Prospecto: information for the user

Inovelon40mg/ml oral suspension

Rufinamida

Read the entire prospect carefully before starting to take the medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you and should not be given to other people, even if they have the same symptomsas you, as it may harm them.
• If you experience adverse effects, consultyour doctor or pharmacist,even if they are not listed in this prospect. (See section 4).

1.What is Inovelon and what is it used for

2.What you need to knowbeforestarting totake Inovelon

3.How to use Inovelon

4.Possible adverse effects

5.Storage of Inovelon

6.Contents of the package and additional information

Inovelon containsa medicine calledrufinamide.It belongs to a group of medicines calledantiepileptics, which are used to treatepilepsy (a disease that causes seizure crises or epileptic attacks).

Inovelon is used with other medicines to treat seizure crises associated with Lennox‑Gastaut syndrome in adults, adolescents, and children over 1year 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 or to triazol derivatives or to 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 syndrome (heart electrical alteration), 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 it may be necessary to increase the dose of the medication more slowly. If your liver disease is severe, your doctor may decide that Inovelon is not recommended for you.
• if you develop skin rash or fever. These could be signs of an allergic reaction. Go to your doctor immediately, as it can be severe in rare cases.
• if you experience an increase in the number or severity or duration of seizures, contact your doctor immediately if this occurs.
• if you have difficulty walking, abnormal movements, dizziness, or drowsiness, inform your doctor if any of these occur.
• if you take this medication and have suicidal thoughts or ideation at any time, contact your doctor or go to the hospital immediately(see section 4).

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 1 year of age because there is not enough information on its use in this age group.

Use of Inovelon with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.If you are using the following medications: phenobarbital, fosphenytoin, phenytoin, or primidone,you may need to be closely monitored during the first two weeks of treatment or at the end of treatment with rufinamide, or after any significant change in dose. You may need to adjust the dose of the other medications, 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), inform them that you are taking Inovelon, as you may need 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 you may need to adjust your Inovelon dose.

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 medication used to treat heart diseases).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 if you plan to become pregnant, consult your doctoror pharmacist before using this medication. You should only take Inovelon during pregnancy if your doctor indicates it.

It is recommended that you do not breastfeedwhile taking Inovelon, as it is unknown 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 using any medication at the same time as Inovelon.

Driving and operating machinery

Inovelon may cause dizziness, drowsiness, 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 sorbitol (E420)

Inovelon contains 175mg of sorbitol (E420) per milligram. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Taking Inovelon with another antiepileptic medication that contains sorbitol may affect your functioning. Inform your doctor or pharmacist if you are taking antiepileptic medications with sorbitol.

Inovelon contains benzoic acid (E210)

Inovelon contains less than 0.01mg of benzoic acid (E210) per milligram. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns up to 4weeks of age.

Inovelon contains sodium

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

Inovelon contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate

These components may cause allergic reactions (possibly delayed).

Follow exactly the administration instructions for 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 aged 1 to 4 years

The recommended starting dose is 10 mg (0.25 ml) per kilogram of body weight per day. Take two equal doses, half in the morning and the other half at night. Your doctor will calculate your dose and may increase it by 10 mg (0.25 ml) 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 valproate is 45 mg (1.125 ml) per kilogram of body weight per day. The maximum daily dose with valproate is 30 mg (0.75 ml) 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 (5 ml) per day. Take two equal doses, 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 valproate is 1,000 mg (25 ml) per day. The maximum daily dose with valproate is 600 mg (15 ml) per day.

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

The recommended starting dose is 400 mg (10 ml) per day. Take two equal doses, half in the morning and the other half at night.

Your doctor will calculate your dose and may increase it by 400 mg (10 ml) every other day.

The maximum daily dose will depend on whether you are or are not taking valproate. The maximum daily dose without valproate cannot exceed 3,200 mg (80 ml) per day, depending on your body weight. The maximum daily dose with valproate cannot exceed 2,200 mg (55 ml) per day, 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 oral suspension should be taken twice a day, once in the morning and once at night. Inovelon should be taken with food.

Administration form

Use the syringe and adapter provided for administration.

Below are the instructions for use of the syringe and adapter:

1.Shake well before use.

2.Press and turn the cap to open the bottle.

3.Insert the adapter into the neck of the bottle until it is tightly closed.

4.Insert the plunger of the syringe completely.

5.Insert the syringe into the opening of the adapter as far as possible.

6.Place the bottle upside down and extract the prescribed amount of Inovelon.

7.Place the bottle upright and remove the syringe.

8.Leave the adapter in place and replace the cap on the bottle. Wash the syringe with clean water and dry it well.

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 emergency department of the nearest hospital, and bring the medication.

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 an increase in 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/ seizures that are more frequent and last a long time (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:

Problems associated with the nervous system that include: difficulty walking, abnormal movements, seizures/convulsions, unusual eye movements, blurred vision, tremors.

Problems associated with the stomach that include: stomach pain, constipation, indigestion, soft stools (diarrhea), loss or changes in appetite, weight loss.

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

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

The less common 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 that does not appear 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 label of the bottle and on the box. The expiration date is the last day of the month indicated.

If more than 90 days have passed since the first opening, the suspension remaining in the bottle should not be used.

Do not use the suspension if you observe that the appearance or the smell of the medication has changed. Take the medication to your pharmacist.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and of the medications that you no longer need. In this way, you will help to protect the environment.

Composition of Inovelon

• The active ingredient is rufinamide.Each milliliter contains40mg of rufinamide.5ml contain200mg of rufinamide.

• The other components are microcrystalline cellulose and sodium carmellose, anhydrous citric acid, simethicone emulsion30%, (which contains purified water, silicon oil, poloxamer65, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid, benzoic acid (E210) and sulfuric acid), poloxamer188, orange flavor, hydroxyethylcellulose, methylparaben (E218), potassium sorbate (E202), propylparaben, propylene glycol (E1520), sorbitol(E420), non-crystallizing liquid and purified water.

Appearance of the product and contents of the container

• Inovelon is a slightly viscous white suspension. It comes in a 460 ml bottle with two identical syringes and a pressure bottle adapter (PIBA). The syringes are graduated in increments of0.5ml.

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 marketing authorization holder:

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