Ergenyl 100, 300 and 500 mg enteric tablets, 60 mg \/ ml oral solution, 200 mg \/ ml oral drops, solution<\/p>\n\n\n\n
sodium valproate<\/p>\n\n\n\n
Ergenyl is a medicine used to treat epilepsy.<\/p>\n\n\n\n
Sodium valproate contained in Ergenyl 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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The mechanism of action is not fully understood, but it is believed that Ergenyl prevents or attenuates impulses in the brain that trigger epileptic seizures.
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Epilepsy<\/em><\/p>\n\n\n\n Treatment with Ergenyl requires close monitoring with a call to blood tests for liver and pancreatic functions and platelets. You must go for these checks. This is especially true at the beginning of treatment, as well as during surgeries. The use of acetylsalicylic acid (for pain, fever) in children under 3 years of age should be avoided due to the risk of liver damage. In case of blood disease, certain skin diseases ( SLE ), impaired kidney function, metabolic disease (especially hereditary enzyme deficiency diseases) or if you easily get bruises or bleeding, the doctor should be informed about this. Always follow the doctor’s prescription carefully! Consult a doctor if you are unsure. There is a risk of weight gain when taking Ergenyl. Contact a doctor if you need help checking your weight. A small number of people who are treated with antiepileptic drugs such as valproate have had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately. Always consult a doctor if the following symptoms occur: Loss of appetite, nausea, drowsiness,<\/em> and fatigue, which sometimes occur with repeated vomiting or abdominal pain, jaundice, swelling in the legs or feet, and the case of sudden impaired seizure control. This can be a sign of a serious effect on the liver or pancreas. This is especially true in infants and children under 3 years of age with severe forms of epilepsy (especially children with brain damage, developmental disorders, genetic and\/or metabolic diseases) and combination therapy with other antiepileptic drugs. See also section 4 Possible side effects. Talk to your doctor if you know that there is a hereditary problem in your family that is disrupting the cells’ energy supply. As with other antiepileptic medicines, seizures may worsen or occur more often when you take this medicine. Contact a doctor immediately if this happens. You should not stop the medication abruptly, as the risk of seizures may increase. Never change the prescribed dose yourself without consulting your doctor.<\/p>\n\n\n\n Ergenyl may affect or be affected by other medicines such as:<\/p>\n\n\n\n You, therefore, need to tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ergenyl is unlikely to affect the effect of birth control pills.<\/p>\n\n\n\n Alcohol should not be consumed during treatment, as Ergenyl increases the effect of alcohol.<\/p>\n\n\n\n Important advice for women<\/strong> Epilepsy<\/em><\/p>\n\n\n\n The risks of valproate when taken during pregnancy (regardless of the disease for which valproate is used):<\/em><\/p>\n\n\n\n Please select and read the situations that apply to you from the situations described below:<\/strong><\/p>\n\n\n\n I BEGIN TREATMENT WITH ERGENYL<\/strong><\/p>\n\n\n\n If this is the first time you have been prescribed Ergenyl, your doctor will explain the risks to an unborn baby if you become pregnant. If you can have children, you must ensure that you use an effective method of contraception without interruption during your treatment with Ergenyl. Talk to your doctor or midwife if you need contraceptive advice. Main message:<\/strong><\/p>\n\n\n\n I TAKE ERGENYL BUT I DON’T PLAN TO HAVE CHILDREN<\/strong><\/p>\n\n\n\n If you continue treatment with Ergenyl but do not plan to have children, make sure you use an effective contraceptive without interruption throughout the treatment with Ergenyl. Talk to your doctor or midwife if you need contraceptive advice. Main message:<\/strong><\/p>\n\n\n\n I TAKE ERGENYL AND PLAN TO HAVE CHILDREN<\/strong><\/p>\n\n\n\n If you are planning to have a baby, make an appointment with your doctor.<\/p>\n\n\n\n Do not stop taking Ergenyl or your contraceptive until you have discussed it with your doctor. Your doctor will give you further advice. Children born to mothers who have taken valproate have a serious risk of birth defects and developmental disorders that can be severely impaired. Your doctor will refer you to a specialist who has experience in treating epilepsy so that other treatment options can be evaluated early. Your specialist doctor can take several measures so that your pregnancy goes as smoothly as possible and any risks to you and your unborn child are reduced as much as possible. Your specialist doctor may decide to change your dose of Ergenyl or switch to another medicine, or stop your treatment with Ergenyl, well in advance of your pregnancy – to ensure that your disease is stable. Consult your doctor about taking folic acid when planning to have children. Folic acid can lower the overall risk of spina bifida<\/em> and early miscarriage that occurs with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use. Main message:<\/strong><\/p>\n\n\n\n I AM PREGNANT AND I TAKE ERGENYL<\/strong><\/p>\n\n\n\n Do not stop taking Ergenyl unless your doctor tells you that your condition may be getting worse. Tell your doctor immediately if you are pregnant or think you may be pregnant. Your doctor will give you further advice. Children born to mothers who have taken valproate have a serious risk of birth defects and developmental disorders that can be severely impaired.<\/p>\n\n\n\n You will be referred to a specialist doctor who has experience in treating epilepsy so that other treatment options can be evaluated. In the exceptional circumstances when Ergenyl is the only available treatment option during pregnancy, you will be examined very carefully both in terms of your medical condition and to check how your unborn baby is developing. You and your partner can get advice and support regarding pregnancy that is exposed to valproate. Ask your doctor for folic acid. Folic acid can lower the overall risk of spina bifida<\/em> and early miscarriage that occurs with all pregnancies. However, it is unlikely that it will reduce the risk of birth defects associated with valproate use. Main message:<\/strong><\/p>\n\n\n\n Make sure you read the patient information brochure that you will receive from your doctor. Your doctor will discuss the annual risk confirmation form and will ask you to sign and keep it. You will also receive a patient card from your doctor to remind you of the risks of valproate during pregnancy.<\/strong> Extremely rare cases of blood coagulation problems have been reported in neonates whose mothers were treated with valproate during pregnancy. Although hypoglycemia (low blood glucose) and hypothyroidism (malfunction of the thyroid gland, which can cause tiredness and weight increase) may occur in the newborn. Withdrawal symptoms may occur in newborns whose mothers have taken Ergenyl during the last third of pregnancy. Breast-feeding<\/strong><\/p>\n\n\n\n Valproate passes into breast milk. Talk to your doctor before using Ergenyl during breast-feeding. Fertility<\/strong><\/p>\n\n\n\n Ergenyl may reduce fertility in both men and women. However, available information indicates that fertility returns to normal when treatment with Ergenyl is stopped.<\/p>\n\n\n\n You are responsible<\/em> for assessing whether you are fit to drive motor vehicles or perform risky work. 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. A description of these effects and side effects can be found under other headings in the package leaflet. 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 If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ergenyl oral solution. Ergenyl oral solution contains preservatives<\/strong><\/p>\n\n\n\n Ergenyl oral solution contains preservatives, which may cause an allergic reaction(possibly delayed). Ergenyl oral solution contains ethanol<\/strong><\/p>\n\n\n\n Ergenyl oral solution contains small amounts of ethanol (alcohol) less than 100 mg per dose. Ergenyl treatment must be initiated and supervised by a doctor who specializes in the treatment of epilepsy.<\/em> Dose one should be determined by a doctor, who will tailor it individually for you.<\/p>\n\n\n\n The daily dose can vary greatly depending on age, body weight, and the severity of the seizures. The packages with an oral solution<\/em> and oral drops<\/em> contain dosing syringes to facilitate dosing (see instructions for use below).<\/p>\n\n\n\n The oral solution<\/em> contains sweeteners and has the taste of raspberries and cherries.<\/p>\n\n\n\n The oral drops<\/em> have a bitter taste. They can be given on a spoon together with a little fruit puree or similar. Gastro-resistant is<\/em> to be swallowed whole. Do not stop treatment without consulting your doctor. Otherwise, the disease may worsen. Instructions for use for the plastic cap on the bottles with an oral solution and oral drops, solution<\/strong><\/p>\n\n\n\n The graduation of the dosing syringes is designed so that the correct amount can be measured in units of 1 ml for oral solution and 0.1 ml for oral drops.<\/p>\n\n\n\n If you have ingested too much medicine, always contact a doctor, hospital, or the Poison Information Center.<\/p>\n\n\n\n If you forget to take your medicine, take a dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Angioedema <\/strong>Uncommon (may affect up to 1 in 100 people):<\/em><\/p>\n\n\n\n Stop taking Ergenyl and contact a doctor immediately if you get any of the following symptoms ( angioedema ):<\/p>\n\n\n\n Severe effects on the liver or pancreas <\/strong>Uncommon (may <\/em>affect <\/strong>up to 1 in 100 people):<\/em><\/p>\n\n\n\n Contact a doctor immediately if the following symptoms occur: loss of appetite, nausea, drowsiness, and fatigue, which sometimes occur with repeated vomiting or abdominal pain, jaundice, swelling in the legs or feet, and the case of sudden impaired seizure control. This can be a sign of a serious effect on the liver or pancreas (sometimes fatal). This has usually affected children under the age of 3 with several disabilities, children who have received high doses in combination with other antiepileptic drugs, and more rare children who only take Ergenyl. Agranulocytosis<\/strong> Rare (may affect up to 1 in 1,000 people):<\/em><\/p>\n\n\n\n Ergenyl can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat\/throat\/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication. Rhabdomyolysis <\/strong>Rare (may affect up to 1 in 1,000 people):<\/em><\/p>\n\n\n\n Stop taking Ergenyl and contact your doctor as soon as possible if you experience unexplained muscle pain, muscle cramps, or muscle weakness. (There is an increased risk of rhabdomyolysis in people with a special enzyme deficiency, CPT type II.) Lyell’s syndrome ( toxic epidermal necrolysis ) <\/strong>Rare (may affect up to 1 in 1,000 people):<\/em><\/p>\n\n\n\n Contact a doctor immediately if you get serious widespread skin damage (skin peeling of the epidermis and superficial mucous membranes). Stevens-Johnson syndrome <\/strong>Rare (may affect up to 1 in 1,000 people):<\/em><\/p>\n\n\n\n An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes, such as genitals.<\/p>\n\n\n\n Contact a doctor immediately if you get such a reaction. Other side effects that may occur<\/strong><\/p>\n\n\n\n Very common (may affect more than 1 user in 10):<\/em><\/p>\n\n\n\n Common (may affect up to 1 in 10 people):<\/em><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people):<\/em><\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people):<\/em><\/p>\n\n\n\n Oral solution and oral drops<\/em> are stored at a maximum of 25 \u00baC.<\/p>\n\n\n\n The enteric tablets are<\/em> sensitive to moisture and must be stored in the original packaging.<\/p>\n\n\n\n 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. 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 Ergenyl 100 mg, 300 mg, and 500 mg gastro s<\/strong><\/p>\n\n\n\n 1 entero-tablet contains:<\/em><\/p>\n\n\n\n Ergenyl 100 mg and 300 mg enteric tablets are<\/em> available in glass jars of 100 and 300 tablets.<\/p>\n\n\n\n Ergenyl 500 mg is<\/em> available in glass jars of 100 and 200 tablets.<\/p>\n\n\n\n Not all pack sizes may be marketed. Ergenyl 60 mg \/ ml oral solution<\/strong><\/p>\n\n\n\n 1 ml oral solution contains:<\/em><\/p>\n\n\n\n Ergenyl oral solution is<\/em> available in a 200 ml glass bottle, a dosing syringe is included in the package. Ergenyl 200 mg \/ ml oral drops, solution<\/strong><\/p>\n\n\n\n 1 ml oral drops, the solution contains:<\/em><\/p>\n\n\n\n Ergenyl oral drops the s<\/em>, the solution is available in a glass bottle with 100 ml, a dosing syringe is included in the package.<\/p>\n\n\n\n Sanofi AB, Box 30052, 104 25 Stockholm Detailed and updated information about this product is available by scanning the QR code contained in the package leaflet with a smartphone. Ergenyl is a medicine used to treat epilepsy.. Sodium valproate contained in Ergenyl 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.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2205,2200],"tags":[3947,3949,2213,3935,3937,2211,3948],"class_list":["post-8291","post","type-post","status-publish","format-standard","hentry","category-e","category-medicines","tag-ergenyl","tag-ergenyl-side-effects","tag-medicines","tag-sodium-valproate","tag-sodium-valproate-side-effects","tag-tablets","tag-what-is-ergenyl"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8291","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=8291"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8291\/revisions"}],"predecessor-version":[{"id":10439,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8291\/revisions\/10439"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=8291"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=8291"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=8291"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Warnings and cautions<\/h2>\n\n\n\n
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Ergenyl contains sorbitol<\/h2>\n\n\n\n
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4. Possible side effects<\/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
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