RENOCEPTIN 500 Tablet 10’s

INTRODUCTION RENOCEPTIN 500 TABLET contains Mycophenolate mofetil which belongs to the group of medicines called Immunosuppressants. It is used to prevent your body rejecting a transplanted organ (such as kidney, heart, and liver). It is also given with other medications such as corticosteroids and ciclosporin. Your doctor will perform some regular blood tests to monitor any changes in your body. RENOCEPTIN 500 TABLET may increases the risk of skin cancer. Limit your exposure to sunlight and ultraviolet light by covering the exposed areas of skin as much as possible and by applying sunscreen with a high protective factor. RENOCEPTIN 500 TABLET can cause birth defects and miscarriage, hence it is strictly not recommended for use in pregnant women and breastfeeding women. RENOCEPTIN 500 TABLET is not recommended for use in children under 2 years of age. Contact your doctor before taking. RENOCEPTIN 500 TABLET should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking RENOCEPTIN 500 TABLET. The most common side effects of taking RENOCEPTIN 500 TABLET are nausea, vomiting, diarrhea, stomach pain, headache, high blood pressure, and low number of white blood cells. Contact your doctor if the above side effects worsen. USES OF RENOCEPTIN 500 TABLET Used to prevent your body rejecting a transplanted organ (such as kidney, heart, and liver) HOW RENOCEPTIN 500 TABLET WORKS RENOCEPTIN 500 TABLET belongs to immunosuppressants which reduces the action of the body’s own defense system (the immune system) and prevents rejection of the transplanted organ. DIRECTIONS FOR USE Take RENOCEPTIN 500 TABLET as advised by your physician. Swallow the medicines with a glass of water. Do not crush or chew the medicine. Your dosage will vary depending on the type of transplant you received. Do not stop the medicine suddenly without the concern of your doctor. SIDE EFFECTS OF RENOCEPTIN 500 TABLET COMMON Decreased white blood cells Decrease in calcium levels of blood Abnormal potassium levels in the blood (high or low) Raised uric acid levels in the blood High or low blood pressure Anxiety Diarrhoea Joint or muscle pain Tiredness, shortness of breath and pale skin (decrease in red blood cells) Unexpected bleeding and bruising (decrease in blood platelets) Hypomagnesemia (decrease in magnesium levels of blood) Dizziness Headache Cough Shortness of breath Stomach pain, inflammation of the lining of the stomach, abdominal bloating, constipation, indigestion, flatulence, loose stools, nausea, vomiting Tiredness Fever Change in liver and kidney function test results Respiratory infection Acne Weakness Swelling of hands, ankles, or feet Itching UNCOMMON Fast heartbeat or irregular heartbeat Fluid in the lungs   Presence of cyst in lymph   Trembling, difficulty in sleeping Conjunctivitis, blurry vision Bad breath, gas formation, intestinal blockage, ulcers on lips, heartburn, discoloration of tongue, dry mouth, inflammation of the gums Loss of appetite Wheezing Blockage of salivary glands Elevated lipid levels Increase in blood glucose levels or blood cholesterol levels Strange dreams, delusions Pain, rigors Inability to keep an erection Cough, difficulty breathing, painful breathing Fever, chills, nausea, vomiting, low body temperature, fast heartbeat RARE Stop taking RENOCEPTIN 500 TABLET and contact your doctor immediately if you experience any of the following side effects: Yellowish discoloration of skin and whites of eyes, nausea, loss of appetite and dark urine Persistent cough or become breathlessness Signs of infection such as fever, chills, sore throat, sweating, feeling tired, drowsy, or lack of energy Blood vomit blood or blood in stools due stomach, or intestinal ulcer Swelling of glands, development of a new skin growth or enlargement of an existing skin growth, or changes in an existing mole. may lead to development of cancer of the skin or lymph nodes Rashes, swelling of face, lips, tongue or throat causing difficulty breathing HOW TO MANAGE SIDE EFFECTS Diarrhoea: Drink plenty of water and fruit juice to keep yourself hydrated. Contact your doctor if the diarrhea did not improve. Headache: Rest and relax. Drink plenty of fluids such as water and electrolytes. Apply a pain-relieving balm on the head if necessary. Do not consume alcohol. Contact your doctor if the headache did not improve. Nausea and Vomiting: Take the medicine, with or just after a meal. Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if nausea and vomiting did not improve. Dizziness: Try to rest and relax. Get enough sleep. Avoid driving or operate any machines while you are feeling dizzy. Do not drink alcohol, as it can aggravate your dizziness. Contact your doctor if the dizziness did not improve. Stomach pain: Try to rest and relax. Eat small meals but take frequently. Keep a heat pad on your stomach. Contact your doctor if the stomach pain did not improve. WARNING & PRECAUTIONS PREGNANCY RENOCEPTIN 500 TABLET is not recommended for use in pregnant women. Inform your doctor if you are planning to have a child before taking this medicine. Contact your doctor before taking RENOCEPTIN 500 TABLET. BREASTFEEDING RENOCEPTIN 500 TABLET is generally not recommended for use in breastfeeding women, hence small amounts of the medicine can pass into the mother’s milk. Contact your doctor before taking RENOCEPTIN 500 TABLET. DRIVING AND USING MACHINES Do not drive or operate any machines if you feel drowsiness, somnolence, dizziness, tremor, low blood pressure, numb or confusion after taking RENOCEPTIN 500 TABLET. KIDNEY RENOCEPTIN 500 TABLET should be used with caution in patients with kidney diseases. Contact your doctor before taking RENOCEPTIN 500 TABLET. LIVER RENOCEPTIN 500 TABLET should be used with caution in patients with liver diseases. Contact your doctor before taking RENOCEPTIN 500 TABLET. ALLERGY Do not take RENOCEPTIN 500 TABLET if you are allergic (hypersensitive) to Mycophenolate mofetil, or to some sugars such as lactose, galactose, or glucose or to other ingredients of this medicine. LUNGS RENOCEPTIN 500 TABLET should be used with caution in patients with lung diseases. Contact your doctor before taking RENOCEPTIN 500 TABLET. HEART DISEASE RENOCEPTIN 500 TABLET should be used with caution in patients with heart diseases. Contact your doctor before taking RENOCEPTIN 500 TABLET. OTHERS RENOCEPTIN 500 TABLET is not recommended for use if you: Have hereditary enzyme deficiency such as Lesch-Nyhan (neurogenetic disorder) and Kelley-Seegmiller syndrome (partial deficiency of the enzyme hypoxanthine guanine phosphoribosyl transferase) Before taking RENOCEPTIN 500 TABLET, inform your doctor if you: Have any unexpected bruising (skin discoloration from a skin or tissue injury) or bleeding Have digestive problems (such as a stomach ulcer) Have a rare problem with your metabolism called phenylketonuria (hereditary condition that results in an accumulation of the phenylalanine) Are planning to get live vaccinations Have Hepatitis B or C infections Have skin cancer or lymphoma Use in pediatrics: RENOCEPTIN 500 TABLET is not recommended for use in children under the age of 2, because there is limited information on its safety and effectiveness. Contact your doctor before taking RENOCEPTIN 500 TABLET. Use in geriatrics: RENOCEPTIN 500 TABLET should be used with caution in elderly patients aged 65 years or above. Contact your doctor before taking RENOCEPTIN 500 TABLET. INTERACTIONS A. Drug-Drug interactions: Before taking RENOCEPTIN 500 TABLET, inform your doctor if you are taking any of the following medicine: Azathioprine, tacrolimus, belatacept, cyclosporine A (suppress your immune system given after a transplant operation) Cholestyramine (medicine used to treat high cholesterol) Rifampicin (medicines used to prevent and treat infections such as TB) Medicines used to treat ulcer problems (antacids such as aluminium hydroxide, magnesium hydroxide, sodium bicarbonate, calcium carbonate or proton pump inhibitors such as omeprazole, rabeprazole, pantoprazole) Phosphate binders (used to reduce phosphate absorption into the blood is used by patients with chronic renal failure) such as ferric citrate, calcium acetate, sevelamer Antibiotics (medicines used to treat bacterial infections) amoxicillin and clavulanic acid, doxycycline, ciprofloxacin, clindamycin, metronidazole, azithromycin, trimethoprim/sulfamethoxazole, amikacin, cefadroxil, norfloxacin Isavuconazole (medicine used to treat fungal infections) Telmisartan (medicine used to treat high blood pressure) Activated charcoal (used to treat digestive problems) Acyclovir or ganciclovir (medicines used to treat viral infections) Oral contraceptives such as Ex. ethinylestradiol and levonorgestrel (medicines used to prevent pregnancy) Probenecid (medicines used to treat gout) Iron salts such as Ex. ferrous sulphate (medicines used to treat iron deficiency) Overdosage: If you or anyone else accidentally takes too much of RENOCEPTIN 500 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms include nausea, vomiting, diarrhea, and neutropenia. SYNOPSIS Drug :   Mycophenolate mofetil Pharmacological Category :   Immunosuppressants Therapeutic Indication :   Prevents your body from rejecting a transplanted organ                        Dosage Forms :   Tablet, Capsule, Suspension, Oral suspension MORE INFORMATION Keep RENOCEPTIN 500 TABLET out of the sight and reach of children Store RENOCEPTIN 500 TABLET below 30°C FAQs ABOUT RENOCEPTIN 500 TABLET What is RENOCEPTIN 500 TABLET used for? RENOCEPTIN 500 TABLET is used to prevent your body from rejecting an organ transplant (such as kidney, heart, and liver). Contact your doctor before taking RENOCEPTIN 500 TABLET. Can I use RENOCEPTIN 500 TABLET in pregnancy? No. RENOCEPTIN 500 TABLET is strictly not recommended for use in pregnant women unless considered necessary. Contact your doctor before taking RENOCEPTIN 500 TABLET. Is RENOCEPTIN 500 TABLET safe? Yes, RENOCEPTIN 500 TABLET is safe and well tolerated. Contact your doctor before taking. Can I use RENOCEPTIN 500 TABLET in children? No, RENOCEPTIN 500 TABLET is not recommended for use in children under the age of 2, because there is limited information on its safety and effectiveness for them. Contact your doctor before taking. How RENOCEPTIN 500 TABLET work? RENOCEPTIN 500 TABLET belongs to immunosuppressants which reduces the action of the body’s own defense system (the immune system) and prevents rejection of the transplanted organ. Can I use RENOCEPTIN 500 TABLET while breast feeding? No. RENOCEPTIN 500 TABLET is generally not recommended for use in breastfeeding women, small amounts of the medicine can pass into the mother’s milk. Contact your doctor before taking it. REFERENCES 1. KD Tripathi. Immunosuppressant Drugs. Essentials of Medical Pharmacology. Seventh Edition,2013. Page – 883. 2. Jeffrey J Swigris, Amy L Olson, Aryeh Fischer, David A Lynch, Gregory P Cosgrove, Stephen K Frankel, Richard T Meehan, Kevin K Brown. Uses of Mycophenolate mofetil. National Institute of Health. NLM. National Centre for Biotechnology Information. Pubmed.gov. 2006. [Accessed on 16th July 2022] https://pubmed.ncbi.nlm.nih.gov/16840379/ 3. Novartis Pharma GmbH. Electronic Medicines Compendium (EMC); [Revised on July 2021] [Accessed 16th July 2022] https://www.medicines.org.uk/emc/files/pil.5560.pdf 4. Roche Products Limited. Electronic Medicines Compendium (EMC); [Revised on January 2022] [Accessed 16th July 2022] https://www.medicines.org.uk/emc/files/pil.1102.pdf 5. Novartis Pharma GmbH. Electronic Medicines Compendium (EMC); [Revised on July 2021] [Accessed 16th July 2022] https://www.medicines.org.uk/emc/files/pil.7793.pdf 6. Accord Healthcare B.V. Electronic Medicines Compendium (EMC); [Revised on Oct 2020] [Accessed 16th July 2022] https://www.medicines.org.uk/emc/files/pil.5989.pdf 7. Roche Pharma AG. European Medical Agency. [Revised in Jan 2021] [Accessed on 16th July 2022] https://www.ema.europa.eu/en/documents/product-information/cellcept-epar-product-information_en.pdf 8. Biocon. Mycophenolate mofetil. [Accessed on 16th July 2022] https://www.biocon.com/docs/prescribing_information/nephrology/renodapts540_pi.pd 9. Hoffmann-La Roche Limited. Mycophenolate mofetil. [Revised on January 2022] [Accessed 16th July 2022] https://www.rochecanada.com/PMs/CellCept/CellCept_PM_E.pdf 10. Mycophenolate mofetil. Mims.com. [Accessed on 16th July 2022] https://www.mims.com/india/drug/info/mycophenolic acid?type=full&mtype=generic USEFUL DIAGNOSTIC TESTS Complete blood count Liver function test Kidney function test PRODUCT DETAILS Country Of Origin India