MIZOLLEN Modified-release tablet Ref.[8631] Active ingredients: Mizolastine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Therapeutic indications

Mizolastine is a long-acting H1-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.

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 unabsorbed medicinal product.

Studies in patients with renal insufficiency suggest that haemodialysis does not increase clearance of the medicinal product.

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 not store above 25°C.

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 caps: Packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Tablets should not be taken if they become discoloured.

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