Package Insert: Information for the Patient

Levotiroxine Sodium Teva 75 micrograms Tablets EFG

Levotiroxine Sodium

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Levotiroxine Sodium Teva and what is it used for

2. What you need to know before starting to take Levotiroxine Sodium Teva

3. How to take Levotiroxine Sodium Teva

4. Possible side effects

5. Storage of Levotiroxine Sodium Teva

6. Contents of the pack and additional information

Teva Levotiroxina Sodium contains a thyroid hormone as the active ingredient.

The goal of treatment with Teva Levotiroxina Sodium is to replace the thyroid hormone and/or alleviate the stress on the thyroid gland.

Teva Levotiroxina Sodium is used as:

• Treatment of hormone substitution for all forms of hormone in case of thyroid gland malfunction,
• Prevention of recurrence of goiter after surgery in patients with normal thyroid function,
• Treatment of malignant goiter (benign tumor) in patients with normal thyroid function,
• In combination with antithyroid agents for excess thyroid hormones, after achieving a normal metabolic level,
• Treatment of malignant thyroid tumors, especially after surgery to suppress the growth of a new tumor and as a supplement for the lack of thyroid hormones.

Do not take Levotiroxina sódica Teva

• if you are allergic to levotiroxina sódica or any of the other components of this medication (listed in section 6).

• if you have any of the following conditions or diseases:
• • untreated hyperthyroidism,
  • adrenal insufficiency and do not have adequate replacement treatment,
  • untreated hypopituitarism, if this has led to adrenal insufficiency requiring treatment,
  • acute myocardial infarction,
  • acute myocarditis,
  • acute pancarditis.

During pregnancy, levotiroxina should not be used at the same time as medications for an overactive thyroid gland (antithyroid medications) (see also “Pregnancy, lactation and fertility”).

Check for diseases

Before starting treatment with Levotiroxina sódica Teva, the following diseases must be ruled out or treated:

–coronary insufficiency

–intense chest pain (angina pectoris)

–high blood pressure (hypertension)

–adrenal and/or hypopituitary insufficiency

–areas of the thyroid gland that produce uncontrolled amounts of thyroid hormone (thyroid autonomy).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levotiroxina sódica Teva.

–If you have already had a heart attack or have coronary heart failure, heart muscle weakness, arrhythmias with tachycardia, or acute non-inflammatory heart muscle inflammation, or if you have chronic thyroid insufficiency.

A medical check-up is necessary to monitor the symptoms caused by excessive thyroid hormone levels due to the administration of Levotiroxina sódica Teva, (see section 4. “Possible side effects”) and to avoid excessively high levels of hormone in the blood. In these cases, you will need to undergo frequent checks of your thyroid hormone levels (see section 3).

–If you have a thyroid dysfunction caused by hypopituitarism (see also “Do not take Levotiroxina sódica Teva”).

–If you have adrenal insufficiency.

This disease must be treated (hydrocortisone treatment) before starting treatment with thyroid hormones (see also “Do not take Levotiroxina sódica Teva”).

–If you suspect uncontrolled overproduction of thyroid hormones (thyroid autonomy) in areas of the thyroid gland, it is recommended to perform checks to review the thyroid regulation system before starting treatment.

• In women receiving hormone replacement therapy after menopause and who have a higher risk of osteoporosis, thyroid function must be checked more frequently to avoid increasing the level of levotiroxina in the blood and ensure the minimum required dose.

–If you have diabetes, you may need to adjust your antidiabetic medication (see also “Do not take Levotiroxina sódica Teva”).

–If you are being treated with certain anticoagulants or medications that can affect thyroid function (e.g. amiodarone, tyrosine kinase inhibitors [for cancer treatment], salicylates, and furosemide in high doses). Please note the information provided in the section "Other medications and Levotiroxina sódica Teva”.

–If you have epilepsy (seizures). Seizures may occur at the beginning of treatment with levotiroxina.

Consult your doctor:

• before starting, stopping or changing a treatment with orlistat (weight loss medication); You may need closer monitoring and dose adjustment.
• if you experience signs of psychotic disorders (You may need closer monitoring and dose adjustment).
• if you experience an allergic reaction (see section 4. “Possible side effects”). Contact your doctor immediately or go to the nearest hospital emergency room immediately.
• if you are about to undergo laboratory tests to control your thyroid hormone levels. You must inform your doctor and/or the 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 results of your laboratory tests. Depending on the test, the results may be falsely high or low due to biotin. Your doctor may ask you to stop taking biotin before performing laboratory tests. You should also be aware that other products you may be taking, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin. This could affect the results of laboratory tests. Inform your doctor and/or laboratory staff if you are taking these products (Note the information in the section “Other medications and Levotiroxina Teva”).

Improper use

Thyroid hormones are not suitable for weight loss. Taking thyroid hormones will not reduce your weight if you have a normal level of thyroid hormone. If you increase the dose without special control by your doctor, serious side effects or even life-threatening effects may occur, especially if taken with other weight loss medications.

Change of therapy

If you need to change your medication to another treatment that contains levotiroxina, a thyroid imbalance may occur. Consult your doctor if you have any doubts about the change in treatment. Close monitoring (clinical and biological) is necessary during the transition period. You must inform your doctor if you have any side effects, as your dose may need to be adjusted up or down.

Children

Regular blood pressure control will be performed when starting treatment with levotiroxina in premature newborns with very low birth weight because a rapid drop in blood pressure (known as circulatory collapse) may occur.

If your child is receiving thyroid hormone replacement therapy, hair loss may occur during the first few months of starting this medication, although it is a transient and normal phenomenon and hair usually grows back.

Older adults

In elderly patients, the dose must be carefully measured and individually determined, especially in patients with heart failure, and they must be monitored by their doctor more frequently.

Levotiroxina sódica Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Levotiroxina sódica Teva affects the efficacy of the following medications:

Antidiabetic medications (medications to reduce blood sugar levels)

Levotiroxina may reduce the effect of these medications that reduce blood sugar levels, such as metformin, glimepiride, glibenclamide, and insulin. You may need additional checks of your blood sugar levels, especially at the beginning and end of treatment, and if necessary, the dose of antidiabetic medications may be adjusted.

Coumarin derivatives (medications used to prevent blood coagulation)

Levotiroxina may potentiate the effect of these medications due to the displacement of protein binding. You may need periodic checks of your blood coagulation values during treatment with levotiroxina; if necessary, the dose of your coumarin medication may be adjusted.

The efficacy of Levotiroxina sódica Teva may be affected by the following medications:

Ion exchange resins, acid-binding resins

Medications for cholesterol treatment (such as cholestyramine, colestipol, colesevelam) or to reduce high potassium or phosphate levels in the blood (calcium and sodium sulfate polystyrene, sevelamer) by blocking the absorption of levotiroxina from the intestine. Therefore, make sure to take Levotiroxina sódica Teva 4-5 hours beforesthese medications.

Antacids containing aluminum, medications containing iron, or calcium

Medications containing aluminum used to bind to stomach acid (antacids, sucralfate), medications containing iron and calcium may reduce the absorption of levotiroxina from the intestine. Therefore, make sure to take Levotiroxina sódica Teva 2 hours beforesthese medications.

Proton pump inhibitors

Proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) are used to reduce the amount of acid produced by the stomach, which may reduce the absorption of levotiroxina in the intestine, and therefore making it less effective. If you are taking levotiroxina at the same time as proton pump inhibitors, your doctor must monitor your thyroid function and may need to adjust the dose of Levotiroxina sódica Teva.

Propylthiouracil (antithyroid medication), glucocorticoids (cortisol hormones), and beta-blockers (medications that reduce heart rate and low blood pressure)

These substances block the conversion of levotiroxina to its active form, triiodothyronine, and therefore may make Levotiroxina sódica Teva less effective.

Amylase (medication used to treat heart rhythm disorders) and contrast agents containing iodine(certain agents used in X-ray diagnosis),may lead to high iodine content, resulting in hypothyroidism and hyperthyroidism. Special caution is required in patients with nodular thyroid autonomy (nodules in the thyroid gland that secrete hormones).

Amylase blocks the conversion of levotiroxina to triiodothyronine, the active form, and therefore may affect the effect of Levotiroxina sódica Teva. You may need to adjust the dose of Levotiroxina sódica Teva.

Salicylates, dicumarol, furosemide, clofibrate

Levotiroxina may be displaced from its binding to plasma proteins by salicylates (medications used to relieve pain and reduce fever), specifically in doses above 2.0 g / day, dicumarol (medication to prevent blood coagulation), furosemide in high doses of 250 mg (diuretic), clofibrate (medication to reduce blood fat levels) and other substances. This may result in an increase in free thyroxine levels in the blood.

Medications containing estrogens used in hormone replacement therapy during and after menopause or to prevent pregnancy

The need for levotiroxina may increase in patients receiving hormone replacement therapy (the pill) or hormone replacement therapy during and after menopause.

Sertraline (antidepressant), chloroquine or proguanil (medication to prevent or treat malaria and rheumatic disorders)

These substances reduce the effect of levotiroxina and increase the level of TSH in the blood.

Tricyclic antidepressants (such as amitriptyline, imipramine)

If you are taking levotiroxina, the response to treatment with tricyclic antidepressants will be accelerated, due to increased sensitivity of receptors to catecholamines.

Tyrosine kinase inhibitors (cancer and anti-inflammatory medications)

These medications (e.g. imatinib, sunitinib, sorafenib, motesanib) may reduce the concentration of levotiroxina (thyroxine) in the blood. Your doctor may need to adjust the dose of Levotiroxina sódica Teva.

Digoxin (medication used to treat heart disorders)

If you start treatment with levotiroxina while taking digoxin, your doctor may need to adjust the dose of digoxin. Hypothyroid patients may need a gradual increase in digoxin dose due to initial sensitivity to digoxin.

Sympathomimetic agents (such as adrenaline)

When sympathomimetic agents are used with levotiroxina, its effect is potentiated.

Medications that activate certain enzymes

Rifampicin (antibiotic), carbamazepine (medication used to treat seizures), phenytoin (medication used to treat seizures and heart rhythm disorders), barbiturates (used in seizures, anesthesia; certain sleep medications) and products containing St. John's Wort (a plant-based medication) may weaken the effect of levotiroxina.

Protease inhibitors (medications to treat HIV and chronic hepatitis C infection)

A loss of therapeutic effect of levotiroxina has been reported when used with –lopinavir/ritonavir. Therefore, close clinical and thyroid function monitoring is necessary in patients taking levotiroxina and protease inhibitors.

Orlistat (medication used to treat obesity)

When orlistat and levotiroxina are administered together, hypothyroidism and/or reduced control of hypothyroidism may occur.

Semaglutide

If you are taking levotiroxina at the same time as semaglutide (an antidiabetic medication), this may affect the level of levotiroxina and your doctor may need to monitor your thyroid levels and adjust the dose of levotiroxina.

Interference with laboratory tests

Biotin

If you are taking or have recently taken biotin, inform your doctor and/or laboratory staff when you are about to undergo laboratory tests to control your thyroid hormone levels. Biotin may affect the results of your laboratory tests (see “Warnings and precautions”).

Levotiroxina sódica Teva with food and beverages

If your diet contains soy, your doctor will monitor your blood levels of thyroid hormone more frequently. Your doctor may need to adjust the dose of levotiroxina during and after the interruption of this diet (you may need unusually high doses), as soy products may alter the absorption of levotiroxina in the intestine and therefore make it less effective.

Do not take Levotiroxina sódica Teva with coffee, as this may reduce the absorption of levotiroxina in the intestine and therefore reduce its effectiveness. After taking levotiroxina, wait at least 30 minutes to 1 hour before taking coffee. It is recommended that patients already being treated with levotiroxina do not change their coffee-drinking habit without having their levotiroxina levels controlled and monitored by their doctor.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Thyroid hormone treatment is especially important during pregnancy and lactation, so it must be continued under the supervision of your doctor. Despite extensive use during pregnancy, no adverse effects have been reported for levotiroxina on pregnancy or the health of the fetus or newborn.

During pregnancy, the need for levotiroxina may increase due to high estrogen levels (female sex hormone). Therefore, thyroid function must be monitored during and after pregnancy, and the dose of thyroid hormone adjusted accordingly.

During pregnancy, do not take Levotiroxina sódica Teva at the same time as antithyroid medications (the so-called thyroid suppressants), as this will result in the need for a higher thyroid suppressant dose. Thyroid suppressants (unlike levotiroxina) can enter the bloodstream of the fetus through the placenta and are capable of causing hypothyroidism in the fetus. If you have an overactive thyroid gland, your doctor must treat it during pregnancy only with thyroid suppressants in low doses.

If you are breastfeeding, continue taking levotiroxina as directed by your doctor.

Even during treatment with high doses of levotiroxina, the amount of levotiroxina that passes into breast milk during breastfeeding is very low and harmless.

It is likely that hypothyroidism or hyperthyroidism will affect fertility. When treating patients with hypothyroidism, the dose of Levotiroxina sódica Teva must be adjusted based on laboratory test results, as an insufficient dose may not improve hypothyroidism and an excessive dose may cause hyperthyroidism.

Driving and operating machinery

No studies have been conducted on the effects on driving and operating machinery. Since levotiroxina is identical to the naturally produced thyroid hormone, it is not expected that Levotiroxina sódica Teva will interfere with driving and operating machinery.

Levotiroxina sódica Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine your individual dose based on the tests and laboratory analyses that have been performed on you.

If any thyroid function remains, a low dose of thyroid hormone will be sufficient.

When starting treatment, special caution is required in elderly patients, patients with heart failure, and patients with severe or long-standing hypothyroidism. This means starting with a low dose that will be gradually increased slowly and at large time intervals, with frequent laboratory tests. It has also been shown that in patients with low body weight and large goiters, it is necessary to start with low doses.

Dose

For individual treatment, tablets are available in different doses from 25 to 200 micrograms of levothyroxine sodium. In most cases, only one tablet will be taken per day.

Adults with hypothyroidism (hypothyroidism) will start with 25-50 micrograms of levothyroxine sodium per day (equivalent to 25-50 micrograms of levothyroxine sodium). This dose will be increased following the doctor's instructions in 25-50 micrograms of levothyroxine sodium (equivalent to half a tablet to one tablet) at intervals of 2 to 4 weeks, until a daily dose of 100 to 200 micrograms of levothyroxine sodium is reached.

To prevent the reappearance of goiter after surgery and to treat benign goiter, 75-200 micrograms of levothyroxine sodium will be taken daily.

As an adjunct to antithyroid treatment in the case of hyperthyroidism, 50-100 micrograms of levothyroxine sodium will be taken per day.

After thyroid gland surgery for malignant thyroid tumor, the daily dose is 150-300 micrograms of levothyroxine sodium.

Generally, treatment starts with a low dose that will be gradually increased in adults and for treatment in children.

The tablet can be divided into equal doses.

Use in children

In newborns and infants with hypothyroidism, for whom it is essential to start treatment as soon as possible to achieve normal mental and physical development, the recommended initial dose is 10-15 micrograms per kilogram of body weight for the first three months. From then on, your doctor will adjust the dose individually.

Children with acquired hypothyroidism will start with a maximum daily dose of 12.5-50 micrograms of levothyroxine sodium; this dose will be gradually increased and at prolonged intervals, following the doctor's instructions. The dose for long-term treatment will depend on the child's age and body weight.

Administration form

Take a single dose per day with an empty stomach in the morning, at least half an hour before breakfast, as the active principle is better absorbed with an empty stomach than before or after meals. Tablets must be swallowed whole without chewing, preferably with a little liquid, for example, with half a glass of water.

Children can take their entire daily dose 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 (10-15 ml) and give it to the child with a little more liquid (5-10 ml). Always prepare the mixture at the time of taking.

Treatment duration

- If you have hypothyroidism or have undergone surgery for a malignant thyroid tumor, you will take levothyroxine for the rest of your life.

- To prevent the reappearance of goiter after surgery and to treat benign goiter, the treatment duration is 6 months to 2 years for the rest of your life.

- Concomitant treatment of hyperthyroidism is indicated during the period in which the antithyroid drug is administered.

- For the treatment of benign goiter with normalized thyroid function, the treatment duration is 6 months to 2 years. If Levotiroxina sódica Teva treatment does not produce the expected result within this time period, other treatments should be considered.

If you take more Levotiroxina sódica Teva than you should

In case of overdose, typical symptoms of hyperthyroidism (see section 4 "Possible adverse effects") will be observed. Consult your doctor immediately if these symptoms appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Levotiroxina sódica Teva

Do not take a double dose to compensate for the missed doses.

Continue taking your tablets regularly as prescribed.

If you interrupt the treatment with Levotiroxina sódica Teva

You must take Levotiroxina sódica Teva daily at the dose prescribed by your doctor.

Under no circumstances should you modify, suspend, or interrupt the treatment prescribed without consulting your doctor. Symptoms may return if you suspend or interrupt treatment before you should. The nature of these symptoms depends on the underlying disease.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Hypersensitivity to the active ingredient or to the other components of levotiroxine

In case of hypersensitivity to sodium levotiroxine or to any of the other components of Levotiroxina sódica Teva, allergic reactions may occur in the skin and in the respiratory tract region (immediately or several days after administration of the drug), which may put life at risk. Symptoms may include difficulty breathing, swelling of the eyelids, face, lips, throat, or tongue (angioedema), skin rash, urticaria, or itching.Notify a doctor immediately or go to the nearest hospital emergency room immediately.

Intolerance to the dose, overdose

If the administered dose is not tolerated or the dose is too high, typical symptoms of hyperthyroidism (thyrotoxicosis) may appear, particularly if the dose is increased rapidly at the beginning of treatment.

Very common (may affect more than 1 in 10 patients)

• palpitations (strong heartbeats),
• difficulty sleeping,
• headache.

Common (may affect up to 1 in 10 patients)

• rapid heart rate (tachycardia),
• nervousness.

Rare (may affect up to 1 in 1000 patients)

• increased intracranial pressure (especially in children).

Not known (frequency cannot be estimated from available data):

- shortness of breath, excessive sweating,

- weight loss,

- tremor, restlessness, excitability,

- angina (chest pain with oppression),

- cardiac rhythm disturbances,

- high blood pressure (hypertension), heart failure, myocardial infarction,

- circulatory collapse in premature neonates with very low birth weight (see section 2. “What you need to know before starting to take Levotiroxina Teva”),

- difficulty breathing (dyspnea),

- increased appetite, nausea, vomiting, diarrhea, abdominal pain

- muscle weakness and muscle cramps,

- fragile bones (osteoporosis) at high doses of levotiroxine, especially in postmenopausal women, mainly when treated for a prolonged period,

- fever,

- intolerance to heat,

- mild hair loss in children,

- menstrual disorders in women.

Consult your doctor if you notice any of these side effects. Normally, side effects disappear when the dose is changed.

In children, an overdose of levotiroxine sodium may cause premature fusion of bones and interruption of growth.

Measures to treat an overdose

In case of adverse effects, report to your doctor. Your doctor may consider interrupting treatment for several days or reducing the daily dose until adverse effects have disappeared. Treatment may be resumed when adverse effects have disappeared.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levotiroxina sódica Teva

- The active ingredient is levotiroxina sódica.

Cada comprimido contains 75 microgramos of levotiroxina sódica.

- The other excipients are cornstarch, pregelatinized cornstarch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the packaging

Levotiroxina sódica Teva 75 microgramos comprimidos are white or off-white, round, 8 mm in diameter, and flat with a cross-shaped groove on one face and the inscription “L3” on the other face.

Levotiroxina sódica Teva 75 microgramos is available in the following packaging sizes:

20, 28, 30, 50, 56, 60, 84, 90, 100, 112, and 250 (blisters),

50x1 (single-dose blister), 98 (calendar pack);

Not all packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Responsible manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen,

Hungary

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

Germany: L-Thyroxin-Na-CT

Italy: Levotiroxina Teva

Poland: Wolarex

Spain: Levotiroxina sódica Teva 75 microgramos comprimidos EFG

Netherlands: Levothyroxinenatrium Teva

Portugal: Levotiroxina sódica Ratiopharm

Last review date of this leaflet:December 2024

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/77044/P_77044.html