BREXIN SACHETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PIROXICAM AS BETA-CYCLODEXTRIN

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

M02AA07

Pharmaceutical form:

WATER SOLUBLE POWDER

Composition:

PIROXICAM AS BETA-CYCLODEXTRIN 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CHIESI FARMACEUTICI S.P.A., ITALY

Therapeutic group:

PIROXICAM

Therapeutic area:

PIROXICAM

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 desicion to prescribe piroxocam should be based on an assesment of the individual's patient overall risk

Authorization date:

2022-04-30

Summary of Product characteristics

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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
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