Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nebivolol hydrochloride
Zentiva Pharma UK Ltd
C07AB12
Nebivolol hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5000283653592
BBBA3195 * 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 NEBIVOLOL 5MG TABLETS PIL - UK Black BBBA3195 R.Wrey 18/10/181 26.02.19 S.Anson 190x600 12pt Teva Bulgaria Dupnitsa 18/10/18 29/10/18 6 Version 2 01.11.2017 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 NEBIVOLOL 5MG TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL 5MG TABLETS 3 HOW TO TAKE NEBIVOLOL 5MG TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE NEBIVOLOL 5MG TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT NEBIVOLOL 5MG TABLETS ARE AND WHAT THEY ARE USED FOR Nebivolol 5mg tablets belong to a group of medicines known as beta-blockers. They work by blocking the activity of specific proteins in the heart, lungs, pancreas, liver, and blood circulation system. Nebivolol 5mg tablets are used to treat: • high blood pressure (hypertension) • chronic heart failure in patients aged 70 years or older. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL 5MG TABLETS DO NOT TAKE NEBIVOLOL 5MG TABLETS IF Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nebivolol 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride). Excipient(s) with known effect: Each tablet contains 121.64mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, white colour tablet, cross scored on one side and debossed with “N” and “5” on either side of breakline on the other side. Dimension: 9.10mm x 3.00mm The tablet can be divided in equal quarters. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension. Chronic heart failure (CHF) Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients > 70 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Hypertension _Adults _ The dose is 5 mg daily, preferably at the same time of the day. The blood pressure lowering effect becomes evident after 1-2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks. _Combination with other antihypertensive agents _ Beta-blockers can be used alone or concomitantly with other antihypertensive agents. To date, an additional antihypertensive effect has been observed only when Nebivolol 5 mg is combined with hydrochlorothiazide 12.5-25 mg. _Patients with renal insufficiency _ In patients with renal insufficiency, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg. _Patients with hepatic insufficiency _ Data in patients with hepatic insufficiency or impaired liver function are limited. Therefore the use of Nebivolol in these patients is contra-indicated. _Elderly _ In patients over 65 years, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg. However, in view of the limited experience in patients above 75 years, caution must be exercised and these patients monitored closely. _Paediatric popula Citiți documentul complet