Product Details

What you need to know before you take Epanutin Suspension

Do not take Epanutin · if you are allergic (hypersensitive) to phenytoin, or any of the other ingredients of this medicine (listed in section 6) · if you are allergic to other medicines for epilepsy · if you are also taking delavirdine (used for HIV therapy). Warnings and precautions Talk to your doctor or pharmacist before you take Epanutin if you suffer from or have suffered in the past from any of the following conditions: · Liver disease · Kidney disease · Porphyria (an inherited disease that affects haemoglobin biosynthesis) Page 2 of 9 2021-0070143 · Alcohol dependence. · If you are of Chinese or Thai origin and tests have shown that you carry the genetic variant HLA-B*1502. · If you are of Taiwanese, Japanese, Malaysian or Thai origin and tests have shown that you carry the genetic variant CYP2C9*3. Epanutin can cause problems with your heart, including a slow heartbeat. Let your healthcare provider know right away if you have these symptoms. You should be administered Epanutin with caution if you suffer from kidney or liver problems. A small number of people being treated with antiepileptics such as phenytoin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Epanutin, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Epanutin, you must not be re-started on Epanutin at any time. If you develop a rash or these skin symptoms, seek urgent advice from a doctor and tell him that you are taking this medicine. Consult your doctor before discontinuing Epanutin. If you suddenly stop taking this medicine you may have a seizure. Black patients may be at greater risk of liver problems, serious skin reactions and allergic reactions. Cases of swelling of the face, mouth (lip, gum, tongue) and neck that can lead to life-threatening breathing difficulty have been reported in people being treated with phenytoin. If at any time you have these signs or symptoms immediately contact your doctor. There is a risk of harm to the unborn child if Epanutin is used during pregnancy. Women of childbearing age should use effective contraception during treatment with Epanutin (see Pregnancy, contraception in women, and breast-feeding). Other medicines and Epanutin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines can affect the way Epanutin works, or Epanutin itself can reduce the effectiveness of other medicines taken at the same time. These include (Not all medicines are listed here. Talk with your doctor or pharmacist): · Medicines used for heart and circulation problems (e.g. dicoumarol, digitoxin, digoxin, disopyramide, mexiletine, nisoldipine, amiodarone, furosemide, quinidine, reserpine and calcium channel blockers including diltiazem and nifedipine) Page 3 of 9 2021-0070143 · Medicines used to prevent blood clots, anticoagulants (e.g. apixaban, dabigatran, edoxaban, rivaroxaban, warfarin), antiplatelets (e.g. ticagrelor) · Medicines used for epilepsy (e.g. carbamazepine, lacosamide, lamotrigine, phenobarbital, sodium valproate and valproic acid, topiramate, oxcarbazepine, succinimides including ethosuximide and vigabatrin) · Medicines used to treat fungal infections (e.g. amphotericin B, fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole and miconazole) · Medicines used for tuberculosis and other infections (e.g. chloramphenicol, isoniazid, rifampicin, sulfonamides, sulfadiazine, sulfamethiazole, sulfamethoxazole-trimethoprim, sulfaphenazole, sulfisoxazole, doxycycline and ciprofloxacin) · Medicines used for stomach ulcers (e.g. omeprazole, sucralfate, the medicines known as H2 antagonists including cimetidine, ranitidine, famotidine and some antacids) · Medicines used for asthma and bronchitis (e.g. theophylline) · Medicines used for pain and inflammation (e.g. phenylbutazone, salicylates including aspirin and steroids) · Medicines used for sleeplessness, depression and psychiatric disorders (e.g. chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, quetiapine, trazodone, tricyclic antidepressants, fluvoxamine, sertraline and viloxazine) · Medicines used for diabetes (e.g. tolbutamide) · Medicines used for cancer (e.g. antineoplastic agents e.g. teniposide, fluorouracil), capecitabine, bleomycin, carboplatin, cisplatin, doxorubicin and methotrexate · Some hormone replacement therapies (oestrogens), oral contraceptives (the birth control pill) (see Pregnancy, contraception in women, and breast-feeding) · Medicines used for organ and tissue transplants, to prevent rejection (e.g. ciclosporin, tacrolimus) · Medicines used to lower high blood cholesterol and triglycerides (e.g. atorvastatin, fluvastatin, simvastatin) · Medicines used in the treatment of HIV infection (e.g. delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir) · Medicines used to expel parasitic worms from the body (e.g. albendazole, praziquantel) · Muscle relaxants used for surgery (neuromuscular blockers), some anaesthetic drugs (e.g. halothane, methadone) · Some products available without a prescription (e.g. folic acid, vitamin D). Your doctor may need to test the amount of phenytoin in your blood to help decide if any of these drugs are affecting your treatment. The herbal preparation St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St John’s wort, consult your doctor before stopping the St John’s wort preparation. If you are being fed by a tube this can affect the concentrations of phenytoin, the active ingredient of Epanutin 30 mg/5 ml Oral Suspension, in your blood. Your doctor or pharmacist will tell you how to take this medicine with your feeds. Epanutin 30 mg/5 ml Oral Suspension may also interfere with certain laboratory tests that you may be given. Epanutin with food, drink and alcohol Page 4 of 9 2021-0070143 Epanutin can be taken before or after food and drink. Drinking a lot of alcohol can also affect the concentration of phenytoin in your blood. Talk to your doctor or pharmacist for advice. Pregnancy, contraception in women, and breast-feeding Pregnancy Epanutin can cause major birth defects. Taking phenytoin during pregnancy increases the chance that the baby may have physical birth abnormality. Studies with women treated with phenytoin for epilepsy during pregnancy have shown that around 6 babies in every 100 will have serious physical birth abnormalities. This compares to 2-3 babies in every 100 born to women who don’t have epilepsy. The most common types of serious physical birth abnormalities (major congenital malformations) report for phenytoin include abnormalities of the lip and palate, heart, skull, nail and finger disorders and growth abnormalities. Some of these may occur together as part of a fetal hydantoin syndrome. Your unborn baby should be closely monitored if you have taken Epanutin while pregnant. Epanutin should not be used during pregnancy unless nothing else works for you. Taking more than one epilepsy medicine at the same time may also increase the risk of physical birth abnormalities. Where possible, your doctor will consider using one epilepsy medicine only to control your epilepsy. Your doctor may advise you to take folic acid if you’re planning to become pregnancy and while you’re pregnant. Your doctor may adjust your epilepsy medicine when you take folic acid. Some studies observed that taking phenytoin during pregnancy increases the chance that the baby have problems affecting learning and thinking abilities. Problems with neurodevelopment (development of the brain) have been reported in babies born to mothers who used phenytoin during pregnancy. Some studies have shown that phenytoin negatively affects neurodevelopment of children exposed to phenytoin in the womb, while other studies have not found such an effect. The possibility of an effect on neurodevelopment cannot be ruled out. There have been isolated reports of tumours, including tumours affecting nerve tissue, in children whose mothers received phenytoin during pregnancy. If you take Epanutin during pregnancy, your baby is also at risk for bleeding problems right after birth. Your doctor may give you and your baby a medicine to prevent this. Moreover, your child should be closely monitored. Contraception in women Page 5 of 9 2021-0070143 If you are a woman of childbearing age and are not planning a pregnancy, you should use effective contraception during treatment with Epanutin. Epanutin may affect how hormonal contraceptives, such as the contraceptive (birth control) pill, work and make them less effective at preventing pregnancy. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking Epanutin. If you are a woman of childbearing age and are planning a pregnancy, talk to your doctor before you stop contraception and before you become pregnant about switching to other suitable treatments in order to avoid exposing the unborn baby to phenytoin. If you are or think you might be pregnant, tell your doctor straight away. You should not stop taking your medicine until you have discussed this with your doctor. Stopping your medication without consulting your doctor could cause seizures which could be dangerous to you and your unborn child. Your doctor may decide to change your treatment. Closer monitoring of your unborn child is also recommended. Breast-feeding Epanutin passes into breast milk. You should not breast-feed if you are taking Epanutin. Driving and using machines Epanutin may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery and contact your doctor. Epanutin contains sodium benzoate (E211), sucrose, alcohol (ethanol), sodium and the colouring agents Sunset yellow FCF (E110) and carmoisine (E122) Epanutin contains 25 mg sodium benzoate in each 5 ml which is equivalent to 5 mg/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). Epanutin can contain up to 17 g of sucrose, a type of sugar, per dose. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine may be harmful to the teeth. Epanutin contains 19.875 mg alcohol (ethanol) in each 5 ml of oral suspension which is equivalent to 3.975 mg/ml. The amount of alcohol in a 300 mg dose (50 ml volume) of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The amount of alcohol in a 500 mg dose (83.3 ml volume) of this medicine is equivalent to less than 9 ml beer or 4 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. Epanutin contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodiumfree’. When the dose is greater than 7.9 ml it cannot be considered ‘sodium-free’. The maximum recommended daily dose of this medicinal product (83.3 ml) contains 242.4 mg of sodium. This is equivalent to 12.12% of the recommended maximum daily dietary intake of sodium for an adult. Epanutin also contains the colouring agents Sunset yellow FCF (E110) and carmoisine (E122), which may cause allergic reactions.