AMLO 10 amlodipine 10 mg (as besilate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.867 mg (Equivalent: amlodipine, Qty 10 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

amlodipine besilate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: mannitol; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension: AMLO 10 tablets are 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 adrenoreceptor blocking agent or an angiotensin-converting enzyme inhibitor. Angina: AMLO 10 tablets are indicated for the first line treatment of chronic stable angina. AMLO 10 tablets may be used alone, as monotherapy or in combination with other antianginal drugs.

Product summary:

Visual Identification: white to off-white, octagonal shaped, debossed with "AM 10" on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-10-22

Patient Information leaflet

AMLO
Contains the active ingredient amlodipine (besilate)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AMLO.
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 AMLO 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 need to read it again.
WHAT AMLO IS USED
FOR
AMLO 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.
AMLO is not for the relief of a sudden
attack of angina. Your doctor will give
you other medication to treat this.
_HOW IT WORKS_
AMLO 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.
Your doctor may have prescribed
Amlodipine for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AMLO HAS
BEEN PRESCRIBED FOR YOU.
This medicine is only available 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 AMLO
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AMLO IF:
•
you have ever had an allergic
reaction to amlodip

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – AMLO (AMLODIPINE
BESILATE) UNCOATED TABLETS
1
NAME OF THE MEDICINE
Amlodipine besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMLO contains the active ingredient Amlodipine besilate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AMLO tablets are available in two strengths.
•
5 mg tablets- White to off-white, octagonal shaped, uncoated tablets,
debossed with “AM 5”
on one side and scoreline on the other side containing 5 mg of
amlodipine (as besilate)
•
10 mg tablets - White to off-white, octagonal shaped uncoated tablets,
debossed with “AM
10” on one side and plain on the other side containing 10 mg of
amlodipine (as besilate)
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
1.
_Hypertension: _AMLO tablets are 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: _AMLO tablets are indicated for the first line treatment of
chronic stable angina.
AMLO tablets may be used alone, as monotherapy or in combination with
other antianginal
drugs.
4.2
D
OSE 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 tablets to
other antihypertensive
therapy.
AMLO 5 mg tablets can be divided in half along the scoreline if your
doctor has prescribed a 2.5 mg
dose.
Dosage should be adjusted according to each patient's need. In
general, titration should proceed
over 7 to 14