LEVOTHYROXINE SODIUM TEVA 150 micrograms TABLETS

Introduction

Package Leaflet: Information for the Patient

Levothyroxine Sodium Teva 150 micrograms Tablets EFG

Levothyroxine Sodium

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

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

Contents of the Package Leaflet

1. What is Levothyroxine Sodium Teva and what is it used for
2. What you need to know before you start taking Levothyroxine Sodium Teva
3. How to take Levothyroxine Sodium Teva
4. Possible side effects
5. Storage of Levothyroxine Sodium Teva
6. Contents of the pack and further information

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

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

The goal of treatment with levothyroxine sodium is to replace the thyroid hormone and/or alleviate stress on the thyroid gland.

Levothyroxine Sodium is used as:

• Replacement therapy for all forms of the hormone in case of thyroid gland dysfunction,
• 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,
• 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,
• Thyroid suppression test.

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

Do not take Levothyroxine Sodium Teva

• if you are allergic to levothyroxine sodium or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from any of the following disorders or diseases:

• untreated hyperthyroidism,
• underactive adrenal glands (adrenal insufficiency) and you do not have adequate replacement therapy
• untreated hypopituitarism, if this has led to adrenal insufficiency that requires treatment,

• acute myocardial infarction,
• acute myocarditis (inflammation of the heart muscle),
• acute inflammation of all the heart walls (pancarditis).

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

Check for diseases

Before starting treatment with Levothyroxine Sodium Teva, the following diseases should be ruled out or treated:

• coronary insufficiency
• severe chest pain (angina pectoris)
• high blood pressure (arterial hypertension)
• adrenal and/or pituitary insufficiency
• areas of the thyroid gland that produce amounts of thyroid hormone in an uncontrolled manner (thyroid autonomy).

These disorders and diseases must be ruled out or treated before performing a thyroid suppression test, except for thyroid autonomy, which may be the reason for performing the suppression test.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levothyroxine Sodium Teva.

• If you have already suffered a heart attack or if you have coronary heart failure, cardiac muscle weakness, arrhythmias with tachycardia or non-acute inflammation of the heart muscle, or if you have chronic thyroid insufficiency.

Medical monitoring of possible symptoms caused by excess thyroid hormone caused by the administration of Levothyroxine Sodium Teva is necessary (see section 4. “Possible side effects”) and thus avoid excessively high hormone levels 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 gland dysfunction caused by hypopituitarism (see also “Do not take Levothyroxine Sodium Teva”).

• If you have underactive adrenal glands (adrenal insufficiency).

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

• If you suspect uncontrolled overproduction of thyroid hormones (thyroid autonomy) in areas of the thyroid gland, controls are recommended to review the thyroid regulation system before starting treatment.

• In women who receive treatment after menopause and who have a higher risk of bone fractures (osteoporosis), thyroid function should be reviewed more frequently to avoid increasing the level of levothyroxine in the blood and ensure the minimum required dose

• If you have diabetes, it may be necessary to adjust the dose of your antidiabetic medicine (see also “Do not take Levothyroxine Sodium Teva”).

• If you are being treated with certain anticoagulant agents or medicines that may 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 medicines and Levothyroxine Sodium Teva”.

• If you have epilepsy (seizures). Seizures may appear at the start of treatment with levothyroxine.

Consult your doctor:

• before starting, stopping or changing treatment with orlistat (medicine for treating obesity); 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 a doctor immediately or go to the emergency department of the nearest hospital immediately.
• if you are about to undergo laboratory tests to check your thyroid hormone levels. You must inform your doctor and/or laboratory personnel that you are taking or have recently taken biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin can 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 note 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 personnel if you are taking such products (Note the information in the section “Other medicines and Levothyroxine 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 medicines intended for weight loss.

Therapy change

If you need to change your medication to another treatment that contains levothyroxine, 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. It is necessary for you to comment to your doctor if you have any side effects as your dose will need to be adjusted upwards or downwards.

Children

Blood pressure will be regularly checked when starting treatment with levothyroxine 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 replacement therapy, partial hair loss may occur during the first few months of starting this medicine, although it is something transient and normally the hair grows back.

Elderly

In elderly patients, the dose should be carefully measured and individualized, especially for patients with heart failure, and should be supervised by their doctor more frequently.

Taking Levothyroxine Sodium Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Levothyroxine Sodium Teva affects the efficacy of the following medicines:

Antidiabetics (medicines to reduce blood sugar levels)

Levothyroxine may reduce the effect of these medicines that reduce blood glucose levels such as metformin, glimepiride, glibenclamide as well as insulin. You may need additional checks of your blood sugar levels, especially at the start and end of treatment, and if necessary, the dose of antidiabetic medicines will be adjusted.

Coumarin derivatives (medicines used to prevent blood clotting)

Levothyroxine may enhance the effect of these medicines due to the displacement of the binding to plasma proteins. You may need periodic checks of your blood coagulation values during treatment with levothyroxine; if necessary, the dose of your coumarin medicine will be adjusted.

The efficacy of Levothyroxine Sodium Teva may be affected by the following medicines:

Ionic exchange resins, bile acid sequestrants

Medicines for the treatment of cholesterol (such as cholestyramine, colestipol, colesevelam) or to reduce high levels of potassium or phosphate in the blood (calcium and sodium salts of sulfonic polystyrene, sevelamer) by blocking the absorption of levothyroxine from the intestine. For this reason, make sure to take Levothyroxine Sodium Teva 4-5 hours before these medicines.

Antacids containing aluminum, medicines containing iron, or calcium

Medicines containing aluminum used to bind stomach acid (antacids, sucralfate), medicines containing iron and calcium may reduce the absorption of levothyroxine from the intestine. For this reason, make sure to take Levothyroxine Sodium Teva 2 hours before these medicines.

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 levothyroxine in the intestine, and thus making it less effective. If you are taking levothyroxine at the same time as proton pump inhibitors, your doctor should monitor your thyroid function and may need to adjust the dose of Levothyroxine Sodium Teva

Propylthiouracil (antithyroid medicine), glucocorticoids (adrenal cortex hormones) and beta-blockers (medicines that reduce heart rate and low blood pressure)

These substances block the conversion of levothyroxine into the more active form, liotrix, and thus may make Levothyroxine Sodium Teva less effective.

Amiodarone (medicine used for the treatment of heart rhythm disorders) and contrast media containing iodine (certain agents used in X-ray diagnosis),may result in high iodine content leading to hypothyroidism and hyperthyroidism. Particular caution is required in patients with autonomous nodular goiter (nodules in the thyroid gland that secrete hormones).

Amiodarone blocks the conversion of levothyroxine into liotrix, the more active form, and thus may affect the effect of Levothyroxine Sodium Teva. A dose adjustment of Levothyroxine Sodium Teva may be necessary.

Salicylates, dicumarol, furosemide, clofibrate

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

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

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

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

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

Tricyclic antidepressants (such as amitriptyline, imipramine)

If you take levothyroxine, the response to treatment with antidepressants will be accelerated, as it increases the sensitivity of receptors to catecholamines.

Tyrosine kinase inhibitors (anti-cancer and anti-inflammatory medicines

These medicines (e.g. imatinib, sunitinib, sorafenib, motesanib) may reduce the concentration of levothyroxine (thyroxine) in the blood. Your doctor may adjust the dose of Levothyroxine Sodium Teva.

Digitalis preparations (such as digoxin used in the treatment of heart disorders)

If you start treatment with levothyroxine while taking digitalis preparations, your doctor may need to adjust the dose of these. Hyperthyroid patients may need a gradual increase in the dose of digoxin because they are initially relatively sensitive to digoxin.

Sympathomimetic agents (such as adrenaline)

When sympathomimetic agents are used together with levothyroxine, their effect is enhanced.

Medicines that activate certain enzymes

Rifampicin (an antibiotic), carbamazepine (medicine used to treat seizures), phenytoin (medicine used to treat seizures and heart rhythm disorders), barbiturates (used in seizures, for anesthesia; certain sleeping pills) and products containing St. John's Wort (a plant-based medicine) may weaken the effect of levothyroxine.

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

A loss of the therapeutic effect of levothyroxine has been reported when used together with lopinavir/ritonavir. For this reason, clinical symptoms and thyroid function should be closely monitored in patients using levothyroxine and protease inhibitors.

Orlistat (medicine used to treat obesity)

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

Semaglutide

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

Interference with laboratory tests

Biotin

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

Levothyroxine Sodium Teva with food and drinks

If your diet contains soy, your doctor will monitor your blood thyroid hormone levels more frequently. It is possible that your doctor will need to adjust the dose of levothyroxine during and after stopping such a diet (unusually high doses may be necessary), as soy products may alter the absorption of levothyroxine in the intestine and thus make it less effective.

Do not take Levothyroxine Sodium Teva with coffee, as this may reduce the absorption of levothyroxine in the intestine and thus reduce its efficacy. After taking levothyroxine, you should wait at least half an hour to an hour before taking coffee. It is recommended that patients who are already being treated with levothyroxine do not change their coffee drinking habit without their levothyroxine levels being checked and monitored by their doctor.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Treatment with thyroid hormones is especially important during pregnancy and breastfeeding, so it should be continued under medical supervision. Despite extensive use during pregnancy, no adverse effects of levothyroxine on pregnancy or the health of the fetus or newborn have been reported.

During pregnancy, the need for levothyroxine may increase due to high levels of estrogen (female sex hormone). Therefore, thyroid function should be monitored during and after pregnancy, as well as the dose of thyroid hormone, which will be adjusted accordingly.

During pregnancy, you should not take Levothyroxine Sodium Teva at the same time as antithyroid medicines (so-called thyrostatic agents), as this will lead to the need for a higher dose of thyrostatic agents. Thyrostatic agents (unlike levothyroxine) can enter the baby's bloodstream through the placenta and are capable of causing underactive thyroid function in the fetus. If you have an overactive thyroid gland, your doctor should treat you during pregnancy only with thyrostatic agents in low doses.

If you are breastfeeding, continue taking levothyroxine as directed by your doctor. Even during treatment with high doses of levothyroxine, the amount of levothyroxine that passes into breast milk during breastfeeding is very low and therefore harmless.

Hypothyroidism or hyperthyroidism may affect fertility. When treating patients with hypothyroidism, the dose of Levothyroxine Sodium Teva should be adjusted according to laboratory test results, as an insufficient dose may not improve hypothyroidism and an overdose may cause hyperthyroidism.

The thyroid suppression test should not be performed during pregnancy and breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. Since levothyroxine is identical to the naturally produced thyroid hormone, it is unlikely that Levothyroxine Sodium Teva will interfere with the ability to drive and use machines.

Levothyroxine Sodium Teva contains sodium

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

3. How to take Levothyroxine sodium Teva

Follow the administration instructions for this medication exactly as 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 tests and laboratory analyses that have been performed on you.

If any residual 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-term hypothyroidism. This means starting with a low dose that will be gradually increased at long 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 ranging from 25 to 200 micrograms of levothyroxine sodium. In most cases, only one tablet will be taken per day.

Adults with 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 by 25-50 micrograms of levothyroxine sodium (equivalent to half a tablet to 1 tablet) at intervals of 2 to 4 weeks, up to a daily dose of 100 to 200 micrograms of levothyroxine sodium.

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

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

For the thyroid suppression test, 200 micrograms of levothyroxine sodium should be taken per day for 14 days until the test is performed.

In general, treatment is started with a low dose that will be increased in adults and for treatment in children.

The tablet can be divided into equal doses.

Use in children

In newborns and babies 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 during the first 3 months. After that, 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 at prolonged intervals, following the doctor's instructions. The dose for long-term treatment will depend on the child's age and body weight.

Method of administration

Take a single dose per day on an empty stomach in the morning, at least half an hour before breakfast, as the active ingredient is better absorbed on an empty stomach than before or after meals. The tablets should 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 administration, 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 administration.

Duration of treatment

• If you have hypothyroidism or have undergone surgery for a malignant tumor in the thyroid, you will take levothyroxine for the rest of your life.
• To prevent the recurrence of goiter after surgery and to treat benign goiter, the necessary duration of treatment is 6 months to 2 years for the rest of your life.
• Concomitant treatment of hyperthyroidism is indicated during the period when the antithyroid drug is administered.
• For the treatment of benign goiter with normalized thyroid function, the necessary duration of treatment is 6 months to 2 years. If treatment with Levothyroxine sodium Teva does not produce the expected result within this period, other treatments should be considered.

If you take more Levothyroxine sodium Teva than you should

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

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

If you forget to take Levothyroxine sodium Teva

Do not take a double dose to make up for forgotten doses.

Continue taking your tablets regularly as prescribed by your doctor.

If you interrupt treatment with Levothyroxine sodium Teva

You should take Levothyroxine sodium Teva daily at the dose prescribed by your doctor. Under no circumstances should the prescribed treatment be modified, suspended, or interrupted 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people will experience them.

Hypersensitivity to the active substance or to the other components of levothyroxine

In case of hypersensitivity to levothyroxine sodium or to any of the other components of Levothyroxine sodium Teva, allergic reactions may occur on the skin and in the respiratory tract region (immediately or several days after administration of the medication), which can be life-threatening. Symptoms may include difficulty breathing, swelling of the eyelids, face, lips, throat, or tongue (angioedema), skin rash, urticaria, or itching. Consult a doctor immediately or go to the emergency room of the nearest hospital immediately.

Intolerance to the dose, overdose

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

Unknown (frequency cannot be estimated from available data):

• flushing, excessive sweating,
• weight loss,
• tremors, restlessness, excitability,
• angina (chest pain with oppression),
• heart rhythm disorders,
• high blood pressure (hypertension), heart failure, infarction,
• circulatory collapse in premature neonates with very low birth weight (see section 2. "What you need to know before taking Levothyroxine Teva"),

fever,

• heat intolerance,
• mild hair loss in children,
• in women, menstrual disorders.

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

In children, an overdose of levothyroxine sodium can cause premature fusion of the bones and interruption of growth.

Measures to treat an overdose

In case of appearance of side effects, inform your doctor. Your doctor may consider interrupting treatment for several days or reducing the daily dose until the side effects have disappeared. Treatment can be started again when the side effect has disappeared.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this prospectus. You can also report them directly through the Spanish Medicines and Health Products Agency's pharmacovigilance system: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levothyroxine sodium Teva

Keep this medication out of sight and reach of children.

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

Do not store above 25°C.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Levothyroxine sodium Teva

• The active ingredient is levothyroxine sodium.

Each tablet contains 150 micrograms of levothyroxine sodium.

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

Appearance of the product and package contents

Levothyroxine sodium Teva 150 micrograms tablets are white or almost white, round, 8 mm in diameter, and flat with a cross-shaped notch on one side and the inscription "L6" on the other side.

Levothyroxine sodium Teva 150 micrograms is available in the following package sizes:

20, 28, 30, 50, 56, 60, 84, 90, 100, 112, and 250 tablets (blister packs)

50 x 1 (unit-dose blister); 98 (calendar pack)

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Holder

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen,

Hungary

or

PLIVA Krakow Zaklady Farmaceutyczne S.A.,

ul. Mogilska 80. 31-546, Krakow,

Poland

or

Pharmachemie B.V.,

Swensweg 5, 2031 GA Haarlem,

Netherlands

or

TEVA Santé,

Rue Bellocier, 89107 Sens,

France

or

Teva Czech Industries s.r.o.,

Ostravska 29, c.p. 305, 74770

Opava-Komarov, Czech Republic

or

TEVA PHARMA S.L.U.,

C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza,

Spain

or

Teva Kutno S.A.,

Ul. Sienkiewicza 25,

99-300 Kutno, Poland

or

Merckle GmbH,

Ludwig-Merckle Strasse 3,

D-89143 Blaubeuren, Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: L-Thyroxin-Na-CT

Italy: Levotiroxina Teva

Spain: Levothyroxine sodium Teva 150 micrograms tablets EFG

Netherlands: Levothyroxinenatrium Teva

Poland: Levothyroxine Teva

Portugal: Levotiroxina sódica Ratiopharm

Romania: Levotiroxina Teva

Date of the last revision of this prospectus:December 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77047/P_77047.html

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