TELMISARTAN SANDOZ telmisartan 40mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

telmisartan, Quantity: 40 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Telmisartan

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium hydroxide; meglumine; lactose; magnesium stearate; povidone; lactose monohydrate; crospovidone

Administration route:

Oral

Units in package:

7, 28, 56, and 98 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Telmisartan Sandoz is indicated for treatment of hypertension, prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage.

Product summary:

Visual Identification: white, oblong, plain tablet scored on one side and debossed with 40 on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-07-01

Patient Information leaflet

TELMISARTAN SANDOZ
®
1
TELMISARTAN
SANDOZ
®
_Telmisartan Tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Telmisartan
Sandoz
®
.
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 this medicine
against the benefits they expect it
will 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 TELMISARTAN
SANDOZ
® IS USED
FOR
This medicine is used to:
•
treat high blood pressure (also
called hypertension)
•
prevent cardiovascular
complications, including death
due to cardiovascular causes, in
patients older than 55 years of
age with coronary artery disease,
peripheral vascular disease,
previous stroke, previous
transient ischaemic attack (TIA)
or high risk diabetes with
evidence of end organ damage.
TREATMENT OF HYPERTENSION:
Telmisartan Sandoz
®
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 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. If high
blood pressure is not treated, it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
_HOW TELMISARTAN SANDOZ _
_WORKS _
It contains the active ingredient,
telmisartan which belongs to a group
of medicines called angiotensin II
receptor antagonist. It works by
blocking the effect of angiotensin II.
When the effect of angiotensin II is
blocked, your blood vessels relax and
yo

Summary of Product characteristics

220928-Telmisartan Sandoz-pi
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
TELMISARTAN SANDOZ
® (TELMISARTAN) TABLETS
1
NAME OF THE MEDICINE
telmisartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Telmisartan Sandoz
®
40 mg tablet contains 40 mg telmisartan.
Each Telmisartan Sandoz
®
80 mg tablet contains 80 mg telmisartan.
Excipients with known effect: Sugars as lactose
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Telmisartan Sandoz® 40 mg tablets - white, oblong, plain tablet
scored on one side and
debossed with 40 on the other side.
Telmisartan Sandoz® 80 mg tablets - white, oblong, plain tablet
scored on one side and
debossed with 80 on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Telmisartan Sandoz
®
is indicated for:
•
Treatment of hypertension
•
Prevention of cardiovascular morbidity and mortality in patients 55
years or older with
coronary artery disease, peripheral artery disease, previous stroke,
transient ischaemic
attack or high risk diabetes with evidence of end organ damage (see
Section 5
Pharmacological properties/ Clinical trials)
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_TREATMENT OF HYPERTENSION _
_Adults_
The recommended dose is 40 mg once daily. In cases where the target
blood pressure is not
achieved, telmisartan dose can be increased to 80 mg once daily. When
considering raising the
dose, it must be borne in mind that, while reduction in blood pressure
is achieved after the first
dose, the maximum antihypertensive effect is generally attained four
to eight weeks after the
start of treatment. Telmisartan may be used in combination with
thiazide-type diuretics such as
hydrochlorothiazide or calcium-channel blockers such as amlodipine,
which has been shown
to have an additive blood pressure lowering effect with telmisartan.
220928-Telmisartan Sandoz-pi
Page 2 of 22
_PREVENTION OF CARDIOVASCULAR MORBIDITY AND MORTALITY _
The recommended dose is 80 mg once daily. It is not known whether
doses lower than 80 mg
of