Asacol 1g/application foam enema

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Mesalazine

Disponible desde:

Allergan Ltd

Código ATC:

A07EC02

Designación común internacional (DCI):

Mesalazine

Dosis:

1gram/1application

formulario farmacéutico:

Rectal foam

Vía de administración:

Rectal

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 01050100

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USERS
ASACOL FOAM ENEMA
(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 Foam Enema is and what it is used for
4. Possible side effects
2. Before you use Asacol Foam Enema
5. How to store Asacol Foam Enema
3. How to use Asacol Foam Enema
6. Further information
1. WHAT ASACOL FOAM ENEMA IS AND WHAT IT IS USED FOR
Asacol Foam Enema contains the active substance mesalazine (also known
as 5-aminosalicylic acid) which is
an anti-inflammatory drug used in the treatment of ULCERATIVE COLITIS.
Ulcerative colitis is 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 enema acts locally in the lower part of the colon
to reduce the inflammation.
2. BEFORE YOU USE ASACOL FOAM ENEMA
DO NOT USE ASACOL FOAM ENEMA if you:
• are ALLERGIC (hypersensitivity) to any of the ingredients in the
product _(see Section 6 on ‘What Asacol_
_Foam Enema contains’)_
• are allergic to ASPIRIN or any other salicylate
• had KIDNEY problems or BLOOD abnormalities while taking other
medicines such as SULPHASALAZINE
• have confirmed severe KIDNEY impairment.
DO NOT use the foam in CHILDREN under 2 years of age.
TAKE SPECIAL CARE WITH ASACOL FOAM ENEMA
• Asacol should be used with extreme caution in patients with
confirmed mild to moderate kidney impairment
• Asacol should be used with caution in the elderly.
TAKING OTHER MEDICINES
Please tell your doctor if you are tak

Ficha técnica

OBJECT 1
ASACOL FOAM ENEMA
Summary of Product Characteristics Updated 14-Apr-2016 | Allergan Ltd
1. Name of the medicinal product
Asacol
®
Foam Enema
2. Qualitative and quantitative composition
Mesalazine (5-aminosalicylic acid), 1g per metered dose
3. Pharmaceutical form
White, aerosol foam enema
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of mild to moderate acute exacerbations of
ulcerative colitis affecting the distal colon.
4.2 Posology and method of administration
_Route of administration:_ Rectal
_Adults: _For disease affecting the rectosigmoid region, one metered
dose 1g a day for 4 - 6 weeks; for
disease involving the descending colon, two metered doses 2g once a
day for 4 - 6 weeks.
_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
sulfasalazine. 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 a
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). Treatment with mesalazine
should be discontinued if renal
function deteriorates. If dehydration develops, normal electrolyte and
fluid balance should be restored as
soon as possible.
Serious blood dyscrasias have been reported very rarely with
mesalazine. Haematological investigations
should be performed if the patient develops unexplained bleeding,
bruising, purpura, anaemia, fever or
sore throat. Treatment should be stopped if there is suspicion or
evidence of blood dyscrasia.
4.5 Interactio