GRISEOFULVIN Film-coated tablets (2011)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Griseofulvin 500mg Tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 500mg griseofulvin. For a full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White to off white, round, biconvex film-coated tablet.
Therapeutic indications
The treatment of fungal infections of the skin, scalp, hair, or nails (Tinea barbae, Tinea capitis, Tinea corporis, Tinea cruris, Tinea pedis, Tinea unguium) where topical therapy is considered inappropriate, ...
Posology and method of administration
General For oral administration. Tablets should be swallowed whole with a glass of water. Griseofulvin is recommended to be taken after a high fat meal, for increased absorption and minimising GI distress, ...
Contraindications
Griseofulvin is contraindicated in patients who have: Hypersensitivity to griseofulvin or to any of the excipients, see section 6.1 Porphyria Severe hepatic impairment Systemic Lupus Erythematosus (SLE) ...
Special warnings and precautions for use
Griseofulvin is reccomended after a high fat meal for increased absorption and minimising GI distress. Griseofulvin is contraindicated in patients with severe hepatic impairment, see section 4.3. In patients ...
Interaction with other medicinal products and other forms of interaction
Medicinal Products Griseofulvin may depress plasma levels, and therefore the efficacy, of concommitantly administered medicinal products that are metabolised by cytochrome P450 3A4. Interactions of Griseofulvin ...
Pregnancy and lactation
Pregnancy There are case reports of human foetal abnormalities associated with griseofulvin. There are no adequate and well controlled studies in man, and inadequate epidemiological data. Griseofulvin ...
Effects on ability to drive and use machines
Griseofulvin has no or negligible influence on the ability to drive and use machines. However, it may cause drowsiness, confusion dizziness, and impaired co-ordination, see section 4.8. Patients should ...
Undesirable effects
The following frequencies are used for the description of the occurrence of undesirable effects: Very common: ≥1/10 Common: ≥1/100, <1/10 Uncommon: ≥1/1,000, <1/100 Rare: ≥1/10,000, <1/1,000 Very rare: ...
Overdose
No case of overdose has been reported. Symptoms The likely symptoms of any overdose would be nausea, nomiting, headache, numbness and tingling, confusion, and vertigo. Urticaria or porphyria could occur. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antifungals for systemic use ATC code: D01BA01 Griseofulvin is an antifungal antibiotic that is active in vivo against common dermatophytes. The antifungal effect is manifested ...
Pharmacokinetic properties
Absorption The absorption of griseofulvin from the gastrointestinal tract is varaible and incomplete. On average, less than 50% of the oral dose is absorbed, but administration after a fatty meal, and ...
Preclinical safety data
Griseofulvin can induce aneuploidy and meiotic delay in mouse oocytes following oral administration of high doses, i.e. 250mg/kg or greater. In addition, griseofulvin caused increases in numerical and ...
List of excipients
Tablet core: Maize starch Microcrystalline cellulose E460 Sodium laurilsulphate Povidone E1201 Magnesium stearate E470b Film coat: Hypromellose E464 Ethylcellulose E462 Polysorbate 80 E433 Propylene glycol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Unopened container: 36 Months. Opened container: 6 Months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Polypropylene (PP) tablet container with linear low density polyethylene (LLDPE) screw closure. Tablet containers with 90 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Brown &Burk UK Ltd, 5 Marryat Close, Hounslow West, Middlesex, TW4 5DQ, United Kingdom
Marketing authorization number(s)
PL25298/0094
Date of first authorization / renewal of the authorization
25/05/2010 / 09/03/2014
Date of revision of the text
30/11/2011
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
