This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

Inovelon®

Rufinamide film-coated tablets
(ru-fin-a-mide)


Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Inovelon.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT INOVELON IS USED FOR

Inovelon is used with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults, adolescents and children from 4 years 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.

It contains the active ingredient rufinamide. Rufinamide belongs to a group of medicines called anti epileptics.

It works by reducing the number of fits that you have.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

BEFORE YOU TAKE INOVELON

When you must not take it

Do not take this medicine if you have an allergy to:

  • Rufinamide, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description

Inovelon tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, tell your doctor before taking Inovelon.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whetheryou should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart),
  • heart problems,
  • liver problems,
  • have or have had suicidal thoughts or actions, depression or mood problems.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. You must only take Inovelon during your pregnancy if the doctor tells you to.

You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Inovelon.

You should continue doing this for one month after stopping treatment.

Tell your doctor if you are taking hormonal contraceptives. Inovelon may make certain hormonal contraceptives less effecti