XEFO Film-coated tablets (2015)
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Περιεχόμενα
Name of the medicinal product
Xefo 4 mg film-coated tablets.
Qualitative and quantitative composition
One film-coated tablet contains 4 mg lornoxicam. Excipients: 94 mg Lactose monohydrate. For a full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White to yellowish oblong film-coated tablet with imprint L04.
Therapeutic indications
Short-term relief of acute mild to moderate pain. Symptomatic relief of pain and inflammation in osteoarthritis. Symptomatic relief of pain and inflammation in rheumatoid arthritis.
Posology and method of administration
For all patients the appropriate dosing regimen should be based upon individual response to treatment. Pain 8-16 mg lornoxicam daily divided into 2 or 3 doses. Maximum recommended daily dose is 16 mg. ...
Contraindications
Hypersensitivity to lornoxicam or to any of the excipients. Thrombocytopenia. Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including acetylsalicylic acid. ...
Special warnings and precautions for use
For the following disorders, lornoxicam should only be administered after careful risk-benefit assessment: Renal impairment: Lornoxicam should be administered with precaution in patients with mild (serum ...
Interaction with other medicinal products and other forms of interaction
Concomitant administration of lornoxicam and: Cimetidine: Increased plasma concentrations of lornoxicam. (No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated). ...
Pregnancy and lactation
Pregnancy Lornoxicam is contraindicated on the third trimester of pregnancy and should not be used during pregnancy in the first and second trimesters and delivery, as no clinical data on exposed pregnancies ...
Effects on ability to drive and use machines
Patients showing dizziness and/or sleepiness under treatment with lornoxicam should refrain from driving or operation machinery.
Undesirable effects
The most commonly observed adverse events of NSAIDs are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). ...
Overdose
At this time, there is no experience of overdose to permit definition of the consequence of an overdose, or to suggest specific managements. However, it can be expected that after an overdose with lornoxicam, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids, oxicams ATC code: M01AC05 Lornoxicam is a non-steroidal anti-inflammatory drug with analgesic properties and belongs ...
Pharmacokinetic properties
Absorption Lornoxicam is absorbed rapidly and almost completely from the gastrointestinal tract. Maximum plasma concentrations are achieved after approximately 1-2 hours. The absolute bioavailability of ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Lornoxicam caused renal toxicity ...
List of excipients
Core: Lactose monohydrate Cellulose, microcrystalline Povidone K 30 Croscarmellose sodium Magnesium stearate Film: Macrogol Titanium dioxide (E171) Talc Hypromellose
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Blister: Do not store above 30°C.
Nature and contents of container
Blister: Opaque PVC/Aluminium. Each blister strip contains 10 film-coated tablets. Pack sizes: 10, 20, 30, 50 and 100 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS HP10 0DF, United Kingdom
Marketing authorization number(s)
PA 1547/005/001
Date of first authorization / renewal of the authorization
Date of First Authorisation: 22 May 2009 Date of last renewal: 17 January 2011
Date of revision of the text
February 2015
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