Inovelon is a medicine containing the active substance rufinamide. It is available as tablets (100 mg, 200 mg or 400 mg) and as an oral suspension (40 mg/ml).
- Inovelon contains a medicine called rufinamide. It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy.
- Inovelon is used with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults, adolescents and children over 4 years of age. Lennox-Gastaut syndrome is the name given to a group of severe epilepsies in which you may experience repeated seizures of various types.
- Inovelon has been given to you by your doctor to reduce the number of your seizures or fits.
What you need to know before you take Inovelon
Do not take Inovelon:
- if you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon.
Warnings and precautions
Talk to your doctor or pharmacist if:
- you have Congenital Short QT Syndrome or a family history of such a syndrome (electricaldisturbance of the heart), as taking rufinamide could make it worse.
- you suffer from liver problems. There is limited information on the use of rufinamide in this group, so the dose of your medicine may need to be increased more slowly. If your liver disease is severe the doctor may decide Inovelon is not recommended for you.
- you get a skin rash or fever. These could be signs of an allergic reaction. See the doctor immediately as very occasionally this may become serious.
- you suffer an increase in the number or severity or duration of your seizures, you should contact the doctor immediately, if this happens.
- you experience difficulty walking, abnormal movement, dizziness or sleepiness inform the doctor, if any of these happen.
- If you take this medicine and have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Please consult the doctor, even if these events occurred at any time in the past.
- Inovelon should not be given to children younger than 4 years of age since there is not enough information on its use in this age group.
Other medicines and Inovelon
- Tell the doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are taking the following medicines: Phenobarbital, fosphenytoin, phenytoin or primidone, you may need to be carefully monitored for two weeks at the start of, or after the end of treatment with rufinamide, or after any marked change in the dose. A change in the dose of the other medicines may be needed as they may become slightly less effective when given with rufinamide.
Antiepileptic medicines and Inovelon
- If the doctor prescribes or recommends an additional treatment for epilepsy (e.g., valproate) you must tell the doctor you are taking Inovelon as the dose may need adjusting.
- Adults and children taking high doses of valproate at the same time as rufinamide will result in high levels of rufinamide in the blood, therefore the dose of Inovelon may need adjusting.
- If you are also taking carbamazepine, phenobarbital, phenytoin, vigabatrin or primidone, these can reduce the amount rufinamide that is effective at keeping your condition under control. Tell your doctor if you are taking any of these medicines, as it may be necessary to adjust your dose of rufinamide.
- Tell the doctor if you are taking hormonal/oral contraceptives, e.g., “The pill”. Inovelon may make the pill not effective at preventing pregnancy. Therefore, it is recommended that you use an additional safe and effective contraceptive method (such as a barrier method, e.g., condoms) when taking Inovelon.
- Tell the doctor if you are taking the blood thinner – warfarin. The doctor may need to adjust the dose.
- Tell the doctor if you are taking digoxin. The doctor may need to adjust the dose.
- If you are pregnant, or think you might be pregnant, or are planning to get pregnant, ask the doctor or pharmacist for advice before taking Inovelon. You must only take Inovelon during your pregnancy if the doctor tells you to.
- You are advised not to breast-feed while taking Inovelon, as it is not known if rufinamide will be present in breast milk.
- If you are a woman of childbearing age, you must use contraceptive measures while taking Inovelon.
- Ask the doctor or pharmacist for advice before taking any medicine at the same time as Inovelon.
Driving and using machines
- Inovelon may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment or after a dose increase. If this happens to you do not drive or operate machinery.
Inovelon contains lactose
- If you have been told by the doctor that you have an intolerance to some sugars, contact the doctor before taking this medicinal product.
How to use Inovelon
Always take this medicine exactly as your doctor has told you. Check with the doctor or pharmacist if you are not sure.
Children four years of age or older weighing less than 30 kg (not taking valproate)
The recommended starting dose is 200 mg a day taken in two doses. The dose will be adjusted for you by the doctor and may be increased by 200 mg at intervals of two days, to a daily dose of no more than 1000 mg.
Children four years of age or older weighing less than 30 kg (taking valproate)
For children less than 30 kg who are taking valproate (a treatment for epilepsy) the maximum recommended daily dose of Inovelon is 600 mg a day.
The recommended starting dose is 200 mg a day taken in two doses. The dose will be adjusted for you by the doctor and may be increased by 200 mg at intervals of two days, to the maximum recommended dose of 600 mg a day.
Adults, adolescents and children weighing 30 kg or over
The usual starting dose is 400 mg a day taken in two doses. The dose will be adjusted for you by the doctor and may be increased by 400 mg at intervals of two days, to a daily dose of no more than 3200 mg, depending upon your weight.
Some patients may respond to lower doses and your doctor may adjust the dose depending on how you respond to the treatment.
If you experience side effects, your doctor may increase the dose more slowly.
Inovelon tablets must be taken twice daily with water, in the morning and in the evening. Inovelon should be taken with food. If you have difficulty swallowing, you can crush the tablet, then mix the powder in about half a glass (100 ml) of water and drink immediately.
Do not reduce the dose or stop this medicine unless the doctor tells you to.
If you take more Inovelon than you should
If you may have taken more Inovelon than you should, tell the doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking the medicine with you.
If you forget to take Inovelon
If you forget to take a dose, continue taking the medicine as normal. Do not take a double dose to make up for forgotten dose. If you miss taking more than one dose, seek advice from the doctor.
If you stop taking Inovelon
If the doctor advises stopping treatment, follow their instructions concerning the gradual reduction of Inovelon in order to lower the risk of an increase in seizures.
If you have any further questions on the use of this product, ask the doctor or pharmacist.
Possible side effects
Like all medicines, Inovelon can cause side effects, although not everybody gets them.
The following side effects can be very serious:
Rash and/or fever. These could be signs of an allergic reaction. If they happen to you tell your doctor or go to a hospital immediately:
Change in the types of seizures you experience / more frequent seizures which last a long time (called status epilepticus). Tell your doctor immediately.
A small number of people being treated with antiepileptics such as Inovelon have had thoughts of harming or killing themselves. If at any time you have these thoughts contact your doctor immediately.
You may experience the following side effects with this medicine. Tell the doctor if you have any of the following:
Very common (more than 1 in 10 patients) side effects of Inovelon are:
- Dizziness, headache, nausea, vomiting, sleepiness, fatigue.
Common (more than 1 in a 100 patients) side effects of Inovelon are:
- Problems associated with nerves including: difficulty walking, abnormal movement, convulsions/seizures, unusual eye movements, blurred vision, trembling.
- Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
- Infections: Ear infection, flu, nasal congestion, chest infection.
- In addition patients have experienced: anxiety, insomnia, nose bleeds, acne, rash, back pain, infrequent periods, bruising, head injury (as a result of accidental injury during a seizure).
Uncommon (between 1 in a 100 and 1 in a 1000 patients) side effects of Inovelon are:
- Allergic reactions and an increase in markers of liver function (hepatic enzyme increase).
How to store Inovelon
- 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 blister and carton. The expiry date refers to the last day of that month.
- Do not store above 30°C.
- Do not use this medicine if you notice that the appearance of the medicine has changed.
- 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.