Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Atorvastatin calcium trihydrate
Aspire Pharma Ltd
C10AA05
Atorvastatin calcium trihydrate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5060209730769
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PREVENCOR 10MG TABLETS / ATORVASTATIN 10MG TABLETS (atorvastatin calcium) THIS PRODUCT IS AVAILABLE IN OTHER STRENGTHS. Your medicine is known as either Prevencor 10mg Tablets or Atorvastatin 10mg Tablets, but will be referred to as Prevencor / Atorvastatin Tablets throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Prevencor / Atorvastatin Tablets are and what they are used for 2. What you need to know before you take Prevencor / Atorvastatin Tablets 3. How to take Prevencor / Atorvastatin Tablets 4. Possible side effects 5. How to store Prevencor / Atorvastatin Tablets 6. Contents of the pack and other information 1. WHAT PREVENCOR / ATORVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR Prevencor / Atorvastatin Tablets belong to a group of medicines known as statins, which are lipid (fat) regulating medicines. Prevencor / Atorvastatin Tablets are used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Prevencor / Atorvastatin Tablets can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREVENCOR / ATORVASTATIN TABLETS DO NOT TAKE PREVENCOR / ATORVASTATIN TABLETS: if you are allergic to atorvastatin or any of the other ingredients o Prečítajte si celý dokument
OBJECT 1 ATORVASTATIN 10MG FILM-COATED TABLETS Summary of Product Characteristics Updated 17-Apr-2018 | Aspire Pharma Ltd 1. Name of the medicinal product Atorvastatin 10mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium). _Excipients: _ Each 10 mg film-coated tablet contains 41.42-43.64 mg of lactose monohydrate. For a full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated tablet Atorvastatin 10mg film-coated tablets are presented as white, oval, biconvex tablets, with dimensions 10.1±0.1mm x 5.6±0.1mm and 3.7±0.2mm in thickness The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. Clinical particulars 4.1 Therapeutic indications _Hypercholesterolaemia: _ Atorvastatin 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 non-pharmacological measures is inadequate. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatment (e.g. LDL apheresis) or if such treatments are unavailable. _Prevention of cardiovascular disease: _ Prevention of cardiovascular events in adult patients 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 and should continue on this diet during treatment with Atorvastatin. The dose should be individualised ac Prečítajte si celý dokument