Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lisinopril
Arrow Generics Ltd
C09AA03
Lisinopril
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5060034831983
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Lisinopril, Capsules, 2.5, 5, 10, 20mg, 28s & UK 296x210 (Reel Fed) 50979114 Leaflet for Blisters 3433 RH 23-09-19 * 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 LISINOPRIL 2.5MG, 5MG, 10MG & 20MG 28 TABLETS PIL - UK Black Profile BBBA6371 RH 25-09-19 10-10-19 RH 296 x 210 7pt Accord Barnstaple n/a n/a 03 Version 2 01.11.2017 page 4 page 1 50979114 BBBA6371 LISINOPRIL 2.5MG, 5MG, 10MG AND 20MG TABLETS _Continued over page_ _Continued top of next column_ 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 LISINOPRIL TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL TABLETS 3 HOW TO TAKE LISINOPRIL TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE LISINOPRIL TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT LISINOPRIL TABLETS ARE AND WHAT THEY ARE USED FOR Lisinopril belongs to a group of medicines called ACE inhibitors. These cau Lees het volledige document
OBJECT 1 LISINOPRIL 5MG TABLETS Summary of Product Characteristics Updated 13-Nov-2019 | 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 Fertility, 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 1. Name of the medicinal product LISINOPRIL 5mg TABLETS 2. Qualitative and quantitative composition Each tablet contains 5mg of Lisinopril as Lisinopril dihydrate. For the full list excipients, see section 6.1. 3. Pharmaceutical form Tablet White, round, flat 8 mm tablets, scored on both sides. The tablet can be divided into equal halves. 4. Clinical particulars 4.1 Therapeutic indications • Hypertension: Treatment of hypertension. • Heart failure: Treatment of symptomatic heart failure. • Acute myocardial infarction: Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction. • Renal complications of diabetes mellitus: Treatment of renal disease in hypertensive patients with Type 2 diabetes mellitus and incipient nephropathy (see section 5.1). 4.2 Posology and method of administration POSO Lees het volledige document