100 mg, 200 mg, 400 mg film-coated tablets
1. What Inovelon is and what it is used for
Inovelon contains the drug rufinamide. It belongs to a group of medicines called antiepileptic drugs and is used to treat epilepsy (a disease that manifests itself in seizures and seizures).
Inovelon is used with other medicines to treat epileptic seizures associated with Lennox-Gastauts syndrome in adults, adolescents, and children from 1 year of age. Lennox-Gastauts syndrome is the name of a severe form of epilepsy that can cause repeated seizures of various types.
Your doctor has prescribed Inovelon for you to reduce the number of seizures.
What you need to know before you take Inovelon
Do not take Inovelon
- if you are allergic to rufinamide or triazole derivatives or to any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to a doctor or pharmacist:
- if you have a congenital short QT syndrome or if such a syndrome is present in the family (disturbance of the electrical conduction in the heart) as rufinamide may aggravate it.
- if you have liver problems. There is limited information on the use of rufinamide in this group so your dose of the medicine may need to be increased more slowly. If your liver disease is severe, your doctor may decide that Inovelon is not suitable for you.
- if you get a rash or fever. This may be a sign of an allergic reaction . Contact a doctor immediately as this can be serious in some cases.
- If your seizures increase in number, severity or last longer, you should contact a doctor immediately.
- If you have difficulty walking, have abnormal movements or dizziness or drowsiness, tell your doctor.
- if you are taking this medicine and ever have thoughts of harming or killing yourself , contact a doctor immediately or see a hospital (see section 4).
Also, consult your doctor if any of these events described above have occurred before.
Children
Inovelon should not be given to children under 1 year of age, as there is a lack of sufficient information on its use in this age group.
Other medicines and Inovelon
Tell 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, phosphenytoin, phenytoin, or primidone, you may need to be closely monitored for two weeks at the beginning or end of rufinamide treatment, or after a marked dose change. The dose of one of the other medicines may need to be changed as they may have a slightly reduced effect when taken with rufinamide.
Medicines for epilepsy and Inovelon
If your doctor prescribes or recommends another medicine to treat epilepsy (eg valproate ), you must tell him/her that you are already taking Inovelon, as the dose may need to be adjusted.
Taking valproate at the same time as rufinamide results in high levels of rufinamide in the blood of adults and children. Tell your doctor if you are taking valproate, as your Inovelon dose may need to be reduced by your doctor.
Tell your doctor if you are taking birth control pills or other hormonal contraceptives. Inovelon can make pills ineffective. Therefore, it is recommended that you use an additional method of contraception (such as a barrier method, such as a condom) that is safe and effective when you take Inovelon.
Tell your doctor if you are taking the blood-thinning medicine warfarin. Your doctor may need to adjust dose one.
Tell your doctor if you are taking digoxin (a medicine used to treat heart disease). Your doctor may need to adjust dose one.
Inovelon with food and drink
See section 3 “How to take Inovelon” for advice on how to take Inovelon with food and drink.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should only take Inovelon during pregnancy if your doctor tells you to.
You should not breastfeed while taking Inovelon as it is not known if rufinamide passes into breast milk.
If you are a woman of childbearing potential, you must use an effective method of contraception while taking Inovelon.
Ask your doctor or pharmacist for advice before taking any medicine while you are taking Inovelon.
Driving and using machines
You may feel drowsy, dizzy, and have blurred vision when taking Inovelon, especially at the beginning of treatment or when the dose has been increased. If this happens, do not drive or use machines.
Inovelon contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Inovelon
Always take Inovelon exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
It may take a while to find the dose of Inovelon that is best for you. The dose is calculated for you by your doctor based on your age, weight, and if you are taking Inovelon with another medicine called valproate.
Children between one and four years
The recommended starting dose is 10 mg per kg body weight and day. It is taken in two equal doses – one in the morning and one in the evening. Dose one is calculated for you by your doctor and can be increased in increments of 10 mg per kg body weight every three days.
The highest daily dose depends on whether you are also taking valproate or not. The maximum daily dose if you do not take valproate is 45 mg per kg body weight per day. The highest daily dose if you take valproate is 30 mg per kg body weight and day.
Children over 4 years weighing less than 30 kg
The recommended starting dose is 200 mg per day. It is taken in two equal doses, one in the morning and one in the evening. Dose one is calculated for you by your doctor and can be increased by 200 mg every three days.
The highest daily dose depends on whether you are also taking valproate or not. The maximum daily dose if you do not take valproate is 1,000 mg per day. The maximum daily dose if you take valproate is 600 mg per day.
Adults, adolescents, and children weighing at least 30 kg
The recommended starting dose is 400 mg daily. It is taken in two equal doses, one in the morning and one in the evening. Dose one is calculated for you by your doctor and can be increased by 400 mg every other day.
The highest daily dose depends on whether you are also taking valproate or not. The maximum daily dose if you do not take valproate is a maximum of 3,200 mg depending on your body weight. The maximum daily dose if you take valproate is no more than 2,200 mg depending on your body weight.
Some patients may respond to a lower dose and your doctor may adjust a dose depending on how you respond to treatment.
If you experience side effects, your doctor may increase the dose at a slower rate.
Inovelon tablets must be taken twice daily with water, once in the morning and once in the evening. Inovelon should be taken with food. If you have difficulty swallowing, you can crush the tablet, mix the powder in half a glass of water (about 100 ml) and drink it immediately. You can also break the tablets into two equal parts and swallow them with water.
You should not reduce the dose or stop taking the medicine unless your doctor tells you to.
If you take more Inovelon than you should
If you happen to take more Inovelon than you should, tell your doctor or pharmacist immediately or contact your nearest emergency department and take the medicine with you.
If you forget to take Inovelon
If you forget to take a dose, just continue to take your 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 his / her instructions for gradually reducing the dose one of Inovelon. In this way, the risk of seizures is reduced.
If you have any further questions on the use of this product, ask your 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:
- Skin rash and / or fever. This may be a sign of an allergic reaction . Contact a doctor or see a hospital immediately.
- Changes in the type of seizures you experience / more frequent seizures that last a long time (called status epilepticus ). Contact a doctor immediately.
- A small number of patients treated with antiepileptic drugs such as Inovelon have had thoughts of self-harm or suicide. Contact a doctor immediately if you experience such thoughts (see section 2).
You can get the following side effects from this drug. Tell your doctor if you get any of the following side effects:
Very common (more than 1 in 10 patients) side effects of Inovelon are:
- Dizziness, headache, nausea, vomiting, drowsiness and fatigue.
Common (more than 1 in 100 patients) side effects of Inovelon are:
- Problems with the nervous system, including: difficulty walking, abnormal movements, convulsions / seizures, unusual eye movements, blurred vision, tremors.
- Problems associated with the gastrointestinal tract, including: Stomach pain, constipation, indigestion, loose stools (diarrhea), decreased or altered appetite, weight loss.
- Infections: Ear infection, flu , nasal congestion, respiratory infection.
- In addition, patients have suffered from: Anxiety, insomnia, nosebleeds, acne , rash, back pain, sparse menstruation, bruising, head injury (as a result of accidental injury during a seizure).
Uncommon (between 1 in 100 and 1 in 1000 patients) side effects from Inovelon are:
- Allergic reactions and increase in liver function markers (elevated liver enzymes).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 expiration date is the last day of the specified month.
Do not store above 30 ° C.
Do not use this medicine if you notice that the appearance of the medicine has changed. Return the medicine to the pharmacy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is rufinamide.One 100 mg film-coated tablet contains 100 mg of rufinamide.One 200 mg film-coated tablet contains 200 mg of rufinamide.One 400 mg film-coated tablet contains 400 mg of rufinamide.
- The other ingredients are lactose monohydrate , microcrystalline cellulose, maize starch, croscarmellose sodium, hypromellose, magnesium stearate, sodium lauryl sulphate and anhydrous colloidal silica. The film coating consists of hypromellose, macrogol (8000), titanium dioxide (E171), talc and red iron oxide (E172).
What the medicine looks like and contents of the pack
- Inovelon 100 mg tablets are pink, oval, slightly convex, film-coated tablets, scored on both sides, debossed “Є261” on one side and glossy 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, scored on both sides, debossed “Є262” on one side and glossy 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, scored on both sides, debossed “Є263” on one side and glossy on the other.They are available in packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
email: medinfo_de@eisai.net
Manufacturer:
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany