Leaflet ROXAMPEX 10mg / 5mg / 8mg film-coated tablets

Indicated for: dyslipidemia

Route of administration: oral

Substance: rosuvastatin + amlodipine + perindopril (statin lipid-lowering agent + calcium channel blocker + ACE inhibitor)

ATC: C10BX14 (Cardiovascular system | Lipid modifying agents, combinations | Lipid modifying agents in combination with other drugs)

Precautions:
Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Avoid grapefruit
Avoid grapefruit

Avoid grapefruit and grapefruit juice.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Hypotension / fall risk
Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myopathy / rhabdomyolysis
Myopathy / rhabdomyolysis

Seek medical advice if unexplained muscle pain occurs.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Electrolyte disturbances
Electrolyte disturbances

This medicine may change blood electrolyte levels.

Rosuvastatin+amlodipine+perindopril is a combination medication used for the treatment of dyslipidemia, hypertension, and the prevention of cardiovascular diseases. Rosuvastatin lowers LDL cholesterol and triglycerides, amlodipine is a calcium channel blocker that relaxes blood vessels and lowers blood pressure, and perindopril is an angiotensin-converting enzyme (ACE) inhibitor that helps reduce blood pressure and provides cardiovascular protection.

This combination is taken orally, usually once daily, and is indicated for patients at high cardiovascular risk, including those with hypertension and associated dyslipidemia. It is commonly used to reduce the risk of major cardiovascular events such as myocardial infarction and stroke.

Common side effects include dizziness, headache, nausea, and muscle pain. In rare cases, severe adverse reactions such as kidney failure, peripheral edema, or rhabdomyolysis may occur. Regular monitoring of renal function, blood pressure, and lipid profile is essential.

Rosuvastatin+amlodipine+perindopril is a comprehensive therapeutic option for patients with multiple cardiovascular risk factors, offering significant benefits in a single administration.

General data about ROXAMPEX 10mg / 5mg / 8mg

  • Substance: rosuvastatin + amlodipine + perindopril
  • Date of latest medicines list: 01-06-2026
  • Product code: W66920001
  • Concentration: 10mg / 5mg / 8mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 30
  • Product type: Generic medicine
  • Price: 96.14 RON
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: KRKA, D.D., NOVO MESTO - SLOVENIA
  • Holder: KRKA, D.D., NOVO MESTO - SLOVENIA
  • Number: 15792/2025/01
  • Shelf life: 2 years

Concentrations available for rosuvastatin + amlodipine + perindopril

  • 10mg/10mg/8mg
  • 10mg/5mg/4mg
  • 10mg/5mg/8mg
  • 20mg/10mg/8mg
  • 20mg/5mg/4mg
  • 20mg/5mg/8mg