LEVOTHYROXINE SANOFI 50 micrograms TABLETS

Introduction

Package Leaflet: Information for the User

Levotiroxina Sanofi 50 micrograms tablets

Levothyroxine sodium

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

• Keep this 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Levotiroxina Sanofi 50 micrograms and what it is used for
2. What you need to know before you take Levotiroxina Sanofi 50 micrograms
3. How to take Levotiroxina Sanofi 50 micrograms
4. Possible side effects
5. Storing Levotiroxina Sanofi 50 micrograms
6. Package contents and further information

1. What is Levotiroxina Sanofi 50 micrograms and what it is used for

Levotiroxina Sanofi 50 micrograms is a medicine that contains levothyroxine, a thyroid hormone, as the active substance. It has the same effect as the hormone that is produced naturally. Levotiroxina Sanofi is used to replace the thyroid hormone that you lack and/or to relieve the malfunction of your thyroid gland.

Levotiroxina Sanofi is used:

• to replace the lack of hormone in all forms of hypothyroidism (underactive thyroid),

• to prevent the recurrence of new goiters (enlargement of the thyroid) after thyroid surgery in patients with normal thyroid function (depending on thyroid function after surgery),
• to treat benign goiter (benign tumor) in patients with normal thyroid function,
• as supplementary therapy for hyperthyroidism (overactive thyroid) in patients receiving antithyroid agents (thyroid medication), after achieving a normal metabolic status,
• for malignant thyroid tumors, especially after surgery to suppress the growth of a new tumor and as a supplement in the absence of thyroid hormone.

2. What you need to know before you start taking Levothyroxine Sanofi 50 micrograms

Do not takeLevothyroxine Sanofi

• if you are hypersensitive (allergic) to levothyroxine sodium or to any of the other components of this medicine (listed in section 6),
• if you have any of the following disorders or conditions:
• • an untreated overactive thyroid,
  • untreated adrenal insufficiency (poor adrenal function),
  • poor pituitary gland function not treated, if it has resulted in adrenal insufficiency (poor adrenal function) that requires treatment,
  • an acute myocardial infarction,
  • acute inflammation of the heart muscle (myocarditis),
  • acute inflammation of all layers of the heart (pancarditis).

If you are pregnant, you should not take Levothyroxine Sanofi at the same time as another medicine for an overactive thyroid (called thyrostatic agents) (see section "Pregnancy, breastfeeding and fertility").

Review of medical conditions

Before starting treatment with Levothyroxine Sanofi, the following disorders or conditions should be ruled out or treated:

• coronary artery disease,
• chest pain with a feeling of oppression (angina pectoris),
• high blood pressure,
• poor pituitary gland function and/or poor adrenal function,
• areas in the thyroid gland that produce uncontrolled amounts of thyroid hormone (thyroid autonomy).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levothyroxine Sanofi.

Be particularly careful with Levothyroxine Sanofi

• if you have already had a heart attack, or if you have coronary artery disease, heart failure, heart rhythm disorders (tachycardias) or chronic cardiomyopathy (non-acute inflammation of the heart muscle), or if you have had an underactive thyroid for a long time. In these cases, excessively high hormone levels in the blood should be avoided. Your thyroid hormone levels should therefore be monitored more frequently. Consult your doctor if you experience milder signs of an overactive thyroid as a result of taking Levothyroxine Sanofi (see section 4. "Possible side effects").
• if you have an underactive thyroid due to a pituitary gland disease. In this case, you may also have poor adrenal function, which will need to be treated first by your doctor (treatment with hydrocortisone). This can trigger an acute adrenal crisis without proper treatment.
• if it is suspected that you have areas in the thyroid gland that produce uncontrolled amounts of thyroid hormone. Before starting treatment, this should be investigated with further thyroid function tests.
• if you are a postmenopausal woman and have a high risk of osteoporosis, your doctor should monitor your thyroid function more frequently. This is to avoid increasing the levels of thyroid hormone in the blood and to ensure that the lowest required dose is administered.
• if you have diabetes. See the information in the section "Other medicines and Levothyroxine Sanofi".
• if you are being treated with certain anticoagulants (blood-thinning medicines, such as dicumarol) or medicines that can affect thyroid function (e.g. amiodarone, tyrosine kinase inhibitors [for cancer treatment], salicylates and high-dose furosemide). See the information in the section "Other medicines and Levothyroxine Sanofi".

• if a newborn premature baby with low birth weight is being treated. Extreme caution is required when starting treatment with levothyroxine, as circulatory collapse may occur due to immature adrenal function (see section 4. "Possible side effects"). Blood pressure will be monitored regularly when starting treatment with levothyroxine in premature newborns with very low birth weight, as a rapid drop in blood pressure (known as circulatory collapse) may occur.

• if you have a history of epilepsy, as the risk of seizures increases when levothyroxine is administered.
• if you experience an allergic reaction (see section "Possible side effects"). Contact your doctor or healthcare professional immediately or go to the emergency room of the nearest hospital immediately.
• if you are going to have laboratory tests to check your thyroid hormone levels, you must 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 can affect the results of laboratory tests. 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 having the 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 or laboratory staff if you are taking these products (see the information in the section "Other medicines and Levothyroxine Sanofi").

Inappropriate use (off-label)

You should not take Levothyroxine Sanofi to lose weight. If your thyroid hormone levels in the blood are within the normal range, taking additional thyroid hormones will not cause weight loss. Serious or life-threatening side effects may occur if you take additional thyroid hormones or increase the dose without the special advice of your doctor, especially in combination with certain weight loss products.

Change of treatment

Thyroid imbalance may occur if you need to switch your medicine to another product containing levothyroxine. Consult your doctor if you have any doubts about how to change your medicine. Close monitoring (clinical and laboratory parameters) is required during the transition period. You should inform your doctor if you experience any side effects, as this may indicate that your dose needs to be adjusted upwards or downwards.

Elderly patients

In elderly patients, a more careful dose adjustment is required (especially if they have heart problems) and more frequent medical check-ups should be performed.

Other medicines and Levothyroxine Sanofi

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicine.

Levothyroxine Sanofi affects the effects of the following agents and groups of medicines:

• Antidiabetics (medicines that lower blood sugar levels) (such as metformin, glimepiride and glibenclamide, as well as insulin):

If you have diabetes, you should regularly monitor your blood sugar levels, especially when starting and stopping treatment with thyroid hormone.

Your doctor may need to adjust the dose of your antidiabetic medication, as levothyroxine may reduce the effect of medicines that lower blood sugar levels.

• Anticoagulant medicines that prevent blood clotting - called anticoagulants (coumarin derivatives):

In combination treatment with Levothyroxine Sanofi and coumarin derivatives (e.g. dicumarol), you should regularly check your blood coagulation. Your doctor may need to reduce the dose of your anticoagulant medicines, as levothyroxine may increase their effect.

The effect of Levothyroxine Sanofi is influenced by other medicines, as indicated below:

• Ion exchange resins:

After taking Levothyroxine Sanofi, you should wait 4-5 hours before taking agents used to lower blood fat levels (e.g. cholestyramine, colestipol) or to eliminate high concentrations of potassium or phosphate in the blood (calcium and sodium salts of sulfonic acid of polystyrene, sevelamer). Otherwise, these medicines will block the absorption of levothyroxine in the intestine and therefore make it less effective.

• Bile acid sequestrants:

Colesevelam (a medicine used to lower high cholesterol levels in the blood) binds to levothyroxine and thereby reduces the absorption of levothyroxine in the intestine. Therefore, Levothyroxine Sanofi should be taken at least 4 hours before colesevelam.

• Medicines containing aluminum used to bind stomach acid, medicines containing iron, calcium carbonate, proton pump inhibitors:

• Take Levothyroxine Sanofi at least 2 hours before taking medicines containing aluminum used to bind stomach acid (antacids, sucralfate), medicines containing iron or calcium carbonate. Otherwise, these medicines may reduce the absorption of levothyroxine in the intestine and therefore make it less effective.
• Proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole and lansoprazole) are used to reduce the amount of acid produced by the stomach, which can reduce the intestinal absorption of levothyroxine and therefore make it less effective. If you are taking levothyroxine at the same time as receiving a proton pump inhibitor, your doctor should monitor your thyroid function and may need to adjust the dose of Levothyroxine Sanofi.

• Propylthiouracil, glucocorticoids, beta-blockers (especially propranolol):

Propylthiouracil (used for an overactive thyroid), glucocorticoids (adrenocortical hormones, "cortisone") and beta-blockers (used to reduce heart rate and lower blood pressure) block the conversion of levothyroxine to liothyronine, the more active form, and may therefore make Levothyroxine Sanofi less effective.

• Amiodarone, iodine-containing contrast media:

Amiodarone (used in the treatment of heart rhythm disorders) and iodine-containing contrast media (some agents used in X-ray diagnostics) can - due to their high iodine content - trigger both an overactive and underactive thyroid function. Particular caution is required in the case of nodular goiter, where there may be undetected areas in the thyroid gland producing uncontrolled amounts of thyroid hormone (autonomies). Amiodarone blocks the conversion of levothyroxine to liothyronine, the more active form, and may therefore affect the effect of Levothyroxine Sanofi. Your doctor may adjust the dose of Levothyroxine Sanofi.

• Tyrosine kinase inhibitors (for cancer treatment):

If you are using levothyroxine at the same time as tyrosine kinase inhibitors (e.g. imatinib, sunitinib, sorafenib or motesanib), your doctor should carefully monitor your symptoms and thyroid function. There may be some loss of effect of levothyroxine. Your doctor may adjust the dose of Levothyroxine Sanofi.

• The following medicines may influence the effect of Levothyroxine Sanofi:
• • salicylates, especially at doses greater than 2.0 g/day (medicines that reduce fever and relieve pain),
  • dicumarol (an anticoagulant),
  • high doses of furosemide (250 mg) (used to increase urine production),
  • clofibrate (used to lower high fat levels in the blood).
• Contraceptive medicines or hormone replacement therapy medicines:

If you are taking hormonal contraceptives containing estrogens ("the pill") or receiving hormone replacement therapy after menopause, you may have an increased need for levothyroxine.

• Sertraline; chloroquine/proguanil:

Sertraline (an antidepressant) and chloroquine/proguanil (used for malaria and rheumatic disease) reduce the efficacy of levothyroxine.

• Rifampicin, carbamazepine, phenytoin, barbiturates, products containing hypericum:

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

• Protease inhibitors (used to treat HIV infections):

If you are using levothyroxine at the same time as protease inhibitors (lopinavir, ritonavir), your doctor should carefully evaluate your symptoms and monitor your thyroid function. There may be some loss of effect of levothyroxine when administered at the same time as lopinavir/ritonavir.

• 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 dose of Levothyroxine Sanofi.
• If you are taking or have recently taken biotin, you should inform your doctor or laboratory staff when they are going to perform laboratory tests to check your thyroid hormone levels. Biotin can affect the results of laboratory tests (see "Warnings and precautions").
• Orlistat - used to treat obesity.

Levothyroxine Sanofi with food and drinks

If your diet contains soy, your doctor will monitor your blood thyroid hormone levels more frequently. Your doctor may need to adjust the dose of Levothyroxine Sanofi during and after stopping this diet (unusually high doses may be required), as soy products can affect the absorption of levothyroxine in the intestine and therefore make it less effective.

Do not take Levothyroxine Sanofi with coffee, as it can reduce the absorption of levothyroxine in the intestine and therefore make it less effective. After taking Levothyroxine Sanofi, you should wait at least half an hour to one hour before taking coffee. Patients with a coffee consumption habit and being treated with levothyroxine are advised not to change their "coffee consumption habit" without their doctor monitoring and supervising levothyroxine levels.

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.

Correct treatment with thyroid hormones is of particular importance during pregnancy and breastfeeding to ensure the optimal health of the mother and the fetus. Therefore, it should be continued regularly and under the supervision of your doctor. Despite its widespread use during pregnancy, there have been no adverse effects on pregnancy or on the health of the fetus or newborn due to levothyroxine.

Thyroid function should be reviewed during and after pregnancy. Your doctor may need to adjust the dose, as the need for thyroid hormone may increase due to the increase in blood estrogen levels (female sex hormone) during pregnancy.

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

If you are breastfeeding, continue taking levothyroxine as recommended by your doctor.

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

It is likely that hypothyroidism or hyperthyroidism will have an effect on fertility. When treating patients with hypothyroidism, the dose of Levothyroxine Sanofi should be adjusted based on laboratory test results, as an insufficient dose may not improve hypothyroidism and an overdose may cause hyperthyroidism.

Driving and using machines

No studies have been conducted to investigate the effects of Levothyroxine Sanofi on the ability to drive vehicles and use machines.

Levothyroxine Sanofi contains sodium

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

3. How to take Levotiroxina Sanofi 50 micrograms

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will determine the daily dose you need, based on the follow-up of your exams.

Dose

Tablets with different concentrations of active substance (25, 50, 75, 100, 125, 150, 175, and 200 micrograms of levotiroxine sodium) are available for individualized treatments. This means that you will only need to take a single tablet daily in most cases.

To start treatment, to increase the dose in adults, and to treat children, your doctor may prescribe tablets with a lower amount of active substance.

Depending on the symptoms, your doctor will be guided by the following recommendations:

• To treat thyroid hypofunction, adults will start taking 25 - 50 micrograms of levotiroxine sodium per day (equivalent to half - 1 tablet of Levotiroxina Sanofi 50 micrograms). This dose can be increased, following the doctor's instructions, by 25 - 50 micrograms of levotiroxine sodium, at intervals of 2 to 4 weeks, until a daily dose of 100 - 200 micrograms of levotiroxine sodium (equivalent to 2 - 4 tablets of Levotiroxina Sanofi 50 micrograms).
• To prevent new episodes of goiter after goiter removal and to treat benign goiter, 75 - 200 micrograms of levotiroxine sodium will be taken per day (equivalent to 1 and a half - 4 tablets of Levotiroxina Sanofi 50 micrograms).
• As supplementary treatment in the treatment of hyperactive thyroid with thyrostatic agents, 50 - 100 micrograms of levotiroxine sodium will be taken per day (equivalent to 1 - 2 tablets of Levotiroxina Sanofi 50 micrograms).
• After thyroid surgery due to malignant thyroid tumor, the daily dose is 150 - 300 micrograms of levotiroxine sodium.

In some cases, a lower dose of thyroid hormone may be sufficient.

Method of administration

The total daily dose should be taken in the morning on an empty stomach, at least half an hour before breakfast. The tablets should be swallowed whole (without chewing) with plenty of liquid, preferably with a glass of water.

The active substance is better absorbed on an empty stomach than before or after a meal.

Children will receive the total daily dose at least half an hour before the first meal of the day. They can also take the tablet dissolved in a little water (10 - 15 ml) and the fine dispersion resulting from it (which must be prepared just for each dose), will be administered with a little more liquid (5 - 10 ml).

Use in children

In the long-term treatment of congenital hypothyroidism and hereditary hypothyroidism (underactive thyroid), the daily dose is generally 100 to 150 micrograms of levotiroxine sodium per m2 of body surface area.

In neonates and babies with congenital hypothyroidism (underactive thyroid), rapid hormonal replacement is especially important to achieve normal mental and physical development.

For this type of underactive thyroid, the recommended daily dose is 10 - 15 micrograms of levotiroxine sodium per kg of body weight, during the first 3 months of treatment. From then on, your doctor will adjust the required dose individually, according to the follow-up of controls (including blood levels of thyroid hormone).

In children with acquired hypothyroidism (underactive thyroid), the recommended dose of levotiroxine sodium is 12.5 - 50 micrograms per day, at the start of treatment. Your doctor will gradually increase the dose, every 2 to 4 weeks, until the required dose for long-term treatment is reached. During this time, your doctor should be guided in particular by the levels of thyroid hormone in the blood.

Elderly patients, patients with coronary artery disease, patients with hypothyroidism

In elderly patients, in patients with coronary artery disease, and in patients suffering from severe or long-term hypothyroidism (underactive thyroid), special care should be taken when starting treatment with thyroid hormones (a low initial dose, which is slowly increased and at prolonged intervals, with frequent monitoring of thyroid hormone).

Patients with low body weight and patients with a large goiter

Experience shows that a low dose is sufficient even in patients with low body weight and in patients with a large goiter.

Duration of treatment

• In most cases, Levotiroxina Sanofi should be taken for a long period in cases of underactive thyroid, after goiter or thyroid removal, and to prevent the growth of a new goiter after goiter removal.
• When used as supplementary therapy to treat hyperactive thyroid, Levotiroxina Sanofi 50 micrograms is taken for the same time as thyrostatic agents (antithyroid medications).
• For the treatment of benign goiter in patients with normal thyroid function, a treatment period of between 6 months and 2 years is necessary. If treatment with Levotiroxina Sanofi has not achieved the desired result in due time, your doctor should consider other therapeutic options.

If you take more Levotiroxina Sanofi than you should

The signs of overdose are described in section 4. "Possible side effects". Consult your doctor immediately if these symptoms appear.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562.04.20, indicating the medication and the amount ingested.

If you forget to take Levotiroxina Sanofi

If you have taken too small a amount or if you have forgotten a dose, do not take a double dose to make up for the forgotten dose. Continue taking your tablets according to your regular treatment.

If you interrupt treatment with Levotiroxina Sanofi

For your treatment to be successful, you must take Levotiroxina Sanofi regularly at the dose prescribed by your doctor. You should never change, suspend, or interrupt treatment with Levotiroxina Sanofi on your own too soon, since symptoms may reappear.

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

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4. Possible side effects

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

Hypersensitivity to the active substance or to other components of Levotiroxina Sanofi

In case of hypersensitivity to levotiroxine or to any of the other components of Levotiroxina Sanofi, allergic reactions of the skin and respiratory tract (either immediately or after several days of administration of the medication) may occur, which can be life-threatening. Symptoms may include skin rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue. Contact your doctor or healthcare professional immediately or go to the emergency room of the nearest hospital.

Intolerance to posology, overdose

If the posology is not tolerated in individual cases, or in the case of an overdose, typical symptoms of hyperactive thyroid (hyperthyroidism) may appear, especially if the dose is increased too quickly at the beginning of treatment.

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

• palpitations
• insomnia
• headache

Common side effects(may affect up to 1 in 10 patients)

• rapid heart rate (tachycardia)
• nervousness

Rare side effects(may affect up to 1 in 1,000 patients)

• increased pressure in the brain (especially in children)

Other side effects of unknown frequency(cannot be estimated from the available data)

• hypersensitivity
• heart rhythm disorders
• chest pain (symptoms of angina pectoris)
• allergic skin reactions (e.g., angioedema [difficulty breathing, or swelling of the face, lips, throat, or tongue], rash, urticaria)
• inner restlessness
• muscle weakness and muscle cramps
• bone fragility (osteoporosis) at high doses of levotiroxine, especially in postmenopausal women, mainly when treated for a long period
• feeling of heat
• menstrual disorders
• diarrhea
• vomiting
• nausea
• weight loss
• tremor
• excessive sweating
• fever
• circulatory collapse in premature newborns with low birth weight (see section 2. "Warnings and precautions").

Inform your doctor if side effects occur. He will decide if the daily dose should be reduced or if the medication should be interrupted for a few days. As soon as the side effect disappears, treatment can be restarted with a cautious dose.

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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levotiroxina Sanofi 50 micrograms

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 after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of 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. Contents of the packaging and additional information

Composition of Levotiroxina Sanofi 50 micrograms tablets

• The active substance is levotiroxine sodium. Each tablet contains 50 micrograms of levotiroxine sodium.
• The other components are: cornstarch, pregelatinized starch (from corn), microcrystalline cellulose, sodium carbonate, sodium thiosulfate (F.E.), anhydrous colloidal silica, and hydrogenated castor oil.

Appearance of the product and contents of the packaging

Levotiroxina Sanofi 50 micrograms are round, white, scored tablets with the inscription "2L" on both sides.

The tablets can be divided into two equal halves.

Levotiroxina Sanofi 50 micrograms is available in packages of 28 (calendar packaging), 50, 84 (calendar packaging), 98 (calendar packaging), 100, and 500 tablets (10 x 50 tablets).

Not all packaging sizes may be marketed.

Marketing authorization holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

sanofi-aventis, S.A.

Ctra C35 La Batlloria a Hostalric, km 63.09

Riells i Viabrea, 17404 - Girona

Spain

or

Sanofi-Aventis Deutschland GmbH

Industriepark Hoechst-Brüningstrasse 50

65926 Frankfurt am Main

Germany

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

Germany: L-Thyroxin Winthrop 50 µg Tabletten

Spain: Levotiroxina Sanofi 50 micrograms tablets

France: L-Thyroxin Henning 50 micrograms scored tablet

Date of the last revision of this leaflet: March 2023

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/