Eltroxin

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Eltroxin, 50 micrograms, tablets
Levothyroxinum natricum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

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 sodium levothyroxine anhydrous, a synthetic thyroid hormone.
Levothyroxine is normally produced in the body by the thyroid gland, a gland located in the neck.
It affects many bodily functions, primarily growth and metabolism.
Eltroxin is used in the treatment of hypothyroidism, a condition in which the thyroid gland does not produce sufficient amounts of levothyroxine.

2. Important information before using Eltroxin

When not to use Eltroxin

• if the patient is allergic to sodium levothyroxine 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 or acute pericarditis,
• if the patient has adrenal insufficiency (adrenal cortex insufficiency) and is not receiving appropriate replacement therapy.

During pregnancy, Eltroxin must not be used simultaneously with medicines used for the treatment of hyperthyroidism (antithyroid drugs).
If any of the above conditions apply to the patient, they must inform their doctor.
Warnings and precautions
Before starting treatment with Eltroxin, discuss this with your doctor or pharmacist.
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• Rapid dose increase may lead to adverse reactions (listed in section 4). If any adverse reactions occur, inform your doctor.
• Medicines containing thyroid hormones are not suitable for weight reduction. Taking them will not result in weight loss if thyroid hormone levels are within the normal range. Increasing the dose without specific medical advice may lead to severe or even life-threatening adverse reactions, especially if thyroid hormones are used together with other weight-reducing medicines.
• If the patient is taking weight-reducing medicines, e.g. orlistat, they should inform their doctor before using Eltroxin. A minimum 4-hour interval must be maintained between administration of Eltroxin and orlistat.
• When switching from one medicine containing levothyroxine to another medicine containing this substance, disturbances in thyroid function may occur. In case of any questions regarding a change in medication, consult your doctor or another healthcare professional. Close monitoring of the patient (clinical and biological parameters) is required during the transition period. Contact your doctor if any adverse reactions occur, as dose adjustment may be necessary.

Before starting treatment with Eltroxin, inform your doctor if:

• the patient has diabetes – a change in the dose of antidiabetic medication may be required;
• the patient has high blood pressure, heart failure or myocardial infarction (the doctor may recommend an ECG for patients with heart disease or elderly patients);
• the patient has any disease affecting adrenal function (the doctor will advise whether additional treatment is needed);
• the patient is over 50 years old;
• the patient has a history of long-term low thyroxine levels;
• the patient has seizures (epileptic fits), as their frequency may increase;
• the patient has myxoedema (a pale, soft swelling of the skin and subcutaneous tissue);
• the patient has malabsorption syndromes;
• the patient is pregnant or planning to become pregnant. In such cases, contact your doctor as soon as possible, as they will closely monitor the pregnancy and adjust the levothyroxine dose if necessary (see section "Pregnancy, breastfeeding and fertility");
• the patient is postmenopausal;
• the patient has adrenal insufficiency (adrenal cortex insufficiency).

Even though some of the above situations may seem obvious, it is important to inform the doctor if any of them apply to the patient.
Children
When starting treatment with levothyroxine in preterm infants with very low birth weight, blood pressure should be monitored regularly, as a sudden drop in blood pressure (so-called circulatory collapse) may occur.
Eltroxin and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines may affect the action of Eltroxin. Eltroxin may also reduce or enhance the effect of other medicines. The patient should inform their doctor if they are taking:

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The following medicines may affect the absorption of Eltroxin

• cholestyramine, which reduces cholesterol (fat) levels in the blood;
• bile acid sequestrants (such as colestipol);
• ion-exchange resins (such as polystyrene sulfonate, sevelamer);
• iron supplements (e.g. ferrous sulfate);
• sucralfate, used in the treatment of peptic ulcer disease;
• compounds containing aluminium, magnesium, calcium, iron supplements;
• proton pump inhibitors (used to reduce gastric acid production);
• weight-reducing medicines, e.g. orlistat.

The following medicines may affect the action of Eltroxin

• anticonvulsants (e.g. phenytoin, carbamazepine, barbiturates), used to prevent seizures;
• propranolol, used in the treatment of 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 in the treatment of hyperthyroidism;
• glucocorticosteroids, e.g. dexamethasone, used in the treatment of inflammatory conditions and allergic reactions;
• tyrosine kinase inhibitors (imatinib or sunitinib), tamoxifen and 5-fluorouracil, used in cancer treatment;
• methadone, used in addiction treatment;
• medicines known as statins (e.g. simvastatin and lovastatin) and clofibrate, used to lower cholesterol levels;
• medicines containing hormones, such as oral contraceptives, estrogens, used in hormone replacement therapy;
• sertraline, used in the treatment of depression and anxiety;
• ritonavir – used to control HIV infection and chronic hepatitis C virus infection.

Many medicines may affect laboratory test results assessing thyroid function.
Eltroxin may affect the action of the following medicines

• insulin and oral antidiabetic medicines, used in the treatment of diabetes;
• anticoagulants (e.g. warfarin), used in the treatment of blood clots;
• phenytoin (used in the treatment of epilepsy);
• medicines known as cardiac glycosides (e.g. digoxin), used in the treatment of heart diseases such as heart failure;
• sympathomimetic agents, such as adrenaline;
• tricyclic antidepressants, used in the treatment of depression.

Patients taking the following medicines should contact their doctor, as they may interfere with laboratory tests,
causing test results to be unreliable

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

Eltroxin with food and drink
Soy-containing mixtures and high-fibre diets may reduce the absorption of Eltroxin.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
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Pregnancy
Maintaining proper hormonal balance throughout pregnancy is essential for the healthy development of the 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, especially during the first half of pregnancy, should be initiated as soon as possible. After delivery, thyroid function testing in the newborn is recommended.
During pregnancy, Eltroxin must not be taken simultaneously with medicines used for hyperthyroidism (antithyroid drugs). Eltroxin crosses the placenta in very small amounts, whereas antithyroid drugs readily cross the placenta. This may pose a risk of hypothyroidism in the newborn.
Breastfeeding
Replacement therapy with levothyroxine may be used during breastfeeding.
Fertility
No studies have been conducted on the effect of this medicine on fertility. Hypo- or hyperthyroidism may affect fertility.
Driving and operating machinery
No effect of Eltroxin on the ability to drive or operate machinery is expected.

3. How to take Eltroxin

This medicine should always be taken exactly as prescribed by your doctor. DO NOT take a higher dose than prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual starting dose for adults is 50 to 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 together with other medicines that may interact with it should leave at least a 4-hour interval between taking Eltroxin and those other medicines (see section 2 - Eltroxin with other medicines).

Elderly patients and patients with heart disease

In patients over 50 years of age, the starting dose should not exceed 50 micrograms per day.
The recommended starting dose for patients with heart disease is 50 micrograms every other day.
The doctor may then increase the patient's daily dose by 50 micrograms every four weeks, or every other day, until an optimal response to treatment is achieved.

Use in children

Children under 12 years of age:

The dose in children depends on age, body weight, and the type of thyroid disorder being treated.
The doctor will monitor the child's condition to ensure that the correct dose is being administered.
The maintenance dose is usually 100 to 150 micrograms per m² of body surface area.

In newborns and infants with congenital hypothyroidism, in whom rapid initiation of replacement therapy is essential, the recommended initial dose is 10 to 15 micrograms per kg of body weight per day for the first 3 months. The dose should then be individually adjusted based on clinical evaluation and serum thyroid hormone and TSH levels.

In children with acquired hypothyroidism, the recommended starting dose is 12.5 to 50 micrograms per day. The dose should be gradually increased every 2 to 4 weeks based on clinical evaluation and thyroid hormone and TSH levels until the full replacement dose is reached.

Method of administration

The tablets should be swallowed whole with a glass of water, preferably before breakfast. Eltroxin tablets should be taken on an empty stomach.

For infants, the total daily dose should be given once daily, at least 30 minutes before the first meal of the day. The tablets should be dispersed in a small amount of water (10 to 15 ml). This suspension, freshly prepared just before each administration, should be given together with an additional small amount of liquid (5 to 10 ml).

Eltroxin tablets must not be crushed or divided.

Always follow exactly the instructions given by your doctor. Never take more or fewer tablets than prescribed without consulting your doctor.

Taking more Eltroxin than prescribed

If you take more Eltroxin than prescribed, or if someone else takes the medicine, contact your doctor or the nearest hospital emergency department immediately. Bring the medicine packaging, any remaining tablets, and this leaflet with you so that medical staff know which medicine has been taken. The following symptoms may occur: excitation (nervousness), disorientation, irritability, hyperactivity, headache, sweating, dilated pupils, rapid heartbeat, irregular heartbeat, rapid breathing, fever, increased bowel movements, and seizures. Clinical signs of hyperthyroidism may also appear up to five days after overdose. Thyroid storm rarely occurs as a result of chronic overdose and may lead to irregular heartbeat, heart failure, and coma.

If you miss a dose of Eltroxin

If you forget to take your daily dose, take the usual dose as soon as you remember, unless it is almost time for your next scheduled dose. Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping Eltroxin

If treatment needs to be discontinued, Eltroxin should be withdrawn gradually under medical supervision.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the dose of Eltroxin used is too high, the following adverse reactions may occur.
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All medicines can cause allergic reactions. The frequency of these reactions after
administration of Eltroxin is unknown.
If sudden symptoms occur, such as: wheezing, difficulty breathing, eyelid, facial or lip swelling, sudden redness of the face, rash and itching
(especially affecting the whole body), you should contact a doctor immediately.
Other serious adverse reactions (frequency unknown):

• angina-like chest pain, cardiac arrhythmias (irregular heartbeat), palpitations (excessive heartbeat), heart failure (circulatory failure), myocardial infarction;
• hyperthyroidism;
• pseudotumor cerebri (increased intracranial pressure and visual disturbances);
• excessive dosage in children may lead to craniosynostosis (premature fusion of skull bones before completion of brain growth) and premature closure of epiphyseal cartilage, which may affect adult height.

If any of these symptoms occur, Eltroxin should be discontinued immediately and medical advice should be sought without delay.
Other adverse reactions that may occur (frequency unknown):

• tachycardia (rapid heartbeat), high blood pressure;
• convulsions;
• decreased bone density;
• headache;
• tremor, anxiety, emotional lability, nervousness, psychomotor restlessness, excitation;
• insomnia;
• muscle cramps or decreased muscle strength;
• abdominal pain, nausea, vomiting, abdominal cramps;
• diarrhea;
• increased appetite, weight loss;
• fever, sweating, fatigue (exhaustion, tiredness);
• intolerance to high temperature;
• excessive sweating, hair loss;
• irregular menstruation, infertility;
• fluid accumulation (edema);
• angioedema, rash, urticaria.

If any of these symptoms occur, contact your doctor. These symptoms usually resolve after dose adjustment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Eltroxin

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Keep this medicine out of the sight and reach of children.
Store 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 container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Eltroxin contains

• The active substance is levothyroxine sodium.
• The other ingredients are: microcrystalline cellulose, maize pregelatinised 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 embossed with the code "GS51F".
The pack contains 100 tablets in a container placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in the Netherlands, country of export: RVG 08451
Parallel import authorisation number: 7/22
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