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.

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.

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.

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.

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.

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.

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.

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.

The medicine can only be obtained with a prescription and is available as capsules.

The dose and how often the medicine is taken depends on the condition being treated and whether the patient is an adult or a child.

For further information, see the package leaflet or contact your doctor or pharmacist.

The active substance in Zonisamide Viatris, 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 Viatris 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.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zonegran, and do not need to be repeated for Zonisamide Viatris.

As for every medicine, the company provided studies on the quality of Zonisamide Viatris. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Zonisamide Viatris 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.

The European Medicines Agency concluded that, in accordance with EU requirements, Zonisamide Viatris has been shown to have comparable quality and to be bioequivalent to Zonegran. Therefore, the Agency’s view was that, as for Zonegran, the benefits outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zonisamide Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Zonegran also apply to Zonisamide Viatris where appropriate.

As for all medicines, data on the use of Zonisamide Viatris are continuously monitored. Suspected side effects reported with Zonisamide Viatris are carefully evaluated and any necessary action taken to protect patients.

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

The name of the medicine was changed to Zonisamide Viatris on 15 October 2024.