Inovelon

Patient Information Leaflet: Information for the User

Inovelon 100 mg film-coated tablets, 200 mg film-coated tablets, 400 mg film-coated tablets

Rufinamide
Please read this leaflet carefully before using 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 disorder characterized by epileptic seizures or fits).
Inovelon is used in combination with other medicines to treat epileptic 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 repeated epileptic seizures of various types may occur.
Your doctor has prescribed Inovelon to help reduce the number of epileptic seizures or fits you have.

2. What you need to know before taking Inovelon

Do not take Inovelon

• if you are allergic to rufinamide, triazole derivatives, or any of the other ingredients of this medicine (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 (a disorder affecting the heart's electrical impulse conduction), as taking rufinamide could worsen it.
• if you have liver problems. There is limited information on the use of rufinamide in this patient group, so the dose may need to be increased more slowly. If liver disease is severe, your doctor may decide that Inovelon is not recommended for you.
• if a skin rash or fever develops. These could be signs of an allergic reaction. Contact your doctor immediately, as very rarely this condition can become serious.
• if you experience an increase in the number, severity, or duration of epileptic 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 are taking this medicine and at any time have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately (see section 4).

Also consult your doctor if any of these events have occurred in the past.
Children
Inovelon must not be given to children under 1 year of age because there is insufficient information on the use of this medicine in this age group.
Other medicines and Inovelon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines 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 substantial dose adjustment. A dose adjustment of the other medicines may be necessary, as they may become slightly 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 a dose adjustment may be needed.
In both adults and children, taking valproate together with rufinamide results in higher blood levels of rufinamide. Inform your doctor if you are taking valproate, as your doctor may need to reduce the dose of Inovelon.
Inform your doctor if you are taking hormonal/oral contraceptives, e.g. "the pill". Inovelon may render the pill ineffective in preventing pregnancy. Therefore, it is recommended to use a reliable and effective additional contraceptive method (such as a barrier method, e.g. condoms) during treatment with Inovelon.
Inform your doctor if you are taking warfarin, an anticoagulant. Your doctor may need to adjust the dose.
Inform your doctor if you are taking digoxin (a medicine used to treat heart disorders). Your doctor may need to adjust the dose.
Inovelon with food and drinks
See section 3 "How to take Inovelon" for advice on taking Inovelon with food and drinks.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Inovelon. Take Inovelon during pregnancy only if instructed by your doctor.
Breastfeeding is not recommended during treatment with Inovelon, as it is not known whether rufinamide passes into breast milk.
If you are a woman of childbearing age, you must use contraceptive measures during treatment with Inovelon.
Ask your doctor or pharmacist for advice before taking any medicine together with Inovelon.
Driving and using machines
Inovelon may cause dizziness, drowsiness, or blurred vision, especially at the beginning of treatment or after a dose increase. If you experience these symptoms, do not drive and do not operate machinery.
Inovelon contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.
Inovelon contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per daily dose, i.e. essentially 'sodium-free'.

3. How to use Inovelon

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Finding the best dose of Inovelon for you may take some time. Your doctor will calculate your dose based on your age, body weight, and whether you are taking Inovelon together with another medicine called valproate.

Children aged 1 to 4 years
The recommended starting dose is 10 mg per kilogram of body weight per day, 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 10 mg per kilogram of body weight every three days.
The maximum daily dose depends on whether or not you are taking valproate. The maximum daily dose when not taking valproate is 45 mg per kilogram of body weight per day. The maximum daily dose when taking valproate is 30 mg 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 per day, 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 every three days.
The maximum daily dose depends on whether or not you are taking valproate. The maximum daily dose when not taking valproate is 1,000 mg per day. The maximum daily dose when taking valproate is 600 mg per day.

Adults, adolescents, and children weighing 30 kg or more
The recommended starting dose is 400 mg per day, 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 depends on whether or not you are taking valproate. The maximum daily dose when not taking valproate is up to 3,200 mg per day, depending on body weight. The maximum daily dose when taking valproate is up to 2,200 mg per day, depending on body weight.
Some patients may respond to lower doses, and your doctor may adjust the dose according to your response to treatment.
If you experience side effects, your doctor may increase the dose more slowly.

Inovelon tablets should be taken with water twice daily, in the morning and evening. Inovelon should be taken with food. If you have difficulty swallowing, you may crush the tablet, mix the powder in about half a glass (100 ml) of water, and drink it immediately. You may also split the tablet into two equal parts and swallow them with water.

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 think you may have taken more Inovelon than you should, contact your doctor or pharmacist immediately, or go to 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 a forgotten dose. If you miss more than one dose, consult your doctor.

If you stop taking Inovelon
If your doctor advises you to stop treatment, follow their instructions on gradually reducing the dose of Inovelon in order to reduce the risk of increased seizures.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects can be very serious:
Skin rash and/or fever. These could be signs of an allergic reaction. If these occur, contact your doctor or go to hospital immediately.
Change in the type of epileptic seizures experienced / epileptic seizures becoming more frequent and lasting longer (called status epilepticus). Inform your doctor immediately.
A small number of people treated with antiepileptic medicines, such as Inovelon, have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, contact your doctor immediately (see section 2).

The following side effects may occur with the use of this medicine. Inform your doctor if you experience any of the following:

Very common side effects of Inovelon (affecting more than 1 in 10 patients) are:
Dizziness, headache, nausea, vomiting, somnolence, fatigue.

Common side effects of Inovelon (affecting more than 1 in 100 patients) are:
Problems affecting the nervous system, such as: difficulty walking, abnormal movements, seizures/epileptic seizures, unusual eye movements, blurred vision, tremor.
Problems affecting the stomach, such as: stomach ache, constipation, indigestion, loose stools (diarrhoea), loss or changes in appetite, weight loss.
Infections: ear infection, influenza, nasal congestion, chest infection.
In addition, 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 of Inovelon (affecting between 1 in 100 and 1 in 1000 patients) are:
Allergic reactions and increased indicators of liver function (elevated liver enzymes).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. 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 stated on the blister and on the 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 any change in its appearance.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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.

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

Description of the appearance of Inovelon and contents of the pack

• Inovelon 100 mg tablets are pink, oval, slightly convex, film-coated tablets, with a break line on both sides, marked with ‘Є261’ on one side and no marking on the other. They are available in packs of 10, 30, 50, 60 and 100 film-coated tablets.
• Inovelon 200 mg tablets are pink, oval, slightly convex, film-coated tablets, with a break line on both sides, marked with ‘Є262’ on one side and no marking on the other. They are available in packs of 10, 30, 50, 60 and 100 film-coated tablets.
• Inovelon 400 mg tablets are pink, oval, slightly convex, film-coated tablets, with a break line on both sides, marked with ‘Є263’ on one side and no marking on the other. They are 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Eisai SA/NV Eisai GmbH
Tél/Tel: +32 (0)800 158 58 Tel: + 49 (0) 69 66 58 50
България Luxembourg/Luxemburg
Eisai GmbH Eisai SA/NV
Teл.: + 49 (0) 69 66 58 50 Tél/Tel: +32 (0)800 158 58
(Germany) (Belgique/Belgien)
Česká republika Magyarország
Eisai GesmbH organizačni složka Ewopharma Hungary Ltd.
Tel: + 420 242 485 839 Tel.: +36 1 200 46 50
Danmark Malta
Eisai AB Cherubino LTD
Tlf: + 46 (0) 8 501 01 600 Tel.: +356 21343270
(Sverige)
Deutschland Nederland
Eisai GmbH Eisai B.V.
Tel: + 49 (0) 69 66 58 50 Tél/Tel: + 31 (0) 900 575 3340
Eesti Norge
Eisai GmbH Eisai AB
Tel: + 49 (0) 69 66 58 50 Tlf: + 46 (0) 8 501 01 600
(Germany) (Sverige)
Ελλάδα Österreich
Arriani Pharmaceutical S.A. Eisai GesmbH
Τηλ: + 30 210 668 3000 Tel: + 43 (0) 1 535 1980-0
España Polska
Eisai Farmacéutica, S.A. Eisai GmbH
Tel: + (34) 91 455 94 55 Tel: + 49 (0) 69 66 58 50
(Germany)
France Portugal
Eisai SAS Eisai Farmacêtica, Unipessoal Lda
Tél: + (33) 1 47 67 00 05 Tel: + 351 214 875 540
Hrvatska România
Eisai GmbH Eisai GmbH
Tel: + 49 (0) 69 66 58 50 Tel: + 49 (0) 69 66 58 50
(Germany)
Ireland Slovenija
Eisai GmbH Ewopharma d.o.o.
Tel: + 49 (0) 69 66 58 50 Tel: +386 590 848 40
Ísland Slovenská republika
Eisai AB Eisai GesmbH organizačni složka
Sími: + 46 (0)8 501 01 600 Tel.: + 420 242 485 839
(Sweden) (Czech Republic)
Italia Suomi/Finland
Eisai S.r.l. Eisai AB
Tel: + 39 02 5181401 Puh/Tel: + 46 (0) 8 501 01 600
(Finland)
Κύπρος Sverige
Arriani Pharmaceuticals S.A. Eisai AB
Τηλ: + 30 210 668 3000 Tel: + 46 (0) 8 501 01 600
(Greece)
Latvija United Kingdom (Northern Ireland)
Eisai GmbH Eisai GmbH
Tel: + 49 (0) 69 66 58 50 Tel: + 49 (0) 69 66 58 50
(Germany) (Germany)

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: information for the user

Inovelon 40 mg/ml oral suspension

Rufinamide
Please read this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Inovelon is and what it is used for
2. What you need to know before taking Inovelon
3. How to use 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 known as antiepileptic drugs, which are used to treat epilepsy (a disorder characterised by epileptic seizures or fits).
Inovelon is used in combination with other medicines to treat epileptic 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 repeated epileptic seizures of various types may occur.
Your doctor has prescribed Inovelon to reduce the number of epileptic seizures or fits you experience.

2. What you need to know before taking Inovelon

Do not take Inovelon

• if you are allergic to rufinamide, triazole derivatives, or any of the other ingredients of this medicine (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 (a disorder affecting the heart's electrical impulse conduction), as taking rufinamide could worsen it.
• If you have liver problems, because there is limited information on the use of rufinamide in this patient group and your dose may need to be increased more slowly. If your liver disease is severe, your doctor may decide that Inovelon is not recommended for you.
• If you develop a skin rash or fever. These could be signs of an allergic reaction. Contact your doctor immediately, as very rarely this condition can become serious.
• If you experience an increase in the number, severity, or duration of epileptic 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 are taking this medicine and at any time have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately (see section 4).

Also consult your doctor if any of these events have occurred in the past.
Children
Inovelon must not be given to children under 1 year of age because there is insufficient information on the use of this medicine in this age group.
Other medicines and Inovelon
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines 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 rufinamide treatment, or after any substantial change in dose. A dose adjustment of the other medicines may be necessary, as they may become slightly 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 a dose adjustment may be required.
In adults and children, taking valproate together with rufinamide results in higher blood levels of rufinamide. Inform your doctor if you are taking valproate, as it may be necessary for your doctor to reduce your dose of Inovelon.
Inform your doctor if you are taking hormonal/oral contraceptives (e.g. "the pill"). Inovelon may render the pill ineffective in preventing pregnancy. Therefore, it is recommended to use a reliable and effective additional contraceptive method (such as a barrier method, e.g. condoms) during treatment with Inovelon.
Inform your doctor if you are taking warfarin, an anticoagulant. Your doctor may need to adjust your dose.
Inform your doctor if you are taking digoxin (a medicine used to treat heart disorders). Your doctor may need to adjust your dose.
Inovelon with food and drink
See section 3 "How to take Inovelon" for advice on taking Inovelon with food and drink.
Pregnancy, breastfeeding and fertility
If you are or think you may be pregnant, or if you plan to become pregnant, ask your doctor or pharmacist for advice before taking Inovelon. Take Inovelon during pregnancy only if instructed by your doctor.
Breastfeeding is not recommended during treatment with Inovelon, as it is not known whether rufinamide passes into breast milk.
If you are a woman of childbearing age, you must use contraceptive measures during treatment with Inovelon.
Ask your doctor or pharmacist for advice before taking any medicine together with Inovelon.
Driving and using machines
Inovelon may cause dizziness, drowsiness, or visual disturbances, especially at the beginning of treatment or after a dose increase. If you experience these symptoms, do not drive and do not operate machinery.
Inovelon contains sorbitol (E420)
Inovelon contains 175 mg of sorbitol (E420) per mL. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
Taking Inovelon together with another antiepileptic medicine containing sorbitol may impair their effectiveness. Inform your doctor or pharmacist if you are taking other antiepileptic medicines containing sorbitol.
Inovelon contains benzoic acid (E210)
Inovelon contains less than 0.01 mg of benzoic acid (E210) per mL. Benzoic acid may increase 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 (23 mg) of sodium per daily dose, i.e. essentially 'sodium-free'.
Inovelon contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate
These excipients may cause allergic reactions (including delayed reactions).

3. How to use Inovelon

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Finding the best dose of Inovelon for you may take time. Your doctor will calculate the dose based on your age, body weight, and whether you are taking Inovelon together with another medicine 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, taken in two equal doses—half in the morning and half in the evening. Your doctor will calculate the dose and may increase it by 10 mg (0.25 mL) per kilogram of body weight every three days.

The maximum daily dose depends on whether you are 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 aged 4 years and older weighing less than 30 kg

The recommended starting dose is 200 mg (5 mL) per day, taken in two equal doses—half in the morning and half in the evening. Your doctor will calculate the dose and may increase it by 200 mg (5 mL) every three days.

The maximum daily dose depends on whether you are 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 weighing 30 kg or more

The recommended starting dose is 400 mg (10 mL) per day, taken in two equal doses—half in the morning and half in the evening. Your doctor will calculate the dose and may increase it by 400 mg (10 mL) on alternate days.

The maximum daily dose depends on whether you are taking valproate. The maximum daily dose without valproate is up to 3,200 mg (80 mL), depending on body weight. The maximum daily dose with valproate is up to 2,200 mg (55 mL), depending on body weight.

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

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

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

Method of administration

For administration, use the syringe and adapter provided.

Instructions for using the syringe and adapter are shown below:

1. Shake well before use.
2. Press (1) and twist (2) the cap to open the bottle.
3. Insert the adapter into the neck of the bottle until it is securely sealed.
4. Push the plunger of the syringe fully down.
5. Insert the syringe as far as possible into the opening of the adapter.
6. Turn the bottle upside down and draw the prescribed amount of Inovelon from the bottle.
7. Return the bottle to an upright position and remove the syringe.
8. Leave the adapter in place and replace the cap on the bottle.
9. After administering the dose, separate the syringe barrel from the plunger and immerse both components completely in HOT soapy water.
10. Rinse the syringe barrel and plunger with water to remove any residual soap, remove excess water, and allow the components to air dry. Do not dry the administration devices by wiping them with a cloth.
11. Do not clean and reuse the syringe after 40 uses, or if markings on the syringe are removed during washing.

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 think you have taken more Inovelon than you should, contact your doctor or pharmacist immediately, or go to 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 missed dose. If you miss more than one dose, consult your doctor.

If you stop taking Inovelon

If your doctor advises you to stop treatment, follow their instructions on gradually reducing the dose of Inovelon to reduce the risk of increased epileptic seizures.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be very serious:
Skin rash and/or fever. These could be signs of an allergic reaction. If they occur, contact your doctor or go to hospital immediately.
Change in the type of seizures experienced / seizures occurring more frequently and lasting longer (called status epilepticus). Contact your doctor immediately.
A small number of people treated with antiepileptic medicines such as Inovelon have had thoughts of harming themselves or of suicide. If at any time you have such thoughts, contact your doctor immediately (see section 2).
The following side effects may occur with this medicine. Contact your doctor if you experience any of the following:
Very common side effects of Inovelon (affecting more than 1 in 10 people) are:
Dizziness, headache, nausea, vomiting, somnolence (sleepiness), fatigue.
Common side effects of Inovelon (affecting more than 1 in 100 people) are:
Problems affecting the nervous system, such as: difficulty walking, abnormal movements, seizures/epileptic fits, unusual eye movements, blurred vision, tremor.
Problems affecting the stomach, such as: stomach ache, constipation, indigestion, loose stools (diarrhoea), loss of appetite or changes in appetite, weight loss.
Infections: ear infection, influenza, nasal congestion, chest infection.
In addition, 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 of Inovelon (affecting between 1 in 100 and 1 in 1000 patients) are:
Allergic reactions and increased indicators of liver function (elevated liver enzymes).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. 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 stated on the bottle label and on the carton. The expiry date refers to the last day of that month.
If any suspension remains in the bottle for more than 90 days after first opening, do not use it.
Do not use the suspension if you notice any changes in the appearance or smell of the medicine. Return the medicine to the pharmacist.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Inovelon contains

• 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 carmellose sodium, 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 sulfuric acid), poloxamer 188, orange flavour, hydroxyethylcellulose, methylparahydroxybenzoate (E218), potassium sorbate (E202), propylparahydroxybenzoate, propylene glycol (E1520), sorbitol (E420), liquid (non-crystallising), and purified water.

Description of the appearance of Inovelon and contents of the pack

• Inovelon is a white, slightly viscous suspension. It is supplied in a 460 ml bottle, with two identical syringes and a press-fit 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Eisai SA/NV Eisai GmbH
Tél/Tel: +32 (0)800 158 58 Tel: + 49 (0) 69 66 58 50
България Luxembourg/Luxemburg
Eisai GmbH Eisai SA/NV
Teл.: + 49 (0) 69 66 58 50 Tél/Tel: +32 (0)800 158 58
(Germany) (Belgique/Belgien)
Česká republika Magyarország
Eisai GesmbH organizačni složka Eisai GmbH
Tel: + 420 242 485 839 Tel.: + 49 (0) 69 66 58 50
Danmark Malta
Eisai AB Cherubino LTD
Tlf: + 46 (0) 8 501 01 600 Tel.: +356 21343270
(Sweden)
Deutschland Nederland
Eisai GmbH Eisai B.V.
Tel: + 49 (0) 69 66 58 50 Tél/Tel: + 31 (0) 900 575 3340
Eesti Norge
Eisai GmbH Eisai AB
Tel: + 49 (0) 69 66 58 50 Tlf: + 46 (0) 8 501 01 600
(Germany) (Sweden)
Ελλάδα Österreich
Arriani Pharmaceutical S.A. Eisai GesmbH
Τηλ: + 30 210 668 3000 Tel: + 43 (0) 1 535 1980-0
España Polska
Eisai Farmacéutica, S.A. Eisai GmbH
Tel: + (34) 91 455 94 55 Tel: + 49 (0) 69 66 58 50
(Germany)
France Portugal
Eisai SAS Eisai Farmacêutica, Unipessoal Lda
Tél: + (33) 1 47 67 00 05 Tel: + 351 214 875 540
Hrvatska România
Eisai GmbH Eisai GmbH
Tel: + 49 (0) 69 66 58 50 Tel: + 49 (0) 69 66 58 50
(Germany)
Ireland Slovenija
Eisai GmbH Eisai GmbH
Tel: + 49 (0) 69 66 58 50 Tel: + 49 (0) 69 66 58 50
(Slovenia)
Ísland Slovenská republika
Eisai AB Eisai GesmbH organizačni složka
Sími: + 46 (0)8 501 01 600 Tel.: + 420 242 485 839
(Iceland) (Czech Republic)
Italia Suomi/Finland
Eisai S.r.l. Eisai AB
Tel: + 39 02 5181401 Puh/Tel: + 46 (0) 8 501 01 600
(Finland)
Κύπρος Sverige
Arriani Pharmaceuticals S.A. Eisai AB
Τηλ: + 30 210 668 3000 Tel: + 46 (0) 8 501 01 600
(Greece)
Latvija United Kingdom (Northern Ireland)
Eisai GmbH Eisai GmbH
Tel: + 49 (0) 69 66 58 50 Tel: + 49 (0) 69 66 58 50
(Latvia) (Germany)
More detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.