Nebivolol 5mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Nebivolol hydrochloride

Tilgjengelig fra:

Accord-UK Ltd

ATC-kode:

C07AB12

INN (International Name):

Nebivolol hydrochloride

Dosering :

5mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02040000; GTIN: 5012617017819

Informasjon til brukeren

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 YOU:
• are ALLERGIC to nebivolol or any of the other
ingredients of this medicine (listed in section
6).
• suffer from LIVER problems.
• have LOW BLOOD PRESSURE or POOR CIRCULATION
in the arms or legs.
• have a very SLOW HEARTBEAT (less than 60 beats
per minute).
• have certain serious HEART RHYTHM PROBLEMS.
• have the condition HEART FAILURE which has
just occurred or which has recently become
worse.
• have ASTHMA or WHEEZING (now or in the past).
• have been told by your doctor that you have a
TUMOUR in your adrenal gland which is located
on top of the kidneys (the medical term for this
is an untreated phaeochromocytoma).
• have METABOLIC ACIDOSIS such as diabetic
ketoacidosis

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nebivolol 5mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nebivolol 5mg Tablet contains 5mg of nebivolol (as hydrochloride)
Excipient with known effect:
Each tablet contains 191.950mg of lactose.
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Round, white, convex cross-scored tablets (snap-tab cross score),
marked
“NE3” 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 day. Tablets may be taken with meals.
The blood pressure lowering effect may take up to 1-2 weeks of
treatment to
become evident. Occasionally, the optimal effect is only reached only
after 4
weeks.
_ _
Beta-blockers can be used alone or concomitantly with other
antihypertensive
agents. An additional antihypertensive effect has been observed when
Nebivolol 5mg Tablets are combined with hydrochlorothiazide
12.5mg-25mg.
_Patients with renal insufficiency _
_ _
The recommended starting dose for patients with renal insufficiency is
2.5mg
daily. If needed, the daily dose may be increased to 5mg.
_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
contraindicated.
_Elderly _
_ _
In patients over 65 years, the recommended starting dose is 2.5mg
daily. If
needed, the daily dose may be increased to 5mg. However, in view of
the
limited experience in patients above 75 years, caution must be
exercised and
these patients monitored closely.
_Paediatric population _
_ _
Nebivolol is not rec