Rivarox 2.5mg 56 tablets

RIVAROX 2.5 mg film-coated tablets for oral use • Active substance: Rivaroxaban 2.5 mg; • Excipients: Lactose monohydrate, sodium lauryl sulfate, hypromellose, croscarmellose sodium, microcrystalline cellulose, magnesium stearate. Tablet coating: Yellow coating powder – macrogol 3350, hypromellose, iron oxide yellow (E172), titanium dioxide (E171). Read the instructions carefully before taking the medicine. • Keep the instructions. You may need to read them again. • If you have any additional questions, consult your doctor or pharmacist. • The medicine was prescribed only for you. Do not give it to others, even if their symptoms are similar to yours. • If any side effects worsen or if you experience any side effects not listed in these instructions, consult your doctor or pharmacist. In these instructions, you will learn: 1. What RIVAROX is and what it is used for 2. What you need to know before taking RIVAROX 3. How to take RIVAROX 4. Possible side effects 5. How to store RIVAROX 1. What RIVAROX is and what it is used for RIVAROX is: Round, biconvex, light yellow, film-coated tablets, with a score mark “III” on one side. Each box contains 56 film-coated tablets. RIVAROX is prescribed if you have: • Had a recent acute coronary syndrome (a condition characterized by heart attack, unstable angina, severe chest pain) and have elevated cardiac biomarkers in your blood according to cardiac test results. In adult patients, RIVAROX reduces the risk of heart attack and sudden death that may be associated with heart and blood vessel diseases. RIVAROX is not taken alone. Your doctor will prescribe it: - in combination with acetylsalicylic acid, or - in combination with acetylsalicylic acid plus clopidogrel or ticlopidine. • High risk of bleeding due to the presence of ischemic heart disease and peripheral artery disease. In adult patients, RIVAROX reduces the risk of clot formation. RIVAROX is not taken alone. Your doctor will prescribe it in combination with acetylsalicylic acid. RIVAROX contains the active substance rivaroxaban and is an antithrombotic agent that works by blocking blood clotting (Factor Xa) and thus reduces the ability of blood to clot. 2. What you need to know before taking RIVAROX Do not take RIVAROX if: • You are allergic (hypersensitive) to any of the components of the medicine. • You have severe bleeding. • You have a disease or pathological condition of any organ that increases the risk of significant bleeding (e.g., stomach ulcer, brain injury or hemorrhage, recent surgery on the brain or eye. • You are taking anticoagulant medications (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant therapy or administering heparin to prevent blockage of blood vessels in arteries and veins. • You have acute coronary syndrome and have had a stroke or transient ischemic attack. • You have ischemic heart disease and peripheral artery disease, have had a hemorrhagic or lacunar stroke, as well as any type of stroke in the last month. • You have liver disease that increases the risk of bleeding. • You are pregnant or breastfeeding. Do not take RIVAROX and inform your doctor if you have any of the above conditions. Precautions: Consult your doctor before taking RIVAROX. Do not use RIVAROX with certain medications (e.g., prasugrel or ticagrelor), except for acetylsalicylic acid and clopidogrel/ticlopidine. Caution is required if you have: • Increased risk of bleeding, which may be caused by the following conditions: - severe kidney failure (kidney function affects the drug concentration in the blood) - taking other anticoagulant medications (e.g., warfarin, dabigatran, apixaban, or heparin), except when changing anticoagulant therapy or administering heparin to prevent blockage of blood vessels in arteries and veins - bleeding disorders - very high blood pressure that is not controlled by medication - gastrointestinal diseases that may be complicated by bleeding, such as inflammatory bowel disease, esophageal inflammation caused by gastroesophageal reflux (stomach acid entering the esophagus) - vascular problems of the fundus of the eye (retinopathy) - respiratory disease with bronchial dilation and sputum (bronchiectasis) or a history of lung bleeding - age over 75 years - body weight of 60 kg or less - ischemic heart disease with signs of acute heart failure artificial heart valve antiphospholipid syndrome (an immune system disorder that increases the risk of bleeding). Inform your doctor about this syndrome. Your doctor will decide if your prescribed treatment needs to be changed. Inform your doctor before taking RIVAROX if you have any of the above conditions. Your doctor will decide on the necessity of prescribing the medicine and medical supervision. If surgery is necessary: It is very important to take RIVAROX at the exact time before and after surgery as determined by your doctor. If the surgery involves catheterization or injection into the spinal cord (e.g., epidural or spinal anesthesia or pain relief): - It is very important to take RIVAROX at the exact time determined by your doctor, both before and after the injection or catheter removal - Immediately inform your doctor about any weakness or numbness in your legs, as well as problems with your bowel or bladder function that may occur after the anesthesia is completed, as these require urgent medical intervention. Children and adolescents: RIVAROX is not recommended for children and adolescents under 18 years of age. Data on use in children and adolescents are insufficient. Interactions with other medicines: Tell your doctor or pharmacist if you are taking, have taken, or might take any other medicines, including over-the-counter medicines. • Medications for fungal infections (e.g., fluconazole, itraconazole, voriconazole, posaconazole), except for topical use only • Ketoconazole tablets (for Cushing's syndrome, when the body produces excess cortisol) • Certain antibacterial medications (e.g., clarithromycin, erythromycin) • Certain antiviral medications used to treat HIV infection (e.g., ritonavir) • Other anticoagulant medications (e.g., enoxaparin, clopidogrel, or vitamin K antagonists such as warfarin and acenocoumarol) • Anti-inflammatory and pain-relieving medications (e.g., naproxen or acetylsalicylic acid) • Dronedarone – a medication used to treat abnormal heart rhythm • Certain antidepressants (selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors) Since the above medications may increase the effect of RIVAROX, inform your doctor about taking them before taking RIVAROX. Your doctor will decide on the necessity of prescribing the medicine and medical supervision. If there is an increased risk of developing stomach or intestinal ulcers, your doctor will prescribe anti-ulcer treatment. Also, inform your doctor if you are taking: • Certain anti-epileptic medications (phenytoin, carbamazepine, phenobarbital); • St. John's Wort (Hypericum perforatum), a herbal remedy for depression. Since the above medications may weaken the effect of RIVAROX, inform your doctor about taking them before taking RIVAROX. Your doctor will decide on the necessity of prescribing the medicine and medical supervision. Pregnancy and breastfeeding: The use of the medicine is contraindicated during pregnancy and breastfeeding. Use effective methods of contraception during treatment with this medicine to avoid pregnancy. If you become pregnant while taking the medicine, inform your doctor immediately, who will decide on the further course of your treatment. Ability to drive and operate machinery: Dizziness (a common side effect) or fainting (an uncommon side effect) may occur when using RIVAROX. If these side effects occur, you should avoid driving or operating machinery. Important information about some excipients in RIVAROX: RIVAROX contains lactose. If you have an intolerance to certain types of sugar, consult your doctor before taking the medicine. 3. How to take RIVAROX Take RIVAROX exactly as prescribed by your doctor. If you have any questions, consult your doctor. What dose of RIVAROX to take: The recommended dose of RIVAROX is 2.5 mg twice daily. Take the tablet at the same time each day (one in the morning, one in the evening). The medicine can be taken with or after food. If you have difficulty swallowing, the RIVAROX tablet can be crushed immediately before use, mixed with water or soft food (e.g., applesauce) and taken in this form. In some cases, it may be necessary to administer the crushed RIVAROX tablet through a gastric tube. RIVAROX should not be taken on your own. Your doctor will prescribe it with acetylsalicylic acid. In case of acute coronary syndrome, your doctor may also prescribe clopidogrel or ticlopidine. Your doctor will choose the dosage of these medications for you at the indicated dose, specifically: acetylsalicylic acid at a daily dose of 75 mg to 100 mg, or acetylsalicylic acid at a daily dose of 75 mg to 100 mg in combination with clopidogrel at a daily dose of 75 mg, or in combination with ticlopidine at a standard daily dose. When to start taking RIVAROX: Treatment with RIVAROX should be started as soon as possible after stabilization of the condition related to acute coronary syndrome, including revascularization procedures. Treatment should be started no less than 24 hours after hospitalization and when parenteral anticoagulant therapy is usually discontinued. Your doctor will choose the course of treatment if you have ischemic heart disease or peripheral artery disease. Your doctor will decide the duration of treatment. If you take too much RIVAROX, seek medical attention immediately. Taking too much RIVAROX increases the risk of bleeding. If you miss a dose of RIVAROX: If you miss a tablet, continue taking the recommended dose of the medicine at the next scheduled time. Do not take a double dose to compensate for a missed dose. Stopping RIVAROX: Take RIVAROX regularly for the duration prescribed by your doctor. Do not stop taking RIVAROX without informing your doctor beforehand. Stopping the medicine increases the risk of heart attack and sudden death due to vascular diseases. If you have any additional questions, consult your doctor. 4. Possible side effects Like all medicines, RIVAROX may cause side effects in some patients, although not everyone gets them. Like other similar acting medicines (antithrombotic agents), RIVAROX can cause life-threatening bleeding and, consequently, a sudden drop in blood pressure (shock). In some cases, bleeding may be hidden. Side effects related to bleeding If you experience any of the following side effects, inform your doctor immediately: • Prolonged and heavy bleeding • Severe weakness, fatigue, paleness, dizziness, headache, unexplained swelling, difficulty breathing, chest pain, or angina attack Side effects involving serious skin damage If you experience any of the following side effects, inform your doctor immediately: • Skin rash that spreads rapidly, blistering skin lesions, such as in the mouth or around the eyes (Stevens-Johnson syndrome / toxic epidermal necrolysis). These side effects are very rare (1 in 10,000 cases) • Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, inflammation in the body, hematological changes, and systemic involvement. This syndrome is very rare (1 in 10,000 cases) Side effects involving severe allergic reactions If you experience any of the following side effects, inform your doctor immediately: • Swelling of the face, lips, mouth, tongue, and throat; difficulty swallowing; hives and difficulty breathing; sudden drop in blood pressure. These side effects are very rare (anaphylactic reactions including anaphylactic shock; occur in 1 in 10,000 cases) or uncommon (angioedema and allergic swelling; occur in 1 in 100 cases) Other possible side effects: Frequent (less than 1 in 10 patients): • Anemia, characterized by pale skin, weakness, shortness of breath • Bleeding from the gastrointestinal tract, genitourinary tract (including hematuria and menorrhagia), nose, gums • Bleeding into the eye (including bleeding into the conjunctiva). • Bruising of soft tissues (hematoma, contusion) • Bloody sputum • Skin and subcutaneous bruising • Postoperative bleeding • Bloody discharge from surgical wounds • Swelling of the extremities • Pain in the extremities • Impaired kidney function (determined by laboratory tests) • Fever • Abdominal pain, dyspepsia, nausea, constipation, diarrhea • Low blood pressure (may manifest as dizziness or syncope) • General weakness and lack of energy (including rapid fatigue and asthenia), headache, dizziness • Skin rash, itching • Increased activity of liver enzymes in the blood Uncommon (less than 1 in 100 patients): • Bleeding into the brain and intracranial hemorrhage • Bleeding into joints, causing pain and swelling • Thrombocytopenia • Allergic reaction, allergic dermatitis • Impaired liver function (determined by laboratory tests) • Increased bilirubin, pancreatic or liver enzymes, thrombocythemia according to laboratory tests; • Fainting • Feeling unwell • Rapid heartbeat • Dry mouth • Hives Rare (less than 1 in 1000 patients): • Bleeding into muscles • Cholestasis, hepatitis (including hepatocellular disorder) • Yellowing of the skin and whites of the eyes • Localized swelling • Hematoma in the groin area (complication of cardiac procedures involving femoral artery catheterization (pseudoaneurysm)) Unknown (frequency cannot be determined from available data): • Kidney failure after severe bleeding • Bleeding into the extremities, causing swelling, pain, decreased sensation, numbness, or paralysis (compartment syndrome as a complication of bleeding) If you experience any side effects, including those not described in these instructions, consult your doctor. 5. How to store RIVAROX The medicine does not require special storage conditions. Keep out of reach of children! Dispensing rule: Pharmaceutical product group II, dispensed with prescription form #3. Use considering the expiry date: Do not use RIVAROX after the expiry date indicated on the box. Do not use RIVAROX if you notice that the medicine or its packaging is damaged. Also, see: Rivarox - RIVAROX 10mg 10 tablets