Asacol 400mg MR gastro-resistant tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Mesalazine

Tersedia dari:

AbbVie Ltd

Kode ATC:

A07EC02

INN (Nama Internasional):

Mesalazine

Dosis:

400mg

Bentuk farmasi:

Gastro-resistant tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 01050100; GTIN: 5012617025586 5012617025593

Selebaran informasi

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ASACOL
® 400MG MR TABLETS
(mesalazine)
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 400mg MR tablets are and what they are used for
2. Before you take Asacol 400mg MR tablets
3. How to take Asacol 400mg MR tablets
4. Possible side effects
5. How to store Asacol 400mg MR tablets
6. Further information
1. WHAT ASACOL 400MG MR TABLETS ARE AND WHAT THEY ARE USED
FOR
Asacol 400mg MR tablets 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. Asacol 400mg MR
tablets act locally in the
colon to reduce inflammation and can also prevent further episodes
(flares) of ulcerative
colitis.
•
CROHN’S ILEO-COLITIS
– a disease affecting the small bowel (terminal ileum) and colon in
which the lining of the bowel becomes swollen and sore. This may lead
to the development
of ulcers, abscesses and narrowing (strictures) in the bowel. Asacol
400mg MR tablets act
locally in the terminal ileum and colon to control the disease and
prevent further flares of
Crohn’s ileocolitis.
2. BEFORE YOU TAKE ASACOL 400MG MR TABLETS
Do not take Asacol 400mg MR tablets if you:
• are allergic (hypersensitive) to any of the ingredients in the
product (
_see Section 6 on ‘What _
_Asacol 400mg MR tablets contain’) _
• are allerg

Karakteristik produk

OBJECT 1
ASACOL 400MG MR TABLETS
Summary of Product Characteristics Updated 14-Apr-2016 | Allergan Ltd
1. Name of the medicinal product
Asacol 400mg MR Tablets
2. Qualitative and quantitative composition
400 mg mesalazine per tablet.
3. Pharmaceutical form
Red-brown, oblong, modified release tablets.
4. Clinical particulars
4.1 Therapeutic indications
_Ulcerative Colitis:_
For the treatment of mild to moderate acute exacerbations. For the
maintenance of remission.
_Crohn's_ _ileo-colitis_
For the maintenance of remission.
4.2 Posology and method of administration
Swallow whole with water. Do not break, crush or chew the tablets
before swallowing.
_ADULTS:_
_Oral:_
_Acute disease: _Six tablets a day in divided doses, with concomitant
corticosteroid therapy where clinically
indicated.
_Maintenance therapy:_ Three to six tablets once daily or in divided
doses.
_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 less than 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, N-acetyl-5-
aminosalicylic 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). Patients on mesalazine
should have renal function
monitored, (with serum creatinine levels measured) prior to treatment
start. Renal function should then be
monitored periodically during treatment, for example every 3 months
for the first year, then 6 monthly for
the next 4 years and annually thereafter, based on individual patient
history. Physicians sho