk), croscarmellose sodium, hydroxypropyl methylcellulose (E5) (hypromellose), magnesium stearate, poloxamer 188 (micronized), Opadry 04F220012 yellow (HPMC 2910/hypromellose, macrogol/PEG, titanium dioxide, yellow iron oxide).
What is RIVOKSAR and what is it used for?
• Rivaroxaban belongs to a group of medicines called antithrombotic agents and exerts its effect by inhibiting factor Xa, thereby reducing the tendency for blood clot formation.
• It is used in cardiovascular diseases, symptomatic coronary artery disease (CAD) or peripheral arterial disease (PAD); for the prevention of heart attack and blood clot formation in blood vessels after stent placement. Your doctor will also prescribe other antithrombotic agents such as acetylsalicylic acid, or acetylsalicylic acid together with anticoagulants—clopidogrel or ticlopidine.
Do not take RIVOKSAR:
• if you are allergic to rivaroxaban or any of the other ingredients of this medicine
• if you have a disease or condition in any organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery)
• if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or when heparin is administered via a venous or arterial catheter to maintain patency
• if you have acute coronary syndrome and previously had bleeding or a clot in the brain (stroke)
• if you have coronary artery disease or peripheral arterial disease and previously had bleeding in the brain (stroke) or blockage of small arteries supplying the deep tissues of the brain (lacunar stroke), or if you had a clot in the brain (ischemic, non-lacunar stroke) within the previous month
• if you have liver disease associated with an increased risk of bleeding
• if you are pregnant or breastfeeding.
The efficacy and safety of rivaroxaban have been studied in combination with acetylsalicylic acid (aspirin) and clopidogrel/ticlopidine. Use with other antiplatelet agents (medicines that reduce platelet aggregation), such as prasugrel or ticagrelor, has not been studied and therefore should not be used.
Take special care with RIVOKSAR if:
If you have an increased risk of bleeding, which may be in the following situations:
• severe kidney disease, since kidney function may affect the amount of medicine active in your body
• if you are taking medicines to prevent blood clots (e.g. warfarin, dabigatran, apixaban or heparin) when switching anticoagulant therapy, or receiving heparin via a venous or arterial catheter to maintain patency
• bleeding disorders
• very high blood pressure not controlled by medication
• stomach or intestinal diseases that may cause bleeding, e.g. inflammation of the stomach or intestines, or inflammation of the esophagus, e.g. due to gastroesophageal reflux disease (a condition in which stomach acid flows back into the esophagus)
• problems with blood vessels at 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
• age over 75 years
• body weight of 60 kg or less
• coronary artery disease with severe symptomatic heart failure
• if you have a prosthetic heart valve
• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether treatment needs to be changed.
If you need surgery:
• It is very important to take RIVOKSAR exactly at the times prescribed by your doctor before and after surgery.
• If your surgery involves a catheter or injection into the spinal cord (e.g. during epidural or spinal anesthesia or for pain relief):
- It is very important to take RIVOKSAR exactly at the times instructed by your doctor before and after the injection or removal of the catheter.
- Inform your doctor immediately if, after anesthesia, you experience numbness or weakness in the legs, or bowel or bladder problems, as urgent measures may be required.
Children and adolescents: RIVOKSAR is not recommended for people under 18 years of age.
Advancing age may increase the risk of bleeding.
Neuraxial (epidural/spinal) anesthesia or spinal puncture (removal of fluid from the spinal cord) in patients receiving antithrombotic agents for the prevention of thrombus and embolism (agents that prevent blood clotting) may carry a risk of epidural or spinal hematoma (collection of blood on or within the spinal cord), which may result in long-term or permanent paralysis.
If you experience any of the following side effects, inform your doctor immediately:
• extensive skin rash, blisters, or mucosal lesions that spread (e.g. in the mouth or eyes) (Stevens–Johnson syndrome/toxic epidermal necrolysis), fever, visceral inflammation, hematological disorders, and a drug reaction causing systemic disease (DRESS syndrome).
If any of these warnings apply to you, even at any time in the past, please consult your doctor.
Taking RIVOKSAR with food and drink: RIVOKSAR can be taken with or without food.
Pregnancy:
Consult your doctor or pharmacist before using this medicine.
- RIVOKSAR should not be used during pregnancy.
- It may be used only with effective contraception if there is a possibility of becoming pregnant.
- If you discover you are pregnant during treatment, contact your doctor or pharmacist immediately.
Breastfeeding: RIVOKSAR should not be used in breastfeeding mothers.
Driving and using machines: RIVOKSAR may cause side effects such as dizziness or weakness. If you have such symptoms, do not drive or use machines.
Important information about some of the ingredients of RIVOKSAR:
RIVOKSAR contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Other medicines and RIVOKSAR:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), if not used only on the skin
• ketoconazole tablets (used to treat Cushing’s syndrome—when the body produces excessive cortisol)
• certain medicines to treat bacterial infections (e.g. clarithromycin, erythromycin)
• certain antiviral medicines for HIV/AIDS (e.g. ritonavir)
• other medicines that reduce blood clotting (e.g. enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol, prasugrel and ticagrelor)
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• dronedarone, a medicine used to treat abnormal heart rhythm
• certain medicines for depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)).
If any of the above apply to you, inform your doctor before taking RIVOKSAR, as its effect may be increased. Your doctor will decide whether you should use this medicine and whether you should be monitored more closely. If your doctor considers you to be at increased risk of stomach or intestinal ulcers, preventive ulcer treatment may be used.
If you are taking:
• certain medicines for epilepsy (phenytoin, carbamazepine, phenobarbital)
• St John’s wort (Hypericum perforatum), a herbal medicine used for depression
• rifampicin, an antibiotic
If any of the above apply to you, inform your doctor before taking this medicine, as the effect of RIVOKSAR may be reduced.
If you are currently using or have recently used any prescription or non-prescription medicines, please inform your doctor or pharmacist.
How to take RIVOKSAR:
- Recommended dose: 1 tablet of 2.5 mg twice daily.
- RIVOKSAR will not be given alone. Your doctor will also prescribe acetylsalicylic acid to take with it.
- If you are taking RIVOKSAR after acute coronary syndrome, your doctor may also advise you to take clopidogrel or ticlopidine. Your doctor will tell you how much to take (usually 75–100 mg acetylsalicylic acid daily, or 75–100 mg acetylsalicylic acid daily plus 75 mg clopidogrel or the standard daily dose of ticlopidine).
Method and route of administration:
- Take RIVOKSAR twice daily with water, until your doctor tells you to stop.
- It may be taken with or without food.
- Take RIVOKSAR every day at approximately the same times (e.g. one tablet in the morning, one tablet in the evening). Your doctor will decide how long treatment should continue.
- For patients who cannot swallow tablets whole, RIVOKSAR may be crushed and mixed with soft food immediately before use, such as water or apple purée.
- The crushed RIVOKSAR tablet may be administered via a gastric tube. Before administration, it must be confirmed that the tube is correctly positioned in the stomach. The crushed tablet should be administered through the tube dissolved in a small amount of water, followed by flushing the tube with water.
Treatment with RIVOKSAR after acute coronary syndrome should be started as soon as possible after stabilization of the condition; it should be started no earlier than 24 hours after hospital admission and when parenteral (injectable) anticoagulant therapy is discontinued. If you have been diagnosed with acute coronary disease or peripheral arterial disease, your doctor will tell you when to start RIVOKSAR and how long to continue treatment.
Use in children: RIVOKSAR is not recommended for use in children under 18 years of age.
Use in the elderly: It may be used in the same way; no special dose adjustment is required.
Use in special cases:
Renal impairment:
In mild to moderate renal impairment, it may be used at the same dose. Use with caution in patients with severe renal impairment. RIVOKSAR should not be used if you have very severe renal impairment.
Hepatic impairment:
It should not be used in patients with liver disease associated with an increased risk of bleeding.
If you feel that the effect of RIVOKSAR is too strong or too weak, consult your doctor or pharmacist.
If you take more RIVOKSAR than you should: Overdose increases the risk of bleeding. Contact your doctor or pharmacist.
If you forget to take RIVOKSAR: Skip the missed dose and take the next tablet at the usual time. Do not take a double dose to make up for a missed dose.
Effects when stopping RIVOKSAR treatment:
Use RIVOKSAR regularly and for as long as prescribed by your doctor.
Do not stop taking RIVOKSAR without consulting your doctor.
If you stop taking this medicine, the risk of another heart attack or stroke, or death due to heart or vascular disease, may increase.
Possible side effects:
RIVOKSAR may cause potentially life-threatening bleeding. Excessive bleeding may cause a sudden drop in blood pressure (shock). In some cases, bleeding may be hidden.
Possible side effects that may be signs of bleeding:
Inform your doctor immediately if you experience any of the following:
• prolonged or excessive bleeding
• extreme weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain or angina, which may be signs of bleeding.
• The risk of such bleeding is higher in people with very high blood pressure and/or those taking anticoagulants concurrently.
Your doctor may decide to monitor you more closely or change your treatment.
Possible side effects that may be signs of severe skin reactions:
Inform your doctor immediately if you have skin reactions such as:
• widespread intense rash, blisters, or mucosal lesions (e.g. in the mouth or eyes) (Stevens–Johnson syndrome/toxic epidermal necrolysis). Frequency: very rare (up to 1 in 10,000).
• drug reaction causing rash, fever, inflammation of internal organs, blood abnormalities, and systemic disease (DRESS syndrome). Frequency: very rare (up to 1 in 10,000).
Possible side effects that may be signs of severe allergic reactions:
Inform your doctor immediately if you experience any of the following:
• swelling of the face, lips, mouth, tongue or throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. Frequency: very rare (anaphylactic reactions, including anaphylactic shock; up to 1 in 10,000) and rare (angioedema and allergic edema; up to 1 in 100).
Other side effects:
Common:
• reduction in red blood cells, which may cause pale skin, weakness, and shortness of breath
• bleeding from the stomach or intestines, urogenital bleeding (including blood in urine and heavy menstrual bleeding), nosebleeds, bleeding from the gums
• bleeding in the eye (including bleeding into the sclera)
• bleeding into tissues or body cavities (hematoma, bruising)
• coughing up blood
• bleeding from or under the skin
• bleeding after surgery
• discharge of blood or fluid from a surgical wound
• swelling of the limbs
• pain in the limbs
• impaired kidney function (may be detected in tests performed by your doctor)
• fever
• stomach pain, indigestion, nausea or vomiting, constipation, diarrhea
• low blood pressure (symptoms may include dizziness or fainting when standing up)
• general weakness and lack of energy (weakness, fatigue), headache, dizziness
• rash, itching of the skin
• blood tests may show increased liver enzymes
Uncommon:
• bleeding in the brain or intracranial bleeding
• bleeding into joints causing pain and swelling
• thrombocytopenia (low platelet count—cells that help blood clot)
• allergic reactions, including allergic skin reactions
• liver function impairment (may be seen in tests ordered by your doctor)
• blood tests may show increased bilirubin, pancreatic or liver enzymes, or platelet count
• fainting
• feeling unwell
• rapid heartbeat
• dry mouth
• hives
Rare:
• bleeding into muscles
• cholestasis (reduced bile flow), including hepatitis; hepatocellular injury (liver inflammation, liver damage)
• yellowing of the skin and sclera of the eyes (jaundice)
• local swelling
• collection of blood (hematoma) in the groin as a complication of cardiac procedures when a catheter is inserted into the femoral artery (pseudoaneurysm)
Unknown:
• kidney failure after severe bleeding
• increased pressure in the muscles of the leg or arm after bleeding, causing pain, swelling, sensory impairment, numbness, or paralysis (compartment syndrome after bleeding)
If you notice side effects not listed in this leaflet, consult your doctor or pharmacist.
How to store RIVOKSAR:
Keep out of the reach of children, in its original packaging.
Store at room temperature, not above 25°C, in the original package.
Use according to the expiry date.
Do not use RIVOKSAR after the expiry date stated on the package. The expiry date refers to the month, and the last day of that month is the expiry date.
Do not use RIVOKSAR if you notice any damage to the product and/or its packaging.
Do not dispose of expired or unused medicines! Hand them over to the collection system designated by the Ministry of Environmental Protection and Urbanization.
Dispensing conditions: Pharmaceutical product, Group II, dispensed with prescription form No. 3.
Marketing authorization holder:
Abdi İbrahim İlaç San. ve Tic. A.Ş.
Reşitpaşa Mahallesi Eski Büyükdere Cad. No:4 34467
Maslak / Sarıyer / İstanbul / Türkiye
Manufacturing site:
Abdi İbrahim İlaç San. ve Tic. A.Ş.
Orhan Gazi Mahallesi, Tunç Caddesi No: 3
Esenyurt / İstanbul / Türkiye
