APO-AMLODIPINE amlodipine 10 mg (as besilate) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 14 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

amlodipine besilate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; maize starch; lactose monohydrate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to off white, round, unscored tablets, engraved APO on one side and AML over 10 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2007-12-13

Patient Information leaflet

APO-AMLODIPINE
1
APO-AMLODIPINE
_Amlodipine besylate _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about 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 using this medicine
against the benefits they expect it
will 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Amlodipine is used to lower high
blood pressure (hypertension) or treat
angina. It belongs to a group of
medicines called calcium channel
blockers.
_HOW IT WORKS _
Amlodipine works 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend using amlodipine in
children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
amlodipine
•
other calcium channel blockers
•
or any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
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,
T

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- AMLODIPINE (AMLODIPINE BESILATE) TABLETS
1
NAME OF THE MEDICINE
Amlodipine besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg, 5 mg or 10 mg of amlodipine (as besilate)
as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
2.5 MG TABLETS:
White to off-white, round unscored tablets, Engraved APO on one side
and “AML” over “2.5”
on the other side.
5 MG TABLET:
White to off-white, round scored tablets. Engraved “AML” over
score “5” on one side, “APO”
on the other side.
10 MG TABLET:
White to off-white, round unscored tablets. Engraved APO on one side
and “AML” over “10”
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
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.
ANGINA
Amlodipine is indicated for the first line treatment of chronic stable
angina. amlodipine may
be used alone, as monotherapy or in combination with other antianginal
drugs.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Amlodipine tablets are intended for oral 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.
Small, fragile or elderly individuals, or patients with hepatic
insufficiency should be started on
2.5
mg
once
daily
and
this
dose
may
be
used
when
adding
amlodipine
to
other
antihypertensive therapy.
Dosage should be adjusted according to each patient's need. In
general, titration should
proceed over 7 to