Product Details

What you need to know before you take 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 sulphonamide medicines. Examples include: sulphonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines, • if you are allergic to peanut or soya, do not use this medicinal product. Warnings and precautions Zonegran 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 Zonegran therapy, including cases of Stevens-Johnson syndrome. The use of Zonegran 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 2 (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 Zonegran 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, Zonegran is not recommended for you. • are elderly, as your dose of Zonegran 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 Zonegran (see section 4 Possible side effects). • suffer from liver problems, as your dose of Zonegran may need adjusting. • have eye problems such as glaucoma. • suffer from kidney problems as your dose of Zonegran 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. Zonegran 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 Zonegran 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 Zonegran. Children and adolescents Talk to your doctor about the following risks: Preventing overheating and dehydration in children Zonegran 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 Zonegran: • 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. Zonegran 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 3 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 Zonegran Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. • Zonegran 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 • Zonegran 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 Zonegran, which may require an adjustment of your dose of Zonegran. Zonegran with food and drink Zonegran can be taken with or without food. Pregnancy, breast-feeding and fertility • 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. • If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant. • 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 zonisamide 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 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. Breast-feeding Do not breast-feed whilst taking, or for one month after stopping Zonegran. Fertility 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 Zonegran 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 Zonegran affects you in this way. 4 Important information about some of the ingredients of Zonegran Zonegran contains sunset yellow FCF (E110) and allura red AC (E129) Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110) and a red colour called allura red AC (E129), which may cause allergic reactions. Zonegran contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.