Epixx solution 100mg/ml 150ml

EPIXX 100 mg/ml oral suspension is taken orally · Active substance: Contains 100mg levetiracetam per ml. · Excipients: Sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), potassium acesulfame, ammonium glycyrrhizinate, sodium cyclamate, sodium citrate dihydrate, citric acid monohydrate, maltitol solution, glycerol, mixed fruit flavor, deionized water. Read this leaflet carefully before using the medicine as it contains important information for you. Keep this leaflet. You may need to read it again. • If you have any further questions, please consult your doctor or pharmacist. This medicine is prescribed for your personal use, do not pass it on to others. When going to the doctor or hospital while using this medicine, inform the doctor that you are using this medication. Follow the written information in this instruction exactly. Do not use a higher or lower dose than recommended. This leaflet explains the topics mentioned above: 1. What is EPIXX and what is it used for? 2. Before using EPIXX 3. How to use EPIXX? 4. What are the possible side effects? 5. How to store EPIXX? 1. What is EPIXX and what is it used for? EPIXX is a clear liquid. Available in a box, in a 300 ml amber glass bottle, with a 10 ml graduated oral syringe. EPIXX is an antiepileptic (seizure prevention) drug used to treat epileptic seizures. EPIXX alone is used to treat partial seizures with or without secondary generalization in patients aged 16 years and older. EPIXX is used as an add-on to other antiepileptic drugs: • Initial partial seizures with or without generalization, in infants from 1 month of age, children and adults (partial seizures with or without secondary generalization) • Myoclonic seizures in adults and adolescents aged 12 years and older • Primary generalized tonic-clonic seizures in adults and adolescents aged 12 years and older. 2. Before using EPIXX Do not take EPIXX in the following situations: • If you are allergic (hypersensitive) to levetiracetam, the active substance of EPIXX, or any of the other ingredients of EPIXX. Take special care when taking EPIXX in the following situations: • If you have kidney problems, follow your doctor's instructions. Your doctor should decide if a dose adjustment is necessary. • If you notice a slowing of your child's growth or premature pubertal development, consult your doctor. • Very few people being treated with antiepileptic drugs like EPIXX have thoughts of harming themselves or suicide. If you have any symptoms of depression and/or suicidal thoughts, please consult your doctor. • If you experience fatigue, high fever, recurrent infections, or coagulation disorders, please consult your doctor. • If you have a family or medical history of irregular heartbeat (visible on an electrocardiogram), have a condition that predisposes to heart rhythm disorders or electrolyte imbalance, and/or are receiving treatment. If any of the following side effects become serious or last for more than a few days, inform your doctor or ask your 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. Rarely, your seizures may 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 EPIXX, consult your doctor as soon as possible. If these warnings apply to you, even in the past, at any time, please consult your doctor. Taking EPIXX with food and drink EPIXX can be taken with or without food. For safety reasons, do not take EPIXX with alcohol. Pregnancy • Consult your doctor or pharmacist before taking the medicine. • If you are pregnant or think you might be pregnant, please inform your doctor. • Do not stop EPIXX treatment without consulting your doctor. The risk of congenital defects caused by EPIXX in your unborn child cannot be ignored. EPIXX has shown adverse reproductive effects in animal studies at doses higher than those needed to control your seizures. • If you notice during treatment that you are pregnant, contact your doctor or pharmacist immediately. Breastfeeding • Consult your doctor or pharmacist before taking the medicine. • Breastfeeding is not recommended during treatment. Driving and using machinery EPIXX may impair your ability to drive or operate any tools or machinery, as EPIXX may cause drowsiness and sleepiness. This is more likely at the beginning of treatment or after increasing the dose. You should not drive or operate machinery until your doctor determines that EPIXX treatment does not affect your ability to perform these activities. Important information about some of the excipients in EPIXX Because EPIXX 100 mg/ml oral solution contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217), it may cause allergic reactions (likely delayed). EPIXX 100 mg/ml oral solution contains maltitol solution (hydrogenated glucose syrup). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicinal product. EPIXX 100 mg/ml oral solution contains glycerol; however, no warning is needed due to the dose. EPIXX 100 mg/ml oral solution contains 1.7 mg/ml sodium cyclamate and 4.0 mg/ml sodium citrate dihydrate. This should be considered for patients on a controlled sodium diet. Use with other medications Do not take macrogol (a medicine used as a laxative) one hour before and one hour after taking EPIXX, as this may reduce the effect of EPIXX. If you are using EPIXX with methotrexate (a medicine used for conditions such as immune system disorders or cancer), please inform your doctor. If you are currently using or have recently used any prescription or over-the-counter medicines, please inform your doctor or pharmacist. 3. How to take EPIXX? • Instructions for proper use and dose/frequency of administration: Take the oral solution as directed by your doctor. You should take EPIXX twice a day, once in the morning and once in the evening, at approximately the same time each day. Monotherapy (independent treatment with EPIXX) Use in adults and adolescents (16 years and older): • For patients aged 4 years and older, measure the appropriate dose using the 10 ml syringe provided in the package. • Recommended dose: 1000 mg (10 ml) to 3000 mg (30 ml) per day, divided into 2 doses per day. • When you first start taking EPIXX, your doctor will prescribe a lower dose for 2 weeks before reaching the lowest daily dose. For example: If your daily dose is 1000 mg, you should take 500 mg (5 ml) in the morning and evening. Adjunctive therapy (concomitant treatment with other antiepileptic drugs) Use in adults (≥18 years) and adolescents (12 to 17 years): • For patients aged 4 years and older, measure the appropriate dose using the 10 ml syringe provided in the package. • Recommended dose: EPIXX is taken twice a day in two equal doses. Each dose is measured from 5 ml (500 mg) to 15 ml (1500 mg). For example: If your daily dose is 1000 mg, you should take 500 mg (5 ml) in the morning and evening. Use in children aged 6 months and older: Your doctor will prescribe the most appropriate pharmaceutical form of EPIXX according to age, weight, and dose. • For children aged 6 months to 4 years, measure the appropriate dose using the 3 ml syringe provided in the package. • For children aged 4 years and older, measure the appropriate dose using the 10 ml syringe provided in the package. • Recommended dose: EPIXX is taken twice a day in two equal doses. Each dose is measured from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see table below for dose examples). For example: For a daily dose of 20 mg/kg, if your child weighs 15 kg, give 150 mg (1.5 ml) in the morning and evening. Use in children aged 6 months and older: Weight Initial dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily 6 kg 0.6 ml twice daily 1.8 ml twice daily 8 kg 0.8 ml twice daily 2.4 ml twice daily 10 kg 1 ml twice daily 3 ml twice daily 15 kg 1.5 ml twice daily 4.5 ml twice daily 20 kg 2 ml twice daily 6 ml twice daily 25 kg 2.5 ml twice daily 7.5 ml twice daily 50 kg and above 5 ml twice daily 15 ml twice daily Use in infants (1 month to 6 months): • For infants aged 1 month to 6 months, measure the appropriate dose using the 1 ml syringe provided in the package. • Recommended dose: EPIXX is taken twice a day in two equal doses. Each dose is measured from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the child's body weight (see table below for dose examples). For example: For a recommended daily dose of 14 mg/kg, if your child weighs 4 kg, give 28 mg (equivalent to 0.3 ml) in the morning and evening. Weight Initial dose: 0.07 ml/kg twice daily Maximum dose: 0.21 ml/kg twice daily 4 kg 0.3 ml twice daily 0.85 ml twice daily 5 kg 0.35 ml twice daily 1.05 ml twice daily 6 kg 0.45 ml twice daily 1.25 ml twice daily 7 kg 0.5 ml twice daily 1.5 ml twice daily • Method and route of administration: EPIXX 100 mg/ml oral solution can be diluted in a glass of water or in your child's bottle. Instructions for use: Open the cap by pressing and twisting. Place the syringe in the bottle to draw up the medicine. Pull the plunger to the level indicated by your doctor's prescription and fill the syringe with the medicine. Remove the syringe from the bottle. The scale indicated on the piston shows the amount of medicine (in mg) in the syringe. Push the piston and take the medicine as advised by your doctor. Wash the syringe with running water. Close the medicine bottle with the cap. Time of use: • Treatment with EPIXX is long-term. You must continue treatment with EPIXX for as long as your doctor tells you to. • Do not stop treatment without your doctor's advice, as seizures may worsen. • Different age groups: Use in children: EPIXX can be prescribed for infants from 1 month of age, children and adults. Use in the elderly: For elderly patients (≥65 years), if kidney function is impaired, the EPIXX dose will be adjusted by your doctor. • Special prescription conditions: Renal/hepatic insufficiency: If you have kidney insufficiency, the EPIXX dose will be adjusted by your doctor according to your kidney function. If you have severe hepatic insufficiency, the dose will be adjusted by your doctor. If you have the impression that the effect of EPIXX is too high or too low, consult your doctor or pharmacist. If you take more EPIXX than you should Possible side effects of EPIXX overdose include drowsiness, agitation, hostile behavior/aggression, clouded consciousness, respiratory depression, and coma. Your doctor will determine the best possible treatment for overdose. Consult your doctor or pharmacist if you have taken more EPIXX than you should. If you forget to take EPIXX If you miss one or more doses, consult your doctor. Do not take a double dose to make up for missed doses. Effects that may occur upon completion of EPIXX treatment • EPIXX is used as a chronic (long-term) medication. You must continue treatment with EPIXX until your doctor advises you to stop. • Do not stop treatment as prescribed by your doctor, otherwise your seizures may worsen. Your doctor will decide when your treatment with EPIXX will be discontinued. Your doctor will inform you about discontinuing EPIXX treatment by gradually reducing the dose. If you have any questions about the use of the product, consult your doctor or pharmacist. 4. What are the possible side effects? Like all medicines, side effects can occur in people sensitive to the ingredients of EPIXX. If any of the following occur, stop using EPIXX and inform your doctor immediately and contact the emergency department of the nearest hospital: • Weakness, lightheadedness or dizziness, or difficulty breathing; these signs may be signs of a severe allergic (anaphylactic) reaction. Swelling of the face, lips, tongue, and throat (angioedema). • Widespread rash with high fever, followed by flu-like symptoms and redness of the face, increased liver enzyme levels, and one type of white blood cell (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS]). • Reduced urine volume, fatigue, nausea, vomiting, confusion, swelling of the legs, ankles, or feet; these results may indicate a sudden decrease in kidney function. Skin rash (erythema multiforme), which can form blisters and resemble small target lesions (dark spots in the center, lighter area around, and 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis). • Serious mental changes, or if your loved ones notice neurological symptoms such as confusion, somnolence (drowsiness), amnesia, memory impairment, abnormal behavior, or involuntary or uncontrolled movements. These may be signs of encephalopathy (brain disease, damage, or dysfunction). The frequency of possible side effects is listed by the following categories: Very common: May affect more than 1 in 10 patients Common: May affect 1 to 10 in 100 patients Uncommon: May affect 1 to 10 in 1000 patients Rare: May affect 1 to 10 in 10,000 patients Very rare: May affect less than 1 in 10,000 patients Unknown: Cannot be estimated from available data Very common: • Nasopharyngitis (inflammation of the nose and pharynx) • Drowsiness • Headache Common: • Anorexia • Depression • Hostile behavior/aggression • Anxiety • Insomnia • Nervousness or hypersensitivity to stimuli (irritability) • Involuntary muscle contractions (spasms) • Balance disorder • Dizziness • Involuntary trembling (tremor) • Immobility accompanied by impaired consciousness (lethargy) • Feeling of spinning (vertigo) • Increased cough • Abdominal pain • Diarrhea • Indigestion (dyspepsia) • Nausea • Vomiting • Rash • Fatigue (asthenia/weakness) Uncommon: • Decrease in platelet count in the blood • Decrease in white blood cell count • Weight gain • Weight loss • Attempted suicide and suicidal thoughts • Mental disorder • Abnormal behaviors • Hallucinations • Anger • Confusion • Panic attack • Emotional changes/mood swings • Excessive agitation • Memory impairment (amnesia), decreased alertness (loss of concentration) • Forgetfulness (memory impairment) • Impaired coordination of movements (ataxia) • Tingling (paresthesia) • Double vision • Blurred vision • Impaired liver function tests • Hair loss • Skin inflammation (eczema) • Itching • Muscle weakness • Muscle pain (myalgia) • Injuries Rare: • Infection • Decrease in the count of all types of blood cells • Severe allergic reactions (DRESS) (redness and rash of the skin, swelling of the face, abnormal blood tests, enlarged lymph nodes, etc.) • Decrease in sodium concentration in the blood • Suicide • Personality disorders (behavioral problems) • Abnormal thinking (slow thinking, inability to concentrate) • Involuntary muscle contractions (choreoathetosis) • Difficulty controlling movements (dyskinesia) • Hyperactivity, hyperkinesia • Pancreatitis (inflammation of the pancreas) • Liver failure • Hepatitis (inflammation of the liver) • Condition characterized by various types of blisters (papule, vesicle or bulla, etc.) on the skin or mucous membranes (erythema multiforme) • Formation of blisters on the skin around the mouth, eyes, or genitals (Stevens-Johnson syndrome) • Skin peeling (toxic epidermal necrolysis, a serious condition affecting more than 30% of the body surface) • 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 • 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. Some side effects, such as drowsiness, fatigue, dizziness, etc., may occur more frequently at the beginning of treatment or after increasing the dose. However, these effects should disappear over time. If you notice any side effects not mentioned in this instruction, inform your doctor or pharmacist. 5. How to store EPIXX? Store out of reach of children, in the original packaging. Store at room temperature below 25°C. After opening, the bottle should be stored below 25°C and used within 7 months; do not use thereafter. Due to light sensitivity, store in the original packaging. Use it by the expiry date. Do not take EPIXX after the expiry date indicated on the packaging. If you notice any damage to the product and/or packaging, do not take EPIXX. Dispensing regime: Pharmaceutical product group - II, dispensed with prescription form №3