Vasorex
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
30-11-2020
Summary of Product characteristics
(SPC)
18-11-2020
Active ingredient:
Amlodipine besilate 13.87mg equivalent to 10.0 mg amlodipine base
Available from:
REX Medical Ltd
INN (International Name):
Amlodipine besilate 13.87 mg (equivalent to 10.0 mg amlodipine base)
Dosage:
10 mg
Pharmaceutical form:
Tablet
Composition:
Active: Amlodipine besilate 13.87mg equivalent to 10.0 mg amlodipine base Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Sodium starch glycolate
Units in package:
Blister pack, Aluminium foil/PVC-VMCH coated, 30 tablets (10 per blister), 30 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Cipla Ltd
Therapeutic indications:
Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor.
Product summary:
Package - Contents - Shelf Life: Blister pack, Aluminium foil/PVC-VMCH coated, 30 tablets (10 per blister) - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Aluminium foil/PVC-VMCH coated, 30 tablets (10 per blister) - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, HDPE with Tekni-Plex Foil Liner Bottle with CRC Cap and Induction Liner - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, HDPE with non-CRC cap and silica gel bag - 1000 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
Authorization date:
2005-09-16
Patient Information leaflet
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
VASOREX
AMLODIPINE BESYLATE TABLETS 2.5 MG, 5 MG, AND 10 MG
WHAT IS IN THIS LEAFLET
The information enclosed answers several general questions about
VASOREX.
This leaflet does not include all the accessible information on
VASOREX.
All medication has benefits and risks. Your doctor will have
considered the risks of you
using VASOREX against the benefits expected.
Discuss with your doctor any concerns you may have.
This leaflet was last updated on the date at the end of this leaflet.
KEEP THIS INFORMATION WITH YOUR MEDICINE AND REFER TO THIS LEAFLET IF
YOU HAVE ANY
QUERIES.
WHAT VASOREX IS USED FOR
VASOREX tablets are used for the treatment of:
•
Hypertension (high blood pressure)
Blood pressure should be regularly checked as hypertension typically
does not have
any obvious symptoms. Hypertension can cause serious health issues if
not managed
effectively.
•
Chronic chest pain that occurs when the heart does not get enough
oxygen-rich
blood (angina), including a specific type of angina known as
Prinzmental’s
angina pectoris.
VASOREX helps to prevent chest pain due to a shortage of oxygen-rich
blood to the
heart. It is not for the relief of a sudden angina attack. Your doctor
will have prescribed
you a “reliever” medication for sudden-onset chest pain.
VASOREX tablets contain the active ingredient amlodipine, which
belongs to the group
of medicines known as
calcium channel blockers or calcium channel antagonists.
Calcium channel blockers block the entry of calcium into the heart
muscle cells and
blood vessel walls. This reduces electrical conduction in the heart
and widens blood
2
vessels, making it easier for the heart to pump, increasing the supply
of oxygen-rich
blood to the heart and lowering blood pressure.
You may also be prescribed other heart medications to be used with
VASOREX to
treat your heart condition.
Your doctor may have prescribed VASOREX for a different reason.
If you have any concerns about why VASOREX has been prescribed, please
discuss
this wi
Read the complete document
Summary of Product characteristics
1
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Vasorex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amlodipine besilate 2.5 mg, 5 mg and 10 mg tablets
3 PHARMACEUTICAL FORM
Vasorex 2.5 mg tablets are white to off white, round with “C”
debossed on one side and
“126” on the other side. Alternatively, they are debossed on one
side with “3235” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 2.5 mg of
amlodipine.
Vasorex 5 mg tablets are white to off white, round with “C”
debossed on one side and
“127” on the other side. Alternatively, they are debossed on one
side with “3236” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 5 mg
amlodipine.
Vasorex 10 mg tablets are white to off white, round with “C”
debossed on one side and
“128” on the other side. Alternatively, they are debossed on one
side with “3237” and
“WPI” on the other side. Each tablet contains amlodipine besilate
equivalent to 10 mg
amlodipine.
Do not halve the tablet as dose equivalence when the tablet is divided
has not been
established.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Vasorex is indicated for the first line treatment of hypertension and
can be used as the
sole agent to control blood pressure in the majority of patients.
Patients not adequately
controlled on a single antihypertensive agent may benefit from the
addition of amlodipine,
which has been used in combination with a thiazide diuretic, beta
adrenoceptor blocking
agent, or an angiotensin-converting enzyme inhibitor.
Vasorex is indicated for the first line treatment of myocardial
ischaemia, whether due to
fixed obstruction (stable angina) and/or vasospasm/vasoconstriction
(Prinzmetal's or
variant angina) of coronary vasculature.
Vasorex
may
be
used
where
the
clinical
presentation
suggests
a
possible
vasospastic/vasoconstrictive component but where
vasospasm/vasoconstriction has not
been confirmed. Vasorex may be used alone as monotherapy, or in
combination with other
anti
Read the complete document
