Tirosint sol: detailed information

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
Levothyroxine sodium

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms appear identical.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Leaflet Contents

What TIROSINT SOL is and what it is used for
Important information before taking TIROSINT SOL
How to take TIROSINT SOL
Possible side effects
How to store TIROSINT SOL
Contents of the pack and other information

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

The active substance in TIROSINT SOL is levothyroxine sodium, a synthetic thyroid hormone (T4) identical in structure and function to the naturally occurring thyroid hormone.

TIROSINT SOL is used:

as replacement therapy for thyroid hormone in cases of deficiency due to insufficient thyroid function,
to prevent recurrence of goiter after surgery in patients with normal thyroid function,
in the treatment of mild goiter in patients with normal thyroid function,
to suppress recurrence of thyroid tumor (malignant neoplasm), especially after surgery, and as replacement therapy in cases of hormone deficiency,
as adjunctive therapy in the treatment of hyperthyroidism,
in thyroid suppression testing.

2. Important information before taking TIROSINT SOL

When not to take TIROSINT SOL:

if the patient is 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 inflammation of all layers of the heart wall (inflammation of the entire heart),
during pregnancy and concomitant use of antithyroid drugs (thyrostatics) (see "Pregnancy and breastfeeding"),
in case of untreated adrenal insufficiency, untreated pituitary insufficiency (hypopituitarism) and/or untreated hyperthyroidism.

Special caution must be exercised when using TIROSINT SOL
Before starting treatment with TIROSINT SOL, discuss this with your doctor or
pharmacist. Consult your doctor or pharmacist before taking
TIROSINT SOL.
Special caution is required when using TIROSINT SOL in patients with any of the following heart conditions:

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

These conditions must be treated pharmacologically before starting TIROSINT SOL
and during treatment with TIROSINT SOL, thyroid hormone levels should be monitored more frequently.
Inform your doctor if you are unsure whether any of these conditions apply to you, or if you have one of these conditions but have not yet been treated.
If laboratory tests to assess thyroid hormone levels are to be performed, the patient should inform the doctor or laboratory staff about current or recent use of biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin may affect laboratory test results. Depending on the type of test, results may be falsely elevated or falsely decreased due to biotin intake. The doctor may advise the patient to discontinue biotin before laboratory testing. It is also important to remember that other products the patient may be taking, such as multivitamin preparations or supplements for hair, skin, and nails, may also contain biotin. This may affect laboratory test results. If the patient is taking such products, they should inform the doctor or laboratory staff (see information in section “TIROSINT SOL and other medicines”).

Before starting treatment

To determine whether the patient has adrenal, pituitary or thyroid disorders due to uncontrolled overproduction of thyroid hormones (thyroid autonomy), the doctor will perform tests, as these conditions must be pharmacologically treated before starting TIROSINT SOL.
Inform the doctor if the patient is currently experiencing menopause or is postmenopausal. Due to the risk of osteoporosis, regular monitoring of thyroid function may be necessary.
Inform the doctor if psychotic symptoms occur (closer monitoring and dose adjustment may be required).
Inform the doctor about starting or stopping orlistat or changing orlistat therapy (a weight-loss medication; the patient may require closer monitoring and dose adjustment).
Some heart conditions require treatment before taking TIROSINT SOL; carefully read the information provided in the section “Special caution must be exercised when using TIROSINT SOL”.
If the patient has blood glucose disorders (diabetes) or is being treated with certain anticoagulant drugs, read carefully the information in the section “TIROSINT SOL and other medicines”.
Changing from another medication to a different levothyroxine-containing product may cause thyroid dysfunction. If you have any questions regarding changing treatment, consult your doctor. Close clinical and biological monitoring is necessary during the transition period. If any adverse symptoms occur, inform your doctor, as they may indicate the need for dose adjustment.
Do not take TIROSINT SOL for weight reduction. If thyroid hormone levels in the blood are within normal limits, taking additional thyroid hormones does not lead to weight loss. Taking additional thyroid hormones without medical advice may cause serious or even life-threatening adverse effects, especially when combined with certain weight-loss medications.
Special caution is required in patients with epilepsy. Rare cases of seizures have been reported at the initiation of levothyroxine therapy in patients with a history of epilepsy.

Elderly patients:
In elderly patients, careful dosing and frequent medical examinations are required.
Premature infants:
When initiating levothyroxine treatment in premature infants with very low birth weight, blood pressure should be monitored regularly, as a sudden drop in blood pressure (so-called circulatory collapse) may occur.

TIROSINT SOL and other medicines
Taking other medicines while using TIROSINT SOL may affect the action of both this medicine and other medicines being taken. Ensure that your doctor knows which medicines you are taking.
Do not take any other medicines while using TIROSINT SOL unless you have informed your doctor or pharmacist and consulted them. This also applies to medicines available without a prescription.
Inform your doctor if you are taking any of the following medicines:

Medicines that lower blood glucose (antidiabetic drugs): TIROSINT SOL may weaken the effect of blood glucose-lowering medicines. Additional tests may be necessary to measure blood glucose levels, especially at the beginning of TIROSINT SOL therapy. During treatment with TIROSINT SOL, the dose of antidiabetic medication may require adjustment.
Anticoagulant drugs (coumarin derivatives): TIROSINT SOL may enhance the effect of these medicines. Regular monitoring of blood coagulation may be necessary, especially at the beginning of TIROSINT SOL therapy. During treatment with TIROSINT SOL, dose adjustment of coumarin derivative drugs may be required.
Propylthiouracil (a drug used in hyperthyroidism),
Glucocorticoids (anti-allergic and anti-inflammatory drugs),
Beta-blockers (drugs that lower blood pressure, also used in heart disease treatment),
Sertraline (an antidepressant),
Chloroquine or proguanil (medicines used to prevent or treat malaria),
Antiepileptic drugs such as carbamazepine, phenytoin, phenobarbital, primidone,
Estrogen-containing drugs used for hormone replacement therapy during or after menopause or for contraception.
Salicylates (pain-relieving and fever-reducing drugs),
Dicumarol (a drug that inhibits blood clotting),
Furosemide at high doses of 250 mg or more (a drug that increases urine production),
Clofibrate (a drug that reduces blood lipid levels),
Amiodarone (a drug used for cardiac arrhythmias),
Ritonavir, indinavir, lopinavir – used to control HIV infection and chronic hepatitis C virus infection,
Sevelamer (a drug used in dialyzed or non-dialyzed patients with chronic kidney disease),
Tyrosine kinase inhibitors (anticancer and anti-inflammatory drugs),
Orlistat (a drug used to reduce body weight).
Herbal medicines containing St. John's wort,
Proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole and lansoprazole) used to reduce stomach acid production, which may impair levothyroxine absorption from the intestine and reduce its effectiveness. If the patient is taking levothyroxine during treatment with proton pump inhibitors, the doctor should monitor thyroid function and adjust the dose if necessary.
Biotin – if the patient is currently or recently taking biotin, they must inform the doctor or laboratory staff if thyroid hormone laboratory tests are to be performed. Biotin may affect laboratory test results (see “Special caution must be exercised when using TIROSINT SOL”).

Recommended timing (intervals) must be observed when it is necessary to take any of the following medicines:

Antacids (medicines that relieve stomach discomfort and heartburn), sucralfate (used to treat stomach ulcers), and medicines containing aluminum, iron or calcium: TIROSINT SOL should be taken at least 2 hours before taking any of these medicines, as they may reduce the effectiveness of TIROSINT SOL.
Drugs that bind bile acids and reduce cholesterol levels (such as cholestyramine or colestipol): TIROSINT SOL should be taken 4–5 hours before these drugs, as they may inhibit the absorption of TIROSINT SOL from the intestine.

Additional considerations when using with other medicines:
If an X-ray examination or any other diagnostic test using a contrast agent is required, inform the doctor about taking TIROSINT SOL, as injection of a substance that may affect thyroid function may be necessary.

TIROSINT SOL with food and drink
Inform your doctor about consuming soy products, especially if there is a change in the proportion of soy products in the diet. Soy products may reduce levothyroxine absorption from the intestine, so dose adjustment of TIROSINT SOL may be necessary.

Pregnancy and breastfeeding

The patient should consult a doctor or pharmacist before using this medicine.

Pregnancy

Treatment with TIROSINT SOL is particularly important during pregnancy and therefore must not be discontinued. This is essential for proper fetal development. Consult your doctor, as the dose may require adjustment, because the need for levothyroxine may increase during pregnancy. Close monitoring of thyroid function is necessary.
During pregnancy, TIROSINT SOL must not be used simultaneously with antithyroid drugs (thyrostatics). Hyperthyroidism during pregnancy should be treated exclusively with low-dose thyrostatics (see “Do not take TIROSINT SOL”).

Breastfeeding

TIROSINT SOL can be used during breastfeeding. There is no evidence indicating that use of TIROSINT SOL by a breastfeeding mother harms an infant with normal thyroid function.

Driving and operating machinery
There is no evidence that taking TIROSINT SOL impairs the ability to drive or operate machinery, 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, meaning the medicine is considered "sodium-free".

3. How to take TIROSINT SOL

This medicine should always be taken according to the doctor's instructions. In case of
doubt, consult your doctor or pharmacist.
Your doctor will adjust the individual dose based on laboratory test results.
Dosage:
For individual treatment, TIROSINT SOL is available in single-dose packages containing 13–200 micrograms of sodium levothyroxine, so usually only one single-dose package 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 the dose by 25–50 micrograms of sodium levothyroxine every two to four weeks until reaching a daily dose of 100–200 micrograms of sodium levothyroxine (corresponding to 1 to 2 single-dose units of TIROSINT SOL).
Prevention of goiter recurrence after surgical removal and treatment of benign goiter: The daily dose is 75–200 micrograms of sodium levothyroxine.
Replacement therapy in the treatment of hyperthyroidism with antithyroid drugs: 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 thyroid suppression testing: The daily dose is 200 micrograms of sodium levothyroxine for 14 days prior to radiological examination (scintigraphy).

Elderly patients, patients with coronary heart disease, and patients with severe or long-standing hypothyroidism:
Thyroid hormone therapy should be initiated with particular caution. This means starting with a lower initial dose, which will then be gradually increased at longer intervals, with frequent monitoring through laboratory tests.
Children:
The dose for children depends on their age, body 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 according to 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.

Inform your doctor or pharmacist if you feel that the effect 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 child the medicine at least half an hour before the first meal of the day.
TIROSINT SOL may be administered:
- diluted or mixed with water, or
- directly by squeezing into the mouth or onto a spoon
Do not dilute 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 package. Return unused containers back into the sachet before putting it aside.
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. Administration of TIROSINT SOL after dilution or mixing:
  - Turn the single-dose container upside down.
  - Gently squeeze the central, softer part of the container with your index finger and thumb slowly to empty the liquid medicine into a glass or cup containing water, then release the pressure and wait a few seconds.
  - While holding the container inverted, repeat this procedure at least 5 times , until no more medicine flows out of the container .
  - Mix the solution.
  - Drink the liquid medicine immediately .
  - Rinse the glass or cup with additional water and drink it to ensure the entire dose has been taken.

Direct administration of TIROSINT SOL into the mouth or onto a spoon:

Turn the single-dose container upside down.
Gently squeeze the central, softer part of the container with your index finger and thumb slowly to empty the liquid medicine into the mouth or onto a spoon, then release the pressure and wait a few seconds.
For newborns and infants , squeeze the contents of the single-dose container onto the inside of the cheek or onto a spoon.
While holding the container inverted, repeat this procedure at least 5 times , until no more medicine flows out of the container . 5. Discard (dispose of) the empty container.

Duration of treatment:
Take the medicine for the period indicated by your doctor.

In hypothyroidism or after surgical removal of a malignant thyroid tumor, TIROSINT SOL usually needs to be taken for life.
In benign goiter and for prevention of goiter recurrence, TIROSINT SOL should be taken for a period ranging from several months or several years to lifelong.
In replacement therapy during antithyroid drug treatment of hyperthyroidism, TIROSINT SOL should be taken throughout the entire period of antithyroid therapy.
In the treatment of benign goiter with normal thyroid function, the required treatment duration is from 6 months to 2 years. If treatment with TIROSINT SOL does not achieve the desired result within this period, other treatment options should be considered.

Taking more TIROSINT SOL than recommended
If you take more medicine than recommended, symptoms of hyperthyroidism may occur, such as palpitations, anxiety, restlessness, excessive sweating, or tremor (see "4. Possible side effects"). In such a case, contact your doctor.
Missing a dose of TIROSINT SOL
If you miss a dose, do not take it when you remember. Instead, skip it and take your next dose as usual the following day.
Stopping TIROSINT SOL treatment
To achieve successful treatment outcomes, TIROSINT SOL should be taken regularly at the dose prescribed by your doctor. Do not change, interrupt, or stop treatment without prior consultation. Discontinuation or temporary interruption of treatment may cause symptoms to reappear.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, TIROSINT SOL may cause adverse reactions, although not
everyone will experience them.
The risk of adverse reactions is negligible if the patient follows the doctor's
recommendations and keeps scheduled medical appointments for laboratory
tests.
This is due to the fact that the active substance in TIROSINT SOL is levothyroxine,
identical to the naturally occurring thyroid hormone.
The following adverse reactions occur with unknown frequency: angioedema,
rash, urticaria.
In case of hypersensitivity, respiratory and skin allergic reactions may occur.
In such a case, contact your doctor immediately.
If an overdose of TIROSINT SOL is taken or intolerance to too high a dose occurs
(e.g. if the dose is too high relative to individual needs), symptoms characteristic
of hyperthyroidism may appear, such as:

weight loss, increased appetite,
tremors, nervousness, insomnia, headache, increased intracranial pressure with eye swelling (especially in children),
palpitations, cardiac arrhythmias, especially tachycardia, chest pain with a feeling of pressure (angina pectoris),
increased blood pressure,
vomiting, diarrhea,
muscle weakness and cramps,
irregular menstruation,
excessive sweating, hair loss, sensation of warmth (flushing), fever.

If any of these symptoms occur, inform your doctor immediately. The doctor
will decide whether treatment should be interrupted for a few days or the dose
reduced until adverse reactions subside.
Reporting adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie
181C PL-02 222
Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows collection of additional information on the
medicine's safety.

5. How to store TIROSINT SOL

Keep the medicine out of the sight and reach of children. Do not store at temperatures above 25°C.
Store in the original packaging to protect from light.
Shelf life after first opening of the sachet: 15 days.
Shelf life after first opening of the single-dose container: the solution should be consumed
immediately. Do not use this medicine after the expiry date stated on the label after
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines
you no longer use. 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 the TIROSINT SOL oral solution, 13 micrograms contains 13 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 25 micrograms contains 25 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 50 micrograms contains 50 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 75 micrograms contains 75 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 88 micrograms contains 88 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 100 micrograms contains 100 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 112 micrograms contains 112 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 125 micrograms contains 125 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 137 micrograms contains 137 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 150 micrograms contains 150 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 175 micrograms contains 175 micrograms of sodium levothyroxine.
1 ml of the TIROSINT SOL oral solution, 200 micrograms contains 200 micrograms of sodium levothyroxine.
The other ingredient is: glycerol 85%.

What TIROSINT SOL looks like and contents of the pack
A clear, colourless or slightly yellowish solution supplied in a white, opaque single-dose container with a capacity of 1 ml. Each single-dose container is labelled with a coloured label indicating the strength and the name of the medicine (TIROSINT SOL).

Dosage [micrograms]	Color
13	green
25	orange
50	white
75	purple
88	olive
100	yellow
112	reddish
125	brown
137	teal
150	blue
175	lilac
200	pink

The TIROSINT SOL medicine is supplied in sachets made of polyethylene terephthalate/aluminum/polyethylene (PET/Aluminum/PE), each containing 5 single-dose containers.
TIROSINT SOL is available in packages of 30 x 1 ml single-dose containers.
Marketing Authorisation Holder and Importer:
Marketing Authorisation 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