Telmisartan/Amlodipine GENPAR 40/10 telmisartan/amlodipine (as besilate) 40/10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.87 mg; telmisartan, Quantity: 40 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

amlodipine besilate,Telmisartan

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium hydroxide; meglumine; povidone; magnesium stearate; citric acid; mannitol; Colour

Administration route:

Oral

Units in package:

28, 14, 30, 98, 56, 7 (sample pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Product summary:

Visual Identification: Oblong uncoated bilayered tablets white to off-white, debossed with C7 on one side and blue plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-06-16

Summary of Product characteristics

Telmisartan/Amlodipine GENPAR
1
TELMISARTAN/AMLODIPINE GENPAR
(TELMISARTAN/AMLODIPINE)
NAME OF THE MEDICINE
Telmisartan/Amlodipine GENPAR contains the active ingredients
telmisartan and amlodipine (as
the besilate salt).
DESCRIPTION
Telmisartan is white or slightly yellowish crystalline powder. It is
practically insoluble in water, ,
slightly soluble in methanol and sparingly soluble in methylene
chloride and dissolves in 1M
sodium hydroxide
Amlodipine besilate is a white or almost white crystalline powder that
is slightly soluble in
water, freely soluble in methanol, sparingly soluble in anhydrous
ethanol and slightly soluble in
2-propanol.
Telmisartan/Amlodipine GENPAR is available in four tablet strengths
for oral administration,
containing 40 mg or 80 mg telmisartan and 5 mg or 10 mg amlodipine (as
the besilate salt), in
the following combinations:
•
Telmisartan/Amlodipine GENPAR 40/5 mg containing telmisartan 40
mg/amlodipine 5
mg
•
Telmisartan/Amlodipine GENPAR 40/10 mg containing telmisartan 40
mg/amlodipine 10
mg
•
Telmisartan/Amlodipine GENPAR 80/5 mg containing telmisartan 80
mg/amlodipine 5
mg
•
Telmisartan/Amlodipine GENPAR 80/10 mg containing telmisartan 80
mg/amlodipine 10
mg
Excipients:
Each
Telmisartan/Amlodipine
GENPAR
tablet
also
contains
mannitol,
povidone,sodium hydroxide, meglumine, citric acid, magnesium stearate,
Neelilake Brilliant
Telmisartan/Amlodipine GENPAR
2
Blue Lake (ARTG ID 111399) as colouring agent.
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: angiotensin II antagonists, plain
(telmisartan) combinations with
dihydropyridine derivatives (amlodipine).
Mechanism of action
Telmisartan/Amlodipine Tablets combines two antihypertensive compounds
with complementary
mechanisms to control blood pressure in patients with essential
hypertension: an angiotensin II
receptor antagonist, telmisartan, and a dihydropyridinic calcium
channel blocker, amlodipine.
The combination of these substances has an additive antihypertensive
effect, reducing blood
pressure to a greater degr