Eltroxin

Leaflet accompanying the packaging: patient information

Eltroxin, 50 micrograms, tablets

Eltroxin, 100 micrograms, tablets

Levothyroxine sodium

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. 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 normally produced in the body by the thyroid gland, located in the neck.
It affects many functions of the body 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.

• 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 the thyroid hormone levels are within the normal range. 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 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 of Eltroxin may need to be adjusted.
• 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. The patient should also remember that other products they are taking, 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 dose of antidiabetic medicine may need to be changed;
• have high blood pressure, heart failure, or myocardial infarction (the doctor may recommend an ECG for patients with heart disease or elderly patients);
• have any disease affecting adrenal function (the doctor will advise on any additional treatment needed);
• are over 50 years old;
• have a history of long-term, low thyroid hormone levels;
• have seizures (epileptic fits), as their frequency may increase;
• have myxedema (a soft, white, and swollen skin condition);
• have malabsorption syndromes;
• are pregnant or breastfeeding, or think they may be pregnant or plan to become pregnant, as they should consult their doctor or pharmacist before taking this medicine (see "Pregnancy, breastfeeding, and fertility");
• are postmenopausal;
• 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, 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, a cholesterol-lowering medicine;
• 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, 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 epileptic fits;
• ciprofloxacin, used to treat infections;
• 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;
• 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 infections;
• proton pump inhibitors (e.g., omeprazol, esomeprazol, pantoprazol, rabeprazol, and lansoprazol), used to reduce stomach acid production, which may decrease levothyroxine absorption from the intestine and make it less effective. If the patient is taking levothyroxine during treatment 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, thinks they may be pregnant, or plans to become pregnant, 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 throughout pregnancy. Therefore, levothyroxine treatment should be continued throughout pregnancy, and the doctor may adjust the dose as needed.
Close monitoring of thyroid function will be initiated as soon as possible, especially during the first half of pregnancy. After delivery, it is recommended to check the newborn's thyroid function.
During pregnancy, Eltroxin should not be taken at the same time as 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 advised 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 through blood tests.
Patient's 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").

Elderly 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 4 weeks, until an optimal response to treatment is achieved.

Use in children

Children under 12 years:
The dose in children depends on their 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 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 crucial, 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 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, 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.

Taking a higher dose of Eltroxin than recommended

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 packaging, any remaining tablets, and this leaflet, so the medical staff knows which 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, which is rare, may occur as a result of chronic overdose and leads to irregular heartbeat, heart failure, and coma.

Missing a 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 their 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.
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 brain has finished growing) 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 instability, 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 the dose is adjusted.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Reporting side effects will help to gather more information 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 use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the container tightly closed. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. 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 or 100 micrograms of levothyroxine sodium (anhydrous).
• The other ingredients of Eltroxin are: microcrystalline cellulose, pregelatinized starch, talc, colloidal anhydrous silica, magnesium stearate.

What Eltroxin looks like and contents of the pack

Eltroxin, 50 micrograms: round, biconvex, white or almost white tablets with "GS 11E" engraved on one side and "50" on the other.
Eltroxin, 100 micrograms: round, biconvex, white or almost white tablets with "GS 21C" engraved 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: