Nebilet Plus 5 mg / 25 mg film-coated tablets

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

HYDROCHLOROTHIAZIDE, NEBIVOLOL HYDROCHLORIDE

から入手可能:

Menarini International Operations Luxembourg S.A 1 Avenue de la Gare, L-1611, Luxembourg

ATCコード:

C07BB

INN（国際名）:

HYDROCHLOROTHIAZIDE 25 mg NEBIVOLOL HYDROCHLORIDE 5 mg

医薬品形態:

FILM-COATED TABLET

構図:

HYDROCHLOROTHIAZIDE 25 mg NEBIVOLOL HYDROCHLORIDE 5 mg

処方タイプ:

POM

治療領域:

BETA BLOCKING AGENTS

認証ステータス:

Authorised

承認日:

2009-03-09

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBILET PLUS 5 mg / 25 mg film-coated tablets
Nebivolol / Hydrochlorothiazide
READ
ALL 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 Nebilet Plus is and what it is used for
2.
What you need to know before you take Nebilet Plus
3.
How to take Nebilet Plus
4.
Possible side effects
5.
How to store Nebilet Plus
6.
Contents of the pack and other information
1.
WHAT NEBILET PLUS IS AND WHAT IT IS USED FOR
Nebilet Plus contains nebivolol and hydrochlorothiazide as the active
ingredients.
•
Nebivolol is 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 and controls heart pumping
strength. It also widens blood vessels, which helps to lower your
blood pressure.
•
Hydrochlorothiazide is a diuretic, that acts by increasing the amount
of urine you produce.
_ _
Nebilet Plus is a one-tablet combination of nebivolol and
hydrochlorothiazide and is used for the treatment of
raised blood pressure (hypertension). It is used instead of the two
separate products for those patients who are
already taking them together.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBILET PLUS
DO NOT TAKE NEBILET PLUS
•
if you are allergic to nebivolol or to hydrochlorothiazide or to any
of the other ingredients of this
medicine (listed in section 6).
•
if you are allergic (hypersensitive) to other sulphonamide-derived
substances (like hydrochlorothiazide,
which is a su

製品の特徴

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nebilet Plus 5 mg / 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Nebilet Plus 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),
and
25
mg
of
hydrochlorothiazide).
Excipient with known effect: each tablet contains 116.75 mg of lactose
(see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Nebilet Plus 5 mg / 25 mg: Almost violet, round, slight biconvex
film-coated tablets with “5/25”
embossed on one side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_ _
Treatment of essential hypertension.
Nebilet Plus 5 mg/25 mg fixed dose combination is indicated in
patients whose blood pressure is
adequately controlled on nebivolol 5 mg and hydrochlorothiazide 25 mg
given concurrently.
_ _
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_ _
_Adults_
Nebilet Plus 5 mg/25 mg is indicated in patients whose blood pressure
is demonstrated to be
adequately controlled on nebivolol 5 mg and hydrochlorothiazide 25 mg
given concurrently.
The dose is one tablet (5 mg/25 mg) daily, preferably at the same time
of the day.
_Patients with renal insufficiency _
Nebilet Plus should not be given to patients with severe renal
insufficiency (see also 4.3 and 4.4).
_Patients with hepatic insufficiency_
Data in patients with hepatic insufficiency or impaired liver function
are limited. Therefore the use of
Nebilet Plus in these patients is contra-indicated.
_ _
_Older people _
In view of the limited experience in patients above 75 years, caution
must be exercised and these
patients monitored closely.
_Paediatric population _
The efficacy and safety of Nebilet Plus in children and adolescents
aged below 18 years has not been
established. No data are available. Therefore, use in children and
adolescents is not recommended.
2
Method of administration
Oral use.
Tablets may be ta