Leaflet ROSUVASTATINA/FENOFIBRAT ALTHERA 10mg / 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)
Dose adjustment may be needed in liver disease.
Dose adjustment may be needed in kidney disease.
Do not use this medicine while breastfeeding.
Do not use this medicine during pregnancy.
Avoid alcohol during treatment.
This medicine may affect the liver.
This medicine may have important interactions with other medicines.
Seek medical advice if unexplained muscle pain occurs.
This medicine is subject to additional monitoring.
Periodic laboratory tests may be required during treatment.
Older people may have an increased risk of side effects.
Rosuvastatin + fenofibrate is used in adults for disorders of blood fats, especially when high LDL cholesterol is associated with high triglycerides or low HDL cholesterol. Rosuvastatin is a statin that reduces cholesterol production in the liver, while fenofibrate is a fibrate that lowers triglycerides and may increase HDL cholesterol.
It is taken by mouth at the prescribed dose, usually together with diet, physical activity, weight control and diabetes management when relevant. The combination is usually not the first step of treatment; the doctor may start or adjust the individual components before using a fixed-dose product. Do not stop treatment without medical advice, because lipid levels may rise again.
Side effects may include muscle pain, cramps, weakness, abdominal pain, nausea, constipation, diarrhoea, headache, increased liver enzymes or changes in kidney function. The risk of muscle injury is higher in older patients, kidney disease, untreated hypothyroidism, high doses, heavy alcohol use or combination with certain medicines.
Contact a doctor urgently if unexplained muscle pain, severe weakness, fever, dark urine, jaundice, strong abdominal pain, persistent nausea or allergic reactions occur. Tell the doctor about liver, kidney or gallbladder disease, pregnancy, breastfeeding and all medicines used. Blood tests for lipids, liver, kidney function and creatine kinase may be needed during treatment.
General data about ROSUVASTATINA/FENOFIBRAT ALTHERA 10mg / 160mg
- Substance: rosuvastatin + fenofibrate
- Product code: W71951001
- Concentration: 10mg / 160mg
- Pharmaceutical form: film-coated tablets
- Product type: Generic medicine
- 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.
Concentrations available for rosuvastatin + fenofibrate
- 10mg/160mg
- 20mg/160mg