Epixx 500mg 50 tablets

Epixy 500 mg film-coated tablets are taken orally · Active substance: Each film-coated tablet contains 500 mg of levetiracetam. · Excipients: Corn starch, starch 1500, talc, Aerosil 200, PVP K-30, magnesium stearate, Opadry Yellow 02F220014 (HPMC E5, PEG 4000, titanium dioxide, sodium benzoate, iron yellow oxide (quinoline yellow, sunset yellow E110). Read this leaflet carefully before using this 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 has been prescribed specifically for you. Do not pass it on to others. Tell your doctor that you are taking this medication if you go to the doctor or hospital. Follow the instructions in this leaflet. Do not use a higher or lower dose than recommended for you. This leaflet contains the following sections: 1. What is Epixy and what is it used for? 2. Before using Epixy 3. How to use Epixy? 4. What are the possible side effects? 5. How to store Epixy? 1. What is Epixy and what is it used for? The active substance of Epixy 500 mg film-coated tablets is levetiracetam. Each box contains 50 yellow, oval, biconvex tablets with a score on one side. Epixy is an antiepileptic medicine used to treat epileptic seizures. Epixy is used as monotherapy to treat partial seizures, with or without secondary generalization, in patients aged 16 years and older. Epixy is used as an add-on treatment to other antiepileptic medicines to treat the following conditions: • Initial partial seizures with or without generalization in adults and children aged 4 years and older (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 Epixy Do not use Epixy in the following conditions · If you are allergic to levetiracetam, the active substance of Epixy, or any of the excipients (hypersensitivity). Use Epixy with caution in the following conditions · If you have kidney problems, follow your doctor's recommendations. Your doctor will decide if a dose adjustment is necessary. · If developmental delay or signs of premature sexual development are observed in your child, inform your doctor. · In a small number of patients treated with Epixy and similar antiepileptic drugs, suicidal thoughts or self-harm may occur. If you notice any signs of depression and/or suicidal thoughts, please inform your doctor. · If you experience weakness, high fever, recurrent infections, and/or purulent processes, please inform your doctor. · If you have a history of irregular heart rhythm (may be detected on an electrocardiogram) in your family or medical history, if you have a condition that causes irregular heart rhythm or electrolyte imbalance, and/or if you are undergoing treatment. If any of the following side effects become serious or last for more than a few days, consult your doctor or pharmacist. · Abnormal thoughts, nervous irritability, and/or unusually aggressive reactions or significant changes in mental state and behavior that you, your family members, and/or friends notice. · Worsening of epilepsy, seizures may rarely occur or increase in frequency within the first month of starting treatment or increasing the dose. If you experience any of these signs while taking Epixy, inform your doctor as soon as possible. If these warnings apply to you, even in the past, please consult your doctor. Using Epixy with food and drink Epixy can be taken with or without food. For safety reasons, do not take Epixy with alcohol. Pregnancy Before using the medicine, consult your doctor or pharmacist for advice. If you are pregnant or think you may be pregnant, inform your doctor. Epixy should not be used during pregnancy unless clearly needed. The potential risk to your unborn child is unknown. Epixy has shown adverse reproductive effects in animal studies at doses higher than those needed to control seizures. If you discover you are pregnant during treatment, contact your doctor immediately. Breastfeeding Before taking the medicine, talk to your doctor or pharmacist. Breastfeeding is not recommended during treatment. Effects on ability to drive and use machines Epixy may cause drowsiness, which can negatively affect your ability to drive and use machines. This condition is more likely to occur at the beginning of treatment or when the dose is increased. Do not drive or operate machinery until your doctor has assessed and determined your ability to drive and operate machinery. Important information about some excipients in Epixy If you do not have hypersensitivity to the excipients in Epixy, side effects from these substances are not expected. Since Epixy contains sunset yellow (E110), it may cause allergic reactions. Use with other medicines Do not use macrogol (laxative) one hour before or one hour after taking Epixy, as this may reduce the effect of Epixy. Do not take methotrexate (a medicine used to treat immune system disorders or cancer-like diseases) with Epixy, please inform your doctor. If you are taking or have recently taken any medicine, including medicines obtained without a prescription, please inform your doctor or pharmacist. 3. How to use Epixy? · Correct use and doses/frequency of use and instructions: Your doctor will explain how many tablets of Epixy you should take per day, and follow your doctor's instructions accordingly. · Take Epixy twice a day, in the morning and evening, at approximately the same time each day. Monotherapy (treatment with Epixy only) Use in adults and adolescents aged 16 years and older: · Recommended dose: between 1000 mg (2 tablets) and 3000 mg (6 tablets) per day. · If you are starting treatment with Epixy for the first time, your doctor will prescribe a low dose of Epixy for 2 weeks before starting the lowest maintenance dose. For example, if the daily dose is 2000 mg, you should take 2 tablets in the morning and 2 tablets in the evening. Add-on therapy (concomitant treatment with other antiepileptic drugs) Use in adults (≥ 18 years) and adolescents (12-17 years) weighing 50 kg or more: • Recommended dose: 1000 mg (2 tablets) to 3000 mg (6 tablets) per day. When you first start taking Epixy, your doctor will prescribe a lower daily dose of Epixy for 2 weeks before giving you the lowest maintenance dose. For example, if your daily dose is 1000 mg, you should take one tablet in the morning and one tablet in the evening. Use in children aged 4-11 years and adolescents (12-17 years) weighing 50 kg or less: · The dose is between 20 mg per kg of body weight and 60 mg per kg of body weight per day. · Your doctor will prescribe the most appropriate pharmaceutical form of Epixy based on the child's body weight and dose. For example, if the daily dose calculated per body weight is 20 mg/kg, a child weighing 25 kg will need to take one 250 mg tablet of Epixy in the morning and one in the evening. Route and method of administration: Epixy tablets are taken orally. Take Epixy tablets with a sufficient amount of water (e.g., one glass of water). After oral administration, levetiracetam may leave a bitter taste in the mouth. Duration of use: · Treatment with Epixy is long-term. You should continue taking it for the duration prescribed by your doctor. · Do not stop treatment with Epixy without your doctor's recommendation, as the frequency of seizures may increase. · Different age groups: Use in children: Epixy can be used in children and adolescents aged 4 years and older. Use in the elderly: In elderly patients (≥65 years) with impaired kidney function, the dose of Epixy needs to be adjusted by a doctor. · Special conditions of use: Kidney failure/liver failure If you have kidney failure, your doctor will adjust the dose of Epixy according to your kidney function. If you have severe liver failure, your doctor will reduce the prescribed dose. If you think the effect of Epixy is too strong or too weak, inform your doctor or pharmacist. If you take more Epixy than you should: If you take more Epixy than you should, side effects may include drowsiness, increased restlessness, aggression, confusion, respiratory arrest, and coma. In case of overdose, your doctor will prescribe appropriate treatment. If you take more Epixy than you should, consult your doctor or pharmacist. If you forget to take Epixy: If you forget to take one or more doses, consult your doctor. Do not take a double dose to make up for a missed dose. If you stop taking Epixy: · Epixy is taken for a long (chronological) period. You should continue treatment with Epixy as recommended by your doctor. · Do not stop treatment without your doctor's recommendation, as this may lead to an increase in the frequency of seizures. · Your doctor will decide when to stop treatment with Epixy. Your doctor will gradually discontinue treatment with Epixy. If you have any questions about the use of Epixy, consult your doctor or pharmacist. 4. What are the possible side effects? Like all medicines, side effects can occur in patients who are sensitive to the substances in Epixy. If you experience any of the following conditions, stop taking Epixy, inform your doctor immediately, and go to the nearest emergency department: · Weakness, mild dizziness or lightheadedness, or difficulty breathing. These signs may indicate a serious allergic reaction (anaphylaxis). · Swelling of the face, lips, tongue, and throat (angioedema). · Flu-like symptoms and redness of the face, accompanied by high fever, widespread rash, increased liver enzymes in blood tests, and an increase in one type of white blood cell (eosinophils), enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS]). · Reduced urine volume, fatigue, nausea, vomiting, confusion, swelling of the legs and ankles. These signs may indicate sudden deterioration of kidney function. · Skin rash (erythema multiforme), which may appear as raised bumps and small target lesions (dark spots in the center, lighter around, and a dark ring on the outer edge). · Widespread rash (Stevens-Johnson syndrome), characterized by blistering, especially around the mouth, nose, eyes, and genitals, accompanied by peeling and shedding of the skin. · Severe rash affecting more than 30% of the body surface (toxic epidermal necrolysis). · Serious mental changes or if neurological symptoms such as confusion, somnolence, amnesia, memory impairment, abnormal behavior, or involuntary and uncontrolled movements are noticed by loved ones, consult your doctor. These signs may indicate encephalopathy (disease, damage, or functional disorder of the brain). All these conditions are serious side effects. If you experience any of these, you may require urgent medical attention or hospitalization. Side effects by category are listed below: Very common: occurs in at least 1 in 10 users Common: occurs in at least 1 to 10 in 100 users. Uncommon: occurs in at least 1 to 10 in 1000 users. Rare: occurs in at least 1 to 10 in 10,000 users. Very rare: occurs in less than 1 in 10,000 users. Unknown: cannot be estimated from available data Very common: · Nasopharyngitis (inflammation of the nose and throat) · Somnolence (drowsiness) · Headache Common: · Anorexia (loss of appetite) · Depression · Hostile behavior/aggression · Anxiety · Insomnia · Nervousness or irritability · Involuntary muscle contractions (convulsions) · Impaired balance · Dizziness · Involuntary trembling (tremor) · Lethargy accompanied by confusion · Feeling of spinning (vertigo) · Cough · Abdominal pain · Diarrhea · Indigestion (dyspepsia) · Nausea · Vomiting · Rash · Fatigue (asthenia/weakness) Uncommon: · Reduced number of blood clotting cells · Reduced number of white blood cells · Weight gain · Weight loss · Suicide attempt and suicidal thoughts · Mental disorders · Abnormal behavior · Hallucinations · Irritability · Confusion · Panic attack · Emotional instability/sudden mood changes · Agitation · Memory loss (amnesia), attention disorders (decreased concentration) · Memory impairment (forgetfulness) · Abnormal coordination/impaired coordinated movements (ataxia) · Tingling (paresthesia) · Diplopia (double vision) · Blurred vision · Abnormal liver function tests · Hair loss · Skin inflammation (eczema) · Itching · Muscle weakness · Muscle pain (myalgia) · Formation of injuries Rare: · Infection · Reduced number of all blood cells in complete blood count · Severe allergic reactions (DRESS), (redness and rash of the skin, facial swelling, changes in blood count, enlarged lymph nodes, and others) · Reduced sodium concentration in the blood · Suicide · Personality disorders (behavioral disorders) · Abnormal thinking (slow thinking, inability to concentrate) · Delirium (delusions, hallucinations) · Encephalopathy (for detailed description of symptoms, see subsection "If any of the following develop, stop using Epixy and inform your doctor immediately") · Involuntary muscle spasms (choreoathetosis) · Difficulty controlling movements (dyskinesia) · Hyperactivity, hyperkinesia · Pancreatitis · Liver failure · Hepatitis · Sudden deterioration of kidney function · Skin rash (erythema multiforme), which may appear as raised bumps and small target lesions (papules, vesicles, bullous rash). · Widespread rash (Stevens-Johnson syndrome), characterized by blistering, especially around the mouth, nose, eyes, and genitals, accompanied by peeling of the skin. · Severe rash causing shedding of skin over more than 30% of the body surface (toxic epidermal necrolysis). · Rhabdomyolysis (disruption of muscle tissue) and associated increase in creatine phosphokinase in the blood. It should be noted that the incidence is significantly higher in Japanese patients than in non-Japanese patients. · Difficulty walking · Combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and decreased 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 observed side effects are: nasopharyngitis, somnolence (drowsiness), headache, fatigue, dizziness. Drowsiness, fatigue, and dizziness may also occur at the beginning of treatment or when the dose is increased, but these effects should decrease after some time. If you experience any side effects, whether or not described in this leaflet, consult your doctor or pharmacist. 5. How to store Epixy? Store in the packaging, out of reach of children. Store at room temperature not exceeding 250C and in a dry place. Do not use after the expiry date Do not use Epixy after the expiry date indicated on the packaging. Do not use Epixy if you notice damage to the product or packaging. Dispensing regime: Pharmaceutical product group - II, dispensed with prescription form №3