InfoCons Consumer Protection informs you – Zonisamide Viatris – Package Leaflet

Before anything else

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

Zonisamide Viatris contains the active substance zonisamide, a nd is used as an antiepileptic medicine.

Zonisamide Viatris is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation).

Zonisamide Viatris may be used:

• on its own to treat seizures in adults
• with other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and abo ve.

⚠️ 2. What you need to know before you take Zonisamide Viatris

Do not take Zonisamide Viatris

• if you a re allergic to zonisamide or any of the other ingredients of this medicine (listed in section 6).
• if you a re allergic to other sulfonamide medicines. Exa mples include: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.

Warn ings and precautions Zonisamide Viatris belongs to a group of medicines (sulfonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4. Pos sible Side Ef fects).

A small number of people being treated with antiepileptics such as zonisamide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Serious rashes occur in association with zonisamide therapy, including cases of Stevens-Johnson syndr ome.

The use of Zonisamide Viatris may lead to high levels of ammonia in the blood which could lead to a change in brain function, especially if you are also taking other medicines which can increase ammonia levels (for example valproate), have a genetic disorder causing build -up of too mu ch ammonia in the body (urea cycle disorder), or if you have liver problems. Tell your doctor immediately if you become unusually drowsy or confused.

Talk to your doctor or pharmacist before taking Zonisamide Viatris if you:

• are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumon ia and liver problems. If you are younger than 6 years old, Zonisamide Viatris is not recommended for you
• are elderly, as your dose of Zonisamide Viatris may need a djusting, and you may be more likely to develop an a llergic reaction, severe skin rash, sw elling of the feet and legs, and itchiness when taking Zonisamide Viatris (see section 4 P ossible Side Effects)
• suffer from liver problems, as your dose of Zonisamide Viatris may need a djusting
• have eye problems such as glaucoma
• suffer from kidney problems as your dose of Zonisamide Viatris may need a djusting
• have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones. Reduce the risk of kidney stones by drinking sufficient water
• live in a place or are on holiday in a place where the weather is warm. Zonisamide Viatris can make you pe rspire less, which can cause your body temperature to increase. Reduce the risk of overheating by drinking sufficient water and k eeping cool
• are underweight, or have lost a lot of weight as Zonisamide Viatris can cause you to lose more weight. Tell your doctor as this may need to be monitored.
• are pregnant or could become pregnant (see section ‘pregnanc y, breas t-feeding and fertilit y’ for further information).

If any of these applies to you, tell your doctor before you take Zonisamide Viatris .

Children and adolescents

Talk to your doctor about the following risks:

Preventing overheating and dehydration in children Zonisamide Viatris can ca use your child to sweat less and overheat and if your child is not treated this can lead to brain damage and dea th. Children are most at risk especially in hot weather.

When your child is taking Zonisamide Viatris :

• keep your child cool especially in hot weather
• your child must avoid hea vy exercise especially when the we ather is hot
• give your child plenty of cold water to drink
• your child must not take these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, h aloperidol, imipramine and oxybutynin).

If your child’s skin feels very hot with little or no sw eating, beco mes confused, has muscle cramps, or your child’s heartbeat or breathing beco mes rapid:

• take your child to a cool, shaded place
• spon ge your child’s skin with cool (not cold) water
• give your child cold water to drink
• seek urgent medical assistance.
• Body weight: You sh ould monitor your c hild’s weight every month and see your doctor as soon as possible if your child is not gaining enou gh weight. Zonisamide Viatris is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
• Increased acid level in the blood and kidney stones: Reduce these risks by ensuring that your child drinks enough water and is not taking any other medicine whi ch could cause kidney stones (see Other medicines). Your doctor will monitor your child’s blood bicarbonate levels and kidneys (see also section 4).

Do not give this medicine to ch ildren below the age of 6 years because it is not known for this age group whether the potential benefits are greater than the risks.

Other medicines and Zonisamide Viatris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained wi thout a prescription.

• Zonisamide Viatris should be used carefully in adults when taken with medicines that can cause kidney s tones, like topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide Viatris could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
• Other medicines like phen ytoin, carbamazepine, p henobarbitone and rifampicin can decrease your blood levels of Zonisamide Viatris , which may require an adjustment of your dose of Zonisamide Viatris .

Zonisamide Viatris with food a nd drink Zonisamide Viatris can be taken w ith or without food.

Pregnanc y, breast-feeding and fertility If you are a woman of childbearing age you must use adequ ate contraception while taking, and for one month after stopping, Zonisamide Viatris .

If you are planning a pregnancy, talk to your doctor before you stop contraception and before you become pregnant about the possibility of switching to other suitable treatments. If you are or think you might be pregnant, tell your doctor straight away. You should not stop your treatment without discussing this with your doctor.

You must only take Zonisamide Viatris during your pregnancy if your doctor tells you to. Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems with brain development) for your child after taking Zonisamide Viatris during your pregnancy is unknown. A study showed that babies born to mothers using zonisamide during pregnancy were smaller than expected for their age at birth, compared with babies born to mothers treated with lamotrigine monotherapy. Make sure you are fully informed about the risks and the benefits of using zonisamide fo r epilepsy during pregnancy.

Do not breast-feed whilst taking, or for one month after stopping Zonisamide Viatris .

There are no clinical data available on the effects of zonisamide on human fertility. Studies in animals have shown changes in fertility parameters.

Driving and u sing machines Zonisamide Viatris may affect your conce ntration, a bility to react/respond, a nd may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased. Be especially careful while driving or operating machinery if Zonisamide Viatris affects you in this way.

Zonisamide Viatris contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule , that is to say essentially ‘sodium – free’.

💊 3. How to take Zonisamide Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pha rmacist if you are not sure.

The recommended adult dose When you take Zonisamide Viatris on its own:

• The starting dose is 100 mg taken on ce a day.
• This may be increased by up to 100 mg at intervals of two weeks.
• The recommended dose is 300 mg once a day.

When you take Zonisamide Viatris with other a ntiepileptic medicines:

• The starting dose is 50 mg daily taken in two equal doses of 25 mg.
• This may be increased by up to 100 mg at intervals of one to two weeks.
• The recommended daily dose is between 300 mg and 500 mg.
• Some peop le respond to lower doses. The dose may be increased more slowly if you expe rience side effects, are elderly or if you su ffer from kidney or liver problems.

Use in children (aged 6 to 11 yea rs) and adolescents (aged 12 to 17 years) weighing at least 20 kg:

• The starting dose is 1 mg per kg of body weight taken once a day.
• This 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 with a body weight of up to 55 kg or 300 to 500 mg for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day.

Example: A child who weighs 25 kg should take 25 mg once a day for the first week, and then increase the daily dose by 25 mg at the start of each week until a daily dose between 150 to 200 mg is reache d.

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

• Zonisamide Viatris capsules must be swallowed wh ole with water.
• Do not chew the capsules.
• Zonisamide Viatris can be taken on ce or twice daily, as instructed by your doctor.
• If you take Zonisamide Viatris twice a day, take half the daily dose in the morning and h alf in the evening.

If you take more Zonisamide Viatris than you shou ld If you may have taken more Zonisamide Viatris than you should, tell a carer (relative or friend), your doctor or pha rmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you. You may beco me sleepy and c ould lose consciousness. You might also feel sick, have a so re stomach, muscle twitches, eye movement, feel faint, have a slowed heartbeat, and reduced breathing and kidney function. Do not try to drive.

If you forget to take Zonisamide Viatris

• If you forget to take a dose, don’t worry: take the next dose when it is due.
• Do not take a dou ble dose to make up for a forgotten do se.

If you stop taking Zonisamide Viatris

• Zonisamide Viatris is meant to be taken as a long-term medicine. Do not reduce your dose or stop your medicine unless your doctor tells you to.
• If your doctor advises you to stop taking Zonisamide Viatris your dose will be reduced gradually to lower the risk of more seizures.

If you ha ve any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Zonisamide Viatris belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, s evere skin rashes, and blood disorders, which very rarely can be fatal.

Conta ct your d octor immediately if you:

• have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction
• have signs of overheating – high body temperature but little or no swe ating, rapid heartbeat and breathing, muscle cramps, and co nfusion
• have thoughts of harming or killing yourself. A small number of people being treated with anti- epileptics such as Zonisamide Viatris have had thoughts of harming or killing themselves
• have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems
• get a sudden pain in your back or stomach, ha ve pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones
• develop visual problems such as eye pain or blurred vision while taken zonisamide .

Conta ct your d octor as soon as po ssible if you:

• have an une xplained skin rash, as this could develop into a more severe skin rash or skin peeling
• feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder
• have signs of increased acid level in the blood- heada ches, drowsiness, shortness of breath and loss of appetite. Your doctor may need to monitor or treat this.

Your doctor may decide that you sho uld stop using Zonisamide Viatris .

The most common side effects of Zonisamide Viatris are mild. They occur during the first month of treatment and usually decrease with continued treatment. In children ages 6 – 17 years old, side effects were consistent with those described below with the following exceptions: pneumonia, deh ydration, sweating decreased (common), abnormal liver enzymes (unco mmon), middle ear infection, sore throat, sinus and chest infections, cough, nosebleeds, runny nose, stomach pain, vomiting, rash, eczema and fever .

Very c ommon (may affect more than 1 in 10 people):

• agitation, irritability, con fusion, depression
• poor muscle coordination, dizziness, poor memory, sleepiness, dou ble vision
• loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from beco ming acidic).

Common (may affect up to 1 in 10 peo ple)

• difficulty sleeping, strange or unusual thoughts, feeling anxious or emotional
• slowed thoughts, loss of concen tration, speech abnormalities, abnormal skin sensation (pins and need les), tremor, involuntary movement of the eyes
• kidney stones
• skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss
• ecchymosis (a small bruise caused by blood leaking from broken blood vessels in the skin)
• loss of weight, nausea, indigestion, stomach p ains, diarrhoea (loose stools), constipation
• swelling of the feet and legs
• vomiting
• mood swings
• increased blood levels of creatinine (a waste product that your kidneys should normally remove)
• increased levels of liver enzymes in the blood .

Uncommon (may affect up to 1 in 100 people)

• anger, aggression, thoughts of suicide, suicide attempt
• gall bladder inflammation, gallstones
• urinary stones
• lung infection / inflammation, u rinary tract infections
• low blood potassium levels, con vulsions/seizures
• breathing disorders
• hallucinations
• abnormal urine tests .

Very ra re (may affect up to 1 in 10,000 people):

• memory loss, coma, neu roleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures)
• shortness of breath, inflammation of the lungs
• inflammations of the pancreas (severe pain in the stomach or back)
• liver problems, kidney failure
• severe rashes or skin peeling (at the same time you may feel unwell or develop a fever)
• abno rmal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems
• swol len glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and c an make you look pale, feel tired and feverish, and bruise more easily)
• decreased sweating, overheating
• problems with your urine
• increased blood levels of creatine phosphokinase or ure a which can be seen in a blood test
• abnormal results from liver function tests
• glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye. Eye pain , blurred vision or decreased vision may occur and can be signs of glaucoma .

Repor ting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 the 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack 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 ingredients are:

• capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate
• 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 ingredients are:

• capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate
• capsule shell: gelatin and titanium dioxide (E171)
• printing ink: shellac and iron oxide red (E172) Zonisamide 100 mg hard capsules:

The active substance is zonisamide. Each capsule contains 100 mg of zonisamide.

The other ingredients are:

• capsule contents: microcrystalline cellulose, hydrogenated vegetable o il and sodium laurilsulfate
• capsule shell: gelatin and titanium dioxide (E171)
• printing ink: shellac, black iron oxide (E172) and potassium hydroxide.

What Zonisamide Viatris looks like and con tents of the pack Zonisamide Viatris 25 mg hard capsules have a white body and a white cap, marked ‘Z 25’ in black and contain a white/almost white powder.

Zonisamide Viatris 50 mg hard cap sules have a white body and white cap, marked ‘Z 50’ in red and contain a white/almost white powder.

Zonisamide Viatris 100 mg hard capsules have a white body and white cap , marked ‘Z 100’ in black and contain a white/almost white powder.

Zonisamide Viatris 25 mg and 50 mg a re available in blister packs of 14, 28, 56 capsules and perforated unit dose blister packs of 14 x 1 capsules.

Zonisamide Viatris 100 mg a re available in blister packs of 28, 56, 98 and 196 capsules and perforated unit dose blister packs of 56 x 1 capsules.

Not all pack sizes may be marketed.

Mark eting Autho risation Holder Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN Ireland Man ufacturer Noucor Health, S.A.

Av Cami Reial 51 -57 08184 Palau -Solita i Plegamans – Barcelona Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation 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 Mylan BV Tel: + 31 (0)20 426 3300 Eesti Viatris OÜ Tel: + 372 6363 052 Norge Viatris AS Tlf: + 47 66 75 33 00 Ελλάδα Viatris Hellas Ltd Τηλ: + 30 210 0 100 002 Österreich Viatris Austria GmbH Tel: + 43 1 86390 España Viatris Pharmaceuticals S.L.

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 (0)2 612 46921 Suomi/Finland Viatris Oy Puh/Tel: + 358 20 720 9555 Κύπρος GPA Pharmaceuticals Ltd Τηλ: + 357 22863100 Sverige Viatris AB Tel: + 46 (0)8 630 19 00 Latvija Viatris SIA Tel: + 371 676 055 80 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: + 353 18711600

This leaflet was last revised in MM/YYYY

Detailed information on this medicine is available on the Eur opean Medicines Agency web site: http://www .ema.europa.eu

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Zonisamide Viatris (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1093).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.