Atenomel 50 mg Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Atenolol

Tilgængelig fra:

Clonmel Healthcare Ltd

ATC-kode:

C07AB; C07AB03

INN (International Name):

Atenolol

Dosering:

50 milligram(s)

Lægemiddelform:

Tablet

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Beta blocking agents, selective; atenolol

Autorisation status:

Marketed

Autorisation dato:

1988-07-25

Indlægsseddel

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATENOMEL 25MG TABLETS
ATENOMEL 50MG TABLETS
ATENOMEL 100MG 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Atenomel Tablets are and what they are used for
2.
What you need to know before you take Atenomel Tablets
3.
How to take Atenomel Tablets
4.
Possible side effects
5.
How to store Atenomel Tablets
6.
Contents of the pack and other information
1.
WHAT ATENOMEL TABLETS ARE AND WHAT THEY ARE USED FOR
Atenomel Tablets contain the active substance atenolol. Atenolol
belongs to a group of
medicines called beta-blockers. These medicines control the heart rate
and blood pressure by
making your heart beat more slowly and with less force. Atenomel is
used to:

Control high blood pressure (hypertension)

Help prevent chest pain (angina)

Treat uneven heart beats (arrhythmias)

Protect the heart in early treatment after a heart attack (myocardial
infarction)

Help prevent another heart attack from happening.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATENOMEL TABLETS
DO NOT TAKE ATENOMEL TABLETS
-
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 disorders:
-
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
with a pacemaker)
-
very slow or irregular heart-beat, very low blood pre

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atenomel 50 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains atenolol 50 mg.
Excipients with known effect:
Each tablet contains lactose monohydrate 30.9mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets
White, round biconvex tablet with a breakline and marked “C24”
The breakline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A beta-adrenoceptor blocker for the treatment of essential
hypertension.
Management of angina pectoris.
Control of cardiac arrhythmias.
In early intervention in the acute phase of myocardial indarction and
for long-term prophylaxis after recovery from
myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 Atenomel 25 mg with other antihypertensive
agents.
MANGEMENT 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 atenolol is 50 mg to 100 mg, given once
daily.
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
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___