Propranolol 10mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PROPRANOLOL HYDROCHLORIDE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

C07AA05

INN (International Name):

PROPRANOLOL HYDROCHLORIDE 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PROPRANOLOL HYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Withdrawn

Authorization date:

2012-12-12

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPRANOLOL 10 MG FILM-COATED TABLETS
PROPRANOLOL 40 MG FILM-COATED TABLETS
PROPRANOLOL 80 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 or
nurse.
•
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 of the side effects, talk to your doctor or pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Propranolol is and what it is used for
2.
What you need to know before you take Propranolol
3.
How to take Propranolol
4.
Possible side effects
5.
How to store Propranolol
6.
Contents of the pack and other information
1.
WHAT PROPRANOLOL IS AND WHAT IT IS USED FOR
Propranolol contains propranolol hydrochloride which belongs to a
group of medicines called beta-
blockers. It has effects on the heart and circulation and also on
other parts of the body.
Propranolol can be used for:Hypertension (high blood pressure)
•
Angina (chest pain)
•
Some arrythmias (disorders of heart rhythm)
•
Protection of the heart after a myocardial infarction (heart attack)
•
Migraine
•
Essential tremor (involuntary and rhythmic shaking)
•
Certain thyroid conditions (thyrotoxicosis and hyperthyroidism, which
are caused by an
overactive thyroid gland)
•
Hypertrophic cardiomyopathy (thickened heart muscle)
•
Phaeochromocytoma (high blood pressure due to a tumour usually near
the kidney)
•
Bleeding in the oesophagus caused by high blood pressure in the liver.
Page 2 of 8
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPRANOLOL
DO NOT TAKE PROPRANOLOL TABLETS IF YOU:
•
are allergic (hypersensitive) to propranolol hydrochloride or any of
t

Summary of Product characteristics

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11
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Propranolol 10 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propranolol hydrochloride 10 mg, film-coated tablet.
Each tablet contains 10 mg propranolol hydrochloride.
Also contains 33.40 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
10 mg: White to off-white round, biconvex film-coated tablets
imprinted with "AI" on one
side and a score line on the other side.
NOTE:
Diameter of the tablet 5.5 mm
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
•
Angina pectoris.
•
Hypertension.
•
Long-term prophylaxis against myocardial
reinfarction after recovery from acute myocardial
infarction
•
Hypertrophic obstructive cardiomyopathy.
•
Essential tremor.
•
Supraventricular cardiac arrhythmia.
•
Ventricular cardiac arrythmias.
•
Hyperthyroidism and thyrotoxicosis
•
Phaeochromocytoma (with an alpha-blocker).
•
Migraine.
•
Prophylaxis of upper gastrointestinal bleeding in patients with portal
hypertension and
oesophageal varices.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
HYPERTENSION
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A starting dose of 80 mg twice a day may be increased at weekly
intervals according to
response. The usual dose range is 160 to 320 mg per day. With
concurrent diuretic or other
antihypertensive drugs a further reduction of blood pressure is
obtained.
ANGINA, MIGRAINE AND ESSENTIAL TREMOR
The starting dose is 40 mg two to three times daily, increasing by the
same amount at
weekly intervals according to the patient response. An adequate
response in migraine and
essential tremor is usually seen in the range 80 to 160 mg/day and in
angina in the range 120
to 240 mg/day.
ARRHYTHMIAS, TACHYCARDIA, HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY AND
THYROTOXICOSIS
A dosage range of 10 to 40 mg three or four times a day usually
achieves the required