Deralin 10 tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

propranolol hydrochloride, Quantity: 10 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; croscarmellose sodium; calcium carbonate; magnesium stearate; Gelatin; titanium dioxide; hypromellose; sunset yellow FCF; erythrosine; macrogol 400

Administration route:

Oral

Units in package:

500, 100, 90

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. Angina pectoris. 2. Hypertension. 3. Prevention of migraine. 4. Cardiac dysrythmias: certain intrinsic cardiac dysrythmias; dysrythmias associated with thyrotoxicosis; anxiety tachycardia; certain drug induced dysrythmias (eg. tachycardia due to digitalis or adrenaline overdosage). 5. Essential tremor including familial and senile tremor. 6. Phaeochromocytoma (only with concurrent alpha antagonist). 7. Hypertrophic subaortic stenosis. 8. Suspected or definite myocardial infarction.

Product summary:

Visual Identification: 7 mm red film coated normal convex tablet marked PP/10 with G on reverse; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-20

Patient Information leaflet

DERALIN
®
_contains the active ingredient propranolol hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DERALIN.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking DERALIN
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DERALIN IS
USED FOR
DERALIN works by affecting the
body's response to some nerve
impulses, especially in the heart.
As a result, it decreases the heart's
need for blood and oxygen and
therefore reduces the amount of work
the heart has to do. It also widens the
blood vessels in the body, as well as
helping the heart to beat more
regularly.
DERALIN contains the active
ingredient propranolol hydrochloride,
which belongs to a group of
medicines called beta-blockers.
DERALIN is used to treat or prevent
a number of conditions. These
include:
•
hypertension (high blood
pressure)
•
angina
•
heart beat or heart rhythm
irregularities, including those
caused by anxiety or an
overactive thyroid gland
•
essential tremor (shaking of head,
chin, hands)
•
phaeochromocytoma, a rare
tumour of the adrenal gland
(only when used in combination
with another medicine)
•
heart attack prevention or
treatment, or to reduce the risk of
heart problems after a heart attack
•
Fallot's Tetralogy
•
migraine headache prevention.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DERALIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
DERALIN for another reason.
DERALIN is not addictive.
DERALIN is available only with a
doctor's prescription.
BEFORE YOU TAKE
DERALIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DERALIN IF YOU ARE
ALLERGIC TO:
•
propranolol hydrochloride
•
any of the ingredients listed at the
end of this leaflet
�

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
DERALIN
®
_propranolol hydrochloride film coated tablet _
1
NAME OF THE MEDICINE
Propranolol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DERALIN tablet contains 10 mg, 40 mg or 160 mg of propranolol
hydrochloride as the active ingredient.
Excipients of known effect: sulfites.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DERALIN 10 tablet: red film coated, marked PP/10 on one side, G on
reverse.
DERALIN 40 tablet: red film coated, marked PP/40 on one side, G on
reverse.
DERALIN 160 tablet: red film coated, marked PP/160 on one side, G on
reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Angina pectoris
•
Hypertension
•
Prevention of migraine
•
Cardiac
dysrhythmias:
certain
intrinsic
cardiac
dysrhythmias;
dysrhythmias
associated
with
thyrotoxicosis; anxiety tachycardia; certain drug induced dysrhythmias
(eg. tachycardia due to
digitalis or adrenaline (epinephrine) overdosage)
•
Essential tremor, including familial and senile tremor
•
Phaeochromocytoma (only with concurrent alpha-receptor blockade)
•
Hypertrophic subaortic stenosis
•
Suspected or definite myocardial infarction
•
Fallot’s Tetralogy
4.2
DOSE AND METHOD OF ADMINISTRATION
_Note._
DERALIN tablets may be taken before or after food.
ADULTS
Hypertension
The standard starting dose is 40 mg twice daily, increasing by the
same amount at weekly intervals according
to patient response. An adequate response is usually seen in the range
120 to 320 mg/day. Although higher
DERALIN
®
– PRODUCT INFORMATION
2
doses may be required, and have been used, the value and safety of
doses exceeding 320 mg/day have not
been established.
Angina Pectoris and Essential Tremor
40 mg two or three times daily, increasing by the same amount at
weekly intervals according to patient
response. An adequate response in essential tremor is usually seen in
the range 80 to 160 mg/day and in angina
120 to 320 mg/day.
Migraine
The standard starting dose is 40 mg twi