AVAPRO HCT 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg 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:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Hydrochlorothiazide,Irbesartan

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: Carnauba Wax; lactose monohydrate; magnesium stearate; hypromellose; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; iron oxide yellow; iron oxide red; macrogol 3000

Administration route:

Oral

Units in package:

14, 98, 5, 56, 3, 7, 28, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Peach coloured, biconvex, film-coated, oval tablet with heart shape debossed on one side and '2875' engraved 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

Authorization status:

Licence status A

Authorization date:

2005-05-18

Patient Information leaflet

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING AVAPRO HCT?
Avapro HCT contains the active ingredients irbesartan and
hydrochlorothiazide. Avapro HCT is used to treat high blood pressure,
which doctors call hypertension. For more information, see Section 1.
Why am I taking Avapro HCT? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE AVAPRO HCT?
Do not take if you have ever had an allergic reaction to Avapro HCT 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 Avapro HCT? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Avapro HCT 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 AVAPRO HCT?
•
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 Avapro HCT at
about the same time each day.
More instructions can be found in Section 4. How do I take Avapro HCT?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING AVAPRO HCT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Avapro HCT.
•
If you become pregnant while taking Avapro HCT tell your doctor
immediately
•
Before being started on any new medicine, tell your doctor and
pharmacist you are taking Avapro HCT
•
If you plan to have surgery that needs a general anaesthetic, tell
your doctor or dentist that you are taking
Avapro HCT
•
Make sure you drink enough water during exercise and hot weather when
you are taking Avapro HCT
•
If you have excessiv

Summary of Product characteristics

avapro-hct-ccdsv17-piv15-29jan21
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
AVAPRO HCT (IRBESARTAN/HYDROCHLOROTHIAZIDE)
1
NAME OF THE MEDICINE
Irbesartan/hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Avapro HCT 150/12.5 tablets contain 150 mg of irbesartan and 12.5 mg
of
hydrochlorothiazide.
Avapro HCT 300/12.5 tablets contain 300 mg of irbesartan and 12.5 mg
of
hydrochlorothiazide.
Avapro HCT 300/25 tablets contain 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Avapro HCT 150/12.5 tablets are peach to mottled peach coloured,
biconvex, oval-shaped,
film-coated tablets debossed with a heart on one side and the number
“2875” on the other
side.
Avapro HCT 300/12.5 tablets are peach to mottled peach coloured,
biconvex, oval-shaped,
film-coated tablets debossed with a heart on one side and the number
“2876” on the other
side.
Avapro HCT 300/25 tablets are pink, biconvex, oval-shaped, film-coated
tablets debossed
with a heart on one side and the number “2788” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avapro HCT is indicated for the treatment of hypertension. Treatment
should not be initiated
with this fixed-dose combination.
avapro-hct-ccdsv17-piv15-29jan21
Page 2 of 23
4.2
DOSE AND METHOD OF ADMINISTRATION
Avapro HCT 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:
•
Avapro HCT 150/12.5 mg may be administered to patients whose blood
pressure is
not adequately controlled with hydrochlorothiazide or irbesartan 150
mg alone.
•
Avapro HCT 300/12.5 mg may be administered to patients insufficiently
controlled
by irbesart