SALAZOPYRIN EN

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

SULFASALAZINE

Tilgjengelig fra:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-kode:

A07EC01

Legemiddelform:

TABLETS ENTERIC COATED

Sammensetning:

SULFASALAZINE 500 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

RECIPHARM UPPSALA AB, SWEDEN

Terapeutisk gruppe:

SULFASALAZINE

Terapeutisk område:

SULFASALAZINE

Indikasjoner:

For active rheumatoid arthritis which is not controlled by antiinflammatory drugs.Ulcerative colitis, Crohn's disease, Pyoderma gangrenosum.

Autorisasjon dato:

2013-12-31

Informasjon til brukeren

Salazopyrin, Salazopyrin EN WC 15 Feb 2022
2021-0073859
2
NS
IO
ARMACISTS' REGULAT
E PH
WITH TH
N ACCORDANCE
I
KAGE INSERT
AC
ENT P
PATI
986
1
-
S)
ON
(PREPARATI
This medicine is dispensed with a doctor’s prescription only
SALAZOPYRIN
®
Tablets
SALAZOPYRIN
® EN
Enteric-coated tablets
Each tablet contains sulfasalazine 500 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this
medicine’s ingredients’ and section 6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE 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 for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
Treatment of ulcerative colitis and Crohn’s disease.
•
Salazopyrin EN enteric-coated tablets are also used for treatment of
rheumatoid arthritis
and inflammatory skin ulcers (pyoderma gangrenosum).
THERAPEUTIC GROUP:
Anti-inflammatory drug of aminosalicylic acid type.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THE MEDICINE:
•
If you are sensitive (allergic) to the active ingredient or to any of
the other
ingredients in this medicine (see section 6), to salicylates (such as
aspirin) or to
sulfonamides (a
certain type of antibiotic).
•
If you have a disease known as porphyria (a rare blood system
disorder).
•
IN CHILDREN UNDER THE AGE OF TWO YEARS.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
BEFORE TREATMENT WITH SALAZOPYRIN, TELL YOUR DOCTOR:
•
If you have a deficiency of the G6PD enzyme which is responsible for
normal function
of red blood cells.
•
If you have or have ever had asthma.
•
If you have or have ever had impaired function of the liver or the
kidney.
•
If you have or have ever had impaired function of the blood system
(such as coagulation).
•
If you have or have ever had an acute allergy.
•
In

Preparatomtale

Salazopyrin, Salazopyrin EN LPD CC 19 Oct 2023
2021-0073860, 2013 -0002669, 2023-0087979
1
Salazopyrin
®
Salazopyrin
®
EN
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Salazopyrin
®
Salazopyrin
®
EN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Salazopyrin
®
uncoated tablet for oral administration contains 500 mg of
sulfasalazine.
Each Salazopyrin
®
EN coated gastro-resistant tablet for oral administration contains 500
mg of
sulfasalazine.
Excipient with known effect:
Salazopyrin
®
EN contains 5 mg propylene glycol in each tablet.
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Tablets: Yellow-orange round embossed “KPh” on one side and
“101” and a score line on the other.
Enteric coated tablets: Yellow-orange film-coated, elliptical, convex,
embossed “Kph” on one side
and “102” on the other.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
Salazopyrin
®
: Treatment of ulcerative colitis and Crohn’s disease.
Salazopyrin
®
EN
: For active rheumatoid arthritis which is not controlled by
antiinflammatory drugs.
Ulcerative colitis, Crohn's disease and Pyoderma gangrenosum.
4.2.
Posology and Method of Administration
The dosage of Salazopyrin
®
should be individually adjusted according to the patient's tolerance
and
response to treatment.
EN-tabs must be swallowed intact, preferably after meals, and should
not be crushed or broken.
Elderly Patients
No special precautions are necessary.
A) Ulcerative colitis
Adults
Salazopyrin, Salazopyrin EN LPD CC 19 Oct 2023
2021-0073860, 2013 -0002669, 2023-0087979
2
_Severe Attacks _
Salazopyrin
®
2-4 tablets four times a day may be given in conjunction with
steroids as part of an intensive management regime. Rapid passage of
the tablets
may reduce effect of the drug.
Night-time interval between doses should not exceed 8 hours.
_Moderate Attack _
2-4 tablets four times a day may be given in conjunction with
steroids.
For the EN tablets: Mild Attack: 2 tablets four times a day with or
without ster