BREXIN TABLETS

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

PIROXICAM AS BETA-CYCLODEXTRIN

제공처:

TARO INTERNATIONAL LTD, ISRAEL

ATC 코드:

M02AA07

약제 형태:

TABLETS

구성:

PIROXICAM AS BETA-CYCLODEXTRIN 20 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

CHIESI FARMACEUTICI S.P.A., ITALY

치료 그룹:

PIROXICAM

치료 영역:

PIROXICAM

치료 징후:

Piroxicam is indicated for symptomatic relief of osteoarthritis rheumatoid arthritis or ankylosing spondylitis. When an NSAID is indicated piroxicam should be considered as a second line option. The desicion to prescribe piroxocam should be based on an assesment of the individual's patient overall risk.

승인 날짜:

2022-04-30

환자 정보 전단

1
Brexin
–
PIL- HEB
–
09.23
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
- 1986
This medicine is dispensed with a doctor’s prescription only
BREXIN TABLETS
ACTIVE INGREDIENT
Each tablet contains piroxicam (as beta-cyclodextrin) 20 mg
Inactive ingredients and allergens in this medicine: see
section 2 under ‘Important
information about some of this medicine’s ingredients’
and
section 6 ‘Additional information'
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For symptomatic relief of osteoarthritis, rheumatoid arthritis or
ankylosing spondylitis. Your
doctor will prescribe this medicine for you only after failure of
treatment with another non-
steroidal anti-inflammatory drug (NSAID).
THERAPEUTIC GROUP: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in
this medicine (listed in section 6).
•
You previously had any allergic reaction and/or skin reactions,
regardless of severity,
such as erythema multiforme, Stevens-Johnson syndrome or toxic
epidermal necrolysis,
after taking other medicines, including other NSAIDs, or medicines
containing the same
active substance.
•
You have had symptoms of angioedema, asthma, rash, nasal polyps or
rhinitis due to
the use of NSAIDs or acetylsalicylic acid (aspirin).
•
You are taking other NSAIDs or acetylsalicylic acid (aspirin) to
relieve pain.
•
You currently have a stomach and/or duodenal ulcer, or you have
digestion problems
(dyspepsia) or stomach inflammation (gastritis).
•
You have had intestinal or stomach ulcer

제품 특성 요약

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT:
BREXIN TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains:
piroxicam
β
-cyclodextrin 191.2 mg, (equivalent to piroxicam 20 mg).
Excipient with known effect: lactose monohydrate, sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Piroxicam
is
indicated
for
symptomatic
relief
of
osteoarthritis
rheumatoid
arthritis or ankylosing spondylitis. When an NSAID is indicated
piroxicam
should be considered as a second line option. The decision to
prescribe piroxicam
should be based on an assessment of the individual's patient overall
risk.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The prescription of piroxicam should be initiated by physicians with
experience
in the diagnosis and treatment of patients with inflammatory or
degenerative
rheumatic diseases.
The maximum recommended daily dose is 20 mg.
Undesirable effects may be minimised by using the minimum effective
dose for
the shortest duration of treatment necessary to control symptoms. The
benefit and
tolerability of treatment should be reviewed within 14 days. If it is
considered
necessary to continue treatment, this should be accompanied by
frequent review.
Given that piroxicam has shown to be associated with an increased risk
of
gastrointestinal complications, the possible need for combination
therapy with
gastro-protective agents (e.g. misoprostol or proton pump inhibitors)
should be
carefully considered, in particular for elderly patients.
PAEDIATRIC POPULATION
Dosage and indications in children have not been established yet.
ELDERLY
In elderly patients, the posology must be carefully established by the
physician
who will have to consider a possible reduction of the dosage indicated
above.
METHOD OF ADMINISTRATION
BREXIN should be administered once daily.
1 tablet per day. The tablet is for oral use. The score on the tablet
is intended to
Page 2 of 14
ease the spli