Neoclarityn 5 mg film-coated tablets (2011)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Merck Sharp & Dohme Limited |
|---|---|
| Διεύθυνση | Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU |
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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