MECOLZINE Suppository (2022)
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Περιεχόμενα
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.
4.1. 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 physicians criteria, depending on the patients characteristics and disease. The recommended dose in adults is: Treatment of mild or ...
4.3. Contraindications
Hypersensitivity to the active substance (mesalazine), salicylates or any of the excipients listed in section 6.1. Severe renal impairment and severe liver impairment. Haemorrhagic diathesis.
4.4. Special warnings and precautions for use
Therapy with Mecolzine 500 mg suppositories should be performed under medical supervision. Blood tests (complete blood count, liver function parameters such as transaminases, creatinine) and urine tests, ...
4.5. Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed. Concomitant use of nephrotoxic medicines such as NSAIDs and azathioprine may increase the risk of renal toxicity. Mesalazine may increase the myelosuppressive ...
4.6. Fertility, pregnancy and lactation
Mesalazine should not be used during pregnancy and lactation except when the potential benefits of the treatment outweigh the possible hazards in the opinion of the physician. The underlying condition ...
4.7. Effects on ability to drive and use machines
The effects on the ability to drive and the use of machines have not been studied.
4.8. Undesirable effects
The frequency of undesirable effects listed below has been defined on the basis of the following convention (MedDRA Convention): Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); ...
4.9. Overdose
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 ...
5.1. Pharmacodynamic properties
Intestinal Antiinflammatory agents. Aminosalicylic acid and similar agents. <b>ATC code:</b> A07EC02 Mechanism of Action Mecolzine 500 mg suppositories contains mesalazine, also known as 5-aminosalicylic ...
5.2. Pharmacokinetic properties
General characteristics of the active substance Pharmacokinetics and local availability The therapeutic activity of mesalazine depends on the local contact of the drug with the affected area of the intestinal ...
5.3. Preclinical safety data
Toxic renal effects have been demonstrated in all species tested. Rat and monkey dosages and plasma concentrations at the No Observed Adverse Effect Levels (NOAELs) exceed those used in humans by a factor ...
6.1. List of excipients
Hard fat.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
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 ...
6.6. Special precautions for disposal and other handling
There are no special requirements.
7. Marketing authorization holder
FAES FARMA, S.A., Máximo Aguirre, 14, 48940 – Leioa, Spain
8. Marketing authorization number(s)
MA1278/00301
9. Date of first authorization / renewal of the authorization
Date of first authorization: 20-10-2020
10. Date of revision of the text
01/2022
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