L-Thyroxin 150 Berlin-Chemie tabl 150mcg in bl. in pack. №25×4

NameL-Thyroxin 150 Berlin-Chemie tab 150mcg in bl. in pack. №25×4 What l-thyroxine 150 Berlin-Chemie is and what it is used forL-Thyroxine 150 Berlin-Chemie is a drug whose active ingredient is the thyroid hormone levothyroxine. It has the same effect as the natural hormone. L-Thyroxine 150 Berlin-Chemie is taken to replace the missing thyroid hormone and / or to reduce the load on the thyroid gland. L-Thyroxine 150 Berlin-Chemie is used: – as a substitute for the missing hormone in all forms of hypothyroidism – for the prevention of recurrence of goiter (enlargement of the thyroid gland) after surgery to remove the goiter with normal thyroid function – for the treatment of benign goiter with normal function thyroid gland – with a malignant tumor of the thyroid gland, mainly after surgery, to suppress the recurrence of the tumor and replace the missing thyroid hormone. – for the study of thyroid function (thyroid suppression test) L-Thyroxine 150 Berlin-Chemie is used in all age groups. L-thyroxine 150 Berlin-Chemie is contraindicated: – in the presence of an allergy (hypersensitivity) to levothyroxine-sodium or other components of the drug (given in the section “Composition of the drug L-Thyroxine 150 Berlin-Chemie”) – in the presence of the following diseases or conditions: – untreated hyperthyroidism – untreated adrenocortical insufficiency – untreated pituitary insufficiency if it has led to adrenocortical insufficiency requiring treatment – recent acute myocardial infarction – acute inflammation of the heart muscle (myocarditis) – acute inflammation of all layers of the heart wall (pancarditis) – If pregnancy is present and concomitant use of drugs for the treatment of hyperthyroidism (thyreostatics) L-Thyroxine 150 Berlin-Chemie should not be taken (see also the section “Pregnancy, breastfeeding and fertility”). Before you start taking the drug L-Thyroxine 150 Berlin-Chemie, the presence of the following diseases or conditions should be excluded or treated: – coronary artery disease – pain in the heart and a feeling of tightness in the chest (angina pectoris) – high blood pressure – pituitary gland insufficiency and / or the adrenal cortex – the presence in the thyroid gland of areas that produce uncontrolled thyroid hormone (thyroid autonomy) – atherosclerosis Before carrying out the so-called test with suppression of the thyroid gland to study its function, it is necessary to exclude the presence of these diseases or conditions, or to treat them. However, it is not necessary to exclude the presence of thyroid autonomy, since, among other things, the test serves to detect it. Warnings and Precautions – If you have had a heart attack, or have coronary artery disease, weak heart muscle, rhythm disturbances (tachycardia), heart failure, inflammation of the heart muscle without an exacerbation, or long-term hypothyroidism, then you should avoid too high a level hormones in the blood. Therefore, it is necessary to check the level of thyroid hormones more often. If there are minor signs of hyperthyroidism associated with taking the drug L-Thyroxine 150 Berlin-Chemie, you should inform your doctor (see section “Possible side effects”) – If hypothyroidism is caused by pituitary disease. Perhaps this condition is accompanied by insufficiency of the adrenal cortex, which should be eliminated before treatment with thyroid hormone (hydrocortisone therapy). – If there is a suspicion of the presence in the thyroid gland of areas that produce uncontrolled thyroid hormone, a study of thyroid function should be carried out before starting treatment. – In post-menopausal women with an increased risk of osteoporosis, thyroid function should be checked more frequently to avoid an increase in thyroid hormone levels in the blood. – If you have diabetes or are taking certain anticoagulants (eg dicoumarol), you should pay attention to the section “Taking other medicines”. – If you notice signs of mental disorders, contact your doctor immediately, as you may need to adjust the dose of levothyroxine. – If you, as a dialysis patient, are prescribed, for example, the drug Sevelamer for elevated blood phosphate levels, your doctor may consider it necessary to monitor certain blood parameters to determine the effectiveness of taking levothyroxine (see also section “Taking Other Medications”). – If you are taking orlistat (an anti-obesity drug), stop taking it or contact your doctor for a dose adjustment. Your doctor will likely consider monitoring certain blood parameters and adjusting the dose of levothyroxine. Talk to your doctor or pharmacist before taking L-Thyroxin 150 Berlin-Chemie. Misuse Do not take L-Thyroxine 150 Berlin-Chemie to reduce body weight. If you have a normal level of thyroid hormones in your blood, additional intake of thyroid hormones will not lead to weight loss. Additional use can lead to serious or even life-threatening side effects, especially when combined with certain drugs for weight loss. Changing therapy If you are already taking L-Thyroxine 150 Berlin-Chemie, changing this drug to another drug containing thyroid hormones should only be done under medical supervision and against the background of monitoring blood parameters. Elderly patients Elderly patients require careful dosing of the drug (especially in the presence of heart disease) and more frequent medical supervision. Taking l-thyroxine 150 Berlin-Chemie and other medicines Talk to your doctor or pharmacist if you are taking/are taking or have recently taken/have taken or may have taken/have taken/have taken other medicines. L-Thyroxine 150 Berlin-Chemie affects the action of the following drugs or groups of drugs: Antidiabetic drugs (drugs that lower blood sugar): If you have diabetes; blood sugar levels should be checked regularly, especially at the start of thyroid hormone treatment. It may be necessary for the attending physician to adjust the dose of drugs that lower blood sugar levels, since levothyroxine can reduce the effect of these drugs. Coumarin derivatives (anticoagulants): When L-Thyroxin 150 Berlin-Chemie is taken together with coumarin derivatives (eg dicumarol), blood coagulation parameters should be monitored regularly. It may be necessary to reduce the dose of anticoagulants by the attending physician, since levothyroxine can enhance the effect of these drugs. The following medicines affect the effect of L-Thyroxine 150 Berlin-Chemie: blood lipid-lowering medicines, blood potassium-lowering medicines (ion exchange resins): Blood lipid-lowering medicines (e.g. cholestyramine, colestipol and colesevelam), or drugs to reduce the concentration of potassium in the blood (calcium and sodium salts of polystyrene sulfonic acid) should be taken from 4 to 5 hours after taking the drug L-Thyroxine 150 Berlin-Chemie. These drugs inhibit the absorption of levothyroxine from the intestines, thus reducing its effectiveness. Sevelamer and lanthanum carbonate: Sevelamer and lanthanum carbonate (drugs to lower blood phosphate levels in dialysis patients) may reduce the absorption and effectiveness of levothyroxine. The attending physician should check thyroid function more often than usual (see also the Warnings and Precautions section), aluminum-containing antacids, and iron- and calcium-containing drugs: L-Thyroxine 150 Berlin-Chemie should be taken at least 2 hours before taking aluminum-containing antacids (antacids, sucralfate), as well as iron-containing and calcium-containing drugs. These drugs inhibit the absorption of levothyroxine from the intestines, thus reducing its effectiveness. Propylthiouracil, glucocorticoids, beta-blockers: Propylthiouracil (an overactive thyroid medication), glucocorticoids (adrenal cortex hormones, “cortisone”), and β-blockers (drugs that decrease heart rate and lower blood pressure) may inhibit the conversion of levothyroxine to its more effective form is liothyronine, thus reducing the effectiveness of the drug L-Thyroxine 150 Berlin-Chemie. Amiodarone, iodinated radiopaque agents: Amiodarone (a drug used to treat arrhythmias) and iodinated radiopaque agents (certain x-ray drugs) can cause both an increase and a decrease in thyroid activity due to their high iodine content. Particular attention should be observed in nodular goiter with possibly unrecognized areas in the thyroid gland that produce thyroid hormones uncontrollably (autonomy). If necessary, the attending physician will adjust the dose of L-Thyroxine 150 Berlin-Chemie. Contraceptives or hormone replacement therapy: The need for levothyroxine may increase when taking contraceptive hormonal drugs (“pills”) or during hormone replacement therapy in the period after menopause. Sertraline, chloroquine/proguanil: Sertraline (a drug used to treat depression) and chloroquine/proguanil (a drug used to treat malaria and rheumatoid diseases) reduce the effectiveness of levothyroxine. Barbiturates, rifampicin, carbamazepine: Barbiturates (drugs used to treat seizures, anesthetics, certain types of sleeping pills), rifampicin (antibiotic), and carbamazepine (drug used to treat seizures) may reduce the effect of levothyroxine. Protease inhibitors (drugs used to treat HIV infection), phenytoin (medicine used to treat seizures): When levothyroxine and protease inhibitors (lopinavir, ritonavir) or phenytoin are taken together, the physician should closely monitor symptoms and monitor thyroid function. Co-administration of lopinavir/ritonavir or phenytoin may reduce the effect of levothyroxine. Tyrosine kinase inhibitors (imatinib and sunitinib): Treatment with imatinib and sunitinib (drugs used to treat chronic myeloid leukemia) results in an increased need for levothyroxine in patients with hypothyroidism. Orlistat (obesity drug) Orlistat may reduce the effectiveness of levothyroxine. The following medicines may increase the effect of L-Thyroxine 150 Berlin-Chemie: – salicylates (antipyretics and painkillers) – dicoumarol (a drug that inhibits blood clots) – high doses of furosemide (a diuretic) (250 mg) – clofibrate (drug to lower blood lipids) – phenytoin (a drug used to treat seizures and irregular heartbeats) Taking L-Thyroxine 150 Berlin-Chemie with food and drink L-Thyroxine 150 Berlin-Chemie should not be taken with foods that are especially rich in calcium ., milk and dairy products), as this can significantly reduce the absorption of levothyroxine. If you consume products containing soy, your doctor should check your thyroid hormone levels more frequently. During the use of the soy diet and at the end of it, dose adjustment of the drug may be required (unusually high doses may be required), since products containing soy may interfere with the absorption of levothyroxine in the intestine, thus reducing its effectiveness. Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this drug. During pregnancy and breastfeeding, proper thyroid hormone therapy is especially important. Therefore, it must be continued continuously under the supervision of the attending physician. Despite the widespread use of the drug during pregnancy, undesirable effects of levothyroxine on the course of pregnancy and on the health of the fetus or newborn have so far been identified. Thyroid function should be monitored both during and after pregnancy. Due to the increased level of estrogen in the blood (female sex hormone), the need for thyroid hormone during pregnancy may increase, which may require dose adjustment by the attending physician. During pregnancy, L-Thyroxine 150 Berlin-Chemie should not be taken simultaneously with drugs for the treatment of hyperthyroidism (thyreostatics), as this leads to the need for higher doses of thyreostatics. Thyreostatics can (unlike levothyroxine) cross the placenta into the fetal circulation and lead to hypothyroidism in the fetus. Therefore, hyperfunction of the thyroid gland during pregnancy should be treated exclusively with low doses of thyreostatics. The amount of thyroid hormone that enters breast milk is very small even with high doses of levothyroxine and, therefore, the drug is not dangerous. During pregnancy and breastfeeding, a doctor should not perform a thyroid suppression test. There is no scientific evidence of fertility problems in men or women. There is no suspicion or indication of this. Effects on Ability to Drive and Use Machines Since levothyroxine is identical to the natural thyroid hormone, L-thyroxine 150 Berlin-Chemie is not expected to affect the ability to drive or use machines. Studies on the effect of the drug L-Thyroxin 150 Berlin-Chemie on the ability to drive vehicles and maintain mechanisms have not been conducted. How to take l-thyroxine 150 Berlin-Chemie L-Thyroxine 150 Berlin-Chemie should be taken strictly according to the doctor’s recommendations. If you have any doubts, ask your doctor or pharmacist. The individual daily dose should be determined by the attending physician based on the results of examinations. DosageDivisible tablets are available with different active substance contents for individual treatment, eg for initiation of treatment, dose escalation in adults, as well as for the treatment of children. Depending on the existing symptoms, the attending physician is guided by the following recommendations: For the treatment of hypothyroidism, adults should take 25-50 micrograms of levothyroxine sodium per day at the beginning. At the direction of the doctor, this dose can be increased at intervals of 2-4 weeks by 25-50 mcg of levothyroxine sodium to a daily dose of 100-200 mcg of levothyroxine sodium. To prevent recurrence of goiter after surgical removal of the goiter and treatment of benign goiter, 75-200 mcg of levothyroxine sodium per day should be taken. After surgery on the thyroid gland for a malignant tumor of the thyroid gland, 150 – 300 mcg of levothyroxine sodium per day should be taken (corresponding to 2 tablets of the drug L-Thyroxine 150 Berlin-Chemie). When examining thyroid function using the thyroid suppression test, levothyroxine sodium 75 mcg (equivalent to 1/2 tablet L-Thyroxine 150 Berlin-Chemie) should be taken once a day for 4 weeks before the test. 3 weeks before the test, the above regimen is maintained. Then you need to take 150 mcg of levothyroxine sodium (1 tablet of L-Thyroxine 150 Berlin-Chemie) per day for 14 days before the radiological examination (scintigraphy). Lower doses of thyroid hormone may also be sufficient. Children suffering from hypothyroidism (congenital and acquired hypothyroidism) – In long-term treatment of hypothyroidism (congenital and acquired hypothyroidism), the maintenance dose is usually 100-150mcg of levothyroxine per square meter of body surface area per day. – For newborns and infants with congenital hypothyroidism, for whom the rapid replacement of levothyroxine in the body is especially important for their normal mental and physical development, the recommended initial dose is 10-15 micrograms of levothyroxine per kilogram of body weight per day for the first 3 months. Then the doctor should adjust the dose on an individual basis – depending on the clinical data (especially on the level of thyroid hormone in the blood). – For children with acquired hypothyroidism, the recommended starting dose is 12.5-50 micrograms of levothyroxine per day. Every 2-4 weeks, the doctor should gradually increase this dose until the full dose is reached, when hormone replacement is complete. At the same time, the level of thyroid hormone in the blood is of particular importance for the doctor. Elderly patients, patients with coronary artery disease, and patients with hypothyroidism Treatment with thyroid hormones should be initiated with extreme caution in elderly patients, patients with coronary artery disease, and in patients with severe or prolonged hypothyroidism. This means that the drug should be started with the lowest dose and increased slowly, with long time intervals, with frequent monitoring of thyroid hormones. Patients with low body weight and patients with large nodular goiter Experience shows that with low body weight and with a large nodular goiter, a lower dose of the drug is also quite sufficient. Note on dividing the tablet: Tablets can be divided into two equal parts. Place the tablet on a hard, flat surface with the score line facing up. After pressing a finger on the tablet, it will be divided into two halves. Dosing and Administration The full daily dose should be swallowed with plenty of liquid, if possible with a glass of water. The drug should be taken in the morning on an empty stomach, at least half an hour before breakfast. It is better to take the drug on an empty stomach than before or after a meal. Infants should be given the full daily dose at least half an hour before their first meal. The tablet should be dissolved in a small amount of water (10-15 ml) and the resulting suspension should be given to the baby (each time it must be freshly prepared!) With some additional liquid (5-10 ml). Duration of use In case of hypofunction of the thyroid gland and after surgery on the thyroid gland for a malignant tumor of the thyroid gland, L-Thyroxin 150 Berlin-Chemie is usually taken throughout life. For benign goiter and for the prevention of goiter recurrence: from several months or years to lifelong use. For the treatment of benign goiter with normal thyroid function, a treatment period of 6 months to two years is required. If treatment with L-Thyroxin 150 Berlin-Chemie has not brought the desired result during this time, the attending physician should consider using another treatment. What to do in case of drug overdose L-Thyroxine 150 Berlin-Chemie An overdose of levothyroxine can cause symptoms of hyperthyroidism and acute psychosis, especially in patients at high risk of psychotic disorders. Other signs of overdose are described in the “Possible side effects” section. If you experience these symptoms, you should contact your doctor. If you forget to take L-Thyroxine 150 Berlin-Chemie If you take too little or miss a dose, do not take a double dose to make up for the missed one. The next tablet should be taken at the usual time, following the prescribed frequency of administration. If you stop taking L-Thyroxine 150 Berlin-Chemie In order for the treatment to be successful, L-Thyroxine 150 Berlin-Chemie must be taken regularly at the prescribed dosage. Treatment should not be changed, interrupted or terminated prematurely at one’s discretion under any circumstances, as the symptoms of the disease may recur. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Possible side effects Like all medicines, L-Thyroxine 150 Berlin-Chemie can cause side effects, although not everybody gets them. Intolerance to the dose level, overdose If in some cases the dose level is not tolerated by the patient or an overdose occurs, then, especially if the dose is increased too quickly at the beginning of treatment, typical signs of hyperactive thyroid gland may occur: – palpitations – heart rhythm disturbances, especially increased frequency heart contractions (tachycardia) – pain accompanied by a feeling of tightness in the chest (angina pectoris) – muscle weakness and muscle cramps – feeling hot, excessive sweating – shaking (tremor) – restlessness, insomnia – diarrhea, weight loss – headache – menstrual irregularities Also may observed such atypical signs as fever, vomiting, and increased cerebral pressure (especially in children). There have been reports of cases of angioedema (Quincke’s edema). Hypersensitivity to the active substance or other components of the drug L-Thyroxine 150 Berlin-Chemie In the presence of hypersensitivity to levothyroxine or any other component of the drug L-Thyroxine 150 Berlin-Chemie, skin allergic reactions and allergic reactions from the respiratory tract may occur. If hypersensitivity reactions occur you should stop taking the drug and consult a doctor immediately. If you experience side effects, tell your doctor about it. He will determine if the daily dose should be reduced, or if the pill should be interrupted for several days. Immediately after the disappearance of side effects, it is recommended to resume treatment, carefully selecting the dose of the drug. Reporting side effects If you experience any side effects, tell your doctor or pharmacist. This applies to any side effects, including those not listed in this package insert. How to store l-thyroxine 150 berlin-chemi Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton. The expiration date refers to the last day of the specified month. Store at a temperature not exceeding 25°C. Do not dispose of any medication down the drain. Talk to your pharmacist about how to dispose of an unused drug. These measures contribute to the protection of the environment. Composition of the drug l-thyroxine 150 berlin-chemi Active ingredient: levothyroxine sodium One tablet contains 159.6 – 170.4 micrograms of levothyroxine sodium x H2O (equivalent to 150 micrograms of levothyroxine-sodium) Other components: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium salt starch glycolate (type A) (Ph. Eur.), dextrin (from corn starch), long chain partial glycerides. Appearance of the drug l-thyroxine 150 Berlin-Chemie Round, slightly convex tablets from almost white to slightly beige, with a notch for dividing on one side and embossed “150” on the other; Tablets can be divided into two equal halves. Packaging Primary packaging: Aluminum-aluminum blister Blister made of coated aluminum foil and hermetically sealed with aluminum foil One original package contains: 100 tablets (4 blisters of 25 tablets) and leaflet. Release conditions L-Thyroxine 150 Berlin-Chemie is released only by prescription. in pack. №25×4 Price for L-Thyroxine 150 Berlin-Chemie tab 150mcg in bl. in pack. №25x4Instruction for use for L-Thyroxin 150 Berlin-Chemie tab 150mcg in bl. in pack. №25×4