ATENOLOL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ATENOLOL

Available from:

SYRI Limited, t/a Thame Laboratories

ATC code:

C07AB03

INN (International Name):

ATENOLOL

Dosage:

5 Mg/Ml

Pharmaceutical form:

Oral Solution

Administration route:

oral use

Units in package:

Pack size: 100 ml, 150 ml and 300 ml

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Syri Limited t/a Thame Laboratories

Therapeutic group:

Beta-blocking agents, plain, selective

Therapeutic area:

atenolol

Therapeutic indications:

Management of hypertension Management of angina Management of cardiac arrhythmias Myocardial infarction. Early intervention in the acute phase

Authorization status:

Not Marketed

Authorization date:

2015-10-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATENOLOL 5MG/ML ORAL SOLUTION
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atenolol 5mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is Atenolol.
Each ml of oral solution contains 5mg Atenolol.
_Excipients with known effect_:
Each ml of oral solution contains 0.28g sorbitol (E420), 1.8mg methyl
parahydroxybenzoate (E218), 0.2mg propyl
parahydroxybenzoate (E216) 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.
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