Nebivolol 5mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Nebivolol hydrochloride

から入手可能:

Phoenix Healthcare Distribution Ltd

ATCコード:

C07AB12

INN（国際名）:

Nebivolol hydrochloride

投薬量:

5mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 02040000

情報リーフレット

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

製品の特徴

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