LEVOTIROXINE ARISTO 100 micrograms TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Levotiroxina Aristo 100 micrograms EFG tablets

levotiroxina 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 Aristo and what is it used for
2. What you need to know before you take Levotiroxina Aristo
3. How to take Levotiroxina Aristo
4. Possible side effects
5. Storage of Levotiroxina Aristo
6. Contents of the pack and further information

1. What is Levotiroxina Aristo and what is it used for

Thyroxine is a hormone that is naturally produced in the body by the thyroid gland. Levotiroxina sodium is a synthetic thyroid hormone that is chemically identical to this hormone.

This medicine is used to replace the missing thyroid hormone or to relieve the stress on the thyroid gland.

Levotiroxina Aristo is used for:

• To replace the missing thyroid hormone in all forms of underactive thyroid function (hypothyroidism) or after the removal of the thyroid gland,
• to prevent the recurrence of new goiters after thyroid surgery in patients with normal thyroid function,
• to treat non-malignant goiter (benign struma) in patients with normal thyroid function,
• as additional therapy in the antithyroid treatment of an overactive thyroid, after the metabolic state has been normalized,
• for malignant thyroid tumors, particularly after surgery to suppress the growth of new tumors and as a supplement for the missing thyroid hormone,
• in the thyroid suppression test

2. What you need to know before you take Levotiroxina Aristo

Do not takeLevotiroxinaif:

• you are allergic to levotiroxina or any of the other ingredients of this medicine (listed in section 6);

• you have an untreated overactive thyroid gland (hyperthyroidism, thyrotoxicosis);
• you have an untreated adrenal gland deficiency (adrenal insufficiency) and do not have adequate replacement therapy;
• you have an untreated pituitary gland disorder;
• you have acute heart disease (heart attack or heart inflammation);
• you are pregnant, do not take Levotiroxina with other medicines used to treat an overactive thyroid gland (antithyroid medicines).

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

• coronary artery disease,
• chest pain with chest pressure (angina pectoris),
• fat deposits in the arteries (arteriosclerosis),
• high blood pressure (hypertension),
• conditions in which the pituitary gland/adrenal glands do not produce enough hormones (pituitary and/or adrenal insufficiency)
• areas of the thyroid gland that produce uncontrolled amounts of thyroid hormone (thyroid autonomy)

Warnings and precautions

Thyroid hormones should not be used for weight loss. Taking thyroid hormones will not help you lose weight if your thyroid hormone levels are normal. If you increase the dose without being specifically advised to do so by your doctor, you may experience serious side effects or even life-threatening effects, especially in combination with certain weight loss products (see section 2 "Other medicines and levotiroxina").

If you need to change your medicine to another one that contains levotiroxina, a thyroid imbalance may occur. Talk to your doctor if you have any questions about changing your medicine. During the transition period, close monitoring (clinical and biological) is required. You should tell your doctor if you experience any side effects, as this may indicate that your dose needs to be adjusted by increasing or decreasing it.

Talk to your doctor or pharmacist before taking levotiroxina,

• if you have had an underactive thyroid gland since birth or acquired in childhood;
• if you have heart problems such as angina pectoris, coronary artery disease, weak heart muscle, heart rhythm disorders, or high blood pressure or arteriosclerosis;
• if you have recently had a heart attack;
• if you are being treated with certain anticoagulants (blood-thinning medicines) (e.g., phenprocoumon). You may need to change the dose of this medicine (see section 2. "Other medicines and Levotiroxina Aristo);
• if you have diabetes, as you may need to adjust the dose of your antidiabetic treatment, as levotiroxina may increase blood sugar levels (see section 2. "Other medicines and Levotiroxina Aristo);
• in postmenopausal women, their thyroid function should be monitored more frequently to avoid an increase in levotiroxina levels in the blood, which can cause osteoporosis (brittle bones);
• if you have epilepsy (seizures), as rare cases of seizures have been reported when starting treatment with levotiroxina or rapidly increasing the dose;
• if you have myxedema (swelling of the skin and subcutaneous tissue), as the dose of Levotiroxina Aristo may need to be reduced;
• if you have intestinal disease, as it may also inhibit the absorption of the medicine (malabsorption syndromes, e.g., celiac disease, lactose intolerance), and you may need treatment to ensure that your treatment with Levotiroxina Aristo works properly.
• if you have an underactive adrenal gland (adrenal insufficiency), a pituitary gland disorder, or a thyroid gland disorder with uncontrolled overproduction of thyroid hormones, as this must be medically controlled before starting to take Levotiroxina.
• If you are going to have laboratory tests to check your thyroid hormone levels, you should inform your doctor or the 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 advise 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 the laboratory staff if you are taking these products (see the information in the section "Other medicines and Levotiroxina Aristo").

Contact your doctor if you experience signs of psychotic disorders.

When starting treatment with levotiroxina in premature newborns with very low birth weight, hemodynamic parameters should be monitored due to the risk of circulatory collapse caused by the immaturity of adrenal function.

In the elderly, the dose should be carefully and individually adjusted, for example, for those with heart problems, and they should be supervised by their doctor.

Blood testsBefore starting to take levotiroxina, your doctor will perform a blood test to determine how much thyroxine your thyroid gland is producing and what dose of medicine you will need. Once you start taking the medicine, your doctor will want you to have regular blood tests to see if the medicine is working properly.

Other medicines andlevotiroxina

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription, herbal remedies, and vitamin supplements. Many medicines affect the way levotiroxina works. The effects of other medicines can also be affected by levotiroxina.

If you are about to have a test with iodine-based contrast media, you should inform your doctor that you are taking Levotiroxina Aristo.

If you are taking or have recently taken biotin, you should inform your doctor or the 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).

The following medicines may affect how levotiroxina works:

• medicines to treat epilepsy or seizures, such as carbamazepine, phenytoin, primidone, and barbiturates
• products containing hypericum (a plant-based medicine),
• sertraline, lithium: to treat depression, mood, and anxiety disorders
• Statins such as simvastatin and lovastatin (used to treat high cholesterol)
• rifampicin, to treat infections
• 5-fluorouracil, imatinib, and sunitinib (used for antineoplastic treatment [against cancer])
• beta-blocker medicines such as propranolol, atenolol, and sotalol, used to treat high blood pressure and heart problems
• medicines containing estrogens for hormone replacement therapy (HRT) and contraception ("the pill")
• medicines containing androgens for male hormone replacement therapy
• glucocorticoids, such as cortisone, hydrocortisone, prednisolone, and dexamethasone, used to treat inflammation
• amiodarone: to treat irregular heartbeats
• anti-inflammatory medicines, such as phenylbutazone or acetylsalicylic acid
• methadone, used for opioid substitution treatment
• furosemide: to treat high blood pressure or edema
• propylthiouracil, used to treat an overactive thyroid gland
• iodide (used to protect the thyroid gland from radiation)
• oral contrast agents - taken before certain examinations to make parts of the body visible on the scan.
• chloroquine, proguanil, used for malaria prophylaxis and rheumatic diseases.
• ritonavir, used to control HIV and chronic hepatitis C virus
• weight loss medicines (e.g., orlistat)
• proton pump inhibitors (such as omeprazol, esomeprazol, pantoprazol, rabeprazol, and lansoprazol) are used to reduce the amount of acid produced by the stomach, which can reduce the intestinal absorption of levotiroxina and make it less effective. If you are taking levotiroxina at the same time as a proton pump inhibitor, your doctor should monitor your thyroid function and may need to adjust the dose of Levotiroxina Aristo.

Levotiroxina should be taken at least 4-5 hours before taking the following medicines:

• Calcium, magnesium, aluminum, iron, or lanthanum supplements;
• Cholestyramine, colestipol, or clofibrate (used to reduce cholesterol levels in the blood);
• Sodium polystyrene sulfonate (used to treat kidney disease);
• Orlistat (weight loss medicines);
• Cimetidine (used to reduce excess stomach acid);
• Proton pump inhibitors, such as omeprazol, esomeprazol, used to treat excess stomach acid;
• Sucralfate, antacids (to treat stomach ulcers);

The following medicines may be affected by levotiroxina:

• anticoagulant medicines to prevent blood clot formation, such as warfarin, dicumarol, and phenprocoumon;
• medicines to treat diabetes, such as insulin and metformin;
• tricyclic antidepressants, such as amitriptyline, imipramine, and dosulepin;
• medicines that stimulate the sympathetic nervous system, such as adrenaline (used to treat severe allergic reactions) or phenylephrine (a decongestant found in many cold and flu treatments);
• digoxin, to treat heart problems.
• Phenytoin, an antiepileptic medicine

Takinglevotiroxinawith food and drink

Products containing soy and foods with high fiber content may affect the absorption of levotiroxina. As a result, your doctor may need to adjust the dose of levotiroxina.

Pregnancy and breastfeeding

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

Uniform treatment with thyroid hormones is especially important during pregnancy and breastfeeding, and therefore, should continue under the supervision of the treating doctor.

The need for levotiroxina may increase during pregnancy due to the increase in blood levels of estrogen (female sex hormone). Therefore, thyroid function should be monitored during and after pregnancy, and the dose of levotiroxina should be adjusted as necessary.

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

Suppression tests should not be performed during pregnancy and breastfeeding.

Driving and using machines

Levotiroxina Aristo is not expected to have any influence on the ability to drive and use machines, as levotiroxina is identical to the natural thyroid hormone.

Levotiroxina Aristo 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 Aristo

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

Special attention should be paid when initiating treatment with thyroid hormones in elderly patients, patients with coronary heart disease, and patients with chronic or severe hypothyroidism. This means that a lower initial dose should be selected, which is then increased slowly and at longer intervals, with frequent monitoring of thyroid hormones.

Experience has shown that a lower dose is also sufficient in patients with low body weight and in patients with extensive nodular goiter.

Dosage

For individual treatment, tablets are available with graduated levels ranging from 25 to 200 micrograms of Levotiroxina Aristo, which means that in most cases, only one tablet per day is necessary.

Your doctor will determine your individual dose based on exams and laboratory tests. In general, treatment begins with a low dose, which is increased every 2 to 4 weeks, until the complete individual dose is reached. During the first weeks of treatment, you will have an appointment for laboratory analysis to adjust the dose.

Method of AdministrationThe total daily dose is taken in the morning on an empty stomach, at least half an hour before breakfast, since the active ingredient is better absorbed with an empty stomach than before or after a meal. The tablets are swallowed whole without chewing, with a glass of water.

The daily dose should be given to infants at least half an hour before the first meal of the day. For this purpose, the tablet may be dissolved in a little water. If necessary, the tablet may be divided. It is not recommended to crush or dissolve the tablet in water or other liquids, as the dose may not be accurate.

Levotiroxina can be divided into equal parts.

Duration of Administration

You should take this medication for the time indicated by your doctor.

If you have an underactive thyroid gland or have undergone thyroid surgery for a malignant thyroid tumor, you will normally take Levotiroxina Aristo for life.

For benign goiter and to prevent recurrent goiter growth, you should take Levotiroxina Aristo for a variable period of time, from several months or years to a lifetime.

In additional therapy for the treatment of hyperactive thyroid, you should take Levotiroxina Aristo while taking a thyrostatic medication.

For the treatment of benign goiter with normal thyroid function, a treatment period of 6 months to 2 years is necessary. If treatment with Levotiroxina Aristo has not produced the desired result within this period, other treatment options should be considered.

To perform thyroid suppression tests, 150 or 200 micrograms of Levotiroxina Aristo are taken daily for 14 days.

If you take morelevotiroxinathan you should

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.

The signs of an overdose may include: agitation, confusion, irritability, fever, chest pain (angina), rapid or irregular heartbeat, rapid breathing, muscle cramps, headache, restlessness, hyperactivity, hot flashes, sweating, dilated pupils, diarrhea, tremors, difficulty sleeping, anxiety or nervousness, fatigue or emotions, seizures. These symptoms may take up to 6 days to appear. Bring all remaining tablets and this prospectus so that medical personnel know exactly what you have taken.

If you forget to takelevotiroxina

If you forget a dose, take the usual dose when your next dose is due. Do not take a double dose to make up for missed individual doses. If you are unsure, consult your doctor or pharmacist.

If you interrupt treatment withlevotiroxina

For your treatment to be successful, you must take Levotiroxina Aristo regularly at the dose prescribed by your doctor. Under no circumstances should you change, suspend, or interrupt the prescribed treatment without consulting your doctor, as symptoms may recur.

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

4. Possible Adverse Effects

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

Stop taking the tablets and go to the hospital immediately if you have:

• an allergic reaction such as swelling of the eyelids, tongue, lips, and/or throat and/or difficulty swallowing or hives with difficulty breathing (angioedema), rash, or itching (especially if it affects the whole body), joint pain, sensitivity to the sun, general feeling of discomfort (frequency unknown). You may need urgent medical attention.

Some patients may experience a severe adverse reaction to high levels of thyroid hormone. This is called "thyroid crisis." Stop taking the tablets and go to the hospital if you have any of the following symptoms (frequency unknown):

• Very high temperature, rapid heartbeat (tachycardia), irregular heartbeats, low blood pressure, heart failure, jaundice, confusion, seizures, and coma.

Tell your doctor or pharmacist if any of the following adverse effects continue, worsen, or if you notice other adverse effects not listed.

Most adverse effects are similar to those of an overactive thyroid gland (hyperthyroidism, where the thyroid gland produces too much thyroxine), especially if the dose is increased too quickly at the start of treatment. They usually disappear when the dose is reduced or treatment is interrupted. Inform your doctor if side effects occur. He/She will decide whether to reduce the daily dose or stop taking the tablets for a few days. However, do not change the dose or suspend taking the tablets without consulting your doctor first.

Unknown frequency: the frequency cannot be estimated from the available data.

• Increased appetite
• restlessness, excitability, difficulty sleeping (insomnia)
• agitation (tremor), headache, seizures
• chest pain (angina pectoris), palpitations, irregular heartbeats, palpitations (very strong heartbeats)
• heart failure, heart attack
• high blood pressure, flushing
• difficulty breathing (dyspnea)
• diarrhea, vomiting, discomfort, stomach pain
• increased sweating, itching, skin rash, hives
• muscle cramps, muscle weakness, joint pain, a decrease in bone density (osteoporosis), particularly in postmenopausal women taking high doses for prolonged periods
• In women: irregular periods
• fever (high temperature), swelling (edema), general feeling of discomfort
• weight loss
• hyperactive thyroid (hyperthyroidism)

Additional side effects in children

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

• a increase in intracranial pressure in children that is not caused by a tumor or other diseases (benign intracranial hypertension)

Unknown frequency: the frequency cannot be estimated from the available data

• premature interruption of child growth due to changes in bone growth
• mild hair loss in children.
• skull deformity in infants caused by early closure of the joints in the skull bone (craniostenosis)
• heat intolerance

In case of hypersensitivity to levotiroxina or to any of the other components of Levotiroxina Aristo, allergic reactions may occur in the skin and respiratory tract.

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

5. Conservation of Levotiroxina Aristo

Keep this medication out of sight and reach of children.

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

Do not store at a temperature above 30°C.

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

6. Package Contents and Additional Information

• The active ingredient is anhydrous levotiroxina sodium. Each tablet contains 100 micrograms of anhydrous levotiroxina sodium.
• The other components are microcrystalline cellulose, cornstarch, heavy magnesium oxide, sodium glycolate cornstarch (Type A), vegetable magnesium stearate (E572).

Appearance of the Product and Package Contents

White, round, uncoated tablets, domed (pressure score) with a break line on one side and engraved with 100 on the other side. The tablets have a diameter of approximately 7 mm and a height of 3 mm.

The tablets are presented in PVC/Aluminum blisters in packages with 15, 20, 25, 30, 50, 60, 84, 90, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Or

Lindopharm GmbH

Neustraße 82

40721 Hilden

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Austria Levothyroxin Aristo 100 Mikrogramm Tabletten

Czech Republic Levothyroxine Aristo 100 mikrogramu tablety

Finland Levothyroxine Aristo 100 mikrogrammaa tabletit

Germany L-Thyroxin Aristo 100 Mikrogramm Tabletten

Ireland Levothyroxine sodium Aristo 100 micrgram tablets

Italy Levotiroxina DOC 100 microgrammi compresse

Netherlands Levothyroxinenatrium Aristo 100 microgram tabletten

Poland Eferox 100 mikrogramów tabletki

Portugal Levotiroxina Aristo 100 microgramas comprimidos

Spain Levotiroxina Aristo 100 microgramos comprimidos EFG

Sweden Levothyroxine Aristo 100 mikrogram tabletter

Date of the Last Revision of this Prospectus: June 2023

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