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SPC: AERIUS Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Aerius 5 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 5 mg desloratadine. Excipient(s) with known effect: This medicine contains lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablets.

Therapeutic indications

Aerius is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: Allergic rhinitis (see section 5.1). Urticaria (see section 5.1).

Posology and method of administration

Posology Adults and adolescents (12 years of age and over) The recommended dose of Aerius is one tablet once a day. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or ...

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine.

Special warnings and precautions for use

In the case of severe renal insufficiency, Aerius should be used with caution (see section 5.2). Desloratadine should be administered with caution in patients with medical or familial history of seizures, ...

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). Paediatric population Interaction ...

PFertility, pregnancy and lactation

Pregnancy A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/neonatal toxicity of desloratadine. Animal studies do not indicate direct or indirect ...

Effects on ability to drive and use machines

Aerius has no or negligible influence on the ability to drive and use machines based on clinical trials. Patients should be informed that most people do not experience drowsiness. Nevertheless, as there ...

Undesirable effects

Summary of the safety profile 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 ...

Overdose

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen with therapeutic doses, but the magnitude of the effects can be higher. Treatment In the ...

Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H<sub>1</sub> antagonist ATC code: R06AX27 Mechanism of action Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H ...

Pharmacokinetic properties

Absorption 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 ...

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

Shelf life: 2 years.

Special precautions for storage

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

Nature and contents of container

Aerius is supplied in blisters comprised of laminate blister film with foil lidding. The materials of the blister consist of a polychlorotrifluoroethylene (PCTFE)/Polyvinyl Chloride (PVC) film (product ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/00/160/001-013 EU/1/00/160/036

Date of first authorization / renewal of the authorization

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

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