SUVEZEN 10 mg/10 mg FILM-COATED TABLETS

TABLET, FILM COATED

**4.2 DOSAGE AND METHOD OF ADMINISTRATION** Dosage The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Suvezen. Suvezen is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. Patient should use the strength corresponding to their previous treatment. The recommended dose is one Suvezen tablet daily. _Co-administration with bile acid sequestrants_ Dosing of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. _Paediatric population_ The safety and efficacy of Suvezen in children below the age of 18 years have not yet been established. Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _Elderly_ A start dose of 5 mg rosuvastatin is recommended in patients >65 years (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The combination is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible. _Hepatic impairment_ No dosage adjustment is required in patients with mild hepatic impairment (Child Pugh score 5 to 6). Treatment with Suvezen is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score>9) liver dysfunction. Suvezen is contraindicated in patients with active liver disease. _Renal impairment_ No dose adjustment is necessary in patients with mild to moderate renal impairment. For patients with severe renal impairment the use of rosuvastatin is contraindicated. The 40 mg/10 mg dose is contraindicated in patients with moderate renal impairment. _Race_ Increased systemic exposure of rosuvastatin has been seen in Asian subjects. The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Suvezen 40 mg/10 mg film-coated tablets are contraindicated in these patients (see sections 4.3 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The physician who elects to use rosuvastatin at doses higher than 20 mg should periodically re-evaluate the long-term risk/benefit of rosuvastatin for the individual patient. _Genetic polymorphisms_ Genotypes of SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA have been shown to be associated with an increase in rosuvastatin exposure (AUC) compared to SLCO1B1 c.521TT and ABCG2 c.421CC. For patients known to have the c.521CC or c.421AA genotype, a maximum once daily dose of 20 mg of rosuvastatin is recommended. _Dosage in patients with pre-disposing factors to myopathy_ The recommended start dose is rosuvastatin 5 mg in patients with pre-disposing factors to myopathy. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. _Concomitant therapy_ Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir. Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where co-administration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered. Method of administration Route of administration is oral. Suvezen can be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water.