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Simvastatin Abbreviated Prescribing Information

Abbreviated Prescribing Information: Simvastatin Rosemont 20mg/5ml and 40mg/5ml Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: A white to off-white oral suspension containing 20mg or 40mg simvastatin per 5ml Therapeutic Indications: Hypercholesterolaemia and reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy. Posology and Method of Administration: Adults: The dosage range is 5 – 80mg/day depending on condition given orally as a single dose in the evening. Adjustments of dosage should be made at intervals of not less than 4 weeks, to a maximum of 80mg/day. The 80mg dose is only recommended in patients with severe hypercholesterolaemia and high risk for cardiovascular complications. In patients taking lomitapide concomitantly with simvastatin, the dose of Simvastatin Oral Suspension must not exceed 40 mg/day. In patients with severe renal insufficiency (creatinine clearance <30ml/min), dosages above 10mg/day should be carefully considered. Children: 10-17 years of age, boys Tanner Stage II and above and girls who are at least one-year post-menarche with heterozygous familial hypercholesterolaemia, starting dose is 10mg once a day in the evening. The recommended dosing range is 10–40 mg/day. Adjustments should be made at intervals of 4 weeks or more. The experience of simvastatin in pre-pubertal children is limited. Elderly: No dosage adjustment is necessary. Contra-indications: Hypersensitivity to simvastatin or to any of the excipients. Concomitant administration of gemfibrozil, ciclosporin, danozol or potent CYP3A4 inhibitors. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy and lactation. In patients with HoFH, concomitant administration of lomitapide with doses > 40mg simvastatin. Special Warnings and Precautions for use: Myopathy/Rhabdomyolysis: risk of myopathy is increased by high levels (80mg and above) and is greater than other statin-based therapies with similar LDL-C-lowering efficacy. Hepatic effects: persistent increases in serum transaminases have occurred. When simvastatin was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pre-treatment levels. Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis. Use with caution in patients who consume substantial quantities of alcohol. Interstitial lung disease: exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy. Diabetes Mellitus: some evidence suggests that statins as a class can raise blood glucose. The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with products containing elbasvir or grazoprevir due to an increased risk of myopathy. Cases of myopathy and/or rhabdomyolysis have been reported with HMG-CoA reductase inhibitors (e.g., simvastatin) co-administered with daptomycin. Paediatric population: Simvastatin has not been studied in patients younger than 10 years of age, nor in pre-pubertal children and pre-menarchal girls. Also, doses greater than 40mg have not been studied patients 10-17 years of age. Excipient Warnings: contains parahydroxybenzoates which may cause allergic reactions, and propylene glycol. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: not applicable. Legal Category: Prescription only medicine. A list of common and serious adverse reactions (include statement to consult the SmPC for full details of other adverse reactions): Blood and lymphatic system disorders: Rare: anaemia. Psychiatric disorders: Very rare: insomnia. Not known: depression. Nervous system disorders: Rare: headache, paraesthesia, dizziness, peripheral neuropathy. Very rare: memory impairment. Eye disorders: Rare: vision blurred, visual impairment. Respiratory, thoracic and mediastinal disorders: Not known: interstitial lung disease. Gastrointestinal disorders: Rare: constipation, abdominal pain, flatulence, dyspepsia, diarrhoea, nausea, vomiting, pancreatitis. Hepatobiliary disorders: Rare: hepatitis/jaundice. Very rare: hepatic failure. Skin and subcutaneous tissue disorders: Rare: rash, pruritus, alopecia. Very rare: lichenoid drug eruptions. Musculoskeletal, connective tissue and bone disorders: Rare: myopathy, rhabdomyolysis, myalgia, muscle cramps. Very rare: muscle rupture. Not known: tendinopathy, immune-mexdiated necrotizing myopathy. Reproductive system and breast disorders: Very rare: gynecomastia. Not known: erectile dysfunction. General disorders and administration site conditions: Rare: asthenia, apparent hypersensitivity syndrome. Immune system disorders: Very rare: anaphylaxis. Investigations: Rare: increases in serum transaminases, elevated alkaline phosphatase, increase in serum CK levels, increases in HbA 1c and fasting serum glucose levels and rare post-marketing reports of cognitive impairment have been reported. Pack Size and NHS Price: 20mg/5ml 150ml – £203.00, 40mg/5ml 150ml £285.00. Marketing Authorisation Number: 20mg/5ml PL 00427/0230, 40mg/5ml PL 00427/0231. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [December-2022]

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