25 mg, 50 mg, and 100 mg hard capsules
zonisamide
What Zonegran is and what it is used for
Zonegran contains the active substance zonisamide and is used as an antiepileptic drug.
Zonegran 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).
Zone fir 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 taking Zonegran
Do not take Zonegran
- 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,
- if you are allergic to peanuts or soy, do not use this medicine.
Warnings and precautions
Zonegran 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 association with treatment with Zonegran. |
Using Zonegran 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.
Talk to your doctor or pharmacist before taking Zonegran 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, Zonegran is not recommended for you.
- are older, as the dose of Zonegran you are taking may need to be adjusted, and you may be more likely to have an allergic reaction , severe rash, swelling of the feet and legs and itching when taking Zonegran (see section 4 Possible side effects ).
- have liver problems, as your dose of Zonegran may need to be adjusted.
- have eye problems such as glaucoma .
- have kidney problems, as your dose of Zonegran 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. Zonegran can cause you to sweat less, which can 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 Zonegran. Weight may have to be monitored during treatment.
- are pregnant or could become pregnant (see section “Pregnancy, breast-feeding and fertility” for further information).
Talk to your doctor before you start taking Zonegran, 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 Zonegran 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. When your child takes Zonegran, your child shouldkept cool, especially in hot weatheravoid vigorous exertion, especially in hot weatherdrink very cold waterdo 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. Zonegran is not recommended for children who are underweight or have a poor appetite, and 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 Zonegran
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
- Zonegran should be used with caution in adults when taken together with drugs that can cause kidney stones such as topiramate or acetazolamide. This combination is not recommended for children.
- Zonegran may possibly 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 Zonegran in the blood, and the dose of Zonegran may need to be adjusted.
Zonegran with food and drink
Zonegran can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are a woman of childbearing age, you must use an adequate contraceptive method during treatment with Zonegran and for one month after finishing treatment with Zonegran.
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 Zonegran 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 breast-feed while taking Zonegran and for the first month after you stop taking Zonegran.
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
Zonegran may 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 Zonegran affects you in this way.
Important information about any ingredient in Zonegran
Zonegran contains para-orange (E110) and allura red AC (E129)
Zonegran 100 mg hard capsules contain a yellow dye called para-orange (E110) and a red dye called allura red (E129). These dyes can cause allergic reactions.
Zonegran contains soybean oil. If you are allergic to peanut or soya, you should not use this medicine.
How to take Zonegran
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Recommended dose for adults
When taking Zonegran 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 Zonegran with other antiepileptic drugs:
- 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.
- The 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 Zonegran is too strong or too weak, contact your doctor or pharmacist.
- Zonegran capsules must be swallowed whole with water.
- Do not chew the capsules.
- Zonegran can be taken once or twice a day according to the doctor’s prescription .
- If you take Zonegran 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 Zonegran
If you have ingested too much medicine, tell a relative and 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 Zonegran
- If you forget to take a dose of Zonegran, simply take the next dose as usual.
- Do not take a double dose to make up for a missed dose .
If you stop taking Zonegran
- Zonegran 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 taking Zonegran, your dose will be reduced gradually to reduce the risk of you having more attacks.
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.
Zonegran belongs to a group of drugs ( 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, rapid heartbeat and rapid breathing, muscle cramps and confusion.
- have thoughts of harming yourself or committing suicide. A small number of people treated with anti- epileptic drugs , such as Zonegran, 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 Zonegran.
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, 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 Zonegran.
The most common side effects of Zonegran 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 side effects ( may affect more than 1 in 10 users):
- 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 side effects ( 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 (tingling), 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 side effects ( 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 side effects ( may affect up to 1 in 10,000 users):
- hallucinations, memory loss, coma , neuroleptic malignant syndrome (inability to move, sweating, fever, incontinence ), status epilepticus (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 cause you to 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 Zonegran should be stored
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.
Store at a maximum of 30°C.
Do not use this 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 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 in Zonegran is zonisamide.
Zonegran 25 mg hard capsules contain 25 mg zonisamide. Zonegran 50 mg hard capsules contain 50 mg zonisamide. Zonegran 100 mg hard capsules contain 100 mg zonisamide.
- Other ingredients in the capsule are: microcrystalline cellulose, hydrogenated vegetable oil (from soybeans) and sodium lauryl sulfate.
- The capsule shell consists of: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide and black iron oxide (E172). The shell of the 100 mg capsule also contains dyes para-orange (E110) and allura red (E129).
See section 2 for important information on ingredients: para- orange FCF (E110), allura red AC (E129) and hydrogenated vegetable oil (from soybean).
Appearance and package sizes of the medicine
- Zonegran 25 mg hard capsules have a white opaque body and white opaque cap and are marked with “ZONEGRAN 25” in black.
- Zonegran 50 mg hard capsules have a white opaque body and gray opaque cap and are marked with “ZONEGRAN 50” in black.
- Zonegran 100 mg hard capsules have a white opaque body and red opaque cap and are marked and “ZONEGRAN 100” in black.
Zonegran capsules are packaged in blisters that are delivered in cartons if:
- 25 mg: 14, 28, 56 and 84 capsules
- 50 mg: 14, 28, 56 and 84 capsules
- 100 mg: 28, 56, 84, 98 and 196 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amdipharm Limited
3 Burlington Road,
Dublin 4, D04 RD68,
Ireland
email: medicalinformation@advanzpharma.com
Manufacturer
SKYEPHARMA PRODUCTION SAS
Zone Industrielle Chesnes Ouest,
55 rue du Montmurier,
SAINT QUENTIN FALLAVIER,
38070, FRANCE
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany