IRBESARTAN GH irbesartan 150mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

irbesartan, Quantity: 150 mg

Disponible des:

Lupin Australia Pty Limited

Designació comuna internacional (DCI):

Irbesartan

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: mannitol; crospovidone; povidone; sodium lauryl sulfate; colloidal anhydrous silica; magnesium stearate; purified water; titanium dioxide; hypromellose; macrogol 400

Vía de administración:

Oral

Unidades en paquete:

30 Tablets (2 x 15 tablets), 98 Tablets (7 x 14 tablets), 56 Tablets (4 x 14 tablets), 28 Tablets (2 x 14 tablets), 14 Tablets (1 x 14 tablets)

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

For the treatment of hypertension. For delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (equal to or greater than 30mg per 24 hours) or urinary protein in excess of 900mg per 24 hours.

Resumen del producto:

Visual Identification: White to off-white oval shaped film coated tablets plain on one-side and 'I2' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

2013-07-24

Informació per a l'usuari

Irbesartan GH v4.0
1
IRBESARTAN GH
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING IRBESARTAN GH?
Irbesartan GH contains the active ingredient irbesartan. Irbesartan GH
is used to treat high blood pressure and is also used in
the treatment of kidney disease in patients with high blood pressure
and type 2 diabetes. For more information, see Section 1.
Why am I taking Irbesartan GH? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE IRBESARTAN GH?
Do not use if you have ever had an allergic reaction to Irbesartan GH
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I take Irbesartan GH? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Irbesartan GH and affect how it
works. A list of these medicines is in Section 3. What if I
am taking other medicines? in the full CMI.
4.
HOW DO I TAKE IRBESARTAN GH?
•
Your doctor will tell you how many tablets to take each day. The
standard dose is one 150 mg tablet per day. This dose
may be increased to a 300 mg once per day.
•
Swallow the table whole with a glass of water and take Irbesartan GH
at about the same time each day.
More instructions can be found in Section 4. How do I take Irbesartan
GH? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING IRBESARTAN GH?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are taking Irbesartan
GH.
•
If you become pregnant or plan to breastfeed while taking Irbesartan
GH tell your doctor immediately.
•
If you are to be started on any new medicine, tell your doctor and
pharmacist you are taking
Irbesartan GH.
•
If you plan to have surgery that needs a general anaesthetic, tell
your doctor or dentist that

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION – IRBESARTAN GH
(IRBESARTAN) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Irbesartan.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg, 150 mg or 300 mg irbesartan.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Irbesartan GH 75 mg tablets are white to off-white, oval shaped,
film-coated tablets plain on one side
and ‘I1’ on the other side.
Irbesartan GH 150 mg tablets are white to off-white, oval shaped,
film-coated tablets plain on one side
and ‘I2’ on the other side.
Irbesartan GH 300 mg tablets are white to off-white, oval shaped,
film-coated tablets plain on one side
and ‘I3’ on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan GH tablets are indicated for the treatment of hypertension.
Irbesartan GH tablets are indicated for delaying the progression of
renal disease in hypertensive type II
diabetics with persistent micro-albuminuria (≥30 mg per 24 hours) or
urinary protein in excess of 900 mg
per 24 hours.
4.2 DOSE AND METHOD OF ADMINISTRATION
Irbesartan may be used either alone or in combination with other
antihypertensive agents (eg. thiazide
diuretic, beta-adrenergic blocking agent, long-acting calcium-channel
blocking agent).
The usual initial and maintenance dose of Irbesartan GH is 150 mg once
daily. Irbesartan GH may be
administered with or without food. Therapy should be adjusted
according to blood pressure response.
Patients requiring further reduction in blood pressure should have the
dose increased to 300 mg once
daily.
In patients with hypertension and type II diabetic renal disease, 300
mg of Irbesartan GH once daily is
the preferred maintenance dose. Although irbesartan slowed the
progression of renal disease in
hypertensive patients separately to its effect on blood pressure, this
does not remove the clinical
Irbesartan GH v5
Page 2 of 16
(irbesartan) film-coated tablet
requirement for a patient’s blood pressure to be adequately
controlled. If irbesartan a