Isoptin SR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Verapamil hydrochloride 180mg;  

Available from:

Knoll Australia Pty Limited

INN (International Name):

Verapamil hydrochloride 180 mg

Dosage:

180 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Verapamil hydrochloride 180mg   Excipient: Ferric hydroxide Glycol montanate Hypromellose Macrogol 400 Macrogol 6000 Magnesium stearate Microcrystalline cellulose Povidone Purified talc Purified water Sodium alginate Titanium dioxide

Units in package:

Bottle, glass, 30, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Abbott GmbH & Co. KG

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 30 - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, 60 - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1995-05-04

Summary of Product characteristics

Page 1 of 16
NEW ZEALAND DATA SHEET
ISOPTIN
®
ISOPTIN SR
®
1. PRODUCT NAME
ISOPTIN 40 mg and 80 mg tablets.
ISOPTIN SR 120 mg and 240 mg modified release tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ISOPTIN tablet contains 40 mg or 80 mg of verapamil
hydrochloride.
Each ISOPTIN SR tablet contains 120 mg or 240 mg verapamil
hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ISOPTIN 40 mg tablets are white, film coated, marked “40” on one
side and with “Knoll-triangle” on
reverse side and have a diameter of about 7mm.
ISOPTIN 80 mg tablets are white, film coated, marked with “ISOPTIN
80” on one side and “Knoll” on
reverse side above the score and have a diameter of about 9mm.
ISOPTIN SR 120 mg sustained release tablets are white, biconvex and
film coated with dimensions
5mm x 10mm. The tablet is embossed with “120 SR” on one side and
“KNOLL” on the other side.
ISOPTIN SR 240 mg sustained release tablets are light green, capsule
shaped, scored and film
coated with dimensions 6.5 x 18.5mm. The tablet is embossed with a
double Knoll triangle on one
side. Sustained release characteristics are not altered when the
tablet is divided in half.
ISOPTION 40 mg, 80 mg tablets and ISOPTIN SR 120 mg tablet cannot be
divided into equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
ISOPTIN SR

Essential hypertension

Secondary prevention post myocardial infarction - for secondary
prevention after acute
myocardial infarction, especially where

blocking agents are not tolerated such as in patients
with asthma, diabetes, peripheral vascular disease with intermittent
claudication, etc.

Angina pectoris – for the prophylaxis and treatment of coronary
insufficiency: chronic stable
angina pectoris; angina at including vasospastic (Prinzmetal’s,
variant angina) and unstable
angina (crescendo, pre-infarction angina); angina pectoris post
myocardial infarction.
Page 2 of 16
ISOPTIN 40 MG OR 80 MG (IMMEDIATE RELEASE)

Essential h