25 mg, 50 mg, 100 mg hard capsule
zonisamide
What Zonisamide Accord is and what it is used for
Zonisamide Accord contains the active substance zonisamide and is used as an antiepileptic drug.
Zonisamide Accord 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 Accord can be used:
- Single to treat seizures in adults
- With other antiepileptic medicines to treat adults, adolescents, and children aged 6 years or older.
Zonisamide contained in Zonisamide Accord may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Zonisamide Accord
Do not use Zonisamide Accord
- 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. These are, for example, sulfonamide-type antibiotics, thiazide diuretics, and antidiabetics of the sulfonylurea class.
Warnings and precautions
Zonisamide Accord 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 ).
| Severe skin rashes, including cases of Stevens-Johnson syndrome, occur in connection with treatment with Zonisamide Accord. |
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Talk to your doctor or pharmacist before taking Zonisamide Accord
- if you are under 12 years of age, as you may be at greater risk of reduced sweating, heat stroke, pneumonia, and liver problems. If you are younger than 6 years, Zonisamide Accord is not recommended for you.
- if you are elderly, because the dose of Zonisamide Accord 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 Accord (see section 4 Possible side effects are).
- if you have liver problems, because the dose of Zonisamide Accord you are taking may need to be adjusted.
- have eye problems such as glaucoma.
- if you have kidney problems, the dose of Zonisamide Accord you are taking may need to be adjusted.
- if you have previously had kidney stones because then you run a greater risk of getting more kidney stones. Reduce the risk of kidney stones by drinking enough water.
- if you live or vacation in a place where the weather is warm. Zonisamide Accord can make you sweat less, which can cause your body temperature to rise. Reduce your risk by drinking enough water and staying cool.
- if you are underweight or have lost a lot of weight, as your weight may decrease further while taking Zonisamide Accord. Talk to your doctor about this as weight may need to be monitored.
- are pregnant or could become pregnant (see section “Pregnancy, breast-feeding and fertility” for further information).
Talk to your doctor before you start taking Zonisamide Accord if any of the above apply to you.
Use of Zonisamide Accord can cause high levels of ammonia in the blood, which can lead to altered 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.
Children and young people
Talk to your doctor about the following risks:
| Prevention of overheating and dehydration in children Zonisamide Accord can make your child sweat less and overheat and if your child is not treated it can lead to brain damage and death. Children are most vulnerable, especially in hot weather. When your child is taking Zonisamide Accord, 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 a doctor as soon as possible if your child is not gaining enough weight. Zonisamide Accord 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 blood acidity 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 and Zonisamide Accord). 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 Accord
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
- Zonisamide Accord 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 Accord can 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 lowered.
- Other medicines such as phenytoin, carbamazepine, phenobarbitone, and rifampicin can reduce the level of Zonisamide Accord in the blood, and the dose of Zonisamide Accord may need to be adjusted.
Zonisamide Accord with food and drink
Zonisamide Accord 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 Accord and for one month after finishing treatment with Zonisamide Accord
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 Accord 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 Accord and for the first month after you stop taking Zonisamide Accord.
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 Accord 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 Accord affects you in this way.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zonisamide Accord contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. it is almost ‘sodium-free’.
How to use Zonisamide Accord
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults
When taking Zonisamide Accord 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 Accord 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 for children and adolescents
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 Accord is too strong or too weak, contact your doctor or pharmacist.
- Zonisamide Accord capsules must be swallowed whole with water.
- Do not chew the capsules.
- Zonisamide Accord can be taken once or twice a day according to the doctor’s prescription.
- If you take Zonisamide Accord twice a day, take half the daily dose in the morning and half the daily dose in the evening.
If you use too much Zonisamide Accord
If you have ingested too much medicine or if, for example, a child has swallowed the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice. Take the medicine package with you.
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 use Zonisamide Accord
If you forget to take a dose of Zonisamide Accord, simply take the next dose as usual.
Do not take a double dose to make up for a missed dose.
If you stop using Zonisamide Accord
Zonisamide Accord 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 Accord, your dose will be reduced gradually to reduce the risk of you having more seizures.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Zonisamide Accord 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 have had a serious allergic reaction.
- signs of overheating – high body temperature but little or no sweating, rapid heartbeat and rapid breathing, muscle cramps, and confusion.
- thoughts of harming yourself or committing suicide. A small number of people who are treated with anti-epileptic drugs, such as Zonisamide Accord, 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 using Zonisamide Accord.
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 Accord.
The most common side effects of Zonisamide Accord are mild. They occur during the first month of treatment and usually subside with continued treatment. In children aged 6 to 17 years, adverse reactions were consistent with those described below with the following exceptions: pneumonia, dehydration, decreased sweating (common), and abnormal liver enzymes (uncommon).
Very common (may affect more than 1 in 10 users):
- restlessness, irritability, confusion, depression
- poor muscle coordination, dizziness, poor memory, sleepiness, double vision
- decreased appetite and decreased levels of bicarbonate in the blood (a substance that prevents acidification of the blood).
Common (may affect up to 1 in 10 users):
- difficulty sleeping, strange or unusual thoughts, feelings of anxiety or emotionality
- slow thinking, reduced ability to concentrate, difficulty speaking, abnormal skin sensations (tingling and 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.
Uncommon (may affect up to 1 in 100 users):
- anger, aggression, suicidal thoughts, suicide attempts
- vomiting
- inflammation of the gallbladder, gallstones
- stones in the urinary tract
- lung infection/ inflammation, urinary tract infection
- low potassium in the blood, convulsions/seizures.
Very rare (may affect up to 1 in 10,000 users):
- hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence ), prolonged or repeated epileptic seizures
- breathing problems, shortness of breath, pneumonia
- inflammation of the pancreas (severe pain in the stomach or back)
- liver problems, kidney failure, increased creatinine in the blood (a waste product normally removed by the kidneys)
- severe skin rash or peeling (while you may feel unwell or have a fever)
- abnormal muscle breakdown (you may have muscle pain or the muscles feel weak) which can 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 make you bruise more easily)
- reduced sweating, heat stroke
- glaucoma, which involves blockage of fluid flow in the eye causing increased pressure in the eye. Eye pain, blurred vision, or impaired vision may occur and be signs of glaucoma.
How to store Zonisamide Accord
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister after “Exp.” The expiration date is the last day of the specified month.
No special storage instructions.
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 declaration
- The active substance is zonisamide. Zonisamide Accord 25 mg hard capsules contain 25 mg zonisamide. Zonisamide Accord 50 mg hard capsules contain 50 mg zonisamide. Zonisamide Accord 100 mg hard capsules contain 100 mg zonisamide.
- Other ingredients are Capsule contents: microcrystalline cellulose, and magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), sodium lauryl sulfate, purified water, black iron oxide (E172) (50 mg hard capsules)Printing ink: shellac, black iron oxide (E172), and potassium hydroxide.
Appearance and package sizes of the medicine
Zonisamide Accord 25 mg hard capsule
White to off-white granular powder in hard capsules with white to off-white capsule body and cap. The lid has the marking “A730” in black ink.
Zonisamide Accord 50 mg hard capsule
White to off-white granular powder in hard capsules, size 3 (15.9 mm x 5.82 mm), with a white to off-white capsule body and a gray cap. The lid has the marking “A735” in black.
Zonisamide Accord 100 mg hard capsule
White to off-white granular powder in hard capsules, size 1 (19.4 mm x 6.91 mm), with white to off-white capsule body and cap. The lid has the marking “A740” in black ink.
Zonisamide Accord capsules are packed in blisters supplied in cartons containing:
- 25 mg: 14, 28, or 56 hard capsules
- 50 mg: 14, 28, or 56 hard capsules
- 100 mg: 28, 56, 98, or 196 hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer:
Balkanpharma-Dupnitsa AD, 3, Samokovsko shosse Str., 2600 Dupnitsa, Bulgaria