Dose adjustment in hepatic impairment
Dose adjustment may be needed in liver disease.
Leaflet ROSUVASTATINA/FENOFIBRAT ALTHERA 10mg / 160mg film-coated tablets
- Product code:
- W71951001
- Indicated for:
- mixed dyslipidemia; hypercholesterolemia and hypertriglyceridemia
- Route of administration:
- oral
- Substance:
- rosuvastatin + fenofibrate (statin + fibrate)
- ATC
- C10BA09 — Cardiovascular system | Lipid modifying agents | Lipid modifying agents, combinations | Combinations of various lipid modifying agents
Precautions:
Dose adjustment in renal impairment
Dose adjustment may be needed in kidney disease.
Contraindicated during breastfeeding
Do not use this medicine while breastfeeding.
Contraindicated during pregnancy
Do not use this medicine during pregnancy.
Avoid alcohol
Avoid alcohol during treatment.
Hepatotoxicity
This medicine may affect the liver.
Major drug interactions
This medicine may have important interactions with other medicines.
Myopathy / rhabdomyolysis
Seek medical advice if unexplained muscle pain occurs.
Additional monitoring
This medicine is subject to additional monitoring.
Requires periodic laboratory tests
Periodic laboratory tests may be required during treatment.
Elderly warning
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.
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