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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in the leaflet, tell 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 mild 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 entire heart),
• in case of pregnancy and concurrent use of medicines for hyperthyroidism (thyrostatics) (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 or pharmacist. You should consult your doctor or pharmacist before taking TIROSINT SOL.
Special caution is required when taking TIROSINT SOL in case of one of the following heart diseases:

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

These diseases must be treatedpharmacologically before taking TIROSINT SOLand during treatment with TIROSINT SOL, it is necessary to check the level of thyroid hormones more frequently.
You should inform your doctor if you are unsure whether you have any of these diseases 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 the results of laboratory tests. 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 the results of laboratory tests. 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 if 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 orlistat or changing orlistat treatment (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 in the "Special warnings and precautions for use" section.
• If you have blood sugar disorders (diabetes)or are being treated with certain blood thinners, you should read the information in the "TIROSINT SOL and other medicines" section carefully.
• Changing the medicine you are taking to another medicine containing levothyroxine may cause thyroid function disorders. If you have 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 tell your doctor, as they may indicate the need to adjust the dose.
• Do not take TIROSINT SOL to lose weight.If your thyroid hormone level is normal, taking extra thyroid hormones will not lead to weight loss. Taking extra thyroid hormones without a doctor's recommendation can cause serious or life-threatening side effects, especially in combination with certain weight loss medications.
• You should be cautious if you have 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 check-ups are necessary.
Preterm infants:
When starting treatment with levothyroxine in preterm infants with very low birth weight, regular blood pressure monitoring 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:

• Medicines that lower blood sugar levels (antidiabetic medicines):TIROSINT SOL may weakenthe action of the medicine that lowers blood sugar levels. 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 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, it may be necessary to adjust the dose of coumarin derivatives.
• 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 to prevent or treat malaria),
• Antiepileptic medicines, 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 arrhythmias),
• Ritonavir, indinavir, lopinavir- used to limit HIV infection and chronic hepatitis C virus infection,
• Sevelamer(a medicine used in patients undergoing dialysis or non-dialysis patients with chronic kidney disease),
• 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 during treatment 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 thyroid hormone laboratory tests. Biotin may affect the results of laboratory tests (see "Special warnings and precautions for use").

It is necessary to follow the recommended frequency (intervals) when taking 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 beforetaking any of these medicines, as they may weaken the action of TIROSINT SOL.
• Bile acid sequestrants and cholesterol-lowering medicines (such as cholestyramineor cholestypol): 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 taking with other medicines:

In case of a need for an X-ray 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 if you change 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, it 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 (thyrostatics).During pregnancy, hyperthyroidism should be treated only with thyrostatics 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

Take this medicine always as directed by your doctor. In case of doubts, 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, it is enough to take only one single-dose container per day.

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 mild goiter: The daily dose is 75-200 micrograms of sodium levothyroxine.
• Adjunctive therapy in the treatment of hyperthyroidism with thyrostatics: 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 correct 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 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 the 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 specified 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 mild goiter and prevention of goiter recurrence, take TIROSINT SOL for a period of several months or years to the end of life.
• In adjunctive therapy for hyperthyroidism, take TIROSINT SOL for the entire period of treatment with thyrostatics.
• In the treatment of mild 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.

Taking a higher dose of TIROSINT SOL than recommended

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 this case, you should contact your doctor.

Missing a dose of TIROSINT SOL

In case of missing a dose, do not take it when you remember, instead, skip it and take the 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.
In case of any further doubts regarding the use of this medicine, 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 check-ups 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 reactions of the respiratory and skin systems may occur.
Consult your doctor immediately.

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 pressure (angina pectoris),
• increased blood pressure,
• vomiting, diarrhea,
• weakness and muscle cramps,
• irregular menstrual periods,
• excessive sweating, hair loss, feeling of heat (flushing), fever.

Inform your doctor if you experience such symptoms.Your doctor will decide whether to interrupt 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, tell 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

Store the medicine out of 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 specified 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 levothyroxine sodium.
1 ml of TIROSINT SOL 25 micrograms oral solution contains 25 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 50 micrograms oral solution contains 50 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 75 micrograms oral solution contains 75 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 88 micrograms oral solution contains 88 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 100 micrograms oral solution contains 100 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 112 micrograms oral solution contains 112 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 125 micrograms oral solution contains 125 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 137 micrograms oral solution contains 137 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 150 micrograms oral solution contains 150 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 175 micrograms oral solution contains 175 micrograms of levothyroxine sodium.
1 ml of TIROSINT SOL 200 micrograms oral solution contains 200 micrograms of levothyroxine sodium.
The other ingredients are glycerol 85%.

What TIROSINT SOL looks like and contents of the pack

A 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