ADENURIC Film-coated tablet (2022)
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Περιεχόμενα
Name of the medicinal product
ADENURIC 80 mg film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 80 mg of febuxostat. Excipient(s) with known effects: Each tablet contains 76.50 mg of lactose (as monohydrate) For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with 80 on one side and a score line on the other side. The score line is only to facilitate breaking for ...
Therapeutic indications
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). ADENURIC is indicated in adults.
Posology and method of administration
Posology The recommended oral dose of ADENURIC is 80 mg once daily without regard to food. If serum uric acid is >6 mg/dL (357 μmol/L) after 2-4 weeks, ADENURIC 120 mg once daily may be considered. ADENURIC ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.8).
Special warnings and precautions for use
Cardio-vascular disorders In patients with pre-existing major cardiovascular diseases (e.g. myocardial infarction, stroke or unstable angina), during the development of the product and in one post registrational ...
Interaction with other medicinal products and other forms of interaction
Mercaptopurine/azathioprine On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended. Inhibition of XO by febuxostat may cause increased plasma concentrations ...
Fertility, pregnancy and lactation
Pregnancy Data on a very limited number of exposed pregnancies have not indicated any adverse effects of febuxostat on pregnancy or on the health of the foetus/new born child. Animal studies do not indicate ...
Effects on ability to drive and use machines
Somnolence, dizziness, paraesthesia and blurred vision have been reported with the use of Febuxostat. Patients should exercise caution before driving, using machinery or participating in dangerous activities ...
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg), post-authorisation safety studies (FAST ...
Overdose
Patients with an overdose should be managed by symptomatic and supportive care.
Pharmacodynamic properties
Pharmacotherapeutic group: Antigout preparation, preparations inhibiting uric acid production ATC code: M04AA03 Mechanism of action Uric acid is the end product of purine metabolism in humans and is generated ...
Pharmacokinetic properties
In healthy subjects, maximum plasma concentrations (C<sub>max</sub>) and area under the plasma concentration time curve (AUC) of febuxostat increased in a dose proportional manner following single and ...
Preclinical safety data
Effects in non-clinical studies were generally observed at exposures in excess of the maximum human exposure. Pharmacokinetic modelling and simulation of rat data suggests that, when co-administered with ...
List of excipients
<u>Tablet core:</u> Lactose monohydrate Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated <u>Tablet coating:</u> Opadry II, Yellow, 85F42129 ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets. ADENURIC 80 mg is available in pack sizes of 14, 28, 42, 56, 84 and 98 film-coated tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Marketing authorization number(s)
EU/1/08/447/001 EU/1/08/447/002 EU/1/08/447/005 EU/1/08/447/006 EU/1/08/447/007 EU/1/08/447/008 EU/1/08/447/013 EU/1/08/447/014 EU/1/08/447/015 EU/1/08/447/016 EU/1/08/447/017 EU/1/08/447/018
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 April 2008 Date of latest renewal: 20 December 2012
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