Mecolzine 1g suppositories

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

MESALAZINE

Disponible desde:

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

Código ATC:

A07EC02

Designación común internacional (DCI):

MESALAZINE 1 g

formulario farmacéutico:

SUPPOSITORY

Composición:

MESALAZINE 1 g

tipo de receta:

POM

Área terapéutica:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estado de Autorización:

Authorised

Fecha de autorización:

2020-10-20

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MECOLZINE 1000 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 1000 mg suppositories is and what it is used for
2. What you need to know before you take Mecolzine 1000 mg
suppositories
3. How to take Mecolzine 1000 mg suppositories
4. Possible side effects
5. How to store Mecolzine 1000 mg suppositories
6. Contents of the pack and other information
1.
WHAT MECOLZINE 1000 MG SUPPOSITORIES IS AND WHAT IT IS USED FOR
Mecolzine 1000 mg suppositories contains the active substance
mesalazine, which is an
anti-inflammatory agent for the treatment of Ulcerative colitis.
Mecolzine 1000 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 1000 MG SUPPOSITORIES
DO NOT TAKE MECOLZINE 1000 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 1000 mg
suppositories:
-
if you suffer problems with your liver or your kidney.
-
if you have a history of problems w

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Mecolzine 1g suppositories
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1000 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
1g
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 to moderate acute exacerbations: one suppository
once daily (1000 mg).
- Maintenance of remission: one suppository once daily (1000 mg). A
lower effective dose may
be considered (in this case 500 mg suppositories should be used).
Pediatric population
_ _
Mecolzine 1g 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 1g 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 1g 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 t