Apo-Propranolol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Propranolol hydrochloride 40mg

Available from:

Ipca Pharma (NZ) Pty Limited

INN (International Name):

Propranolol hydrochloride 40 mg

Dosage:

40 mg

Pharmaceutical form:

Tablet

Composition:

Active: Propranolol hydrochloride 40mg Excipient: Sunset Yellow FCF Aluminium lake Cl15985 Brilliant Blue FCF Aluminium lake Cl42090 Lactose monohydrate Magnesium stearate Maize starch Povidone Quinoline yellow Sodium starch glycolate

Prescription type:

Prescription

Manufactured by:

Ipca Laboratories Limited

Therapeutic indications:

Management of angina pectoris.

Product summary:

Package - Contents - Shelf Life: Bottle, White HDPE bottle with white polypropylene child resistant cap - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2014-06-27

Patient Information leaflet

New Zealand Consumer Medicine Information
APO-PROPRANOLOL
_PROPRANOLOL HYDROCHLORIDE _
10mg and 40mg Tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Propranolol.
This leaflet answers some common questions about Apo-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
Apo-Propranolol against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT APO-PROPRANOLOL IS USED FOR
The name of your medicine is Apo-Propranolol tablet. It contains the
active ingredient
Propranolol hydrochloride.
Apo-Propranolol is used to treat a number of conditions, most of which
are related to
the heart:
•
Management of angina pectoris.
•
Long term prophylaxis after recovery from acute myocardial infarction.
•
Control of most forms of cardiac dysrhythmias.
•
Control of essential and renal hypotension
•
Prophylaxis of migraine.
•
Control of anxiety and anxiety tachycardia
•
Management of essential tremor.
•
Adjunctive management of thyrotoxicosis and thyrotoxic crisis.
•
Management of hypertrophic obstructive cardiomyopathy.
•
Management of phaeochromocytoma (with an alpha-adrenoreceptor blocking
medicine).
Your doctor may have prescribed Apo-Propranolol for another reason.
2
Ask your doctor if you have any questions about why Apo-Propranolol
has been
prescribed for you.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
Apo-Propranolol dose should not be individually determined when
administered to
children.
BEFORE YOU USE APO-PROPRANOLOL
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Apo-Propranolol if:
•
YOU ARE HYPERSENSITIVE TO, OR HAVE HAD AN ALLERGIC REACTION TO
PROPRANOLOL
HYDROCHLORIDE OR ANY OF T

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-PROPRANOLOL
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 10
1. APO-PROPRANOLOL (10MG & 40MG TABLETS)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PROPRANOLOL HYDROCHLORIDE 10MG OR 40MG
Chemical Structure:
Chemical Name:
2-propanol, 1-[(1-methyl-ethyl)amino]-3-(1-naphthalenyloxy),
hydrochloride, (±).
Molecular Formula:
C
16
H
21
NO
2
,HCl
Molecular Weight:
295.8
CAS Registry Number:
318-98-9.
EXCIPIENT(S) WITH KNOWN EFFECT
APO-PROPRANOLOL tablets contain lactose
APO-PROPRANOLOL tablets are gluten free.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
APO-PROPRANOLOL 10mg tablets :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.
APO PROPRANOLOL 40 mg tablets:
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.
The score line is not intended for breaking the tablet
APO-PROPRANOLOL
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 10
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Management of angina pectoris.
•
Long term prophylaxis after recovery from acute myocardial infarction.
•
Control of most forms of cardiac dysrhythmias.
•
Control of essential and renal hypertension
•
Prophylaxis of migraine.
•
Control of anxiety and anxiety tachycardia
•
Management of essential tremor.
•
Adjunctive management of thyrotoxicosis and thyrotoxic crisis.
•
Management of hypertrophic obstructive cardiomyopathy.
•
Management of phaeochromocytoma (with an alpha-adrenoreceptor blocking
medicine).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
ADULTS
:
_HYPERTENSION:_
A starting dose of
80 mg twice a day may be increased at
weekly intervals according to
response.
The usual
dose range is 160-320 mg per day.
With concurrent
diuretic or other
anti-hypertensive drugs a further reduction of blood