25 mg, 50 mg, 100 mg hard capsules
zonisamide
What Zonisamide Mylan is and what it is used for
Zonisamide Mylan contains the active substance zonisamide and is used as an antiepileptic drug.
Zonisamide Mylan is used in the treatment of epileptic seizures affecting one part of the brain ( partial seizure ) with or without subsequent seizures affecting the whole brain (secondary generalization).
Zonisamide Mylan can be used:
- individually to treat adults
- with other antiepileptic medicines to treat adults, adolescents, and children aged 6 years and over.
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 drugs in the sulfonamide group, for example, sulfonamide-type antibiotics, thiazide diuretics, or antidiabetic drugs in the sulfonylurea class.
Warnings and precautions
Zonisamide Mylan belongs to a group of medicines ( sulfonamides ) that can cause serious allergic reactions, severe skin rashes, and blood disorders, which in very rare cases can be fatal (see section 4 Possible side effects ).
A few people treated with antiepileptic drugs such as zonisamide have had thoughts of harming themselves or killing themselves. If you ever have such thoughts, contact your doctor immediately.
| Severe skin rashes, including cases of Stevens-Johnson syndrome, occur in association with treatment with zonisamide. |
The use of Zonisamide Mylan can cause high levels of ammonia in the blood, which can lead to changes in brain function, especially if you are taking other medicines that can increase ammonia levels (for example valproate ) or if you have a hereditary disease that causes the accumulation of too much ammonia in the body (urea cycle disorder) or liver problems. Tell your doctor immediately if you feel unusually sleepy or confused.
Talk to your doctor or pharmacist before taking Zonisamide Mylan if you
- are younger than 12 years, as you may be at greater risk of reduced sweating, heat stroke, lung inflammation, and liver problems. If you are younger than 6 years, Zonisamide Mylan is not recommended for you.
- are older, as the dose of Zonisamide Mylan you are taking may need to be adjusted, and you may be more likely to have an allergic reaction, severe skin rash, swelling of the feet and legs, and itching when taking Zonisamide Mylan (see section 4 Possible side effects ).
- have liver problems, as the dose of Zonisamide Mylan you are taking may need to be adjusted.
- have eye problems, e.g. glaucoma .
- have kidney problems, as the dose of Zonisamide Mylan you are taking may need to be adjusted.
- previously had kidney stones because you are then at greater risk of getting more kidney stones. Reduce the risk of kidney stones by drinking enough water.
- live or vacation in a place where the weather is warm. Zonisamide Mylan may cause you to sweat less, which may cause your body temperature to rise. Reduce your risk by drinking enough water and staying cool.
- is underweight or has lost a lot of weight. Tell your doctor about this, as your weight may decrease further while taking Zonisamide Mylan. Weight may have to be monitored during treatment.
- are pregnant or could become pregnant (see the section “Pregnancy, breast-feeding and fertility” for further information).
Talk to your doctor before you start taking Zonisamide Mylan if any of the above applies to you.
Children and young people
Talk to your doctor about the following risks:
| Prevention of overheating and dehydration in children Zonisamide can cause your child to sweat less and become overheated, and if your child is not treated, it can lead to brain damage and death. Children are most vulnerable, especially in hot weather. While your child is taking zonisamide, your child should be kept cool, especially in hot weather avoid vigorous exertion, especially in hot weather drink very cold water do not take these medicines: carbonic anhydrase inhibitors (such as topiramate and acetazolamide), and anticholinergic agents (such as clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin). If your child’s skin feels very warm with little or no sweating, if the child becomes confused, has muscle cramps, or if your child’s heart starts beating fast or breathing becomes fast: Take your child to a cool, shady place. Bathe the baby’s skin with cool (not cold) water. Give your child cold water to drink. See a doctor quickly. |
- Body weight: You should weigh your child every month and contact the doctor as soon as possible if your child is not gaining enough weight. Zonisamide Mylan is not recommended for children who are underweight or have a poor appetite, and it should be used with caution in children weighing less than 20 kg.
- Increased acidity of the blood and kidney stones: Reduce these risks by making sure your child drinks enough water and is not taking any other medicines that could cause kidney stones (see Other medicines). The doctor will check your child’s blood bicarbonate levels and the kidneys (see also section 4).
Do not give this medicine to children under 6 years of age because for this age group it is unknown whether the possible benefits outweigh the risks.
Other medicines and Zonisamide Mylan
- Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
- Zonisamide Mylan should be used with caution in adults when taken together with medicines that can cause kidney stones such as topiramate or acetazolamide. This combination is not recommended for children.
- Zonisamide Mylan may increase the level of medicines such as digoxin and quinidine in the blood and the dose of one of these medicines may therefore need to be reduced.
- Other medicines such as phenytoin, carbamazepine, phenobarbitone, and rifampicin can reduce the level of Zonisamide Mylan in the blood, and the dose of Zonisamide Mylan may need to be adjusted.
Zonisamide Mylan with food and drink
Zonisamide Mylan can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are a woman of childbearing potential, you must use an adequate method of contraception during treatment with Zonisamide Mylan and for one month after finishing treatment with Zonisamide Mylan.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. Do not stop treatment without discussing this with the doctor.
You may take Zonisamide Mylan while you are pregnant only if your doctor says you can. Research has shown an increased risk of congenital malformations in children of women treated with anti-epileptic drugs.
One study showed that infants born to mothers using zonisamide during pregnancy were smaller than expected for their age at birth, compared to infants born to mothers treated with lamotrigine as monotherapy. Make sure you are fully informed about the risks and benefits of using zonisamide for epilepsy during pregnancy.
You must not breastfeed while taking Zonisamide Mylan and for the first month after you stop taking Zonisamide Mylan.
There are no clinical data on the effects of zonisamide on human fertility. Animal studies have shown changes in fertility parameters.
Driving ability and use of machinery
Zonisamide Mylan can affect your ability to concentrate and react and may make you feel sleepy, especially at the start of treatment and when your dose has been increased. Be especially careful when driving or using machines if Zonisamide Mylan affects you in this way.
Zonisamide Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, i.e. is almost “sodium-free”.
How to take Zonisamide Mylan
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults:
When taking Zonisamide Mylan alone:
- The starting dose is 100 mg taken once daily.
- This can be increased by up to 100 mg at intervals of two weeks.
- The recommended dose is 300 mg once daily.
When taking Zonisamide Mylan with other antiepileptic medicines:
- The starting dose is 50 mg daily divided into two equal doses of 25 mg each.
- Dose one can be increased by up to 100 mg at intervals of one to two weeks.
- Recommended daily dose is between 300 mg and 500 mg.
- Some patients benefit from a lower dose. The dose can be increased more slowly if you experience side effects, if you are elderly or if you have problems with your kidneys or liver.
Use in children (6 to 11 years) and adolescents (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 dose 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 weighing up to 55 kg or 300 to 500 mg for a child weighing more than 55 kg (whichever dose is lower) taken once a day.
Example: A child weighing 25 kg should take 25 mg once a day for the first week, then increase the daily dose by 25 mg at the start of each week until a daily dose between 150 and 200 mg is reached.
If you feel that the effect of Zonisamide Mylan is too strong or too weak, contact your doctor or pharmacist.
- Zonisamide Mylan capsules must be swallowed whole with water.
- Do not chew the capsules.
- Zonisamide Mylan can be taken once or twice a day as prescribed by the doctor.
- If you take Zonisamide Mylan twice a day, take half the daily dose in the morning and half the daily dose in the evening.
If you have taken too much Zonisamide Mylan
If you have ingested too much medicine or if, for example, a child accidentally swallowed the medicine, contact a doctor or hospital for an assessment of the risk and advice. You may become sleepy or lose consciousness. You may also feel sick, have stomach pains, muscle spasms, involuntary eye movements, feel weak, have a slow heart rate, reduced breathing, or reduced kidney function. Don’t drive a car.
If you forget to take Zonisamide Mylan
- If you forget to take a dose, simply take the next dose as usual.
- Do not take a double dose to make up for a missed dose.
If you stop taking Zonisamide Mylan
- Zonisamide Mylan is intended for long-term treatment. Do not reduce the dose or stop taking the medicine, unless your doctor advises you to do so.
- If your doctor advises you to stop treatment with Zonisamide Mylan, your dose will be reduced gradually to reduce the risk of you having more seizures.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Zonisamide Mylan belongs to a group of medicines ( sulfonamides ) that can cause serious, allergic reactions, severe skin rashes, and blood disorders, which in very rare cases can be fatal.
Contact your doctor immediately if you experience the following symptoms:
- difficulty breathing, swelling of the face, lips, or tongue, or severe skin rash as this may indicate that you are having a serious allergic reaction.
- have signs of overheating – high body temperature but little or no sweating, fast heartbeat and rapid breathing, muscle cramps, confusion, thoughts of harming yourself or committing suicide. A small number of people treated with anti-epileptic medicines, such as Zonisamide Mylan, have had thoughts of harming themselves or committing suicide.
- muscle pain or feeling weak as these symptoms may be signs of abnormal muscle breakdown that can lead to kidney problems.
- sudden back or stomach pain, pain when urinating or blood in the urine as these symptoms may indicate kidney stones.
- develop vision problems such as eye pain or blurred vision while taking zonisamide.
Contact your doctor as soon as possible if you:
- get unexplained skin rashes as these can develop into more serious rashes or skin peeling.
- feel unusually tired or feverish, have a sore throat, or swollen glands, or have noticed that you bruise easily, as these symptoms may mean you have a blood disorder.
- have signs of an increased level of acidity in the blood – get a headache, become drowsy, short of breath, or lose appetite. This may need to be checked or treated by a doctor.
Your doctor may decide that you should stop using Zonisamide Mylan.
The most common side effects of Zonisamide Mylan are mild. They occur during the first month of treatment and usually subside with continued treatment. In children aged 6 to 17 years, side effects were the same as those described below with the following exceptions: pneumonia, dehydration, decreased sweating (common) and abnormal liver enzymes (less common), ear infection, sore throat, sinus infection, and respiratory tract infection, cough, epistaxis, runny nose, stomach ache, vomiting, rash, eczema, and fever.
Very common (may affect more than 1 in 10 people)
- restlessness, irritability, confusion, depression
- poor muscle coordination, dizziness, poor memory, sleepiness, double vision
- poor appetite decreased levels of bicarbonate in the blood (a substance that prevents acidification of the blood).
Common (may affect up to 1 in 10 users)
- insomnia, strange or unusual thoughts, feelings of anxiety or emotionality
- slow thinking, reduced ability to concentrate, difficulty speaking, abnormal skin sensations (numbness), tremors, involuntary eye movements
- kidney stone
- skin rash, itching, allergic reactions, fever, fatigue, flu-like symptoms, hair loss
- ecchymosis (a small bruise caused by blood from a leaking blood vessel in the skin)
- weight loss, nausea, indigestion, stomach pain, diarrhea (loose stools), constipation
- swelling in feet and legs.
- vomiting
- Mood swings
- increased creatinine in the blood (a waste product normally removed by the kidneys)
- increased levels of liver enzymes in the blood.
Uncommon (may affect up to 1 in 100 users)
- anger, aggression, suicidal thoughts, suicide attempts
- inflammation of the gallbladder, gallstones
- stones in the urinary tract
- lung infection/ inflammation, urinary tract infection
- low potassium in the blood, convulsions/seizures
- breathing problems
- hallucinations
- abnormal urine tests.
Very rare (may affect up to 1 in 10,000 users)
- memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence ), prolonged or repeated epileptic seizures
- shortness of breath, pneumonia
- inflammation of the pancreas (severe pain in the stomach or back)
- liver problems, kidney failure,
- severe skin rash or peeling (while you may feel unwell or have a fever)
- abnormal muscle breakdown (you may experience muscle pain or muscle weakness) which may lead to kidney problems
- swollen glands, blood disorders (reduced number of blood cells which can lead to infection and make you look pale, feel tired and feverish, or cause you to bruise more easily)
- reduced sweating, heat stroke
- problems with your urine
- increased creatine phosphokinase in the blood or urea which can be detected in a blood test
- abnormal liver function test results.
- Glaucoma is a blockage of fluid in the eye that causes increased pressure in the eye. Eye pain, blurred vision, or impaired vision may occur and be a symptom of glaucoma.
How to store Zonisamide Mylan
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister pack and carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Do not use the medicine if you notice that the capsules, blister, or carton are damaged or if you see signs that the medicine has deteriorated. Return the packaging to the pharmacy.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents of Zonisamide Mylan:
Zonisamide 25 mg hard capsules:
The active substance is zonisamide. Each capsule contains 25 mg of zonisamide.
Other ingredients are:
- The capsule contains microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate.
- capsule shell: gelatin and titanium dioxide (E171)
- marking 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.
Other ingredients are:
- The capsule contains microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate.
- capsule shell: gelatin and titanium dioxide (E171)
- marking ink: shellac and iron oxide red (E172).
Zonisamide 100 mg hard capsules:
The active substance is zonisamide. Each capsule contains 100 mg of zonisamide.
Other ingredients are:
- The capsule contains microcrystalline cellulose, hydrogenated vegetable oil, and sodium lauryl sulfate.
- capsule shell: gelatin and titanium dioxide (E171)
- marking ink: shellac, black iron oxide (E172), and sodium lauryl sulfate.
What Zonisamide Mylan looks like and the contents of the pack
Zonisamide Mylan 25 mg hard capsules have a white body and white cap marked with “Z 25” in black and contain white/almost white powder.
Zonisamide Mylan 50 mg hard capsules have a white body and white cap marked with “Z 50” in red and contain white/almost white powder.
Zonisamide Mylan 100 mg hard capsules have a white body and white cap marked with “Z 100” in black and contain white/almost white powder.
Zonisamide Mylan 25 mg and 50 mg are available in blister packs of 14, 28, and 56 capsules and perforated unit dose blister packs of 14 × 1 capsules.
Zonisamide Mylan 100 mg is available in blister packs of 28, 56, 98, and 196 capsules and perforated unit dose blister packs of 56 × 1 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer
J. Uriach y Compania SA
Of. Cami Real 51–57
08184 Palau-Solita in Plegamans – Barcelona
Spain