ZONISAMIDE 25 mg Hard Capsules

Зміст інструкції

1. Zonisamide Viatris 25 mg hard capsules, 50 mg hard capsules, 100 mg hard capsules
   1. What is Zonisamide Viatris and what it is used for
   2. What you need to know before taking Zonisamide Viatris
   3. How to take Zonisamide Viatris
   4. Possible side effects
   5. How to store Zonisamide Viatris
   6. Contents of the pack and other information

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

zonisamide

Read 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Zonisamide Viatris is and what it is used for
• 2. What you need to know before you take Zonisamide Viatris
• 3. How to take Zonisamide Viatris
• 4. Possible side effects
• 5. How to store Zonisamide Viatris
• 6. Contents of the pack and other information

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

Zonisamide Viatris contains the active substance zonisamide and is used as an antiepileptic drug.
Zonisamide Viatris is used for the treatment of epileptic seizures that affect a part of the
brain (partial seizures), which may or may not be followed by a seizure that affects the whole brain
(secondary generalization).
Zonisamide Viatris can be used:

• alone for the treatment of epileptic seizures in adults
• 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 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 and medicines for diabetes based on sulfonylureas.

Warnings and precautions
Zonisamide Viatris belongs to a group of medicines (sulfonamides) that can cause serious
allergic reactions, severe skin rashes and changes in blood counts, which very rarely can
lead to death (see section 4. Possible side effects).
A small number of people treated with antiepileptics, such as zonisamide, have had self-harming thoughts or suicide. If at any time you have these thoughts, contact your
doctor immediately.

In association with zonisamide therapy, severe skin rashes (rash) occur,
including cases of Stevens-Johnson syndrome.
The use of Zonisamide Viatris can cause high 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 that
causes an excessive amount of ammonia to accumulate in the body (urea cycle disorder) or have
liver problems. Tell 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 greater risk of reduced sweating, heatstroke, pneumonia and liver problems. If you are under 6 years of age, Zonisamide Viatris is not recommended for you.
• you are elderly, as the dosage of Zonisamide Viatris may need to be adjusted and because you may be more likely to develop an allergic reaction, severe rash, swelling of the feet and legs, and itching when taking Zonisamide Viatris (see section 4 Possible side effects).
• you suffer from liver problems, as the dosage may need to be adjusted when you take Zonisamide Viatris.
• you suffer from eye disorders, such as glaucoma.
• you suffer from kidney problems, as the dosage may need to be adjusted when you take Zonisamide Viatris.
• you have had kidney stones in the past, as there may be an increased risk of them developing again. To reduce the risk of kidney stones, drink a sufficient amount of water.
• you live or are on vacation in a place where the climate is hot. Zonisamide Viatris can cause a decrease in sweating, which could cause an increase in body temperature. To reduce the risk of excessive increase in body temperature, drink a sufficient amount of water and try to stay cool.
• you are underweight or have lost a lot of weight, as Zonisamide Viatris may cause further weight loss. Tell your doctor, as this may need to be monitored.
• you are pregnant or might become pregnant (see section “Fertility, pregnancy and breastfeeding” for further information).

If you fall into any of these categories, tell your doctor before taking Zonisamide Viatris.

Children and adolescents
Talk to your doctor about the following risks:
Prevention of overheating and dehydration in children
Zonisamide Viatris can reduce your child's sweating levels and lead to overheating and if
your child is not treated properly, it can cause brain damage and death. Children are
at greater risk, especially when it is very hot.
While your child is taking Zonisamide Viatris:

• keep your child cool, especially in hot weather
• your child should avoid any intense physical activity, especially when it is very hot
• give your child plenty of cold water to drink
• your child should not take these medicines: carbonic anhydrase inhibitors (such as topiramate and acetazolamide) and anticholinergic drugs (such as clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).

If your child's skin is very hot but sweating is poor or absent, if your child feels
confused, if they have muscle cramps or their heartbeat or breathing becomes
faster:

• take your child to a cool, shady place
• apply a sponge soaked in cool (but not cold) water to your child's skin
• give your child cold water to drink
• seek urgent medical attention.
• Body weight: check your child's weight every month and see your doctor as soon as possible if your child's weight is not increasing sufficiently. 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 acids in the blood and kidney stones: reduce these risks by ensuring your child drinks enough water and is not taking other medicines that may lead to the formation of kidney stones (see Other medicines). Your doctor will monitor your child's bicarbonate levels and kidneys (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 possible benefits outweigh 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 those available without a prescription.

• Zonisamide Viatris must be used with caution in adults when taking medicines that can cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide Viatris may increase the levels of some medicines, such as digoxin and quinidine, in the blood; therefore, their dose may need to be reduced.
• Other medicines, such as phenytoin, carbamazepine, phenobarbital and rifampicin, may reduce the levels of Zonisamide Viatris in the blood. This may require an adjustment of the dose of Zonisamide Viatris.

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 potential, you should use adequate contraception 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, tell your doctor immediately. Do not stop treatment without having
spoken to your doctor.
You should only take Zonisamide Viatris during pregnancy as directed by your doctor.
Research has 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 than expected for their age at birth compared to
babies born to mothers treated with lamotrigine monotherapy. Make sure you are fully
aware of the risks and benefits of using zonisamide to treat epilepsy during
pregnancy.
Do not breastfeed while taking Zonisamide Viatris or for one month after stopping taking
Zonisamide Viatris.
There are no clinical data available on the effects of zonisamide on fertility in men. Studies in
animals have shown changes in fertility parameters.

Driving and using machines
Zonisamide Viatris may affect concentration and the ability to react/respond and
may cause you to feel drowsy, especially at the beginning of treatment or after an increase in
the dose. Be particularly careful when driving vehicles or using machines if these effects occur 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 your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.

Recommended dose for adults
When taking Zonisamide Viatris alone:

• The initial dose is 100 mg, taken once a day.
• This dose may be increased in increments of up to 100 mg, at intervals of one or two weeks.
• The recommended dose is 300 mg once a day.

When taking Zonisamide Viatris with other antiepileptic medicines:

• The initial dose is 50 mg per day, taken in two equal doses of 25 mg.
• This dose may be increased to 100 mg at intervals of one or two weeks.
• The recommended daily dose is between 300 mg and 500 mg.
• Some patients respond to lower dosages. The dose may be increased more slowly if side effects occur, in elderly patients, or if there are kidney or liver problems.

Use in children (from 6 to 11 years) and adolescents (from 12 to 17 years) with a body weight of
at least 20 kg:
The initial dose is 1 mg for each kg of body weight, taken once a day.

• This dose may be increased by 1 mg for each kg of body weight, at intervals of one to two weeks.
• The recommended daily dose is from 6 to 8 mg for a child with a body weight of up to 55 kg or from 300 to 500 mg for a child with a body weight of over 55 kg (depending on the lower dose), taken once a day.

Example: a child weighing 25 kg should take 25 mg once a day for the first week,

and 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, contact your
doctor or pharmacist.

• The Zonisamide Viatris capsules must be swallowed whole with water.
• Do not chew the capsules.
• Zonisamide Viatris can be taken once or twice a day, as directed by your doctor.
• If you take Zonisamide Viatris twice a day, half of the daily dose must 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 more Zonisamide Viatris than you should, immediately inform the
person who cares for you (relative or friend), your doctor or pharmacist, or contact the emergency department of the nearest hospital, bringing the medicine with you. An overdose may cause drowsiness and loss of consciousness. You may also experience nausea, stomach pain, muscle contractions, eye movements, a feeling of fainting, 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, do not worry and take the next dose when it is due.
• Do not take a double dose to make up for a missed dose.

If you stop taking Zonisamide Viatris

• Zonisamide Viatris is intended to be taken as a long-term medicine. 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 reduce the risk of further seizures

If you have 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 serious
allergic reactions, severe skin rashes and blood disorders, which very rarely can
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 overheating - high body temperature but with little or no sweating, rapid heartbeat and accelerated breathing, muscle cramps and confusion
• you have thoughts of harming yourself or committing suicide. A small number of people treated with antiepileptics like Zonisamide Viatris have had thoughts of harming themselves or committing suicide
• you have muscle pain or a feeling of weakness, as this could be a sign of abnormal muscle degeneration that could lead to kidney problems
• you experience sudden back or stomach pain, pain when urinating or notice blood in your urine, as these could be a sign 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:

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

The doctor may decide to stop administering Zonisamide Viatris.
The most common side effects of Zonisamide Viatris are mild. They occur during the first
month of treatment and usually subside with continued treatment. In children aged 6 to
17 years, the side effects were consistent with those described below, with the following exceptions:
pneumonia, dehydration, decreased sweating (common), abnormal liver enzymes (not
common), middle ear infection, sore throat, sinus and chest infections, cough, nosebleeds,
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, reduction of bicarbonate levels in the blood (a substance that prevents blood from becoming acidic)

Common: may affect up to 1 in 10 people

• difficulty sleeping, strange or unusual thoughts, anxiety or emotionality
• slowed thinking, loss of concentration, speech abnormalities, abnormal skin sensation (tingling), tremor, involuntary eye movements
• kidney stones
• skin rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss
• bruising (small bruise on the skin caused by blood leaking from a broken blood vessel)
• weight loss, nausea, indigestion, stomach pain, diarrhea (loose stools), constipation
• swelling of the feet and legs
• vomiting
• mood alteration
• increased levels of creatinine (a waste product normally eliminated by the kidneys)
• increased levels of liver enzymes in the blood

Uncommon: may affect up to 1 in 100 people

• anger, aggression, suicidal thoughts, suicide attempt
• inflammation of the gallbladder, gallstones
• urinary stones
• lung infection/inflammation, urinary tract infections
• low levels of potassium in the blood, seizures/epileptic fits
• breathing difficulties
• 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)
• shortness of breath, lung inflammation
• inflammation of the pancreas (severe pain in the stomach or back)
• liver problems, kidney failure
• severe skin rashes or skin peeling (you may also feel unwell or develop a fever)
• abnormal muscle degeneration (you may experience muscle pain or weakness), which could lead to kidney problems
• swollen glands, blood disorders (reduction in the number of blood cells, which can increase the risk of infections and cause paleness, fatigue and fever and promote bruising)
• decreased sweating, excessive increase in body temperature.
• problems concerning urine
• increased levels of creatine phosphokinase or urea in the blood detectable in a blood test
• abnormalities in liver function tests
• glaucoma, which is a blockage of fluid in the eye that causes increased pressure in the eye. Symptoms can include eye pain, blurred vision, or vision loss, which may be signs of glaucoma.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 the package after
Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• capsule content: 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 ingredient is zonisamide. Each capsule contains 50 mg of zonisamide.
The other ingredients are:

• capsule content: 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 ingredient is zonisamide. Each capsule contains 100 mg of zonisamide.
The other ingredients are:

• capsule content: 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 contents of the pack
Zonisamide Viatris 25 mg hard capsules have an opaque white body and a white cap, with
‘Z 25’ printed in black and contain white/off-white powder.
Zonisamide Viatris 50 mg hard capsules have a white body and a white cap, with printed
‘Z 50’ in red and contain white/off-white powder.
Zonisamide Viatris 100 mg hard capsules have a white body and a white cap, with
‘Z 100’ printed in black and contain white/off-white powder.
Zonisamide Viatris 25 mg and 50 mg are available in blisters of 14, 28, 56 capsules and perforated blisters
(unit dose) of 14 × 1 capsule.
Zonisamide Viatris 100 mg is available in blisters of 28, 56, 98 and 196 capsules and perforated blisters (dose
unit) of 56 × 1 capsule.
Not all pack sizes may be available.

Marketing Authorisation 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 on this medicine, 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 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
ViatrisLimited
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

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 18711600
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .