Inderal 10mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROPRANOLOL HYDROCHLORIDE

Available from:

AstraZeneca AB

ATC code:

C07AA; C07AA05

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents, non-selective; propranolol

Authorization status:

Not marketed

Authorization date:

1999-04-01

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
INDERAL 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. 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 Inderal is and what it is used for
2. What you need to know before you take Inderal
3. How to take Inderal
4. Possible side effects
5. How to store Inderal
6. Contents of the pack and other information
1.
WHAT INDERAL IS AND WHAT IT IS USED FOR
The name of your medicine is Inderal 10 mg Film-coated Tablets (called
Inderal in the rest of
this leaflet). Inderal contains a medicine called propranolol
hydrochloride. This belongs to a
group of medicines called beta-blockers.
Inderal is used for many conditions including:

High blood pressure (hypertension).

Chest pain (angina).

Some heart beat problems (arrhythmias).

Protecting the heart after a heart attack.

Preventing migraines.

Essential tremor (shaking with an unknown cause).

Anxiety.

Some thyroid problems (such as thyrotoxicosis which is caused by an
overactive thyroid
gland).

High blood pressure caused by a tumour, usually near the kidney
(phaeochromocytoma).

Prevention of bleeding in the food pipe (oesophagus) caused by high
blood pressure in the
liver.
Inderal works by the effects it has on the heart and circulation and
also on other parts of the
body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDERAL
DO NOT TAKE INDERAL IF:

YOU OR ANYONE IN YOUR FAMILY HAS EVER HAD ASTHMA OR WHEEZING.
Page 2 of 7

You are allergic to propranolol h

Summary of Product characteristics

Health Products Regulatory Authority
25 January 2019
CRN008KKQ
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Inderal 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains propranolol hydrochloride 10mg.
Excipient(s) with known effect:
Each tablet also contains lactose monohydrate 79mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet (Tablet)
Pink round bi-convex film coated tablets impressed with the legend
‘Inderal 10’ on
one face. The impressions are highlighted in white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
i. Control of essential and renal hypertension.
ii. Management of angina pectoris.
iii. Long term prophylaxis after recovery from acute myocardial
infarction.
iv. Control of most forms of cardiac arrhythmia.
v. Prophylaxis of migraine
vi. Management of essential tremor
vii. Control of anxiety and anxiety tachycardia
viii. Prophylaxis of upper gastrointestinal bleeding in patients with
portal
hypertension and oesophageal varices
ix. Adjunctive management of thyrotoxicosis.
x. Management of phaeochromocytoma (‘Inderal’ should only be
started in the
presence of effective alpha blockade).
Health Products Regulatory Authority
25 January 2019
CRN008KKQ
Page 2 of 13
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Since the half-life may be increased in patients with significant
hepatic or renal
impairment, caution must be exercised when starting treatment and
selecting the
initial dose.
POSOLOGY
ADULTS:
Hypertension:
A starting dose of 80mg twice a day may be increased at weekly
intervals according
to response. The usual dosage range is 160-320mg per day. With
concurrent diuretic
or other antihypertensive drugs a further reduction of blood pressure
is obtained.
Angina, anxiety, migraine and essential tremor:
A starting dose of 40mg two or three times daily may be increased by
the same
amount at weekly intervals according to patient response. The usual
dose range in
angina is 80-320mg/day.