TN-AMLODIPINE amlodipine besylate 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

GM Pharma International Pty Ltd

INN (International Name):

amlodipine besilate

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2017-04-13

Patient Information leaflet

1
TN‐AMLODIPINE TABLETS 5 MG, 10 MG
TN-AMLODIPINE TABLETS 5 MG, 10 MG
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Amlodipine
besylate.
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
besylate against the benefits it is
expected to 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 THIS MEDICINE IS
USED FOR
The name of your medicine TN-
AMLODIPINE tablets. It contains
the active ingredient amlodipine
besylate.
_WHAT IT DOES_
This is used to:
•
lower high blood pressure
(hypertension).
There are usually no symptoms of
This medicine is not for the relief of
a sudden attack of angina. Your
doctor will give you other
medication to treat this.
_HOW IT WORKS_
This medicine 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 THIS MEDICINE
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.
ingredient felodipine, nifedipine
or lercanidipine.
Check with your doctor or
pharmacist if you are unsure.
•
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
or other parts of the body
•
rash

Summary of Product characteristics

Page 1
Product Information
TN-AMLODIPINE TABLETS 5 MG AND 10 MG
TN-AMLODIPINE TABLETS 5 MG, 10 MG
NAME OF THE MEDICINE
Amlodipine Tablets 5 mg and 10 mg.
Amlodipine Tablets contains the active ingredient amlodipine besilate.
Amlodipine
besylate is a dihydropyridine derivative and has the following
structural formula:
SO
3
H
H
3
CO
2
C
H
3
C
N
H
Cl
CO
2
CH
2
CH
3
CH
2
OCH
2
CH
2
NH
2
Chemical name:
3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-
dihydro-6-methyl-3,5-pyridinedicarboxylate benzene sulphonate
Molecular formula:
C
20
H
25
ClN
2
O
5.
C
6
H
6
O
3
S
Molecular weight:
567.1 (free base 408.9)
CAS registry numbers: amlodipine 88150-42-9; amlodipine besylate
111470-99-6.
DESCRIPTION
Amlodipine besylate is a white crystalline powder, and is slightly
soluble in water and
sparingly soluble in ethanol.
In
addition
to
amlodipine
besylate,
each
Amlodipine
Tablets
contains
the
following
inactive ingredients: microcrystalline cellulose; calcium hydrogen
phosphate; sodium starch
glycollate; Silica-colloidal anhydrous, magnesium stearate.
PHARMACOLOGY
PHARMACODYNAMICS
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