Letiram 500mg 60 tablets

Composition Letiram composition: The active substance is levetiracetam. Other components are: Core: crospovidone (Type B), povidone K30, colloidal anhydrous silica, magnesium stearate. Film coating, 250mg: hypromellose, macrogol/PEG 400, titanium dioxide (E171), purified talc, indigo carmine, aluminum lake (E132). Film coating, 500mg: hypromellose, macrogol/PEG 400, titanium dioxide (E171), purified talc, iron oxide, yellow (E172). Film coating, 750mg: hypromellose, macrogol/PEG 400, titanium dioxide (E171), purified talc, sunset yellow FCF (E110), iron red oxide (E172). Film coating, 1000mg: hypromellose, macrogol/PEG 400, titanium dioxide (E171), purified talc. Indications Letiram is an antiepileptic medication (a drug used to treat seizures in epilepsy). Letiram is used alone to treat partial seizures in patients over 16 years of age. Letiram is used in patients who are already taking other antiepileptic drugs • to treat partial seizures in adults and children from 1 month of age; • to treat myoclonic seizures in patients with juvenile myoclonic epilepsy, from 12 years of age; • to treat primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age. Dosage and administration 250mg: Doses for adults and adolescents weighing 50kg or more (12-17 years); take the tablets in the quantity prescribed by your doctor. • Usual dose: 1000mg (4 tablets) – 3000mg (12 tablets) every day. • Letiram should be taken twice a day, morning and evening, at the same time every day. For example, if your daily dose is 1000mg, you should take 2 tablets in the morning and 2 tablets in the evening. 500mg: Doses for adults and adolescents weighing 50kg or more (12-17 years); take the tablets in the quantity prescribed by your doctor. • Usual dose: 1000mg (2 tablets) – 3000mg (6 tablets) every day. • Letiram should be taken twice a day, morning and evening, at the same time every day. For example, if your daily dose is 1000mg, you should take 1 tablet in the morning and 1 tablet in the evening. 750mg: Doses for adults and adolescents weighing 50kg or more (12-17 years); take the tablets in the quantity prescribed by your doctor. • Usual dose: 1000mg – 3000mg every day. • Letiram should be taken twice a day, morning and evening, at the same time every day. For example, if your daily dose is 1500mg, you should take 1 tablet in the morning and 1 tablet in the evening. 1000mg: Doses for adults and adolescents weighing 50kg or more (12-17 years); take the tablets in the quantity prescribed by your doctor. • Usual dose: 1000mg – 3000mg every day. • Letiram should be taken twice a day, morning and evening, at the same time every day. For example, if your daily dose is 2000mg, you should take 1 tablet in the morning and 1 tablet in the evening. Doses for infants (6-23 months), children (2-11 years) and adolescents weighing less than 50kg (12-17 years): give your child the dose prescribed by the doctor. • Usual dose: 20 mg/kg – 60 mg/kg every day. The dose should be given orally in the form of a prepared solution, using a 3ml or 10ml syringe, depending on the dose. • Letiram should be given twice a day, morning and evening, at the same time every day. 500mg, 750mg, 1000mg: For infants and young children, Letiram 100 mg/ml oral solution and Letiram 250mg tablets are most suitable. Doses for infants (1 month to 6 months): give your child the amount of oral solution prescribed by the doctor. • Usual dose: 14 mg/kg – 24 mg/kg every day. The dose should be given orally in the form of a prepared solution, using a 1ml syringe. • Letiram should be given twice a day, morning and evening, at the same time every day. Example: for a daily dose of 14 mg/kg, a child weighing 4kg should be given 28mg (0.3ml) in the morning and 28mg (0.3ml) in the evening. Administration: Swallow Letiram tablets with a sufficient amount of liquid (e.g., 1 glass of water). Duration of treatment: • Letiram is used for chronic treatment. Continue treatment with Letiram until your doctor tells you to stop. • Do not stop treatment without consulting your doctor, as this may lead to an increase in seizures. Your doctor will decide to stop treatment with Letiram and will instruct you on how to gradually discontinue Letiram. Side effects Like all medicines, Letiram can cause side effects, although not everybody gets them. If any of the following side effects occur, tell your doctor. Very common side effects of Letiram (>10%) are: • Drowsiness; • Asthenia/fatigue. Common side effects of Letiram (1%-10%) are: • Nervous system disorders: dizziness (feeling of swaying), convulsion, headache, hyperkinesia (hyperactivity), ataxia (impaired coordination of movement), tremor (involuntary shaking), amnesia (memory loss), imbalance, attention disorder (loss of concentration), memory impairment (forgetfulness); • Psychiatric disorders: agitation, depression, emotional lability/mood swings, hostility or aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems), abnormal thinking (slow thinking, inability to concentrate); • Digestive disorders: abdominal pain, nausea, dyspepsia (indigestion), diarrhea, vomiting; • Nutritional disorders: anorexia (loss of appetite), weight gain; • Ear and labyrinth disorders: vertigo (feeling of spinning); • Eye disorders: diplopia (double vision), blurred vision; • Musculoskeletal and connective tissue disorders: myalgia (muscle pain); • Injury: accidental injury; • Infections: infection, nasopharyngitis; • Respiratory disorders: cough (worsening of pre-existing cough); • Skin disorders: rash, eczema, itching; • Blood disorders: decrease in platelet count. Other side effects of Letiram are: • Nervous system disorders: paresthesia (tingling, burning sensation); • Psychiatric disorders: abnormal behavior, anger, anxiety, confusion, hallucinations, mental disorders, suicide, attempted suicide and suicidal thoughts; • Digestive disorders: pancreatitis, liver failure, hepatitis, changes in liver function tests; • Nutritional disorders: weight loss; • Skin disorders: hair loss; • Blood disorders: decrease in the number of red and/or white blood cells. Some side effects, such as drowsiness, fatigue, and dizziness, are more common at the beginning of treatment or when the dose is increased. These effects decrease over time. If any side effect becomes severe or if you notice any side effect not listed here, tell your doctor or pharmacist. Contraindications Letiram is used in adults and children over 1 month of age. Do not take Letiram • if you are allergic (hypersensitive) to levetiracetam or any other component of Letiram. Pregnancy and lactation If you are pregnant or suspect you may be pregnant, ask your doctor for advice. Do not use Letiram during pregnancy unless clearly needed. The potential risk to your baby is unknown. In animal studies, levetiracetam showed adverse reproductive effects at higher doses than those required for seizure control. Breastfeeding is not recommended during treatment. Ask your doctor or pharmacist for advice before taking any medicine. Special warnings • If you have kidney problems, follow your doctor's instructions. He will decide if a dose adjustment is necessary. • In children who received levetiracetam, no impact on growth and maturation processes was observed. However, there is insufficient experience with long-term use in children. • If you notice worsening of seizures (e.g., increased frequency), consult your doctor. • A small number of patients treated with antiepileptic drugs similar to Letiram have had thoughts of self-harm or suicide. If you develop symptoms of depression and/or suicidal thoughts, consult your doctor. Driving and operating machinery Letiram can impair your ability to drive or operate machinery because it causes drowsiness. This is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery until you are sure that your ability to perform such activities is not impaired. Important information about some components of Letiram: 750mg tablets: The dye E110 may cause allergic reactions. Overdose If you have taken more Letiram than you should, inform your doctor. If you have taken more than the prescribed dose. If you forget to take Letiram Inform your doctor if you have missed one or more doses. Do not take a double dose to make up for a missed dose. If you stop taking Letiram Like other antiepileptic drugs, Letiram should be gradually discontinued to avoid an increase in seizures. If you have any further questions about the use of this product, ask your doctor or pharmacist. Interactions with other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Letiram with food and drink. Letiram can be taken with or without food. For your safety, do not take Letiram with alcohol. Storage conditions and expiry dates Keep out of reach of children. Do not use after the expiry date indicated on the carton and blister. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Dispensing from pharmacy Prescription only