Nebivolol 5mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Nebivolol hydrochloride

可用日期:

Arrow Generics Ltd

ATC代码:

C07AB12

INN（国际名称）:

Nebivolol hydrochloride

剂量:

5mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 02040000; GTIN: 5060034835295

资料单张

BBBA3195
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FMD info
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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

产品特点

OBJECT 1
NEBIVOLOL 5MG TABLETS
Summary of Product Characteristics Updated 22-May-2019 | Accord-UK 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 5mg Tablets.
2. Qualitative and quantitative composition
Each Nebivolol 5mg Tablet contains 5mg of nebivolol (as hydrochloride)
Excipients: Lactose monohydrate
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Tablets.
White, round, biconvex, 9mm diameter tablet, cross-scored on one side
and marked with “N5” on the other
side.
The tablet can be divided into 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 old or above.
4.2 Posology and method of administration
Posology
Hypertension
_Adults_
The usual dose is one tablet (5mg) daily, preferably taken at the same
time of the d