IRBESARTAN SANDOZ irbesartan 75mg film coated tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

irbesartan, Quantity: 75 mg

Доступна с:

Sandoz Pty Ltd

ИНН (Международная Имя):

Irbesartan

Фармацевтическая форма:

Tablet, film coated

состав:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate; purified talc; hyprolose; hypromellose; magnesium stearate; macrogol 6000; croscarmellose sodium; titanium dioxide

Администрация маршрут:

Oral

Штук в упаковке:

30

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

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

Обзор продуктов:

Visual Identification: White, oval biconvex film-coated tablets, marked 75 on one side and scored on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизация:

Registered

Дата Авторизация:

2011-10-28

тонкая брошюра

Irbesartan Sandoz® Tablets
1
IRBESARTAN SANDOZ® TABLETS
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 SANDOZ?
Irbesartan Sandoz contains the active ingredient irbesartan.
Irbesartan Sandoz 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 Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE IRBESARTAN SANDOZ?
Do not use if you have ever had an allergic reaction to Irbesartan
Sandoz 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 Sandoz?
in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Irbesartan Sandoz 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 SANDOZ?
•
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 tablet whole with a glass of water and take Irbesartan
Sandoz at about the same time each day.
More instructions can be found in Section 4. How do I take Irbesartan
Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING IRBESARTAN SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Irbesartan Sandoz.
•
If you become pregnant or plan to breastfeed while taking Irbesartan
Sandoz tell your doctor immediately.
•
If you are about to be started on any new medicine, tell your doctor
and pharmacist you are taking
Irbesartan Sando

Характеристики продукта

210226-Irbesartan Sandoz-pi
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
IRBESARTAN SANDOZ
® (IRBESARTAN) TABLETS
1
NAME OF THE MEDICINE
Irbesartan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Irbesartan Sandoz 75 mg tablets contain 75 mg irbesartan.
Irbesartan Sandoz 150 mg tablets contain 150 mg irbesartan.
Irbesartan Sandoz 300 mg tablets contain 300 mg irbesartan.
_Excipients with known effect:_
lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Irbesartan Sandoz 75 mg - white, oval biconvex film-coated tablets,
marked “75” on one side
and scored on the other side.
Irbesartan Sandoz 150 mg - white, oval biconvex film-coated tablets,
marked “150” on one
side and scored on the other side.
Irbesartan Sandoz 300 mg - white, oval biconvex film-coated tablets,
marked “300” on one
side and scored on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Irbesartan Sandoz is indicated for the treatment of hypertension.
Irbesartan Sandoz is 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
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Irbesartan may be used either alone or in combination with other
antihypertensive agents (e.g.,
thiazide diuretic, beta-adrenergic blocking agent, long-acting
calcium-channel blocking agent).
The usual initial and maintenance dose of Irbesartan Sandoz is 150 mg
once daily. 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 Sandoz
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 requirement for