Octasa 400mg MR gastro-resistant tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Mesalazine

Disponibbli minn:

Tillotts Pharma UK Ltd

Kodiċi ATC:

A07EC02

INN (Isem Internazzjonali):

Mesalazine

Dożaġġ:

400mg

Għamla farmaċewtika:

Gastro-resistant tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 01050100; GTIN: 5060327170003 5060327170010

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
Octasa 400 mg Modified Release Tablets
Active substance: 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, please 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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Octasa is and what it is used for
2.
What you need to know before you take Octasa
3.
How to take Octasa
4.
Possible side-effects
5.
How to store Octasa
6.
Contents of the pack and other information
1.
WHAT OCTASA IS AND WHAT IT IS USED FOR
Octasa contains the active substance mesalazine. This is an
anti-inflammatory medicine used to treat
ulcerative
colitis and Crohn’s ileo-colitis.
Octasa is used:
•
to treat and prevent further episodes of ulcerative colitis
•
to prevent further episodes of Crohn’s ileo-colitis once the disease
has been brought under
control.
Ulcerative colitis is a disease of the large bowel (colon) or back
passage (rectum), in which the lining
of the bowel becomes inflamed (red and swollen).
Crohn’s ileo-colitis is a disease that affects the small bowel
(terminal ileum) and the large bowel
(colon) in which the lining of the bowel becomes inflamed. This can
lead to ulcers, abscesses and
narrowing (strictures) in the bowel.
Octasa acts locally at the site of inflammation (colon, rectum and
terminal ileum) to reduce this
inflammation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OCTASA
DO NOT TAKE OCTASA

If you are allergic to mesalazine or any of the other ingredients of
this medication (listed in
section 6)

If you are allergic to salicylates (e. g. aspirin)

If you have severe kidney problems

If you have severe liver problems
WARNINGS AND PRECAUTIONS
Talk

Karatteristiċi tal-prodott

OBJECT 1
OCTASA 400MG MR TABLETS
Summary of Product Characteristics Updated 08-Jan-2018 | Tillotts
Pharma UK Limited
1. Name of the medicinal product
Octasa 400 mg Modified Release Tablets
2. Qualitative and quantitative composition
Each modified release tablet contains: 400 mg mesalazine.
Excipient with known effect: 76.4 mg lactose monohydrate see section
4.4
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified-Release Tablet
Red-brown, oblong, modified-release tablet.
4. Clinical particulars
4.1 Therapeutic indications
Octasa is indicated in adults, children and adolescents above 6 years
for:
_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
Posology
Adults
_Mild acute disease:_ 2.4g (six tablets) once daily or in divided
doses, with concomitant corticosteroid
therapy to be taken when clinically indicated.
_Moderate acute disease: _2.4g to 4.8g (six to twelve tablets) a day
in divided doses, with concomitant
corticosteroid therapy where clinically indicated. 2.4g may be taken
once daily or in divided doses.
Above 2.4g daily should be taken in divided doses.
_Maintenance therapy:_ 1.2g to 2.4g (three to six tablets) taken once
daily or in divided doses.
The maximum adult dose should not exceed twelve tablets a day and not
exceed six tablets taken together
at any one time.
Elderly population
The normal adult dosage may be taken unless liver or renal function is
severely impaired (see sections 4.3
and 4.4). No studies have been carried out in the elderly population.
Paediatric population
There is only limited documentation for an effect in children (age
6-18 years).
Children 6 years of age and older
• _Active disease:_ To be determined individually, starting with
30-50 mg/kg/day in divided doses.
Maximum dose: 75 mg/kg/day in divided doses. The total dose should not
exceed 4 g/day.
• _Maintenance treatment:_ To be dete