Hypoloc 5mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Nebivolol hydrochloride

Disponible desde:

A. Menarini Farmaceutica Internazionale SRL

Código ATC:

C07AB12

Designación común internacional (DCI):

Nebivolol hydrochloride

Dosis:

5mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02040000; GTIN: 5038227000263

Información para el usuario

1
Package leaflet: Information for the user
HYPOLOC
5 mg tablets
Nebivolol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Hypoloc is and what it is used for
2.
What you need to know before you take Hypoloc
3.
How to take Hypoloc
4.
Possible side effects
5.
How to store Hypoloc
6.
Contents of the pack and other information
1.
WHAT HYPOLOC IS AND WHAT IT IS USED FOR
Hypoloc 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.
It is used to treat raised blood pressure (hypertension).
Hypoloc is also used to treat mild and moderate chronic heart failure
in patients aged 70 or over,
in addition to other therapies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYPOLOC
DO NOT TAKE HYPOLOC
•
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 atrioventricular block,
heart conduction disorders).
2
−
heart failure, which has just occurred or which has recently become
worse, or you are
receiving treatment for circula

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
HYPOLOC 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Hypoloc tablet contains 5 mg of nebivolol (as nebivolol
hydrochloride):
2.5 mg of SRRR-nebivolol (or d-nebivolol) and 2.5 mg of RSSS-nebivolol
(or l-
nebivolol).
Excipient with known effect: each tablet contains 141.75 mg of lactose
monohydrate
(see section 4.4 and 6.1).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round, cross-scored tablet.
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 one tablet (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 Hypoloc
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 Hypoloc in these patients is contra-indicated.
_Older people_
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 popu