Levirox

• allergy 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 produced in excess (hyperthyroidism),
• acute heart disease (myocardial infarction or myocarditis).

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

Warnings and precautions

Before starting treatment with Levirox, the patient should inform their doctor or pharmacist if they have any of the following heart diseases:

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

It is necessary to treat these disorders before starting treatment with Levirox or before performing a thyroid suppression test. During treatment with Levirox, it is necessary to frequently monitor thyroid hormone levels. The patient should tell their doctor if they are not sure if any of the above diseases 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 disorders or thyroid dysfunction with uncontrolled excessive thyroid hormone production (autonomous thyroid function), as in such cases, appropriate treatment may be necessary before starting treatment with Levirox or before performing a thyroid suppression test.
When starting treatment with levothyroxine 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.
The patient should discuss with their doctor:

Levirox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 monitoring of blood sugar levels may be necessary, especially at the start of treatment with Levirox. During treatment with Levirox, it may be necessary to adjust the dose of antidiabetic medicine.
• coumarin derivatives (medicines that prevent blood clots, 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 treatment with Levirox. During treatment with Levirox, it may be necessary to adjust the dose of anticoagulant medicine from the coumarin derivative group.

If the patient is taking any of the following medicines at the same time as Levirox, they should strictly follow the recommended time intervals between taking the individual 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 (used to alleviate heartburn caused by stomach acid), sucralfate (used to treat stomach and intestinal ulcers), other medicines containing aluminum, iron-containing medicines, calcium-containing medicines:Levirox should be taken at least 2 hours before taking these medicines, as otherwise, they may reduce the effect of Levirox.

The patient should tell their doctor or pharmacist if they are currently 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),
• corticosteroids (anti-allergic and anti-inflammatory medicines),
• beta-adrenergic blockers (medicines that lower blood pressure, also used to treat heart diseases),
• sertraline (an antidepressant),
• chloroquine or proguanil (medicines used to treat or prevent malaria),
• medicines that stimulate certain liver enzymes, such as barbiturates (sedatives, sleeping pills) 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 their doctor or pharmacist if they are currently 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 alleviate pain and reduce fever),
• dicumarol (a medicine that prevents blood clots),
• furosemide in high doses, above 250 mg (a diuretic),
• clofibrate (a medicine that lowers blood lipid levels).

The patient should tell their doctor or pharmacist if they are currently 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, medicines used to treat HIV infections),
• phenytoin (an antiepileptic medicine). Regular monitoring of thyroid hormone levels and adjustment of the Levirox dose may be necessary.

The patient should tell their doctor if they are taking amiodarone (a medicine used to treat heart rhythm disorders), as it may affect thyroid function.
The patient should tell their doctor about taking Levirox if it is necessary to perform a diagnostic or imaging test with a contrast agent containing iodine, as this test involves an injection that may affect thyroid function.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.
Thyroid hormones should not be used to reduce weight. Taking them will not lead to weight loss if thyroid hormones are maintained at the proper level.
Increasing the dose of the medicine without consulting a doctor may lead to serious and life-threatening side effects, especially if the patient is taking other weight loss medicines at the same time.

Levirox with food and drink

The patient should tell their 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 small intestine, and therefore, it may be necessary to modify the dose of Levirox.

Pregnancy and breastfeeding

During pregnancy, the patient should continue taking Levirox. They should discuss this with their doctor, as it may be necessary to adjust the dose.
If Levirox was taken at the same time as an antithyroid medicine to treat 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 effect of Levirox on the ability to drive and use machines. It is not expected that Levirox will have any effect on the ability to drive and use machines, 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 considered "sodium-free".

3. How to take Levirox

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The doctor will determine the appropriate dose for each patient individually, based on clinical assessment and laboratory tests. Treatment usually starts with a small dose, which is increased every 2 to 4 weeks until the full dose, adjusted individually for each patient, is reached.
In the first few weeks of treatment, laboratory tests will be necessary to allow the doctor to adjust the appropriate dose.
If a child is born with a thyroid disease characterized by insufficient 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 disease,
• 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 at one time, 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 an additional small 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 with each patient how long they should take the medicine.
Most patients need to take Levirox for the rest of their lives.
The tablet can be divided into equal doses.

Taking a higher dose of Levirox than recommended

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 disease, cardiac symptoms may be life-threatening. In such cases, the patient should consult a doctor.

Missing a dose of Levirox

The patient should not take a double dose of the medicine to make up for a missed dose. The next day, they should take their usual dose of the medicine.
If the patient has any further doubts about taking Levirox, they should consult 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 prescribed 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, pseudo-tumor cerebri (increased pressure in the head), tremors, restlessness, sleep disturbances, sweating, weight loss, diarrhea.
If any of the above 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.
It is possible to have allergic reactions to the ingredients of Levirox (see section 6. "What does Levirox contain").
Allergic reactions may include swelling of the face or throat (angioedema), rash, or hives (frequency not known, cannot be estimated from available data). If such an allergic reaction occurs, the patient should immediately consult a doctor.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
tel.: +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 gather more information on the safety of the medicine.

5. How to store Levirox

The medicine should be stored out of 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 packaging and other information

What does Levirox contain

• 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 silicon dioxide, 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 the inscription "25" on one side and a dividing line on the other side.
Levirox, 50 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with the inscription "50" on one side and a dividing line on the other side.
Levirox, 75 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with the inscription "75" on one side and a dividing line on the other side.
Levirox, 100 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with the inscription "100" on one side and a dividing line on the other side.
Levirox, 125 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with the inscription "125" on one side and a dividing line on the other side.
Levirox, 150 micrograms, tablets are white or almost white, round tablets with a diameter of 7.5 mm, with the inscription "150" on one side and a dividing 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.
[email protected]

Date of last revision of the leaflet: