Asacol 500mg Suppositories

Ország: Egyesült Királyság

Nyelv: angol

Forrás: myHealthbox

Aktív összetevők:

Mesalazine

Beszerezhető a:

Warner Chilcott UK Limited

ATC-kód:

A07EC02

INN (nemzetközi neve):

Mesalazine

Adagolás:

500mg

Gyógyszerészeti forma:

suppositories

Az alkalmazás módja:

rectal use

db csomag:

10 suppositories

Recept típusa:

POM - Prescription Only Medicine

Gyártó:

Actavis Group PTC

Terápiás csoport:

Aminosalicylic acid and similar agents

Terápiás javallatok:

For the treatment of mild to moderate acute exacerbations of ulcerative colitis. The suppositories are particularly appropriate in patients with distal disease. For the maintenance of remission of ulcerative colitis.

Engedélyezési státusz:

Authorised

Engedély dátuma:

2015-07-30

Betegtájékoztató

Asacol (Mesalazine) PIL Warner Chilcott UK
item no:
print proof no:
origination date:
originated by:
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revised by:
dimensions: 
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
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date sent:
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TECHNICAL APPROVAL
black
AAAI0567 
4
22.6.15
db
22.8.15
db
Haupt Pharma Wulfingen GmbH
170 x 300
7.5 pt
22.6.15
22.6.15
*  Please note that only Actavis Global Artwork Studios are
permitted to make changes to the above 
artwork. No changes are permitted by any 3rd party other than added
notes and mark ups for 
required changes.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
- 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same 
as yours.
-  If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or 
pharmacist.
IN THIS LEAFLET: 
1. What Asacol Suppositories are and what they are used for 
2. Before you use Asacol Suppositories 
3. How to use Asacol Suppositories 
4. Possible side effects 
5. How to store Asacol Suppositories 
6. Further information
1. WHAT ASACOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Asacol Suppositories contain the active substance mesalazine (also
known as 5-aminosalicylic acid) which is an anti-
inflammatory drug used in the treatment of 
ULCERATIVE COLITIS – a disease of the large bowel (colon) and back
passage (rectum) 
in which the lining of the bowel becomes inflamed (red and swollen).
Symptoms can include rectal bleeding, frequent diarrhoea 
and abdominal pain. The suppositories act locally in the rectum to
reduce inflammation and can also prevent further episodes 
(flares) of ulcerative colitis. They are particularly useful when
symptoms of ulcerative colitis affect the

Termékjellemzők

Asacol 500mg Suppositories
Summary of Product Characteristics Updated 14­Sep­2015 | Warner Chilcott UK Limited (a subsidiary of Actavis PLC)
1. Name of the medicinal product
Asacol 500mg Suppositories
2. Qualitative and quantitative composition
Asacol Suppositories contain 500mg mesalazine per suppository.
3. Pharmaceutical form
Opaque, beige suppositories, containing 500mg mesalazine.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of mild to moderate acute exacerbations of ulcerative colitis.
The suppositories are particularly appropriate in patients with distal disease.
For the maintenance of remission of ulcerative colitis.
4.2 Posology and method of administration
_ADULTS:_
_Suppositories 250 mg:_ Three to six suppositories a day in divided doses, with the last dose at bedtime.
_Suppositories 500 mg:_ A maximum of three suppositories a day in divided doses, with the last dose at bedtime.
_ELDERLY: _The normal adult dosage may be used unless renal function is impaired (see section 4.4).
_CHILDREN:_ There is no dosage recommendation.
4.3 Contraindications
A history of sensitivity to salicylates or renal sensitivity to sulphasalazine. Confirmed severe renal impairment (GFR
<20 ml/min). Children under 2 years of age.
4.4 Special warnings and precautions for use
Use in the elderly should be cautious and subject to patients having normal renal function.
Renal disorder: Mesalazine is excreted rapidly by the kidney, mainly as its metabolite, N­acetyl­5­aminosalicylic acid. In
rats, large doses of mesalazine injected intravenously produce tubular and glomerular toxicity. Asacol should be used
with extreme caution in patients with confirmed mild to moderate renal impairment (see section 4.3). Treatment with
mesalazine should be discontinued if renal function deteriora