Basic Information
ROSWERA FILM-COATED TABLETS 5MG
TABLET, FILM COATED
Regulatory Information
SIN16659P
December 29, 2022
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XC10AA07
Company Information
SINGAPORE PHARMACEUTICAL PRIVATE LIMITED
SINGAPORE PHARMACEUTICAL PRIVATE LIMITED
Active Ingredients
Strength: 5.00mg
Detailed Information
Contraindications
**4.3 Contraindications** ROSWERA is contraindicated in patients with hypersensitivity to any component of this product. ROSWERA is contraindicated in patients with active liver disease or unexplained, persistent elevations of serum transaminases. ROSWERA is contraindicated during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures. ROSWERA is contraindicated in patients receiving concomitant cyclosporin. ROSWERA is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min).
Indication Information
**4.1 Therapeutic indications** ROSWERA is indicated for patients with primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type IIa, IIb; and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate. ROSWERA is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate. ROSWERA reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. ROSWERA also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I. ROSWERA is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis). Primary prevention of cardiovascular disease: ROSWERA is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, ROSWERA is indicated to: - reduce the risk of stroke - reduce the risk of myocardial infarction - reduce the risk of arterial revascularization procedures ROSWERA is indicated in children and adolescents 10 to 17 years of age as an adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year postmenarche, 10–17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Paediatric studies were conducted mainly in the non-Asian population and data on Asian children/adolescents is limited.