13 micrograms, 25 micrograms, 50 micrograms, 75 micrograms, 88 micrograms, 100 micrograms, 112 micrograms, 125 micrograms, 137 micrograms, 150 micrograms, 175 micrograms, and 200 micrograms oral solution in single-dose containers
Levothyroxine sodium<\/p>\n\n\n\n
The active substance in Tirosintsol is the synthetically produced thyroid hormone levothyroxine sodium (T4), whose structure and effect are identical to the naturally occurring thyroid hormone.<\/p>\n\n\n\n
Tyrosine is used:<\/p>\n\n\n\n
Levothyroxine sodium contained in Tirosintsol may also be approved to treat other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
<\/p>\n\n\n\n
Talk to your doctor or pharmacist before taking Tirosintsol.<\/p>\n\n\n\n
Be careful with Tirosintsol if you have any of the following heart conditions<\/strong> :<\/p>\n\n\n\n These diseases\u00a0must be treated<\/strong>\u00a0with drugs\u00a0before taking Tirosintsol,<\/strong>\u00a0and during the time you are taking Tirosintsol, you\u00a0must undergo frequent checks of the levels of thyroid hormones.<\/p>\n\n\n\n If you are unsure whether you have any of these conditions, or if they are untreated, see your doctor.<\/a><\/p>\n\n\n\n Elderly patients:<\/em><\/p>\n\n\n\n For elderly patients, careful dosing and regular medical examinations are required.<\/p>\n\n\n\n For premature babies:<\/em><\/p>\n\n\n\n Blood pressure will be checked regularly when treatment with levothyroxine is started in premature babies with very low birth weight as a rapid drop in blood pressure (called circulatory collapse) may occur.<\/a><\/p>\n\n\n\n If you take other medicines at the same time as Tirosintsol, it may affect how this or the other medicines work. Make sure your doctor knows what other medicines you are taking.<\/p>\n\n\n\n Do not take any other medicines while you are taking Tirosintsol unless you have asked your doctor or pharmacist for advice. <\/strong>This includes over-the-counter medicines.<\/p>\n\n\n\n Tell your doctor<\/u><\/strong> if you are taking any of the following medicines:<\/strong><\/p>\n\n\n\n Make sure you follow the recommended time intervals<\/u> if you have to take any of the following medicines:<\/strong><\/p>\n\n\n\n Other things to keep an eye on when using other medicines at the same time:<\/strong><\/p>\n\n\n\n If you have to have X-rays<\/strong> or other diagnostic tests<\/strong> where contrast agents<\/strong> are used, you must tell the doctor that you are taking Tirosintsol, as you may be receiving an injection of a substance that can affect the function of the thyroid gland.<\/a><\/p>\n\n\n\n Tell your doctor if you eat soy products, especially if you change the number of soy products in your diet.\u00a0Soy products can lower the absorption of levothyroxine from the intestine and therefore it may be necessary to adjust the\u00a0dose\u00a0of Tirosintsol.<\/p>\n\n\n\n Consult a doctor or pharmacist before using this medicine.<\/p>\n\n\n\n Pregnancy<\/strong><\/p>\n\n\n\n Breast-feeding<\/strong><\/p>\n\n\n\n There is no evidence to suggest that Tirosintsol limits the ability to drive or use machines, as levothyroxine is identical to the naturally occurring thyroid hormone.<\/a><\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of oral solution, i.e. it is almost “sodium-free”.<\/a><\/p>\n\n\n\n Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n The doctor determines your dose\u00a0based on the results of your laboratory tests.<\/p>\n\n\n\n Dosage:<\/strong><\/p>\n\n\n\n For individual treatment, single-dose containers of Tirosintsol are available with a levothyroxine sodium content of 13 to 200 micrograms, so as a rule you only need to take one single-dose container a day.<\/p>\n\n\n\n Adults:<\/strong><\/p>\n\n\n\n If you are elderly, have heart problems, or have severe or long-term thyroid problems:<\/strong><\/p>\n\n\n\n Special care must be taken when starting treatment with thyroid hormones.\u00a0This means that a lower starting dose must be chosen which is then gradually increased at extended intervals, and in addition, regular monitoring must be carried out using laboratory tests.<\/p>\n\n\n\n Children<\/strong><\/p>\n\n\n\n The dose\u00a0for children depends on the child’s age, weight, and the condition being treated.\u00a0The child will be monitored to ensure that he\/she receives the correct\u00a0dose.<\/p>\n\n\n\n Tell your doctor or pharmacist if you feel that the effects of Tirosintsol are too strong or too weak.<\/p>\n\n\n\n How to take the medicine:<\/strong><\/p>\n\n\n\n Length of treatment:<\/strong><\/p>\n\n\n\n You must take the medicine for as long as the doctor tells you.<\/p>\n\n\n\n If you have taken a higher\u00a0dose\u00a0than prescribed, you may experience symptoms of an overactive\u00a0thyroid gland, such as palpitations, anxiety,\u00a0agitation, sweating, or tremors (see “4. Possible side effects”).\u00a0If any of this happens, contact a doctor.<\/p>\n\n\n\n If you have ingested too much medicine or if, for example,\u00a0If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n If you forget to take a\u00a0dose, do not take it when you remember, but instead skip it and take the normal\u00a0dose,\u00a0as usual, the next day.<\/p>\n\n\n\n For the treatment to work, Tirosintsol must be taken regularly in the dose prescribed by the doctor. You should not change or stop treatment, either temporarily or permanently, without consulting a doctor. Discontinuing treatment temporarily or permanently may cause your symptoms to return.<\/p>\n\n\n\n If you have any further questions about this medicine, ask your doctor or pharmacist.<\/a><\/p>\n\n\n\n Like all medicines, Tirosintsol can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\nBefore starting treatment<\/h2>\n\n\n\n
Other medicines and Tirosintsol<\/h2>\n\n\n\n
Tyrosine with food and drink<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Tyrosine contains sodium<\/h2>\n\n\n\n
How to take Tirosintsol<\/h2>\n\n\n\n
Initially 10 to 15 micrograms per kg of body weight per day for the first 3 months.\u00a0The dose\u00a0will then be adjusted depending on how the child responds to the treatment.<\/li>
Initially 13 to 50 micrograms a day.\u00a0Does\u00a0one should be gradually increased every two to four weeks, depending on how the child responds to treatment.<\/li><\/ul>\n\n\n\nIf you have taken too much Tirosintsol<\/h2>\n\n\n\n
If you forget to take Tirosintsol<\/h2>\n\n\n\n
If you stop taking Tirosintsol<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n