INDERAL

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

PROPRANOLOL HYDROCHLORIDE

Inapatikana kutoka:

AstraZeneca UK Limited

ATC kanuni:

C07AA05

INN (Jina la Kimataifa):

PROPRANOLOL HYDROCHLORIDE

Kipimo:

10 Milligram

Dawa fomu:

Film Coated Tablet

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Eneo la matibabu:

propranolol

Idhini hali ya:

Not Marketed

Idhini ya tarehe:

1979-04-01

Taarifa za kipeperushi

IR PIL Inderal Tablets CV 14 0215(based on CV 13 0157)12/11/14 VS
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 AST

Tabia za bidhaa

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).
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.
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