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Mycophenolate Mofetil 1g/5ml Oral Suspension Abbreviated Prescribing Information

Abbreviated Prescribing Information: Mycophenolate Mofetil 1g/5ml Oral Suspension Consult Summary of Product Characteristics before prescribing. Presentation: White to off white Oral suspension; each 5ml containing 1g of Mycophenolate Mofetil. Therapeutic Indications: Mycophenolate mofetil is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Posology and Method of Administration: Mycophenolate Mofetil is for oral administration. For Use in renal transplant in adults and paediatric population aged 2 to 18 years, the recommended dose is 1 g twice daily. In adults, dose must be initiated within 72 hours following transplantation. In cardiac transplant adult patients, mycophenolate mofetil should be initiated within 5 days following transplantation with a daily recommended dose of 1.5 g twice daily. In hepatic transplant in adults, mycophenolate mofetil should be administered for the first 4 days following hepatic transplant with a recommended dose of 1.5 g twice daily. No data are available for Mycophenolate Mofetil usage in paediatric hepatic and cardiac transplant patients. The recommended dose for elderly remains same as adults. No dose adjustments are needed in patients experiencing renal impairment and severe hepatic impairment. Contra-indications: Mycophenolate mofetil should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or any of the excipients listed; women of childbearing potential who are not using highly effective contraception; in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection, or breastfeeding. Special Warnings and Precautions for use: Caution should be exercised in patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate mofetil. Patients receiving mycophenolate mofetil should be monitored for neutropenia, opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis, and pure red cell aplasia. Use of live attenuated vaccines should be avoided since they can be less effective when receiving mycophenolate mofetil medication. Caution should be exercised in patients with active serious digestive system disease and rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome. Due to their potential to lower plasma levels and the efficacy of mycophenolate mofetil, medications that interfere with the enterohepatic cycle of mycophenolic acid (such as cholestyramine and antibiotics) should be taken with caution. Concomitant administration with azathioprine should be avoided. Caution should be exercised in elderly patients due to increased risk of infections. Cases of spontaneous abortion and congenital malformations have been reported following mycophenolate exposure during pregnancy. Women with childbearing potential must use at least one form of reliable contraception before, during, and for six weeks after stopping the therapy. Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate. Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: POM. A list of very common and common adverse reactions is presented and refer the SmPC for details of other adverse events: Bacterial infections, Fungal infections, Viral infections, Benign neoplasm of skin, Neoplasm, Skin cancer, Anemia, Ecchymosis, Leukocytosis, Leucopenia, Pancytopenia, Pseudolymphoma, Thrombocytopenia, Acidosis, Hypercholesterolemia, Hyperglycemia, Hyperkalemia, Hyperlipidemia, Hypocalcemia, Hypokalemia, Hypomagnesemia, Hypophosphatemia, Hyperuricaemia, Gout, Weight decreased, Confusional state, Depression, Insomnia, Agitation, Anxiety, Thinking abnormal, Dizziness, Headache, Hypertonia, Paresthesia, Somnolence, Tremor, Convulsion, Dysgeusia, Tachycardia, Hypertension, Hypotension, Venousthrombosis, Vasodilatation, Cough, Dyspnea, Pleural effusion, Abdominal distension, Abdominal pain, Colitis, Constipation, Decreased appetite, Diarrhea, Dyspepsia, Esophagitis, Eructation, Flatulence, Gastritis, Gastrointestinal haemorrhage, Gastrointestinal ulcer, Gingival hyperplasia, Ileus, Mouth ulceration, Nausea, Pancreatitis, Stomatitis, Vomiting, Hypersensitivity, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Hepatic enzyme increased, Hepatitis, Hyperbilirubinaemia, Jaundice, Acne, Alopecia, Rash, Skin hypertrophy, Arthralgia, Muscular weakness, Blood creatinine increased, Blood urea increased, Hematuria, Renal impairment, Asthenia, Chills, Edema, Hernia, Malaise, Pain, and Pyrexia. Pack Size and NHS Price: 175ml – £115.16. Marketing Authorisation Number: PLGB 00427/0272 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [September-2023]

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400