Leaflet ROSUVASTATINA/FENOFIBRAT ALTHERA 20mg / 160mg film-coated tablets


Indicated for: mixed dyslipidemia; hypercholesterolemia and hypertriglyceridemia

Route of administration: oral

Substance: rosuvastatin + fenofibrate (statin + fibrate)

ATC: C10BA09 (Cardiovascular system | Lipid modifying agents, combinations | Combinations of various lipid modifying agents)

Precautions:
Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Avoid alcohol
Avoid alcohol

Avoid alcohol during treatment.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

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.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Elderly warning
Elderly warning

Older people may have an increased risk of side effects.

General data about ROSUVASTATINA/FENOFIBRAT ALTHERA 20mg / 160mg

  • Substance: rosuvastatin + fenofibrate
  • Commercial code: W71952001
  • Concentration: 20mg / 160mg
  • Pharmaceutical form: film-coated tablets
  • Product type: generic
  • 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: FUNDACIO PRIVADA DAU - SPANIA
  • Holder: ALTHERA LABORATORIES LIMITED - IRLANDA
  • Number: 16658/2026/01
  • Shelf life: 30 months

Concentrations available for rosuvastatin + fenofibrate

  • 10mg/160mg
  • 20mg/160mg