Leaflet: information for the user

Inovelon100mgfilm-coated tablets

Inovelon200mgfilm-coated tablets

Inovelon400mgfilm-coated tablets

Rufinamide

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consultyour doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Inovelon and what it is used for

2.What you need to know before starting to take Inovelon

3.How to use Inovelon

4.Possible side effects

5.Storage of Inovelon

6.Contents of the pack and additional information

Inovelon contains a medication called rufinamide. It belongs to a group of medications called antiepileptics, which are used to treat epilepsy (a disease that causes seizure crises or epileptic attacks).

Inovelon is used with other medications to treat seizure crises associated with Lennox-Gastaut syndrome in adults, adolescents, and children over 1 year of age. Lennox-Gastaut syndrome is the name given to a group of severe epilepsies in which repeated crises of various types may occur.

Your doctor has prescribed Inovelon to reduce the number of crises or attacks.

Do not take Inovelon:

-if you are allergic to rufinamide, triazolides or any of the other components of Inovelon (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist:

• if you have congenital short QT syndrome or a family history of this type of heart rhythm disorder, as the use of rufinamide may worsen it.

• if you have liver problems. Information on the use of rufinamide in this group is limited, so your doctor may need to increase the dose more slowly. If your liver disease is severe, your doctor may decide that Inovelon is not recommended for you.

• if you develop a skin rash or fever. These could be signs of an allergic reaction. Seek medical attention immediately, as it can be severe in rare cases.

• if you experience an increase in the number or severity or duration of seizures, you must contact your doctor immediately if this occurs.

• if you experience difficulty walking, abnormal movements, dizziness or somnolence, inform your doctor if any of these occur.

• if you take this medicine and have suicidal thoughts or suicidal ideation at any time,contact your doctor or go to the hospital immediately(see section4).

Please consult your doctor, even if you experienced these effects at some point in the past.

Children

Inovelon should not be used in children under 1year of age because there is not enough information on its use in this age group.

Use of Inovelon with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription. If you are using the following medicines: phenobarbital, fosphenytoin, phenytoin or primidone,you may need to be closely monitored for two weeks at the beginning or end of treatment with rufinamide, or after any significant change in dose. You may need to adjust the dose of the other medicines as they may be less effective when taken with rufinamide.

Antiepileptics and Inovelon

If your doctor prescribes or recommends additional treatment for epilepsy (e.g., valproate), you must inform them that you are taking Inovelon, as it may be necessary to adjust your dose.

Taking valproate at the same time as rufinamide in children and adults will result in high levels of rufinamide in the blood. Inform your doctor if you are taking valproate, as your doctor may need to adjust your dose of Inovelon.

Inform your doctor if you use oral contraceptives/hormonal contraceptives, i.e., "the pill". Inovelon may make the pill ineffective in preventing pregnancy. Therefore, it is recommended that you use an additional safe and effective contraceptive method (such as a barrier method, e.g., condoms) while using Inovelon.

Inform your doctorif you use blood thinners, such as warfarin. Your doctor may need to adjust your dose.

Inform your doctorif you use digoxin (a medicine used to treat heart conditions).Your doctor may need to adjust your dose.

Taking Inovelon with food and drinks

See section 3 "How to use Inovelon" for recommendations on taking Inovelon with food and drinks.

Pregnancy, breastfeeding and fertility

If you are pregnant or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should only take Inovelon during pregnancy if your doctor advises it.

You are advised not to breastfeed while taking Inovelon as it is unknown whether rufinamide passes into breast milk.

If you are a fertile woman, you should use contraceptive methods while taking Inovelon.

Consult your doctor or pharmacist before using any medicine at the same time as Inovelon.

Driving and operating machinery

Inovelon may cause dizziness, somnolence and affect your vision, especially at the beginning of treatment or after a dose increase. If this happens, do not drive or operate machinery.

Inovelon contains lactose

If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.

Inovelon contains sodium

This medicine contains less than 1mmol of sodium (23mg) per daily dose; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It may take some time to find the best dose of Inovelon for you. Your doctor will calculate the appropriate dose taking into account your age, weight, and whether you are taking Inovelon with another medication called valproate.

Children between one and four years of age

The recommended starting dose is 10 mg per kilogram of body weight per day. Two equal doses are taken, half in the morning and the other half at night. Your doctor will calculate your dose and may increase it by 10 mg per kilogram of body weight every three days.

The maximum daily dose will depend on whether you are or are not taking valproate. The maximum daily dose without taking valproate is 45 mg per kilogram of body weight per day. The maximum daily dose taking valproate is 30 mg per kilogram of body weight per day.

Children 4 years of age or older who weigh less than 30 kg

The recommended starting dose is 200 mg per day. Two equal doses are taken, half in the morning and the other half at night. Your doctor will calculate your dose and may increase it by 200 mg (5 ml) every three days.

The maximum daily dose will depend on whether you are or are not taking valproate. The maximum daily dose without taking valproate is 1,000 mg per day. The maximum daily dose taking valproate is 600 mg per day.

Adults, adolescents, and children who weigh 30 kg or more

The recommended starting dose is 400 mg per day. Two equal doses are taken, half in the morning and the other half at night. Your doctor will calculate your dose and may increase it by 400 mg every other day.

The maximum daily dose will depend on whether you are or are not taking valproate. The maximum daily dose without taking valproate cannot exceed 3,200 mg, depending on your body weight. The maximum daily dose taking valproate cannot exceed 2,200 mg, depending on your body weight.

Some patients may respond to lower doses, and your doctor may adjust your dose based on your response to treatment.

If you experience side effects, your doctor may increase your dose more slowly.

Inovelon tablets should be taken twice a day with water, in the morning and at night. Inovelon should be taken with food. If you have difficulty swallowing, you can crush the tablet, then mix the powder in approximately half a glass of water (100 ml) and drink it immediately. You can also divide the tablets into two equal halves and swallow them with water.

Do not reduce the dose or stop taking this medication unless your doctor tells you to.

If you take more Inovelon than you should

If you may have taken more Inovelon than you should, inform your doctor or pharmacist immediately, or contact the nearest hospital emergency department, bringing the medication with you.

If you forget to take Inovelon

If you forget to take a dose, continue taking the medication as usual. Do not take a double dose to compensate for the missed dose. If you forget to take more than one dose, consult your doctor.

If you interrupt treatment with Inovelon

If your doctor tells you to stop treatment, follow their instructions regarding the gradual reduction of Inovelon to reduce the risk of increased seizures.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Inovelon can cause side effects, although not everyone will experience them.

The following side effects can be very serious:

Skin rash and/or fever. They may be signs of an allergic reaction. If this happens, inform your doctor or go to the hospital immediately.

Change in the types of seizures you experience/longer-lasting seizures (called status epilepticus). Inform your doctor immediately.

A small number of people taking antiepileptic medicines like Inovelon have had suicidal thoughts or behaviors. If you ever have these thoughts, contact your doctor immediately (see section2).

You may experience the following side effects with this medicine. Inform your doctor if you experience any of the following side effects:

The very common side effects (affecting more than 1 in 10 patients) of Inovelon are:

Dizziness, headache, nausea, vomiting, drowsiness, fatigue.

The common side effects (affecting more than 1 in 100 patients) of Inovelon are:

Neurological problems that include: difficulty walking, abnormal movements, seizures/convulsions, unusual eye movements, blurred vision, tremors.

Gastrointestinal problems that include: stomach pain, constipation, indigestion, soft stools (diarrhea), loss or change in appetite, weight loss.

Infections: ear infection, flu, nasal congestion, lung infection

Additionally, patients have experienced: anxiety, insomnia, nosebleed, acne, skin rash, back pain, infrequent menstruation, bruises, head and brain injuries (as a result of an accidental injury during an epileptic seizure).

The uncommon side effects (affecting between 1 in 100 and 1 in 1,000 patients) of Inovelon are:

Allergic reactions and an increase in liver function markers (elevated liver enzymes).

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this leaflet.You should also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box. The expiration dateis the last day of the month indicated.

Do not store at a temperature above30°C.

Do not use this medication if you observe that it has changed in appearance.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Inovelon

• The active ingredient is rufinamide.

Each film-coated tablet of 100 mg contains 100 mg of rufinamide.

Each film-coated tablet of 200 mg contains 200 mg of rufinamide.

Each film-coated tablet of 400 mg contains 400 mg of rufinamide.

• The other components are lactose monohydrate, microcrystalline cellulose (E460), cornstarch, sodium croscarmellose (E468), hypromellose (E464), magnesium stearate, sodium lauryl sulfate, and colloidal anhydrous silica. The coating consists of hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc, and iron oxide red (E172).

Appearance of Inovelon and contents of the package

• The Inovelon 100 mg tablets are film-coated, pink, oval, and slightly convex, with a notch on both sides, '?261' engraved on one side and nothing on the other.

It is available in packages of 10, 30, 50, 60, and 100 film-coated tablets.

• The Inovelon 200 mg tablets are film-coated, pink, oval, and slightly convex, with a notch on both sides, '?262' engraved on one side and nothing on the other.

It is available in packages of 10, 30, 50, 60, and 100 film-coated tablets.

• The Inovelon 400 mg tablets are film-coated, pink, oval, and slightly convex, with a notch on both sides, '?263' engraved on one side and nothing on the other.

It is available in packages of 10, 30, 50, 60, 100, and 200 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

e-mail: [email protected]

Responsible for manufacturing:

.

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu