ROZEVON FILM-COATED TABLET 40MG/10MG [SIN16534P]

Product Info

ROZEVON FILM-COATED TABLET 40MG/10MG

[SIN16534P]

4.1 Therapeutic indications
ROZEVON is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products.

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.

4.3 Contraindications
ROZEVON is contraindicated:

• in patients with hypersensitivity to the active substances (rosuvastatin, ezetimibe) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• in patients with active liver disease including unexplained, persistent elevations of serum transaminases.

• during pregnancy and breast-feeding and in women of childbearing potential not using appropriate contraceptive measures.

• in patients with severe renal impairment (creatinine clearance <30 ml/min).

• in patients receiving concomitant ciclosporin.