Levotiroxine Aristo 100 micrograms tablets EFG

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levotiroxina Aristo 100 micrograms tablets EFG

sodium levothyroxine

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

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

Contents of the leaflet

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

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

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

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

Levotiroxina Aristo is used for:

• Replacing the missing thyroid hormone in all forms of underactive thyroid function (hypothyroidism) or after removal of the thyroid gland,
• Preventing the recurrence of goitres after goitre surgery in patients with normal thyroid function,
• Treating non-malignant goitre (benign struma) in patients with normal thyroid function,
• As additional therapy in the antithyroid treatment of an overactive thyroid, after normal metabolic status has been achieved,
• In malignant thyroid tumours, particularly after surgery, to suppress the growth of new tumours and as replacement for the missing thyroid hormone,
• In thyroid suppression testing

2. What you need to know before taking Levotiroxina Aristo

Do not take Levotiroxina:

• if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6);
• if you have a condition caused by untreated overactivity of the thyroid gland (hyperthyroidism, thyrotoxicosis);
• if you have adrenal insufficiency (adrenal gland deficiency) and do not have adequate replacement therapy;
• if you have untreated pituitary gland dysfunction;
• if you have an acute heart condition (heart attack or inflammation of the heart (carditis));
• if you are pregnant, do not take Levotiroxina together with other medications used to treat overactive thyroid (antithyroid drugs).

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

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

Warnings and precautions

Thyroid hormones must not be used for weight loss. Taking thyroid hormones will not reduce your weight if your thyroid hormone levels are within the normal range. Increasing the dose without specific medical indication may lead to serious adverse effects or even life-threatening complications, especially when combined with certain weight-loss products (see section 2 “Other medicines and levothyroxine”).

If you need to switch from your current medication to another containing levothyroxine, a thyroid imbalance may occur. Speak with your doctor if you have any concerns about changing your medication. Close monitoring (clinical and biological) is required during the transition period. Inform your doctor if you experience any adverse effects, as this may indicate that your dose needs adjustment (either increased or decreased).

Talk to your doctor or pharmacist before taking levothyroxine:

• if you have congenital or childhood-acquired hypothyroidism;
• if you have heart problems such as angina pectoris, coronary heart disease, weak heart muscle, heart rhythm disorders, or high blood pressure or arteriosclerosis;
• if you recently had a heart attack;
• if you are being treated with certain anticoagulants (blood-thinning medicines) (e.g., phenprocoumon). You may need to adjust the dose of this medicine (see section 2 “Other medicines and Levotiroxina Aristo”);
• if you have diabetes, as your antidiabetic treatment dose may need adjustment, since levothyroxine may increase blood sugar levels (see section 2 “Other medicines and Levotiroxina Aristo”);
• in postmenopausal women: your thyroid function should be monitored more frequently to avoid elevated levothyroxine levels in the blood, which may cause osteoporosis (brittle bones);
• if you have epilepsy (seizures): epileptic seizures have rarely been reported when starting levothyroxine treatment or increasing the dose rapidly;
• if you have myxoedema (swelling of the skin and subcutaneous tissue), as it may be necessary to reduce the dose of Levotiroxina Aristo;
• if you have intestinal disease, as this may impair drug absorption (malabsorption syndromes, e.g., coeliac disease, lactose intolerance), and you may require additional treatment to ensure effective therapy with Levotiroxina Aristo;
• if you have an underactive adrenal gland (adrenal insufficiency), pituitary gland dysfunction, or thyroid gland dysfunction with uncontrolled overproduction of thyroid hormones, as these conditions must be medically managed before starting Levotiroxina;
• if you are undergoing laboratory tests to monitor 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 can interfere with laboratory test results. Depending on the test, results may be falsely elevated or falsely reduced due to biotin. Your doctor may advise you to stop taking biotin before blood tests. Be aware that other products you may be taking, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin, which could affect laboratory test results. Inform your doctor or laboratory staff if you are taking these products (see information in section “Other medicines and Levotiroxina Aristo”).

Contact your doctor if you experience signs of psychotic disorders.

Hemodynamic parameters should be closely monitored when starting levothyroxine treatment in very low birth weight premature infants, as circulatory collapse may occur due to adrenal function immaturity.

In elderly patients, the dose should be carefully and individually adjusted, especially in those with heart conditions, and they should be closely supervised by their doctor.

Blood tests Before starting levothyroxine, your doctor will perform a blood test to determine how much thyroxine your thyroid gland is producing and what dose of medication you require. Once you start taking the medicine, your doctor will arrange regular blood tests to ensure the treatment is working properly.

Other medicines and levothyroxine

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

If you are about to undergo a test involving iodinated contrast agents, 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 undergoing laboratory tests to monitor thyroid hormone levels. Biotin can affect laboratory test results (see Warnings and precautions).

The following medicines may affect how levothyroxine works:

• antiepileptic drugs or seizure medications such as carbamazepine, phenytoin, primidone, and barbiturates;
• products containing St. John’s wort (a herbal medicine);
• sertraline, lithium: used to treat depression, mood disorders, and anxiety disorders;
• statins such as simvastatin and lovastatin (used to treat high cholesterol);
• rifampicin, used to treat infections;
• 5-fluorouracil, imatinib, and sunitinib (used in anticancer [antineoplastic] treatment);
• beta-receptor blocking drugs such as propranolol, atenolol, and sotalol, used to treat high blood pressure and heart problems;
• estrogen-containing medicines for hormone replacement therapy (HRT) and contraception ("the pill");
• androgen-containing medicines for male hormone replacement therapy;
• glucocorticoids such as cortisone, hydrocortisone, prednisolone, and dexamethasone, used to treat inflammation;
• amiodarone: used to treat irregular heartbeats;
• anti-inflammatory medicines such as phenylbutazone or acetylsalicylic acid;
• methadone, used in opioid substitution treatment;
• furosemide: used to treat high blood pressure or oedema;
• propylthiouracil, used to treat overactive thyroid;
• iodide (used to protect the thyroid gland from radiation);
• oral contrast agents – taken before certain scans to improve visibility of body parts;
• 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 omeprazole, esomeprazole, pantoprazol, rabeprazol, and lansoprazol), used to reduce stomach acid production, which may reduce intestinal absorption of levothyroxine and thus reduce its effectiveness. If you are taking levothyroxine while also receiving a proton pump inhibitor, your doctor should monitor your thyroid function and may need to adjust the dose of Levotiroxina Aristo.

Levothyroxine should be taken at least 4–5 hours before taking the following medicines:

• calcium, magnesium, aluminium, iron, or lanthanum supplements;
• colestyramine, colestipol, or clofibrate (used to lower blood cholesterol levels);
• sodium polystyrene sulfonate (used to treat kidney disease/nephropathy);
• orlistat (weight-loss medicine);
• cimetidine (used to reduce excess stomach acid);
• proton pump inhibitors such as omeprazole, esomeprazole, used to treat excess stomach acid;
• sucralfate, antacids (used to treat stomach ulcers).

The following medicines may be affected by levothyroxine:

• anticoagulant medicines to prevent blood clots, such as warfarin, dicoumarol, and phenprocoumon;
• diabetes medicines 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 remedies);
• digoxin, used to treat heart problems;
• phenytoin, an antiepileptic medicine.

Taking levothyroxine with food and drink

Soy-containing products and high-fibre foods may affect the absorption of levothyroxine. As a result, your doctor may need to adjust your levothyroxine dose.

Pregnancy and breastfeeding

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

Consistent thyroid hormone treatment is especially important during pregnancy and breastfeeding, and therefore must continue under the supervision of your treating doctor.

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

Even with high-dose levothyroxine treatment, the amount of thyroid hormone passing into breast milk during lactation is very low and therefore harmless.

Suppression tests must not be performed during pregnancy and breastfeeding.

Driving and using machines

Levotiroxina Aristo is not expected to affect the ability to drive or use machines, as levothyroxine is identical to natural thyroid hormone.

Levotiroxina Aristo contains sodium

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

3. How to take Levotiroxina Aristo

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

Particular caution should be exercised 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 gradually increased 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, the tablets are available in graduated strengths ranging from 25 to 200 micrograms of Levotiroxina Aristo, meaning that in most cases only one tablet per day is required.

Your doctor will determine your individual dose based on laboratory examinations and tests. In general, treatment is started with a low dose, which is increased every 2 to 4 weeks until the individual full dose is reached. During the first weeks of treatment, you will have laboratory appointments to adjust the dose.

Administration method The total daily dose should be taken in the morning on an empty stomach, at least half an hour before breakfast, since the active substance is better absorbed when the stomach is empty than before or after a meal. The tablets should be swallowed whole, without chewing, with a glass of water.

For infants, the total daily dose should be given at least half an hour before the first meal of the day. To do this, the tablet may be allowed to dissolve in a small amount of water. If necessary, you may split the tablet. However, it is not recommended to crush or dissolve it in water or other liquids, as the dose may not be accurate.

Levothyroxine may be divided into equal parts.

Duration of administration

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

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

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

In additional therapy for the treatment of an overactive thyroid, you should take Levotiroxina Aristo for as long as you are taking an antithyroid 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 achieved the desired result within this period, other treatment options should be considered.

For thyroid suppression testing, 150 or –200 micrograms of Levotiroxina Aristo are taken daily for 14 days.

If you take more levotiroxina than you should

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

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 flushes, sweating, dilated pupils, diarrhea, tremors, difficulty sleeping, anxiety or nervousness, fatigue or emotional disturbances, seizures. These symptoms may take up to 6 days to appear. Bring all remaining tablets and this leaflet so that medical personnel know exactly what has been taken.

If you forget to take levotiroxina

If you miss a dose, take your usual dose at the next scheduled time. Do not take a double dose to make up for missed doses. If you are unsure, consult your doctor or pharmacist.

If you stop taking levotiroxina

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Some patients may experience a serious adverse reaction at high levels of thyroid hormone. This is known as "thyroid storm". Stop taking the tablets and go to 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.

Inform your doctor or pharmacist if any of the following adverse effects persist, worsen, or if you notice any adverse effects not listed below.

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 beginning of treatment. They usually resolve when the dose is reduced or treatment is stopped. Inform your doctor if side effects occur. He or she will decide whether the daily dose should be reduced or whether you should stop taking the tablets for a few days. However, you must not change the dose or stop taking the tablets without first consulting your doctor.

Frequency not known: 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, pounding heartbeat (very strong heartbeats)
• heart failure, heart attack
• high blood pressure, flushing
• difficulty breathing (dyspnea)
• diarrhea, vomiting, malaise, stomach pains
• increased sweating, itching, skin rash, urticaria
• muscle cramps, muscle weakness, joint pain, a decrease in 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 being unwell
• weight loss
• overactive thyroid (hyperthyroidism)

Additional side effects in children

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

• increased intracranial pressure in children not caused by a tumour or other diseases (benign intracranial hypertension)

Frequency not known: frequency cannot be estimated from the available data

• premature interruption of the child's growth due to changes in bone growth
• mild hair loss in children
• skull deformity in babies caused by early closure of the joints in the skull bones (craniosynostosis)
• heat intolerance

In case of hypersensitivity to levothyroxine or any of the other components of Levotiroxina Aristo, allergic reactions may occur affecting 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levotiroxina Aristo

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

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

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused or expired containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

• The active substance is levothyroxine sodium anhydrous. Each tablet contains 100 micrograms of levothyroxine sodium anhydrous.
• The other components are microcrystalline cellulose, corn starch, heavy magnesium oxide, sodium starch glycolate from corn (Type A), vegetable magnesium stearate (E572).

Appearance of the product and contents of the pack

White, round, uncoated, biconvex tablets (scored on one side) with a break mark 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 supplied in PVC/aluminum blisters in packs containing 15, 20, 25, 30, 50, 60, 84, 90 and 100 tablets.

Only certain pack 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under 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 microgram 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 most recent review of this summary: June 2023

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