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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

MEZAVANT XL Gastro-resistant, prolonged release tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Mezavant XL 1200mg, gastro-resistant, prolonged release tablets.

Qualitative and quantitative composition

Each tablet contains 1200mg mesalazine. For a full list of excipients, see section 6.1.

Pharmaceutical form

Gastro-resistant, prolonged release tablets. Red-brown, ellipsoidal, film-coated tablet, debossed on one side with S476.

Therapeutic indications

For the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis. For maintenance of remission.

Posology and method of administration

Mezavant XL is intended for once daily, oral administration. The tablets must not be crushed or chewed and should be taken with food. Adults, including the elderly (>65 years) For induction of remission: ...

Contraindications

History of hypersensitivity to salicylates (including mesalazine) or any of the excipients of Mezavant XL. Severe renal impairment (GFR <30ml/min/1.73m²) and/or severe hepatic impairment.

Special warnings and precautions for use

Reports of renal impairment, including minimal change nephropathy, acute/chronic interstitial nephritis and renal failure have been associated with preparations containing mesalazine and pro-drugs of mesalazine. ...

Interaction with other medicinal products and other forms of interaction

Drug-drug interaction studies in healthy adult subjects have been conducted with Mezavant to investigate any effect of Mezavant on the pharmacokinetics and safety of three commonly used antibiotics. There ...

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 ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Mezavant is considered to have negligible influence on these abilities.

Undesirable effects

The most frequently reported adverse drug reactions (ADRs)within the pooled safety analysis of clinical studies with Mezavant, including 3,611 patients, were colitis (including ulcerative colitis) 5.8%, ...

Overdose

Mezavant 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, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Aminosalicyclic acid and similar agents ATC code: A07EC02 Mechanism of action Mesalazine is an aminosalicylate. The mechanism of action of mesalazine is not fully understood, ...

Pharmacokinetic properties

The mechanism of action of mesalazine (5-ASA) is not fully understood but appears to be topical, and therefore the clinical efficacy of Mezavant does not correlate with the pharmacokinetic profile. A major ...

Preclinical safety data

Effects in nonclinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

List of excipients

<u>Tablet core:</u> Carmellose sodium Carnauba wax Stearic acid Silica, colloidal hydrated Sodium starch glycolate (Type A) Talc Magnesium stearate <u>Film-coating:</u> Talc Methacrylic acid – Methyl methacrylate ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Store below 25°C. Store in the original package in order to protect from moisture.

Nature and contents of container

Tablets are packed in polyamide/aluminium/PVC foil blister packs with aluminium push-through foil. Packs contain 60 or 120 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Shire Pharmaceutical Contracts Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom

Marketing authorization number(s)

PL 08081/0040

Date of first authorization / renewal of the authorization

Date of first authorisation: 23<sup>rd</sup> February 2007 Date of last renewal: 13<sup>th</sup> December 2011

Date of revision of the text

April 2019

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