ARCOXIA Film-coated tablet (2016)
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Περιεχόμενα
Name of the medicinal product
ARCOXIA 30 mg film-coated tablets. ARCOXIA 60 mg film-coated tablets. ARCOXIA 90 mg film-coated tablets. ARCOXIA 120 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib. Excipients with known effect: 30 mg tablet: 1.3 mg lactose (as monohydrate). 60 mg tablet: 2.7 mg lactose (as monohydrate). 90 mg tablet: ...
Pharmaceutical form
Film-coated tablets (tablets). 30 mg tablets: Blue-green, apple-shaped biconvex tablets debossed 101 on one side and ACX 30 on the other side. 60 mg tablets: Dark green, apple-shaped, biconvex tablets ...
Therapeutic indications
ARCOXIA is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of ...
Posology and method of administration
Posology As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patients need ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active peptic ulceration or active gastro-intestinal (GI) bleeding. Patients who, after taking acetylsalicylic ...
Special warnings and precautions for use
Gastrointestinal effects Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with etoricoxib. Caution ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Oral anticoagulants In subjects stabilised on chronic warfarin therapy, the administration of etoricoxib 120 mg daily was associated with an approximate 13% increase in prothrombin ...
Fertility, pregnancy and lactation
Pregnancy No clinical data on exposed pregnancies are available for etoricoxib. Studies in animals have shown reproductive toxicity (see section 5.3). The potential for human risk in pregnancy is unknown. ...
Effects on ability to drive and use machines
Patients who experience dizziness, vertigo or somnolence while taking etoricoxib should refrain from driving or operating machinery.
Undesirable effects
Summary of the safety profile In clinical trials, etoricoxib was evaluated for safety in 9,295 individuals, including 6,757 patients with OA, RA, chronic low back pain or ankylosing spondylitis (approximately ...
Overdose
In clinical studies, administration of single doses of etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. There have been reports of acute overdosage ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs ATC code: M01AH05 Mechanism of Action Etoricoxib is an oral, selective cyclo-oxygenase-2 (COX-2) inhibitor ...
Pharmacokinetic properties
Absorption Orally administered etoricoxib is well absorbed. The absolute bioavailability is approximately 100%. Following 120 mg once-daily dosing to steady state, the peak plasma concentration (geometric ...
Preclinical safety data
In preclinical studies, etoricoxib has been demonstrated not to be genotoxic. Etoricoxib was not carcinogenic in mice. Rats developed hepatocellular and thyroid follicular cell adenomas at >2-times the ...
List of excipients
Core: Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Tablet coating: Carnauba wax Lactose monohydrate Hypromellose Titanium dioxide (E171) Triacetin ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Bottles: Keep the container tightly closed in order to protect from moisture. Blisters: Store in the original package in order to protect from moisture.
Nature and contents of container
30 mg: Aluminium/aluminium blisters in packs containing 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets. 60 mg: Aluminium/aluminium blisters in packs containing 2, ...
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
30 mg Tablets: PL 04900/0001 60 mg Tablets: PL 04900/0002 90 mg Tablets: PL 04900/0003 120 mg Tablets: PL 04900/0004
Date of first authorization / renewal of the authorization
Date of latest renewal: 30 mg Tablets: 22/10/2007 60 mg Tablets: 13/02/2002 90 mg Tablets: 13/02/2002 120 mg Tablets: 13/02/2002
Date of revision of the text
8 July 2016
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