Sulazine EC 500mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Sulfasalazine

Предлага се от:

Genesis Pharmaceuticals Ltd

АТС код:

A07EC01

INN (Международно Name):

Sulfasalazine

дозиране:

500mg

Лекарствена форма:

Gastro-resistant tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 01050100; GTIN: 5026440000375 5026440000306

Листовка

PATIENT INFORMATION LEAFLET
SULAZINE-EC 500 MG GASTRO-RESISTANT TABLETS
Sulfasalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
−
KEEP THIS LEAFLET. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
−
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.
THIS LEAFLET CONTAINS
1. WHAT SULAZINE EC IS FOR
2. BEFORE YOU TAKE SULAZINE EC
3. HOW TO TAKE SULAZINE EC
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SULAZINE EC
6. FURTHER INFORMATION
1.
WHAT SULAZINE EC IS FOR
SULAZINE-EC belongs to a group of medicines called the
aminosalicylates. It is used to reduce pain and swelling
in joint disease (rheumatoid arthritis) or gut diseases (Crohn's
disease or ulcerative colitis).
If you are not sure why you have been prescribed these tablets then
please ask your doctor.
2.
BEFORE YOU TAKE SULAZINE EC
DO NOT TAKE SULAZINE EC AND TELL YOUR DOCTOR IF YOU:
•
are allergic to sulfasalazine or any of the other ingredients in the
tablets (listed in section 6 of this leaflet)
•
are allergic to salicylates (e.g. aspirin) or sulfonamides (e.g.
sulfadiazine)
•
suffer from inherited iron disorders (porphyrias)
DO NOT USE THIS MEDICINE IN CHILDREN UNDER 2 YEARS OF AGE.
TAKE SPECIAL CARE WITH SULAZINE EC
Tell your doctor BEFORE you take this medicine if you:
•
have problems with your liver or kidneys
•
suffer from severe allergies or asthma
•
have a blood disorder
•
have been told that you suffer from glucose-6-phosphate dehydrogenase
(G6PD) deficiency, as there is an
increased risk of red blood cell breakdown in the body (haemolytic
anaemia)
•
are treating a child with the condition systemic onset juvenile
rheumatoid arthritis
TESTS ON YOUR LIVER, KIDNEY AND

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
SULAZINE EC 500mg Gastro-Resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500.00 mg Sulfasalazine
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gastro-resistant Tablet
Oval-shaped bi-convex tablets engraved SULAZINE EC
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Induction and maintenance of remission of ulcerative colitis;
treatment of active
Crohn’s disease
2.
Treatment of rheumatoid arthritis which has failed to respond to
non-steroidal
anti-inflammatory drugs (NSAIDs)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
EC tablets should be used where there is gastro-intestinal intolerance
of plain tablets.
They should not be crushed or broken.
The dose is adjusted according to the severity of the disease and the
patient’s
tolerance to the drug, as detailed below.
1. Ulcerative colitis:
Adults and Elderly:
•
_Severe attacks: _
2-4 tablets four times a day which may be given in conjunction with
steroids as
part of an intensive management regime. Rapid passage of the tablets
may reduce
the effect of the drug.
Night-time interval between doses should not exceed 8 hours.
When remission occurs maintenance therapy should be commenced.
•
_Moderate attacks: _
2-4 tablets four times a day may be given in conjunction with steroids
•
_Mild attacks: _
2 tablets four times a day with or without steroids
•
_Maintenance therapy: _
With induction of remission gradually reduce the dose to 4 tablets per
day. The
dosage should be continued indefinitely to avoid relapse, since
discontinuation
even several years after an acute attack is associated with a
four-fold increase in
risk of relapse.
Children over 2 years:
Adjust the dose in proportion to bodyweight
•
Acute attack or relapse: 40-60 mg/kg per day
•
Maintenance therapy: 20-30 mg/kg per day
Sulfasalazine suspension may provide a more flexible dosage form.
2. Crohn’s disease
In active Crohn’s disease, sulfasalazine should be administe