INOVELON 400 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. what inovelon is and what it is used for

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.

2. what you need to know before you take inovelon

Do not take Inovelon:

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

Warnings and precautions

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

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.

Inovelon with food and drink

See section 3 – ‘How to use Inovelon’ for advice on taking Inovelon with food and drink.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

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 lactose

If you have been told by the doctor that you have an intolerance to some sugars, contact the doctor before taking this medicinal product.

3. how to use inovelon

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VARIABLE DATA

(e.g. Lot, Exp, Mfg, 2D code, serialisation etc.)

All Variable data is managed on the Market Specific Requirement Form, and is printed online at the time of packaging.

It does not appear on the artwork, and is not managed by the Artwork Department.

For all queries or requests to change the information please email the mailbox:

Please do not request changes to variable data on the Artwork.

If you take more Inovelon than you should

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 Inovelon

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 you stop taking Inovelon

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.

4. possible side effects

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

• – The other ingredients are lactose monohydrate, microcrystalline

cellulose, maize starch, croscarmellose sodium,

hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica. The film-coating consists of hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172).

What Inovelon looks like and contents of the pack

• – Inovelon 100 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘6261’ on one side and blank on the other side.

They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.

• – Inovelon 200 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘6262’ on one side and blank on the other side.

They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.

• – Inovelon 400 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘6263’ on one side and blank on the other side.

They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.

Marketing Authorisation Holder Eisai Europe Limited, European Knowledge Centre, Mosquito Way, Hatfield, AL10 9SN, United Kingdom

Manufacturer

Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, AL10 9SN, United Kingdom

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 01/2021.

Detailed information on this medicine is available on the Medicines and Healthcare products Regulatory Agency web site:

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).

Reporting of side effects

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 at:.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store 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 refers to the last day of that month.

Do not store above 30°C.

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

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.

6. contents of the pack and other information

What Inovelon contains

– 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.

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2004934

VARIABLE DATA

(e.g. Lot, Exp, Mfg, 2D code, serialisation etc.)

All Variable data is managed on the Market Specific Requirement Form, and is printed online at the time of packaging.

It does not appear on the artwork, and is not managed by the Artwork Department.

For all queries or requests to change the information please email the mailbox:

Please do not request changes to variable data on the Artwork.