Nebilet 5mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Nebivolol hydrochloride

Prieinama:

CST Pharma Ltd

ATC kodas:

C07AB12

INN (Tarptautinis Pavadinimas):

Nebivolol hydrochloride

Dozė:

5mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02040000; GTIN: 5055946800981

Pakuotės lapelis

PATIENT INFORMATION LEAFLET
NEBILET® 5MG TABLETS
(Nebivolol hydrochloride)
The name of your medicine is Nebilet 5mg Tablets, but will be referred
to
as Nebilet throughout the remainder of the leaflet.
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
•
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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
•
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Nebilet is and what it is used for
2. Before you take Nebilet
3. How to take Nebilet
4. Possible side effects
5. How to store Nebilet
6. Further information
1. WHAT NEBILET IS AND WHAT IT IS USED FOR
Nebilet 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).
Nebilet is also used to treat mild and moderate chronic heart failure
in
patients aged 70 or over, in addition to other therapies.
2. BEFORE YOU TAKE NEBILET
DO NOT TAKE NEBILET
•
if you are allergic (hypersensitive) to nebivolol or any of the other
ingredients of Nebilet
•
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 intra

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
NEBILET 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nebilet 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).
Excipients: each tablet contains 141.75 mg of lactose monohydrate (see
section 4.4
and 6.1).
For a 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
Hypertension
_Adults_
The dose is one tablet (5 mg) daily, preferably at the same time of
the day. Tablets
may be taken with meals.
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 Nebilet 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 Nebilet in these patients is contra-indicated.
_Elderly_
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.
_Children_ _and ad