Apo-Amlodipine

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Amlodipine besilate 14mg equivalent to to 10 mg amlodipine;  

Fáanlegur frá:

Apotex NZ Ltd

INN (Alþjóðlegt nafn):

Amlodipine besilate 14 mg (equiv. to 10 mg amlodipine)

Skammtar:

10 mg

Lyfjaform:

Tablet

Samsetning:

Active: Amlodipine besilate 14mg equivalent to to 10 mg amlodipine   Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose

Einingar í pakka:

Blister pack, PVC/PVDC, 120 tablets

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Srini Pharmaceuticals Pvt Ltd

Ábendingar:

APO-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. APO-AMLODIPINE 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. Amlodipine may be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. APO-AMLODIPINE may be used alone as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or beta blockers.

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 120 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 250 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2004-01-05

Upplýsingar fylgiseðill

APO-AMLODIPINE TABLET
1
APO-AMLODIPINE TABLET
_Contains the active ingredient Amlodipine besilate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Apo-Amlodipine.
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
Apo-
Amlodipine against the benefits it is
expected to 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 THIS MEDICINE IS
USED FOR
_WHAT IT DOES _
_ _
Apo-Amlodipine is used to:
•
lower high blood pressure
(hypertension).
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is
to
have
your
blood
pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems.
•
treat angina pectoris.
Angina is a pain or uncomfortable
feeling in the chest, often spreading
to the arms or neck, and sometimes
to the shoulders and back. The pain
of angina is due to a shortage of
oxygen to the heart.
Apo-Amlodipine is not for the relief
of a sudden attack of angina. Your
doctor will give you other medication
to treat this.
_HOW IT WORKS _
_ _
Apo-Amlodipine belongs to a group
of medicines called calcium channel
blockers or calcium ion antagonists.
They work by widening your blood
vessels, making it easier for your
heart to pump blood around the body
and help increase the supply of blood
and oxygen to your heart. Calcium
channel blockers do not change the
amount of calcium in your blood or
bones.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
APO-
AMLODIPINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN _
There is not enough information to
recommend the use of this medicine
for childr

Vara einkenni

NEW ZEALAND DATA SHEET
APO- AMLODIPINE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 10
1. PRODUCT NAME
APO-AMLODIPINE (2.5mg, 5mg and 10mg tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5mg tablet contains amlodipine besilate equivalent to 2.5mg
amlodipine.
Each 5mg tablet contains amlodipine besilate equivalent to 5mg
amlodipine
Each 10mg tablet contains amlodipine besilate equivalent to 10mg
amlodipine
Excipient(s) of known effect
APO-AMLODIPINE contain lactose.
APO-AMLODIPINE does not contain gluten
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
APO-AMLODIPINE 2.5mg are white to off-white, round unscored tablets,
engraved
“APO” on one side and “AML” over “2.5” on the other side.
Each tablet typically weighs
45mg. Do not halve tablet.
APO-AMLODIPINE 5mg are white to off-white, round, scored tablets,
engraved “APO”
on one side and “AML” over scored “5” on the other side. Each
tablet typically weighs
90mg
APO-AMLODIPINE 10mg are white to off-white, round unscored tablets,
engraved
“APO” on one side and “AML” over “10” on the other side.
Each tablet typically weighs
180mg.
4.
CLINICAL PARTICULARS
4.1 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
for the addition of
amlodipine,
which
has
been
used
in
combination
with
a
thiazide
diuretic,
beta
adrenoceptor blocking agent, or an angiotensin converting enzyme
inhibitor.
Amlodipine 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.
Amlodipine
may
be
used
where
the
clinical
presentation
suggests
a
possible
vasospastic/vasoconstrictive component but where
vasospasm/vasoconstriction