ZYLORIC Tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Zyloric 100 mg Tablets. Zyloric 300 mg Tablets.
Qualitative and quantitative composition
Allopurinol 100 mg (Zyloric Tablets). Allopurinol 300 mg (Zyloric-300 Tablets). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Each 100 mg tablet is round, white to off-white, biconvex, bisected tablet, debossed with Z1 on one side. Each 300 mg tablet is round, white to off-white, biconvex, bisected tablet, debossed with ...
Therapeutic indications
Zyloric is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical ...
Posology and method of administration
Posology Adults Zyloric should be introduced at low dosage e.g. 100 mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should ...
Contraindications
Zyloric should not be administered to individuals known to be hypersensitive to allopurinol or to any of the components of the formulation, listed in section 6.1.
Special warnings and precautions for use
Hypersensitivity syndrome, SJS and TEN Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS) and ...
Interaction with other medicinal products and other forms of interaction
6-mercaptopurine and azathioprine Azathioprine is metabolised to 6-mercaptopurine which is inactivated by the action of xanthine oxidase. When 6- mercaptopurine or azathioprine is given concurrently with ...
Pregnancy and lactation
Pregnancy There is inadequate evidence of safety of Zyloric in human pregnancy, although it has been in wide use for many years without apparent ill consequence (see section 5.3). Use in pregnancy only ...
Effects on ability to drive and use machines
Since adverse reactions such as somnolence, vertigo and ataxia have been reported in patients receiving allopurinol, patients should exercise caution before driving, using machinery or participating in ...
Undesirable effects
For this product there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on ...
Overdose
Ingestion of up to 22.5 g allopurinol without adverse effect has been reported. Symptoms and signs including nausea, vomiting, diarrhoea and dizziness have been reported in a patient who ingested 20 g ...
Pharmacodynamic properties
Pharmacotherapeutic group: Preparations inhibiting uric acid production ATC code: M04AA01 Allopurinol is a xanthine-oxidase inhibitor. Allopurinol and its main metabolite oxipurinol lower the level of ...
Pharmacokinetic properties
Absorption Allopurinol is active when given orally and is rapidly absorbed from the upper gastrointestinal tract. Studies have detected allopurinol in the blood 30-60 minutes after dosing. Estimates of ...
Preclinical safety data
Mutagenicity Cytogenetic studies show that allopurinol does not induce chromosome aberrations in human blood cells in vitro at concentrations up to 100 micrograms/ml and in vivo at doses up to 600 mg/day ...
List of excipients
Lactose Maize Starch Povidone Magnesium Stearate Purified Water
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Do not store above 25°C. Store in the original packaging.
Nature and contents of container
Zyloric 100 mg Tablets: PVC/aluminium foil blister packs of 100 tablets. Zyloric-300 Tablets: PVC/aluminium foil blister packs (2 strips of 14 tablets).
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Aspen Pharma Trading Limited 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/0001 – Zyloric 100 mg Tablets PL 39699/0002 – Zyloric-300 Tablets
Date of first authorization / renewal of the authorization
Zyloric 100 mg Tablets: Date of first authorisation: 20.03.80 Renewal: 06.06.90 Date of latest renewal: 14.11.95 Zyloric-300 Tablets: Date of first authorisation: 14.07.80 Renewal: 18.02.91 Date of latest ...
Date of revision of the text
December 2017
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