Propranolol Azure 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Propranolol hydrochloride

Available from:

Azure Pharmaceuticals Ltd

ATC code:

C07AA05

INN (International Name):

Propranolol hydrochloride

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

propranolol

Authorization status:

Not marketed

Authorization date:

2023-12-08

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPRANOLOL AZURE 10 MG FILM-COATED TABLETS
propranolol, hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet, as 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.
WHAT IS IN THIS LEAFLET:
1.
What Propranolol Azure is and what it is used for
2.
What you need to know before you take Propranolol Azure
3.
How to take Propranolol Azure
4.
Possible side effects
5.
How to store Propranolol Azure
6.
Contents of the pack and other information
1. WHAT PROPRANOLOL AZURE IS AND WHAT IT IS USED FOR
Propranolol Azure belongs to a group of medicines called
beta-blockers, which act on different levels in
the body including the heart.
Propranolol Azure is indicated for:
-
Treatment of high blood pressure (hypertension).
-
Treatment of chest pain (angina).
-
Treatment of certain heart disorders (obstructive hypertrophic
cardiomyopathy).
-
Control of irregular heartbeats (arrhythmias).
-
Protection of the heart after a myocardial infarction.
-
Migraine (headache) prevention.
-
Treatment of tremors.
-
Treatment of anxiety symptoms.
-
Treatment of certain thyroid disorders (thyrotoxicosis).
-
Treatment of pheochromocytoma (high blood pressure due to a tumour
usually near the kidney)
administered together with another treatment: an alpha-adrenergic
blocking agent.
-
Prevention of bleeding in the esophagus caused by high blood pressure
in the liver.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPRANOLOL AZURE
DO NOT TAKE PROPRANOLOL AZURE
-
If you are allergic (hypersensitive) to propranolol or to any of the
other ingredients of this medicine

Summary of Product characteristics

Health Products Regulatory Authority
11 December 2023
CRN00DPF9
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propranolol Azure 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of propranolol hydrochloride.
Excipient(s) with known effect: Each tablet contains 75.01 mg of
lactose, around 0.04 mg of sunset yellow FCF (E-110) and
0.01 mg of allura red AC (E-129).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round film-coated tablets scored on one 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

Treatment of renal and essential arterial hypertension.

Treatment of angina pectoris.

Long-term prophylaxis after recovery from acute myocardial infarction.

Treatment of tachyarrhythmias.

Migraine prophylaxis.

Treatment of essential tremor.

Treatment of peripheral symptoms of anxiety (tachycardia, tremor).

Prophylaxis of upper gastrointestinal bleeding in patients with portal
hypertension and oesophageal varices.

Coadjuvant treatment of thyrotoxicosis.

Treatment of hypertrophic obstructive cardiomyopathy.

Treatment of pheochromocytoma (in conjunction with an alpha-adrenergic
blocker).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
As the half-life may be increased in patients with significant hepatic
or renal insufficiency, caution should be exercised when
starting treatment and the starting dose should be selected by
adjusting the dosage to the degree of insufficiency.
Posology
_ADULTS_
_Hypertension:_
The initial dose is 80 mg of propranolol twice a day, which may be
increased in weekly intervals according to the response. The
usual dose range is 160-320 mg per day and the maximum daily dose
should not exceed 640 mg per day (see Table 1). With
the concomitant administration of a diuretic or other antihypertensive
treatment, a greater reduction