Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Moexipril hydrochloride
UCB Pharma Ltd
C09AA13
Moexipril hydrochloride
7.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5015366085320
Note: Artwork Studio checks and approves technical accuracy and pre-press suitability of this artwork only. Ensure the artwork has been thoroughly checked for textual accuracy and has been approved as such! Aesica Pharmaceuticals GmbH Packaging Technology & Artwork Services Alfred-Nobel-Straße 10 40789 Monheim, Germany Artwork Studio Date Operator Approver PT Approval Dispatched to Schlüter Manufacturing Site Artwork Information Fontsize Bodytext 8 pt Linespacing 9 pt Technical Changes MOCK-UP Product Name Perdix Print Colours Techn. Colours Aesica Id.-No. / GBR black external Id.-No. CIA77361A_MU3 Dimensions 140 x 520 mm Operator Peggy Nathaus Creation Date 03.12.2014 Amended by Peggy Nathaus Modific. Date 16.012.2014 Edition No. 02 VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 Perdix is and what it is used for 2. What you need to know before you take Perdix 3. How to take Perdix 4. Possible side effects 5. How to store Perdix 6. Content of the pack and other information CIA77361A_MU3 10/145 1168 PERDIX ® 7.5 MG FILM-COATED TABLETS PERDIX ® 15 MG FILM-COATED TABLETS Moexipril hydrochloride 1. WHAT PERDIX IS AND WHAT IT IS USED FOR Perdix belongs to a group of medicines called “ACE inhibitors”. It works by blocking the effect of a substance called angiotensin-converting enzyme. This enzyme is important in the control of blood pressure. Perdix is used to treat Les hele dokumentet
OBJECT 1 PERDIX 7.5 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 25-Sep-2015 | UCB Pharma Limited 1. Name of the medicinal product Perdix 7.5 mg film-coated tablets 2. Qualitative and quantitative composition Each Perdix 7.5 mg tablet contains moexipril hydrochloride 7.5 mg. Excipients: Each tablet contains 71 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Each Perdix 7.5 mg tablet is pink, round, convex, with a break line above and marked SP/7.5 on the upper side and 707 on the lower side. The tablet can be divided into equal halves. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of hypertension as monotherapy in adult patients. As second line therapy for the treatment of hypertension in combination with diuretics or calcium antagonists e.g. hydrochlorothiazide or nifedipinein adult patients. 4.2 Posology and method of administration _General:_ Perdix should be administered orally in a single daily dose. As with all other medicinal products taken once daily, it should be taken at approximately the same time each day in the morning before having any food, best immediately upon waking. The absorption of Perdix is affected by food. Therefore it should be taken before food (see also section 5.2). _Initial therapy:_ In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 7.5 mg once a day. Dosage should be adjusted according to blood pressure response. The maintenance dose is 7.5 to 15 mg moexipril daily, administered in a single dose. Some patients may benefit from a further increase to 30 mg per day. Doses over 30 mg have been used, but do not appear to give a greater effect. If blood pressure is not controlled with Perdix alone, a low dose of a diuretic may be added. Hydrochlorothiazide 12.5 mg has been shown to provide an additive effect. With concomitant diuretic therapy, it may be possible to reduce the dose of Perdix. _Diuretic treated patients:_ Les hele dokumentet