Isoptin SR
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
08-08-2019
Summary of Product characteristics
(SPC)
08-08-2019
Active ingredient:
Verapamil hydrochloride 240mg
Available from:
Viatris Limited
INN (International Name):
Verapamil hydrochloride 240 mg
Dosage:
240 mg
Pharmaceutical form:
Modified release tablet
Composition:
Active: Verapamil hydrochloride 240mg Excipient: L-Green Lake ZLT 601 Glycol montanate Hypromellose Macrogol 400 Macrogol 6000 Magnesium stearate Microcrystalline cellulose Povidone Purified talc Purified water Sodium alginate Titanium dioxide
Units in package:
Blister pack, Patient Starter pack, 7 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Recordati SpA
Therapeutic indications:
· Angina pectoris - For the prophylaxis and treatment of coronary insufficiency: Chronic stable angina pectoris; angina at rest including vasospastic (Prinzmetal's, variant angina) and unstable angina (crescendo, pre-infarction angina); angina pectoris post myocardial infarction.
Product summary:
Package - Contents - Shelf Life: Blister pack, Patient Starter pack - 7 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization date:
1986-02-28
Patient Information leaflet
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ISOPTIN
®
AND ISOPTIN SR
®
_VERAPAMIL HYDROCHLORIDE_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Isoptin.
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 taking Isoptin
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 need to read it
again.
WHAT ISOPTIN IS USED
FOR
There are two types of Isoptin:
•
Isoptin (40 mg and 80 mg
tablets)
•
Isoptin SR (120 and 240 mg
tablets)
The letters SR in the name Isoptin
SR stand for "sustained release".
This means the medicine is
released into the blood over an
extended period of time, usually
allowing the medicine to be taken
only once a day.
Depending on your condition, your
doctor will prescribe Isoptin or
Isoptin SR.
In most parts of this leaflet, the
name Isoptin is used to refer to both
Isoptin tablets and Isoptin SR
tablets. Where there is information
specific to the type of Isoptin, the
separate names are used.
Isoptin is used in the treatment of:
high blood pressure, also
called hypertension
angina (chest pain)
irregular heartbeats, also
called arrhythmias
Isoptin is also used in patients who
have recently had a heart attack.
Your doctor may have prescribed
Isoptin for another reason. Ask
your doctor if you have any
questions about why Isoptin has
been prescribed for you.
Isoptin belongs to a group of
medicines called calcium channel
blockers or calcium antagonists.
They work by opening up blood
vessels, which lets more blood and
oxygen reach the heart and at the
same time lowers high blood
pressure. Isoptin tablets also help
to control irregular heartbeats.
Isoptin does not change the amount
of calcium in your blood or bones.
Calcium in your diet or taking
calcium supplements will not
inter
Read the complete document
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
Read the complete document
