Atecor 50mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atenolol

Available from:

Rowex Ltd

ATC code:

C07AB; C07AB03

INN (International Name):

Atenolol

Dosage:

50 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:

1989-11-29

Patient Information leaflet

Package leaflet: Information for the user
Atecor 25mg, 50mg & 100mg tablets
atenolol
What is in this leaflet:
1.
What Atecor is and what it is used for
2.
What you need to know before you take Atecor
3.
How to take Atecor
4.
Possible side effects
5.
How to store Atecor
6.
Contents of the pack and other information
1.
What Atecor is and what it is used for
Atecor contains a substance called atenolol. Atenolol belongs to a
group of medicines called beta-blockers and is used for
the treatment of:
• high blood pressure (essential hypertension)
• preventing chest pain (angina)
• irregular or uneven heartbeats (cardiac arrhythmias)
• protect the heart in early treatment after a heart attack
(myocardial infarction)
• long-term prophylaxis after recovery from a heart attack (to
prevent another attack).
This medicine works by making your heart beat more slowly and with
less force.
2.
What you need to know before you take Atecor
Do not take Atecor if:
• you are allergic to atenolol or any of the other ingredients of
this medicine (listed in section 6)
• you have heart failure which is not under control (this usually
makes you breathless and causes your
ankles to swell)
• you suffer from other heart conditions:
-
second- or third-degree heart block (a condition which may be treated
by a pacemaker)
-
bradycardia (very slow or uneven heartbeat)
-
low blood pressure (hypotension)
-
poor circulation (peripheral arterial disease)
• you have a tumour called phaeochromocytoma that is not treated.
This is usually near your kidney and
can cause high blood pressure)
• you have been told that you have higher than normal levels of acid
in your blood (metabolic acidosis).
You should first consult your doctor about these conditions.
WARNINGS AND PRECAUTIONS:
The initial treatment of severe high blood pressure should be very
gradual so as to avoid a sudden drop of blood
pressure.
Talk to your doctor or pharmacist or nurse before taking Atecor if:
• you have asthma, wheezing or any other similar breathing problems
•

Summary of Product characteristics

Health Products Regulatory Authority
17 September 2020
CRN009YFQ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atecor 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Atenolol 50 mg.
Excipients with a known effect:
Each tablet contains lactose monohydrate 2.88 mg and up to 7.6 mg
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, film-coated tablet with a one-sided score
notch and embossed ‘50’ on the other side.
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
As a beta-adrenoceptor blocker Atecor is indicated for the treatment
of:

essential hypertension

angina pectoris

cardiac arrhythmias
Atecor is also indicated in early intervention in the acute phase of
myocardial infarction and for the long-term prophylaxis
after recovery from myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION:
Oral.
Recommended Dosage Schedule:
_ADULTS:_
HYPERTENSION:
The usual daily dose is 50 mg as a single dose. This can be increased
to 100 mg daily if required for control but should only be
done after the effects of the initial dose have been achieved (1 to 2
weeks). Atenolol may be combined with a diuretic if
required or other antihypertensive agents.
ANGINA:
The usual daily dose is 100 mg given orally once daily or 50 mg given
twice daily.
CARDIAC ARRHYTHMIAS:
For maintenance control the usual daily dose is 50 – 100 mg once
daily.
EARLY AND LATE INTERVENTION AFTER MYOCARDIAL INFARCTION:
Oral treatment with atenolol 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 atenolol should be initiated in hospital under
close monitoring. If bradycardia and/or hypotension requiring
treatment, or any other untoward effects occur, at