Asacol 800mg MR gastro-resistant tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Mesalazine

Disponible des:

AbbVie Ltd

Codi ATC:

A07EC02

Designació comuna internacional (DCI):

Mesalazine

Dosis:

800mg

formulario farmacéutico:

Gastro-resistant tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 01050100; GTIN: 5012617025708

Informació per a l'usuari

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ASACOL
® 800MG 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 800mg MR tablets are and what they are used for
2. Before you take Asacol 800mg MR tablets
3. How to take Asacol 800mg MR tablets
4. Possible side effects
5. How to store Asacol 800mg MR tablets
6. Further information
1. WHAT ASACOL 800MG MR TABLETS ARE AND WHAT THEY ARE USED
FOR
Asacol 800mg 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 800mg 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
800mg MR tablets act
locally in the terminal ileum and colon to control the disease and
prevent further flares of
Crohn’s ileo-colitis.
2. BEFORE YOU TAKE ASACOL 800MG MR TABLETS
DO NOT TAKE THE ASACOL 800MG MR TABLETS
if you:
• are allergic (hypersensitive) to any of the ingredients in the
product
_(see Section 6 on “What _
_Asacol 800mg MR tablets contain”). _
• are a

Fitxa tècnica

OBJECT 1
ASACOL 800MG MR TABLETS
Summary of Product Characteristics Updated 14-Apr-2016 | Allergan Ltd
1. Name of the medicinal product
Asacol 800mg MR tablets
2. Qualitative and quantitative composition
Each tablet contains 800 mg of mesalazine (active substance) and
152.75 mg of lactose monohydrate
(excipient).
For full list of excipients, see section 6.1
3. Pharmaceutical form
Modified Release Tablets
Red-brown, oblong tablets marked 'WC 800'.
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:_
_Mild acute exacerbations of ulcerative colitis: _Three tablets (2.4g)
a day in divided doses.
_Moderate acute exacerbations of ulcerative colitis_: Six tablets
(4.8g) a day in divided doses.
_Maintenance of remission of ulcerative colitis: Up to three tablets
(2.4g) a day once daily or in divided _
_doses._
_Maintenance of remission of Crohn's ileocolitis: Up to three tablets
(2.4g) a day in divided doses._
_ELDERLY: _The normal adult dosage may be used unless renal function
is impaired (see section 4.4).
_CHILDREN:_ Not recommended.
4.3 Contraindications
A history of sensitivity to salicylates or renal sensitivity to
sulfasalazine. Confirmed severe renal
impairment (GFR less than 20 ml/min). Hypersensitivity to any of the
ingredients. Severe hepatic
impairment. Gastric or duodenal ulcer, haemorrhagic tendency.
4.4 Special warnings and precautions for use
Geriatric Use
Use in the elderly should be cautious and subject to patients having
normal renal function
Intolerance
Discontinue treatment immediately if acute symptoms of intolerance
occur including vomiting,
abdominal pain or rash. This medicine contains lactose. Patients with
the rare hereditary problems of
galactose intolerance, the Lapp-lactase deficiency o