\n\n250 mg soft capsules
etosuximide<\/p>\n\n\n\n
Ethosuximide Orifarm is a medicine used to treat epileptic seizures ( antiepileptic drugs ).
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Ethosuximide Orifarm is given to adults, elderly patients, and children over 6 years of age to treat:<\/p>\n\n\n\n
Ethosuximide Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
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– if you are allergic to ethosuximide, succinimides (the group of medicines to which ethosuximide belongs), or any of the other ingredients of this medicine (listed in section 6)<\/p>\n\n\n\n
– if you suffer from the metabolic disease porphyria.
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Talk to your doctor, pharmacist, or nurse before taking Ethosuximide Orifarm.
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If movement disorders occur, do not continue to take Ethosuximide Orifarm. In case of significant disturbance, you should consult a doctor who can then give you the medicine diphenhydramine intravenously as an antidote (see section 4).
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Pay special attention to symptoms of bone marrow depression such as fever, inflammation of the throat or polyps behind the nose, and bleeding tendency. Consult your doctor if any of these symptoms occur. Your blood status will be checked regularly (initially every month and after one year every six months) to identify any bone marrow damage. Your liver enzymes will also be checked regularly.
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Mental side effects (anxiety, illusion) may occur, especially in patients with a history of mental disorders. The physician will pay special attention to this when administering Ethosuximide Orifarm to this patient group.
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A small number of patients treated with antiepileptic drugs such as ethosuximide have developed thoughts of self-harm or suicidal ideation. Contact a doctor immediately if you experience such thoughts at any time during treatment.
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Note!<\/em><\/p>\n\n\n\n To prevent tonic-clonic seizures ( grand mal ), which are often associated with complex and atypical absences, ethosuximide can be combined with effective antiepileptic drugs (eg primidone or phenobarbital). Additional prophylaxis against tonic-clonic seizures ( grand mal ) can only be prescribed in epilepsy with psycholeptics absences in school-age children.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effect of Ethosuximide Orifarm may be affected by other antiepileptic drugs(carbamazepine, valproate ). It can not be ruled out that sedative drugs and Ethosuximide Orifarm enhance each other’s sedative (sedative and sleep-inducing) effects<\/p>\n\n\n\n Ethosuximide Orifarm can be taken during or after a meal with half a glass of water. Alcohol can alter and potentiate the effects of Ethosuximide Orifarm in an unpredictable way. Do not drink alcohol or consume foods containing alcohol while taking Ethosuximide Orifarm.<\/p>\n\n\n\n If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy <\/strong><\/p>\n\n\n\n If you are of childbearing potential, your doctor should inform you of the need to plan and monitor any pregnancy before starting treatment with Ethosuximide Orifarm. Do not stop taking Ethosuximide Orifarm without first consulting your doctor as epileptic seizures may recur, which may harm you and\/or your unborn baby.<\/p>\n\n\n\n No specific malformations are known in infants that have been caused by treatment with ethosuximide, the active substance in Ethosuximide Orifarm. However, the risk of developing fetal malformations is generally higher for women treated with antiepileptic drugs than for other women. The most commonly reported malformations are cleft lip, cardiovascular malformation, and neural tube defects (spina bifida). This risk is even higher in patients treated with more than one antiepileptic drug, and therefore combination therapy should be avoided during pregnancy. The minimum effective dose of ethosuximide to ensure seizure control should not be exceeded, especially between day 20 and day 40 of pregnancy. Your concentration of ethosuximide in the blood must be checked regularly and you should take extra folic acid ( folic acid substitution) if you are planning to have a baby or are pregnant. To prevent vitamin K1 deficiency in the baby and bleeding caused by this deficiency, you should receive vitamin K1 during the last month of pregnancy. Breast-feeding<\/strong><\/p>\n\n\n\n Ethosuximide is converted to breast milk. Do not breast-feed while you are being treated with ethosuximide. Fertility<\/strong><\/p>\n\n\n\n The effects of ethosuximide on fertility have not been studied.<\/p>\n\n\n\n Ethosuximide Orifarm may impair the ability to react. For this reason, throughout the treatment period, especially during the adjustment phase, keep in mind that you do not react quickly and purposefully to unexpected and sudden events. Do not drive or use any vehicles. Do not use dangerous power tools or machines. Do not work without a secure grip. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n This medicine contains 13.7 mg sorbitol in each capsule.<\/p>\n\n\n\n Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The recommended dose is:<\/p>\n\n\n\n Adults, elderly patients, and children over 6 years of age: Treatment should be initiated with a low daily dose of 500 mg (2 capsules). Depending on the patient’s tolerance, dose one may be increased every five to seven days in increments of up to 250 mg until seizure control is achieved with a daily dose of 1,000-1,500 mg (4-6 capsules). In some cases, a daily dose of 2,000 mg (8 capsules) may be needed, divided into several doses. This dosage form is not suitable for small children (0-6 years) or for people who cannot swallow capsules. Hemodialysis patients<\/strong><\/p>\n\n\n\n Ethosuximide disappears from the body during dialysis. Hemodialysis patients, therefore, need an additional dose or a modified dosing regimen. During four-hour dialysis, 39\u201352% of the dose taken disappears. How long to take Ethosuximide Orifarm<\/strong><\/p>\n\n\n\n The treatment of epileptic seizures is essentially a long-term treatment. The size of dose one and how it should be distributed throughout the day, and when and how you should stop taking Ethosuximide Orifarm are determined by a specialist experienced in epilepsy treatment. If you have the impression that the effect of Ethosuximide Orifarm is too strong or too weak, talk to your doctor or pharmacist.<\/p>\n\n\n\n If you’ve taken the double dose of Ethosuximide Orifarm accidentally, do not change the dosage regimen, but continue to take Ethosuximide Orifarm exactly as your doctor’s prescription.<\/p>\n\n\n\n If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Symptoms of overdose are fatigue, lethargy (listlessness, apathy ), depressive states and anxiety, in some cases also irritability. The symptoms of overdose are exacerbated by alcohol and other drugs that affect the central nervous system . Do not take a double dose to make up for a forgotten dose . Normally no symptoms occur if you forget to take a single dose . Continue to take the medicine as your doctor prescribed . You should therefore not take the missed dose at a later time. Keep in mind that Ethosuximide Orifarm only controls your epilepsy safely if you take the medicine regularly. If you want to stop treatment, talk to your doctor first. Follow your doctor’s treatment recommendations carefully, as you may have epileptic seizures again. Contact your doctor if you think you may not tolerate Ethosuximide Orifarm.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects , although not everybody gets them. Common<\/strong> (may affect up to 1 in 10 users) to very common<\/strong> (may affect more than 1 in 10 users):<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 people):<\/p>\n\n\n\n Rare<\/strong> (may affect up to 1 in 1,000 people):<\/p>\n\n\n\n Has been reported<\/strong> (occurs in an unknown number of users):<\/p>\n\n\n\n * Side effects that are independent of the drug dose. Note!<\/strong><\/p>\n\n\n\n Long-term treatment can affect the patient’s performance ability, for example school results for children and adolescents. The risk of dose-dependent side effects is reduced if a low starting dose of Ethosuximide Orifarm is used, which is then gradually increased to an optimal dose(the amount should be increased slowly from day to day), and by taking the medicine during or after a meal. If side effects occur that are independent of the dose taken, the drug is normally discontinued and the side effects disappear. They may return when Ethosuximide Orifarm starts taking again. Talk to your doctor if you get one or more of the above side effects so that he or she can determine their severity and what action to take. 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 carton after EXP. The expiration date is the last day of the specified month. Store below 30 \u00b0 C. 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.<\/p>\n\n\n\n Oval, yellow and opaque soft capsules. The capsule size is about 14 \u00d7 8 mm. Blister: 50, 100 or 200 soft capsules. Not all pack sizes may be marketed.<\/p>\n\n\n\n Orifarm Generics A \/ S<\/p>\n\n\n\n Energivej 15<\/p>\n\n\n\n 5260 Odense S<\/p>\n\n\n\n Denmark Local representative<\/strong><\/p>\n\n\n\n Orifarm Generics AB<\/p>\n\n\n\n Box 56048<\/p>\n\n\n\n 102 17 Stockholm <\/p>\n\n\n\n info@orifarm.com 250 mg soft capsulesOther medicines and Ethosuximide Orifarm<\/h2>\n\n\n\n
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<\/p>\n\n\n\nEthosuximide Orifarm with food, drink, and alcohol<\/h2>\n\n\n\n
<\/p>\n\n\n\nPregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
<\/p>\n\n\n\nEthosuximide Orifarm contains sorbitol<\/h2>\n\n\n\n
2. How to take Ethosuximide Orifarm<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you take more Ethosuximide Orifarm then you should<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you forget to take Ethosuximide Orifarm<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you stop taking Ethosuximide Orifarm<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Ethosuximide Orifarm<\/h2>\n\n\n\n
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
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<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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