Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nebivolol hydrochloride
Glenmark Pharmaceuticals Europe Ltd
C07AB12
Nebivolol hydrochloride
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5060204160066
PACKAGE LEAFLET: INFORMATION FOR THE USER NEBIVOLOL 2.5 MG TABLETS NEBIVOLOL 5 MG TABLETS 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 , pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Nebivolol Tablets is and what it is used for 2. What you need to know before you take Nebivolol Tablets 3. How to take Nebivolol Tablets 4. Possible side effects 5. How to store Nebivolol Tablets 6. Contents of the pack and other information 1. WHAT NEBIVOLOL TABLETS IS AND WHAT IT IS USED FOR Nebivolol Tablets contains nebivolol, a cardiovascular drug belonging to the group of selective beta-blocking agents (i.e. with a selective action on the cardiovascular system). It prevents increased heart rate, controls heart pumping strength. It also exerts a dilating action on blood vessels, which contributes as well to lower blood pressure. It is used to treat raised blood pressure (hypertension). Nebivolol Tablets is also used to treat mild and moderate chronic heart failure in patients aged 70 years or over, in addition to other therapies. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL TABLETS DO NOT TAKE NEBIVOLOL TABLETS: • If you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6). • If you have one or more of the following disorders: - low blood pressure - serious circulation problems in the arms or legs - very slow heartbeat (less than 60 heart beats per minute) - certain other serious heart rhythm problems (e.g. 2 nd and 3 rd degree atrioventricular block, heart conduction disorders) - heart failur Les hele dokumentet
OBJECT 1 NEBIVOLOL 2.5MG TABLETS Summary of Product Characteristics Updated 21-Sep-2022 | Glenmark Pharmaceuticals Europe 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 Nebivolol 2.5 mg Tablets Nebivolol 5 mg Tablets 2. Qualitative and quantitative composition Each tablet contains 2.725 mg nebivolol hydrochloride corresponding to 2.5 mg nebivolol Excipient(s) with known effect: 72.5 mg of lactose monohydrate/tablet Each tablet contains 5.45 mg nebivolol hydrochloride corresponding to 5mg nebivolol Excipient: 145.0 mg of lactose monohydrate/tablet For a full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet 2.5mg : Capsule shaped, white biconvex uncoated tablets with breakline on one side and plain on the other side The tablet can be divided into equal halves. 5mg: Circular, white, shallow biconvex uncoated tablets engraved with 'N' and 'L' on either side of the breakline on one side and plain on other side. The tablet can be divided into equal halve Les hele dokumentet