Cholerose 40 mg 28 tablets

Cholerose 40 mg 28 tablets

Composition:

Each tablet contains:
Rosuvastatin calcium 40 mg (active ingredient). 

Product Description:

Cholerose is a lipid-lowering agent belonging to the statin class (HMG-CoA reductase inhibitors).
It reduces cholesterol synthesis in the liver, lowers LDL-C and triglycerides, and raises HDL-C.
It is indicated for patients with severe hypercholesterolemia or high cardiovascular risk who require intensive therapy.

Indications for Use:

Primary hypercholesterolemia (including familial forms).
Mixed dyslipidemia.
Hypertriglyceridemia.
Homozygous familial hypercholesterolemia (HoFH).
Prevention of major cardiovascular events (heart attack, stroke, revascularization) in high-risk adults.

Method of Administration and Dosage:

Oral use, once daily, with or without food.
Usual adult dose range: 5–40 mg/day.
40 mg is the maximum dose, reserved for patients not adequately controlled at lower doses and at high CV risk.
Dose adjustments required for renal impairment, Asian patients, or drug interactions.

Contraindications:

Hypersensitivity to rosuvastatin or excipients.
Active liver disease or unexplained persistent elevations of liver transaminases.
Pregnancy and breastfeeding.
Concomitant use with cyclosporine.

Precautions:

Monitor liver function before and during therapy.
Assess creatine kinase if muscle symptoms occur.
Use caution in patients with renal impairment, hypothyroidism, or history of myopathy.
Avoid excessive alcohol intake.

Adverse Reactions / Side Effects:

Common: headache, abdominal pain, nausea, myalgia.
Serious: rhabdomyolysis, liver enzyme elevations, hypersensitivity reactions.
Rare: memory loss, depression, pancreatitis.

Pregnancy and Lactation

Contraindicated.
Statins may harm fetal development and are excreted in breast milk.

Storage Conditions:

Store below 30 °C, in a dry place, away from direct sunlight.
Keep out of reach of children.

Packaging:

Box of 28 film-coated tablets.