Zonisamide Mylan

zonisamide

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This is a summary of the European public assessment report (EPAR) for Zonisamide Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zonisamide Mylan.

For practical information about using Zonisamide Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

What is Zonisamide Mylan and what is it used for?

Zonisamide Mylan is a medicine used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain). It is used on its own in newly diagnosed adults and as an ‘add-on’ therapy in adults and children aged six years and above already receiving other anti-epilepsy medicines.

Zonisamide Mylan is a ‘generic medicine’. This means that Zonisamide Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Zonegran.

Zonisamide Mylan contains the active substance zonisamide.

How is Zonisamide Mylan used?

The medicine can only be obtained with a prescription and is available as capsules (25, 50 and 100 mg).

When Zonisamide Mylan is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks. The usual maintenance dose is 300 mg a day.

When Zonisamide Mylan is used as an ‘add-on’ to existing treatment in adults, the recommended starting dose is 25 mg twice a day. After one or two weeks, the dose may be increased to 50 mg twice a day and then further increased in steps of 100 mg every week or every other week, depending on the patient’s response. Zonisamide Mylan can be given once or twice a day after an appropriate dose is reached. The usual maintenance dose is between 300 and 500 mg a day.

When Zonisamide Mylan is used as an ‘add-on’ to existing treatment in children aged six years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily. After one or two weeks, the daily dose may be increased in steps of 1 mg per kilogram every one or two weeks until an appropriate dose is reached. The usual maintenance dose is between 300 and 500 mg a day for children weighing more than 55 kg and 6 to 8 mg per kg of body weight in children weighing less than 55 kg.

Dose increases may need to be made less frequently in patients with liver or kidney problems or those taking certain other medicines. Before stopping Zonisamide Mylan, the dose should be decreased gradually. For further information, see the package leaflet.

How does Zonisamide Mylan work?

The active substance in Zonisamide Mylan, zonisamide, is an anti‑epileptic. Epileptic fits are caused by abnormal electrical activity in the brain.

Zonisamide is thought to work by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels, through which sodium or calcium normally enter nerve cells. When calcium and sodium enter nerve cells, electrical impulses can be transmitted between the nerve cells. By blocking these channels, zonisamide is expected to prevent abnormal electrical activity spreading through the brain, thereby reducing the chances of an epileptic fit.

Zonisamide Mylan also acts on the neurotransmitter gamma‑aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other). This may help to stabilise electrical activity in the brain.

How has Zonisamide Mylan been studied?

Because Zonisamide Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zonegran. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Zonisamide Mylan?

Because Zonisamide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Zonisamide Mylan approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zonisamide Mylan has been shown to have comparable quality and to be bioequivalent to Zonegran. Therefore, the CHMP’s view was that, as for Zonegran, the benefit outweighs the identified risk. The Committee recommended that Zonisamide Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Zonisamide Mylan?

A risk management plan has been developed to ensure that Zonisamide Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zonisamide Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Zonisamide Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Zonisamide Mylan on 31 March 2016.

For more information about treatment with Zonisamide Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Zonisamide Mylan : EPAR - Summary for the public BG = bălgarski 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public ES = español 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public CS = čeština 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public DA = dansk 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public DE = Deutsch 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public ET = eesti keel 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public EL = elliniká 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public EN = English 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public FR = français 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public IT = italiano 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public LV = latviešu valoda 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public LT = lietuvių kalba 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public HU = magyar 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public MT = Malti 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public NL = Nederlands 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public PL = polski 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public PT = português 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public RO = română 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public SK = slovenčina 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public SL = slovenščina 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public FI = suomi 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public SV = svenska 2016-04-06  
Zonisamide Mylan : EPAR - Summary for the public HR = Hrvatski 2016-04-06  

This EPAR was last updated on 03/04/2017 .

Authorisation details

Product details

Product details for Zonisamide Mylan
NameZonisamide Mylan
Agency product numberEMEA/H/C/004127
Active substance

zonisamide

International non-proprietary name (INN) or common name

zonisamide

Therapeutic area Epilepsy
Anatomical therapeutic chemical (ATC) code N03AX15
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Zonisamide Mylan
Marketing-authorisation holder

Mylan S.A.S.

Revision1
Date of issue of marketing authorisation valid throughout the European Union31/03/2016

Contact address:

Mylan S.A.S.
117 Allée des Parcs 
69800 Saint Priest 
France

Product information

Product information

17/03/2017  Zonisamide Mylan -EMEA/H/C/004127 -IB/0001/G

Name Language First published Last updated
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03
Zonisamide Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-04-03

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Zonisamide Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

  • Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
  • adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zonisamide Mylan : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-04-03  

Initial marketing-authorisation documents

Name Language First published Last updated
Zonisamide Mylan : EPAR - Public assessment report HR = Hrvatski 2016-04-06  
CHMP summary of opinion for Zonisamide Mylan HR = Hrvatski 2016-01-29  

Authorised

This medicine is approved for use in the European Union

More information on

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