Patient leaflet - Zonisamide Macleods 25 mg capsules, hard
1. What Zonisamide Macleods is and what it is used for
Zonisamide contains the active substance zonisamide, and is used as an antiepileptic medicine.
Zonisamide Macleods 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 Macleods may be used:
Ÿ On its own to treat seizures in adults.
Ÿ With other antiepileptic medicines to treat
seizures in adults, adolescents, and children aged 6 years and above.
2. What you need to know before you take Zonisamide Macleods
Do not take Zonisamide Macleods
Talk to your doctor about the following risks: Ÿ if you are allergic to zonisamide or any of the
other ingredients of this medicine (listed in section 6),
Ÿ if you are allergic to other sulphonamide
medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.
Ÿ if you are allergic to peanut or soya, do not use
this medicinal product.
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
Macleods 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 Macleods capsules:
Ÿ 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 Macleods is not recommended for you.
Ÿ if you are elderly, as your dose of Zonisamide
Ÿ if you suffer from liver problems, as your dose
of Zonisamide Macleods may need adjusting.
Ÿ if you have eye problems such as glaucoma.
Ÿ if you suffer from kidney problems as your dose
of Zonisamide Macleods may need adjusting. Ÿ if you 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.
Ÿ Your child must not take these medicines: Ÿ if you live in a place or are on holiday in a place
where the weather is warm. Zonisamide Macleods 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.
Ÿ if you are underweight, or have lost a lot of
weight as Zonisamide Macleods can cause you to lose more weight. Tell your doctor as this may need to be monitored.
When your child is taking Zonisamide Macleods: Ÿ if you 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 Macleods.
Ÿ Give your child plenty of cold water to drink Children and adolescents
Preventing overheating and dehydration in children
Zonisamide Macleods 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.
Ÿ Keep your child cool especially in hot weather
Ÿ Your child must avoid heavy exercise
especially when the weather is hot
Ÿ carbonic anhydrase inhibitors (like topiramate
and acetazolamide), and anticholinergic agents
(like clomipramine, hydroxyzine,
diphenhydramine, haloperidol,
imipramine and oxybutynin).
confused, has muscle cramps, or your child's heartbeat or breathing becomes rapid:
Ÿ Take your child to a cool, shaded place
Ÿ Sponge your child's skin with cool (not cold)
water
Ÿ Give your child cold water to drink
Ÿ Seek urgent medical assistance
Ÿ 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 Macleods is not recommended for children who are underweight or have a small appetite, and should be used with caution in those below 20 kg.
Ÿ 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).
There are no clinical data available on the effects of zonisamide on human fertility. Studies in animals have shown changes in fertility parameters. 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 Macleods
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Ÿ Zonisamide Macleods 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
Ÿ Zonisamide Macleods could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
Ÿ 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 Macleods.
Zonisamide Macleods with food and drink
Zonisamide Macleods can be taken with or without food.
Pregnancy, breast-feeding and fertility
Ÿ If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby.
Ÿ If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant.
Ÿ 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. The risk of birth defects or neurodevelopmental disorders (problems with brain development) for your child after taking zonisamide during your pregnancy is unknown. If you are a woman of childbearing age you must use adequate contraception while taking zonisamide and for one month after stopping zonisamide.
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.
Studies have shown an increased
risk of physical birth
abnormalities in children of
women taking epilepsy medicines during pregnancy. 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 Macleods.
Driving and using machines
Zonisamide Macleods 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 Macleods affects you in this way.
Important information about some of the ingredients of Zonisamide Macleods
Zonisamide Macleods 100 mg hard capsules contain a yellow color called sunset yellow (E110) and a red color allura red (E129), which may cause allergic reactions.
Zonisamide Macleods contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
Zonisamide Macleods contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free.
3. How to take Zonisamide Macleods
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended adult dose
When you take Zonisamide Macleods on its own:
Ÿ The starting dose is 100 mg taken once
a day.
Ÿ This may be increased by up to 100 mg at intervals of two weeks.
Ÿ The recommended dose is 300 mg once a day.
When you take Zonisamide Macleods with other antiepileptic medicines:
Ÿ The starting dose is 50 mg daily taken in
two equal doses of 25 mg.
Ÿ This may be increased by up to 100 mg
at intervals of one to two weeks.
Ÿ The recommended daily dose is between
300 mg and 500 mg.
Ÿ Some people respond to lower doses. The dose may be increased more slowly if you experience side effects, are elderly or if you suffer from kidney or liver problems.
Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg:
Ÿ The starting dose is 1 mg per kg of body weight
taken once a day.
Ÿ This may be increased by 1 mg per kg of body
weight at intervals of one to two weeks.
Ÿ The recommended daily dose is 6 to 8 mg per
kg for a child with a body weight of up to 55 kg or 300 to 500 mg for a child with a body weight more than 55 kg (which ever dose is lower) taken once a day.
twice daily, as instructed by your doctor. Example: A child who weighs 25 kg should take 25 mg once a day for the first week, and then increase the daily dose by 25 mg at the start of each week until a daily dose between 150 to 200 mg is reached.
Zonisamide Macleods your dose will be reduced gradually to lower the risk of more seizures. If you feel that the effect of Zonisamide Macleods is too strong or too weak, talk to your doctor or pharmacist.
Ÿ Zonisamide Macleods capsules must be
swallowed whole with water.
Ÿ Do not chew the capsules.
Ÿ Zonisamide Macleods can be taken once or
Ÿ agitation, irritability, confusion, depression Ÿ It you take Zonisamide Macleods twice a day,
take half the daily dose in the morning and half in the evening.
If you take more Zonisamide Macleods than you should
If you may have taken more Zonisamide Macleods than you should, tell a carer (relative or friend), your doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking your medicine with you. You may become sleepy and could lose consciousness. You might also feel sick, have a sore stomach, muscle twitches, eye movement, feel faint, have a slowed heart beat, and reduced breathing and kidney function. Do not try to drive.
If you forget to take Zonisamide Macleods
Ÿ If you forget to take a dose, don't worry: take the
next dose when it is due.
Ÿ Do not take double the dose to make up for the
forgotten dose.
If you stop taking Zonisamide Macleods
Ÿ Zonisamide Macleods is meant to be taken as a
long-term medicine. Do not reduce your dose or stop your medicine unless your doctor tells you to.
Ÿ If your doctor advises you to stop taking
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Zonisamide belongs to a group of medicines (sulphonamides) that can cause severe allergic reactions, severe skin rashes, and blood disorders, which very rarely can be fatal.
Contact your doctor immediately if you:
Ÿ have difficulty breathing, a swollen face, lips or
tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction.
Ÿ have signs of overheating - high body
temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
Ÿ have thoughts of harming or killing yourself. A
small number of people being treated with anti-epileptics such as Zonisamide have had thoughts of harming or killing themselves.
Ÿ have pain in your muscles or a feeling of
weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems.
Ÿ get a sudden pain in your back or stomach, have
pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones.
Ÿ loss of weight, nausea, indigestion, Ÿ develop visual problems such as eye pain or
blurred vision while taking Zonisamide Macleods.
Contact your doctor as soon as possible if you:
Ÿ have an unexplained skin rash, as this could
develop into a more severe skin rash or skin peeling.
Ÿ feel unusually tired or feverish, have a sore
throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder.
Ÿ have signs of increased acid level in the blood-
headaches, drowsiness, shortness of breath and loss of appetite. Your doctor may need to monitor or treat this.
Your doctor may decide that you should stop using Zonisamide Macleods.
The most common side effects of Zonisamide Macleods are mild. They occur during the first month of treatment and usually decrease with continued treatment. In children ages 6 – 17 years old, side effects were consistent with those described below with the following exceptions: pneumonia, dehydration, sweating decreased (common) and abnormal liver enzymes (uncommon).
Very common side effects (may affect more than 1 in 10 people)
Ÿ poor muscle coordination, dizziness, poor
memory, sleepiness, double vision
Ÿ loss of appetite, decreased blood levels of
bicarbonate (a substance that prevents your blood from becoming acidic)
Common side effects (may affect up to 1 in 10 people)
Ÿ difficulty sleeping, strange or unusual thoughts,
feeling anxious or emotional.
Ÿ slowed thoughts, loss of concentration, speech
abnormalities, abnormal skin sensation (pins
and needles), tremor, involuntary movement of the eyes.
Ÿ kidney stones.
Ÿ skin rashes, itching, allergic reactions,
fever, tiredness, flu-like symptoms, hair loss.
Ÿ ecchymosis (a small bruise caused by
blood leaking from broken blood vessels in the skin).
stomach pains, diarrhoea (loose stools), constipation.
Ÿ swelling of the feet and legs.
Uncommon side effects (may affect up to 1 in 100 people)
Ÿ anger, aggression, thoughts of suicide, suicide attempt.
Ÿ vomiting.
Ÿ gall bladder inflammation, gallstones.
Ÿ urinary stones.
Ÿ lung infection / inflammation, urinary tract infections.
Ÿ low blood potassium levels, convulsions/seizures.
Very rare side effects (may affect up to 1 in 10,000 people)
Ÿ hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence), status epilepticus (prolonged or repeated seizures).
Ÿ breathing disorders, shortness of breath, inflammation of the lungs.
- 100mg: 14, 28, 56, 84,98 and 196 hard capsules. Ÿ inflammations of the pancreas (severe pain in the stomach or back).
Ÿ liver problems, kidney failure, increased blood levels of creatinine (a waste product that your kidneys should normally remove).
Ÿ severe rashes or skin peeling (at the same time you may feel unwell or develop a fever).
Ÿ abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month. Ÿ swollen glands, blood disorders (reduction in the number of blood cells, which can make infection more likely and can make you look pale, feel tired and feverish, and bruise more easily).
Ÿ decreased sweating, overheating.
Ÿ glaucoma, which is a blockage of fluid in the eye causing increased pressure in the eye. Eye pain, blurred vision or decreased vision may occur and can be signs of glaucoma.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zonisamide Macleods
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage condition.
Do not use this medicine if you notice any damage to the capsules, blister or carton or any visible signs of deterioration in the medicine. Return the pack to your pharmacist.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away
medicines you no longer use.
These measures will help to
protect the environment.
6. Contents of the pack and other information
What Zonisamide Macleods contains
The active substance is zonisamide.
body size "3" hard gelatin capsule imprinted with "J" on cap and “49" on body with black ink containing white to off white powder. Zonisamide Macleods 25mg hard capsule contains 25 mg zonisamide. Zonisamide Macleods
50 mg hard capsules contain 50 mg zonisamide. Zonisamide Macleods 100 mg hard capsules body size "1" hard gelatin capsule imprinted with "J" on cap and “50" on body with black ink containing white to off white powder. contain 100 mg zonisamide.
Ÿ The other ingredients are present in the capsule contents are: cellulose microcrystalline, hydrogenated vegetable oil, sodium laurilsulfate and silica colloidal anhydrous.
Ÿ The capsule shell contains: gelatin, titanium dioxide (E171). Additionally, the 50mg capsule shell contains iron black oxide (E172) and 100 mg capsule shell contains sunset yellow (E110) and allura red (E129).
Printing ink: Shellac (E904), propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide (E525).
See Section 2 for important information about the ingredients hydrogenated vegetable oil (from soyabean).
What Zonisamide Macleods looks like and contents of the pack
Zonisamide Macleods 25 mg hard capsules have a White opaque cap and white opaque body size "4" hard gelatin capsule imprinted with "J" on cap and “48" on body with black ink containing white to off white powder.
Capsule size approximately 14.40 mm ± 0.4 mm.
Zonisamide Macleods 50 mg hard capsules have a Grey opaque cap and white opaque
Capsule size approximately 15.80 mm ± 0.4 mm.
Zonisamide Macleods 100 mg hard capsules have a Red opaque cap and white opaque
Capsule size approximately 19.30 mm ± 0.4 mm.
Zonisamide Macleods capsules are packaged in Clear PVC/PVdC/ Aluminum blister packs supplied in boxes containing:
- 25mg: 14, 28, 56, 84 and 98 hard capsules.
- 50mg: 14, 28, 56, 84 and 98 hard capsules.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Macleods Pharma UK Limited
Wynyard Park House,
Wynyard Avenue, Wynyard,
Billingham, TS22 5TB
United Kingdom.
PL 34771/0220-0230-0231