Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Atorvastatin calcium trihydrate
Viatris UK Healthcare Ltd
C10AA05
Atorvastatin calcium trihydrate
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5016695004716 5016695008899 5016695926643
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Atorvastatin Tablets 10,20,40 & 80mg x 28’s (UK) 296x210 (Reel Fed) 50966743 Leaflet for Blisters 3909 R.Wrey 08/04/19 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) £ No £ Yes £ Details ATORVASTATIN 10MG, 20MG & 40MG FILM-COATED TABLETS PIL - UK Black Profile BBBA4492 R.Wrey 11/04/19 01/05/19 T. Hull 296 x 210 8pt Accord UK n/a 2 Version 2 01.11.2017 page 4 page 1 50966743 BBBA4492 ATORVASTATIN 10MG, 20MG AND 40MG FILM-COATED TABLETS Package leaflet: Information for the user 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • The full name of this medicine is Atorvastatin 10mg, 20mg and 40mg Film- coated Tablets but within the leaflet it will be referred to as Atorvastatin tablets. WHAT IS IN THIS LEAFLET: 1 WHAT ATORVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN TABLETS 3 HOW TO TAKE ATORVASTATIN TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ATORVASTATIN TABLETS 6 CON Прочетете целия документ
OBJECT 1 ATORVASTATINE 20MG FILM-COATED TABLETS Summary of Product Characteristics Updated 25-Jun-2018 | Generics UK T/A Mylan 1. Name of the medicinal product Atorvastatin 20mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient with known effect: Each tablet contains 85mg lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. White, oval, biconvex, film coated tablet, approximately 11.2mm × 6.2mm, plain on one side and debossed '20' on the other side. The scoreline 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 nonpharmacological 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 treatments (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 according to baseline LDL-C levels, the goal Прочетете целия документ