• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask the doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon (listed in section 6).

Talk to your doctor or pharmacist if:

• you have Congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance 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 (see section 4).

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).

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 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.

• The active substance is rufinamide. Each millilitre contains 40 mg of rufinamide. 5 ml contains 200 mg rufinamide.
• The other ingredients are microcrystalline cellulose and carmellose sodium, anhydrous citric acid, simethicone emulsion 30% (containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid, benzoic acid (E210) and sulfuric acid), poloxamer 188, orange flavour, hydroxyethylcellulose, methyl parahydroxybenzoate (E218), potassium sorbate (E202), propyl parahydroxybenzoate, propylene glycol (E1520), sorbitol (E420), liquid (non-crystallising), and purified water.

• Inovelon is a white slightly viscous suspension. It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA). The syringes are graduated in 0.5 ml increments.

Company Contact Address: For further information on your medicine contact Medical Information at Eisai Europe Limited in Hatfield. Tel: + 44 (0) 208 600 1400.