ZONEGRAN Hard capsule (2023)
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Περιεχόμενα
Name of the medicinal product
Zonegran 25 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 25 mg of zonisamide. Excipient with known effect: Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from soyabean). For the full list of excipients, see section ...
Pharmaceutical form
Hard capsule. A white opaque body and a white opaque cap printed with a logo and ZONEGRAN 25 in black.
Therapeutic indications
Zonegran is indicated as: monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1); adjunctive therapy in the ...
Posology and method of administration
Posology Adults Dosage escalation and maintenance Zonegran may be taken as monotherapy or added to existing therapy in adults. The dose should be titrated on the basis of clinical effect. Recommended ...
Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to sulphonamides. Zonegran contains Hydrogenated vegetable oil (from soyabean). Patients must not take this medicinal ...
Special warnings and precautions for use
Unexplained rash <b>Serious rashes occur in association with Zonegran therapy, including cases of Stevens-Johnson syndrome.</b> Consideration must be given to discontinuing Zonegran in patients who develop ...
Interaction with other medicinal products and other forms of interaction
Effect of Zonegran on cytochrome P450 enzymes <em>In vitro</em> studies using human liver microsomes show no or little (<25%) inhibition of cytochrome P450 isozymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential must use effective contraception during treatment with Zonegran, and for one month after discontinuation. Zonegran must not be used in women ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, given that some patients may experience drowsiness or difficulty with concentration, particularly early ...
Undesirable effects
Summary of the safety profile Zonegran has been administered to over 1,200 patients in clinical studies, more than 400 of whom received Zonegran for at least 1 year. In addition there has been extensive ...
Overdose
There have been cases of accidental and intentional overdose in adult and paediatric patients. In some cases, the overdoses were asymptomatic, particularly where emesis or lavage was prompt. In other cases, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiepileptics, other antiepileptics <b>ATC code:</b> N03AX15 Zonisamide is a benzisoxazole derivative. It is an anti-epileptic medicine with weak carbonic anhydrase activity ...
Pharmacokinetic properties
Absorption Zonisamide is almost completely absorbed after oral administration, generally reaching peak serum or plasma concentrations within 2 to 5 hours of dosing. The first-pass metabolism is believed ...
Preclinical safety data
Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric ...
List of excipients
<u>Capsule contents:</u> Microcrystalline cellulose Hydrogenated vegetable oil (from soyabean) Sodium laurilsulfate <u>Capsule shells:</u> Gelatin Titanium dioxide (E171) Shellac Propylene glycol Potassium ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PVC/PVDC/aluminium blisters, packs of 14, 28, 56 and 84 hard capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Amdipharm Limited, 3 Burlington Road, Dublin 4, D04 RD68, Ireland
Marketing authorization number(s)
EU/1/04/307/001 EU/1/04/307/005 EU/1/04/307/002 EU/1/04/307/013
Date of first authorization / renewal of the authorization
Date of first authorisation: 10/03/2005 Date of latest renewal: 21/12/2009
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