APO-Propranolol propranolol hydrochloride 10 mg tablet bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

propranolol hydrochloride, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Propranolol hydrochloride

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; povidone; sunset yellow FCF aluminium lake; magnesium stearate; quinoline yellow; sodium starch glycollate

Administration route:

Oral

Units in package:

100

Prescription type:

(S4) Prescription Only Medicine

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 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

Product summary:

Visual Identification: Orange coloured, round, biconvex tablets, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-02-13

Patient Information leaflet

APO- PROPRANOLOL TABLETS
1
APO-PROPRANOLOL
TABLETS
_Propranolol hydrochloride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about propranolol. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Propranolol is used to treat or prevent
a number of conditions, most of
which are related to the heart:
•
to lower high blood pressure, also
called hypertension
•
to prevent angina
•
to treat or prevent heart attacks,
or reduce your risk of heart
problems following a heart attack
•
to treat irregularities in heartbeat,
including those caused by anxiety
•
essential tremor (shaking of head,
chin, hands)
•
phaeochromocytoma
•
Fallot's Tetralogy
•
to prevent migraine headaches
Propranolol belongs to a group of
medicines called beta-blockers.
_HOW IT WORKS _
Propranolol works by affecting the
body's response to some nerve
impulses, especially in the heart. This
decreases the heart's need for blood
and oxygen, which reduces the
amount of work the heart must do.
Propranolol also widens the blood
vessels in the body and helps the
heart to beat more regularly.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children under 7 years of age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-PROPRANOLOL
(PROPRANOLOL HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Propranolol hydrochloride.
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each tablet contains propranolol hydrochloride as the active
ingredient. In addition, each
tablet contains the following inactive ingredients: lactose
monohydrate, maize starch, sunset
yellow FCF aluminium lake, quinoline yellow, povidone, sodium starch
glycollate,
magnesium stearate and brilliant blue FCF aluminium lake (40 mg only).
EXCIPIENTS WITH KNOWN EFFECT
Sugars (as Lactose monohydrate)
10 MG TABLETS
EACH TABLET CONTAINS 10 MG OF PROPRANOLOL HYDROCHLORIDE.
Orange coloured, round, biconvex tablets, embossed with "P" and "10"
on either side of the
breakline on one side and plain on the other side.
40 MG TABLETS
EACH TABLET CONTAINS 40 MG OF PROPRANOLOL HYDROCHLORIDE.
Green coloured, round, biconvex tablets, embossed with "P" and "40" on
either side of the
breakline on one side and plain on the other side.
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 (e.g. tachycardia due to digitalis or adrenaline
overdosage)
•
Essential tremor, including familial and senile tremor
•
Phaeochromocytoma (only with concurrent α-receptor blockade)
•
Hypertrophic subaortic stenosis
•
Suspected or definite myocardial infarction
•
Fallot’s tetralogy
2
4.2
DOSE AND METHOD OF ADMINISTRATION
NOTE: Tablets may be taken before or after food.
ADULT
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
–
320 mg/day. Although higher doses may be required, and have been used,
the value
and safety of doses exceeding 320 mg/day have not been established.