MECOLZINE Gastro-resistant tablet

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

Mecolzine 500 mg gastro-resistant tablets.

2. Qualitative and quantitative composition

Each tablet of Mecolzine 500 mg gastro-resistant tablets contains 500 mg of mesalazine. Excipient with known effect: Each tablet contains 2.13 mmols of sodium (49 mg). For the full list of excipients, ...

3. Pharmaceutical form

Gastro-resistant tablets. Oblong tablets of 17.9 mm of length and 8.3 mm of diameter, with homogeneous gastro-resistant orange coloured coating.

4.1. Therapeutic indications

Mecolzine 500 mg gastro-resistant tablets is indicated for: Treatment of the acute phase of mild or moderate ulcerative colitis. Maintenance treatment of remission in ulcerative colitis.

4.2. Posology and method of administration

Posology During the acute inflammatory phase and in long-term maintenance therapy, the patient must accurately follow the treatment established by the doctor to ensure the intended therapeutic effect. ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pre-existing hypersensitivity to salicylic acid and its derivatives. Severe impairment of hepatic and renal function. ...

4.4. Special warnings and precautions for use

Patients with severe liver or renal insufficiency. As 5-ASA is eliminated mainly by acetylation and subsequent urinary excretion, patients with impaired liver function or renal failure should be closely ...

4.5. Interaction with other medicinal products and other forms of interaction

In common with other salicylates, mesalazine can: Reduce the anticoagulant activity of anticoagulants derived from coumarin, such as warfarin. Enhance the glucose-lowering effects of sulfonylureas. Antagonize ...

4.6. Fertility, pregnancy and lactation

Pregnancy Limited experience with mesalazine in pregnancy does not indicate an increased risk of drug induced congenital malformations. Mesalazine crosses the placental barrier, but provides foetal concentrations ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Mecolzine 500 mg gastro-resistant tablets is considered to have negligible influence on these abilities.

4.8. Undesirable effects

Organ Class System Frequency According to MedDRA Convention Rare (< 1/10,000 to 1/1,000) Blood and lymphatic system disorders leukopenia, neutropenia, thrombocytopenia, aplastic anemia ...

4.9. Overdose

Mesalazine is an aminosalicylate, and signs of salicylate toxicity include tinnitus, vertigo, headache, confusion, drowsiness, pulmonary oedema, dehydration as a result of sweating, diarrhoea and vomiting, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Aminosalicylic acid and similar Code ATC: A07EC02 Mesalazine is one of the two components of sulfasalazine, the other being sulfapyridine. While mesalazine is the ...

5.2. Pharmacokinetic properties

Absorption After the administration of oral doses of 500 mg of mesalazine t.i.d. to patients with ulcerative colitis, the steady-state mean plasma concentrations of 5-ASA and Ac-5-ASA (major metabolite) ...

5.3. Preclinical safety data

Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, carcinogenic and toxicity to reproduction and development. Kidney toxicity (renal ...

6.1. List of excipients

Sodium carbonate, anhydrous Glycine Povidone Cellulose, microcrystalline Croscarmellose sodium Silica, colloidal anhydrous Calcium stearate Methacrylic acid polymer ethyl acrylate copolymer (1:1) Methacrylic ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Aluminium/Aluminium blister packed in cartons containing 100 tablets.

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

FAES FARMA, S.A., C/Máximo Aguirre, 14, 48940 Leioa (Bizkaia), Spain

8. Marketing authorization number(s)

MA1278/00101

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 14/11/2019

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf