Package Leaflet: Information for the User

Eutirox 25microgram tablets

Eutirox 38microgram tablets

Eutirox 50microgram tablets

Eutirox 63microgram tablets

Eutirox 75microgram tablets

Eutirox 88microgram tablets

Eutirox 100microgram tablets

Eutirox 112microgram tablets

Eutirox 125microgram tablets

Eutirox 137microgram tablets

Eutirox 150microgram tablets

Eutirox 175microgram tablets

Eutirox 200microgram tablets

levothyroxine sodium

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Eutirox's active ingredient, levothyroxine, is a synthetic thyroid hormone for the treatment of thyroid diseases and disorders.It has the same effect as naturally produced thyroid hormones.

Eutirox is used

• to treat benign goiter in patients with normal thyroid function,
• to prevent the recurrence of goiter after surgery,
• to replace natural thyroid hormones when the thyroid gland does not produce enough,
• to stop the growth of tumors in patients with thyroid cancer.

Eutirox 25micrograms, 38 micrograms, 50micrograms, 63 micrograms, 75micrograms, 88micrograms and 100micrograms tablets are also used to balance thyroid hormone levels when excessive hormone production is treated with antithyroid medications.

Eutirox 100micrograms, 150micrograms and 200micrograms tablets may also be usedto test thyroid function.

Do not take Eutirox

in any of the following situations:

• allergy (hypersensitivity) to the active ingredient or to any of the other components of Eutirox (listed in section 6),
• untreated adrenal gland dysfunction, pituitary gland dysfunction, or excessive overproduction of thyroid hormones (hyperthyroidism),
• acute heart disease (myocardial infarction or heart inflammation).

Do not take Eutirox with other antithyroid medications if you are pregnant (see the section "Pregnancy and breastfeeding" below).

Warnings and precautions

Consult your doctor or pharmacist before taking Eutiroxif you have any of the following heart diseases:

• insufficient blood flow to the heart (angina pectoris),
• heart failure,
• rapid and irregular heartbeats,
• high blood pressure,
• deposits of fat in your arteries (arteriosclerosis).

These diseases must be under medical controlbeforeyou start taking Eutirox or before undergoing a thyroid suppression test. While taking Eutirox,you willneed to undergo frequent checks of your thyroid hormone levels.If you are unsure whether you have any of the described diseases or if you are not receiving treatment, consult your doctor.

Your doctor will investigate whether you have adrenal gland dysfunction or pituitary gland dysfunction or uncontrolled overproduction of thyroid hormones (autonomous thyroid function), as this must be medically controlled before starting Eutirox or undergoing a thyroid suppression test.

Thyroid hormone levels should be regularly monitored when starting levotiroxine treatment in premature low-birth-weight neonates, as a rapid drop in blood pressure (known as circulatory collapse) could occur.

If you need to change your medication to one containing levotiroxine, a thyroid hormone imbalance may occur. Consult your doctor if you have any doubts about changing your medication. During the transition period, close clinical and biological monitoring is required. Inform your doctor if you experience any adverse effects, as this may indicate that your dose needs to be adjusted.

Consult your doctor,

• if you are in menopause or postmenopause; your doctor may need to check your thyroid function periodically due to the risk of osteoporosis.

• before starting, stopping, or changing treatment with orlistat (obesity medication); you may need closer monitoring and dose adjustment.
• if you experience signs of psychotic disorders (you may need closer monitoring and dose adjustment).

Thyroid hormones should not be used for weight loss. Taking thyroid hormones will not reduce your weight if your thyroid hormone levels are within a normal range. If you increase your dose without a doctor's recommendation, you may experience severe adverse effects or even put your life at risk.Do not take high doses of thyroid hormones with certain weight loss medications, such as amfepramone, catina, and phenylpropanolamine, as the risk of severe adverse effects or life-threatening effects may increase.

If you are to undergo laboratory tests to control your thyroid hormone levels, inform your doctor or laboratory staff that you are taking or have recently taken biotin (also known as vitamin H, vitamin B7, or vitamin B8). Biotin may affect the test results. Depending on the test, the results may be falsely elevated or falsely reduced due to biotin. Your doctor may instruct you to stop taking biotin before the tests. You should also be aware that other products you may be taking, such as multivitamin preparations or hair, skin, and nail supplements, may also contain biotin. This may affect the test results. Inform your doctor or laboratory staff if you are taking these products (see the section "Other medications and Eutirox" below).

Other medications and Eutirox

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any of the following medications, as Eutirox may affect their effects:

• Antidiabetic medications (medications to reduce blood sugar levels):
  Eutirox mayreducethe effect of your antidiabetic medication, so you may need additional blood sugar level checks, especially when starting Eutirox treatment. While taking Eutirox, you may need to adjust the dose of your antidiabetic medication.
• Coumarin derivatives (medications used to prevent blood clotting):
  Eutirox mayenhancethe effect of these medications, increasing the risk of bleeding, especially in older patients. You may need periodic checks of your blood coagulation values when starting and during Eutirox treatment. While taking Eutirox, you may need to adjust the dose of your coumarin medication.

Make sure to strictly follow the recommended dosing intervals if you need to take any of the following medications:

• Medications used to bind to bile acids and reduce high cholesterol levels (such as cholestyramine or colestipol): ensure that you take Eutirox 4-5 hoursbeforethese medications, as they may block the absorption of Eutirox from the intestine.
• Antacids (for heartburn relief), sucralfate (for stomach or intestinal ulcers), other medications containing aluminum, medications containing iron, medications containing calcium: ensure that you take Eutirox at least 2 hoursbeforethese medications, as they may reduce the effect of Eutirox.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any of the following medications, as they mayreducethe effect of Eutirox:

• propylthiouracil (antithyroid medication),
• glucocorticoids (anti-allergic and anti-inflammatory medications),
• beta-blockers (medications to reduce blood pressure and used to treat heart diseases),
• sertraline (antidepressant medication),
• chloroquine or proguanil (medications to prevent or treat malaria),
• medications that activate certain liver enzymes, such as barbiturates (sedatives, sleep medications), carbamazepine (antiepileptic medication, also used to relieve certain types of pain and control mood disorders)or products containing St. John's Wort,
• medications containing estrogens used in hormone replacement therapy during and after menopause or to prevent pregnancy,
• sevelamer (medication that binds to phosphate, used to treat patients with chronic kidney disease),
• tyrosine kinase inhibitors (anticancer and anti-inflammatory medications),
• bile acid-binding medications (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) used to reduce stomach acid production, which may reduce the intestinal absorption of levotiroxine and make it less effective. If you are taking levotiroxine at the same time as receiving a bile acid-binding medication, your doctor will need to monitor your thyroid function and may need to adjust the dose of Eutirox,
• orlistat (obesity medication).

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any of the following medications, as they mayenhancethe effect of Eutirox:

• Salicylates (medications used to relieve pain and reduce fever),
• dicumarol (medication to prevent blood clotting),
• furosemide in high doses of 250 mg (diuretic medication),
• clofibrate (medication to reduce blood cholesterol levels).

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any of the following medications, as they may affect the effects of Eutirox:

• ritonavir, indinavir, lopinavir (protease inhibitors, medications to treat HIV infection),
• phenytoin (antiepileptic medication).

You may need periodic checks of your thyroid hormone levels. You may need to adjust your Eutirox dose.

Inform your doctor if you are taking amiodarone (medication used to treat irregular heartbeats), as this medication may affect the function and activity of your thyroid gland.

If you need to undergo diagnostic testing or a contrast-enhanced scan with iodine-containing contrast agents, inform your doctor that you are taking Eutirox, as you may be administered an injection that may affect your thyroid function.

If you are taking or have recently taken biotin, inform your doctor or laboratory staff when they are to perform laboratory tests to control your thyroid hormone levels. Biotin may affect the test results (see Warnings and precautions).

Inform your doctor or pharmacist if you are using or have recently used any other medications, even those obtained without a prescription.

Taking Eutirox with food and beverages

Inform your doctor if you take products containing soy, especially if you modify the amount you consume. Soy products may reduce the absorption of Eutirox from the intestine, and you may need to adjust your Eutirox dose.

Pregnancy and breastfeeding

If you are pregnant, continue taking Eutirox. Inform your doctor, as you may need to adjust your dose.

If you have taken Eutirox with an antithyroid medication to treat excessive thyroid hormone production, your doctor will advise you to stop taking Eutirox when you become pregnant.

If you are breastfeeding, continue taking Eutirox as directed by your doctor. The amount of medication excreted in breast milk is so small that it will not affect the baby.

Driving and operating machinery

No studies have been conducted on the effects on driving and operating machinery. Since levotiroxine is identical to the naturally produced thyroid hormone, it is unlikely that Eutirox will interfere with driving and operating machinery.

Important information about some components of Eutirox

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of Eutirox indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again..

Your doctor will determine your individual dose based on the exams and laboratory tests that have been performed on you. In general, you start with a low dose that will be increased every 2-4 weeks until you reach your final individual dose. During the first weeks of treatment, laboratory tests will be performed to adjust the dose.

If your baby was born with hypothyroidism, your doctor may recommend starting with a higher dose as it is essential to achieve rapid substitution. The initial recommended dose is 10 to 15 micrograms per kilogram of body weight for the first three months. From then on, your doctor will adjust the dose individually.

In the following table, the usual dose intervals are indicated. A lower individualized dose may be sufficient:

-if you are an elderly patient,

-if you have heart problems,

-if you have severe or long-standing hypothyroidism,

-if your body weight is low or you have a large goiter.

*Eutirox 112micrograms, 125micrograms, 137micrograms, 150micrograms, 175micrograms, and 200micrograms tablets are not suitable for the lower dose interval indicated here, your doctor may prescribe you Eutirox tablets with lower doses.

Administration

Eutirox is taken orally.Take one dose a day with an empty stomach in the morning (at least half an hour before breakfast), preferably with a little liquid, for example with half a glass of water.

Children can take the entire daily dose of Eutirox at least half an hour before the first meal of the day. Immediately before taking, crush the tablet and mix it with a little water and give it to the child with something more liquid. Prepare the mixture at the time of taking.

Duration of treatment

The duration of treatment may vary depending on the indication for which you use Eutirox. Therefore, your doctor will inform you about the duration of treatment. Most patients have to take Eutirox for the rest of their lives.

If you take more Eutirox than you should

If you have taken a dose higher than prescribed, you may experience symptoms such as rapid heartbeat, anxiety, agitation, or involuntary movements.In patients with neurological disorders such as epilepsy, seizures may occur in isolated cases.In patients at risk of psychotic disorders, acute psychotic symptoms may occur.Consult your doctor if this happens.

In case of overdose or accidental ingestion, consult the Toxicological Information Service: Tel.: 915 620 420.

If you forgot to take Eutirox

Do not take a double dose to compensate for the missed doses, take the normal dose the next day.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Eutirox may produce adverse effects, although not everyone will experience them.

You may experience one or more of the following adverse effects if you take more Eutirox than prescribed or if you do not tolerate the prescribed dose (for example, when the dose is increased rapidly):lIrregular or rapid heartbeats, chest pain, headache, muscle weakness or cramps, flushing (heat and redness of the face), fever, vomiting, menstrual irregularities, pseudotumor cerebri (increased intracranial pressure), tremors, agitation, sleep disturbances, sweating, weight loss, and diarrhea.

Consult your doctor if you observe any of these effects.Your doctor may consider interrupting treatment for several days or reducing the daily dose until the adverse effects have disappeared.

You may experience an allergic reaction to any of the components of Eutirox (see section 6 “Composition of Eutirox”). Allergic reactions may includehives, urticaria, andswelling of the face or throat (angioedema). If this occurs, consult your doctor immediately.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use Eutirox after the expiration date that appears on the packaging, after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C. Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Eutirox

The active ingredient is levothyroxine.

Each Eutirox 25 microgram tablet contains 25 micrograms of levothyroxine sodium.

Each Eutirox 38 microgram tablet contains 38 micrograms of levothyroxine sodium.

Each Eutirox 50 microgram tablet contains 50 micrograms of levothyroxine sodium.

Each Eutirox 63 microgram tablet contains 63 micrograms of levothyroxine sodium.

Each Eutirox 75 microgram tablet contains 75 micrograms of levothyroxine sodium.

Each Eutirox 88 microgram tablet contains 88 micrograms of levothyroxine sodium.

Each Eutirox 100 microgram tablet contains 100 micrograms of levothyroxine sodium.

Each Eutirox 112 microgram tablet contains 112 micrograms of levothyroxine sodium.

Each Eutirox 125 microgram tablet contains 125 micrograms of levothyroxine sodium.

Each Eutirox 137 microgram tablet contains 137 micrograms of levothyroxine sodium.

Each Eutirox 150 microgram tablet contains 150 micrograms of levothyroxine sodium.

Each Eutirox 175 microgram tablet contains 175 micrograms of levothyroxine sodium.

Each Eutirox 200 microgram tablet contains 200 micrograms of levothyroxine sodium.

The other components are cornstarch, citric acid, croscarmellose sodium, gelatin, magnesium stearate, and mannitol (E 421).

Appearance of the product and contents of the package

Eutirox tablets are white, round, flat on both sides, bisected, with a partition groove, and with the inscription “EM 25”, “EM 38”, “EM 50”, “EM 63”, “EM 75”, “EM 88”, “EM 100”, “EM 112”, “EM 125”, “EM 137”, “EM 150”, “EM 175” or “EM 200” on one side.

Eutirox is available in packages of 20, 25, 30, 50, 60, 90, 100, or 500 tablets or in calendar packages of 28 or 84 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Merck, S.L.

María de Molina, 40

28006, Madrid, Spain

Manufacturer responsible

Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt, Germany

FAMAR HEALTH CARE SERVICES MADRID, S.A.U.

Avda. Leganés, 62

Alcorcón, 28923 Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Euthyrox

Denmark:Euthyrox

Germany:Euthyrox

Greece: Euthyrox

Island:Euthyrox

Croatia: Euthyrox

Norway:Euthyrox

Portugal:Eutirox

Spain:Eutirox

Sweden:Euthyrox

Last review date of this leaflet:07/2024

Other sources of information

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information on the following internet address:

Eutirox 25 micrograms:https://cima.aemps.es/info/64011

Eutirox 38 micrograms:https://cima.aemps.es/info/89799

Eutirox 50 micrograms:https://cima.aemps.es/info/64012

Eutirox 63 micrograms:https://cima.aemps.es/info/89800

Eutirox 75 micrograms:https://cima.aemps.es/info/64013

Eutirox 88 micrograms:https://cima.aemps.es/info/70044

Eutirox 100 micrograms:https://cima.aemps.es/info/64014

Eutirox 112 micrograms:https://cima.aemps.es/info/70042

Eutirox 125 micrograms:https://cima.aemps.es/info/64015

Eutirox 137 micrograms:https://cima.aemps.es/info/70043

Eutirox 150 micrograms:https://cima.aemps.es/info/64016

Eutirox 175 micrograms:https://cima.aemps.es/info/64017

Eutirox 200 micrograms:https://cima.aemps.es/info/64018

and on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.