NOUMED TELMISARTAN telmisartan 80 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

telmisartan, Quantity: 80 mg

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

7, 28, 56, and 98 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NOUMED TELMISARTAN 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 CLINICAL TRIALS)

Product summary:

Visual Identification: white to yellow, oblong, plain tablet scored on one side and debossed with 80 on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-02-28

Patient Information leaflet

NOUMED TELMISARTAN
1
NOUMED TELMISARTAN
_telmisartan tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
TELMISARTAN.
It does not contain all of 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 taking this medicine
against the benefits it is expected to
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 NOUMED
TELMISARTAN IS
USED FOR
NOUMED TELMISARTAN tablets
contain the active ingredient
telmisartan, which belongs to a group
of medicines called angiotensin II
receptor antagonists or blockers
(‘sartans’ or ARBs) that help relax
blood vessels.
It is used to:
•
lower high blood pressure (also
called hypertension),
•
prevent cardiovascular
complications (including death)
in elderly patients 55 years or
older with certain related
conditions.
HYPERTENSION
Everyone alive has blood pressure.
As your heart contracts and relaxes to
pump blood into the arteries
providing needed oxygen and
nutrients around your body, the
pressure goes from high (systolic) to
low (diastolic) with each heartbeat.
Your blood pressure may vary at
different times of the day, depending
on how busy, worried or relaxed you
are. It may also change as you grow
older, and the condition of your
heart, arteries and health changes.
There are usually no signs of
hypertension. After regularly
checking your blood pressure, your
doctor may diagnose hypertension if
your blood pressure stays higher than
normal, even when you are calm or
relaxed.
Uncontrolled hypertension can lead
to serious health problems, including
stroke, heart disease and kidney
failure. Telmisartan helps lower
blood pressure either alone or with
other medicines.
CARDIOVASCULAR COMPLICATIONS
Heart attack, stroke, diseases of the
heart muscle and arteries, heart
failure, death

Summary of Product characteristics

Product Information - Australia
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION -
NOUMED TELMISARTAN
(TELMISARTAN 40 MG & 80 MG TABLETS)
1. NAME OF THE MEDICINE
Telmisartan
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NOUMED TELMISARTAN tablet contains either 40 mg or 80 mg of the
active ingredient telmisartan.
Excipients with known effect: sugars (as lactose). For the full list
of excipients, see SECTION 6.1 LIST OF
EXCIPIENTS.
3. PHARMACEUTICAL FORM
NOUMED TELMISARTAN 40mg tablets are white, oblong, plain tablets,
scored on one side and debossed
with 40 on the other side.
NOUMED TELMISARTAN 80mg tablets are white, oblong, plain tablets,
scored on one side and debossed
with 80 on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NOUMED TELMISARTAN 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 5.1
PHARMACODYNAMIC PROPERTIES: CLINICAL
TRIALS).
4.2 DOSE 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.
Telmisartan may be used in combination
with thiazide-type diuretics such as hydrochlorothiazide which has
been shown to have an additive blood
pressure lowering effect with telmisartan. 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.
Product Information - Australia
Page 2 of 19
_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
telmisartan are effective in preventing cardiovascular mo