Galtasa 500 mg suppositories

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Mesalazine

Tersedia dari:

Faes Farma S.A.

Kode ATC:

A07EC02

INN (Nama Internasional):

Mesalazine

Bentuk farmasi:

Suppository

Area terapi:

mesalazine

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2022-10-28

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GALTASA 500 MG SUPPOSITORIES
mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Galtasa is and what it is used for
2.
What you need to know before you take Galtasa
3.
How to take Galtasa
4.
Possible side effects
5.
How to store Galtasa
6.
Contents of the pack and other information
1.
WHAT GALTASA IS AND WHAT IT IS USED FOR
Galtasa contains the active substance mesalazine, which is an
anti-inflammatory agent for the
treatment of Ulcerative Colitis in adults.
Galtasa is indicated for:
- Distal Ulcerative Colitis (proctitis), an inflammatory disease of
the last part of the colon e.g. rectum
(back passage).
- Treatment of mild or moderate acute exacerbations;
- Maintenance of remission.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GALTASA
_ _
DO NOT USE GALTASA:
-
if you are allergic to mesalazine or any of the other ingredients of
this medicine (listed in section
6).
-
if you are allergic to acetylsalicylic acid or any other salicylate.
-
if you have severe kidney impairment and/or liver impairment.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you start using Galtasa.
- if you are or want to become pregnant
- if you are nursing your child
- if you have liver or kidney problems
- if you suffer from any lung disease, for example, asthma
- if you have been allergic to sulfasalazine in the past
- if you have an ulcer in your stomach or bowel intestine
- if you have previously had inflammation of the heart (which could

Karakteristik produk

Health Products Regulatory Authority
11 April 2023
CRN00DDGC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galtasa 500 mg suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 500 mg of mesalazine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository.
Torpedo-shaped suppository with greyish-white to slightly
violet-reddish colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Galtasa is indicated in adults in distal Ulcerative Colitis
(proctitis) for the:
- Treatment of mild or moderate acute exacerbations.
- Maintenance of remission.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Individual dose adjustments should be done according to the
physician's criteria, depending on the patient's characteristics
and intensity of symptoms.
The recommended dose in adults in distal Ulcerative Colitis
(proctitis) is:

Treatment of mild or moderate acute exacerbations: one suppository
twice or thrice daily (corresponding to a daily
dose of 1000-1500 mg of mesalazine).

Maintenance of remission: one suppository once or twice daily
(corresponding to a daily dose of 500-1000 mg of
mesalazine).
Elderly
No studies have been carried out. Administration of Galtasa in the
elderly must be performed with caution and always limited
to patients with normal renal function.
Paediatric population
The safety and efficacy of Mesalazine in children and adolescents has
not been established. Galtasa is not recommended to be
given to children and adolescents. Do not administer to children 5
years or less.
Method of administration:
Galtasa should be used regularly and consistently, either during the
acute phase or during the long-term therapy of the
maintenance phase, to achieve the intended effect.
It is recommended to empty the bowel before administration of the
suppository.
Suppositories should be introduced with the patient lying on the left
side, and it is advisable to remain in this position for
about 1 hour.
Health Products Regulatory