Levothyroxine sodium Teva 50 micrograms tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levotiroxina sódica Teva 50 micrograms tablets EFG

Levotiroxina sódica

Read the entire 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Levotiroxina sódica Teva is and what it is used for
What you need to know before taking Levotiroxina sódica Teva
How to take Levotiroxina sódica Teva
Possible side effects
How to store Levotiroxina sódica Teva
Contents of the pack and other information

1. What Levotiroxina Sódica Teva is and what it is used for

Levotiroxina Sódica Teva contains a thyroid hormone as the active substance.

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

Sodium levothyroxine is used as:

Replacement therapy for all forms of hormone deficiency due to impaired thyroid gland function,
Prevention of goiter recurrence after surgery in patients with normal thyroid function,
Treatment of benign goiter (benign tumor) in patients with normal thyroid function,
In combination with antithyroid agents following achievement of normal metabolic levels in cases of excess thyroid hormones,
Treatment of malignant thyroid tumors, especially after surgery to suppress the growth of new tumors, and as supplementation for thyroid hormone deficiency.

2. What you need to know before taking Levotiroxina sódica Teva

Do not take Levotiroxina sódica Teva

if you are allergic to sodium levothyroxine or to any of the other ingredients of this medicine (listed in section 6).
if you have any of the following disorders or conditions:
- untreated hyperthyroidism,
- underactive adrenal glands (adrenal insufficiency) and you do not have adequate replacement therapy,
- untreated pituitary insufficiency, if this has led to adrenal insufficiency requiring treatment,
- acute myocardial infarction,
- acute inflammation of the heart muscle (myocarditis),
- acute inflammation of all layers of the heart (pancarditis).

During pregnancy, levothyroxine should not be used simultaneously with medications for an overactive thyroid gland (antithyroid drugs) (see also “Pregnancy, breastfeeding and fertility”).

Checking for medical conditions

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

coronary insufficiency
severe chest pain (angina pectoris)
high blood pressure (hypertension)
adrenal and/or pituitary insufficiency
areas of the thyroid gland producing thyroid hormone uncontrollably (thyroid autonomy).

Warnings and precautions

Talk to your doctor or pharmacist before starting Levotiroxina sódica Teva.

If you have previously had a heart attack or if you have coronary heart failure, weakened heart muscle, arrhythmias with tachycardia, or non-acute inflammation of the heart muscle, or if you have chronic hypothyroidism.

Medical monitoring for possible symptoms caused by excess thyroid hormone due to Levotiroxina sódica Teva administration is necessary (see section 4, “Possible side effects”) to avoid excessively high levels of thyroid hormone in the blood. In such cases, you should undergo frequent monitoring of your thyroid hormone levels (see section 3).

If you have thyroid dysfunction due to pituitary insufficiency (see also “Do not take Levotiroxina sódica Teva”).
If you have underactive adrenal glands (adrenal insufficiency). This condition should be treated (hydrocortisone replacement therapy) 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, monitoring of the thyroid regulatory system is recommended before starting treatment.
In postmenopausal women who are at increased risk of bone fractures (osteoporosis). Thyroid function should be monitored more frequently to avoid elevated blood levels of levothyroxine and to ensure the minimum required dose.
If you have diabetes, it may be necessary to adjust the dose of your antidiabetic medication (see also “Do not take Levotiroxina sódica Teva”).
If you are being treated with certain anticoagulants or medications that may affect thyroid function (e.g., amiodarone, tyrosine kinase inhibitors [for cancer treatment], salicylates, and high-dose furosemide). Please refer to the information provided in the section “Other medicines and Levotiroxina sódica Teva”.
If you have epilepsy (seizures). Seizures may occur at the beginning of levothyroxine treatment.

Consult your doctor:

before starting, stopping, or changing treatment with orlistat (a medicine used to treat 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 nearest hospital emergency department.
if you are about to undergo laboratory tests to monitor your thyroid hormone levels. You must inform your doctor and/or laboratory staff that you are taking or have recently taken biotin (also known as vitamin H, vitamin B7, or vitamin B8). Biotin can affect your laboratory test results. Depending on the test, results may be falsely high or low due to biotin. Your doctor may ask you to stop taking biotin before laboratory testing. 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 laboratory test results. Inform your doctor and/or laboratory staff if you are taking such products (see information in section “Other medicines and Levotiroxina sódica Teva”).

Inappropriate use

Thyroid hormones are not suitable for weight reduction. Taking thyroid hormones will not reduce your weight if your thyroid hormone levels are normal. If you increase the dose without special medical supervision, serious adverse effects may occur, which could even be life-threatening, especially if taken with other weight-loss medications.

Changing therapy

If you need to switch from your current medication to another treatment containing levothyroxine, thyroid imbalance may occur. Consult your doctor if you have any doubts about changing treatment. Close monitoring (clinical and biological) is required during the transition period. You must inform your doctor of any adverse effects, as your dose may need to be adjusted up or down.

Children

Blood pressure will be monitored regularly when starting levothyroxine treatment in very low birth weight premature neonates, as 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 taking this medicine, although this is temporary and hair usually regrows.

Elderly patients

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

Taking Levotiroxina sódica Teva with other medicines

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

Levotiroxina sódica Teva affects the effectiveness of the following medicines:

Antidiabetics (medicines to lower blood sugar levels)

Levothyroxine may reduce the effect of these glucose-lowering medicines such as metformin, glimepiride, glibenclamide, and insulin. You may need additional monitoring of your blood sugar levels, especially at the beginning and end of treatment, and the dose of antidiabetic medicines may need to be adjusted.

Coumarin derivatives (medicines used to prevent blood clotting)

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

The effectiveness of Levotiroxina sódica Teva may be affected by the following medicines:

Ion-exchange resins, bile acid sequestrants

Medicines used to treat cholesterol (such as cholestyramine, colestipol, colesevelam) or to reduce high levels of potassium or phosphate in the blood (calcium salts and sodium polystyrene sulfonate, sevelamer) block the absorption of levothyroxine from the intestine. Therefore, ensure you take Levotiroxina sódica Teva 4–5 hours before these medicines.

Antacids containing aluminium, medicines containing iron or calcium

Medicines containing aluminium used to bind stomach acid (antacids, sucralfate), medicines containing iron, and calcium may reduce the intestinal absorption of levothyroxine. Therefore, ensure you take Levotiroxina sódica Teva 2 hours before these medicines.

Proton pump inhibitors

Proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazol) are used to reduce stomach acid production, which may reduce levothyroxine absorption in the intestine and thus make 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 Levotiroxina sódica Teva.

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

These substances block the conversion of levothyroxine into the more active form, triiodothyronine (liothyronine), and therefore may make Levotiroxina sódica Teva less effective.

Amiodarone (a medicine used to treat heart rhythm disorders) and iodine-containing contrast agents (certain agents used in X-ray diagnostics) may lead to high iodine content, resulting in hypothyroidism or hyperthyroidism. Special caution is required in patients with autonomous nodular goitre (nodules in the thyroid that secrete hormones).

Amiodarone blocks the conversion of levothyroxine into liothyronine, the more active form, and therefore may affect the effect of Levotiroxina sódica Teva. A dose adjustment of Levotiroxina sódica Teva may be necessary.

Salicylates, dicoumarol, furosemide, clofibrate

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

Medicines containing oestrogens used in hormone replacement therapy during and after menopause or for contraception

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

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

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

Tricyclic antidepressants (such as amitriptyline, imipramine)

If you take levothyroxine, the response to antidepressant treatment may be accelerated due to increased receptor sensitivity to catecholamines.

Tyrosine kinase inhibitors (anticancer 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 Levotiroxina sódica Teva.

Digitalis preparations (such as digoxin used to treat heart disorders)

If you start levothyroxine treatment while taking digitalis preparations, your doctor may need to adjust the dose of these medicines. Hyperthyroid patients may require a gradual increase in digoxin dose 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 (a medicine used to treat seizures), phenytoin (a medicine used to treat seizures and heart rhythm disorders), barbiturates (used for seizures, anaesthesia, and certain sleeping pills), and products containing St. John’s wort (a herbal medicine) may reduce the effect of levothyroxine.

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

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

Orlistat (a 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 levothyroxine levels, and your doctor may need to monitor your thyroid levels and adjust the levothyroxine dose.

Interference with laboratory tests

Biotin

If you are taking or have recently taken biotin, you must inform your doctor and/or laboratory staff before undergoing laboratory tests to monitor your thyroid hormone levels. Biotin can affect your laboratory test results (see “Warnings and precautions”).

Levotiroxina sódica Teva with food and drinks

If your diet includes soy, your doctor will monitor your blood thyroid hormone levels more frequently. Your doctor may need to adjust the levothyroxine dose during and after stopping such a diet (unusually high doses may be required), as soy-containing products may interfere with levothyroxine absorption in the intestine and thus reduce its effectiveness.

Do not take Levotiroxina sódica Teva with coffee, as this may reduce levothyroxine absorption in the intestine and thus reduce its effectiveness. After taking levothyroxine, wait at least 30 minutes to one hour before drinking coffee. Patients already on levothyroxine treatment are advised not to change their coffee-drinking habits without first having their levothyroxine levels checked and monitored by their doctor.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Treatment with thyroid hormones is especially important during pregnancy and breastfeeding and should continue 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, your need for levothyroxine may increase due to elevated oestrogen levels (female sex hormone). Therefore, thyroid function should 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 medicines (thyrostatic agents), as this would require a higher dose of thyrostatic agents. Thyrostatic agents (unlike levothyroxine) can cross the placenta into the baby’s bloodstream and may cause underactive thyroid function in the fetus. If you have an overactive thyroid, your doctor should treat you during pregnancy using only low-dose thyrostatic agents.

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

Hypothyroidism or hyperthyroidism may affect fertility. In patients treated for hypothyroidism, the dose of Levotiroxina sódica Teva should be adjusted based on laboratory test results, as an insufficient dose may fail to correct hypothyroidism, while an overdose may cause hyperthyroidism.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been conducted. Since levothyroxine is identical to the naturally produced thyroid hormone, Levotiroxina sódica Teva is not expected to affect the ability to drive or use machines.

Levotiroxina sódica 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 exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine your individual dose based on laboratory tests and examinations you have undergone.

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 cardiac insufficiency, and patients with severe or long-standing hypothyroidism. This means treatment should begin with a low dose, which is then gradually increased at long intervals, with frequent laboratory monitoring. It has also been shown that patients with low body weight and large goiters require starting with low doses.

Dosage

For individual treatment, tablets are available in different strengths ranging from 25 to 200 micrograms of levothyroxine sodium. In most cases, you will take only one tablet per day.

Adults with hypothyroidism (underactive thyroid) will start with 25–50 micrograms of levothyroxine sodium daily (equivalent to 25–50 micrograms of levothyroxine sodium). This dose will be increased according to your doctor's instructions by 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 recurrence of goiter after surgery and to treat benign goiter, a daily dose of 75–200 micrograms of levothyroxine sodium should be taken.

As concomitant treatment with antithyroid therapy in cases of hyperthyroidism, 50–100 micrograms of levothyroxine sodium per day should be taken.

After surgical removal of the thyroid gland due to malignant thyroid tumor, the daily dose is 150–300 micrograms of levothyroxine sodium.

In general, treatment is started with a low dose, which is then gradually increased, both in adults and in children.

The tablet may be divided into equal doses.

Use in children

In newborns and infants with hypothyroidism, for whom it is important to start treatment as soon as possible to achieve normal mental and physical development, the recommended initial dose is 10–15 micrograms per kg of body weight during the first 3 months. Thereafter, 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 increased slowly and at prolonged intervals, as directed by your doctor. The dose for long-term treatment will depend on the child's age and body weight.

Method of administration

Take a single dose each 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 small amount of liquid, for example, half a glass of water.

Children may take the 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 small amount of water (10–15 ml), then give it to the child with additional liquid (5–10 ml). Always prepare the mixture immediately before use.

Duration of treatment

Your doctor will inform you about the duration of your treatment with Levothyroxine Sodium Teva 50 micrograms.

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

If you take more Levothyroxine Sodium Teva than you should

In case of overdose, symptoms typical of hyperthyroidism will occur (see section 4 “Possible side effects”). Contact your doctor immediately if these symptoms appear.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Levothyroxine Sodium Teva

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

Continue taking your tablets regularly as prescribed.

If you stop taking Levothyroxine Sodium Teva

You must take Levothyroxine Sodium Teva daily at the dose prescribed by your doctor. Under no circumstances should you modify, stop, or interrupt the prescribed treatment without consulting your doctor. Symptoms may return if you discontinue or interrupt treatment prematurely. The nature of these symptoms depends on the underlying condition.

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

4. Possible adverse effects

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

Hypersensitivity to the active substance or to other components of levothyroxine

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

Dose intolerance, overdose

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

Very common (may affect more than 1 in 10 people):

palpitations (strong heartbeat),
difficulty sleeping,
headache.

Common (may affect up to 1 in 10 people):

rapid heartbeat (tachycardia),
nervousness.

Rare (may affect up to 1 in 1,000 people):

increased intracranial pressure (especially in children).

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

hot flushes, excessive sweating,
weight loss,
tremor, restlessness, excitability,
angina (chest pain with tightness),
cardiac rhythm disturbances,
high blood pressure (hypertension), heart failure, heart attack,
circulatory collapse in very low birth weight premature neonates (see section 2 “What you need to know before starting to take Sodium Levothyroxine Teva”),
difficulty breathing (dyspnea),
increased appetite, nausea, vomiting, diarrhoea, abdominal pain,
muscle weakness and muscle cramps,
fragile bones (osteoporosis) with high doses of levothyroxine, especially in postmenopausal women, particularly when treated for a prolonged period,
fever,
heat intolerance,
mild hair loss in children,
in women, menstrual disorders.

Consult your doctor if you notice any of these effects. Usually, the effects disappear when the dose is adjusted.

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

Measures to treat an overdose

If adverse effects occur, inform your doctor. Your doctor may consider interrupting treatment for several days or reducing the daily dose until the adverse effects have disappeared. Treatment may be restarted once the adverse effect has resolved.

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levothyroxine Sodium Teva

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levotiroxina sódica Teva

The active substance is levothyroxine sodium.

Each tablet contains 50 micrograms of levothyroxine sodium.

The other excipients are corn starch, pregelatinized corn starch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.

Appearance of the medicinal product and contents of the pack

Levotiroxina sódica Teva 50 micrograms tablets are white or almost white, round tablets, 8 mm in diameter, flat, with a cross-shaped score on one side and the imprint “L2” on the other.

Levotiroxina sódica Teva 50 micrograms is available in the following pack sizes:

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

50x1 (unit dose blister), 98 (calendar pack);

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid, Spain

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen,

Hungary

PLIVA Krakow Zaklady Farmaceutyczne S.A.,

ul. Mogilska 80, 31-546 Krakow,

Poland

Pharmachemie B.V.,

Swensweg 5, 2031 GA Haarlem,

The Netherlands

TEVA Santé,

Rue Bellocier, 89107 Sens,

France

Teva Czech Industries s.r.o.,

Ostravska 29, c.p. 305, 74770

Opava-Komarov, Czech Republic

TEVA PHARMA S.L.U.,

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

Spain

Teva Kutno S.A.,

Ul. Sienkiewicza 25,

99-300 Kutno, Poland

Merckle GmbH,

Ludwig-Merckle Strasse 3,

D-89143 Blaubeuren, Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: L-Thyroxin-Na-CT
Italy: Levotiroxina Teva
Spain: Levotiroxina sódica Teva 50 micrograms tablets EFG
The Netherlands: Levothyroxinenatrium Teva
Portugal: Levotiroxina sódica Ratiopharm

Date of the most recent revision of this leaflet: December 2024

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77048/P_77048.html

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