Zonisamide Viatris 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Zonisamide Mylan 25 mg hard capsules EFG

Zonisamide Mylan 50 mg hard capsules EFG

Zonisamide Mylan 100 mg hard capsules EFG

zonisamide

Read the entire leaflet carefully before you start taking this medicine because 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Zonisamida Mylan is and what it is used for

Zonisamida Mylan contains the active substance zonisamide and is used as an antiepileptic.

Zonisamida Mylan 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 entire brain (secondary generalization).

Zonisamida Mylan can be used:

• Alone to treat epileptic seizures in adults.
• In combination with other antiepileptic medicines to treat epileptic seizures in adults, adolescents, and children aged 6 years and older.

2. What you need to know before starting Zonisamide Mylan

Do not take Zonisamide Mylan:

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

Warnings and precautions

Zonisamide Mylan belongs to a group of medicines (sulfonamides) that may cause serious allergic reactions, severe rashes, and blood disorders, which very rarely may lead to death (see section 4. Possible side effects).

A small number of people taking 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.

Consult your doctor or pharmacist before starting to take Zonisamide Mylan:

• if you are under 12 years of age, as you may have an increased risk of reduced sweating, heat stroke, pneumonia, and liver problems. The use of Zonisamide Mylan is not recommended in children under 6 years of age.
• if you are elderly, as the dose of Zonisamide Mylan may need to be adjusted, and you may have a higher risk of developing an allergic reaction, severe rash, swelling of the legs and feet, or itching while taking Zonisamide Mylan (see section 4. Possible adverse effects).
• if you have liver problems, as the dose of Zonisamide Mylan may need to be adjusted.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as the dose of Zonisamide Mylan may need to be adjusted.
• if you have previously had kidney stones, as you may be at increased risk of developing further kidney stones. Reduce the risk of developing kidney stones by drinking enough water.
• if you live in or are travelling to a hot climate. Zonisamide Mylan can reduce your sweating, which may cause your body temperature to rise. Reduce the risk of overheating by drinking enough water and keeping cool.
• if you are underweight or have lost a lot of weight, as Zonisamide Mylan may cause you to lose more weight. Inform your doctor, as monitoring may be necessary.
• if you are pregnant or could become pregnant (for further information, see section

"Pregnancy, breastfeeding and fertility").

If any of these situations apply to you, inform your doctor before taking Zonisamide Mylan.

Children and adolescents

Consult your doctor regarding the following risks:

• Weight: You should monitor your child's weight monthly and consult your doctor as soon as possible if they do not gain sufficient weight. Zonisamida Mylan is not recommended in children who are underweight or have poor appetite, and it should be used with caution in children weighing less than 20 kg.
• Increased acid levels in the blood and kidney stones: Reduce these risks by ensuring your child drinks enough water and does not take any medication that may cause kidney stones (see Other medicines). Your doctor will monitor your child's blood bicarbonate levels and kidney function (see also section 4).

Do not administer this medicine to children under 6 years of age, as it is not known whether the potential benefits outweigh the risks in this age group.

Use of Zonisamida Mylan with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• Zonisamida Mylan should be used with caution in adults if taken with medications that may cause kidney stones, such as topiramate or acetazolamide. This combination is not recommended in children.

• Zonisamida Mylan may possibly increase blood levels of medications such as digoxin and quinidine, and therefore it may be necessary to reduce the dose of these medicines.

• Other medicines such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease blood levels of Zonisamida Mylan, which could require adjustment of the Zonisamida Mylan dose.

Taking Zonisamida Mylan with food and drinks Zonisamida Mylan may be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are a woman of childbearing age, you must use effective contraception during treatment with Zonisamida Mylan and for one month after stopping Zonisamida Mylan.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Do not stop treatment without consulting your doctor.

You should take Zonisamida Mylan during pregnancy only if specifically instructed by your doctor. Research shows an increased risk of birth defects in children of women who take antiepileptic medicines.

One study showed that children whose mothers used zonisamide during pregnancy were smaller than expected for their age at birth, compared to children whose mothers were treated with lamotrigine monotherapy. Make sure you receive detailed information about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed while taking Zonisamida Mylan or during one month after stopping Zonisamida Mylan.

There are no clinical data available on the effect of zonisamide on human fertility. Animal studies have shown changes in fertility parameters.

Driving and use of machines

Zonisamida Mylan may affect concentration and reaction/response ability, and may cause drowsiness, especially at the beginning of treatment or after a dose increase. If Zonisamida Mylan affects you in this way, take special care when driving or operating machinery.

Zonisamida Mylan contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; thus, it is essentially "sodium-free".

3. How to take Zonisamida Mylan

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Recommended dose in adults

If you are taking Zonisamida Mylan alone:

• The initial dose is 100 mg once daily.
• It may be increased by 100 mg at two-week intervals.
• The recommended dose is 300 mg once daily.

If you are taking Zonisamida Mylan with other antiepileptic medicines:

• The initial dose is 50 mg per day, divided into two equal doses of 25 mg.
• It 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 people respond to lower doses. The dose may be increased more slowly if you experience adverse effects or if you have kidney or liver problems.

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

• The initial dose is 1 mg per kg of body weight once daily.
• It may be increased by 1 mg per kg of body weight at intervals of one to two weeks.
• The recommended daily dose is between 6 mg and 8 mg per kg for a child with a body weight of up to 55 kg, or between 300 mg and 500 mg for a child with a body weight above 55 kg (whichever is lower), once daily.

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

If you think that the effect of Zonisamida Mylan is too strong or too weak, inform your doctor or pharmacist.

• Zonisamida Mylan capsules must be swallowed whole with water.
• Do not chew the capsules.
• Zonisamida Mylan may be taken once or twice daily, according to your doctor's instructions.
• If you take Zonisamida Mylan twice daily, take half of the daily dose in the morning and the other half at night.

If you take more Zonisamida Mylan than you should

If you have taken more Zonisamida Mylan than you should, inform immediately the person caring for you (family member or friend), your doctor or pharmacist, or contact the nearest hospital emergency department, and bring the medicine with you. You may feel drowsy and could lose consciousness. You may also feel nauseous, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heartbeat, and experience reduced breathing and kidney function. Do not attempt to drive.

If you forget to take Zonisamida Mylan

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

If you stop taking Zonisamida Mylan

• Zonisamida Mylan is intended to be taken as a long-term medication. Do not reduce the dose or stop taking the medicine unless instructed by your doctor.

• If your doctor advises you to stop taking Zonisamida Mylan, they will gradually reduce the dose to decrease the risk of having more seizures.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Zonisamide Mylan belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe 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 rash, as these symptoms may indicate that you are having a severe allergic reaction.

• you have signs of overheating: high body temperature with little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.

• you have had thoughts of harming yourself or of suicide. A small number of people taking antiepileptic medicines such as Zonisamide Mylan have had thoughts of self-harm or suicide.

• you have muscle pain or feel weak, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems.

• you have sudden pain in your back or stomach, pain when urinating, or notice blood in your urine, as this may be a sign of kidney stones.

• you develop visual problems, such as eye pain or blurred vision, while taking zonisamide.

Contact your doctor as soon as possible if:

• you develop an unexplained rash, as it may 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 more easily, as this may mean you have a blood disorder.
• you have signs of increased acid levels in the blood: headache, drowsiness, difficulty breathing, and loss of appetite. Medical monitoring or treatment may be necessary.

Your doctor may decide that you should stop taking Zonisamide Mylan.

The adverse effects of Zonisamide Mylan most commonly reported are all mild in nature. They occur during the first month of treatment and often decrease with continued treatment. In children aged 6 to 17 years, adverse effects were consistent with those described below, except for the following: pneumonia, dehydration, decreased sweating (frequent), abnormal liver enzymes (infrequent), otitis media (inflammation and infection of the middle ear), sore throat, sinusitis and respiratory tract infection, cough, epistaxis, rhinorrhea, abdominal pain, vomiting, skin rash, 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, decreased levels of bicarbonate in blood (a substance that prevents blood from becoming acidic)

Common (may affect up to 1 in 10 people)

• difficulty sleeping, unusual or strange thoughts, feeling anxious or emotionally unstable.

• slowed thinking, difficulty concentrating, speech abnormalities, abnormal skin sensation (tingling), tremor, involuntary eye movements.

• kidney stones.

• rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss.

• bruising (a small bruise caused by blood from a broken blood vessel in the skin).

• weight loss, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation.

• swelling of legs and feet.

• vomiting

• mood changes

• increased levels of creatinine in blood (creatinine is a waste product normally removed by the kidneys)

• increased levels of liver enzymes in blood.

Uncommon (may affect up to 1 in 100 people)

• rage, aggression, suicidal thoughts, suicide attempt.
• inflammation of the gallbladder or gallstones.
• urinary stones.
• lung infection/inflammation, urinary tract infections.
• low potassium levels in blood and seizures/attacks.
• Respiratory disorders
• Hallucinations
• Abnormal urine test results.

Rare (may affect up to 1 in 1,000 people)

• memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), epileptic status (prolonged or repeated seizures).
• breathing difficulty, lung inflammation.
• pancreatitis (severe stomach or back pain)
• liver problems, kidney failure
• severe rashes or skin peeling (you may also feel unwell and have a fever).
• abnormal muscle breakdown (you may have muscle pain or weakness) which can lead to kidney problems.
• swollen glands, blood disorders (reduction in blood cell count, which may make you more prone to infections, appear pale, feel tired and feverish, and bruise more easily).
• decreased sweating, excessive body temperature.
• problems with urine
• increased levels of creatine phosphokinase or urea in blood, as seen in blood tests
• abnormal liver function test results.
• glaucoma, which is a blockage of fluid in the eye causing increased pressure. Eye pain, blurred vision, or vision loss may occur and may be signs of glaucoma.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zonisamide Mylan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zonisamide Mylan

Zonisamide 25 mg hard capsules EFG:

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 EFG:

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 EFG:

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

The other components are: shellac, black iron oxide (E172) and potassium hydroxide.

• 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.

Appearance of Zonisamide Mylan and contents of the pack

Zonisamide Mylan 25 mg hard capsules have a white body and a white cap, with "Z 25" printed in black and contain a white/almost white powder.

Zonisamide Mylan 50 mg hard capsules have a white body and a white cap, with "Z 50" printed in red and contain a white/almost white powder.

Zonisamide Mylan 100 mg hard capsules have a white body and a white cap, with "Z 100" printed in black and contain a white/almost white powder.

Zonisamide Mylan 25 mg and 50 mg are available in blister packs of 14, 28 and 56 capsules and in unit dose perforated blister packs of 14 x 1 capsule.

Zonisamide Mylan 100 mg is available in blister packs of 28, 56, 98 and 196 capsules and in unit dose perforated blister packs of 56 x 1 capsule.

Only certain pack sizes may be available.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allée des Parcs

69 800 Saint Priest,

France

Manufacturer

• Uriach y Compañía, S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans – Barcelona

Spain

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: March 2018

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.