Mecolzine 500mg suppositories

Țară: Malta

Limbă: engleză

Sursă: Malta Medicines Authority

Ingredient activ:

MESALAZINE

Disponibil de la:

Faes Farma S.A. Maximo Aguirre 14, Leioa Bizkaia 48940, Spain

Codul ATC:

A07EC02

INN (nume internaţional):

MESALAZINE 500 mg

Forma farmaceutică:

SUPPOSITORY

Compoziție:

MESALAZINE 500 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Rezumat produs:

Licence number in the source country: NOT APPLICAPABLE

Statutul autorizaţiei:

Authorised

Data de autorizare:

2020-10-20

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MECOLZINE 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 or 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 Mecolzine 500 mg suppositories is and what it is used for
2. What you need to know before you take Mecolzine 500 mg
suppositories
3. How to take Mecolzine 500 mg suppositories
4. Possible side effects
5. How to store Mecolzine 500 mg suppositories
6. Contents of the pack and other information
1.
WHAT MECOLZINE 500 MG SUPPOSITORIES IS AND WHAT IT IS USED FOR
Mecolzine 500 mg suppositories contains the active substance
mesalazine, which is an
anti-inflammatory agent for the treatment of Ulcerative colitis.
Mecolzine 500 mg suppositories is indicated for:
- Distal Ulcerative colitis, an inflammatory disease of the last part
of the colon e.g. large
bowel and rectum (back passage).
- Treatment of mild or moderate acute exacerbations;
- Maintenance of remission.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MECOLZINE 500 MG SUPPOSITORIES
DO NOT TAKE MECOLZINE 500 MG SUPPOSITORIES:
- if you are allergic (hypersensitive) to mesalazine, salicylates (for
example: aspirin) or
any of the other ingredients of this medicine (listed in section 6).
- if you have severe kidney or liver disease.
- if you have a medical condition that can make you prone to bleeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Mecolzine 500 mg
suppositories:
-
if you suffer problems with your liver or your kidney.
-
if you have a history of problems with your

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Mecolzine 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 color.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mecolzine 500 mg suppositories is indicated in distal Ulcerative
Colitis (proctitis and
proctosigmoiditis) 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 disease.
The recommended dose in adults is:
- Treatment of mild or moderate acute exacerbations: one suppository
twice or thrice daily
(1000-1500 mg);
- Maintenance of remission: one suppository once or twice daily
(500-1000 mg).
Pediatric population
_ _
Mecolzine 500 mg suppositories is not recommended for use in children
younger than 6
years due to a lack of safety and efficacy data. Information of the
use of Mecolzine 500
mg suppositories in children between 6 and 18 years of age is limited.
Currently available
data are described in section 5.1 but no recommendation on a posology
can be made.
Method of administration:
Mecolzine 500 mg suppositories 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.
Suppositories should be introduced deeply into the anus and should be
retained in the
rectum for 1-3 hours to increase the efficacy.
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance (mesalazine), salicyla