Eltroxin

Package leaflet: Information for the patient

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a 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 pack and other information

1. What Eltroxin is and what it is used for

Eltroxin contains sodium levothyroxine anhydrous, which is 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 those related to 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 taking 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 deficiency) and is not receiving appropriate replacement therapy.

During pregnancy, Eltroxin must not be used concomitantly with medicines used to treat hyperthyroidism (antithyroid drugs).
If any of the above conditions apply to the patient, this should be reported to the doctor.
Warnings and precautions
Before starting treatment with Eltroxin, discuss this with your doctor or pharmacist.

• 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 reduce body weight if thyroid hormone levels are within the normal range. Increasing the dose without specific medical advice may cause severe or even life-threatening adverse reactions, especially if thyroid hormones are used concomitantly with other weight-reducing medicines.
• If the patient is taking weight-reducing medicines, e.g. orlistat, the doctor should be informed before starting Eltroxin. A minimum interval of 4 hours must be maintained between taking Eltroxin and orlistat.
• When switching from one medicine containing levothyroxine to another, disturbances in thyroid function may occur. In case of any questions regarding switching medicines, 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 Eltroxin, inform your doctor if:

• the patient has diabetes – the dose of antidiabetic medication may need to be adjusted;
• the patient has high blood pressure, heart failure or myocardial infarction (the doctor may recommend an ECG in patients with heart disease or in 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 of age;
• 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 waxy, 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 careful monitoring of the pregnancy will be required and the dose of levothyroxine may need to be adjusted (see section "Pregnancy and breastfeeding");
• the patient is postmenopausal;
• the patient has adrenal insufficiency (adrenal cortex deficiency).

Although 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 initiating levothyroxine treatment 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 with other medicines
Inform your doctor about all medicines currently taken or 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 increase the effect of other medicines. The patient should inform the doctor if taking:

The following medicines may affect the absorption of Eltroxin

• cholestyramine, used to reduce cholesterol (fat) levels in the blood;
• bile acid-binding drugs (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 stomach 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 epileptic 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, e.g. dexamethasone, used to treat inflammatory conditions and allergic reactions;
• tyrosine kinase inhibitors (imatinib or sunitinib), tamoxifen, and 5-fluorouracil, used in cancer treatment;
• methadone, used in addiction treatment;
• 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 to treat 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 to treat diabetes;
• anticoagulants (e.g. warfarin), used to treat blood clots;
• phenytoin (used to treat epilepsy);
• medicines known as 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, 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 and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Maintaining proper hormonal balance throughout pregnancy is essential for normal fetal development. 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 in the newborn should be evaluated.
During pregnancy, Eltroxin must not be taken concomitantly with 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 using machines
No effect of Eltroxin on the ability to drive or operate machinery is expected.

3. How to use Eltroxin

This medicine should always be taken exactly as directed by your doctor. DO NOT take more than the recommended dose 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 maintain at least a 4-hour interval between taking Eltroxin and those other medicines (see section 2 - Eltroxin and other medicines).

Elderly patients and patients with heart disease

In patients over 50 years of age, the initial 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 other day, or every four weeks, 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.
Your doctor will monitor the child's condition to ensure they are receiving the appropriate dose.
The maintenance dose is usually 100 to 150 micrograms per m² of body surface area.

In newborns and infants with congenital hypothyroidism, in whom prompt 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 assessment and serum thyroid hormone and TSH levels.

In children with acquired hypothyroidism, the recommended initial 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 serum thyroid hormone and TSH levels until the full replacement dose is reached.

Method of administration

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

Infants should receive the full daily dose at once, 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 immediately before each administration, should be given together with an additional small amount of liquid (5 to 10 ml).

Eltroxin tablets should NOT be crushed or divided.

Always follow your doctor's prescription exactly. Never take more or fewer tablets than prescribed without consulting your doctor.

Taking more Eltroxin than prescribed

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

If you miss a dose of Eltroxin

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

Stopping Eltroxin treatment

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 will experience them.
If the dose of Eltroxin used is too high, the following adverse reactions may occur.
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), seek immediate medical advice.
Other serious adverse reactions (frequency unknown):

• angina pain, cardiac arrhythmias (irregular heartbeat), palpitations (excessive heartbeat), heart failure (cardiac insufficiency), 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 are observed, discontinue taking Eltroxin and seek immediate medical attention.
Other possible adverse reactions (frequency unknown):

• tachycardia (rapid heartbeat), high blood pressure;
• convulsions;
• decreased bone density;
• headache;
• tremor, anxiety, emotional lability, nervousness, psychomotor agitation, excitation;
• insomnia;
• muscle cramps or decreased muscle strength;
• abdominal pain, nausea, vomiting, abdominal cramps;
• diarrhoea;
• increased appetite, weight loss;
• fever, sweating, fatigue (exhaustion, tiredness);
• intolerance to high temperature;
• increased sweating, hair loss;
• irregular menstruation, infertility;
• fluid accumulation (oedema);
• 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Store in the original packaging to protect from light.
Keep the container tightly closed to protect from moisture.
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. Such measures will help protect the environment.

6. Contents of the package and other information

What Eltroxin contains

• The active substance is levothyroxine sodium.
• The other ingredients 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 bisecting groove on both sides and the imprint "GS 51F".
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in the Netherlands, country of export: RVG 08451
Parallel import authorisation number: 35/22