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MIZOLLEN Modified-release tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Mizollen 10 mg modified-release tablets.

Qualitative and quantitative composition

Mizolastine 10mg per tablet. Excipients with known effect: Lactose monohydrate (125mg/tablet). Hydrogenated castor oil (25mg/tablet). Propylene glycol (0.45mg/tablet). For the full list of excipients, ...

Pharmaceutical form

Modified-release tablet. Oblong, white tablets with a scored line on one side and a mark MZI 10 on the reverse side.

Therapeutic indications

Mizolastine is a long-acting H<sub>1</sub>-antihistamine indicated for the symptomatic relief of seasonal allergic rhinoconjunctivitis (hay fever), perennial allergic rhinoconjunctivitis and urticaria. ...

Posology and method of administration

Adults, including the elderly, and children 12 years of age and over: The recommended daily dose is one 10mg tablet.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration with macrolide antibiotics or systemic imidazole antifungals. Significantly impaired ...

Special warnings and precautions for use

Mizolastine has a weak potential to prolong the QT interval in a few individuals. The degree of prolongation is modest and has not been associated with cardiac arrhythmias. The elderly may be particularly ...

Interaction with other medicinal products and other forms of interaction

Although the bioavailability of mizolastine is high and the medicinal product is principally metabolised by glucuronidation, systemically administered ketoconazole and erythromycin moderately increase ...

Pregnancy and lactation

Pregnancy The safety of mizolastine for use in human pregnancy has not been established. The evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect ...

Effects on ability to drive and use machines

Most patients taking mizolastine may drive or perform tasks requiring concentration. However, in order to identify sensitive people who have unusual reactions to medicinal products, it is advisable to ...

Undesirable effects

Gastro-intestinal disorders Common: dry mouth, diarrhoea, abdominal pain (including dyspepsia), nausea. Not known: vomiting. Central nervous system disorders and psychiatric disorders Common: drowsiness ...

Overdose

In cases of overdose, general symptomatic surveillance with cardiac monitoring including QT interval and cardiac rhythm for at least 24 hours is recommended, along with standard measures to remove any ...

Pharmacodynamic properties

Antihistamines for systemic use ATC code: R06AX25 Mechanism of action Mizolastine possesses antihistamine and antiallergic properties due to a specific and selective antagonism of peripheral histamine ...

Pharmacokinetic properties

Following oral administration mizolastine is rapidly absorbed. Peak plasma concentration is reached at a median time of 1.5 hours. Bioavailability is 65% and linear kinetics have been demonstrated. The ...

Preclinical safety data

Pharmacological studies in several species have shown an effect on cardiac repolarisation at doses in excess of 10-20 times the therapeutic dose. In conscious dogs, mizolastine has shown pharmacological ...

List of excipients

Core: Hydrogenated castor oil Lactose monohydrate Microcrystalline cellulose Tartaric acid Povidone Anhydrous colloidal silica Magnesium stearate Film-coating: Hypromellose Titanium dioxide (E171) Propylene ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years in Aluminium/ (oPA/Aluminium/PVC) blisters. 2 years in Aluminium/PVC blisters. 3 years in securitainers.

Special precautions for storage

Store in the original package. Aluminium/ (oPA/Aluminium/PVC) blisters: This medicinal product does not require any special temperature storage conditions. Aluminium/PVC blisters and securitainers: Do ...

Nature and contents of container

Aluminium/(oPA/Aluminium/PVC) blisters: Packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets. Aluminium/PVC blisters: Packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets. Polypropylene tablet container with polyethylene ...

Special precautions for disposal and other handling

Tablets should not be taken if they become discoloured.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization number(s)

PL 04425/0384

Date of first authorization / renewal of the authorization

Date of first authorisation: 7 March 2003 Date of latest renewal: 21 November 2005

Date of revision of the text

5 September 2019

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