ROZETIN 40mg / 10mg tablets medication leaflet

C10BA06 rosuvastatin + ezetimibe • Cardiovascular system | Lipid modifying agents, combinations | Combinations of various lipid modifying agents

The combination of rosuvastatin and ezetimibe is used to treat hypercholesterolemia (high cholesterol levels) and to prevent cardiovascular diseases in high-risk patients. It combines two complementary mechanisms to lower LDL cholesterol ('bad cholesterol') levels and improve the lipid profile.

- Rosuvastatin is an HMG-CoA reductase inhibitor (statin) that reduces cholesterol synthesis in the liver, lowering LDL cholesterol and triglycerides while increasing HDL cholesterol ('good cholesterol').
- Ezetimibe works by inhibiting the absorption of cholesterol in the intestines, reducing the amount of cholesterol that enters the bloodstream.

This combination is indicated for patients who cannot achieve target cholesterol levels with statins alone or who require more intensive LDL cholesterol reduction. The medication is taken orally, usually once daily, and the dose is adjusted based on the patient’s needs.

Common side effects include muscle pain, headache, nausea, fatigue, and abdominal discomfort. In rare cases, more serious reactions such as liver dysfunction or rhabdomyolysis (a condition involving muscle tissue breakdown) may occur. Regular monitoring of liver function and lipid levels is essential during treatment.

Treatment with rosuvastatin and ezetimibe should be administered under the supervision of a doctor, and patients should follow a low-fat, low-cholesterol diet to maximize the benefits of therapy.

General data about ROZETIN 40mg / 10mg

Substance: rosuvastatin + ezetimibe

Date of last drug list: 01-06-2025

Commercial code: W67507001

Concentration: 40mg / 10mg

Pharmaceutical form: tablets

Quantity: 30

Product type: generic

Price: 74.70 RON

Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Marketing authorisation

Manufacturer: ELPEN PHARMACEUTICAL CO. INC - GRECIA

Holder: ZENTIVA K.S. - REPUBLICA CEHA

Number: 13806/2021/01

Shelf life: 3 years

Pharmaceutical forms available for rosuvastatin + ezetimibe

Concentrations available for rosuvastatin + ezetimibe

10mg/10mg, 15mg/10mg, 20mg/10mg, 40mg/10mg, 5mg/10mg

Compensation lists for ROZETIN 40mg / 10mg ZENTIVA

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

74.70 RON

35.97 RON

38.73 RON