APO-TELMISARTAN HCTZ 40/12.5mg telmisartan 40mg and hydrochlorothiazide 12.5mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
18-08-2022
Summary of Product characteristics
(SPC)
18-08-2022
Public Assessment Report
(PAR)
20-10-2017
Active ingredient:
telmisartan, Quantity: 40 mg; hydrochlorothiazide, Quantity: 12.5 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Hydrochlorothiazide,Telmisartan
Pharmaceutical form:
Tablet, multilayer
Composition:
Excipient Ingredients: sodium hydroxide; mannitol; povidone; lactose monohydrate; meglumine; magnesium stearate; sodium stearylfumarate; purified water; iron oxide red
Administration route:
Oral
Units in package:
28
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
APO TELMISARTAN HCTZ is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.
Product summary:
Visual Identification: Oblong biconvex bilayered uncoated tablets with one white/off white color layer and one pink colour mottled layer debossed with L199; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-04-08
Patient Information leaflet
APO-TELMISARTAN HCTZ
1
APO-TELMISARTAN/HCTZ
TABLETS
_Telmisartan and Hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 THIS MEDICINE IS
USED FOR
APO-Telmisartan HCTZ 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 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.
Untreated hypertension can lead to
serious health problems, including
stroke, heart disease and kidney
failure.
APO-Telmisartan HCTZ contains
both telmisartan and
hydrochlorothiazide (HCTZ) in one
single tablet. 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 excess fluid in the
body by in
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
APO-TELMISARTAN HCTZ (TELMISARTAN AND
HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Telmisartan and Hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains telmisartan and hydrochlorothiazide as the active
ingredients.
APO-TELMISARTAN HCTZ 40/12.5 MG:
Each tablet contains 40 mg of telmisartan and 12.5 mg of
hydrochlorothiazide.
APO-TELMISARTAN HCTZ 80/12.5 MG:
Each tablet contains 80 mg of telmisartan and 12.5 mg of
hydrochlorothiazide.
APO-TELMISARTAN HCTZ 80/25 MG:
Each tablet contains 80 mg of telmisartan and 25 mg of
hydrochlorothiazide.
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars as lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-TELMISARTAN HCTZ 40/12.5 MG:
Each tablet is a pink mottled and white to off-white biconvex, oval
shaped, two layer tablet.
The white to off-white layer may contain pink specks. The pink mottled
face of tablets are
marked with L199.
APO-TELMISARTAN HCTZ 80/12.5 MG:
Each tablet is a pink mottled and white to off-white biconvex, oval
shaped, two layer tablet.
The white to off-white layer may contain pink specks. The pink mottled
face of tablet is marked
with L200.
APO-TELMISARTAN HCTZ 80/25 MG:
Each tablet is a yellow mottled and white to off-white biconvex, oval
shaped, two layer tablet.
The white to off-white layer may contain yellow specks. The white face
of tablets are marked
with L201.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-Telmisartan HCTZ is indicated for the treatment of hypertension.
Treatment should not
be initiated with these combinations.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Telmisartan HCTZ is intended for oral administration.
DOSAGE
Adults: The recommended dose is one tablet once daily.
The dose of telmisartan can be increased before switching to
APO-Telmisartan HCTZ. Direct
change from monotherapy to the fixed combinations may be considered.
APO-Telmisartan HCTZ 40/12.5 mg may be administered in patients whose
blood pressure is
not a
Read the complete document
