Nebimac 5 (Nebivolol Tablets 5 mg)

Valsts: Malaizija

Valoda: angļu

Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktīvā sastāvdaļa:

NEBIVOLOL HYDROCHLORIDE

Pieejams no:

Macleods Pharmaceuticals Sdn. Bhd.

SNN (starptautisko nepatentēto nosaukumu):

NEBIVOLOL HYDROCHLORIDE

Vienības iepakojumā:

3 x 10 Tablets

Ražojis:

Macleods Pharmaceuticals Limited

Lietošanas instrukcija

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NEBIMAC TABLETS
Nebivolol Tablets (2.5mg, 5mg)
_______________________________________________________________________________________________________
Page 1 of 4 WHAT IS IN THIS LEAFLET?
1. What Nebimac is used for
2. How Nebimac works
3.Before you use Nebimac
4. How to take Nebimac
5.While you are using Nebimac
6. Side effects
7.Storage and Disposal of Nebimac
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
1. WHAT NEBIMAC IS USED
FOR:
Nebimac is used to treat raised
blood pressure (hypertension).
Nebimac is also used to treat mild
and moderate chronic heart failure
in patients aged 70 or over, in
addition to other therapies.
2. HOW NEBIMAC WORKS:
Nebimac contains nebivolol, a
cardiovascular drug 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
3. BEFORE YOU USE
NEBIMAC:
_When you must not use it _
Do not take Nebimac
•If you are allergic (hypersensitive)
to nebivolol or any of the other
ingredients of Nebimac
• 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. 2nd and 3rd
degree atrioventricular block, heart
conduction disorders).
• heart failure, which has just
occurred or which has recently
become worse, or you are
receiving treatment for circulatory
shock due to acute heart failure by
intravenous drip feed to help your
heart work
• Asthma or wheezing (now or in
the past)
• untreated phaeochromocytoma,
a tumour located on top of the
kidneys (in the adrenal glands)
• Liver function disorder
•A metabolic disorder (metabolic
acidosis), for example, diabetic
ketoacidosis

Produkta apraksts

1
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A
LABORATORY
NEBIMAC 2.5
(Nebivolol Tablets 2.5 mg)
NEBIMAC 5
(Nebivolol Tablets 5 mg)
COMPOSITION
Each uncoated tablet contains:
Nebivolol Hydrochloride
equivalent to Nebivolol ………2.5 mg / 5 mg
PRODUCT DESCRIPTION
FOR 2.5 MG:
White to off white, capsule shape, biconvex uncoated tablets
debossed with “T 55” on one side and score line on the other side.
FOR 5 MG:
White to off white, circular, biconvex uncoated tablets, debossed with
“T 56” on one side and cross score line on the other side.
PHARMACOLOGICAL CLASSIFICATION
Selective beta- receptor antagonist
PHARMACOLOGICAL ACTION:
PHARMACODYNAMICS
Selective Beta blocking agent, ATC code: C07AB12
Nebivolol is a race-mate of two enantiomers, SRRR-nebivolol (or
d-nebivolol)
and RSSS-nebivolol (or l-nebivolol). It combines two pharmacological
activities:
It is a competitive and selective beta- receptor antagonist: this
effect is attributed
to the SRRR-enantiomer (d-enantiomer). It has mild vasodilating
properties,
possibly due to an interaction with the L-arginine/nitric oxide
pathway. Single
and repeated doses of nebivolol reduce heart rate and blood pressure
at rest and
during exercise, both in normotensive subjects and in hypertensive
patients. The
antihypertensive effect is maintained during chronic treatment. At
therapeutic
doses, nebivolol is devoid of alpha-adrenergic antagonism. During
acute and
chronic
treatment
with
nebivolol
in
hypertensive
patients
systemic
vascular
resistance is decreased. Despite heart rate reduction, reduction in
cardiac output
during rest and exercise may be limited due to an increase in stroke
volume. The
clinical relevance of these haemodynamic differences as compared to
other beta1
receptor antagonists has not been fully established.
In hypertensive patients, nebivolol increases the NO-mediated vascular
response
to acetylcholine (ACh) which is reduced in patients with endothelial
dysfunction.
In a mortality–morbidity, placebo-controlled trial per