Zonisamide Capsules

Zonisamide Glenmark contains the active substance zonisamide, and is used as an antiepileptic medicine.

Zonisamide is used to treat seizures that affect one part of the brain (partial seizure), which may or may not be followed by a seizure affecting all of the brain (secondary generalisation).

Zonisamide may be used:

On its own to treat seizures in adults.
With other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and above.

Do not take Zonisamide:
If you are allergic to zonisamide or any of the ingredients in Zonisamide (listed in section 6),
If you are allergic to other sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.
Warnings and precautions:
Zonisamide belongs to a group of medicines (sulphonamides) which can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal (see section 4 Possible side effects).

Serious rashes occur in association with Zonisamide therapy, including cases of Stevens-Johnson syndrome.

The use of Zonisamide may lead to high levels of ammonia in the blood which could lead to a change in brain function, especially if you are also taking other medicines which can increase ammonia levels (for example valproate), have a genetic disorder causing build-up of too much ammonia in the body (urea cycle disorder), or if you have liver problems. Tell your doctor immediately if you become unusually drowsy or confused.

Talk to your doctor or pharmacist before taking Zonisamide if you:

are younger than 12 years old, as you may be at greater risk of decreased sweating, heat stroke, pneumonia and liver problems. If you are younger than 6 years old, Zonisamide is not recommended for you.
are elderly, as your dose of Zonisamide may need adjusting, and you may be more likely to develop an allergic reaction, severe skin rash, swelling of the feet and legs, and itchiness when taking Zonisamide (see section 4 Possible Side Effects).
suffer from liver problems, as your dose of Zonisamide may need adjusting.
have eye problems such as glaucoma.
suffer from kidney problems as your dose of Zonisamide may need adjusting.
have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones. Reduce the risk of kidney stones by drinking sufficient water.
live in a place or are on holiday in a place where the weather is warm. Zonisamide can make you perspire less, which can cause your body temperature to increase. Reduce the risk of overheating by drinking sufficient water and keeping cool.
are underweight, or have lost a lot of weight as Zonisamide can cause you to lose more weight. Tell your doctor as this may need to be monitored.
are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
If any of these applies to you, tell your doctor before you take Zonisamide

Children and adolescents
Talk to your doctor about the following risks:

Preventing overheating and dehydration in children

Zonisamide can cause your child to sweat less and overheat and if your child is not treated this can lead to brain damage and death. Children are most at risk especially in hot weather.

When your child is taking Zonisamide: Keep your child cool especially in hot weather

Your child must avoid heavy exercise especially when the weather is hot
Give your child plenty of cold water to drink
Your child must not take these medicines:
Carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
If your child's skin feels very hot with little or no sweating, becomes confused, has muscle cramps, or your child's heartbeat or breathing becomes rapid:

Take your child to a cool, shaded place
Sponge your child's skin with cool (not cold) water
Give your child cold water to drink
Seek urgent medical assistance.
Body weight: You should monitor your child's weight every month and see your doctor as soon as possible if your child is not gaining enough weight. Zonisamide is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
Increased acid level in the blood and kidney stones: Reduce these risks by ensuring that your child drinks enough water and is not taking any other medicine which could cause kidney stones (see Other medicines). Your doctor will monitor your child's blood bicarbonate levels and kidneys (see also section 4).
Do not give this medicine to children below the age of 6 years because it is not known for this age group whether the potential benefits are greater than the risks.

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

Zonisamide should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide. In children, this combination is not recommended
Zonisamide could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonisamide, which may require an adjustment of your dose of Zonisamide.
Zonisamide with food and drink
Zonisamide can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are planning a pregnancy, talk to your doctor before you stop contraception and before you become pregnant about the possibility of switching to other suitable treatments. If you are or think you might be pregnant, tell your doctor straight away. You should not stop your treatment without discussing this with your doctor. Suddenly stopping may lead to breakthrough seizures which may harm you and your unborn baby. It is important that your epilepsy remains well controlled.

Pregnancy

You must only take Zonisamide during your pregnancy if your doctor tells you to. If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Zonisamide.

Studies have shown an increased risk of physical birth abnormalities in children of women taking epilepsy medicines during pregnancy. The risk of birth defects or neurodevelopmental disorders (problems with brain development) for your child after taking Zonisamide during your pregnancy is unknown. The risk of physical birth abnormalities may increase when more than one epilepsy medicine is used at the same time. Where possible, your doctor should consider using one epilepsy medicine to control your epilepsy. More research is needed to better understand whether taking zonisamide during pregnancy increases the risk of having a baby born with a physical birth abnormality or a learning or thinking disability.

Studies have shown that babies born to mothers using zonisamide during pregnancy were smaller than expected for their age at birth, compared with babies born to mothers treated with lamotrigine monotherapy. Make sure you are fully informed about the risks and the benefits of using zonisamide for epilepsy during pregnancy.

Do not breastfeed whilst taking, or for one month after stopping Zonisamide.

There are no clinical data available on the effects of Zonisamide on human fertility. Studies in animals have shown changes in fertility parameters.

Driving and using machines
Zonisamide may affect your concentration, ability to react/respond, and may make you feel sleepy, particularly at the beginning of your treatment or after your dose is increased. Be especially careful while driving or operating machinery, if Zonisamide affects you in this way.