Verpamil SR
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
18-01-2021
Summary of Product characteristics
(SPC)
04-01-2021
Active ingredient:
Verapamil hydrochloride 120mg; ; Verapamil hydrochloride 120mg
Available from:
Viatris Limited
INN (International Name):
Verapamil hydrochloride 120 mg
Dosage:
120 mg
Pharmaceutical form:
Modified release tablet
Composition:
Active: Verapamil hydrochloride 120mg Excipient: Carnauba wax Chloroform Diethyl phthalate Ethanol Hydrogenated castor oil Hypromellose Lactose monohydrate Magnesium stearate Methacrylic acid copolymer Purified talc Active: Verapamil hydrochloride 120mg Excipient: Carnauba wax Diethyl phthalate Ethanol Hydrogenated castor oil Hypromellose Lactose monohydrate Magnesium stearate Methacrylic acid copolymer Purified talc Purified water
Units in package:
Blister pack, 100 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Teva Pharmaceutical Fine Chemicals SrL
Therapeutic indications:
· Essential Hypertension.
Product summary:
Package - Contents - Shelf Life: Blister pack, - 100 tablets - 18 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 250 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization date:
1986-01-22
Patient Information leaflet
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
VERPAMIL SR
_VERAPAMIL SR TABLETS 120MG AND 240MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VERPAMIL SR.
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 VERPAMIL
SR against the benefits they expect
channel blockers. These medicines
work by opening up blood vessels,
causing blood pressure to fall and
allowing more blood and oxygen to
reach the heart.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
DO NOT TAKE VERPAMIL SR IF YOU
ARE TAKING IVABRADINE, A MEDICINE
USED TO TREAT CHEST PAIN.
DO NOT TAKE THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged,
return it to your pharmacist for
disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR.
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
BEFORE YOU TAKE
VERPAMIL SR
_BEFORE YOU START TO TAKE _
_IT_
TELL YOUR DOCTOR IF YOU HAVE
DOCTOR OR PHARMACIST.
ALLERGIES TO ANY OTHER MEDICINES,
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT VERPAMIL SR
IS USED FOR
VERPAMIL SR is available in two
strengths: VERPAMIL SR 120mg
and VERPAMIL SR 240mg.
The letters SR in the name
VERPAMIL 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
once a day.
VERPAMIL SR is used to treat
High blood pressure
(hypertension)
Heart and chest pain
brought on, for example, by
exercise or stress (known
as angina pectoris)
Long-term prevention of
future heart attacks
Your VERPAMIL SR ta
Read the complete document
Summary of Product characteristics
Page 1 of 16
NEW ZEALAND DATA SHEET
VERPAMIL SR
1. PRODUCT NAME
VERPAMIL SR, 120 mg and 240 mg, sustained release tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sustained released tablet contains 120 mg or 240 mg of verampmil
hydrochloride.
VERPAMIL SR 120 contains lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
120 mg sustained-release tablets: Clear, film coated, white biconvex
tablet, 11/32” (8.7 mm)
diameter.
240 mg sustained-release tablets: Light green, film coated, modified
capsule shaped biconvex
tablet, 18.5 mm x 6.5 mm, plain on both sides.
DO NOT HALVE VERPAMIL SR TABLETS.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Essential Hypertension
Secondary Prevention Post Myocardial Infarction:
For secondary prevention after acute myocardial infarction, especially
where β 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 rest including vasospastic (Prinzmetal's, variant angina)
and unstable angina
(crescendo, pre-infarction angina); angina pectoris post myocardial
infarction.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
The individual dose, and frequency of dosing, should be determined in
accordance with the
indication and individual patient response.
Page 2 of 16
ADULTS
_HYPERTENSION_
One tablet VERPAMIL SR 240 mg daily. For elderly patients and patients
new to verapamil
therapy, doctors should consider an initial daily dose of VERPAMIL SR
120 mg.
Maximum dose: one tablet VERPAMIL SR 240 mg twice daily (any single
dose should not exceed
240 mg).
_SECONDARY PREVENTION OF MYOCARDIAL INFARCTION_
Data from studies available suggest that treatment with VERPAMIL SR
can be initiated from 7
days post myocardial infarction.
Generally doses will be 240 mg - 480 mg VERPAMIL SR daily in 1-2
divided doses. The average
daily dose is 360mg. It is a
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