Sulfasalazin-Heyl

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

SULFASALAZINE

Inapatikana kutoka:

Heyl Chem.-pharm. Fabrik GmbH & Co. KG Goerzallee 253, D-14167 Berlin, Germany

ATC kanuni:

A07EC01

INN (Jina la Kimataifa):

SULFASALAZINE 500 mg

Dawa fomu:

GASTRO-RESISTANT TABLET

Tungo:

SULFASALAZINE 500 mg

Dawa ya aina:

POM

Eneo la matibabu:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Idhini hali ya:

Authorised

Idhini ya tarehe:

2007-01-18

Tabia za bidhaa

 
Page 1 of 9 

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Sulfasalazin-Heyl® 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active substance: sulphasalazine 
One enteric coated tablet contains: 500 mg sulphasalazine 

Other ingredients: 
See chapter 6.1 

3 PHARAMCEUTICAL 
FORM 
Tablet, enteric-coated 

4 CLINICAL 
PARICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Active chronic polyarthritis (rheumatoid arthritis) in adults. 
Children with idiopathic pauciarthritis (enthisitis associated
arthritis) from age 6 years who 
did not respond sufficiently to NSAIDs and/or local
steroid injections. 
Children with juvenile polyarthritis and polyarthritic
spondylitis from age 6 onwards 
(enthisitis-associated arthritis) who did not respond
sufficiently to NSAIDs. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Active chronic polyarthritis: 
Unless otherwise prescribed by the doctor, the dosage of
Sulfasalazin-Heyl should be 
introduced gradually:  

Week 1 
Week 2 
Week 3 
Week 4 and every 
further week 
morning   1 
enteric 
coated 
tablet 
1 enteric coated 
tablet 
2 enteric coated 
tablets 
evening 1 
enteric 
coated 
tablet 
1 enteric coated 
tablet 
2 enteric coated 
tablets 
2 enteric coated 
tablets 

In patients who do not respond satisfactorily to 2 x 2 enteric
coated tablets daily after 3 
months, the daily dosage can be increased to 3 x
2 enteric coated tablets. 

Page 2 of 9 

Children, six years of age and older: 
The daily dose should be 50 mg/kg of body weight daily, divided
in two single doses. The 
maximum dose is 2 g per day. In patients who
do not respond satisfactorily after 3 months, 
the daily dosage can
be increased to 75 mg/kg of body weight at a maximum dose
of 3 g of 
sulphasalazine per day. 
To reduce possible gastrointestinal intolerance, it is advisable
to use small i