Tenormin 25 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atenolol

Available from:

AstraZeneca AB

ATC code:

C07AB; C07AB03

INN (International Name):

Atenolol

Dosage:

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; atenolol

Authorization status:

Not marketed

Authorization date:

1997-08-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENORMIN 25 MG, 50 MG AND 100 MG FILM-COATED TABLETS
atenolol
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 phaeochromocytoma that is not being
treated. This is usually
near your kidney and ca

Summary of Product characteristics

Health Products Regulatory Authority
10 December 2020
CRN009T2X
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tenormin 25 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 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 25 on one face and plain 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 100mg daily is recommended for long-term prophylaxis of
myocardial infarction.
PAEDIATRIC POPULATION:
There is no paedi