MECOLZINE Suppository Ref.[50655] Active ingredients: Mesalazine

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.

No cases of overdose toxicity have been reported.

Under normal circumstances the absorption of mesalazine by the colon is limited.

Since there is no specific antidote, in case of overdose, treatment should be symptomatic and supportive.

3 years.

Do not store above 30°C.

Suppositories are packaged in PVC/PE strips.

Each pack contains 12, 24, 60 and 100 suppositories.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

There are no special requirements.