SKILARENCE Gastro-resistant tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Skilarence 30 mg gastro-resistant tablets. Skilarence 120 mg gastro-resistant tablets.
Qualitative and quantitative composition
Skilarence 30 mg: Each gastro-resistant tablet contains 30 mg dimethyl fumarate. Skilarence 120 mg: Each gastro-resistant tablet contains 120 mg dimethyl fumarate. Excipient with known effect: Skilarence ...
Pharmaceutical form
Gastro-resistant tablet. Skilarence 30 mg: White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg: Blue, film-coated, round, biconvex tablet with a diameter ...
Therapeutic indications
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Posology and method of administration
Skilarence is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Posology To improve tolerability, it is recommended to begin treatment ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe gastrointestinal disorders. Severe hepatic or renal impairment. Pregnancy and breast-feeding.
Special warnings and precautions for use
Haematology Skilarence may decrease leukocyte and lymphocyte counts (see section 4.8). It has not been studied in patients with pre-existing low leukocyte or lymphocyte counts. Before treatment Prior to ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Skilarence should be used cautiously in combination with other systemic antipsoriatic therapy (e.g. methotrexate, retinoids, psoralens, ciclosporin, immunosuppressants ...
Fertility, pregnancy and lactation
Women of child-bearing potential Skilarence is not recommended in women of child-bearing potential not using appropriate contraception. In patients experiencing diarrhoea during Skilarence treatment, the ...
Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been conducted. Skilarence may have a minor influence on the ability to drive and use machines. Dizziness and fatigue may occur following administration ...
Undesirable effects
Summary of the safety profile The most common adverse reactions observed with Skilarence in the Phase III clinical study (1102) in psoriasis patients were gastrointestinal events (62.7%), flushing (20.8%) ...
Overdose
Symptomatic treatment is indicated in the case of an overdose. No specific antidote is known.
Pharmacodynamic properties
Pharmacotherapeutic group: Other immunosuppressants ATC code: L04AX07 Mechanism of action The anti-inflammatory and immunomodulating effects of dimethyl fumarate and its metabolite monomethyl fumarate ...
Pharmacokinetic properties
Absorption After oral administration, dimethyl fumarate is not detected in plasma because it is rapidly hydrolysed by esterases to its active metabolite monomethyl fumarate. After oral administration of ...
Preclinical safety data
Non-clinical safety pharmacology and genotoxicity data reveal no special hazard for humans. Toxicology The kidney was identified as a major target organ of toxicity in non-clinical studies. Renal findings ...
List of excipients
Core: Lactose monohydrate Cellulose microcrystalline Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Coating: Skilarence 30 mg: Methacrylic acid-ethyl acrylate copolymer (1:1) Talc ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Skilarence 30 mg: 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs. Skilarence 120 mg: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets in PVC/PVDC-aluminium ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Marketing authorization number(s)
EU/1/17/1201/001 EU/1/17/1201/002 EU/1/17/1201/003 EU/1/17/1201/004 EU/1/17/1201/005 EU/1/17/1201/006 EU/1/17/1201/007 EU/1/17/1201/008 EU/1/17/1201/009 EU/1/17/1201/010 EU/1/17/1201/011 EU/1/17/1201/012 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 june 2017
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