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Neoclarityn 5 mg film-coated tablets (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Merck Sharp & Dohme Limited
Διεύθυνση :
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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Δωρεάν εγγραφή

Name of the medicinal product

Neoclarityn 5 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 5 mg desloratadine. For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablets.

Therapeutic indications

Neoclarityn is indicated for the relief of symptoms associated with: allergic rhinitis (see section 5.1) urticaria (see section 5.1)

Posology and method of administration

Adults and adolescents (12 years of age and over): one tablet once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic ...

Contraindications

Hypersensitivity to the active substance, to any of the excipients, or to loratadine.

Special warnings and precautions for use

Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established. In the case of severe renal insufficiency, Neoclarityn should be used with caution (see section 5.2). ...

Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1). In a clinical pharmacology ...

Pregnancy and lactation

Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during pregnancy has not been established. The use of Neoclarityn during pregnancy is therefore not recommended. ...

Effects on ability to drive and use machines

In clinical trials that assessed the driving ability, no impairment occurred in patients receiving desloratadine. However, patients should be informed that very rarely some people experience drowsiness, ...

Undesirable effects

In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Neoclarityn were reported in 3 ...

Overdose

In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. Based on a multiple dose clinical trial, in which up to ...

Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H1 antagonist ATC code: R06AX27 Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1-receptor antagonist activity. ...

Pharmacokinetic properties

Desloratadine plasma concentrations can be detected within 30 minutes of administration. Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase ...

Preclinical safety data

Desloratadine is the primary active metabolite of loratadine. Non-clinical studies conducted with desloratadine and loratadine demonstrated that there are no qualitative or quantitative differences in ...

List of excipients

Tablet core: Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Maize starch Talc Tablet coating: Film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

Do not store above 30°C. Store in the original package.

Nature and contents of container

Neoclarityn is supplied in unit dose blisters comprised of laminant blister film with foil lidding. The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC) ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom

Marketing authorization number(s)

EU/1/00/161/001-013

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 January 2001 Date of last renewal: 15 January 2006

Date of revision of the text

16 September 2011