Sulfasalazine 500mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Sulfasalazine

Mevcut itibaren:

Crescent Pharma Ltd

ATC kodu:

A07EC01

INN (International Adı):

Sulfasalazine

Doz:

500mg

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 01050100; GTIN: 5017123333170

Bilgilendirme broşürü

Product:
Sulfasalazine 500mg Tablets
Item Code:
P1409T
Size:
210 x 297 mm
Min. Point size:
8.5pt
O. Artwork:
03/03/20
Proof No.
2
Amendment Date
30/03/20
Process Black
Keyline - Does not print
Colours Used
steroid medicine may be given, but not always when the attack is
milder.
CHILDREN 2 YEARS OF AGE AND OVER
ULCERATIVE COLITIS AND CROHN’S DISEASE:
The dose required will be dependent on the child's weight, so it
should be taken as directed by the doctor.
DO NOT GIVE TO CHILDREN UNDER 2 YEARS OF AGE.
The tablets should start to work in a few days.
IF YOU TAKE MORE SULFASALAZINE TABLETS THAN YOU SHOULD
If you think you have taken too many tablets, contact your doctor
straight away or go to the nearest hospital casualty department.
Take with you any remaining tablets and this leaflet so that the
medicine can be identified.
IF YOU FORGET TO TAKE SULFASALAZINE TABLETS
If you forget to take a dose of this medicine, take it as soon as you
remember. However, if it is almost time for the next dose, skip the
missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
IF YOU STOP TAKING SULFASALAZINE TABLETS
Do not stop taking this medicine just because you start to feel
better, you may need to continue taking it for some time because
inflammatory bowel disease may be a lifelong condition. When
your dose needs to be reduced your doctor will lower the amount
you need to take gradually.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sulfasalazine Tablets can cause side effects,
although not everybody gets them.
STOP TAKING THE TABLETS AND CONTACT YOUR DOCTOR
IMMEDIATELY
if you experience any of the following symptoms
after taking this medicine. Although they are very rare, these
symptoms can be serious:
• difficulty breathing, sudden wheezing, itching or rashes
(especially affecting the whole body), swelling of eyelids, face or
lips- these may be signs of a severe allergic react

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sulfasalazine 500 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of sulfasalazine
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Yellow-brown, round, normal convex tablets engraved with RL logo on
one side,
with a breakline and A333 on the other side.
4.1
THERAPEUTIC INDICATIONS
Induction and maintenance of remission of ulcerative colitis;
treatment
of active Crohn's Disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dose is adjusted according to the severity of the disease and the
patient's
tolerance to the drug, as detailed below.
Elderly Patients
No special precautions are necessary.
A) Ulcerative colitis
Adults
_Severe Attacks_
Sulfasalazine_ _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 eight hours.
_Moderate Attack_
2-4 tablets four times a day may be given in conjunction with
steroids.
_Maintenance Therapy_
With induction of remission reduce the dose gradually to 4 tablets per
day.
This dosage should be continued indefinitely since discontinuance even
several years after an acute attack is associated with a four fold
increase in risk
of relapse.
Children
The dose is reduced in proportion to body weight
_Acute Attack or Relapse_
40 - 60 mg / kg per day
_Maintenance Dosage _
20 - 30 mg / kg per day
Sulfasalazine suspension may provide a more flexible dosage form.
B) Crohn’s Disease
In active Crohn’s disease, sulfasalazine should be administered as
in attacks of
ulcerative colitis (see above).
4.3
CONTRAINDICATIONS
Sulfasalazine is contraindicated in:
Infants under the age of 2 years.
Patients with a known hypersensitivity to sulfasalazine, its
metabolites or any of the
excipients as well as sulfonamides or salicylates.
Patients with porphyria.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Com