Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: myHealthbox
atorvastatin
Caduceus Pharma Ltd
C10AA05
atorvastatin
40mg
Film-coated tablets
Oral use
10, 20, 28, 30, 50, 90, 98, 100 tablets
POM - Prescription Only Medicine
Actavis Ltd
Lipid modifying agents, HMG-CoA-reductase inhibitors
It is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Authorised
2015-03-02
296x210 reel fed bi-fold leaflet profile UK BST (DR/RW/MC 10.02.11) ATORVASTATIN 10MG, 20MG AND 40MG FILM-COATED TABLETS • fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature • urine tests that are positive for white blood cells. RARE side effects (affects 1 to 10 users in 10,000) include: • visual disturbance • unexpected bleeding or bruising • cholestasis (yellowing of the skin and whites of the eyes) • tendon injury. VERY RARE side effects (affects less than 1 user in 10,000) include: • an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse • hearing loss • gynecomastia (breast enlargement in men and women). POSSIBLE side effects reported with some statins (medicines of the same type): • Sexual difficulties • Depression • Breathing problems including persistent cough and/or shortness of breath or fever. • Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5 HOW TO STORE Keep out of the sight and reach of children. This medicine does not require any special storage conditions. Do not use Atorvastatin tablets after the expiry date which is stated on the pack after {EXP}. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or hou Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin 40mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40mg of atorvastatin as atorvastatin calcium trihydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. 40mg: White, oval, biconvex, 7.8 x 14.5mm film-coated tablets marked with “40” on one side and “A” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin 40mg Film coated Tablets is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin 40mg Film coated Tablets is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease Prevention of cardiovascular events in adults estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin 40mg Film coated Tablets and should continue on this diet during treatment with Atorvastatin 40mg Film coated Tablets. The dose should be individualised according to baseline L Izlasiet visu dokumentu