TELMISARTAN HCT MYLAN 80/25 MG telmisartan 80mg/hydrochlorothiazide 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 25 mg; telmisartan, Quantity: 80 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Hydrochlorothiazide,Telmisartan

Pharmaceutical form:

Tablet, multilayer

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium hydroxide; maize starch; magnesium stearate; povidone; sodium starch glycollate type A; lactose monohydrate; meglumine; mannitol; iron oxide yellow

Administration route:

Oral

Units in package:

98, 28, 56, 7, 14

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TELMISARTAN HCT MYLAN is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.

Product summary:

Visual Identification: Yellow and white to off white, oblong shaped uncoated, biconvex, bilayered tablets debossed with 'TH3M' on one side and plain on the other side. The white to off white layer may occasionally contain yellow tinge/specks.; 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:

2014-01-08

Patient Information leaflet

TELMISARTAN HCT MYLAN
1
TELMISARTAN HCT
MYLAN TABLETS
_contains the active ingredients Telmisartan and Hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TELMISARTAN
HCT MYLAN. It does not contain all
available information.
It does not take the place of talking to
your doctor or pharmacist.
This leaflet was last updated on the
date at the end of this leaflet.
More recent information may be
available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS INFORMATION WITH YOUR
TELMISARTAN HCT MYLAN
TABLETS.
You may need to read it again later.
_TO FIND OUT MORE ABOUT _
_TELMISARTAN HCT MYLAN_
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT YOUR
MEDICINE IF YOU HAVE ANY CONCERNS
OR IF YOU HAVE ANY TROUBLE BEFORE,
DURING OR AFTER USING
TELMISARTAN HCT MYLAN.
WHAT TELMISARTAN
HCT MYLAN IS USED
FOR
TELMISARTAN HCT MYLAN
lowers high blood pressure, also
called hypertension.
Everyone has blood pressure. This
pressure helps your blood move
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension when your blood
pressure stays higher than normal,
even when you are calm or relaxed.
There are usually no signs of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. You may
feel fine and have no symptoms, but
if high blood pressure is not treated,
it can lead to serious health problems
(such as stroke, heart disease and
kidney failure).
TELMISARTAN HCT MYLAN
helps to lower your blood pressure
but does not cure hypertension.
TELMISARTAN HCT MYLAN
contains telmisartan and
hydrochlorothiazide. Both medicines
reduce blood pressure in different
ways. Telmisartan belongs to a group
of medicines called angiotensin II
recep

Summary of Product characteristics

Molecular formula
:
C
7
H
8
ClN
3
O
4
S
2
Molecular weight
:
297.7
CAS Registry no.
:
58-93-5
PRODUCT INFORMATION
MIZART
®
HCT
_ _
_Telmisartan and Hydrochlorothiazide Tablets_
NAME OF THE MEDICINE
Active ingredient
:
Telmisartan
Chemical name
:
4’-[[4-Methyl-6-(1-methyl-1
_H_
-benzimidazol-2-yl)-2-propyl-1
_H_
-benzimidazol-1-
yl]methyl]biphenyl-2-carboxylic acid
Structural formula
:
Molecular formula
:
C
33
H
30
N
4
O
2
Molecular weight
:
514.6
CAS Registry no.
:
144701-48-4
Active ingredient
:
Hydrochlorothiazide
Chemical name
:
6-Chloro-3,4-dihydro-2
_H_
-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide
Structural formula
:
MIZART
®
HCT contains the active ingredients telmisartan and
hydrochlorothiazide
MIZART
®
HCT is available in three tablet strengths:
MIZART
®
HCT 40/12.5 mg containing telmisartan 40 mg/hydrochlorothiazide 12.5
mg,
MIZART
®
HCT 80/12.5 mg containing telmisartan 80 mg/hydrochlorothiazide 12.5
mg, and
MIZART
®
HCT 80/25 mg containing telmisartan 80 mg/hydrochlorothiazide 25 mg.
MIZART
®
HCT – PRODUCT INFORMATION
2
DESCRIPTION
Telmisartan is a specific angiotensin II receptor (type AT
1
) antagonist. Telmisartan is a white or slightly
yellowish, crystalline powder. It is practically insoluble in water,
very slightly soluble in ethanol, slightly
soluble in methanol, soluble in a mixture of chloroform and methanol
(1:1) and it dissolves in 1M sodium
hydroxide.
Hydrochlorothiazide is a benzothiadiazine (thiazide) diuretic.
Hydrochlorothiazide is a white or almost white,
crystalline powder. It is very slightly soluble in water, soluble in
acetone, sparingly soluble in ethanol (96%). It
dissolves in dilute solutions of alkali hydroxides.
Telmisartan and hydrochlorothiazide tablets contain a combination of
40 mg of telmisartan and 12.5 mg of
hydrochlorothiazide or 80 mg of telmisartan and 12.5 mg or 25 mg of
hydrochlorothiazide. The excipients in
each
tablet
are
povidone,
lactose
monohydrate,
maize
starch,
magnesium
stearate,
meglumine,
microcrystalline cellulose, sodium hydroxide, sodi