Losec

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Omeprazole magnesium 10.3mg equivalent to 10 mg omeprazole;  

제공처:

Bayer New Zealand Limited

INN (국제 이름):

Omeprazole magnesium 10.3 mg (equivalent to 10 mg omeprazole)

복용량:

10 mg

약제 형태:

Enteric coated tablet

구성:

Active: Omeprazole magnesium 10.3mg equivalent to 10 mg omeprazole   Excipient: Crospovidone Ferrous oxide Glyceryl monostearate Hypromellose Methacrylic acid-ethyl acrylate copolymer (1:1) Hydroxypropylcellulose Iron oxide yellow Macrogol 6000 Magnesium stearate Microcrystalline cellulose Polysorbate 80 Purified talc Sodium hydroxide Sodium stearyl fumarate Sugar spheres Synthetic paraffin Titanium dioxide Triethyl citrate

패키지 단위:

Blister pack, Aluminium 7 tablets, 7 tablets

수업:

Pharmacy only

처방전 유형:

Pharmacy only

Manufactured by:

AstraZeneca AB

제품 요약:

Package - Contents - Shelf Life: Blister pack, Aluminium - 7 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium - 14 tablets - 36 months from date of manufacture stored at or below 25°C

승인 날짜:

1998-04-27

환자 정보 전단

_Losec CMI _
_8 May 2015_
Consumer Medicine Information
1
LOSEC
® AND LOSEC
® EXTRA
OMEPRAZOLE 10 MG AND 20 MG GASTRO-RESISTANT TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about LOSEC (including
LOSEC EXTRA) tablets.
It does not contain all the information about LOSEC tablets. It does
not take the place of
talking to your pharmacist or doctor.
All medicines have risks and benefits. You should weigh the risks of
taking LOSEC tablets
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT LOSEC TABLETS ARE USED FOR
LOSEC is presented in MUPS
®
tablets, built on patented technology. The MUPS tablets allow
the active ingredient, omeprazole, to be contained within very small
pellets (which form part
of the tablet mix). These pellets have an enteric coating, allowing
them to pass through the
stomach without being broken down. The pellets release the active
ingredient in the
intestine, where it can be absorbed by your body and take effect.
Without this enteric coating,
the omeprazole would be destroyed by stomach acid and would not be
effective.
LOSEC is used for the relief of reflux-like symptoms – heartburn or
regurgitation. Heartburn is
an acidic or burning feeling, rising up from the stomach towards the
throat. The pain of
heartburn, which is usually associated with acid regurgitation
(reflux), can be caused or
made worse by eating large meals, bending over or lying flat, and by
hot, alcoholic or acidic
drinks such as orange juice.
The symptoms below are NOT usually signs of acid reflux:

cardiac-type chest pain – often felt as a pressure or squeezing in
the chest with
shortness of breath and pain that may extend into the shoulders, arms
or up
toward the back or neck.

abdominal pain or discomfort

nausea, belching or bloating

sore throat or cough
See your pharmacist or doctor if you experience any of these symptoms.
_HOW LOSEC

제품 특성 요약

_Losec Data Sheet _
_25 June 2013_

DATA SHEET 

Page 1 of 11 
LOSEC
® 
AND LOSEC
®
EXTRA 
GASTRO-RESISTANT TABLETS 
OMEPRAZOLE 10 MG AND 20 MG 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
10 mg:  Each gastro-resistant tablet contains  10.3 mg omeprazole magnesium equivalent to 
10 mg omeprazole. 
20 mg:  Each gastro-resistant tablet contains  20.6 mg omeprazole magnesium equivalent to 
20 mg omeprazole. 
_EXCIPIENT _
10 mg:  Each gastro-resistant tablet
contains 19 - 20 mg sucrose. 
20 mg:  Each gastro-resistant tablet contains 19 - 20 mg
sucrose. 
For a
full list of excipients, see Pharmaceutical Particulars. 
PHARMACEUTICAL FORM 
Enteric coated gastro-resistant tablets. 
Losec  10  mg  gastro-resistant  tablets:  Light  pink,  oblong,  biconvex,  film-coated  tablets 
engraved  with 
  or 
  on  one  side  and  10  mg  on  the  other  side.  Each  tablet  contains 
omeprazole magnesium 10.3 mg as enteric coated micropellets.  
Losec  Extra  20  mg  gastro-resistant  tablets:  Pink,  oblong,  biconvex,  film-coated  tablets 
engraved  with 
  or 
  on  one  side  and  20  mg  on  the  other  side.  Each  tablet  contains 
omeprazole magnesium 20.6 mg as enteric coated micropellets.  
The tablets are manufactured using MUPS patented technology. 
CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Losec  (including  Losec  Extra)  tablets  are  indicated  for  the  short-term  relief  of  reflux-like 
symptoms in patients aged 18 years and over. 
POSOLOGY AND METHOD OF ADMINISTRATION 
_ADULTS (AGED 18 YEARS AND OLDER) _
10 MG TABLETS: 20 mg (2 tablets) once daily until symptoms improve, then reduce the dose to 
10 mg (1 tablet) once daily.  If symptoms return the dose may be increased to 2 tablets once 
daily