NORDIP amlodipine (as besilate) 5mg tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg)

Διαθέσιμο από:

Alphapharm Pty Ltd

INN (Διεθνής Όνομα):

amlodipine besilate

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

Excipient Ingredients: magnesium stearate; sodium starch glycollate type A; microcrystalline cellulose; pregelatinised maize starch

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

28, 30, 14

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Visual Identification: White to off-white, round tablet with "AB" over scoreline over "5"on one side and "G" on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/PE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2007-11-30

Φύλλο οδηγιών χρήσης

NORDIP
®
_contains the active ingredient amlodipine besilate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nordip.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Nordip against the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NORDIP IS USED
FOR
_WHAT IT DOES_
Nordip 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.
Nordip is not for the relief of a
sudden attack of angina. Your doctor
will give you other medication to
treat this.
_HOW IT WORKS_
Nordip 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 NORDIP 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
in children.
BEFORE YOU TAKE
NORDIP
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NORDIP IF YOU HAVE AN
ALLERGY TO:
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Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
NORDIP
_Amlodipine besilate _
1
NAME OF THE MEDICINE
Amlodipine besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nordip tablet contains 5 mg or 10 mg of amlodipine (as besilate)
as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Nordip 5 mg
:
White to off-white, round tablet with “AB” over scoreline over
“5” on one side and
“G” on the other.
Nordip 10 mg
:
White to off-white, round tablet with “AB” over scoreline over
“10” on one side and
“G” on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1) HYPERTENSION
Nordip 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 Nordip, which has been used in
combination with a thiazide diuretic,
beta adrenoceptor blocking agent or an angiotensin-converting enzyme
inhibitor.
2) ANGINA
Nordip is indicated for the first line treatment of chronic stable
angina. Nordip 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.
METHOD OF ADMINISTRATION
Nordip is for oral administration.
DOSAGE ADJUSTMENT
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 Nordip 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