Patient Information Leaflet: Package Insert

Levotiroxina Aristo 50 microgramos tablets EFG

levotiroxine sodium

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms 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 leaflet. See section 4.

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

This medication is used to replace the missing thyroid hormone or to alleviate the stress on the thyroid gland.

Levotiroxina Aristo is used for:

• to replace the missing thyroid hormone in all forms of hypothyroidism or after thyroid gland removal,
• to prevent the reappearance of new nodules after thyroid nodule surgery in patients with normal thyroid function,
• to treat non-malignant thyroid nodules (benign goiter) in patients with normal thyroid function,
• as additional therapy in the treatment of hyperactive thyroid after achieving normal metabolic state,
• to treat malignant thyroid tumors, particularly after surgery to suppress the growth of new tumors and as a supplement for the missing thyroid hormone.

Do not takeLevotiroxina:

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

• if you have a condition caused by untreated hyperactivity of the thyroid gland (hyperthyroidism, thyrotoxicosis);
• if you have adrenal insufficiency and are not receiving adequate replacement treatment;
• if you have untreated pituitary gland deficiency;
• if you have an acute heart condition (heart attack or heart inflammation (carditis));
• if you are pregnant, do not take Levotiroxina with other medications used to treat hyperactivity of the thyroid gland (antithyroid medications).

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

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

Warnings and precautions

Thyroid hormones should not be used to lose weight. Taking thyroid hormones will not reduce your weight if your thyroid hormone levels are within a normal range. Increasing the dose without a doctor's recommendation may cause severe side effects or even be life-threatening, especially when combined with certain weight loss products (see section 2 "Other medications and Levotiroxina").

If you need to change your medication to one containing levotiroxina, a thyroid imbalance may occur. Consult your doctor if you have any doubts about changing your medication. During the transition period, close clinical and biological monitoring is required. Inform your doctor if you experience any side effects, as this may indicate that your dose needs to be adjusted.

Consult your doctor or pharmacist before taking levotiroxina,

• if you have a congenital or acquired hypothyroidism since birth or acquired in childhood;
• if you have heart problems such as angina pectoris, coronary heart disease, weak heart muscle, arrhythmias, or high blood pressure or arteriosclerosis;
• if you have recently had a heart attack;
• if you are being treated with certain anticoagulants (blood thinners) (e.g., phenprocoumon). You may need to adjust the dose of this medication (see section 2 "Other medications 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 medications and Levotiroxina Aristo");
• in women after menopause. Your thyroid function should be monitored more frequently to avoid an increase in levotiroxina levels in the blood, which may cause osteoporosis (brittle bones);
• if you have epilepsy (seizures) Rarely, seizures have been reported when starting treatment with levotiroxina or when the dose is increased rapidly;
• if you have myxoedema (swelling of the skin and subcutaneous tissue) as you may need to reduce the dose of Levotiroxina Aristo;
• if you have an intestinal disease, as it may also inhibit the absorption of the drug (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 adrenal insufficiency, pituitary gland dysfunction, or thyroid gland dysfunction with uncontrolled overproduction of thyroid hormones, as this should be medically controlled before starting to take Levotiroxina.
• If you are undergoing laboratory tests to control your thyroid hormone levels, 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 may affect the test results. 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. 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 test results. Inform your doctor or laboratory staff if you are taking these products (see section "Other medications and Levotiroxina Aristo").

Contact your doctor if you experience signs of psychotic disorders.

Thyroid hormone levels will be monitored periodically when starting treatment with levotiroxina in premature infants with very low birth weight due to the risk of a rapid drop in blood pressure (known as circulatory collapse).

In the elderly, the dose should be carefully and individually adjusted, for example, in those with heart problems, and should be closely monitored by your doctor

Blood tests
Before 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 medication you will need. Once you start taking the medication, your doctor will want you to have regular blood tests to see if the medication is working properly.

Other medications andlevotiroxina

Inform your doctor or pharmacist if you are taking/using, have taken/recently taken, or may need to take/use any other medication. This includes over-the-counter medications, herbal remedies, and vitamin supplements. Many medications affect how levotiroxina works. The effects of other medications may also be affected by levotiroxina.

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

If you are taking or have recently taken biotin, inform your doctor or laboratory staff when they are going to perform laboratory tests to control your thyroid hormone levels. Biotin may affect the test results (see Warnings and precautions).

The following medications may affect howlevotiroxina works:

• medications to treat epilepsy or seizures, such as carbamazepine, phenytoin, primidone, and barbiturates
• products containing hypericum (a plant-based medication),
• sertraline, lithium: to treat depression, mood disorders, 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 cancer treatment)
• beta-blockers such as propranolol, atenolol, and sotalol, used to treat high blood pressure and heart problems
• hormone replacement therapy (HRT) and birth control pills ("the pill") containing estrogens
• hormone replacement therapy (HRT) for men containing androgens
• glucocorticoids, such as cortisone, hydrocortisone, prednisolone, and dexamethasone, used to treat inflammation
• amiodarone: to treat irregular heartbeats
• anti-inflammatory medications, such as phenylbutazone or aspirin
• methadone, used for opioid substitution treatment
• furosemide: to treat high blood pressure or edema
• propylthiouracil, used to treat hyperactive thyroid
• iodine (used to protect the thyroid gland from radiation)
• oral contrast agents - taken before certain explorations to make body parts appear better in the scan.
• chloroquine, proguanil, used for malaria prevention and rheumatic diseases
• ritonavir, used to control HIV and chronic hepatitis C virus
• weight loss medications (e.g., orlistat)
• proton pump inhibitors (e.g., omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) are used to reduce stomach acid production, which may reduce intestinal levotiroxina absorption and make it less effective. If you are taking levotiroxina 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 Aristo.

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

• Calcium, magnesium, aluminum, iron, or lanthanum supplements;
• Colestiramine, colestipol, or clofibrate (used to reduce blood cholesterol levels);
• Sodium polystyrene sulfonate (used to treat kidney disease nephropathy);
• Orlistat (weight loss medications);
• Cimetidine (used to reduce excess stomach acid);
• Inhibitors of the proton pump, such as omeprazole, esomeprazole, used to treat excess stomach acid;
• Sucralfate, antacids (used to treat stomach ulcers);

The following medications may be affected by levotiroxina:

• blood thinners to prevent blood clotting, such as warfarin, dicumarol, and phenprocoumon;
• medications to treat diabetes, such as insulin and metformin;
• tricyclic antidepressants, such as amitriptyline, imipramine, and dosulepine;
• medications 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, used to treat heart problems.
• Phenytoin, an antiepileptic medication

Levotiroxina with food and drinks

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

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor before taking this medication.

Uniform treatment with thyroid hormones is especially important during pregnancy and lactation and should therefore be continued under the supervision of your doctor.

The need for levotiroxina may increase during pregnancy due to the increase in blood estradiol levels (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 lactation is very low and therefore harmless.

Do not perform suppression tests during pregnancy and lactation

Driving and operating machines

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

Levotiroxina Aristo contains sodium

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

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

Special attention should be paid when starting treatment with thyroid hormones in elderly patients, patients with coronary heart disease, and patients with chronic or intense hypothyroidism. This means that an initial lower 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 needed.

Your doctor will determine your individual dose based on examinations 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 a scheduled laboratory analysis to adjust the dose.

Administration form
The 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.

Give the daily dose to infants at least half an hour before the first meal of the day. To do this, it is allowed to let the tablet dissolve in a little water. If necessary, you can divide the tablet. Do not recommend crushing or dissolving in water or other liquids, as the dose may not be exact.

Levotiroxina can be divided into equal parts.

Duration of administration

You should take this medication for the time your doctor tells you.

If you have a less active thyroid gland or have undergone thyroid surgery for malignant thyroid tumor, you will usually take Levotiroxina Aristo for life.

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

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

If you take morelevotiroxinathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 heart rate, rapid breathing, muscle cramps, headache, restlessness, hyperactivity, hot flashes, sweating, dilated pupils, diarrhea, tremors, difficulty sleeping, anxiety or nervousness, fatigue or emotions, convulsions. These symptoms may take up to 6 days to appear. Bring all remaining tablets and this leaflet so that the medical staff knows exactly what you have taken.

If you forgot to takelevotiroxina

If you forget a dose, take the usual dose when it is due again. Do not take a double dose to compensate for the missed doses. If you are unsure, consult your doctor or pharmacist

If you interrupt the treatment withlevotiroxina

To be successful, you must take Levotiroxina Aristo regularly at the prescribed dose. In no case should you change, suspend or interrupt the prescribed treatment without consulting your doctor, as symptoms may reappear.

If you have any other questions 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.

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

• an allergic reaction such asswelling of eyelids, tongue, lips, and/or throat and/or difficulty swallowing or rashes withdifficulty breathing (angioedema),exanthema or itching (especially if it affects the entire body), joint pain, sun sensitivity, general feeling of discomfort (unknown frequency). 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 (unknown frequency):

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

Inform your doctor or pharmacist if any of the following side effects continue, worsen, or if you observe other side effects that do not appear in the list.

Most side 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 beginning of treatment. They usually disappear when the dose is reduced or treatment is stopped. Inform your doctor if side effects occur. He/she will decide if the daily dose should be reduced or if you should stop taking the tablets for a few days. However, do not change the dose or stop 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 (trembling), 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, urticaria
• muscle cramps, muscle weakness, joint pain,Decreased bone density (osteoporosis), particularly in women who have gone through menopause and are taking high doses for prolonged periods
• In women: irregular periods
• fever (high temperature), swelling (edema), general feeling of discomfort
• weight loss
• overactive thyroid gland (hyperthyroidism)

Additional side effects in children

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

• an increase in intracranial pressurein 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
• light hair loss in children.
• craniosynostosis in newborns caused by early closure of the skull bone joints (craniostenosis)
• heat intolerance

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

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 on 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 box and on the blister pack 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 disposed of through drains or in the trash. Dispose of packaging and medications that you no longer need at theSIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need. By doing so, you will help protect the environment.

• The active ingredient is levothyroxine sodium anhydrous. Each tablet contains 50 micrograms of levothyroxine sodium anhydrous.
• The other components are microcrystalline cellulose, cornstarch, heavy magnesium oxide, cornstarch glycolate sodium (Type A), vegetable magnesium stearate (E572).

Appearance of the product and contents of the package

White, round, uncoated, domed (pressed notch) tablets with a break line on one side and engraved with 50 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 commercially available.

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

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:

AustriaLevothyroxin Aristo50Mikrogramm Tabletten

Czech RepublicLevothyroxine Aristo50mikrogramu tablety

FinlandLevothyroxine Aristo50mikrogrammaa tabletit

GermanyL-Thyroxin Aristo50Mikrogramm Tabletten

IrelandLevothyroxine sodium Aristo50micrgram tablets

ItalyLevotiroxina DOC50microgrammi compresse

NetherlandsLevothyroxinenatrium Aristo50microgram tabletten

PolandEferox50mikrogramów tabletki

PortugalLevotiroxina Aristo 50 microgramas comprimidos

SpainLevotiroxina Aristo 50 microgramos comprimidos EFG

SwedenLevothyroxine Aristo 50 mikrogram tabletter

Last review date of this leaflet: June 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/