Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nebivolol hydrochloride
Viatris UK Healthcare Ltd
C07AB12
Nebivolol hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5016695003290
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (FOR ALUMINIUM-ALUMINIUM FOIL BLISTERS AND ALUMINIUM-ALUMINIUM PERFORATED UNIT DOSE BLISTERS) 1. NAME OF THE MEDICINAL PRODUCT Nebivolol 5 mg Tablets 2. STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to 5 mg of nebivolol 3. LIST OF EXCIPIENTS Also contains lactose. See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS Tablet 7 tablets 10 tablets 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 60 tablets 84 tablets 90 tablets 98 tablets 100 tablets Perforated unit doses: 28 x 1 tablets 56 x 1 tablets 100 x 1 tablets 5. METHOD AND ROUTE OF ADMINISTRATION Dosage: For oral use. Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP: MMM YYYY 9. SPECIAL STORAGE CONDITIONS 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Mylan Potters Bar, Hertfordshire, EN6 1TL, United Kingdom 12. MARKETING AUTHORISATION NUMBER(S) PL 04569/0885 13. BATCH NUMBER Batch/Lot: 14. GENERAL CLASSIFICATION FOR SUPPLY POM 15. INSTRUCTIONS ON USE 16. INFORMATION IN BRAILLE Nebivolol 5 mg tablets 17. UNIQUE IDENTIFIER – 2D BARCODE_ _ 2D barcode carrying the unique identifier included. 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA_ _ PC: SN: NN: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM-ALUMINIUM FOIL BLISTERS 1. NAME OF THE MEDICINAL PRODUCT Nebivolol 5 mg Tablets nebivolol 2. NAME OF THE MARKETING AUTHORISATION HOLDER Mylan 3. EXPIRY DATE EXP: MMM YYYY 4. BATCH NUMBER [To be completed at the time of packaging]. 5. OTHER PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE 1. NAME OF THE MEDICINAL PRODUCT Nebivolol 5 mg Tablets nebivolol 2. STATEMENT OF ACTIVE SUBSTANCE Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nebivolol 5 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to 5 mg of nebivolol. Excipient with known effect: Each tablet contains 145.45 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, rectangular shaped tablet, quadrisected and embossed separately on the first, second and fourth quadrants with “N”, “L”, “5” respectively on one side; quadrisected and plain on all four quadrants on the other side. The tablet can be divided into 4 equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension. Chronic heart failure (CHF) Treatment of stable, mild to moderate chronic heart failure (CHF) in addition to standard therapies in elderly patients ≥ 70 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Hypertension _ _Adults:_ The dose is one tablet (5 mg) daily, preferably at the same time each 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 ex Les hele dokumentet