Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Simvastatin
Actavis UK Ltd
C10AA01
Simvastatin
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5012617013880
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Simvastatin Tablets all strengths x 28’s (UK) 296x210 (Reel Fed) 50945897 Leaflet for Blisters 4298 R.Wrey 07/03/18 * 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 SIMVASTATIN 10MG, 20MG & 40MG 28 TABLETS PIL - UK Black Profile BBBA1793 S.Anson 07.03.18 296 x 210 7pt Actavis UK n/a n/a 1 Version 2 01.11.2017 page 4 page 1 50945897 BBBA1793 SIMVASTATIN 10MG, 20MG, 40MG 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. WHAT IS IN THIS LEAFLET 1 WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN. 3 HOW TO TAKE SIMVASTATIN. 4 POSSIBLE SIDE EFFECTS. 5 HOW TO STORE SIMVASTATIN. 6 CONTENTS OF THE PACK AND OTHER INFORMATION. 1 WHAT SIMVASTATIN IS AND WHAT IT IS USED FOR Simvastatin contains the active substance simvastatin and belongs to a group of medicines known as statins. These work by reducing the amount of total ch Read the complete document
OBJECT 1 SIMVASTATIN 20MG TABLETS Summary of Product Characteristics Updated 01-Mar-2016 | Accord-UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text • 11. Dosimetry • 12 Instructions for preparation of radiopharmaceuticals 1. Name of the medicinal product Simvastatin 20mg Tablets 2. Qualitative and quantitative composition One film-coated Simvastatin 20mg tablet contains 20 mg of simvastatin; Excipient with known effect: Each tablet contains 131.46 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Simvastatin 20mg Tablets is a tan-coloured, oval, biconvex, film-coated tablet, scored on one side; The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Hypercholesterolaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate Treatment of homozygous famili Read the complete document