APX-OLMESARTAN/HCTZ 40/12.5 olmesartan medoxomil and hydrochlorothiazide 40/12.5 mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

olmesartan medoxomil, Quantity: 40 mg; hydrochlorothiazide, Quantity: 12.5 mg

제공처:

Pharmacor Pty Ltd

약제 형태:

Tablet

구성:

Excipient Ingredients: hyprolose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; purified water; stearic acid; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red; macrogol 400

관리 경로:

Oral

패키지 단위:

10's, 30's

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Olmesartan medoxomil and Hydrochlorothiazide is indicated for:,Treatment of hypertension.,Treatment should not be initiated with this fixed dose combination.

제품 요약:

Visual Identification: Reddish-yellow coloured, oval shape film coated tablets debossed with A002 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Registered

승인 날짜:

2018-01-29

환자 정보 전단

_APX-OLMESARTAN/HCTZ Ver 04 1 _
APX-OLMESARTAN/HCTZ 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 USING APX-OLMESARTAN/HCTZ TABLETS?
APX-OLMESARTAN/HCTZ TABLETS contains the active ingredient Olmesartan
medoxomil and
hydrochlorothiazide. Olmesartan medoxomil and hydrochlorothiazide is
used to treat high blood pressure
(hypertension). For more information, see Section 1.Why am I using
APX-OLMESARTAN/HCTZ
TABLETS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APX-OLMESARTAN/HCTZ TABLETS?
Do not use if you have ever had an allergic reaction to
APX-OLMESARTAN/HCTZ TABLETS 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 use
APX-OLMESARTAN/HCTZ
TABLETS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with APX-OLMESARTAN/HCTZ TABLETS 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 USE APX-OLMESARTAN/HCTZ TABLETS?
The dose of APX-OLMESARTAN/HCTZ TABLETS is one tablet to be taken once
a day or talk to your
doctor before taking this medicine. Follow all directions given to you
by your doctor and pharmacist
carefully.
More instructions can be found in Section 4. How do I use
APX-OLMESARTAN/HCTZ TABLETS? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING APX-OLMESARTAN/HCTZ TABLETS?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
APX-
OLMESARTAN/HCTZ TABLETS.
•
If you are about to be started on any new medicine, remind your doctor
and
pharmacist that you are taking APX-OLMESARTAN/HCTZ TABLETS.
•
If you need to have any blood tests, tell your doctor you are taking
APX-
OLMESART

제품 특성 요약

APX-OLMESARTAN/HCTZ
V04
1
AUSTRALIAN PRODUCT INFORMATION
APX-OLMESARTAN/HCTZ
(OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE) TABLETS
1.
NAME OF THE MEDICINE
APX-OLMESARTAN/HCTZ
Tablet
consists
of
olmesartan
medoxomil
and
hydrochlorothiazide (HCTZ).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-OLMESARTAN/HCTZ 20/12.5
Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of
hydrochlorothiazide.
APX-OLMESARTAN/HCTZ 40/12.5
Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of
hydrochlorothiazide.
APX-OLMESARTAN/HCTZ 40/25
Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of
hydrochlorothiazide.
Olmesartan medoxomil is a white to off white, crystalline powder. It
is practically insoluble
in water and in heptane, slightly soluble in ethanol (96%), sparingly
soluble in methanol.
HCTZ is a white or almost white, crystalline powder. It is very
slightly soluble in water,
soluble in acetone, sparingly soluble in ethanol (96%). It dissolves
in dilute solutions of
alkali hydroxides.
Excipients with known effect: contains sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
APX-OLMESARTAN/HCTZ
20/12.5
TABLETS
are
reddish-yellow,
round,
film
coated
tablets debossed with "A01" on one side & plain on other side.
APX-OLMESARTAN/HCTZ
40/12.5
TABLETS
are
reddish-yellow,
oval,
film
coated
tablets debossed with "A002" on one side & plain on other side.
APX-OLMESARTAN/HCTZ 40/25 TABLETS are pink, oval, film coated tablets
debossed
with "A003" on one side & plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment should not be initiated with this fixed dose combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
NOTE: APX-OLMESARTAN/HCTZ are only available in the 20/12.5mg,
40/12.5mg and
40/25mg
strengths. If 20/25mg is required, an alternative brand should be
sought.
ADULTS
APX-OLMESARTAN/HCTZ is administered once daily, with or without food,
in patients
whose blood pressure is not