Levirox

• hypersensitivity to levothyroxine sodium or any of the other ingredients of this medicine (listed in section 6.),
• adrenal insufficiency (adrenal gland failure) and the patient is not receiving appropriate replacement therapy,
• untreated hypopituitarism or if thyroid hormones are being overproduced (hyperthyroidism),
• acute heart disease (myocardial infarction or myocarditis).

Levirox should not be taken with antithyroid medications if the patient is pregnant (see "Pregnancy and breastfeeding" below).

Warnings and precautions

Before starting Levirox, the patient should inform the doctor or pharmacist about any of the following heart conditions:

• insufficient blood flow in the coronary arteries (angina pectoris),
• heart failure,
• rapid and irregular heart rhythm,
• high blood pressure,
• fatty deposits in the arteries (arteriosclerosis).

It is necessary to treat these conditions before starting Levirox or before performing a thyroid suppression test. During Levirox treatment, it is necessary to frequently monitor thyroid hormone levels. The patient should tell the doctor if they are not sure if any of the above conditions apply to them or if they have not yet started treatment for them.
The doctor will perform tests to check if the patient has adrenal or pituitary gland disorders or thyroid dysfunction with uncontrolled excessive thyroid hormone production (autonomous thyroid function), as in such cases, appropriate treatment may be necessary before starting Levirox or before performing a thyroid suppression test.
When starting levothyroxine treatment in premature infants with very low birth weight, blood pressure should be regularly monitored, as a sudden decrease in blood pressure (so-called circulatory collapse) may occur.

Levirox with other medicines

The patient should tell the doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, as Levirox may affect the action of these medicines:

• antidiabetic medicines (medicines that lower blood sugar levels):Levirox may decrease the effect of antidiabetic medicines, so additional blood sugar level monitoring may be necessary, especially when starting Levirox treatment. During Levirox treatment, it may be necessary to adjust the dose of antidiabetic medicine.
• coumarin derivatives (medicines that prevent blood clot formation, such as warfarin):Levirox may enhance the effect of these medicines, which may increase the risk of bleeding, especially in the elderly. Therefore, regular monitoring of blood coagulation parameters may be necessary at the start and during Levirox treatment. During Levirox treatment, it may be necessary to adjust the dose of the anticoagulant medicine.

If the patient is taking any of the following medicines with Levirox, they should follow the recommended time intervals between taking the medicines:

• bile acid sequestrants and cholesterol-lowering medicines (such as cholestyramine or colestipol):Levirox should be taken 4 to 5 hours before taking these medicines, as they may inhibit the absorption of Levirox from the gut.
• antacids (medicines used to relieve heartburn and indigestion), sucralfate (used to treat stomach and duodenal ulcers), other medicines containing aluminum, iron-containing medicines, or calcium-containing medicines:Levirox should be taken at least 2 hours before taking these medicines, as they may otherwise reduce the effect of Levirox.

The patient should tell the doctor or pharmacist if they are taking, have recently taken, or plan to take any of the following medicines, as they may reduce the effect of Levirox:

• propylthiouracil (an antithyroid medicine),
• glucocorticoids (anti-allergic and anti-inflammatory medicines),
• beta-adrenergic blockers (medicines that lower blood pressure and are also used to treat heart conditions),
• sertraline (an antidepressant),
• chloroquine or proguanil (medicines used to treat or prevent malaria),
• medicines that stimulate certain liver enzymes, such as barbiturates (sedatives or sleep aids) or carbamazepine (an antiepileptic medicine also used to modify a certain type of pain or treat mood disorders),
• medicines containing estrogens, used in hormone replacement therapy during menopause and postmenopause or to prevent pregnancy,
• sevelamer (a phosphate binder used in patients with chronic kidney failure),
• tyrosine kinase inhibitors (medicines used to treat cancer and anti-inflammatory medicines),
• orlistat (a medicine used to treat obesity).

The patient should tell the doctor or pharmacist if they are taking, have recently taken, or plan to take any of the following medicines, as they may enhance the effect of Levirox:

• salicylates (medicines used to relieve pain and reduce fever),
• dicumarol (a medicine that prevents blood clot formation),
• high-dose furosemide (above 250 mg; a diuretic),
• clofibrate (a medicine that lowers blood lipid levels).

The patient should tell the doctor or pharmacist if they are taking, have recently taken, or plan to take any of the following medicines, as they may affect the action of Levirox:

• ritonavir, indinavir, lopinavir (protease inhibitors used to treat HIV infection),
• phenytoin (an antiepileptic medicine). Regular thyroid hormone level monitoring and Levirox dose adjustment may be necessary.

The patient should tell the doctor if they are taking amiodarone (a medicine used to treat heart rhythm disorders), as it may affect thyroid function.
The patient should tell the doctor about taking Levirox if diagnostic or imaging tests with iodine-containing contrast agents are necessary, as these tests may affect thyroid function.
The patient should tell the doctor or pharmacist about all medicines they are taking or have recently taken, including those available without a prescription.
Thyroid hormones should not be used to lose weight. Taking them will not cause weight loss if thyroid hormone levels are normal.
Increasing the dose without consulting a doctor may lead to severe and life-threatening side effects, especially if the patient is taking other weight loss medicines.

Levirox with food and drink

The patient should tell the doctor if they consume soy products, especially if they change the amount of these products they consume. Soy products may reduce the absorption of Levirox from the gut, and therefore, it may be necessary to adjust the Levirox dose.

Pregnancy and breastfeeding

During pregnancy, the patient should continue taking Levirox. The patient should discuss this with their doctor, as dose adjustment may be necessary.
If Levirox was taken with antithyroid medication for excessive thyroid hormone production, the doctor will recommend stopping Levirox after becoming pregnant.
During breastfeeding, the patient should continue taking Levirox as recommended by their doctor. The amount of levothyroxine that passes into breast milk is too small to affect the baby.

Driving and using machines

No studies have been conducted on the effects of Levirox on the ability to drive or operate machinery. It is not expected that Levirox will have any effect on the ability to drive or operate machinery, as levothyroxine is identical to the hormone that occurs naturally.

Levirox contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Levirox

This medicine should always be taken exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
The doctor will determine the appropriate dose for each patient individually, based on clinical evaluation and laboratory tests. Treatment usually starts with a small dose, which is increased every 2 to 4 weeks until the full dose, tailored to each patient, is reached.
In the first few weeks of treatment, laboratory tests will be necessary to allow the doctor to adjust the dose.
If a child is born with a thyroid disorder characterized by insufficient thyroid hormone production, it is essential to supplement them quickly. Therefore, the doctor may recommend a higher initial dose of 10 micrograms to 15 micrograms per kilogram of body weight per day for the first 3 months. Then, the doctor will adjust the dose individually.
Typical dose ranges are presented in the table below. Smaller, individually adjusted doses may be sufficient for:

• the elderly,
• patients with heart conditions,
• patients with severe or prolonged hypothyroidism,
• patients with low body weight or giant goiter.

Method of administration
Levirox is intended for oral use.
The single daily dose should be taken in the morning, on an empty stomach (at least half an hour before breakfast), preferably with a small amount of liquid, e.g., half a glass of water.

Use in children

Infants should be given the entire daily dose of Levirox once a day, at least half an hour before the first meal of the day. Immediately before administration, the tablet should be crushed and mixed with a small amount of water. The resulting suspension should be given with a small additional amount of liquid. A fresh suspension of the medicine should be prepared each time before administration.
Duration of treatment
The duration of treatment may vary depending on the reason for taking Levirox. The doctor will discuss this individually with each patient.
Most patients need to take Levirox for the rest of their lives.
The tablet can be divided into equal doses.

Overdose of Levirox

If a higher dose than recommended is taken, symptoms such as rapid heartbeat, restlessness, excitement, or involuntary movements may occur. In patients with neurological disorders, such as epilepsy, single seizures have been observed.
In patients at risk of psychotic disorders, symptoms of acute psychosis may occur.
In patients with heart conditions, cardiac symptoms can be life-threatening. In such cases, the patient should consult a doctor.

Missed dose of Levirox

The patient should not take a double dose to make up for a missed dose. The next day, they should take their usual dose of Levirox.
If the patient has any further questions about taking Levirox, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Levirox can cause side effects, although not everybody gets them.
If a higher dose of Levirox than recommended is taken or if the recommended dose is not well tolerated (e.g., if the dose is increased too quickly), some of the following side effects may occur:
Irregular or rapid heartbeat, chest pain, headache, weakness or muscle cramps, hot flashes (feeling of heat and facial flushing), fever, vomiting, menstrual disorders, pseudotumor cerebri (increased intracranial pressure), tremors, restlessness, sleep disturbances, sweating, weight loss.
If any of these side effects occur, the patient should contact their doctor. The doctor may decide to stop treatment for a few days or reduce the daily dose until the symptoms disappear.
Allergic reactions to the ingredients of Levirox are possible (see section 6).
Allergic reactions may include facial or throat swelling (angioedema), rash, or hives (frequency not known, cannot be estimated from available data). If such an allergic reaction occurs, the patient should consult a doctor immediately.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health:
Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Levirox

Medicines should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton. The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levirox contains

• The active substance of Levirox is levothyroxine sodium. Each tablet contains 25 micrograms, 50 micrograms, 75 micrograms, 100 micrograms, 125 micrograms, or 150 micrograms of levothyroxine sodium.
• The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, and sodium stearyl fumarate.

What Levirox looks like and contents of the pack

Levirox 25 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with "25" embossed on one side and a score line on the other side.
Levirox 50 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with "50" embossed on one side and a score line on the other side.
Levirox 75 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with "75" embossed on one side and a score line on the other side.
Levirox 100 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with "100" embossed on one side and a score line on the other side.
Levirox 125 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with "125" embossed on one side and a score line on the other side.
Levirox 150 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with "150" embossed on one side and a score line on the other side.
Levirox is available in cartons containing blisters.
Pack sizes:
100 tablets

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer/Importer

Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

Date of last revision of the leaflet: