Eltroxin

Leaflet accompanying the packaging: patient information

Eltroxin, 50 micrograms, tablets

Eltroxin, 100 micrograms, tablets

(Sodium levothyroxine)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Eltroxin is and what it is used for
• 2. Important information before taking Eltroxin
• 3. How to take Eltroxin
• 4. Possible side effects
• 5. How to store Eltroxin
• 6. Contents of the packaging and other information

1. What Eltroxin is and what it is used for

Eltroxin contains anhydrous sodium thyroxine, which is a synthetic thyroid hormone.
Thyroxine is usually produced in the body by the thyroid gland, located in the neck.
It affects many body functions related to growth and metabolism.
Eltroxin is used to treat hypothyroidism, a condition in which the thyroid gland does not produce enough thyroxine.

2. Important information before taking Eltroxin

When not to take Eltroxin

• if you are allergic to sodium levothyroxine or any of the other ingredients of this medicine (listed in section 6),
• if you have hyperthyroidism,
• in case of myocardial infarction, acute myocarditis, and acute pericarditis,
• if you have adrenal insufficiency (adrenal cortex insufficiency) and are not receiving appropriate replacement therapy.

During pregnancy, do not take Eltroxin at the same time as medicines used for hyperthyroidism (antithyroid medicines).
If any of the above conditions apply to you, tell your doctor.

Warnings and precautions

Before starting Eltroxin, discuss it with your doctor or pharmacist.

• Rapid dose increase may lead to side effects (listed in section 4). If you experience any side effects, tell your doctor.
• Thyroid hormone medicines are not suitable for weight loss. Taking them will not lead to weight loss if your thyroid hormone levels are normal. Increasing the dose without a doctor's special recommendation may cause serious or life-threatening side effects, especially if thyroid hormones are taken with other weight loss medicines.
• If you are taking weight loss medicines, such as orlistat, inform your doctor before taking Eltroxin. A minimum 4-hour interval between taking Eltroxin and orlistat is required.
• In case of switching from one levothyroxine-containing medicine to another, thyroid function disorders may occur. If you have any questions about switching medicines, consult your doctor or other healthcare professional. During the transition period, close monitoring of the patient's condition (clinical and biological parameters) is necessary. Contact your doctor if you experience any side effects, as it may be necessary to increase or decrease the dose of Eltroxin.
• If you are to undergo laboratory tests to check your thyroid hormone levels, inform your doctor or laboratory staff about your current or recent use of biotin (also known as vitamin H, vitamin B7, or vitamin B8). Biotin may affect laboratory test results. Depending on the type of test, the results may be falsely elevated or decreased due to biotin use. Your doctor may recommend that you stop taking biotin before undergoing laboratory tests. Also, keep in mind that other products you are taking, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin, which can affect laboratory test results. If you are taking such products, inform your doctor or laboratory staff (see "Eltroxin and other medicines").

Before starting Eltroxin, tell your doctor if:

• you have diabetes - your dose of antidiabetic medicine may need to be changed;
• you have high blood pressure, heart failure, or have had a heart attack (your doctor may recommend an ECG for patients with heart disease or the elderly);
• you have any condition that affects adrenal function (your doctor will advise you if additional treatment is necessary);
• you are over 50 years old;
• you have a history of long-term low thyroxine levels;
• you have seizures (epileptic fits), as their frequency may increase;
• you have myxedema (a white, soft swelling of the skin and subcutaneous tissue);
• you have malabsorption syndromes;
• you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby. In such cases, consult your doctor or pharmacist before taking this medicine.
  Pregnancy
  To ensure proper development of the pregnancy, it is essential to maintain normal balance in the mother's body throughout the pregnancy. Therefore, levothyroxine treatment should be continued throughout the pregnancy, and your doctor may decide to change the doses at the beginning or during the pregnancy.
  For this reason, close monitoring of thyroid function will be initiated as soon as possible, especially in the first half of the pregnancy. After delivery, it is recommended to check the child's thyroid status.
  During pregnancy, do not take Eltroxin at the same time as medicines used for hyperthyroidism (antithyroid medicines). Eltroxin passes through the placenta in very small amounts, while antithyroid medicines easily pass through the placenta. This may cause a risk of hypothyroidism in the newborn.
  Breastfeeding
  Levothyroxine replacement therapy can be used during breastfeeding.
  Fertility
  No studies have been conducted on the effect of this medicine on fertility. Hypothyroidism or hyperthyroidism may affect fertility.

  Children

  When starting levothyroxine treatment in premature infants with very low birth weight, blood pressure should be regularly monitored, as a sudden decrease in blood pressure (so-called circulatory collapse) may occur.

  Eltroxin and other medicines

  Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, even those available without a prescription.
  Some medicines may affect the action of Eltroxin. Eltroxin may also decrease or increase the action of other medicines. You should inform your doctor if you are taking:

  • cholestyramine, which lowers blood cholesterol levels;
  • bile acid binders (such as cholestyramine);
  • ion exchange resins (such as sulfonated polystyrene);
  • iron preparations (e.g., iron sulfate);
  • sucralfate, used to treat stomach ulcers;
  • aluminum, magnesium, calcium, and iron supplements;
  • proton pump inhibitors (used to reduce stomach acid production);
  • weight loss medicines, such as orlistat.

  The following medicines may affect the action of Eltroxin

  • antiepileptic medicines (e.g., phenytoin, carbamazepine, barbiturates), used to prevent epileptic fits;
  • medicines containing St. John's Wort (some herbal medicines);
  • propranolol, used to treat high blood pressure;
  • medicines used to treat irregular heart rhythm (e.g., amiodarone);
  • medicines containing lithium or iodide;
  • oral contrast agents (liquids used in X-ray imaging);
  • propylthiouracil, used to treat hyperthyroidism;
  • glucocorticosteroids, such as dexamethasone, used to treat inflammatory and allergic reactions;
  • tyrosine kinase inhibitors (e.g., imatinib or sunitinib), tamoxifen, and 5-fluorouracil, used to treat cancer;
  • methadone, used to treat addiction;
  • statins (e.g., simvastatin and lovastatin) and clofibrate, used to lower cholesterol levels;
  • hormone-containing medicines, such as oral contraceptives, estrogens, used in hormone replacement therapy;
  • sertraline, used to treat depression and anxiety;
  • ritonavir, used to control HIV and hepatitis C virus infection;
  • proton pump inhibitors (such as omeprazol, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) used to reduce stomach acid production, which may decrease levothyroxine absorption from the intestine and make it less effective. If you are taking levothyroxine while being treated with proton pump inhibitors, your doctor should monitor your thyroid function and adjust the Eltroxin dose if necessary.

  Many medicines can affect the results of laboratory tests that measure thyroid function.
  Eltroxin may affect the action of the following medicines

  • insulin and oral antidiabetic medicines, used to treat diabetes;
  • anticoagulant medicines (e.g., warfarin), used to treat blood clots;
  • phenytoin (used to treat epilepsy);
  • cardiac glycosides (e.g., digoxin), used to treat heart conditions such as heart failure;
  • sympathomimetic medicines, such as adrenaline;
  • tricyclic antidepressants, used to treat depression.

  Patients taking the following medicines should contact their doctor, as they may interfere with laboratory tests, making the results unreliable

  • androgens and anabolic steroids (used in hormone replacement therapy)
  • anti-inflammatory medicines, such as aspirin and phenylbutazone.

  If you are currently taking or have recently taken biotin, you must inform your doctor or laboratory staff if you are to undergo thyroid hormone laboratory tests. Biotin may affect laboratory test results (see "Warnings and precautions").

  Eltroxin with food and drink

  Soy-based mixtures and a high-fiber diet may decrease Eltroxin absorption.

  Pregnancy, breastfeeding, and fertility

  If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
  Pregnancy
  To ensure proper development of the pregnancy, it is essential to maintain normal balance in the mother's body throughout the pregnancy. Therefore, levothyroxine treatment should be continued throughout the pregnancy, and your doctor may decide to change the doses at the beginning or during the pregnancy.
  For this reason, close monitoring of thyroid function will be initiated as soon as possible, especially in the first half of the pregnancy. After delivery, it is recommended to check the child's thyroid status.
  During pregnancy, do not take Eltroxin at the same time as medicines used for hyperthyroidism (antithyroid medicines). Eltroxin passes through the placenta in very small amounts, while antithyroid medicines easily pass through the placenta. This may cause a risk of hypothyroidism in the newborn.
  Breastfeeding
  Levothyroxine replacement therapy can be used during breastfeeding.
  Fertility
  No studies have been conducted on the effect of this medicine on fertility. Hypothyroidism or hyperthyroidism may affect fertility.

  Driving and using machines

  No effect of Eltroxin on the ability to drive and use machines is expected.

  3. How to take Eltroxin

  Always take this medicine exactly as your doctor has told you. DO NOT take a higher dose than recommended by your doctor. If you are unsure, consult your doctor or pharmacist.
  Typically, the initial dose for adults is 50-100 micrograms per day. The dose may be increased after several weeks, depending on the patient's response to treatment, controlled by blood tests.
  Patients taking Eltroxin and other medicines that may interact with it should maintain a minimum 4-hour interval between taking Eltroxin and those medicines (see section 2 - Eltroxin and other medicines).

  Older patients and patients with heart disease

  In patients over 50 years old, the initial dose should not exceed 50 micrograms per day.
  The recommended initial dose in patients with heart disease is 50 micrograms every other day.
  Your doctor may then increase the daily dose by 50 micrograms every other day, every 4 weeks, until an optimal response to treatment is achieved.

  Use in children

  Children under 12 years:

  The dose in children depends on age, body weight, and the type of disease being treated.
  Your doctor will monitor the child's condition to ensure they are receiving the correct dose of Eltroxin.
  The maintenance dose is usually 100-150 micrograms per square meter of body surface area.
  In newborns and infants with congenital hypothyroidism, for whom rapid initiation of replacement therapy is essential, the recommended initial dose is 10-15 micrograms per kilogram of body weight per day for the first 3 months. The dose should then be adjusted individually based on clinical evaluation and thyroid hormone and TSH levels.
  In children with acquired hypothyroidism, the recommended initial dose is 12.5-50 micrograms per day. The dose should be gradually increased every 2-4 weeks based on clinical evaluation and thyroid hormone and TSH levels until full replacement dose is reached.

  Method of administration

  Swallow the tablets with a glass of water, preferably before breakfast. Eltroxin tablets should be taken on an empty stomach.
  Infants should be given the entire daily dose once a day, at least 30 minutes before the first meal of the day. The tablets should be crushed in a small amount of water (10-15 ml). The resulting suspension should be given immediately before each administration, along with an additional small amount of liquid (5-10 ml).
  Eltroxin tablets should not be crushed or divided.
  Always follow the doctor's prescription exactly and never take more or fewer tablets without consulting your doctor.

  Taking a higher dose of Eltroxin than recommended

  In case of overdose or accidental ingestion of the medicine by another person, immediately contact your doctor or the nearest hospital emergency department. Take the packaging, any remaining tablets, and this leaflet with you, so the medical staff knows what medicine has been taken. The following symptoms may occur: excitement (agitation), disorientation, irritability, excessive restlessness, headache, sweating, dilated pupils, rapid heartbeat, irregular heartbeat, rapid breathing, fever, increased bowel movements, and seizures. Clinical symptoms of hyperthyroidism may also occur up to five days after overdose. Thyrotoxic crisis is rare and occurs as a result of chronic overdose, leading to irregular heartbeat, heart failure, and coma.

  Missing a dose of Eltroxin

  If you miss a daily dose, take your usual dose as soon as you remember, unless it is almost time for your next dose. Do not take two doses at the same time. Take the next dose at the usual time.

  Stopping Eltroxin treatment

  If treatment needs to be stopped, Eltroxin should be discontinued gradually, under medical supervision.
  If you have any further questions about taking this medicine, consult your doctor or pharmacist.

  4. Possible side effects

  Like all medicines, Eltroxin can cause side effects, although not everybody gets them.
  If the dose of Eltroxin is too high, the following side effects may occur.
  All medicines can cause allergic reactions. The frequency of these reactions after taking Eltroxin is unknown.

  In case of sudden symptoms such as wheezing, difficulty breathing, swelling of the eyelids, face, or lips, sudden redness of the face, rash, and itching (especially all over the body), contact your doctor immediately.

  Other serious side effects (frequency unknown):

  • angina pectoris, arrhythmias (irregular heartbeat), palpitations (excessive heartbeat), heart failure (circulatory failure), myocardial infarction;
  • hyperthyroidism;
  • pseudotumor cerebri (increased intracranial pressure and vision disturbances);
  • excessive dose in children may cause craniosynostosis (premature closure of the skull bones before the end of brain growth) and premature closure of the epiphyseal plates, which may affect growth in adulthood.

  If you notice any of these symptoms, stop taking Eltroxin and seek medical help immediately.
  Other side effects that may occur (frequency unknown):

  • tachycardia (rapid heartbeat), high blood pressure;
  • seizures;
  • decreased bone density;
  • headache;
  • tremors, anxiety, emotional lability, nervousness, restlessness;
  • insomnia;
  • muscle cramps or muscle weakness;
  • abdominal pain, nausea, vomiting, abdominal cramps;
  • diarrhea;
  • increased appetite, weight loss;
  • fever, sweating, fatigue (exhaustion, tiredness);
  • heat intolerance;
  • increased sweating, hair loss;
  • irregular menstrual periods, infertility;
  • fluid retention (edema);
  • angioedema, rash, urticaria.

  If you experience any of these symptoms, contact your doctor. These symptoms usually disappear after dose adjustment.

  Reporting side effects

  If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
  Side effects can also be reported to the marketing authorization holder.
  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Eltroxin

  Keep the medicine out of the sight and reach of children.
  Do not store above 25°C.
  Keep the container tightly closed.
  Store in the original packaging.
  Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

  6. Contents of the packaging and other information

  What Eltroxin contains

  • The active substance of Eltroxin is sodium levothyroxine. One tablet contains 50 micrograms or 100 micrograms of sodium levothyroxine (Levothyroxinum natricum) in terms of anhydrous substance.
  • The other ingredients are: microcrystalline cellulose, pregelatinized starch, talc, colloidal anhydrous silica, magnesium stearate.

  What Eltroxin looks like and contents of the packaging

  Eltroxin, 50 micrograms:round, biconvex, white or almost white tablets with "GS 11E" embossed on one side and "50" on the other.
  Eltroxin, 100 micrograms:round, biconvex, white or almost white tablets with "GS 21C" embossed on one side and "100" on the other.
  The packaging contains 100 tablets in a container placed in a cardboard box.

  Marketing authorization holder:

  Aspen Pharma Trading Limited
  3016 Lake Drive
  Citywest Business Campus
  Dublin 24
  Ireland
  tel. 00 48 22 104 21 00

  Manufacturer:

  Aspen Bad Oldesloe GmbH
  Industriestrasse 32-36
  D-23843 Bad Oldesloe
  Germany

  Date of last revision of the leaflet: