ROZEVON FILM-COATED TABLET 40MG/10MG

NOVEM PHARMA PRIVATE LIMITED

NOVEM PHARMA PRIVATE LIMITED

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Posology and method of administration** Posology ROZEVON is indicated in adult patients whose hypercholesterolemia is adequately controlled with separately administered monocomponent preparations of the same doses as the recommended combination. The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ROZEVON. The recommended daily dose is one tablet of the given strength, with or without food. ROZEVON are 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. ROZEVON 5 mg/10 mg, 10 mg/10 mg and 20 mg/10 mg film-coated tablets are not suitable for the treatment of patients requiring 40 mg dose of rosuvastatin. ROZEVON should be taken either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. _Paediatric population_ The safety and efficacy of ROZEVON 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_. _Use in the 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. _Dosage in patients with renal insufficiency_ No dose adjustment is necessary in patients with mild to moderate renal impairment. The recommended start dose is rosuvastatin 5 mg in patients with moderate renal impairment (creatinine clearance <60 ml/min). The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. The use of rosuvastatin in patients with severe renal impairment is contraindicated for all doses (see sections 4.3 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Dosage in patients with hepatic impairment_ No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6). Treatment with ROZEVON is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction (See sections 4.4 and 5.2. – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). ROZEVON is contraindicated in patients with active liver disease (see section 4.3). _Race_ Increased systemic exposure of rosuvastatin has been seen in Asian subjects (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. 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 (see Special warnings and precautions for use, Interactions and Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Dosage in patients with pre-disposing factors to myopathy_ Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy/rhabdomyolysis. (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 ROZEVON are 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; see Sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing ROZEVON therapy. In situations where co-administration of these medicinal products with ROZEVON is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Method of administration For oral use. ROZEVON should be taken each day once at the same time of the day with or without food. The tablets should be swallowed whole with a drink of water.