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: PLGB 33967/0020.
Inovelon Oral Suspension
Inovelon 40 mg/ml oral suspension
What is in this leaflet:
1. What Inovelon is and what it is used for
2. What you need to know before you take Inovelon
3. How to use Inovelon
4. Possible side effects
5. How to store Inovelon
6. Contents of the pack and other information
Inovelon contains a medicine called rufinamide. It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy (a condition where someone has seizures or fits).
Inovelon is used with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults, adolescents and children from 1 year 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.
Talk to your doctor or pharmacist if:
Consult the doctor, even if these events occurred at any time in the past.
Inovelon should not be given to children younger than 1 year of age since there is not enough information on its use in this age group.
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 valproate at the same time as rufinamide will result in high levels of rufinamide in the blood. Tell your doctor if you are taking valproate as the dose of Inovelon may need to be reduced by your doctor.
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 (a medicine used to treat heart conditions). The doctor may need to adjust the dose.
See section 3 – ‘How to use Inovelon’ for advice on taking Inovelon with food and drink.
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.
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 175 mg sorbitol (E420) in each mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Taking Inovelon with other anti-epileptic medicine which contains sorbitol, may affect how much they work. Tell your doctor or pharmacist if you are taking any other anti-epileptic medicine(s) with sorbitol.
Inovelon contains less than 0.01 mg benzoic acid (E210) in each mL. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies up to 4 weeks old.
This medicine contains less than 1 mmol sodium (23 mg) per daily dose, that is to say essentially ‘sodium-free’.
These ingredients may cause allergic reactions (possibly delayed).
Always take this medicine exactly as your doctor has told you. Check with the doctor or pharmacist if you are not sure.
It may take a while to find the best dose of Inovelon for you. The dose will be calculated for you by the doctor and will depend on your age, weight and whether you are taking Inovelon with another medicine called valproate.
Children aged between 1 and 4 years of age
The recommended starting dose is 10 mg (0.25 ml) for each kilogram of body weight, each day. Taken in two equal doses, half in the morning and the other half in the evening. The dose will be calculated for you by the doctor and may be increased by 10 mg (0.25 ml) for each kilogram of body weight, every third day.
The maximum daily dose will depend on whether or not you are also taking valproate. Maximum daily dose not taking valproate is 45 mg (1.125 ml) for each kilogram of body weight, each day. Maximum daily dose taking valproate is 30 mg (0.75 ml) for each kilogram of body weight, each day.
Children 4 years of age or older weighing less than 30 kg
The recommended starting dose is 200 mg (5 ml) a day. Taken in two equal doses, half in the morning and the other half in the evening. The dose will be calculated for you by the doctor and may be increased by 200 mg (5 ml) every third day.
The maximum daily dose will depend on whether or not you are also taking valproate. Maximum daily dose not taking valproate is 1,000 mg (25 ml) each day. Maximum daily dose taking valproate is 600 mg (15 ml) each day.
Adults, adolescents and children weighing 30 kg or over
The recommended starting dose is 400 mg (10 ml) a day. Taken in two equal doses, half in the morning and the other half in the evening. The dose will be calculated for you by the doctor and may be increased by 400 mg (10 ml) every other day.
The maximum daily dose will depend on whether or not you are also taking valproate. Maximum daily dose not taking valproate is no more than 3,200 mg (80 ml), depending on body weight.
Maximum daily dose taking valproate is no more than 2,200 mg (55 ml), depending on body 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 oral suspension must be taken twice every day, once in the morning and once in the evening. Inovelon should be taken with food.
Method of administration
For dosing, please use the syringe and adaptor provided.
Instructions on how to use the syringe and adaptor are provided below:
1. Shake well before use.
2. Push down and turn cap to open bottle
3. Insert adaptor into the neck of the bottle until a tight seal is made
4. Push plunger of syringe completely down
5. Insert the syringe into the opening of the adaptor as far as possible.
6. Turn upside down and withdraw the prescribed amount of Inovelon from the bottle.
7. Turn upright and remove the syringe.
8. Leave the adaptor in place and replace cap on bottle.
9. After dose administration, separate barrel and plunger, and fully immerse both components in HOT soapy water.
10.Immerse the barrel and plunger in water to remove any residual detergent, shake off excess water and leave components to air dry. Do not wipe dry the dispensers.
11. Do not clean and reuse the syringe after 40 uses, or if the markings on the syringe wash off.
Do not reduce the dose or stop this medicine unless the doctor tells you to.
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 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 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.
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 (see section 2).
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).
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: 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 label and carton. The expiry date refers to the last day of that month.
If you have any suspension left in the bottle more than 90 days after it was first opened, do not use it.
Do not use the suspension if you notice that the appearance or smell of your medicine has changed. Return the medicine to the 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 to protect the environment.
Company Contact Address: For further information on your medicine contact Medical Information at Eisai Europe Limited in Hatfield. Tel: + 44 (0) 208 600 1400.
This leaflet was last revised in December 2023.