Tenormin 100 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atenolol

Available from:

AstraZeneca UK Limited

ATC code:

C07AB; C07AB03

INN (International Name):

Atenolol

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, selective; atenolol

Authorization status:

Marketed

Authorization date:

1978-05-17

Patient Information leaflet

BODY TEXT SIZE
12.0 pt
SMALLEST TEXT SIZE
6.0 pt
552958-A02
14-04-17
P043470
630170L4
564
AN
Atenolol 25mg, 50mg, 100mg
Leaflet: Combined IE-MT
Black
Technical Info
Profile
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.
In this leaflet:
1. What Tenormin is and what it is
used for
2. What you need to know before you
take Tenormin
3. How to take Tenormin
4. Possible side effects
5. How to store Tenormin
6. Contents of the pack and other
information
1. What Tenormin is and what it is
used for
Tenormin contains a medicine called
atenolol. This belongs to a group
of medicines called beta‑blockers.
Tenormin is used to:
•
Treat high blood pressure
(hypertension).
•
Help prevent chest pain (angina).
•
Treat uneven heart beats
(arrhythmias).
•
Protect the heart in the early
treatment after a heart attack
(myocardial infarction).
•
Help prevent another heart attack
from happening.
It works by making your heart beat
more slowly and with less force.
2. What you need to know before
you take Tenormin
Do not take Tenormin:
•
If you are allergic to atenolol 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
phaeoc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tenormin 100 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg Atenolol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex, film-coated tablets, which are intagliated
with 100 on one face and bisected on the reverse
face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Control of hypertension.
Management of angina pectoris.
Control of cardiac arrhythmias.
In early intervention in the acute phase of myocardial infarction and
for long-term prophylaxis after recovery from
myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
CONTROL OF HYPERTENSION:
Most patients respond to 50 mg daily given orally as a single dose. If
necessary, the dose may be increased to 100 mg
daily. The effect will be fully established after one to two weeks. A
further reduction in blood pressure may be
achieved by combining Tenormin 25 mg with other antihypertensive
agents.
MANAGEMENT OF ANGINA PECTORIS:
Most patients with angina pectoris will respond to 100 mg daily given
orally as a single dose or as 50 mg given twice a
day. It is unlikely that additional benefit will be gained by
increasing the dose.
CONTROL OF CARDIAC ARRHYTHMIAS:
An oral maintenance dose of Tenormin is 50–100 mg, given once daily.
EARLY AND LATE INTERVENTION AFTER MYOCARDIAL INFARCTION:
Oral treatment with Tenormin can be initiated in haemodynamically
stable patients with 50 mg twice daily, and then
100 mg once daily. During the early phase of acute myocardial
infarction, treatment with Tenormin should be initiated
in hospital under close monitoring. If bradycardia and/or hypotension
requiring treatment, or any other untoward
effects occur, Tenormin should be discontinued.
Tenormin 100 mg daily is recommended for long-term prophylaxis of
myocardial infarction.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___