Tenoretic 100mg/25mg Film-coated Tablets

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

CHLORTALIDONE; ATENOLOL

Tersedia dari:

AstraZeneca UK Limited

Kode ATC:

C07CB03

INN (Nama Internasional):

CHLORTALIDONE; ATENOLOL

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

CHLORTALIDONE 25 mg; ATENOLOL 100 mg

Jenis Resep:

POM

Area terapi:

BETA BLOCKING AGENTS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2005-10-11

Selebaran informasi

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING 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. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Tenoretic is and what it is
used for
2. What you need to know before you
take Tenoretic
3. How to take Tenoretic
4. Possible side effects
5. How to store Tenoretic
6. Contents of the pack and other
information
1.
WHAT TENORETIC IS AND WHAT IT IS
USED FOR
Tenoretic is used to treat high blood
pressure (hypertension). It contains
two different medicines: atenolol and
chlortalidone. These medicines work
together to lower your blood pressure.
•
Atenolol belongs to a group of
medicines called beta‑blockers. It
works by making your heart beat
more slowly and with less force.
•
Chlortalidone belongs to a group of
medicines called diuretics. It works
by increasing the amount of urine
produced by your kidneys.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE TENORETIC
DO NOT TAKE TENORETIC:
•
if you are allergic to atenolol or
chlortalidone or any of the other
ingredients of this medicine (listed in
section 6).
•
if you have ever had any of the
following heart problems:
‑
heart failure which is not under
control (this usually makes you
breathless and causes your ankles
to swell)
‑
second‑ or third‑degree heart
block (a condition which may be
treated by a pacemaker)
‑
very slow or very uneven heart
beats, very low blood pressure or
very poor circulation.
•
if you have a tumour called
phaeochromocytoma that is not being
treated. This is usually near your
kidney and can cause high blood
pressure.
•
if you have been told that you have
h

Karakteristik produk

Summary of Product Characteristics
Page 1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Tenoretic 100 mg/25 mg Film-coated Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atenolol 100 mg
Chlortalidone 25 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White, film-coated tablets, intagliated Tenoretic on one side and
bisected on the
reverse. 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
Tenoretic 100 mg/25 mg Film-coated Tablets are indicated for the
treatment of
essential hypertension in patients whose blood pressure is not
adequately controlled
on atenolol or chlorthalidone alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
When clinically appropriate direct change from monotherapy to the
fixed
combination may be considered in patients whose blood pressure is not
adequately
controlled.
ADULTS
The usual maintenance dose of Tenoretic 100 mg/25 mg Film-coated
Tablets is one
tablet daily. There is little or no further fall in blood pressure
with increased dosage,
and where necessary, another antihypertensive drug, such as a
vasodilator, can be
added. Patients can be transferred directly to Tenoretic 100 mg/25 mg
Film-coated
Tablets from other antihypertensive treatments, with the exception of
clonidine (see
section 4.4).
Summary of Product Characteristics
Page 2 of 13
ELDERLY
Dosage requirements are often lower in this age group.
PAEDIATRIC POPULATION
The use of Tenoretic 100 mg/25 mg Film coated Tablets is not
recommended in
children. The safety and efficacy of Tenoretic 100 mg/25 mg Film
coated Tablets in
children less than 18 years has not yet been established.
RENAL IMPAIRMENT
Due to the properties of the chlortalidone component, Tenoretic 100
mg/25 mg
Film-coated Tablets has reduced efficacy in the presence of renal
insufficiency.
This fixed dose combination should thus not be administrated to
patients with
severe renal impairment (see section 4.3).