SIMVATE 3D BOX

Simvaten®

Simvastatin 10mg, 20mg and 40mg

Tablets for oral use

Product leaflet summary

Therapeutic Indications

Hypercholesterolemia

Treatment of primary hypercholesterolemia or mixed dyslipidemia, along with diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.

Treatment of homozygous familial hypercholesterolemia along with diet and other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.

Cardiovascular disorders prevention

Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardio protective therapy.

 

Dosage and Administration

The dosage range is 5-80 mg/day given orally as a single dose in the evening.

Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. The 80-mg dose is only recommended in patients with severe hypercholesterolemia and high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks

 

Contraindications

Hypersensitivity to simvastatin or to any of the excipients

Active liver disease or unexplained persistent elevations of serum transaminases.

Pregnancy and lactation. Concomitant administration of potent CYP3A4 inhibitors (e.g. Itraconazole, ketoconazole, HIV protease inhibitors, Boceprevir, Telaprevir, Erythromycin, Clarithromycin, Telithromycin and Nefazodone).

Concomitant administration of Gemfibrozil, Cicliosporin, or Dnazol.

 

Pregnancy and Lactation

 

Pregnancy:

SIMVATEN is contraindicated during pregnancy.

Safety in pregnant women has not been established. Simvastatin must not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant.

 

Lactation:

It is not known whether Simvastatin is excreted in human milk. Patients taking SIMVATEN should not breastfeed their infants.

 

Ability to drive and machinery use

SIMVATEN has no or negligible influence on the ability to drive and use machines. However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported rarely in post-marketing experiences.

 

Package Presentation:

1- A box of 30 Tablets each contains 10 mg Simvastatin.

2- A box of 30 Tablets each contains 20 mg Simvastatin.

3- A box of 30 Tablets each contains 40 mg Simvastatin