Tirosint Sol

PATIENT INFORMATION LEAFLET

TIROSINT SOL, 13 micrograms, oral solution in a single-dose container

TIROSINT SOL, 25 micrograms, oral solution in a single-dose container

TIROSINT SOL, 50 micrograms, oral solution in a single-dose container

TIROSINT SOL, 75 micrograms, oral solution in a single-dose container

TIROSINT SOL, 88 micrograms, oral solution in a single-dose container

TIROSINT SOL, 100 micrograms, oral solution in a single-dose container

TIROSINT SOL, 112 micrograms, oral solution in a single-dose container

TIROSINT SOL, 125 micrograms, oral solution in a single-dose container

TIROSINT SOL, 137 micrograms, oral solution in a single-dose container

TIROSINT SOL, 150 micrograms, oral solution in a single-dose container

TIROSINT SOL, 175 micrograms, oral solution in a single-dose container

TIROSINT SOL, 200 micrograms, oral solution in a single-dose container

Sodium levothyroxine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is TIROSINT SOL and what is it used for
• 2. Important information before taking TIROSINT SOL
• 3. How to take TIROSINT SOL
• 4. Possible side effects
• 5. How to store TIROSINT SOL
• 6. Contents of the pack and other information

1. What is TIROSINT SOL and what is it used for

The active substance of TIROSINT SOL is a synthetically produced thyroid hormone - sodium levothyroxine (T4), which has the same structure and action as the naturally occurring thyroid hormone.
TIROSINT SOL is used:

• as replacement therapy for thyroid hormone deficiency due to insufficient thyroid function,
• to prevent recurrence of goiter after surgery in patients with normal thyroid function,
• to treat benign goiter in patients with normal thyroid function,
• to inhibit the recurrence of thyroid cancer (malignant tumor) and as replacement therapy for thyroid hormone deficiency,
• as adjunctive therapy in the treatment of hyperthyroidism,
• in the thyroid suppression test.

2. Important information before taking TIROSINT SOL

When not to take TIROSINT SOL:

• if you are allergic to sodium levothyroxine or any of the other ingredients of this medicine (listed in section 6),
• in case of recent myocardial infarction, acute myocarditis and (or) acute pericarditis (inflammation of the heart),
• in case of pregnancy and concurrent use of anti-thyroid drugs (thyreostatics) (see "Pregnancy and breastfeeding"),
• in case of untreated adrenal insufficiency, untreated hypopituitarism (pituitary insufficiency) and (or) untreated hyperthyroidism.

Special warnings and precautions for use

Before starting treatment with TIROSINT SOL, discuss it with your doctor, pharmacist. You should consult your doctor or pharmacist before taking TIROSINT SOL.
Special caution is required when using TIROSINT SOL in case of one of the following heart diseases:

• high blood pressure,
• accelerated or irregular heartbeat,
• fat deposits on the walls of the arteries (atherosclerosis),
• chest pain with a feeling of compression (angina pectoris),
• insufficient blood flow in the coronary arteries (coronary artery disease).

These diseases must be treatedpharmacologically before taking TIROSINT SOL
and during treatment with TIROSINT SOL, it is necessary to check the thyroid hormone levels more frequently.
You should inform your doctor if you are unsure whether any of these diseases apply to you, or if you have one of these diseases but have not yet been treated.
If you are to undergo laboratory tests to check your thyroid hormone levels, you should inform your doctor or laboratory staff if you are currently taking or have recently taken biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin may affect laboratory test results. Depending on the type of test, the results may be falsely elevated or falsely decreased due to biotin intake. Your doctor may advise you to stop taking biotin before undergoing laboratory tests. You should also remember that other products you are taking, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin. This may affect laboratory test results. If you are taking such products, you should inform your doctor or laboratory staff (see "TIROSINT SOL and other medicines").

Before starting treatment

• In order to determine whether you have adrenal, pituitary or thyroid disorders due to uncontrolled overproduction of thyroid hormones (thyroid autonomy), your doctor will perform tests, as these disorders must be treated pharmacologically before taking TIROSINT SOL.
• You should inform your doctor if you are currently in menopause or if you are in the postmenopausal period. Due to the risk of osteoporosis, regular monitoring of thyroid function may be necessary.
• You should inform your doctor if you experience symptoms of psychotic disorders(more frequent monitoring and dose adjustment may be necessary)
• You should inform your doctor about starting or stopping treatment with orlistator changing treatment with orlistat (obesity medication; you may need more frequent monitoring and dose adjustment).
• Certain heart diseasesrequire treatment before taking TIROSINT SOL, you should carefully read the information contained in the section "Special warnings and precautions for use".
• If you have blood sugar disorders (diabetes)or are being treated with certain blood thinners, you should read the information in the section "TIROSINT SOL and other medicines" carefully.
• Switching from one levothyroxine-containing medicine to another may cause thyroid function disorders. If you have any questions about changing your treatment, you should consult your doctor. During the transition period, close clinical and biological monitoring of the patient is necessary. If you experience any side effects, you should inform your doctor, as they may indicate the need to adjust the dose.
• Do not take TIROSINT SOL to lose weight.If your thyroid hormone levels are within the normal range, taking additional thyroid hormones will not lead to weight loss. Taking additional thyroid hormones without a doctor's recommendation can cause serious or even life-threatening side effects, especially in combination with certain weight loss medications.
• Special caution is required in patients with epilepsy. In patients with a history of epilepsy, rare cases of seizures have been reported when starting treatment with levothyroxine.

Elderly patients:
For elderly patients, careful dosing and frequent medical examinations are necessary.
Preterm infants:
When starting treatment with levothyroxine in preterm infants with very low birth weight, regular monitoring of blood pressure is necessary, as a sudden drop in blood pressure (so-called circulatory collapse) may occur.

TIROSINT SOL and other medicines

Taking other medicines while taking TIROSINT SOL may affect the action of both this and other medicines you are taking. You should make sure your doctor knows what medicines you are taking.

Do not take any other medicines while taking TIROSINT SOL unless

you have informed your doctor or pharmacist and asked for their advice.This also applies to medicines that can be obtained without a prescription.

You should inform your doctor if you are taking any of the following medicines:

• Blood sugar lowering medicines (antidiabetic drugs):TIROSINT SOL may weakenthe action of the blood sugar lowering medicine. In order to measure blood sugar levels, especially at the beginning of treatment with TIROSINT SOL, additional tests may be necessary. During treatment with TIROSINT SOL, the dose of the antidiabetic medicine may need to be adjusted.
• Blood thinners (coumarin derivatives): TIROSINT SOL may enhancethe action of these medicines. Regular monitoring of blood coagulation, especially at the beginning of treatment with TIROSINT SOL, may be necessary. During treatment with TIROSINT SOL, the dose of the coumarin derivative may need to be adjusted.
• Propylthiouracil(a medicine used for hyperthyroidism),
• Corticosteroids(anti-allergic and anti-inflammatory medicines),
• Beta-blockers(medicines that lower blood pressure, also used to treat heart diseases),
• Sertraline(an antidepressant),
• Chloroquine or proguanil(a medicine used to prevent or treat malaria),
• Antiepileptic drugs, such as carbamazepine, phenytoin, phenobarbital, primidone,
• Estrogen-containing medicinesfor hormone replacement therapy during or after menopause or for contraception.
• Salicylates(medicines that relieve pain and reduce fever),
• Dicumarol(a medicine that prevents blood clotting),
• Furosemidein high doses of 250 mg or more (a medicine that increases urine production),
• Clofibrate(a medicine that lowers blood fat levels),
• Amiodarone(a medicine used for heart rhythm disorders),
• Ritonavir, indinavir, lopinavir- used to limit HIV infection and chronic hepatitis C virus infection,
• Sevelamer(a medicine used in patients undergoing dialysis or in patients with chronic kidney disease who are not undergoing dialysis),
• Tyrosine kinase inhibitors(anticancer and anti-inflammatory medicines),
• Orlistat(a medicine used to reduce body weight).
• Medicines containing St. John's Wort(herbal medicines),
• Proton pump inhibitors(such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) used to reduce stomach acid production, which may weaken the absorption of levothyroxine from the intestine and make it less effective. If you are taking levothyroxine while being treated with proton pump inhibitors, your doctor should monitor your thyroid function and modify the dose of the medicine if necessary.
• Biotin- if you are currently taking or have recently taken biotin, you must inform your doctor or laboratory staff if you are to undergo laboratory tests for thyroid hormones. Biotin may affect laboratory test results (see "Special warnings and precautions for use").

It is necessary to follow the recommended frequency (intervals) when using one of the following medicines:

• Antacids (medicines that neutralize stomach acid), sucralfate(for the treatment of stomach ulcers), and medicines containing aluminum, iron, or calcium: TIROSINT SOL should be taken at least 2 hours beforeusing any of these medicines, as they may weaken the action of TIROSINT SOL.
• Bile acid sequestrants and cholesterol-lowering medicines (such as cholestyramineor colestipol): TIROSINT SOL should be taken 4-5 hours beforethese medicines, as they may inhibit the absorption of TIROSINT SOL from the intestine.

What else to pay attention to when using in combination with other medicines:

In case of a radiographic examinationor any other diagnostic testusing a contrast agent, you should inform your doctor about taking TIROSINT SOL, as it may lead to the injection of a substance that can affect thyroid function.

TIROSINT SOL with food and drink

You should inform your doctor about consuming soy products, especially about changing the proportion of soy products in your diet. Soy products may reduce the absorption of levothyroxine from the intestine, so it may be necessary to adjust the dose of TIROSINT SOL.

Pregnancy and breastfeeding

You should consult your doctor or pharmacist before taking this medicine.

Pregnancy

• Treatment with TIROSINT SOLis particularly important during pregnancy and therefore should not be interrupted. This is necessary for the proper development of the fetus. You should consult your doctor, as the dose of the medicine may need to be adjusted, since the need for levothyroxine may increase during pregnancy. Close monitoring of thyroid function is necessary.
• During pregnancy, do not take TIROSINT SOL at the same time as

medicines for hyperthyroidism (thyreostatics).During pregnancy, hyperthyroidism should be treated only with thyreostatics in low doses (see "Do not take TIROSINT SOL").

Breastfeeding

• TIROSINT SOL can be used during breastfeeding. There is no evidence that taking TIROSINT SOL by a breastfeeding mother harms the child with normal thyroid function.

Driving and using machines

There is no evidence that taking TIROSINT SOL affects the ability to drive or use machines, as levothyroxine is identical to the naturally occurring thyroid hormone.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of oral solution, i.e. the medicine is considered "sodium-free".

3. How to take TIROSINT SOL

This medicine should always be taken as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
Your doctor will adjust the individual dose based on laboratory test results.

Dosage:

In the case of individual treatment, TIROSINT SOL is available in single-dose containers containing 13-200 micrograms of sodium levothyroxine, usually one single-dose container per day is sufficient.

Adults:

• Treatment of hypothyroidism: Initially, adults should take 25-50 micrograms of sodium levothyroxine per day. Your doctor may recommend increasing this dose by 25-50 micrograms of sodium levothyroxine every two to four weeks, up to a daily dose of 100-200 micrograms of sodium levothyroxine (which corresponds to 1 to 2 single-dose containers of TIROSINT SOL per day).
• Prevention of goiter recurrence after surgical removal and treatment of benign goiter: The daily dose is 75-200 micrograms of sodium levothyroxine.
• Adjunctive therapy in the treatment of hyperthyroidism with thyreostatics: The daily dose is 50-100 micrograms of sodium levothyroxine.
• After surgery for malignant thyroid tumor: The daily dose is 150-300 micrograms of sodium levothyroxine.
• For diagnostic purposes during the thyroid suppression test: The daily dose is 200 micrograms of sodium levothyroxine for 14 days before the radiological examination (scintigraphy).

Elderly patients, patients with coronary artery disease, and patients with severe or prolonged hypothyroidism:

Treatment with thyroid hormones should be started with caution.
This means that a smaller initial dose should be chosen, which will then be gradually increased at longer intervals, with frequent laboratory monitoring.

Children:

The dose for children depends on their age, weight, and health status during treatment. The child will be monitored to ensure they receive the appropriate dose.

• Congenital hypothyroidism in infants: Initially, 10-15 micrograms/kg body weight per day for the first 3 months. The dose will then be adjusted based on the response to treatment.
• Acquired hypothyroidism in children: Initially, 13 to 50 micrograms per day. The dose should be gradually increased every 2 to 4 weeks, depending on the response to treatment.

You should inform your doctor or pharmacist if you feel that the action of TIROSINT SOL is too strong or too weak.

How to take the medicine:

• Take the full daily dose in the morning on an empty stomach at least half an hour before breakfast.The active substance is better absorbed on an empty stomach than before or after a meal.
• Give the medicine to the child at least half an hour before the first meal of the day.
• TIROSINT SOL can be taken:
• after dilution or mixing with water or
• directly by squeezing into the mouth or onto a spoon
• Do notdilute or mix TIROSINT SOL with any liquid other than water
• Open the single-dose container and prepare the solution immediately before taking TIROSINT SOL
• After dilution or mixing, TIROSINT SOL should be taken or discarded.
• 1. Open the aluminum sachet by tearing along the perforated line.
• 2. Remove the single-dose container intended for use from the foil packaging. Unused containers should be put back into the sachet before it is stored.
• 3. Hold the container vertically (cap on top) between your index finger and thumb, without squeezing. Open the container by unscrewing it from the top.
• 4.

Taking TIROSINT SOL after dilution or mixing:

• Turn the single-dose container upside down.
• Squeeze the softer, middle part of the container with your index finger and thumb slowlyto pour the liquid medicine into a glass or cup containing water, then release the pressure and wait a few seconds.
• Holding the container upside down, repeat this action at least 5 times until the medicine stops flowing from the container.
• Mix the solution.
• Drink the liquid medicine immediately.
• Rinse the glass or cup with a larger amount of water and drink it to ensure that all the medicine is taken.

Taking TIROSINT SOL directly into the mouth or onto a spoon:

• Turn the single-dose container upside down.
• Squeeze the softer, middle part of the container with your index finger and thumb slowlyto pour the liquid medicine into your mouth or onto a spoon, then release the pressure and wait a few seconds.
• In the case of newborns and infants, the contents of the single-dose container should be squeezed onto the inner cheek or onto a spoon.
• Holding the container upside down, repeat this action at least 5 times until the medicine stops flowing from the container.
• 5. Discard (dispose of) the empty container.

Duration of treatment:

Take the medicine for the period prescribed by your doctor.

• In the case of hypothyroidism or after surgery for malignant thyroid tumor, TIROSINT SOL is usually taken for life.
• In the case of benign goiter and prevention of recurrence, take TIROSINT SOL for a period of several months or years, or for life.
• In adjunctive therapy for hyperthyroidism, take TIROSINT SOL for the entire period of treatment with thyreostatics.
• In the treatment of benign goiter with normal thyroid function, the necessary treatment period is from 6 months to 2 years. If treatment with TIROSINT SOL does not produce the desired result within this period, other treatment options should be considered.

Overdose of TIROSINT SOL

In case of taking a higher dose of the medicine than recommended, symptoms of hyperthyroidism may occur, such as palpitations, anxiety, agitation, excessive sweating, or tremors (see "4. Possible side effects"). In such a case, you should contact your doctor.

Missed dose of TIROSINT SOL

If you miss a dose, do not take it when you remember it, instead, skip it and take your normal dose as usual the next day.

Stopping treatment with TIROSINT SOL

In order for the treatment to be successful, TIROSINT SOL should be taken regularly in the dose recommended by your doctor. Do not change, stop, or terminate treatment without prior consultation. Stopping or temporarily stopping treatment may cause the symptoms to recur.
If you have any further questions about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, TIROSINT SOL can cause side effects, although not everybody gets them.
The risk of side effectsis minimal if you follow your doctor's instructions and attend scheduled medical appointments for laboratory tests.
This is because the active substance of TIROSINT SOL is levothyroxine, which is identical to the naturally occurring thyroid hormone.
The following side effects occur with an unknown frequency: angioedema, rash, urticaria.
In case of hypersensitivity, allergic respiratory and skin reactions may occur.
Immediately contact your doctor.

In case of taking a higher dose of TIROSINT SOL than recommended or intolerance to too

high a dose(e.g. if the dose is too high for individual needs), symptoms characteristic of hyperthyroidism may occur, such as:

• weight loss, increased appetite,
• tremors (trembling), agitation, difficulty sleeping, headache, increased intracranial pressure with eye swelling (especially in children),
• palpitations, arrhythmias, especially tachycardia, chest pain with a feeling of compression (angina pectoris),
• increased blood pressure,
• vomiting, diarrhea,
• weakness and muscle cramps,
• irregular menstrual periods,
• excessive sweating, hair loss, feeling of heat (flushing), fever.

If you experience such symptoms, inform your doctor.Your doctor will decide whether to stop treatment for a few days or reduce the dose until the side effects disappear.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TIROSINT SOL

Keep the medicine out of the sight and reach of children. Do not store above 25°C.
Store in the original packaging to protect from light. Shelf life after opening the sachet: 15 days.
Shelf life after opening the single-dose container: the solution should be taken immediately. Do not use the medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What TIROSINT SOL contains

The active substance is sodium levothyroxine.
1 ml of TIROSINT SOL 13 micrograms oral solution contains 13 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 25 micrograms oral solution contains 25 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 50 micrograms oral solution contains 50 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 75 micrograms oral solution contains 75 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 88 micrograms oral solution contains 88 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 100 micrograms oral solution contains 100 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 112 micrograms oral solution contains 112 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 125 micrograms oral solution contains 125 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 137 micrograms oral solution contains 137 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 150 micrograms oral solution contains 150 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 175 micrograms oral solution contains 175 micrograms of sodium levothyroxine.
1 ml of TIROSINT SOL 200 micrograms oral solution contains 200 micrograms of sodium levothyroxine.
The other ingredients are: glycerol 85%.

What TIROSINT SOL looks like and contents of the pack

Clear, colorless or slightly yellowish solution supplied in a white, opaque single-dose container with a capacity of 1 ml. Each single-dose container is labeled with the dose and the name of the medicine (TIROSINT SOL).
TIROSINT SOL is supplied in sachets made of polyethylene terephthalate/aluminum/polyethylene (PET/Aluminum/PE), containing 5 single-dose containers.
TIROSINT SOL is available in packs of 30 x 1 ml single-dose containers.

Marketing authorization holder and importer:

Marketing authorization holder:
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia 2
26900 Lodi
Italy
Importer:
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia 2
26900 Lodi
Italy
Date of last revision of the leaflet:January 2023