IRBESARTAN/HCT SANDOZ 150/12.5 irbesartan 150 mg/hydrochlorothiazide 12.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 12.5 mg; irbesartan, Quantity: 150 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Hydrochlorothiazide,Irbesartan

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Irbesartan/HCT Sandoz is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Product summary:

Visual Identification: Apricot, oval biconvex film-coated tablet, debossed with 150H on one 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

Authorization status:

Registered

Authorization date:

2011-10-28

Patient Information leaflet

Irbesartan/HCT Sandoz® Tablets
1
IRBESARTAN/HCT 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/HCT SANDOZ?
Irbesartan/HCT Sandoz contains the active ingredient irbesartan and
hydrochlorothiazide. Irbesartan/HCT Sandoz is used to
treat high blood pressure, which doctors call hypertension. For more
information, see Section
1. Why am I taking
Irbesartan/HCT Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE IRBESARTAN/HCT SANDOZ?
Do not use if you have ever had an allergic reaction to Irbesartan/HCT
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/HCT
Sandoz? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Irbesartan/HCT 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/HCT SANDOZ?
•
Your doctor will tell you how many tablets to take each day. The usual
dose is one tablet per day.
•
Swallow the table whole with a glass of water and take Irbesartan/HCT
Sandoz at about the same time each day.
More instructions can be found in Section 4. How do I take
Irbesartan/HCT Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING IRBESARTAN/HCT SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Irbesartan/HCT Sandoz.
•
If you become pregnant while taking Irbesartan/HCT Sandoz tell your
doctor immediately.
•
Before being started on any new medicine, tell your doctor and
pharmacist you are taking
Irbesartan/HCT Sandoz.
•
If you plan to have surgery that needs a general anaesthetic, tell
your

Summary of Product characteristics

210830-irbesartan/hct-sandoz-pi
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
IRBESARTAN/HCT SANDOZ
® (IRBESARTAN
/HYDROCHLOROTHIAZIDE)
1
NAME OF THE MEDICINE
Irbesartan/Hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Irbesartan/HCT Sandoz 150 mg/12.5 mg film-coated tablets contain 150
mg irbesartan and
12.5 mg hydrochlorothiazide.
Irbesartan/HCT Sandoz 300 mg/12.5 mg film-coated tablets contain 300
mg irbesartan and
12.5 mg hydrochlorothiazide.
Irbesartan/HCT Sandoz 300 mg/25 mg film-coated tablets contain 300 mg
irbesartan and 25
mg hydrochlorothiazide.
_Not all strengths may be marketed in Australia. _
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Irbesartan/HCT Sandoz 150 mg/12.5 mg film-coated tablets are apricot,
oval biconvex film-
coated tablets, debossed with “150 H” on one side.
Irbesartan/HCT Sandoz 300 mg/12.5 mg film-coated tablets are apricot,
oval biconvex film-
coated tablets, debossed with “300 H” on one side.
Irbesartan/HCT Sandoz 300 mg/25 mg film-coated tablets are dark pink,
oval biconvex film-
coated tablets, debossed with “300” on one side and “25 H” on
the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Irbesartan/HCT Sandoz is indicated for the treatment of hypertension.
Treatment should not be
initiated with this fixed-dose combination.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Irbesartan/HCT Sandoz should not be initiated as first-line therapy.
The daily dose can be
administered with or without food.
_REPLACEMENT THERAPY _
The combination may be substituted for the titrated components at the
same dose level.
_DOSE TITRATION BY CLINICAL EFFECT _
When clinically appropriate, direct change from monotherapy to the
fixed combinations may
be considered:
210830-irbesartan/hct-sandoz-pi
Page 2 of 21
•
Irbesartan/HCT Sandoz 150 mg/12.5 mg may be administered to patients
whose blood
pressure is not adequately controlled with hydrochlorothiazide or
irbesarta