PHARMACOR AMLODIPINE amlodipine (as besilate) 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

amlodipine besilate, Quantity: 6.93 mg (Equivalent: amlodipine, Qty 5 mg)

Available from:

Pharmacor Pty Ltd

INN (International Name):

amlodipine besilate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: sodium starch glycollate type A; silicon dioxide; calcium phosphate; magnesium stearate; microcrystalline cellulose

Administration route:

Oral

Units in package:

10 tablets - sample pack, 30 tablets, 7 tablets - sample pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension PHARMACOR 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 PHARMACOR AMLODIPINE, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor. Angina PHARMACOR AMLODIPINE is indicated for the first line treatment of chronic stable angina. PHARMACOR AMLODIPINE may be used alone, as monotherapy or in combination with other antianginal drugs.

Product summary:

Visual Identification: White to off-white, octagonal, flat faced, bevelled edged scored tablet debossed with "210" and "5" on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-07-25

Patient Information leaflet

Pharmacor Amlodipine
Page 1 of 4
PHARMACOR AMLODIPINE

_Amlodipine <_
_am-load-i-peen> _
_Besilate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Pharmacor
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
Pharmacor
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 PHARMACOR
AMLODIPINE IS USED FOR
_WHAT IT DOES _
Pharmacor 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.
Pharmacor 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 _
Pharmacor
Amlodipine
belongs
to
a
group
of
medicines
called
_calcium _
_channel _
_blockers _
or
_calcium _
_ion _
_antagonists. _
They
work
by
widening
your blood vessels, ma k i n g it e a s i e r
fo r y o u r 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
PHARMACOR
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
n

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Summary of Product characteristics

____________________________________________________________________________________
PHARMACOR AMLODIPNE
(Version 04)
Page
1
of
13
AUSTRALIAN PRODUCT INFORMATION PHARMACOR AMLODIPINE
(AMLODIPINE BESILATE)
1.
NAME OF THE MEDICINE
Amlodipine Besilate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR AMLODPINE 5 MG TABLETS
Each tablet contains 5 mg amlodipine as amlodipine Besilate
PHARMACOR AMLODPINE 10 MG TABLETS
Each tablet contains 10 mg amlodipine as amlodipine Besilate
For the full list of excipients, see
SECTION 6.1 - LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
PHARMACOR AMLODIPINE 5 mg: White to off-white, octagonal, flat faced,
bevelled edged
scored tablet, debossed with "210” & "5" on one side and plain on
other side
PHARMACOR AMLODIPINE 10 mg: White to off-white, octagonal, flat faced,
bevelled edged
tablet, debossed with "209” & "10" on one side and plain on other
side
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. HYPERTENSION
PHARMACOR 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
PHARMACOR
AMLODIPINE, which
has
been
used in
combination
with
a thiazide
diuretic,
beta
adrenoceptor
blocking agent or an angiotensin-converting enzyme inhibitor.
2. ANGINA
PHARMACOR AMLODIPINE is indicated for the first line treatment of
chronic stable angina.
PHARMACOR AMLODIPINE may be used alone, as monotherapy or in
combination with other
antianginal drugs.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
For hypertension or angina the usual initial dose is 2.5 to 5 mg once
daily which may be increased
to a maximum dose of 10 mg depending on the individual patient's
response.
____________________________________________________________________________________
PHARMACOR AMLODIPNE
(Version 04)
Page
2
of
13
METHOD OF ADMINISTRATION
PHARMACOR AMLODIPINE is administered orally.
DOSAGE ADJUSTMENT
Small,

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