INOVELON 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Inovelon100mgfilm-coated tablets

Inovelon200mgfilm-coated tablets

Inovelon400mgfilm-coated tablets

Rufinamide

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your 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 your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Inovelon and what is it used for
2. What you need to know before you take Inovelon
3. How to take Inovelon
4. Possible side effects
5. Storage of Inovelon
6. Contents of the pack and other information

1. What is Inovelon and what is it used for

Inovelon contains the active substance rufinamide. It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy (a condition that causes 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 a severe form of epilepsy with multiple seizure types.

Your doctor has prescribed Inovelon to reduce the number of seizures or fits.

2. What you need to know before you take Inovelon

Do not take Inovelon:

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

Warnings and precautions

Tell your doctor or pharmacist:

• if you have congenital short QT syndrome or a family history of this condition (a heart electrical disorder), as rufinamide may worsen it.

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

• if you develop a skin rash or fever. These could be signs of an allergic reaction. See a doctor immediately, as it can occasionally be severe.

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

• if you have difficulty walking, abnormal movements, dizziness, or drowsiness, tell your doctor if any of these occur. If you are taking this medicine and have suicidal thoughts or thoughts of self-harm at any time, contact your doctor or go to hospital immediately(see section 4).

Please consult your doctor, even if you have had these effects in the past.

Children

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

Using Inovelon with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. If you are taking the following medicines: phenobarbital, fosphenytoin, phenytoin, or primidone, you may need to be closely monitored for two weeks when starting or stopping treatment with rufinamide, or after any significant change in dose. You may need to have the dose of the other medicines changed, as they may be less effective when given with rufinamide.

Antiepileptics and Inovelon

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

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

Tell your doctor if you are using oral/hormonal contraceptives, i.e., "the pill". Inovelon may make the pill less effective in preventing pregnancy. Therefore, it is recommended that you use another reliable and effective method of contraception (such as a barrier method, e.g., condoms) while taking Inovelon.

Tell your doctor if you are using blood thinners, such as warfarin. Your doctor may need to adjust the dose.

Tell your doctor if you are using digoxin (a medicine used to treat heart conditions). Your doctor may need to adjust the dose.

Taking Inovelon with food and drinks

See section 3 "How to take 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 if you plan to become pregnant, consult your doctor or pharmacist before taking 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 not known whether rufinamide passes into breast milk.

If you are a woman of childbearing age, you should use contraceptive methods while taking Inovelon.

Consult your doctor or pharmacist before taking any medicine with Inovelon.

Driving and using machines

Inovelon may make you feel dizzy, drowsy, and affect your vision, especially at the start of treatment or after a dose increase. If this happens, do not drive or use machines.

Inovelon contains lactose

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

Inovelon contains sodium

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

3. How to take Inovelon

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

It may take some time to find the best dose of Inovelon for you. Your doctor will calculate the right dose based on your age, weight, and whether you are taking Inovelon with another medicine called valproate.

Children between 1 and 4 years old

The recommended starting dose is 10 mg per kilogram of body weight per day. It is taken in two equal doses, half in the morning and half in the evening. Your doctor will calculate your dose and may increase it in increments of 10 mg per kilogram of body weight every three days.

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

Children 4 years or older who weigh less than 30 kg

The recommended starting dose is 200 mg per day. It is taken in two equal doses, half in the morning and half in the evening. 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 taking valproate or not. The maximum daily dose without valproate is 1,000 mg per day. The maximum daily dose with 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. It is taken in two equal doses, half in the morning and half in the evening. 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 taking valproate or not. The maximum daily dose without valproate should not exceed 3,200 mg, depending on your body weight. The maximum daily dose with valproate should not exceed 2,200 mg, depending on your body weight.

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

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

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

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

If you take more Inovelon than you should

If you may have taken more Inovelon than you should, tell your doctor or pharmacist immediately, or contact the nearest hospital emergency department, taking the medicine with you.

If you forget to take Inovelon

If you forget to take a dose, continue taking the medicine as usual. Do not take a double dose to make up for the forgotten dose. If you forget to take more than one dose, consult your doctor.

If you stop taking Inovelon

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

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

4. Possible side effects

Like all medicines, Inovelon can cause side effects, although not everybody gets them.

The following side effects may be serious:

Skin rash and/or fever. These can be signs of an allergic reaction. If this happens, tell your doctor or go to hospital immediately.

Change in seizure types or more frequent or longer-lasting seizures (called status epilepticus). Tell your doctor immediately.

A small number of people taking antiepileptics like Inovelon have had suicidal thoughts or thoughts of self-harm. If you have these thoughts at any time, contact your doctor immediately(see section 2).

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

Very common side effects (more than 1 in 10 patients) of Inovelon are:

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

Common side effects (more than 1 in 100 patients) of Inovelon are:

Nervous system problems, including difficulty walking, abnormal movements, seizures/convulsions, unusual eye movements, blurred vision, tremors.

Stomach problems, including 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 reported: anxiety, insomnia, nosebleeds, acne, skin rash, back pain, infrequent menstruation, bruising, head injuries (as a result of accidental injury during an epileptic seizure).

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

Allergic reactions and increased liver enzymes (liver function tests).

Reporting of side effects

If you experience 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 Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

Do not store above 30°C.

Do not use this medicine if you notice that the appearance of the medicine has changed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inovelon

• The active substance is rufinamide.

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

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

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

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

Appearance of Inovelon and contents of the pack

• Inovelon 100 mg tablets are pink, oval, and slightly convex, with a score line on both sides, '?261' engraved on one side and nothing on the other.

Available in packs of 10, 30, 50, 60, and 100 film-coated tablets.

• Inovelon 200 mg tablets are pink, oval, and slightly convex, with a score line on both sides, '?262' engraved on one side and nothing on the other.

Available in packs of 10, 30, 50, 60, and 100 film-coated tablets.

• Inovelon 400 mg tablets are pink, oval, and slightly convex, with a score line on both sides, '?263' engraved on one side and nothing on the other.

Available in packs of 10, 30, 50, 60, 100, and 200 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

e-mail: [email protected]

Manufacturer:

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu