Sulfasalazine 250mg/5ml oral suspension

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Sulfasalazine

Saadav alates:

Special Order

ATC kood:

A07EC01

INN (Rahvusvaheline Nimetus):

Sulfasalazine

Annus:

50mg/1ml

Ravimvorm:

Oral suspension

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 01050100

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 your pharmacist.
•
This medicine has been prescribed only for you. Do not pass it on to
others. It may
harm them, even if their signs of illness 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.
WHAT IS IN THIS LEAFLET
1.
What Sulfasalazine Suspension is and what it is used for
2.
What you need to know before you take Sulfasalazine Suspension
3.
How to take Sulfasalazine Suspension
4.
Possible side effects
5.
How to store Sulfasalazine Suspension
6.
Contents of the pack and other information
1. WHAT SULFASALAZINE SUSPENSION IS AND WHAT IT IS USED FOR
The active ingredient in Sulfasalazine Suspension is sulfasalazine
which is an anti-
inflammatory drug and belongs to a group of medicines called
aminosalicylates.
Your doctor may give you Sulfasalazine to treat and manage
inflammatory bowel
disease.
INFLAMMATORY BOWEL DISEASE
The main forms of inflammatory bowel disease are Ulcerative Colitis
and Crohn’s
disease. Although the diseases have some features in common, there are
some
important differences
•
Ulcerative Colitis is an inflammatory disease which affects only the
large bowel
(colon and back passage). The lining of the bowel becomes inflamed
(red and
swollen) and symptoms include abdominal pain and diarrhoea (which may
contain
blood and mucus). Sulfasalazine is used to control the flare-ups of
ulcerative
colitis. It may also be used at lower doses to prevent more flare-ups
of ulcerative
colitis
•
Crohn’s disease is an inflammatory disease which may affect any part
of the
digestive system from the mouth to the anus, but it most commonly
affects the last
part of the small bowel and the first part of the larg

Toote omadused

OBJECT 1
SULFASALAZINE 250MG/5ML ORAL
SUSPENSION
Summary of Product Characteristics Updated 13-Sep-2019 | Rosemont
Pharmaceuticals Limited
•
1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
•
4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Sulfasalazine 250mg/5ml Oral Suspension
2. Qualitative and quantitative composition
Sulfasalazine 250mg/5ml
3. Pharmaceutical form
Oral Suspension
4. Clinical particulars
4.1 Therapeutic indications
Induction and maintenance of remission of ulcerative colitis and
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 of the drug, as
detailed below.
A) Ulcerative Colitis
Adults and the Elderly
_Severe attacks_: 20 to 40 ml four times a day may be given in
conjunction with steroids as part of an
intensive management regime. Rapid passage of the suspension may
reduce the effect of the drug.
The night time interval between doses should not exceed 8 hours.
_Moderate attacks_: 20 m