TELMISARTAN/HCT SANDOZ 80mg/12.5mg telmisartan 80mg / hydrochlorothiazide 12.5mg blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

telmisartan, Quantity: 80 mg; hydrochlorothiazide, Quantity: 12.5 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Hydrochlorothiazide,Telmisartan

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose; povidone; citric acid monohydrate; sodium hydroxide; macrogol poly(vinyl alcohol) grafted polymer; magnesium stearate; meglumine; colloidal anhydrous silica; lactose monohydrate; crospovidone

Administration route:

Oral

Units in package:

7, 14, 28, 56 and 98 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Telmisartan/HCT Sandoz? is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.

Product summary:

Visual Identification: White to white off, oval, biconvex film-coated tablet debossed with 80 on one side and with 12.5 on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-01-31

Patient Information leaflet

TELMISARTAN/HCT SANDOZ
®
1
TELMISARTAN/HCT
SANDOZ
® TABLETS
_Telmisartan and Hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Telmisartan/HCT
Sandoz.
It does not contain all available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking this medicine
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
TELMISARTAN/HCT
SANDOZ IS USED
FOR
This medicine is used to lower high
blood pressure (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 (high blood pressure)
when your blood pressure stays
higher than is needed, 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. If high
blood pressure is not treated, it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
_HOW TELMISARTAN/HCT _
_SANDOZ WORKS _
This medicine contains the active
ingredients telmisartan and
hydrochlorothiazide. These two
active ingredients help to reduce
blood pressure in different ways:
•
Telmisartan belongs to a group of
medicines called angiotensin II
receptor antagonists. Angiotensin
II is a substance in the body
which causes blood vessels to
narrow, thus increasing blood
pressure. Telmisartan works by
blocking the effect of angiotensin
II. When the effect of angiotensin
II is blocked, your blood vessels
relax and your blood pressure
goes down.
•
Hydrochlorothiazide belongs to
the group of medicines called
diuretics. Diuretics help to reduce
the amount of exc

Summary of Product characteristics

220930-Telmisartan/HCT Sandoz-pi
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
TELMISARTAN/HCT SANDOZ
® (TELMISARTAN
HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Telmisartan/Hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Telmisartan/HCT Sandoz
®
40 mg/12.5 mg tablet contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide
.
Each Telmisartan/HCT Sandoz
®
80 mg/12.5 mg tablet contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide
.
Each Telmisartan/HCT Sandoz
®
80 mg/25 mg tablet contains 80 mg telmisartan and 25 mg
hydrochlorothiazide
.
_List of excipients with known effect:_
Sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Telmisartan/HCT Sandoz
®
40 mg/12.5 mg tablet - red, oval, biconvex film-coated tablet
debossed with 40 on one side and with 12.5 on the other side
Telmisartan/HCT Sandoz
®
80 mg/12.5 mg tablet - white to white off, oval, biconvex film-
coated tablet debossed with 80 on one side and with 12.5 on the other
side
Telmisartan/HCT Sandoz
®
80 mg/25 mg tablet - yellow, oval, biconvex film-coated tablet
debossed with 80 on one side and with 25 on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Telmisartan/HCT Sandoz is indicated for the treatment of hypertension.
Treatment should not
be initiated with these combinations.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_Adults_
The recommended dose is one tablet once daily.
The dose of telmisartan can be increased before switching to
Telmisartan/HCT Sandoz. Direct
change from monotherapy to the fixed combinations may be considered.
Telmisartan/HCT Sandoz 40/12.5 mg may be administered in patients
whose blood pressure is
not adequately controlled by telmisartan 40 mg or hydrochlorothiazide.
Telmisartan/HCT Sandoz 80/12.5 mg may be administered in patients
whose blood pressure is
not adequately controlled by Telmisartan 80 mg or by Telmisartan/HCT
Sandoz 40/12.5 mg.
220930-Telmisartan/HCT Sandoz-pi
Page 2 of 25
Telmisartan/HCT Sandoz 80/2