ZONISAMIDE VIATRIS 25 mg HARD CAPSULES

2. What you need to know before you take Zonisamide Mylan

Do not take Zonisamide Mylan:

• 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 sulfonamides, e.g. sulphonamide antibiotics, thiazide diuretics and sulphonylurea antidiabetics.

Warnings and precautions

Zonisamide Mylan belongs to a group of medicines (sulfonamides) that may cause severe allergic reactions, serious skin reactions and blood disorders, which very rarely can be life-threatening (see section 4. Possible side effects).

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

Tell your doctor or pharmacist before you start taking Zonisamide Mylan:

• if you are under 12 years old, as you may have a higher risk of decreased sweating, heat stroke, pneumonia and liver problems. Zonisamide Mylan is not recommended in children under 6 years.
• if you are elderly, as your dose of Zonisamide Mylan may need to be adjusted, and you may have a higher chance of developing an allergic reaction, serious skin reaction, swelling of legs and feet and itching when taking Zonisamide Mylan (see section 4. Possible side effects).
• if you have liver problems, as your dose of Zonisamide Mylan may need to be adjusted.
• if you have eye problems such as glaucoma.
• if you have kidney problems, as your dose of Zonisamide Mylan may need to be adjusted.
• if you have previously had kidney stones, as you may have a higher risk of having more kidney stones. Reduce the risk of having kidney stones by drinking plenty of water.
• if you live in a hot place or are going on holiday to a hot place. Zonisamide Mylan may make you sweat less, which can result in your body temperature increasing. Reduce the risk of overheating by drinking plenty of water and keeping cool.
• if you are underweight or have lost a lot of weight, as Zonisamide Mylan may make you lose more weight. Tell your doctor, as your weight may need to be monitored.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine (see section “Pregnancy, breast-feeding and fertility”).

Children and adolescents

Tell your doctor about the following risks:

• Weight: you should check your child’s weight monthly and see a doctor as soon as possible if they are not gaining enough weight. Zonisamide Mylan is not recommended in children who are underweight or have a poor appetite, and should be used with caution in children with a weight below 20 kg.

• Increased blood acid levels and kidney stones: reduce these risks by making sure your child drinks plenty of water and does not take any medicines that may cause kidney stones (see Other medicines). Your doctor will check your child’s blood bicarbonate levels and kidneys (see also section 4).

Do not give this medicine to children under 6 years old as it is not known if the potential benefits are greater than the risks in this age group.

Using Zonisamide Mylan with other medicines

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

• Zonisamide Mylan should be used with caution in adults if taken with medicines that may cause kidney stones, such as topiramate or acetazolamide. In children, this combination is not recommended.
• Zonisamide Mylan may increase the levels in the blood of medicines such as digoxin and quinidine, and therefore may need to have their dose reduced.
• Other medicines such as phenytoin, carbamazepine, phenobarbitone and rifampicin may decrease the levels in the blood of Zonisamide Mylan, which may require an adjustment of the dose of Zonisamide Mylan.

Taking Zonisamide Mylan with food and drink

Zonisamide Mylan can be taken with or without food.

Pregnancy, breast-feeding and fertility

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not stop treatment without talking to your doctor.

You should only take Zonisamide Mylan during pregnancy if your doctor advises it. Research has shown a higher risk of birth defects in children of women taking antiepileptics.

A study has shown 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 are fully informed about the risks and benefits of using zonisamide for epilepsy during pregnancy.

Do not breast-feed while you are taking Zonisamide Mylan or for one month after stopping Zonisamide Mylan.

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

Driving and using machines

Zonisamide Mylan may affect your concentration, ability to react/respond, and may make you feel drowsy, especially at the start of treatment or after a dose increase. If Zonisamide Mylan affects you in this way, be especially careful when driving or using machines.

Zonisamide Mylan contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

3. How to take Zonisamide Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Recommended dose in adults

If you are taking Zonisamide Mylan on its own:

• The initial dose is 100 mg once a day.
• This can be increased by up to 100 mg at intervals of two weeks.
• The recommended dose is 300 mg once a day.

If you are taking Zonisamide Mylan with other antiepileptics:

• The initial dose is 50 mg a day divided into two equal doses of 25 mg.
• This can 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 side effects or have kidney or liver problems.

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

• The initial dose is 1 mg per kg body weight once a day.
• This can be increased by 1 mg per kg body weight at intervals of one to two weeks.
• The recommended daily dose is between 6 mg and 8 mg per kg body weight for a child weighing up to 55 kg or between 300 mg and 500 mg for a child weighing over 55 kg (the lower of these two doses) once a day.

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

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

• Zonisamide Mylan capsules should be swallowed whole with water.
• Do not chew the capsules.
• Zonisamide Mylan can be taken once or twice a day, as instructed by your doctor.
• If you take Zonisamide Mylan twice a day, take half the daily dose in the morning and the other half in the evening.

If you take more Zonisamide Mylan than you should

If you have taken more Zonisamide Mylan than you should, tell the person taking care of you (family or friend), your doctor or pharmacist, or contact the nearest hospital emergency department and take the medicine with you. You may feel drowsy and may lose consciousness. You may also feel sick, have stomach pain, muscle spasms, eye movements, feel faint, have a slow heart rate and decreased kidney and respiratory function. Do not try to drive.

If you forget to take Zonisamide Mylan

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

If you stop taking Zonisamide Mylan

• Zonisamide Mylan is intended to be taken as a long-term medicine. Do not reduce the dose or stop taking the medicine unless your doctor tells you to.

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

If you have any further questions on 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 all people suffer from them.

Zonisamida Mylan belongs to a group of medicines (sulfonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which can very rarely cause 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 excessive heat: high body temperature with little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
• you have had thoughts of self-harm or suicide. A small number of people receiving treatment with antiepileptics such as Zonisamida 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 that can lead to kidney problems.
• you have sudden back or stomach pain, painful urination, or blood in your urine, as this may be a sign of kidney stones.
• visual problems occur, such as eye pain or blurred vision, when taking zonisamida.

Contact your doctor as soon as possible if:

• you suffer from an unexplained rash, as it may become a more severe rash or skin peeling.
• you feel especially tired or feverish, have a sore throat, swollen glands, or notice that you bruise more easily, as this may indicate that you have a blood disorder.
• you have signs of increased acid levels in the blood: headaches, drowsiness, difficulty breathing, and loss of appetite. Medical monitoring or treatment may be necessary.

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

The most frequently reported adverse effects of Zonisamida Mylan are all mild. They occur during the first month of treatment and often decrease as treatment continues. In children from 6 to 17 years old, the adverse effects were consistent with those described below, except for the following exceptions: pneumonia, dehydration, decreased sweating (frequent), and abnormal liver enzymes (infrequent), otitis media (inflammation and infection of the middle ear), sore throat, sinusitis, and respiratory tract infections, 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 bicarbonate levels (a substance that prevents blood from becoming acidic) in the blood

Common (may affect up to 1 in 10 people)

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

• slow thinking, loss of concentration, speech disorders, abnormal sensation in the skin (tingling), tremors, involuntary eye movements.
• kidney stones.
• rashes, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss.
• bruising (a small hematoma caused by blood from a broken blood vessel in the skin).
• weight loss, nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.
• swelling of the legs and feet.
• vomiting
• mood changes
• increased creatinine levels in the blood (creatinine is a waste product that the kidneys should normally eliminate)
• increased liver enzyme levels in the blood.

Uncommon (may affect up to 1 in 100 people)

• rage, aggression, suicidal thoughts, attempted suicide.
• inflammation of the gallbladder or gallstones.
• urinary stones.
• pulmonary infection/inflammation, urinary tract infections.
• low potassium levels in the blood and seizures/attacks.
• Respiratory disorders
• Hallucinations
• Abnormalities in urine analysis.

Very Rare (may affect up to 1 in 10,000 people)

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

Reporting Adverse Effects

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

5. Storage of Zonisamida Mylan

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

Do not use this medicine after the expiration date that appears on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Zonisamida Mylan

Zonisamida 25 mg hard capsules EFG:

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, iron oxide black (E172), and potassium hydroxide.

Zonisamida 50 mg hard capsules EFG:

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 iron oxide red (E172)

Zonisamida 100 mg hard capsules EFG:

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

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

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

Appearance of Zonidamida Mylan and Package Contents

The hard capsules of zonisamida Mylan 25 mg have a white body and a white cap, with “Z 25” printed in black and contain a white/almost white powder.

The hard capsules of zonisamida Mylan 50 mg have a white body and a white cap, with “Z 50” printed in red and contain a white/almost white powder.

The hard capsules of zonisamida Mylan 100 mg have a white body and a white cap, with “Z 100” printed in black and contain a white/almost white powder.

Zonisamida Mylan 25 mg and 50 mg are available in packs with blisters of 14, 28, and 56 capsules and packs with perforated unit-dose blisters of 14 x 1 capsules.

Zonisamida Mylan 100 mg is available in packs with blisters of 28, 56, 98, and 196 capsules and packs of perforated unit-dose blisters of 56 x 1 capsules.

Not all pack sizes may be available.

Marketing Authorization 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:March 2018

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