Eltroxin

Package Leaflet: Information for the Patient

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

Eltroxin, 50 micrograms, tablets

Levothyroxine sodium

The patient should carefully read the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 pack and other information

1. What Eltroxin is and what it is used for

Eltroxin contains anhydrous levothyroxine sodium, 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 at the same time as medicines used for hyperthyroidism (antithyroid medicines).
If any of the above conditions apply to the patient, they should inform their doctor.

Warnings and precautions

Before starting Eltroxin, the patient should discuss it with their doctor or pharmacist.
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• Rapidly increasing the dose may lead to side effects (listed in section 4). If any side effects occur, the patient should inform their doctor.
• Thyroid hormone medicines are not suitable for weight loss. Taking them will not lead to weight loss if thyroid hormone levels are normal. Increasing the dose without a doctor's recommendation 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 the dose may need to be adjusted.

Before starting Eltroxin, the patient should tell their doctor if:

• they have diabetes - their diabetes medicine dose may need to be adjusted;
• they have high blood pressure, heart failure, or myocardial infarction (their doctor may recommend an ECG for patients with heart disease or elderly patients);
• they have any adrenal gland disease (their doctor will advise on any additional treatment needed);
• they are over 50 years old;
• they have a history of long-term, low thyroxine levels;
• they have seizures (epileptic fits), as the frequency may increase;
• they have myxedema (a soft, white swelling of the skin and subcutaneous tissue);
• they have malabsorption syndromes;
• they are pregnant or plan to become pregnant. In this case, they should contact their doctor as soon as possible, who will closely monitor the pregnancy and adjust the levothyroxine dose if necessary (see section "Pregnancy, breastfeeding, and fertility");
• they are postmenopausal;
• they have adrenal insufficiency (adrenal cortex insufficiency).

Although some of these situations may be obvious, it is essential to inform the doctor if any 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, as well as any medicines they 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. The patient should inform their doctor if they are taking:

• cholestyramine, which lowers blood cholesterol levels;
• bile acid sequestrants (such as cholestyramine);
• ion exchange resins (such as sulfonated polystyrene);
• iron preparations (e.g., iron sulfate);
• sucralfate, used to treat gastrointestinal ulcers;
• aluminum, magnesium, calcium, or 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 seizures;
• 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;
• 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.

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.

Eltroxin with food and drink

Soy-based mixtures and a high-fiber diet may reduce the absorption of Eltroxin.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.
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Pregnancy
To ensure proper fetal development, it is essential to maintain normal thyroid 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 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 thyroid function of the child.
During pregnancy, Eltroxin should not be taken 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

This medicine should always be taken exactly as prescribed by the doctor. DO NOT TAKE A HIGHER DOSE THAN RECOMMENDED BY THE DOCTOR. If in doubt, consult a 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, monitored 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).

Patients over 50 years old 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, until an optimal response to treatment is achieved.

Use in children

Children under 12 years:

The dose in children depends on age, 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 the medicine.
The maintenance dose is usually 100-150 micrograms per m² body surface area.
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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 achieved.

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 administered immediately before each dose, 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 exactly 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 bring the medicine packaging, remaining tablets, and this leaflet so that the medical staff knows which medicine has been taken. The following symptoms may occur: excitement (agitation), disorientation, irritability, excessive restlessness, headache, sweating, dilation of the 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.

Missed dose of Eltroxin

If a daily dose is missed, the patient 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 treatment needs to be stopped, Eltroxin should be discontinued gradually, under medical supervision.
If the patient has any further doubts about taking this medicine, they 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.
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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 completion 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 seek medical help.
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 the patient experiences any of these symptoms, they should contact their doctor. These symptoms usually disappear after adjusting the dose.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Medicines Evaluation Board, P.O. Box 16229, 2500 BP The Hague, The Netherlands, or via the website: www.lareb.nl/en. By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Eltroxin

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The medicine should be kept out of sight and reach of children.
Store in a temperature below 25°C.
Keep the container tightly closed to protect from moisture.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 pack and other information

What Eltroxin contains

• The active substance of Eltroxin is levothyroxine sodium.
• The other ingredients of Eltroxin are: microcrystalline cellulose, maize starch, talc, colloidal anhydrous silica, magnesium stearate.

What Eltroxin looks like and contents of the pack

White, round tablets, with a score line on both sides, and with "GS51F" embossed.
The pack contains 100 tablets in a container placed in a cardboard box.
For more detailed information, the patient should contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Netherlands, 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, D-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
Netherlands, the country of export, licence number: RVG 08451

Parallel Import Licence number: 7/22 Date of revision of the leaflet: 11.01.2022

[Information about trademark]
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