Nebivolol 5mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Nebivolol hydrochloride

Tillgänglig från:

Viatris UK Healthcare Ltd

ATC-kod:

C07AB12

INN (International namn):

Nebivolol hydrochloride

Dos:

5mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 02040000; GTIN: 5016695003290

Bipacksedel

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

Produktens egenskaper

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