KARVEZIDE 300/25 irbesartan 300mg and hydrochlorothiazide 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irbesartan, Quantity: 300 mg; hydrochlorothiazide, Quantity: 25 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Hydrochlorothiazide,Irbesartan

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: iron oxide red; iron oxide yellow; croscarmellose sodium; silicon dioxide; Carnauba Wax; lactose monohydrate; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Pink, biconvex, film-coated, oval shaped tablet, engraved with "2788" on one side and debossed with a heart shape 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:

Registered

Authorization date:

2007-04-18

Patient Information leaflet

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

Summary of Product characteristics

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Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
KARVEZIDE
® (IRBESARTAN/HYDROCHLOROTHIAZIDE)
1
NAME OF THE MEDICINE
Irbesartan/hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Karvezide 150/12.5 tablets contain 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Karvezide 300/12.5 tablets contain 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Karvezide 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
Karvezide 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.
Karvezide 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.
Karvezide 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
Karvezide is indicated for the treatment of hypertension. Treatment
should not be initiated
with this fixed dose combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
Karvezide should not be initiated as first-line therapy. The daily
dose can be administered with
or without food.
karvezide-ccdsv17-piv20-29jan21
Page 2 of 22
REPLACEMENT THERAPY
The combination may be substituted for the titrated components.
DOSE TITRATION BY CLINICAL EFFECT
When clinically appropriate, direct change from monotherapy to the
fixed combinations may
be considered:
•
Karvezide 150/12.5 mg may be administered to patients whose blood
pressure is not
adequately controlled with hydrochlorothiazide or irbesartan 150 mg
alone.
•
Karvezide 300/12.5 mg may be administered to patients insufficiently
controlled by
irbesartan 300 mg or by Karvezide 150/1