Tenoret 50mg/12.5mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorthalidone; Atenolol

Available from:

AstraZeneca UK Limited

ATC code:

C07CB; C07CB03

INN (International Name):

Chlorthalidone; Atenolol

Dosage:

50/12.5 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 other diuretics; atenolol and other diuretics

Authorization status:

Not marketed

Authorization date:

1985-01-21

Patient Information leaflet

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 Tenoret is and what it is
used for
2. What you need to know before you
take Tenoret
3. How to take Tenoret
4. Possible side effects
5. How to store Tenoret
6. Contents of the pack and other
information
1.
WHAT TENORET IS AND WHAT IT IS
USED FOR
Tenoret 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.
Tenoret is half the strength of another
medicine called Tenoretic. Tenoret
may also be called ‘Half Strength
Tenoretic’.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE TENORET
DO NOT TAKE TENORET IF:
•
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tenoret 50mg/12.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Atenolol 50 mg
Chlortalidone 12.5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, biconvex, film-coated tablet intagliated with the name
‘Tenoret 50’ on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tenoret 50 mg/12.5 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 Tenoret 50 mg/12.5 mg Film-coated
Tablets is one tablet daily. For patients who do not
respond adequately to Tenoret 50 mg/12.5 mg Film-coated Tablets, the
dosage may be increased to one tablet of
Tenoretic.
Where necessary, another antihypertensive drug, such as a vasodilator,
can be added.
PAEDIATRIC POPULATION
The use of Tenoret 50 mg/12.5 mg Film
-
coated Tablets is not recommended in children. The safety and efficacy
of
Tenoret 50 mg/12.5 mg in children less than 18 years has not been
established.
RENAL IMPAIRMENT
Due to the properties of the chlortalidone component, Tenoret 50
mg/12.5 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).
HEPATIC IMPAIRMENT
Dose adjustments are not required in patients with hepatic impairment.
METHOD OF ADMINISTRATION
Tenoret 50 mg/12.5 mg film-coated Tablets are administered orally.
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