What Inovelon 40 mg Oral Suspension is used for and how to use it
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Inovelon 40 mg Oral Suspension - Consumer Medicine Information

Manufacture: Eisai Inc.
Country: Great Britain
Condition: Lennox-Gastaut Syndrome, Seizures (Convulsions)
Class: Anticonvulsants
Form: Liquid solution, Syrup
Ingredients: rufinamide, microcrystalline cellulose and carmellose sodium, anhydrous citric acid, simeticone emulsion 30% (containing benzoic acid, cyclotetrasiloxane, dimethicone, glycol stearate and glyceryl distearate, methylcellulose, PEG-40 stearate [polyethylene glycol stearate], polysorbate 65, silica gel, sorbic acid, sulphuric acid and water), poloaxamer 188, hydroxyethylcellulose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), potassium sorbate, propylene glycol (E1520), sorbitol, liquid (non-crystallising), orange flavour and water

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 over 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.

What You Need to Know Before You Take Inovelon

Do not Take Inovelon

  • you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon (listed Contents of the pack and other information)

Warnings and Precautions

Please inform the 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 be increased more slowly. If your liver disease is severe the doctor may decide Inovelon is not recommended for you.
  • you get a skin rash or fever. These could be signs of an allergic reaction. See the doctor immediately as very occasionally this may become serious.
  • you suffer an increase in the number or severity or duration of your seizures, you should contact the doctor immediately.
  • you experience difficulty walking, abnormal movement, dizziness or sleepiness inform the doctor.

Please consult the doctor, even if these statements were applicable at any time in the past.

Children

Inovelon should not be given to children younger than 4 years of age since there is not enough information on its use in this age group.

Other Medicines and Inovelon

Tell the doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.If you are taking other medicines removed from the body by the CYP3A4 enzyme system you may need to be carefully monitored for two weeks at the start of, or after the end of treatment with rufinamide, or after any marked change in the dose. A change in the dose of the other medicines may be needed as they may become slightly less effective when given with rufinamide.

Tell the doctor if you are taking hormonal/oral contraceptives. Inovelon may make hormonal/oral contraceptives such as the contraceptive pill less effective. Therefore, it is recommended that you use an additional safe and effective contraceptive method 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.

If the doctor prescribes or recommends an additional treatment for epilepsy (e.g. valproate) you must tell the doctor you are taking Inovelon as the dose may need adjusting.

Inovelon With Food and Drink

See How to use Inovelon for advice on taking Inovelon with food and drink.

Pregnancy and Breast-feeding

If you are a woman of childbearing age, you must use contraceptive measures while taking Inovelon.

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.

Ask the doctor or pharmacist for advice before taking any medicine.

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 methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)

These ingredients may cause allergic reactions (possibly delayed).

How to Use Inovelon

Always take this medicine exactly as your doctor has told you. Check with the doctor or pharmacist if you are not sure.

Children four years of age or older weighing less than 30 kg (not taking valproate)

The recommended starting dose is 200 mg a day taken in two doses. This is 5 ml of suspension given as one 2.5 ml dose in the morning and another 2.5 ml dose in the evening.

The dose will be adjusted for you by the doctor and may be increased by 200 mg at intervals of two days, to a daily dose of no more than 1000 mg (25 ml).

Children four years of age or older weighing less than 30 kg (taking valproate)

For children less than 30 kg who are taking valproate (a treatment for epilepsy) the maximum recommended daily dose of Inovelon is 600 mg a day.

The recommended starting dose is 200 mg a day taken in two doses. This is 5 ml of suspension given as one 2.5 ml dose in the morning and another 2.5 ml dose in the evening.

The dose will be adjusted for you by the doctor and may be increased by 200 mg at intervals of two days, to the maximum recommended daily dose of 600 mg (15 ml).

Adults and children weighing 30 kg or over

The usual starting dose is 400 mg a day taken in two doses. This is 10 ml of suspension taken as one 5 ml dose in the morning and another 5 ml dose in the evening.

The dose will be adjusted for you by the doctor and may be increased by 400 mg at intervals of two days, to a daily dose of no more than 3200 mg, depending upon your weight.

Some patients may respond to lower doses and your doctor may adjust the dose depending on how you respond to the treatment.

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

Inovelon must be taken twice every day, once in the morning and once in the evening. It should be taken with food.

Method of administration

For dosing please use the syringe and adaptor provided.

Instructions on how to use the syringe and adaptor are provided below

  1. Shake well before use.
  2. Push down and turn cap to open bottle.
  3. Insert adaptor into the neck of the bottle until a tight seal is made.
  4. Push plunger of syringe completely down.
  5. Insert the syringe into the opening of the adaptor as far as possible.
  6. Turn upside down and withdraw the prescribed amount of Inovelon from the bottle.
  7. Turn upright and remove the syringe.
  8. Leave the adaptor in place and replace cap on bottle. Wash the syringe with clean water and dry thoroughly.

Do not reduce the dose or stop this medicine unless the doctor tells you to.

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.

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 status epilepticus (seizures which last a long time, repeated seizures). 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.

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 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 nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below).

Yellow Card Scheme Website:www.mhra.gov.uk/yellowcard

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

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 bottle label and carton. The expiry date refers to the last day of that month.

If you have any suspension left in the bottle more than 90 days after it was first opened, you should not use it.

Do not use the suspension if you notice that the appearance or smell of your medicine has changed. Return the medicine to the pharmacist.

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.

Contents of the Pack and Other Information

What Inovelon Contains

  • The active substance is rufinamide. Each millilitre contains 40 mg of rufinamide. 5 ml contains 200 mg rufinamide.
  • The other ingredients are microcrystalline cellulose and carmellose sodium, anhydrous citric acid, simeticone emulsion 30% (containing benzoic acid, cyclotetrasiloxane, dimethicone, glycol stearate and glyceryl distearate, methylcellulose, PEG-40 stearate [polyethylene glycol stearate], polysorbate 65, silica gel, sorbic acid, sulphuric acid and water), poloaxamer 188, hydroxyethylcellulose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), potassium sorbate, propylene glycol (E1520), sorbitol, liquid (non-crystallising), orange flavour and water.

What Inovelon Looks Like and Contents of the Pack

  • Inovelon is a white slightly viscous suspension. It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA). The syringes are graduated in 0.5 ml increments.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Eisai Ltd, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, UK.

Manufacturer

Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, UK.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Eisai Europe Ltd.
Tél/Tel: + 32 (0) 2 502 58 04

България
Eisai Ltd.
Tel: + 44 (0) 20 8600 1400
(Обединеното кралство)

Česká republika
Eisai GesmbH organizační složka
Tel: + 420 242 485 839

Danmark
Eisai AB
Tlf: +46 (0) 8 501 01 600
(Sverige)

Lietuva
Eisai Ltd.
Tel: + 44 (0) 20 8600 1400
(Jungtinė Karalystė)

Luxembourg/Luxemburg
Eisai Europe Ltd.
Tél/Tel: + 32 (0) 2 502 58 04
(Belgique/Belgien)

Magyarország
Eisai Ltd.
Tel.: + 44 (0) 20 8600 1400
Egyesült Királyság (Nagy-Britannia)

Malta
Associated Drug Company Ltd
Tel: + 356 (0) 2277 8000

Deutschland
Eisai GmbH
Tel: + 49 (0) 696 65 85-0

Nederland
Eisai BV.
Tel: + 31 (0) 900 575 3340

Eesti
Eisai Ltd.
Tel: + 44 (0) 20 8600 1400
(Ühendkuningriik)

Ελλάδα
Arriani Pharmaceuticals S.A.
Τηλ: + 30 210 668 3000

España
Eisai Farmacéutica, S.A.
Tel: +(34) 91 455 94 55

France
Eisai SAS
Tél: + (33) 1 47 67 00 05

Hrvatska
Eisai Ltd.
Tel: + 44 (0) 20 8600 1400
(Velika Britanija)

Ireland
Eisai Ltd.
Tel: + 44 (0) 20 8600 1400
(United Kingdom)

Ísland
Eisai AB
Sími: + 46 (0) 8 501 01 600
(Svíþjóð)

Italia
Eisai S.r.l.
Tel: + 39 02 5181401

Κύπρος
Arriani Pharmaceuticals S.A.
Τηλ: +30 210 668 3000
(Ελλάδα)

Latvija
Eisai Ltd.
Tel: + 44 (0) 20 8600 1400
(Liebritānija)

Norge
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sverige)

Österreich
Eisai GesmbH
Tel: + 43 (0) 1 535 1980-0

Polska
Eisai Ltd.
Tel.: + 44 (0) 20 8600 1400
(Wielka Brytania)

Portugal
Eisai Farmacêutica, Unipessoal Lda
Tel: + 351 21 487 55 40

România
Eisai Ltd.
Tel: + 44 (0) 208 600 1400
(Marea Britanie)

Slovenija
Eisai Ltd.
Tel: + 44 (0) 20 8600 1400
(Velika Britanija)

Slovenská republika
Eisai GesmbH organizační složka
Tel: + 420 242 485 839
(Česká republika)

Suomi/Finland
Eisai AB
Puh/Tel: + 46 (0) 8 501 01 600
(Ruotsi/Sverige)

Sverige
Eisai AB
Tel: + 46 (0) 8 501 01 600

United Kingdom
Eisai Ltd.
Tel: + 44 (0) 20 8600 1400