Nebivolol 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nebivolol hydrochloride

Available from:

Advanz Pharma

ATC code:

C07AB12

INN (International Name):

Nebivolol hydrochloride

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5021691020479

Patient Information leaflet

NEBIVOLOL 2.5 MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Nebivolol
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 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 TABLET IS AND WHAT IT IS USED
FOR
Nebivolol Tablets contain nebivolol, a cardiovascular
medicine
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
Tablet
is
also
used
to
treat
mild
and
moderate chronic heart failure in patients aged 70 or
over, in addition to other therapies.
You must talk to a doctor if you do not feel better or if
you feel worse.
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
beats
per
minute)
• certain other serious heart rhythm problems (e.g.
2
nd
and 3
rd
degree atriove

Summary of Product characteristics

OBJECT 1
NEBIVOLOL 2.5MG TABLETS
Summary of Product Characteristics Updated 05-Sep-2019 | ADVANZ Pharma
•
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
2. Qualitative and quantitative composition
Each tablet contains 2.5 mg of nebivolol (as nebivolol hydrochloride).
Excipient(s) with known effect:
Each tablet contains 70.775 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White to off white, round, plain biconvex tablets with score line on
one side.
The tablet can be divided into equal doses.
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
For oral administration
Posology
_Hypertension_
_Adults_
The dose is 5 mg (one 5 mg tablet or two 2.5 m