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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension ALKEM 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 ALKEM AMLODIPINE, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor Angina ALKEM AMLODIPINE is indicated for the first line treatment of chronic stable angina. ALKEM 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:

Licence status A

Authorization date:

2014-07-25

Patient Information leaflet

Alkem Amlodipine
Page 1 of 4
ALKEM AMLODIPINE

_Amlodipine <_
_am-load-i-peen> _
_Besilate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Alkem 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 Alkem 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 ALKEM AMLODIPINE
IS USED FOR
_WHAT IT DOES _
Alkem 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.
Alkem
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 _
Alkem Amlodipine belongs to a group of
medicines
called
_calcium _
_channel _
_blockers _
or
_calcium _
_ion _
_antagonists. _
They
work
by
widening
your
blood
vessels, m a 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
ALKEM
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
reco

Read the complete document

Summary of Product characteristics

____________________________________________________________________________________
ALKEM AMLODIPNE
(Version 04)
Page
1
of
13
AUSTRALIAN PRODUCT INFORMATION ALKEM AMLODIPINE
(AMLODIPINE BESILATE)
1.
NAME OF THE MEDICINE
Amlodipine Besilate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALKEM AMLODPINE 5 MG TABLETS
Each tablet contains 5 mg amlodipine as amlodipine Besilate
ALKEM 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
ALKEM 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
ALKEM 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
ALKEM 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
ALKEM AMLODIPINE, which
has
been
used
in
combination
with
a
thiazide
diuretic,
beta
adrenoceptor
blocking agent or an
angiotensin-converting enzyme inhibitor.
2. ANGINA
ALKEM AMLODIPINE is indicated for the first line treatment of chronic
stable angina. ALKEM
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.
____________________________________________________________________________________
ALKEM AMLODIPNE
(Version 04)
Page
2
of
13
METHOD OF ADMINISTRATION
ALKEM AMLODIPINE is administered orally.
DOSAGE ADJUSTMENT
Small, fragile or elderly individuals, or patients with

Read the complete document