Hypericum perforatum<\/em>\u00a0) should not be taken at the same time as this medicine.\u00a0If you are already taking St. John’s\u00a0wort, consult your doctor before stopping taking the St. John’s\u00a0wort\u00a0preparation.<\/p>\n\n\n\nPro-Epanutin may also affect some laboratory tests that may be performed.<\/p>\n\n\n\n
Pro-Epanutin with alcohol<\/h2>\n\n\n\n
If you drink large amounts of alcohol or drink alcohol frequently, it can also affect the concentration of Pro-Epanutin in your blood.<\/p>\n\n\n\n
Pregnancy, contraception for women, and breastfeeding<\/h2>\n\n\n\n
Pregnancy <\/p>\n\n\n\n
Consult your doctor as soon as possible if you are pregnant. Do not stop taking this medicine until you have discussed this with your doctor. If you stop treatment without talking to your doctor, you may have seizures that can be dangerous for you and your pregnancy. Your doctor may decide to change your treatment. Careful monitoring of the baby you are expecting may also be considered.<\/p>\n\n\n\n
Pro-Epanutin can cause birth defects.\u00a0If you take Pro-Epanutin during pregnancy, the risk of birth defects is higher.\u00a0Fetal injuries that have been reported are deformities of the face, skull, nails, fingers, and heart.<\/p>\n\n\n\n
If you are of childbearing age and planning to have children, make a doctor’s visit before you become pregnant. Discuss your treatment options with your doctor.<\/p>\n\n\n\n
If you take Pro-Epanutin during pregnancy, there is also a risk of bleeding in the baby immediately after birth.\u00a0Your doctor may give you and your child medicine to prevent this.\u00a0In addition, your child should be closely monitored.<\/p>\n\n\n\n
Contraceptives for women<\/p>\n\n\n\n
If you are of\u00a0childbearing potential, discuss your treatment options and effective contraceptive methods with your doctor.\u00a0Pro-Epanutin may lead to worse effects than hormonal contraceptives.\u00a0Therefore, consult your doctor about other effective contraceptive methods.<\/p>\n\n\n\n
Breast-feeding<\/p>\n\n\n\n
Pro-Epanutin passes into breast milk.\u00a0You should not use Pro-Epanutin if you are breastfeeding.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Pro-Epanutin may cause dizziness or drowsiness. If you get such symptoms, do not drive or use any tools or machines.<\/p>\n\n\n\n
Pro-Epanutin contains sodium<\/h2>\n\n\n\n
When calculating the total amount of\u00a0sodium, any dilution of fosphenytoin sodium for\u00a0injection\u00a0with sodium chloride solution should be taken into consideration.<\/p>\n\n\n\n
Each 10 ml\u00a0vial\u00a0contains 85 mg of\u00a0sodium\u00a0(the main ingredient in table salt\/table salt).\u00a0This corresponds to 4.25% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n
Each 2 ml vial contains 17 mg of sodium which is less than 1 mmol of sodium (23 mg).<\/p>\n\n\n\n
How to get Pro-Epanutin<\/h2>\n\n\n\n
You will receive Pro-Epanutin in hospital.<\/p>\n\n\n\n
The drug is given as an\u00a0injection\u00a0either into a large vein (\u00a0intravenous\u00a0infusion\u00a0) or into a muscle (\u00a0intramuscularly\u00a0).\u00a0If Pro-Epanutin is given\u00a0intravenously, it must be diluted.<\/p>\n\n\n\n
Your\u00a0ECG,\u00a0blood pressure,\u00a0and respiration will be monitored at all times during\u00a0infusion\u00a0one and for approximately 30 minutes after the end of\u00a0infusion\u00a0one.<\/p>\n\n\n\n
The dose\u00a0and concentration of the Pro-Epanutin solution that you receive are determined by your doctor and are expressed in phenytoin sodium equivalents (FE).\u00a0Dose\u00a0one is given in milligrams per\u00a0dose\u00a0if given as an\u00a0injection\u00a0and in milligrams per milliliter (mg\/ml) solution if given as\u00a0an infusion.<\/p>\n\n\n\n
Adults<\/strong><\/p>\n\n\n\nSevere epileptic seizures or seizures ( status epilepticus )<\/strong><\/p>\n\n\n\nPro-Epanutin is usually given after treatment with either\u00a0diazepam\u00a0or lorazepam in injection.<\/p>\n\n\n\n
The first\u00a0dose\u00a0of Pro-Epanutin is called the\u00a0loading\u00a0dose and is injected into a vein.\u00a0After a\u00a0loading\u00a0dose, you can get a lower\u00a0dose\u00a0of Pro-Epanutin given in a vein or a muscle.\u00a0These are called maintenance doses.<\/p>\n\n\n\n
If your seizures cannot be stopped with Pro-Epanutin, try other treatments.<\/p>\n\n\n\n
Brain surgery or head injury<\/strong><\/p>\n\n\n\nThe first\u00a0dose\u00a0is called a\u00a0loading\u00a0dose and it is injected into a vein or muscle.\u00a0After a\u00a0loading\u00a0dose, you can get a lower\u00a0dose\u00a0of Pro-Epanutin in a vein or a muscle.\u00a0These are called maintenance doses.<\/p>\n\n\n\n
Maintenance doses<\/strong><\/p>\n\n\n\nYour doctor may take blood samples to determine the appropriate maintenance dose for you.<\/p>\n\n\n\n
If your doctor thinks you need to continue treatment, you can start treatment taken by mouth at the appropriate time.\u00a0In that case, you will receive\u00a0phenytoin\u00a0because Pro-Epanutin (fosphenytoin) cannot be taken orally.<\/p>\n\n\n\n
Temporary replacement for oral phenytoin treatment<\/strong><\/p>\n\n\n\nIf you are receiving Pro-Epanutin because you cannot take phenytoin orally (orally), you do not need a loading dose and the dose you receive is the same as your phenytoin dose. Because the dose of Pro-Epanutin is given in FE (phenytoin sodium equivalents), the number of milligrams FE of Pro-Epanutin should be the same as the number of milligrams of phenytoin sodium you take by mouth.<\/p>\n\n\n\n
Children from 5 years of age<\/strong><\/p>\n\n\n\nThe dose of Pro-Epanutin per kilogram of body weight is the same for children (from 5 years of age) as for adults.<\/p>\n\n\n\n
In children from 5 years of age, Pro-Epanutin is given only as a drip ( infusion ) into a vein ( intravenously ).<\/p>\n\n\n\n
Elderly patients over 65 years, very ill patients, and patients with kidney or liver disease<\/strong><\/p>\n\n\n\nThe dose\u00a0of a Pro-Epanutin may be reduced, alternatively\u00a0injection\u00a0into a vein may be given more slowly.<\/p>\n\n\n\n
If you take more Pro-Epanutin than you should<\/h2>\n\n\n\n
An overdose of Pro-Epanutin is dangerous. You will receive Pro-Epanutin in hospital and the dose will be calculated individually for you. Your doctor will monitor you during treatment and equipment for treating heart problems will be available. If you think you have been given too much Pro-Epanutin, contact your doctor immediately.<\/p>\n\n\n\n
If you are no longer in hospital and think that you have been given too much medicine or if e.g.\u00a0If a child has ingested the medicine by mistake, contact a doctor or hospital,for risk assessment and advice.<\/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
Possible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n
Tell your doctor immediately<\/strong> if you get any of the following symptoms after taking this medicine. Although rare, these symptoms can be serious.<\/p>\n\n\n\nUncommon: may affect up to 1 in 100 people<\/p>\n\n\n\n
- If you get a\u00a0severe rash with blisters<\/strong>\u00a0(which may also occur in the mouth and on the tongue).\u00a0These skin reactions often occur along with\u00a0fever and\u00a0flu-like symptoms.\u00a0This may be a sign of a condition called\u00a0Stevens-Johnson syndrome\u00a0or\u00a0toxic epidermal necrolysis\u00a0(TEN).\u00a0In these cases, your doctor will stop your treatment.<\/strong>\u00a0<\/li><\/ul>\n\n\n\n
Has been reported (occurs in an unknown number of users)<\/p>\n\n\n\n
- If you get\u00a0bruises, fever, look pale<\/strong> or have a very sore throat.\u00a0These may be the first signs of an abnormal change in the blood such as decreased number of\u00a0red blood cells,\u00a0white blood cells,\u00a0or\u00a0platelets.\u00a0Your doctor may take blood samples regularly to check this.<\/li>
- Skin rash and fever with swollen\u00a0lymph nodes, yellowing of the skin and eyes, especially during the first two months of treatment.\u00a0This may be a sign of a\u00a0hypersensitivity reaction.\u00a0If the symptoms are severe and you also have pain and\u00a0inflammation\u00a0in the joints, it may be due to a condition called systemic lupus erythematosus.<\/li>
- If you get\u00a0discolored skin, swelling, and pain\u00a0where\u00a0the injection\u00a0was given, which then begins to spread down the arm to the hands and fingers.\u00a0This can mean that you have a so-called “purple glove syndrome”.\u00a0In most cases, it gets better on its own, but in some cases, it can become serious and require\u00a0urgent\u00a0medical treatment.<\/li>
- Red skin areas with\u00a0small raised blisters filled with white\/yellow fluid\u00a0that is often stronger in skin folds.\u00a0Swelling of the face may also occur (\u00a0acute\u00a0generalized exanthematous\u00a0pustulosis\u00a0(AGEP)).<\/li>
- Skin rash, fever, swollen\u00a0lymph nodes, increase in a type of\u00a0white blood cell\u00a0(\u00a0eosinophilia\u00a0), and\u00a0inflammation\u00a0of internal organs\u00a0(liver, lungs, heart, kidneys, and colon).\u00a0This may be a sign of a\u00a0hypersensitivity reaction\u00a0(drug-induced reactions with\u00a0eosinophilia\u00a0and systemic symptoms (DRESS)).\u00a0<\/li>
- If you become\u00a0confused or severely mentally ill.\u00a0This may be a sign that you have high levels of\u00a0phenytoin\u00a0in your blood.\u00a0In rare cases, high levels\u00a0of phenytoin\u00a0have remained in the blood and this has led to permanent brain damage.\u00a0Your doctor may take blood samples to see how much\u00a0phenytoin\u00a0you have in your blood and possibly change your\u00a0dose.<\/li>
- Sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or\u00a0itching\u00a0(especially all over the body).\u00a0This may be a sign of a\u00a0hypersensitivity reaction.<\/li><\/ul>\n\n\n\n
Other side effects that may occur are:<\/p>\n\n\n\n
Very common: may affect more than 1 user in 10<\/p>\n\n\n\n