AMLODIPINE-GA amlodipine 10 mg (as besilate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.868 mg (Equivalent: amlodipine, Qty 10 mg)

Available from:

Medis Pharma Pty Ltd

INN (International Name):

amlodipine besilate

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hypertension: Amlodipine-GA 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. Angina: Amlodipine-GA tablets are indicated for the first line treatment of chronic stable angina. Amlodipine-GA may be used alone, as monotherapy or in combination with other antianginal drugs.

Product summary:

Visual Identification: white to off-white, elongated octagonal, flat-faced, bevelled edge, uncoated tablet debossed with '10' on one side and breakline on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-02-15

Patient Information leaflet

_Consumer Medicine Information _
AMLODIPINE-GA CMI v3 080910 Page 1 of 10
AMLODIPINE-GA TABLETS
AMLODIPINE
BESILATE
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Amlodipine-GA
tablets.
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 Amlodipine-
GA 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 AMLODIPINE-GA TABLETS ARE USED FOR
Amlodipine-GA tablets are 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.
Amlodipine-GA tablets belong 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.
_Consumer Medicine Information _
AMLODIPINE-GA CMI v3 080910 Page 2 of 10
Amlodipine-GA tablets are also used to 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.
Amlodipine-GA tablets are not for the relief of a sudden attack of
angina. Your doctor will have
given you other medication to treat this.
Your doctor may have prescribed Amlodipine-GA tablets for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AMLODIPINE-GA
TABLETS HAVE BEEN
PRESCRIBED FOR YOU.
This medi

Summary of Product characteristics

PRODUCT INFORMATION
AMLODIPINE – GA TABLETS
NAME OF THE MEDICINE:
AMLODIPINE BESILATE.
Amlodipine besilate is a dihydropyridine derivative, and has the
following chemical name:
3-Ethyl 5-methyl (4_RS_)-2-[(2-aminoethoxy)
methyl]-4-(2-chlorophenyl)-6-methyl-1, 4-dihydropyridine-3,
5-dicarboxylate
benzenesulphonate.
CAS NUMBER: 111470-99-6
DESCRIPTION:
Empirical formula: C
20
H
25
ClN
2
O
5
.C
6
H
6
O
3
S
Molecular weight of 567.1
Amlodipine besilate is a white crystalline powder and is freely
soluble in methanol slightly soluble in water, 2-propanol and
sparingly soluble in ethanol.
In addition to amlodipine besilate, each Amlodipine-GA tablet contains
the following inactive ingredients: cellulose
microcrystalline; calcium hydrogen phosphate anhydrous; sodium starch
glycollate (Type A); magnesium stearate.
ACTIONS:
Amlodipine
is
a
calcium
ion
influx
inhibitor
(slow
channel
blocker
or
calcium
ion
antagonist)
and
inhibits
the
transmembrane influx of calcium ions into cardiac and vascular smooth
muscle.
Experimental data suggest that amlodipine binds to both
dihydropyridine and nondihydropyridine binding sites. The
contractile processes of cardiac muscle and vascular smooth muscle are
dependent upon the movement of extracellular
calcium ions into these cells through specific ion channels.
Amlodipine inhibits calcium ion influx across cell membranes
selectively, with a greater effect on vascular smooth muscle cells
than on cardiac muscle cells. Negative inotropic effects
can be detected _ in vitro_ but such effects have not been seen in
intact animals at therapeutic doses. Serum calcium
concentration is not affected by amlodipine. Within the physiologic pH
range, amlodipine is an ionized compound
Product Information
_ _
Page 2 of 11
Amlodipine-GA v3 PI 080715
(pKa=8.6), and its kinetic interaction with the calcium channel
receptor is characterized by a gradual rate of association
and dissociation with the receptor binding site, resulting in a
gradual onset of effect.
Amlodipine is a peripheral arterial vasodilator t