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

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

amlodipine besilate, Quantity: 6.935 mg (Equivalent: amlodipine, Qty 5 mg)

Διαθέσιμο από:

Arrotex Pharmaceuticals Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

Excipient Ingredients: calcium hydrogen phosphate dihydrate; microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type A; magnesium stearate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30, 84, 14, 28, 56, 50, 10

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

1. 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.,2. 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.

Περίληψη προϊόντος:

Visual Identification: White to off-white, circular, biconvex, uncoated tablets debossed with 'E 21' on one side and score line on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2018-10-25

Φύλλο οδηγιών χρήσης

BTC AMLODIPINE
1
BTC AMLODIPINE
_Amlodipine besilate _
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

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION –
BTC AMLODIPINE (AMLODIPINE)
1
NAME OF THE MEDICINE
Amlodipine besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg or 10 mg of amlodipine besilate, equivalent
to 5 mg or 10 mg of
Amlodipine.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
BTCAMLODIPINE 5 MG TABLET:
White to off white, circular biconvex, uncoated tablets debossed with
‘E21’ on one side and
score line on the other side.
BTC AMLODIPINE 10 MG TABLET:
White to off white, round, biconvex, uncoated tablets with ‘10’
debossing on one 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.>
4.2
DOSE AND METHOD OF ADMINISTRATION
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 14 days so that the physician can fully assess the
patient's response to
each dose level. Titration may proceed more rapidly, however, if
clinically warranted,
provided the patient is assessed frequently. See section4.8 ADVERSE
EFFECTS (UNDESIRA