Properties
What is it?
Instructions for use EPIXI 1000 mg film-coated tablet is taken orally. • Active substance: Each film-coated tablet contains 1000 mg of levetiracetam. • Excipients: Corn starch, starch, PVP K-30, talc, Aerosil 200, magnesium stearate, Opadry White 02F280013 (titanium dioxide, PEG 4000, HPMC E5, sodium benzoate). Read the instructions for use carefully before you start using this medicine, as it contains important information for you. • Keep these instructions for use, you may need to read them again later. • If you have any other questions, please consult your doctor or pharmacist. • This medicine has been prescribed for you personally, do not pass it on to others. • When using this medicine, inform your doctor that you are using this medicine when visiting a doctor or hospital. • Follow the instructions in this leaflet exactly. Do not use higher or lower doses than the dose recommended for you. This leaflet includes: 1. What is EPIXI and what is it used for? 2. What to consider before using EPIXI 3. How to use EPIXI? 4. What are the possible side effects? 5. Storage of EPIXI headings. 1. What is EPIXI and what is it used for? The active substance of EPIXI 1000 mg film-coated tablet is levetiracetam. Each package contains 30 and 50 white oval film-coated tablets with a score on one side. EPIXI is an antiepileptic (epilepsy prophylactic) drug used to treat epileptic seizures. EPIXI is used for partial seizures with or without secondary generalization in patients aged 16 years and older. In addition to other epilepsy medications currently in use, EPIXI: • Partial onset seizures (partial onset seizures with or without secondary generalization) in children aged 4 years and older and adults, with or without generalization. • For myoclonic seizures in adolescents and adolescents over 12 years of age. • Used for seizures (primary generalized tonic-clonic seizures) with primary generalized convulsions in adolescents and adults over 12 years of age. 2. What to consider before using EPIXI Do not use EPIXI in the following situations • If you are allergic to levetiracetam, which is the active substance of EPIXI, or any of its excipients (if you are hypersensitive). Use EPIXI with caution in the following situations • Follow your doctor's instructions if you have kidney problems. Your doctor may decide if your dose needs to be adjusted. • If you notice a decrease in your child's growth or sudden development of puberty in your child, please consult your doctor. • A small number of people who have been treated with antiepileptic drugs like EPIXI have had thoughts of harming themselves or committing suicide. If you have signs of depression and/or suicidal thoughts, please consult your doctor. • Please consult your doctor if you experience fatigue, high fever, recurrent infections, or coagulation disorders. • If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram) if you have a condition that predisposes to heart rhythm disorders or salt imbalance and/or if you are being treated. If any of the following side effects become serious or last for more than a few days, consult your doctor or pharmacist. • If you, your family and/or friends notice abnormal thoughts, feel irritable or react more aggressively than usual, or significant changes in your mood or behavior. • Worsening of epilepsy, your seizures may rarely worsen or become more frequent, especially in the first month after starting treatment or increasing the dose. If you experience any new symptoms while taking EPIXI, consult your doctor as soon as possible. If these warnings apply to you at any time in the past, please consult your doctor. Using EPIXI with food and drink You can take EPIXI with or without food. For safety reasons, do not take EPIXI with alcohol. Pregnancy Consult your doctor or pharmacist before using this medicine. If you are pregnant or think you may be pregnant, please inform your doctor. You should not stop treatment with EPIXI without consulting your doctor. The risk of congenital defects in your unborn child from EPIXI cannot be completely ruled out. EPIXI has shown adverse reproductive effects in animal studies at doses higher than those required to control your seizures. If you realize you are pregnant during treatment, consult your doctor immediately. Lactation Consult your doctor or pharmacist before using the product. Breastfeeding is not recommended during treatment. Use of machinery and mechanisms EPIXI may cause drowsiness, which may impair your ability to use any tools or mechanisms. This is more likely at the beginning of treatment or after increasing the dose. During treatment with EPIXI, your doctor will assess your response to treatment and give you permission. Do not use machinery or mechanisms while being treated with EPIXI until your doctor has assessed your response to treatment and given you permission. Important information about some excipients in EPIXI It does not contain excipients that require a warning. Use with other medicines Do not take Macrogol (a medicine used as a laxative) one hour before and one hour after taking EPIXI, as this may cause EPIXI to lose its effect. If you are using Methotrexate (a medicine used for conditions such as immune system disorders or cancer) with EPIXI, please inform your doctor. If you are currently taking or have recently taken any prescription or over-the-counter medicines, please tell your doctor or pharmacist about them. 3. How to use EPIXI? • Appropriate instructions for use and dose/frequency of administration: Your doctor will tell you how many EPIXI tablets to use, take the tablets accordingly. You should take EPIXI 2 times a day, once in the morning and once in the evening, at approximately the same time every day. Monotherapy (treatment with EPIXI only) Use in adults and adolescents over 16 years of age: • Recommended dose: 1000 mg (2 tablets) - 3000 mg (3 tablets) per day. • If you are starting treatment with EPIXI for the first time, your doctor will prescribe a low dose of EPIXI for 2 weeks until you reach the lowest daily dose. For example, if your daily dose is 2000 mg, you should take 1 tablet in the morning and one in the evening. Add-on therapy (treatment with other antiepileptic drugs) Use in adults (≥18 years) and adolescents (12-17 years) weighing 50 kg or more: • Recommended dose: 1000 mg - 3000 mg per day. • If you are starting treatment with EPIXI for the first time, your doctor will prescribe a low dose of EPIXI for 2 weeks until you reach the lowest daily dose. For example, if your daily dose is 2000 mg, you should take one tablet in the morning and one in the evening. Use in children aged 4-11 years and adolescents (12-17 years) weighing less than 50 kg: • Recommended dose: 20 mg/kg to 60 mg/kg of body weight per day. • Your doctor will prescribe the most appropriate pharmaceutical form of EPIXI for your child's body weight and dose. For example, with a daily dose of 20 mg/kg, you should give your 25 kg child one EPIXI 250 mg tablet every morning and evening. • Route and method of administration: EPIXI tablets are intended for oral administration. Swallow EPIXI tablets with a sufficient amount of liquid (e.g., a glass of water). Levetiracetam may leave a bitter taste after oral administration. Duration of use: • Treatment with EPIXI is long-term. You should continue treatment with EPIXI for as long as your doctor tells you. • Do not stop treatment without consulting your doctor, as seizures may worsen. • Different age groups: Use in children: EPIXI film-coated tablet can be used in children over 4 years of age and adults. Use in the elderly: In elderly patients (over 65 years of age), if kidney function is impaired, the dose of EPIXI will be adjusted by your doctor. • Special cases of use: Kidney/liver failure: If you have kidney failure, the dose of EPIXI will be adjusted according to your kidney function. If you have severe liver failure, the dose will be reduced by your doctor. If you have the impression that the effect of EPIXI is too strong or too weak, consult your doctor or pharmacist. If you use more EPIXI than you should: Possible side effects of EPIXI overdose include drowsiness, extreme restlessness, hostility/aggression, confusion, respiratory arrest, and coma. Your doctor will prescribe the best treatment in case of possible overdose. If you have used more EPIXI than you should, talk to your doctor or pharmacist. If you forget to use EPIXI: If you miss one or more doses, consult your doctor. Do not take a double dose to make up for a missed dose. Effects that may occur when stopping EPIXI treatment: • EPIXI is used as chronic (long-term) treatment, you should continue treatment with EPIXI until your doctor tells you to. • Do not stop treatment without your doctor's advice, as this may increase your seizures. • Your doctor should decide to stop treatment with EPIXI. Your doctor will inform you about stopping treatment with EPIXI by gradually reducing the dose. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 4. What are the possible side effects? Like all medicines, side effects can occur in people who are sensitive to the substances in EPIXI. If any of the following occur, stop using EPIXI and inform your doctor immediately and go to the emergency department of the nearest hospital: • Weakness, mild dizziness or lightheadedness, or difficulty breathing; these effects may be signs of a serious allergic (anaphylactic) reaction. • Swelling of the face, lips, tongue and throat (angioedema). • Widespread rash with high fever accompanied by flu-like symptoms and redness of the face, increased liver enzyme levels and an increase in one type of white blood cell (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS]). • Decreased urine volume, fatigue, nausea, vomiting, confusion, swelling of the legs, ankles or feet; these findings may indicate sudden deterioration of kidney function. • Skin rash (erythema multiforme) which may cause blisters and look like small target lesions (dark spots in the center, a lighter area around it, and a dark ring on the outside). • Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). • A more severe type of rash that causes skin peeling over more than 30% of the body surface (toxic epidermal necrolysis). • Serious mental changes or confusion in loved ones (confusion), if you notice neurological signs such as somnolence (drowsiness), amnesia (memory loss), amnesia (forgetfulness), abnormal behavior, or involuntary or uncontrolled movements. These may be signs of encephalopathy (brain disease, damage, or dysfunction). These are all very serious side effects. If you have one of these, you may need urgent medical attention or hospitalization. Side effects are listed in the following categories: Very common: May affect more than 1 in 10 patients. Common: Affects less than 1 in 10 patients, but more than 1 in 100 patients. Uncommon: Affects less than 1 in 100 patients, but more than 1 in 1000 patients. Rare: Affects less than 1 in 1000 patients, but more than 1 in 10,000 patients. Very rare: Affects less than 1 in 10,000 patients. Unknown: Cannot be estimated from the available data. Very common: • Nasopharyngitis (inflammation of the nose and pharynx). • Somnolence (drowsiness). • Headache. Common: • Loss of appetite (anorexia). • Depression. • Hostile behavior/aggression. • Anxiety (anxiety). • Insomnia (insomnia). • Irritability or overreaction to stimuli (irritability). • Involuntary muscle contractions (spasms). • Balance disorder. • Dizziness. • Immobility accompanied by numbness (lethargy). • Involuntary tremor (tremor). • Dizziness, feeling of spinning (vertigo). • Cough. • Abdominal pain. • Diarrhea. • Indigestion (dyspepsia). • Nausea. • Vomiting. • Rash. • Fatigue (asthenia/weakness). Uncommon: • Decrease in the number of cells that allow blood to clot. • Decrease in the number of white blood cells in the blood. • Weight gain. • Weight loss. • Attempted suicide and suicidal thoughts. • Mental disorder. • Abnormal behavior. • Seeing or hearing unreal things (hallucination, hallucination). • Resentment. • Confusion (confusion). • Panic attack. • Emotional lability/mood swings. • Extreme restlessness (agitation). • Memory loss (amnesia). • Forgetfulness (memory impairment). • Coordination disorder/incompatible movement disorder (ataxia). • Tingling sensation (paresthesia). • Distraction (loss of concentration). • Double vision. • Blurred vision. • Increased/impaired liver function test values. • Hair loss. • Skin inflammation (eczema). • Itching. • Muscle weakness. • Muscle pain (myalgia). • Injuries. Rare: • Infection. • Decrease in the number of all types of blood cells. • Severe hypersensitivity reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction], angioedema [swelling of the face, lips, tongue, and throat]). • Decreased sodium concentration in the blood. • Suicide. • Personality disorders (behavioral disorder). • Abnormal thinking (slow thinking, inability to concentrate). • Delirium (delirium, delusion). • Encephalopathy (for detailed description of symptoms, see subheading "If any of the following occur, stop using EPIXI and inform your doctor immediately"). • Worsening or more frequent seizures. • Involuntary muscle contractions in the head, trunk, and limbs (choreoathetosis). • Difficulty controlling movements (dyskinesia). • Hyperactivity, hyperactivity (hyperkinesia). • Changes in heart rhythm (electrocardiogram). • Pancreatitis (inflammation of the pancreas). • Liver failure. • Hepatitis (inflammation of the liver). • Sudden deterioration of kidney function. • Skin rash (erythema multiforme) which may cause blisters and look like small target lesions (dark spots in the center, a lighter area around it, and a dark ring on the outside). • Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). • A more severe type of rash that causes skin peeling over more than 30% of the body surface (toxic epidermal necrolysis). • Rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The incidence is significantly higher in Japanese patients than in non-Japanese patients. • Difficulty walking. • A combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, and low level of consciousness (which may be signs of a disorder known as neuroleptic malignant syndrome). The incidence is significantly higher in Japanese patients than in non-Japanese patients. The most frequently reported side effects are nasopharyngitis, somnolence (drowsiness), headache, fatigue, and dizziness. Some side effects, such as drowsiness, fatigue, dizziness, may be more pronounced at the beginning of treatment or when the dose is increased. However, these effects should decrease over time. If you have any side effects not listed in this leaflet, tell your doctor or pharmacist. Reporting side effects Talk to your doctor, pharmacist, or nurse about any side effects that are listed or not listed in the instructions for use. 5. Storage of EPIXI Keep out of reach of children and in its packaging. Store below 25°C at room temperature and in a dry place. Use according to expiry dates. Do not use EPIXI after the expiry date indicated on the packaging. Do not use EPIXI if you notice any defects in the product and/or its packaging. Do not dispose of expired or unused medicines! Hand them over to the collection system determined by the Ministry of Environment and Urbanization.
