PHARMACOR OLMESARTAN HCTZ 40/12.5 olmesartan medoxomil and hydrochlorothiazide 40/12.5 mg tablet bottle pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

Download 환자 정보 전단 (PIL)
23-04-2022
Download 제품 특성 요약 (SPC)
23-04-2022
Download 공공 평가 보고서 (PAR)
16-05-2019

유효 성분:

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

제공처:

Pharmacor Pty Ltd

약제 형태:

Tablet

구성:

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

관리 경로:

Oral

패키지 단위:

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: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

승인 상태:

Registered

승인 날짜:

2018-01-29

환자 정보 전단

                                _PHARMACOR OLMESARTAN HCTZ Ver 03 1 _
PHARMACOR 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 PHARMACOR OLMESARTAN HCTZ TABLETS?
PHARMACOR 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
PHARMACOR
OLMESARTAN HCTZ TABLETS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PHARMACOR OLMESARTAN HCTZ TABLETS?
Do not use if you have ever had an allergic reaction to PHARMACOR
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
PHARMACOR OLMESARTAN
HCTZ TABLETS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PHARMACOR 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 PHARMACOR OLMESARTAN HCTZ TABLETS?
The dose of PHARMACOR 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 PHARMACOR
OLMESARTAN HCTZ
TABLETS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PHARMACOR OLMESARTAN HCTZ TABLETS?
THINGS YOU SHOULD
DO
•
Remind
any
doctor,
dentist
or
pharmacist
you
visit
that
you
are
using
PHARMACOR OLMESARTAN HCTZ TABLETS.
•
If you are about to be started on any new medicine, remind your doctor
and
pharmacist
that
you
are
taking
PHARMACOR
OLMESARTAN
HCTZ
TABLET
                                
                                전체 문서 읽기
                                
                            

제품 특성 요약

                                PHARMACOR OLMESARTAN HCTZ V03
1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR OLMESARTAN HCTZ
(OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE) TABLETS
1.
NAME OF THE MEDICINE
PHARMACOR
OLMESARTAN
HCTZ
Tablet
consists
of
olmesartan
medoxomil
and
hydrochlorothiazide (HCTZ).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR OLMESARTAN HCTZ 20/12.5
Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of
hydrochlorothiazide.
PHARMACOR OLMESARTAN HCTZ 40/12.5
Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of
hydrochlorothiazide.
PHARMACOR 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.
PHARMACOR OLMESARTAN HCTZ 20/12.5 TABLETS are reddish-yellow, round,
film
coated tablets debossed with "A01" on one side & plain on other side.
PHARMACOR OLMESARTAN HCTZ 40/12.5 TABLETS are reddish-yellow, oval,
film
coated tablets debossed with "A002" on one side & plain on other side.
PHARMACOR 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
PHARMACOR OLMESARTAN HCTZ V03
2
Treatment of hypertension.
Treatment should not be initiated with this fixed dose combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
NOTE:
PHARMACOR
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
PHARMACOR OLMESAR
                                
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