Zonisamide Viatris: detailed information

Patient Information Leaflet

Zonisamide Viatris 25 mg hard capsules, 50 mg hard capsules, 100 mg hard capsules

zonisamide
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Zonisamide Viatris is and what it is used for
What you need to know before taking Zonisamide Viatris
How to take Zonisamide Viatris
Possible side effects
How to store Zonisamide Viatris
Contents of the pack and other information

1. What Zonisamide Viatris is and what it is used for

Zonisamide Viatris contains the active substance zonisamide and is used as an antiepileptic medicine.
Zonisamide Viatris is used to treat seizures affecting one part of the
brain (partial seizures), which may or may not be followed by a seizure affecting the whole brain
(secondarily generalized).
Zonisamide Viatris can be used:

alone for the treatment of epileptic seizures in adults
in combination with other antiepileptic medicines for the treatment of epileptic seizures in adults, adolescents, and children from 6 years of age.

2. What you need to know before taking Zonisamide Viatris

Do not take Zonisamide Viatris:

if you are allergic to zonisamide or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to other sulfonamide medicines, for example: sulfonamide antibiotics, thiazide diuretics, or sulfonylurea antidiabetic medicines.

Warnings and precautions
Zonisamide Viatris belongs to a group of medicines (sulfonamides) that may cause severe
allergic reactions, serious skin rashes, and blood disorders, which very rarely may
lead to death (see section 4. Possible side effects).
A small number of people treated with antiepileptic medicines, such as zonisamide, have had
thoughts of self-harm or suicide. If you have these thoughts at any time, contact your
doctor immediately.
Serious skin rashes (rash), including cases of Stevens-Johnson syndrome, may occur
during treatment with zonisamide.
The use of Zonisamide Viatris may cause elevated levels of ammonia in the blood, which could
lead to changes in brain function, especially if you are also taking other medicines
that can increase ammonia levels (e.g., valproate), have a genetic disorder causing excessive
ammonia accumulation in the body (urea cycle disorder), or have liver problems. Contact your doctor immediately if you experience unusual drowsiness or disorientation.
Talk to your doctor or pharmacist before taking Zonisamide Viatris if:

you are under 12 years of age, as you may be at increased risk of reduced sweating, heat stroke, pneumonia, and liver problems. If you are under 6 years of age, Zonisamide Viatris is not recommended for you.
you are elderly, because your dose of Zonisamide Viatris may need to be adjusted and you may have a higher risk of developing an allergic reaction, serious skin rash, swelling of the feet and legs, and itching when taking Zonisamide Viatris (see section 4 Possible side effects).
you have liver problems, because your dose of Zonisamide Viatris may need to be adjusted.
you have eye disorders, such as glaucoma.
you have kidney problems, because your dose of Zonisamide Viatris may need to be adjusted.
you have previously had kidney stones, as there may be an increased risk of recurrence. To reduce the risk of kidney stones, drink an adequate amount of water.
you live in or are visiting a hot climate. Zonisamide Viatris may cause reduced sweating, which could lead to increased body temperature. To reduce the risk of excessive rise in body temperature, drink sufficient amounts of water and try to stay cool.
you are underweight or have lost a lot of weight, because Zonisamide Viatris may cause further weight loss. Inform your doctor, as this may need to be monitored.
you are pregnant or may become pregnant (see section “Fertility, pregnancy and breastfeeding” for further information).

If you fall into any of these categories, inform your doctor before taking Zonisamide Viatris.
Children and adolescents
Discuss the following risks with your doctor:
Prevention of overheating and dehydration in children
Zonisamide Viatris may reduce your child’s sweating and lead to overheating; if
your child is not treated promptly, this may result in brain damage or death. Children are
at higher risk, especially in hot weather.
While your child is taking Zonisamide Viatris:

keep your child cool, especially in high temperatures
your child should avoid strenuous physical activity, especially in hot weather
ensure your child drinks plenty of cold water
your child should not take the following medicines: carbonic anhydrase inhibitors (such as topiramate and acetazolamide) and anticholinergic medicines (such as clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin).

If your child’s skin is very hot but sweating is little or absent, if your child feels confused, has muscle cramps, or has rapid heartbeat or breathing:

move your child to a cool, shaded place
sponge your child’s skin with cool (but not cold) water
give your child cold water to drink
contact your doctor urgently.
- Body weight: monitor your child’s weight monthly and see your doctor as soon as possible if your child is not gaining weight adequately. Zonisamide Viatris is not recommended for underweight children or those with poor appetite, and should be used with caution in children weighing less than 20 kg.
- Increased levels of acid in the blood and kidney stones: reduce these risks by ensuring your child drinks enough water and is not taking other medicines that may promote kidney stone formation (see Other medicines). Your doctor will monitor your child’s blood bicarbonate levels and kidney function (see also section 4).

Do not give this medicine to children under 6 years of age, as it is not known in this age group whether the potential benefits outweigh the risks.
Other medicines and Zonisamide Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those without a prescription.

Zonisamide Viatris should be used with caution in adults who are also taking medicines that may cause kidney stones, such as topiramate or acetazolamide. This combination is not recommended in children.
Zonisamide Viatris may increase blood levels of certain medicines, such as digoxin and quinidine; therefore, their dose may need to be reduced.
Other medicines, such as phenytoin, carbamazepine, phenobarbital, and rifampicin, may reduce the blood levels of Zonisamide Viatris. This may require adjustment of the Zonisamide Viatris dose.

Zonisamide Viatris with food and drink
Zonisamide Viatris can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are a woman of childbearing age, you must use an adequate contraceptive method while taking Zonisamide Viatris and for one month after stopping it.
If you are planning a pregnancy, talk to your doctor before stopping contraception and before becoming pregnant about the possibility of switching to other suitable treatments. If you are or suspect you may be pregnant, inform your doctor immediately. Do not stop treatment without discussing it with your doctor.
You should take Zonisamide Viatris during pregnancy only as directed by your doctor.
Studies have shown an increased risk of birth defects in children of women treated with
antiepileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems with brain development) for your baby after taking Zonisamide Viatris during pregnancy is not known. One study showed that babies born to mothers who used zonisamide during pregnancy were smaller at birth than expected compared to babies born to mothers treated with lamotrigine monotherapy. Make sure you are fully aware of the risks and benefits of using zonisamide for the treatment of epilepsy during pregnancy.
Do not breastfeed while taking Zonisamide Viatris or for one month after stopping Zonisamide Viatris.
There are no clinical data available on the effects of zonisamide on fertility in men. Animal studies have shown changes in fertility parameters.
Driving and using machines
Zonisamide Viatris may affect your concentration and your ability to react/respond,
and may make you feel drowsy, especially at the beginning of treatment or after a dose increase. Exercise particular caution when driving or operating machinery if you experience these effects after taking Zonisamide Viatris.
Zonisamide Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to take Zonisamide Viatris

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose for adults

When taking Zonisamide Viatris alone:

The starting dose is 100 mg taken once daily.
This dose may be increased by up to 100 mg at intervals of one or two weeks.
The recommended dose is 300 mg once daily.

When taking Zonisamide Viatris with other antiepileptic medicines:

The starting dose is 50 mg per day, taken as two equal doses of 25 mg.
This dose may be increased by up to 100 mg at intervals of one or two weeks.
The recommended daily dose ranges from 300 mg to 500 mg.
Some patients respond to lower doses. The dose may be increased more slowly if side effects occur, in elderly patients, or in patients with kidney or liver problems.

Use in children (6 to 11 years) and adolescents (12 to 17 years) with body weight of at least 20 kg:

The starting dose is 1 mg per kg of body weight, taken once daily.

This dose may be increased by 1 mg per kg of body weight at intervals of one to two weeks.
The recommended daily dose is 6 to 8 mg per kg for a child weighing up to 55 kg, or 300 to 500 mg once daily for a child weighing more than 55 kg (whichever is lower).

Example: a child weighing 25 kg should take 25 mg once daily during the first week, then increase the daily dose by 25 mg at the beginning of each week, until reaching a daily dose between 150 and 200 mg.

If you feel that the effect of Zonisamide Viatris is too strong or too weak, consult your doctor or pharmacist.

Zonisamide Viatris capsules must be swallowed whole with water.
Do not chew the capsules.
Zonisamide Viatris may be taken once or twice daily, according to your doctor's instructions.
If you take Zonisamide Viatris twice daily, half of the daily dose should be taken in the morning and half in the evening.

If you take more Zonisamide Viatris than you should

If you think you may have taken too much Zonisamide Viatris, immediately contact the person caring for you (a relative or friend), your doctor or pharmacist, or go to the nearest hospital emergency department, taking the medicine with you. Taking an excessive dose may cause drowsiness and loss of consciousness. You may also experience nausea, stomach ache, muscle twitching, eye movements, feeling faint, slowed heartbeat, and reduced breathing and kidney function. Do not attempt to drive.

If you forget to take Zonisamide Viatris

If you forget to take a dose, do not worry; take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Zonisamide Viatris

Zonisamide Viatris is intended for long-term use. Do not reduce the dose or stop taking the medicine unless instructed by your doctor.
If your doctor advises you to stop taking Zonisamide Viatris, the dose will be gradually reduced to lower the risk of further epileptic seizures.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Zonisamide Viatris belongs to a group of medicines (sulfonamides) that can cause serious allergic reactions, severe skin rashes and blood disorders, which very rarely may lead to death.

Contact your doctor immediately if:

you have difficulty breathing, swelling of the face, lips or tongue, or a severe skin rash, as these symptoms could indicate a serious allergic reaction
you have signs of heat stroke – high body temperature but with little or no sweating, rapid heartbeat and fast breathing, muscle cramps and confusion
you have thoughts of harming yourself or of suicide. A small number of patients treated with antiepileptic medicines such as Zonisamide Viatris have had thoughts of self-harm or suicide
you have muscle pain or feel weak, as these could be signs of abnormal muscle breakdown which could lead to kidney problems
you suddenly get back or stomach pain, have painful urination or notice blood in your urine, as these could be signs of kidney stones
you develop vision problems, such as eye pain or blurred vision, while taking zonisamide.

Contact your doctor as soon as possible if:

you develop an unexplained skin rash, as it could progress to a more serious rash or skin peeling
you feel unusually tired or feverish, have a sore throat, swollen glands or notice you bruise easily, as this could mean a blood disorder
you develop signs of increased acid levels in the blood – headache, drowsiness, shortness of breath and loss of appetite. This may require monitoring or treatment by your doctor.

Your doctor may decide to stop treatment with Zonisamide Viatris.
The most common side effects of Zonisamide Viatris are mild. They occur during the first month of treatment and usually improve with continued treatment. In children aged 6 to 17 years, side effects were consistent with those described below, with the following exceptions: pneumonia, dehydration, decreased sweating (common), liver enzyme abnormalities (uncommon), middle ear infection, sore throat, sinus and chest infections, cough, epistaxis, rhinorrhea, stomach pain, vomiting, skin rashes, eczema and fever.

Very common: may affect more than 1 in 10 people

agitation, irritability, confusion, depression
poor muscle coordination, dizziness, poor memory, drowsiness, double vision
loss of appetite, reduced levels of bicarbonate in the blood (a substance that prevents the blood from becoming too acidic)

Common: may affect up to 1 in 10 people

difficulty sleeping, unusual or strange thoughts, anxiety or emotional lability
slowed thinking, difficulty concentrating, speech abnormalities, abnormal sensations on the skin (tingling), tremor, involuntary eye movements
kidney stones
skin rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss
bruising (small discoloured area on the skin caused by bleeding from a broken blood vessel)
weight loss, nausea, indigestion, stomach pain, diarrhoea (loose stools), constipation
swelling of the feet and legs
vomiting
mood changes
increased levels of creatinine (a waste product normally removed by the kidneys)
increased levels of liver enzymes in the blood

Uncommon: may affect up to 1 in 100 people

rage, aggression, suicidal thoughts, suicide attempt
inflammation of the gallbladder, gallstones
urinary stones
lung infection/inflammation, urinary tract infections
low potassium levels in the blood, seizures/epileptic fits
breathing disorders
hallucinations
abnormal urine tests

Very rare: may affect up to 1 in 10,000 people

memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures)
breathlessness, lung inflammation
pancreatitis (severe stomach or back pain)
liver problems, kidney failure
severe skin rashes or skin peeling (you may also feel unwell or develop a fever)
abnormal muscle breakdown (you may feel muscle pain or weakness), which could lead to kidney problems
swollen glands, blood disorders (reduced number of blood cells, which may increase the risk of infections, cause paleness, tiredness and fever, and make bruising more likely)
decreased sweating, excessive increase in body temperature
problems related to urine
increased blood levels of creatine phosphokinase or urea detectable in a blood test
abnormalities in liver function tests
glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye. Symptoms may include eye pain, blurred vision or reduced vision, which may be signs of glaucoma.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zonisamide Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zonisamide Viatris contains
Zonisamide 25 mg hard capsules.
The active substance is zonisamide. Each capsule contains 25 mg of zonisamide.
The other components are:

capsule contents: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate
capsule shell: gelatin and titanium dioxide (E171)
printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Zonisamide 50 mg hard capsules
The active substance is zonisamide. Each capsule contains 50 mg of zonisamide.
The other components are:

capsule contents: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate
capsule shell: gelatin and titanium dioxide (E171)
printing ink: shellac and red iron oxide (E172)

Zonisamide 100 mg hard capsules
The active substance is zonisamide. Each capsule contains 100 mg of zonisamide.
The other components are:

capsule contents: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate
capsule shell: gelatin and titanium dioxide (E171)
printing ink: shellac, black iron oxide (E172), and potassium hydroxide.

Description of the appearance of Zonisamide Viatris and package contents
Zonisamide Viatris 25 mg hard capsules have an opaque white body and a white cap, printed with ‘Z 25’ in black, and contain white/whitish powder.
Zonisamide Viatris 50 mg hard capsules have a white body and a white cap, printed with ‘Z 50’ in red, and contain white/whitish powder.
Zonisamide Viatris 100 mg hard capsules have a white body and a white cap, printed with ‘Z 100’ in black, and contain white/whitish powder.
Zonisamide Viatris 25 mg and 50 mg are available in blister packs of 14, 28, 56 capsules and perforated blister packs (unit dose) of 14 × 1 capsules.
Zonisamide Viatris 100 mg is available in blister packs of 28, 56, 98, and 196 capsules and perforated blister packs (unit dose) of 56 × 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Noucor Health, S.A.
Av. Camí Reial, 51–57
08184 Palau-Solita i Plegamans – Barcelona
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00 (Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft
Tel.: +36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: +356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylian BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OU
Tel: +372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals S.L.U.
Tel: +34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: +48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: +351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: +39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20-720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Sverige
Viatris AB
Tel: +46 (0) 8630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 1 8711600

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu