Inovelon 40 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Inovelon 40 mg/ml oral suspension

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effect is not listed in this leaflet. (See section 4).

What is in this leaflet:

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

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 that causes epileptic seizures or fits).

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

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

2. What you need to know before starting INOVELON

Do not take Inovelon:

• if you are allergic to rufinamide or to triazole derivatives or to any of the other ingredients 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 syndrome (an electrical disorder of the heart), as the use of rufinamide may worsen it.
• if you have liver problems. Information on the use of rufinamide in this group is limited; therefore, 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. Seek medical advice immediately, as very rarely this may become serious.
• if you experience an increase in the number, severity, or duration of seizures, you must contact your doctor immediately if this occurs.
• if you experience difficulty walking, abnormal movements, dizziness, or drowsiness, inform your doctor if any of these occur.
• if you take this medicine and have thoughts of self-harm or suicide 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 in the past.

Children

Inovelon must not be used in children under 1 year of age, as there is insufficient 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 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 dose change. The dose of these other medicines may need to be adjusted, as they may become less effective when taken with rufinamide.

Antiepileptic medicines 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 your dose may need to be adjusted.

Taking valproate together with rufinamide in children and adults will result in higher blood levels of rufinamide. Inform your doctor if you are taking valproate, as your dose of Inovelon may need to be adjusted.

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

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

Inform your doctor if you are using 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 specifically instructed by your doctor.

You are advised not to breastfeed while 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 medicine together with Inovelon.

Driving and using machines

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

Inovelon contains sorbitol (E420)

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

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Taking Inovelon with another antiepileptic medicine containing sorbitol may affect its effectiveness. Inform your doctor or pharmacist if you are taking antiepileptic medicines containing sorbitol.

Inovelon contains benzoic acid (E210)

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

Inovelon contains sodium

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

Inovelon contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate

These ingredients may cause allergic reactions (possibly delayed).

3. How to use Inovelon

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Children between one and four years of age

The recommended starting dose is 10 mg (0.25 ml) per kilogram of body weight per day. This is given as two equal doses, half in the morning and half at night. Your doctor will calculate your dose and may increase it in increments of 10 mg (0.25 ml) per kilogram of body weight every three days.

The maximum daily dose will depend on whether you are also 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 when taking valproate is 30 mg (0.75 ml) per kilogram of body weight per day.

Children aged 4 years and older weighing less than 30 kg

The recommended starting dose is 200 mg (5 ml) per day. This is given as two equal doses, half in the morning and 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 taking valproate. The maximum daily dose without valproate is 1,000 mg (25 ml) per day. The maximum daily dose when taking valproate is 600 mg (15 ml) per day.

Adults, adolescents and children weighing 30 kg or more

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

Your doctor will calculate your dose and may increase it by 400 mg (10 ml) on alternate days.

The maximum daily dose will depend on whether you are taking valproate. The maximum daily dose without valproate must not exceed 3,200 mg (80 ml), depending on your body weight. The maximum daily dose when taking valproate must not exceed 2,200 mg (55 ml), depending on your body weight.

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

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

Inovelon oral suspension should be taken twice daily, once in the morning and once at night. Inovelon should be taken with food.

Method of administration

Use the syringe and adapter supplied for administration.

The following are instructions for using the syringe and adapter:

1. Shake well before use.
2. Press and twist the cap to open the bottle.
3. Insert the adapter into the neck of the bottle until it is securely sealed.
4. Fully insert the plunger of the syringe.
5. Insert the syringe into the opening of the adapter as far as possible.
6. Turn the bottle upside down and withdraw the prescribed amount of Inovelon.
7. Turn 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 thoroughly.

Do not reduce the dose or stop taking this medicine unless instructed by your doctor.

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, and bring 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 the gradual reduction of Inovelon to reduce the risk of an increase in seizures.

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

4. Possible adverse effects

Like all medicines, Inovelon can cause adverse effects, although not everyone experiences them.

The following adverse effects may be very serious:

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

Change in the type of seizures you experience/seizures becoming more frequent and lasting longer (called status epilepticus). Inform your doctor immediately.

A small number of people taking antiepileptic medicines such as Inovelon have had thoughts of self-harm or suicide. If you ever have such thoughts, contact your doctor immediately (see section 2).

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

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

Dizziness, headache, nausea, vomiting, somnolence, fatigue.

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

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

Stomach-related problems including: stomach pain, constipation, indigestion, soft stools (diarrhoea), loss of appetite or appetite changes, weight loss.

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

In addition, patients have experienced: anxiety, insomnia, nosebleeds, acne, skin rash, back pain, infrequent menstruation, bruising, head injuries (as a result of accidental injury during an epileptic seizure).

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

Allergic reactions and increased liver function markers (elevated liver enzymes).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse 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 stated on the label of the bottle and on the carton. The expiry date refers to the last day of the month indicated.

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

Do not use the suspension if you notice any changes in the appearance or smell of the medicine. Return the medicine to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inovelon

• The active substance is rufinamide. Each millilitre contains 40 mg of rufinamide. 5 ml contain 200 mg of rufinamide.

• The other components are microcrystalline cellulose and sodium carmellose, anhydrous citric acid, simethicone emulsion 30 % (containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid, benzoic acid (E210) and sulphuric acid), poloxamer 188, orange flavour, hydroxyethylcellulose, methylparahydroxybenzoate (E218), potassium sorbate (E202), propylparahydroxybenzoate, propylene glycol (E1520), sorbitol (E420), liquid (non-crystallising) and purified water.

Appearance of the product and contents of the pack

• Inovelon is a slightly viscous white suspension. It is supplied in a 460 ml bottle with two identical syringes and a press-in bottle adapter (PIBA). The syringes are graduated in 0.5 ml increments.

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

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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