Nebilet Plus 5 mg/25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nebivolol; Hydrochlorothiazide

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

C07BB; C07BB12

INN (International Name):

Nebivolol; Hydrochlorothiazide

Dosage:

5/25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, selective, and thiazides; nebivolol and thiazides

Authorization status:

Marketed

Authorization date:

2009-03-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEBILET PLUS 5 MG / 25 MG FILM-COATED TABLETS
NEBIVOLOL / HYDROCHLOROTHIAZIDE
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 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 sul

Summary of Product characteristics

Health Products Regulatory Authority
28 January 2022
CRN00CQ93
Page 1 of 12
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.
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.
Method of administration
Oral use.
Ta