Nebilet Plus 5 mg / 12.5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCHLOROTHIAZIDE, NEBIVOLOL HYDROCHLORIDE

Available from:

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

ATC code:

C07BB

INN (International Name):

HYDROCHLOROTHIAZIDE 12.5 mg NEBIVOLOL HYDROCHLORIDE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg NEBIVOLOL HYDROCHLORIDE 5 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Authorised

Authorization date:

2009-03-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBILET PLUS 5 mg / 12.5 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 hydrochlorothiaz

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nebilet Plus 5 mg / 12.5 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
12.5
mg
of
hydrochlorothiazide).
Excipient with known effect: each tablet contains 129.25 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 / 12.5 mg: Almost pink, round, slightly biconvex
film-coated tablets with “5/12.5”
embossed on one side and a score line on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_ _
Treatment of essential hypertension.
Nebilet Plus 5 mg/12.5 mg fixed dose combination is indicated in
patients whose blood pressure is
adequately controlled on nebivolol 5 mg and hydrochlorothiazide 12.5
mg given concurrently.
_ _
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_ _
_Adults_
Nebilet Plus 5 mg/12.5 mg is indicated in patients whose blood
pressure is demonstrated to be
adequately controlled on nebivolol 5 mg and hydrochlorothiazide 12.5
mg given concurrently.
The dose is one tablet (5 mg/12.5 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