Product Details

What you need to know before you take Plenadren

Do not take Plenadren – if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Plenadren – when you have a condition that makes you unable to take this medicine or when the medicine is not absorbed properly from your stomach. This may happen when you have stomach problems involving vomiting and/or diarrhoea. In these situations you should seek immediate medical care in order to receive treatment with injections of hydrocortisone and extra fluid administration. 2 – if you have short-term or temporary illness such as infections, fever or situations causing a great amount of physical stress, such as surgery: your dose of hydrocortisone must be temporarily increased. Ask your doctor promptly for information on how you should handle these situations. If you are to have surgery, tell your doctor/dentist before the surgery that you are taking this medicine. – if for any other reason your general health is declining although you take your medicine as prescribed; seek immediate medical care. – if your thyroid gland is not working normally tell your doctor since your dose of Plenadren may need to be adjusted. Children and adolescents Plenadren is not recommended for use in children and adolescents under 18 years old as it has not been studied in these patients. Other medicines and Plenadren Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. During long term treatment with medicines treating infections (antibiotics) the dose of Plenadren may need adjustment by your doctor. If used with mifepristone, a treatment used to end a pregnancy, the effect of Plenadren may be reduced. In addition, tell your doctor or pharmacist if you are using any of the following medicines, as the dose of Plenadren may need to be changed: • Phenytoin, carbamazepine and barbiturates – used to treat epilepsy • Rifampicin or rifabutin – used to treat tuberculosis • Ritonavir, efavirenz and nevirapine – used to treat HIV infection • St. Johns wort – used to treat depression and other conditions • Ketoconazole, itraconazole, posaconazole and voriconazole – used to treat fungal infections • Erythromycin, telithromycin and clarithromycin – used to treat bacterial infections Plenadren with food and drink Do not take this medicine with grapefruit juice as the juice will conflict with the action of this medicine. Pregnancy, breast feeding and fertility 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. It is important that you continue treatment with Plenadren during pregnancy. Treatment in pregnant women with adrenal insufficiency is unlikely to cause any harmful effects on the mother and/or the baby. You should tell your doctor if you become pregnant as the dose of Plenadren may have to be adjusted. You can breast-feed during Plenadren treatment. Hydrocortisone is excreted in breast milk. Doses of hydrocortisone used for replacement therapy are unlikely to have any effect on the child. However, talk to your doctor if you plan to breast-feed your baby. Fertility in women with adrenal insufficiency or cortisol deficiency may be reduced. There is no indication that Plenadren, in doses used for replacement therapy, will have an effect on fertility. Driving and using machines This medicine may have minor influence on your ability to drive and use machines. Extreme tiredness and episodes of short-lasting dizziness (vertigo) have been reported. Poorly treated or untreated adrenal insufficiency reduces your ability to concentrate and will affect your ability to drive and use machines. 3 It is therefore important to take this medicine as directed by your doctor when driving or using machines. If you are affected do not drive or use machines, until you have discussed the issue with your doctor.