Atenolol 5mg/ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atenolol

Available from:

Syri Pharma Limited t/a Thame Laboratories

ATC code:

C07AB; C07AB03

INN (International Name):

Atenolol

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Therapeutic area:

Beta blocking agents, selective; atenolol

Authorization status:

Not marketed

Authorization date:

2015-10-09

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ATENOLOL 5MG/ML ORAL SOLUTION
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE
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.
The name of the medicine is Atenolol
5mg/ml Oral Solution but will be
referred to as Atenolol throughout this
leaflet.
WHAT IS IN THIS LEAFLET:
WHAT ATENOLOL IS AND WHAT IT IS
USED FOR
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ATENOLOL
HOW TO TAKE ATENOLOL
POSSIBLE SIDE EFFECTS
HOW TO STORE ATENOLOL
CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT ATENOLOL IS AND WHAT IT
IS USED FOR
Atenolol contains the active substance
atenolol. This belongs to a group of
medicines called beta-blockers. Atenolol
is used to:
Treat high blood pressure
(hypertension).
Treat uneven heart beats
(arrhythmias).
Help prevent chest pain (angina).
Protect the heart in the early
treatment after a heart attack
(myocardial infarction).
It works by making your heart beat
more slowly and with less force.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ATENOLOL
DO NOT TAKE ATENOLOL IF:
You are allergic to Atenolol or any of
the other ingredients of Atenolol
(listed in Section 6).
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.
You have a tumour called
phaeochromocytoma that is not
being treated. This is usually near
your kidney and

Summary of Product characteristics

Health Products Regulatory Authority
30 April 2021
CRN009LYV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atenolol 5mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 5mg Atenolol.
_Excipients with known effect_:
Each ml of oral solution contains 280mg sorbitol (E420), 1.8mg methyl
parahydroxybenzoate (E218), 0.2mg propyl
parahydroxybenzoate (E216), 3.03mg propylene glycol (E1520) and 2.79mg
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear colourless oral solution with orange flavour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
i. Management of hypertension
ii. Management of angina
iii. Management of cardiac arrhythmias
iv. Myocardial infarction. Early intervention in the acute phase
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Oral administration
As food impairs the bioavailability of atenolol, it should not be
taken with the food.
The dose must always be adjusted to individual requirements of the
patients, with the lowest possible starting dosage. The
following are guidelines:
ADULTS
HYPERTENSION
A starting dose of 25 mg is recommended. The usual maintenance dosage
in hypertension is one tablet (50-100 mg) daily. The
maximum effect will be reached after 1-2 weeks. If further improvement
of the blood pressure is desired, atenolol may be
combined with another anti-hypertensive e.g., a diuretic.
ANGINA
50-100 mg daily, depending on the clinical effect, in order to obtain
a heartbeat in rest of 55-60 beats per minute. Increasing
the dose above 100 mg daily does not generally lead to an increased
antianginous effect. If desired the dosage of 100 mg daily
can be divided in two dosages.
CARDIAC ARRHYTHMIAS
Initially controlled intravenously. A suitable oral maintenance dosage
is 50-100 mg daily, given as a single dose.
MYOCARDIAL INFARCTION
Health Products Regulatory Authority
30 April 2021
CRN009LYV
Page 2 of 8
Initially controlled intravenously, followed by 50 mg orally about