The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL14040/0036 .
Desizon 20 mg/ml oral suspension
Desizon 20 mg/ml oral suspension
1. What Desizon is and what it is used for
2. What you need to know before you take Desizon
3. How to take Desizon
4. Possible side effects
5. How to store Desizon
6. Contents of the pack and other information
Desizon contains the active substance zonisamide, and is used as an antiepileptic medicine. Desizon 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).
Desizon may be used:
Desizon 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 Desizon therapy, including cases of Stevens-Johnson syndrome.
The use of Desizon 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 Desizon if you:
If any of these applies to you, tell your doctor before you take Desizon.
Talk to your doctor about the following risks:
Preventing overheating and dehydration in children
Desizon 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 Desizon:
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:
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.
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
If you are a woman of childbearing age you must use adequate contraception while taking and for one month after stopping Desizon.
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.
You must only take Desizon during your pregnancy if your doctor tells you to.
Research has shown an increased risk of birth defects in children of women taking antiepileptic medicines. The risk of birth defects or neurodevelopmental disorders (problems with brain development) for your child after taking Desizon during your pregnancy is unknown. A study showed 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 breast-feed whilst taking, or for one month after stopping Desizon.
There are no clinical data available on the effects of zonisamide on human fertility. Studies in animals have shown changes in fertility parameters.
Desizon 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 Desizon affects you in this way.
Sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) may cause allergic reactions (possibly delayed).
Sulphur dioxide (E220) may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 0.026 mg fructose in each dosing syringe (10 ml). Fructose may damage teeth.
This medicine contains glucose and sucrose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Desizon contains sodium, but less than 1 mmol sodium (23 mg) per 10 ml oral suspension, i.e. it is essentially “sodium-free”.
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
When you take Desizon on its own:
When you take Desizon with other antiepileptic medicines:
Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg:
Body Weight : Initial Dose : Maintenance Dose
20 kg : 20 mg/day = 1 ml/day : 120 – 160 mg/day = 6 – 8 ml/day
25 kg : 25 mg/day = 1.25 ml/day : 150 – 200 mg/day = 7.5 – 10 ml/day
30 kg : 30 mg/day = 1.5 ml/day : 180 – 240 mg/day = 9 – 12 ml/day
35 kg : 35 mg/day = 1.75 ml/day : 210 – 280 mg/day = 10.5 – 14 ml/day
40 kg : 40 mg/day = 2 ml/day : 240 – 320 mg/day = 12 – 16 ml/day
45 kg : 45 mg/day = 2.25 ml/day : 270 – 360 mg/day = 13.5 – 18 ml/day
50 kg : 50 mg/day = 2.5 ml/day : 300 – 400 mg/day = 15 – 20 ml/day
55 kg : 55 mg/day = 2.75 ml/day : 330 – 440 mg/day = 16.5 – 22 ml/day
Example: A child who weighs 25 kg should take 25 mg (= 1.25 ml) once a day for the first week, and then increase the daily dose by 25 mg (= 1.25 ml) at the start of each week until a daily dose between 150 to 200 mg (= 7.5 to 10 ml) is reached.
If you feel that the effect of Desizon is too strong or too weak, talk to your doctor or pharmacist.
Shake the bottle vigorously for 30 seconds in a bottom up position. After measuring the correct dose with the provided syringe, Desizon may be swallowed directly from the oral syringe followed by a glass of water. Alternatively, the oral suspension may also be diluted in a glass of water or orange juice. Carbonated beverages such as sparkling water should not be taken with the suspension.
You may take Desizon with or without food. Desizon can be mixed with yoghurt to mask its taste.
Instruction for use: a comprehensive explanation for the administration of Desizon is given at the end of this package leaflet.
The oral suspension may also be administered via a feeding tube that should be rinsed three times immediately after administration with at least 5 ml of water for each rinse. If this method of administration is used, the suspension should be prepared as described above for oral use immediately before administration.
If you may have taken more Desizon 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 heartbeat, and reduced breathing and kidney function. Do not try to drive.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Desizon 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.
Your doctor may decide that you should stop using Desizon.
The most common side effects of Desizon are mild. They occur during the first month of treatment and usually decrease with continued treatment. In children aged 6-17 years, 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
Common side effects: may affect up to 1 in 10 people
Uncommon side effects: may affect up to 1 in 100 people
Very rare side effects: may affect up to 1 in 10,000 people
Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the carton box after EXP. The expiry date refers to the last day of that month.
Do not use after 1 month of first opening the bottle.
This medicinal product does not require any special storage conditions.
Do not use this medicine if you notice any damage to the bottle, closure or carton. 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 protect the environment.
The active substance is zonisamide.
The other ingredients are: Xanthan gum, sodium dihydrogen phosphate dihydrate, potassium monohydrogen phosphate, docusate sodium, sucralose, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), strawberry flavour (containing traces of sodium), sweetness modulator flavour (containing traces of fructose, glucose, sucrose, E220 and sodium), masking flavour (containing traces of sodium), phosphoric acid 85 %, purified water.
Desizon oral suspension is a white liquid with strawberry flavour.
1 glass bottle with 250 ml of Desizon oral suspension packed in a cardboard box containing an oral syringe of 10 ml graduated every 0.25 ml and an adapter.
2 glass bottles with 250 ml of Desizon oral suspension each packed in a cardboard box containing an oral syringe of 10 ml graduated every 0.25 ml and an adapter.
Not all pack sizes may be marketed.
This leaflet was last revised in March 2023.
Read these instructions carefully so that you know how to use this medicine.
There are three parts to the medicine kit:
1. A plastic adapter and a 10 ml oral dosing syringe which fits into the plastic adapter.
2. A bottle containing 250 ml of the medicine, with a child-resistant cap. Always replace the cap after use.
1. Shake the bottle vigorously for 30 seconds in a bottom up position. If a sediment is detected at the bottom of the bottle, shake the bottle for another 30 seconds.
2. Open the child-resistant cap by firmly pressing it down and twisting it anti-clockwise (see top of cap).
Note: Keep the cap nearby to close the bottle after each use.
3. Hold the bottle upright on a table. Firmly push the plastic adapter with the oral syringe into the bottle opening, as far as you can.
Note: You may not be able to push the adapter down fully but it will be forced into the bottle when you screw the cap back on.
After the first use the adapter remains in the bottle.
4. Hold the oral syringe in place and carefully turn the bottle upside down. Slowly pull out the plunger so that the oral syringe fills up with the suspension. Push the plunger back up completely to remove any large air bubbles that may be trapped inside the oral syringe.
5. Drawing the prescribed dose: Slowly pull out the syringe plunger, until the top of the wider part of the plunger is exactly on a level with the marker on the oral syringe barrel that indicates the prescribed dose.
Note: If the prescribed dose is more than 10 ml, fill the oral syringe to the 10 ml mark, and take the 10 ml. Then reload the oral syringe to the required level to take the remaining amount.
Ask your pharmacist if you are unsure.
6. Carefully turn the bottle and oral syringe the right way up. Remove the oral syringe by carefully twisting it from out of the adapter.
The adapter must always stay in the bottle.
7. Administer the dose directly into the mouth of the patient, who should be sitting in an upright position. Press the plunger slowly in order to allow for easy swallowing. The patient should drink a glass of water directly after intake. Carbonated beverages such as sparkling water should not be taken with the suspension.
Alternatively, the dose can be mixed in a small glass of water, orange juice or yoghurt just prior to administration. Stir and take the entire mixture right away. Carbonated beverages such as sparkling water should not be taken with the suspension.
8. Replace the child-resistant cap after use, leaving the adapter in place.
9. Cleaning: After use, wipe the outside of the syringe with a dry, clean tissue.