OTEZLA Film-coated tablets (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Otezla 10 mg film-coated tablets. Otezla 20 mg film-coated tablets. Otezla 30 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 10 mg of apremilast. Each film-coated tablet contains 20 mg of apremilast. Each film-coated tablet contains 30 mg of apremilast. Excipient(s) with known effect: Each film-coated ...
Pharmaceutical form
Film-coated tablet (tablet). Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with APR engraved on one side and 10 on the opposite side. Brown, diamond shaped 20 mg film-coated tablet of 10 ...
Therapeutic indications
Psoriatic arthritis Otezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had ...
Posology and method of administration
Treatment with Otezla should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis. Posology The recommended dose of apremilast is 30 mg twice daily ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6).
Special warnings and precautions for use
Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Diarrhoea, Nausea, and Vomiting There ...
Interaction with other medicinal products and other forms of interaction
Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of apremilast. Therefore, ...
Fertility, pregnancy and lactation
Women of childbearing potential Pregnancy should be excluded before treatment can be initiated. Women of childbearing potential should use an effective method of contraception to prevent pregnancy during ...
Effects on ability to drive and use machines
Apremilast has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions in Phase III clinical studies have been gastrointestinal (GI) disorders including diarrhoea (15.7%) and nausea (13.9%). These ...
Overdose
Apremilast was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg BID) for 4.5 days without evidence of dose limiting toxicities. In case of an overdose, it is recommended ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosupressants, selective immunosuppressants ATC code: L04AA32 Mechanism of action Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly ...
Pharmacokinetic properties
Absorption Apremilast is well absorbed with an absolute oral bioavailability of approximately 73%, with peak plasma concentrations (C<sub>max</sub>) occurring at a median time (t<sub>max</sub>) of approximately ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity. There is no evidencefor immunotoxic, dermal irritation, or phototoxic ...
List of excipients
Tablet core: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate Film-coating: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350 Talc Iron oxide red (E172) The ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
The treatment initiation pack contains 27 film-coated tablets (4 x10 mg, 4x 20 mg, 19 30 mg). Not all pack sizes may be marketed
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
Marketing authorization number(s)
EU/1/14/981/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 January 2015
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