Eltroxin

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Eltroxin (Thevier 50), 50 micrograms, tablets

Levothyroxine sodium
Eltroxin and Thevier 50 are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Eltroxin and what is it 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 is Eltroxin and what is it used for

Eltroxin contains anhydrous levothyroxine sodium, which is a synthetic thyroid hormone.
Levothyroxine 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 levothyroxine.

2. Important information before taking Eltroxin

When not to take Eltroxin

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

During pregnancy, Eltroxin should not be taken with medicines used for hyperthyroidism (antithyroid medicines).
If any of the above conditions apply to the patient, they should tell their doctor.

Warnings and precautions

Before starting Eltroxin, the patient should discuss it with their doctor or pharmacist.

• Rapid increase in dose may lead to side effects (listed in section 4). If any side effects occur, the patient should tell their doctor.
• Thyroid hormone medicines are not suitable for weight loss. Taking them will not lead to weight loss if thyroid hormone levels are within the normal range. Increasing the dose without special recommendation from a doctor may cause serious or life-threatening side effects, especially if thyroid hormones are taken with other weight-loss medicines.
• If the patient is taking weight-loss medicines, such as orlistat, they should inform their 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 the patient has any questions about switching medicines, they should consult their doctor or another healthcare professional. During the transition period, close monitoring of the patient's condition (clinical and biological parameters) is necessary. The patient should contact their doctor if they experience any side effects, as it may be necessary to increase or decrease the dose of Eltroxin.
• If the patient is to undergo laboratory tests to check thyroid hormone levels, they should inform their doctor or laboratory staff about current or recent biotin intake (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 intake. The doctor may recommend that the patient stop taking biotin before undergoing laboratory tests. It is also important to note that other products taken by the patient, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin. This may affect laboratory test results. If the patient is taking such products, they should inform their doctor or laboratory staff (see "Eltroxin and other medicines"). Before starting Eltroxin, the patient should tell their doctor if:
• they have diabetes - their diabetes medicine dose may need to be changed;
• they have high blood pressure, heart failure, or myocardial infarction (the doctor may recommend an ECG for patients with heart disease or elderly patients);
• they have any adrenal gland disorder (the doctor will advise on additional treatment if necessary);
• they are over 50 years old;
• they have a history of long-term, low thyroid hormone levels;
• they have seizures (epileptic fits), as the frequency of seizures may increase;
• they have myxedema (a pale, soft swelling of the skin and subcutaneous tissue);
• they have malabsorption syndrome;
• they are pregnant or breastfeeding, or plan to become pregnant, as they should consult their doctor or pharmacist before taking this medicine (see "Pregnancy, breastfeeding, and fertility");
• they are postmenopausal;
• they have adrenal insufficiency (adrenal cortex insufficiency).

Although some of the above situations may be obvious, it is essential to inform the doctor if any of them apply to the patient.

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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those that do not require a prescription.
Some medicines may affect the action of Eltroxin. Eltroxin may also decrease or increase the action of other medicines. The patient should inform their doctor if they are taking:

• cholestyramine, which lowers cholesterol (fat) levels in the blood;
• bile acid sequestrants (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 seizures;
• ciprofloxacin, used to treat infections;
• hypericum perforatum (St. John's Wort) (some herbal medicines);
• propranolol, used to treat high blood pressure;
• medicines used to treat irregular heart rhythm (e.g., amiodarone);
• lithium or iodide-containing medicines;
• oral contrast agents (liquids used in X-ray imaging);
• propylthiouracil, used to treat hyperthyroidism;
• glucocorticoids, 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 (e.g., omeprazol, esomeprazol, pantoprazol, rabeprazol, and lansoprazol), used to reduce stomach acid production, which may decrease levothyroxine absorption and make it less effective. If the patient is taking levothyroxine while being treated with proton pump inhibitors, the doctor should monitor 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 the patient is currently taking or has recently taken biotin, they must inform their doctor or laboratory staff if they 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 the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
To ensure proper fetal development, it is essential to maintain normal thyroid hormone balance in the mother throughout pregnancy. Therefore, levothyroxine treatment should be continued throughout pregnancy, and the doctor may decide to adjust the dose at the beginning of or during pregnancy.
For this reason, close monitoring of thyroid function will be initiated as soon as possible, especially in the first half of pregnancy. After delivery, it is recommended to check the baby's thyroid function.
During pregnancy, Eltroxin should not be taken with medicines used for hyperthyroidism (antithyroid medicines). Eltroxin crosses the placenta in very small amounts, while antithyroid medicines easily cross 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

This medicine should always be taken exactly as prescribed by the doctor. DO NOT take a higher dose than recommended by the doctor. In case of doubts, the patient should consult their 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.
The doctor may then increase the daily dose by 50 micrograms every other day, every four weeks, to achieve the optimal response to treatment.

Use in children

Children under 12 years:
The dose in children depends on age, body weight, and the type of disease being treated.
The 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 three months. The dose should then be adjusted individually based on clinical assessment 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 assessment and thyroid hormone and TSH levels until full replacement dose is reached.

Method of administration

Tablets should be swallowed 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.
The patient should always follow the doctor's prescription and never take more or fewer tablets without consulting their doctor.

Overdose of Eltroxin

In case of overdose or accidental ingestion of the medicine by another person, the patient should immediately contact their doctor or the nearest hospital emergency department. They should take the medicine packaging, remaining tablets, and this leaflet with them so that 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 heart rate, irregular heart rhythm, 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 heart rhythm, heart failure, and coma.

Missed dose of Eltroxin

If the patient misses a daily dose, they should take their usual dose as soon as they remember, unless it is almost time for the next dose. They should not take two doses at the same time. The next dose should be taken at the usual time.

Stopping Eltroxin treatment

If it is necessary to stop treatment, Eltroxin should be discontinued gradually, under medical supervision.
In case of any further doubts about taking this medicine, the patient should consult their 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), the patient should immediately contact their doctor.

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 the patient notices any of these symptoms, they should stop taking Eltroxin and immediately consult their doctor.

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 any of these symptoms occur, the patient should contact their doctor. These symptoms usually resolve after dose adjustment.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Eltroxin

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. The tablets should be kept in a tightly closed container to protect them from light and moisture.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Eltroxin contains

• The active substance of Eltroxin is levothyroxine sodium. One tablet contains 50 micrograms of levothyroxine sodium (Levothyroxine sodium) in terms of anhydrous substance.
• The other ingredients of the medicine are: microcrystalline cellulose, maize starch, talc, colloidal anhydrous silica, magnesium stearate.

What Eltroxin looks like and contents of the pack

White to almost white, round, biconvex tablets with a score line and engraved with "GS 51F".
The packaging contains 100 tablets in a container placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German marketing authorization number: 6080298.00.00

Parallel import authorization number: 177/25

Date of leaflet approval: 20.05.2025

[Information about the trademark]