UNI DRUG HOUSE SDN. BHD.

<p><strong>4.1 Therapeutic indications</strong><br> Rosuvastatin tablets 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.</p> <p>Rosuvastatin tablets is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyperlipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate.</p> <p>Rosuvastatin tablets reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. Rosuvastatin tablets 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.</p> <p>Rosuvastatin tablets 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).</p> <p>Primary prevention of cardiovascular disease: Rosuvastatin tablets is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age &ge; 50 years old in men and &ge; 60 years old in women, hsCRP &ge; 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, Rosuvastatin tablets is indicated to:</p> <ul> <li>reduce the risk of stroke</li> <li>reduce the risk of myocardial infarction</li> <li>reduce the risk of arterial revascularization procedures</li> </ul> <p>Rosuvastatin tablets 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&ndash;17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present:<br> LDL-C &gt; 190 mg/dL or &gt; 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.</p>

<p><strong>4.1 Therapeutic indications</strong><br> Treatment of erectile dysfunction in adult males.<br> In order for tadalafil to be effective, sexual stimulation is required.<br> Tadalafil is not indicated for use by women.</p>