Prospect: information for the patient

Zonisamida Mylan 25 mg hard capsules EFG

Zonisamida Mylan 50 mg hard capsules EFG

Zonisamida Mylan 100 mg hard capsules EFG

zonisamida

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Zonisamida Mylan contains the active ingredient zonisamida, and is used as an antiepileptic.

Zonisamida Mylan is used to treat seizures that affect a part of the brain (partial seizures), which may or may not be followed by a seizure that affects the entire brain (secondary generalization).

Zonisamida Mylan may be used:

• Alone to treat convulsive seizures in adults.
• With other antiepileptics to treat convulsive seizures in adults, adolescents, and children 6 years of age and older.

Do not take Zonisamida Mylan:

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

Warnings and precautions

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

A small number of people receiving treatment with antiepileptic drugs 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 Zonisamida Mylan:

• if you are under 12 years old, as you may have a higher risk of developing decreased sweating, heatstroke, pneumonia, and liver problems. Zonisamida Mylan is not recommended for children under 6 years old.

• if you are elderly, as you may need to adjust the dose of Zonisamida Mylan, and you may have a higher risk of developing an allergic reaction, severe skin rash, swelling of the legs and feet, and itching when taking Zonisamida Mylan (see section 4. Possible side effects).

• if you have liver problems, as you may need to adjust the dose of Zonisamida Mylan.
• if you have eye problems such as glaucoma.

• if you have kidney problems, as you may need to adjust the dose of Zonisamida Mylan.

• if you have previously had kidney stones, as you may be at a higher risk of developing more kidney stones.Reduce the risk of developing kidney stones by drinking enough water.

• if you live in a hot place or are going on vacation to a hot place. Zonisamida Mylan may cause you to sweat less, which can lead to a higher body temperature.Reduce the risk of overheating by drinking enough water and staying cool.

• if you are underweight or have lost a lot of weight, as Zonisamida Mylan may cause you to lose more weight. Inform your doctor, as they may need to monitor you.

• If you are pregnant or could become pregnant (for more information, see the section “Pregnancy, breastfeeding, and fertility).

If any of these statements apply to you, inform your doctor before taking Zonisamida Mylan.

Children and adolescents

Consult your doctor about the following risks:

• Weight:you must monitor your child's weight monthly and see your doctor as soon as possible if they are not gaining enough weight.Zonisamida Mylan is not recommended for children who are underweight or have a poor appetite, and should be used with caution in children with a weight under 20 kg.
• Urine acid level 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 medications). Your doctor will monitor your child's bicarbonate levels in their blood and kidneys (see also section 4).

Do not administer this medication to children under 6 years old as it is not known if the potential benefits outweigh the risks in this age group.

Use of Zonisamida Mylan with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may take any other medication, including those purchased 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. In children, this combination is not recommended.
• Zonisamida Mylan may increase the levels of medications such as digoxin and quinidine in the blood, and therefore may require a reduction in the dose of these medications.
• Other medications such as phenytoin, carbamazepine, phenobarbital, and rifampicin may decrease the levels of Zonisamida Mylan in the blood, which may require an adjustment in the dose of Zonisamida Mylan.

Taking Zonisamida Mylan with food and drinks

Zonisamida Mylan can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are a woman of childbearing age, you must use effective contraceptive measures 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 medication. Do not stop treatment without consulting your doctor.

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

A study showed that children whose mothers took zonisamide during pregnancy were smaller than expected for their age at birth, compared to children whose mothers were treated with lamotrigine monotherapy. Ensure you are informed in detail about the risks and benefits of using zonisamide for epilepsy during pregnancy.

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

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

Driving and operating machinery

Zonisamida Mylan may affect your concentration, ability to react/respond, and may cause drowsiness, especially at the beginning of treatment or after increasing the dose. If Zonisamida Mylan affects you in this way, be especially careful when driving or operating machinery.

Zonisamida Mylan contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Recommended dose in adults

When taking Zonisamida Mylan alone:

• The initial dose is 100 mg once a day.
• It can be increased by 100 mg in two-week intervals.
• The recommended dose is 300 mg once a day.

When taking Zonisamida Mylan with other antiepileptic medications:

• The initial dose is 50 mg per day, divided into two equal doses of 25 mg.
• It can be increased by 100 mg in one- to two-week intervals.
• The recommended daily dose is between 300 mg and 500 mg.
• Some people respond to lower doses. The dose could be increased more slowly if you experience side effects or have kidney or liver problems.

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

• The initial dose is 1 mg per kg of body weight once a day.
• It can be increased by 1 mg per kg of body weight in one- to two-week intervals.
• The recommended daily dose is between 6 mg and 8 mg for a child weighing up to 55 kg or between 300 mg and 500 mg for a child weighing more than 55 kg (the lower dose) 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 beginning of each week until reaching a daily dose of 150 to 200 mg.

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

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

When taking more Zonisamida Mylan than you should

If you have taken more Zonisamida Mylan than you should, inform the person taking care of you (family member or friend), your doctor or pharmacist, or contact the nearest hospital emergency service and bring the medication with you. You may feel drowsy and may lose consciousness. You may also feel like vomiting, have stomach pain, muscle spasms, eye movement, feel like fainting, have a slow heart rate, and decreased respiratory and renal function. Do not drive.

When you forget to take Zonisamida Mylan

• 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 compensate for the missed doses.

When interrupting treatment with Zonisamida Mylan

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

• If your doctor advises you to stop taking Zonisamida Mylan, the dose will be gradually reduced to minimize the risk of having more seizures.

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

Like all medicines, this medicine can cause side 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 can cause death.

Immediately contact your doctor if:

• you have difficulty breathing, swelling of the face, lips, or tongue, or a severe rash, as these symptoms may indicate 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 taking antiepileptic medications 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 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.
• you experience visual problems, such as eye pain or blurred vision, when taking zonisamide.

Contact your doctor as soon as possible if:

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

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

The most common side effects of Zonisamide Mylan reported are all mild in nature. They occur during the first month of treatment and often decrease as treatment continues. In children aged 6 to 17 years, the side effects were consistent with the following, 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 in blood

Common (may affect up to 1 in 10 people)

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

• slow thinking, loss of concentration, speech abnormalities, abnormal skin sensations (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 skin vessel).
• weight loss, nausea, indigestion, stomach pain, diarrhea (loose stools), constipation.
• swelling of legs and feet.
• vomiting
• mood changes
• increased creatinine levels in blood (creatinine is a waste product that normal kidneys should eliminate)
• increased liver enzyme levels in blood.

Rare (may affect up to 1 in 100 people)

• rage, aggression, suicidal thoughts, attempted suicide.
• inflammation of the gallbladder or gallstones.
• kidney stones.
• pulmonary infection or inflammation, urinary tract infections.
• low potassium levels in blood and seizures.
• respiratory problems
• hallucinations
• abnormal urine analysis results.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer use. This will help protect the environment.

Composition of Zonisamide Mylan

Zonisamide 25 mg hard capsules EFG:

The active ingredient is zonisamide. Each capsule contains 25 mg of zonisamide.

The other components are:

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

Zonisamide 50 mg hard capsules EFG:

The active ingredient is zonisamide. Each capsule contains 50 mg of zonisamide.

The other components are:

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

Zonisamide 100 mg hard capsules EFG:

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

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

• capsule content: microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate
• capsule coating: gelatin and titanium dioxide (E171)
• ink: shellac, iron oxide black (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 closure cap, with "Z 25" printed in black and contain a white/off-white powder.

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

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

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

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

Only some pack sizes may be available.

Marketing Authorisation Holder

Mylan S.A.S.

117 Allée des Parcs

69 800 Saint Priest,

France

Responsible Person

J. Uriach y Compañía, S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans – Barcelona

Spain

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder::

Last update of the summary of product characteristics:March 2018

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