Asacol 500mg suppositories

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Mesalazine

Предлага се от:

Allergan Ltd

АТС код:

A07EC02

INN (Международно Name):

Mesalazine

дозиране:

500mg

Лекарствена форма:

Suppository

Начин на приложение:

Rectal

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 01050100

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOL 250MG AND 500MG SUPPOSITORIES
(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 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 rectum.
2. BEFORE YOU USE ASACOL SUPPOSITORIES
DO NOT USE ASACOL SUPPOSITORIES if you:
• are allergic (hypersensitive) to any of the ingredients in the
product (see Section 6 on “What Asacol Suppositories contain”).
• 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 give the suppositories to CHILDREN under 2 years of age.
TAKE SPECIAL CARE WITH ASACOL SUPPOSITORIES
• Asacol should be used with extreme caution in pati

Данни за продукта

OBJECT 1
ASACOL 500MG SUPPOSITORIES
Summary of Product Characteristics Updated 11-May-2016 | Allergan Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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 se