Package Insert: Information for the User

Levotiroxine Sanofi 100 micrograms Tablets

Levotiroxine Sodium

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

• Keep this package insert, 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 others even if they have the same symptoms of the disease as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

Levotiroxina Sanofi 100 micrograms is a medication that contains levotiroxine, 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 is lacking or to alleviate the poor functioning of the thyroid gland.

Levotiroxina Sanofi is used:

• to replace the hormone deficiency in all forms of hypothyroidism (underactive thyroid),
• to prevent the reappearance of new goiters (increase in thyroid size) after thyroid surgery in patients with normal thyroid function (depending on thyroid function after surgery),
• to treat benign goiter (benign stroma) in patients with normal thyroid function,
• as supplementary therapy for hyperthyroidism (overactive thyroid) in patients who are receiving thyroid-inhibiting agents (anti-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,
• to investigate thyroid function (thyroid suppression test).

Do not take Levotiroxina Sanofi

• if you are hypersensitive (allergic) to levothyroxine sodium or to any of the other components of this medication (listed in section 6),
• if you have any of the following conditions or any of the conditions listed below:
• • untreated hyperactive thyroid,
  • untreated adrenal insufficiency (poor adrenal function),
  • untreated poor pituitary function, if this has resulted in adrenal insufficiency (poor adrenal function) that requires treatment,
  • acute myocardial infarction,
  • acute inflammation of the heart muscle (myocarditis),
  • acute inflammation of all layers of the heart (pancarditis).

If you are pregnant, do not take Levotiroxina Sanofi at the same time as another medication for hyperactive thyroid (designated as thyroid-stimulating agents) (see section “Pregnancy, lactation, and fertility”).

Medical condition reviews

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

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

These conditions or conditions must also be ruled out or treated before performing the thyroid suppression test, also known as the test, to investigate thyroid function. However, this does not apply to thyroid autonomy, as the test is sometimes used to detect this condition.

Warnings and precautions

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

Be particularly careful with Levotiroxina Sanofi

• if you have already had a heart attack, or if you have coronary disease, heart failure, arrhythmias, or chronic cardiomyopathy (non-acute inflammation of the heart muscle), or if you have had a long-standing hypothyroid condition. In these cases, excessive levels of hormone in the blood must be avoided. Your thyroid hormone levels must therefore be monitored more frequently. Consult your doctor if you experience milder signs of hyperactive thyroid as a result of Levotiroxina Sanofi administration (see section 4. “Possible side effects”).
• if you have hypothyroidism due to a pituitary gland disease. In this case, you may also have poor adrenal function, which must be treated first by your doctor (treatment with hydrocortisone). This can trigger an acute adrenal crisis without adequate treatment.
• if you suspect that you have areas in the thyroid gland that produce uncontrolled amounts of thyroid hormone. Before starting treatment, this must be investigated with further thyroid function tests.
• if you are a postmenopausal woman, and you have a high risk of osteoporosis, your doctor must monitor your thyroid function more frequently. This is to avoid an increase in blood thyroid hormone levels and to ensure that the lowest required dose is administered.
• if you have diabetes. See the information in the section “Other medications and Levotiroxina Sanofi”.
• if you are taking certain anticoagulants (blood-thinning medications, such as dicumarol) or medications that can affect thyroid function (e.g., amiodarone, tyrosine kinase inhibitors [for cancer treatment], salicylates, and furosemide at high doses). See the information in the section “Other medications and Levotiroxina Sanofi”.
• if you are being treated with a premature low-birth-weight newborn. Extreme caution must be exercised when initiating treatment with levotiroxine, as it may cause circulatory collapse due to immature adrenal function (see section 4. “Possible side effects”).Thyroid hormone levels must be monitored periodically when initiating levotiroxine treatment in premature newborns with very low birth weight, as it may cause a rapid drop in blood pressure (known as circulatory collapse).
• if you have a history of epilepsy, as the risk of seizures increases when levotiroxine is administered.
• if you experience an allergic reaction (see section Possible side effects). Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room immediately.
• if you are to undergo laboratory tests to control your thyroid hormone levels, you must inform your doctor or laboratory personnel 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 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 the tests are performed. You should also be aware that other products you may be taking, such as multivitamin preparations or supplements for hair, skin, and nails, may also contain biotin. This may affect the results of laboratory tests. Inform your doctor or laboratory personnel if you are taking these products (note the information in the section “Other medications and Levotiroxina Sanofi”).

Off-label use (outside indication)

Do not take Levotiroxina Sanofi to lose weight. If your blood thyroid hormone levels are within the normal range, an additional dose of thyroid hormone will not cause weight loss.Severe or even 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-reducing products.

Change of treatment

Thyroid imbalance may occur if you need to change your medication to another product containing levotiroxine. Consult your doctor if you have any doubts about how to change your medication. Close monitoring (clinical and laboratory parameters) is required during the transition period. Inform your doctor if you experience any side effects, as this may indicate that your dose needs to be adjusted up or down.

Older patients

In older patients, a more careful dose adjustment (especially if they have heart problems) and more frequent medical reviews are required.

Other medications and Levotiroxina Sanofi

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

Levotiroxina Sanofi affects the effects of the following agents and groups of medications:

• Antidiabetic medications (medications that reduce blood sugar levels) (such as metformin, glimepiride, and glibenclamide, as well as insulin):

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

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

• Anticoagulant medications that prevent blood clotting - designated as anticoagulants (cumarin derivatives):

In combination with Levotiroxina Sanofi and coumarin derivatives (e.g., dicumarol), you must regularly review your blood coagulation. Your doctor may need to reduce the dose of your anticoagulant medications, as levotiroxine may increase their effect.

The effect of Levotiroxina Sanofi is influenced by other medications, as indicated below:

• Ion exchange resins:

After taking Levotiroxina Sanofi, you must wait 4-5 hours before taking medications used to reduce blood lipid levels (e.g., cholestyramine, cholestipol) or eliminate high potassium or phosphate levels in the blood (calcium salts and sodium salts of polystyrene sulfonic acid, sevelamer). Otherwise, these medications will block the absorption of levotiroxine in the intestine and make it less effective.

• Bile acid sequestrants:

Colesevelam (a medication used to reduce elevated blood lipid levels) binds to levotiroxine and reduces its absorption in the intestine. Therefore, Levotiroxina Sanofi must be taken at least 4 hours before colesevelam.

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

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

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

Propylthiouracil (used for hyperactive thyroid), glucocorticoids (adrenocortical hormones, “cortisone”), and beta-blockers (used to reduce heart rate and blood pressure) block the conversion of levotiroxine to triiodothyronine, the more active form, and may therefore make Levotiroxina Sanofi less effective.

• Amiodarone, contrast agents containing iodine:

Amiodarone (used in the treatment of arrhythmias) and contrast agents containing iodine (some agents used in X-ray diagnosis) may, due to their high iodine content, trigger both hyperactive and hypothyroid thyroid function. You must be particularly careful 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 levotiroxine to triiodothyronine, the more active form, and may therefore affect the effect of Levotiroxina Sanofi. Your doctor may adjust the dose of Levotiroxina Sanofi.

• Tyrosine kinase inhibitors (for cancer treatment):

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

• The following medications may influence the effect of Levotiroxina Sanofi:
• • salicylates, especially at doses greater than 2.0 g/day (medications that reduce fever and relieve pain),
  • dicumarol (an anticoagulant),
  • high doses of furosemide (250 mg) (used to increase urine elimination),
  • clofibrate (used to reduce elevated blood lipid levels).
• Anticonceptives or hormone replacement therapy:

If you are taking anticonceptives containing estrogens (“the pill”) or receiving hormone replacement therapy after menopause, you may have an increased need for levotiroxine.

• Sertraline; chloroquine/proguanil:

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

• Rifampicin, carbamazepine,phenytoin, barbiturates, products containing St. John's Wort:

Rifampicin (an antibiotic), carbamazepine (used to treat seizures), phenytoin (used to treat seizures and arrhythmias), barbiturates (used for seizures, anesthesia; certain sleeping pills), and products containing St. John's Wort may weaken the effect of levotiroxine.

• Protease inhibitors (used to treat HIV infections):

If you are taking levotiroxine at the same time as protease inhibitors (lopinavir, ritonavir), your doctor will need to carefully monitor your symptoms and thyroid function. There may be some loss of levotiroxine effect when administered at the same time as lopinavir/ritonavir.

• If you are taking levotiroxine at the same time as semaglutide (an antidiabetic medication), this may affect your levotiroxine levels and your doctor may need to monitor your thyroid hormone levels and adjust the dose of Levotiroxina Sanofi.
• If you are taking or have recently taken biotin, you must inform your doctor or laboratory personnel when they are to perform laboratory tests to control your thyroid hormone levels. Biotin may affect the results of laboratory tests (see “Warnings and precautions”).
• Orlistat – used to treat obesity.

Levotiroxina 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 Levotiroxina Sanofi during and after this diet (unusually, high doses may be required), as soy products may affect the intestinal absorption of levotiroxine and make it less effective.

Do not take Levotiroxina Sanofi with coffee, as it may reduce the intestinal absorption of levotiroxine and make it less effective. After taking Levotiroxina Sanofi, you must wait at least 30 minutes to 1 hour before taking coffee. It is recommended that patients with a coffee habit and taking levotiroxine not change their “coffee habit” without their doctor monitoring and controlling their levotiroxine levels.

Pregnancy, lactation, and fertility

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

The correct treatment with thyroid hormones is particularly important during pregnancy and lactation to ensure optimal health for the mother and the fetus. Therefore, regular monitoring under the supervision of your doctor is required. Despite its extensive use during pregnancy, no adverse effects on pregnancy or the health of the fetus or newborn have been found due to levotiroxine.

Thyroid function must be reviewed during and after pregnancy. Your doctor may need to adjust the dose, as you may have an increased need for thyroid hormone due to the increase in blood estrogen levels during pregnancy.

During pregnancy, do not take Levotiroxina Sanofi at the same time as antithyroid medications (also designated as thyroid-stimulating agents), as this will result in a higher dose of the antithyroid medication. Antithyroid medications (unlike levotiroxine) can enter the bloodstream of the fetus through the placenta and cause hypothyroidism in the fetus. If you have hyperactive thyroid, your doctor must treat you during pregnancy only with low doses of antithyroid medications.

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

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

Your doctor will not perform suppression tests during pregnancy and lactation.

It is likely that hypothyroidism or hyperthyroidism will have an effect on fertility. When treating patients with hypothyroidism, the dose of Levotiroxina Sanofi 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 to investigate the effects of Levotiroxina Sanofi on the ability to drive vehicles and operate machinery.

Levotiroxina Sanofi contains sodium

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

Follow exactly the administration instructions of this medication as 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

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

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

Your doctor will be guided by the following recommendations, depending on the symptoms:

• To treat hypothyroidism, adults will start taking 25 - 50 micrograms of levotiroxine sodium per day. This dose can be increased, following the doctor's instructions, by 25 - 50 micrograms of levotiroxine sodium, at intervals of 2 to 4 weeks, up to a daily dose of 100 - 200 micrograms of levotiroxine sodium (equivalent to 1 - 2 tablets of Levotiroxina Sanofi 100 micrograms).
• To prevent new episodes of goiter after thyroid removal and to treat benign goiter, 75 - 200 micrograms of levotiroxine sodium per day (up to 2 tablets of Levotiroxina Sanofi 100 micrograms) will be taken.
• As supplementary treatment in the treatment of hyperactive thyroid with thyroid agents, 50 - 100 micrograms of levotiroxine sodium per day (equivalent to half a tablet - 1 tablet of Levotiroxina Sanofi 100 micrograms) will be taken.
• After thyroid surgery due to malignant thyroid tumor, the daily dose is 150 - 300 micrograms of levotiroxine sodium (equivalent to 1 and a half - 3 tablets of Levotiroxina Sanofi 100 micrograms).
• To investigate thyroid function through thyroid suppression test, 200 micrograms of levotiroxine sodium (equivalent to 2 tablets of Levotiroxina Sanofi 100 micrograms) will be taken daily for 14 days until the X-ray examination (gammagraphy) is performed.

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

Administration form

The total daily dose must be taken in the morning with 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 absorbed better with 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 (inactive thyroid), the daily dose is generally 100 to 150 micrograms of levotiroxine sodium per m2of body surface.

In neonates and infants with congenital hypothyroidism (inactive thyroid), rapid hormone substitution is especially important to achieve normal mental and physical development.

For this type of inactive thyroid, the recommended daily dose is 10 - 15 micrograms of levotiroxine sodium per kg of body weight, for 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 (inactive thyroid), the recommended dose of levotiroxine sodium is 12.5 - 50 micrograms per day, at the beginning 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 particularly by the levels of thyroid hormone in the blood.

Older patients, patients with coronary disease, patients with severe or long-standing hypothyroidism

In older patients, in patients with coronary disease, and in patients with severe or long-standing hypothyroidism (inactive thyroid), special care should be taken when starting treatment with thyroid hormones (a low initial dose, which is gradually increased and at longer 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.

Treatment duration

• In most cases, Levotiroxina Sanofi should be taken for a long period in cases ofhypothyroidism, after goiter or after thyroid removal, and to prevent the growth of a new goiter after goiter removal.
• When used as supplementary treatment to treat hyperactive thyroid, Levotiroxina Sanofi 100 micrograms is taken for the same time as thyroid agents (antithyroid medications).
• To treat 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 adverse effects”. Consult your doctor immediately if these symptoms appear.

In case of overdose or accidental ingestion, consult the Toxicological 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 little or if you have forgotten a dose, do not take a double dose to compensate for the missed dose. Continue taking your tablets according to your regular treatment.

If you interrupt treatment with Levotiroxina Sanofi

To be successful, you must take Levotiroxina Sanofi regularly at the dose prescribed by your doctor. Do not change, suspend, or interrupt treatment with Levotiroxina Sanofi on your own too soon, as symptoms may reappear.

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

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

Hypersensitivity to the active ingredient 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 medication administration) may occur, which can be life-threatening. Symptoms may include skin rash, itching, difficulty breathing, shortness of breath, facial swelling, lips, throat, or tongue. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room immediately.

Intolerance to thedosage, overdose

If the dosage 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 heartbeat (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 available data)

• hypersensitivity
• cardiac rhythm disorders
• chest pain with pressure (angina pectoris symptoms)
• allergic skin reactions (e.g.angioedema [difficulty breathing, or facial swelling, lips, throat, or tongue],skin 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
• sensation of heat
• menstrual disorders
• diarrhea
• vomiting
• nausea
• weight loss
• tremor
• excessive sweating
• fever
• circulatory collapse in premature infants with low birth weight (see section 2. “Warnings and precautions”).

Inform your doctor if any side effects occur.He will decide whether to reduce the daily dose or interrupt the medication for a few days. As soon as the side effect disappears, the 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 does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about 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 after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

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

Composition of Levotiroxina Sanofi 100 microgramos tablets

• The active ingredient is levotiroxine sodium. Each tablet contains 100 micrograms of levotiroxine sodium.
• The other components are: cornstarch, pregelatinized cornstarch, microcrystalline cellulose, sodium carbonate, sodium thiosulfate (F.E.), anhydrous colloidal silica, and hydrogenated ricin oil.

Appearance of the product and contents of the packaging

Levotiroxina Sanofi 100 microgramos are round, white, scored tablets on one face and with the inscription “4L” on both faces.

The tablets can be divided into two equal halves.

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

Only some sizes of packaging may be commercially available.

Marketing authorization holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing

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

Germany:L-Thyroxin Winthrop100 µg Tablets

Spain:Levotiroxina Sanofi 100 microgramos tablets

France:L-Thyroxin Henning 100 microgrammes scored tablet

Date of the last review of this leaflet:March 2023

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