TIROSINT

Package leaflet: information for the patient

TIROSINT 100 micrograms/ml oral drops, solution

Levothyroxine sodium
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TIROSINT is and what it is used for

The active substance of TIROSINT is sodium levothyroxine (T4), a thyroid hormone produced in
the laboratory (synthetic), whose structure and action are identical to those of the natural thyroid hormone.
TIROSINT is used:

• as replacement therapy in case of thyroid hormone deficiency (hypothyroidism) due to reduced thyroid activity (thyroid hypofunction), or thyroid inflammation (thyroiditis), or goitre;
• to prevent tumour regrowth (recurrence) of the thyroid after surgical intervention (thyroidectomy);
• during treatment with antithyroid agents.

2. What you need to know before taking TIROSINT

Do not take TIROSINT if:

• you are allergic to sodium levothyroxine or to any of the other ingredients of this medicine (listed in section 6);
• you have recently had a heart attack (acute myocardial infarction), acute inflammation of the heart muscle (acute myocarditis), and/or acute inflammation of all layers of the heart wall (pancarditis);
• you are pregnant and are simultaneously taking medicines for hyperthyroidism (thyroid inhibitors);
• you have untreated adrenocortical insufficiency (adrenal insufficiency) or untreated pituitary gland underactivity (hypopituitarism);
• you have an excess of thyroid hormones in the blood (thyrotoxicosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking TIROSINT.
Contact your doctor if you have any of the following heart conditions:

• high blood pressure (hypertension);
• rapid heartbeat (tachycardia);
• fatty deposits on the walls of the arteries (arteriosclerosis); 1 of 14
• chest pain (angina pectoris);
• inflammation of the heart (myocarditis);
• heart attack (myocardial infarction);
• inadequate heart function (heart failure);
• insufficient blood flow in the coronary arteries (coronary insufficiency).
  Before taking TIROSINT, these conditions must be treated with appropriate medications; if you are already taking TIROSINT, thyroid hormone levels must be monitored frequently.

Inform your doctor if you suspect you have any of these conditions, or if you have been diagnosed with one of them and it has not yet been treated.
If you are about to undergo laboratory tests to monitor thyroid hormone levels, you must inform your doctor and/or laboratory staff that you are currently taking or have recently taken biotin (also known as vitamin H, vitamin B7, or vitamin B8). Biotin can affect laboratory test results. Depending on the test, results may be falsely high or falsely low due to biotin. Your doctor may ask you to stop taking biotin before undergoing laboratory tests. You should also be aware that other products you may be taking, such as multivitamin complexes or supplements for hair, skin, and nails, might contain biotin. This could affect laboratory test results. Inform your doctor and/or laboratory staff if you are taking such products (refer to the information in section Other medicines and TIROSINT).

Before starting treatment
Your doctor will perform tests to check whether you have a disorder of the adrenal gland (adrenal insufficiency), pituitary gland (hypopituitarism), or thyroid gland. Inform your doctor if:

• you are postmenopausal or at high risk of osteoporosis;
• you have a blood glucose disorder (diabetes);
• you have liver problems. If, during treatment with TIROSINT, you experience fever, muscle weakness, or abnormal liver function tests, contact your doctor, as your therapy may need to be adjusted;
• you have underactivity of the adrenal gland (adrenal insufficiency).

Elderly patients
Careful dosing and frequent medical monitoring are required in elderly patients.
Premature newborns
Blood pressure will be monitored regularly when starting levothyroxine treatment in premature infants with very low birth weight, as a rapid drop in blood pressure (circulatory collapse) may occur.
When switching to another levothyroxine-containing product, thyroid imbalance may occur. Consult your doctor for any questions regarding a change in medication. Close monitoring (biological and clinical) is required during the transition period. Contact your doctor if you experience any adverse effects, as your dose may need to be increased or decreased.
Thyroid hormones must not be used for weight loss. If your thyroid hormone levels are within normal range, taking thyroid hormones will not cause weight loss. Increasing the dose without specific medical advice may lead to serious or even life-threatening adverse effects, particularly when combined with certain weight-loss substances.

Other medicines and TIROSINT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking other medicines together with TIROSINT may affect its action or the action of the other medicine.
Inform your doctor if you are taking the following medicines.

• Medicines to lower blood glucose (antidiabetics): TIROSINT may reduce the effect of the antidiabetic medicine you are taking. Additional tests to measure blood glucose levels (glycaemia) may be necessary, especially at the beginning of TIROSINT therapy. During treatment with TIROSINT, adjustment of the antidiabetic medicine dosage may be required.
• Medicines that delay blood clotting (coumarin derivatives): TIROSINT may increase the effect of these medicines. Regular monitoring of blood clotting may be necessary, especially at the beginning of TIROSINT therapy. During treatment with TIROSINT, adjustment of the coumarin medicine dosage may be required.
• Propylthiouracil (medicine for treating hyperthyroidism);
• Glucocorticoids (anti-allergic and anti-inflammatory medicines);
• Beta-blockers (medicines used in the treatment of heart diseases);
• Sertraline (medicine for treating depression);
• Chloroquine or proguanil (medicines for prevention or treatment of malaria);
• Rifampicin (an antibiotic);
• Carbamazepine, phenytoin (medicines for treating epilepsy);
• Barbiturates (sedatives);
• Medicines containing estrogens used as contraceptives or for hormone replacement therapy after menopause;
• Salicylates (medicines used to relieve pain or reduce fever);
• Furosemide at high doses (250 mg) (medicine used to increase urine production);
• Clofibrate (medicine used to reduce blood fats);
• Amiodarone (medicine for treating heart rhythm disorders);
• Propranolol (medicine used to treat high blood pressure);
• Orlistat (medicine used for weight loss);
• Ritonavir (used to control HIV and chronic hepatitis C viruses);
• Products containing St. John’s wort (a herbal medicine);
• Proton pump inhibitors: proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) are used to reduce stomach acid production, which may decrease levothyroxine absorption from the intestine and thus reduce its effectiveness. If you are taking levothyroxine during treatment with proton pump inhibitors, your doctor must monitor your thyroid function and may need to adjust the TIROSINT dose;
• Biotin: if you are taking or have recently taken biotin, you must inform your doctor and/or laboratory staff when undergoing laboratory tests to monitor thyroid hormone levels. Biotin can affect laboratory test results (see section “Warnings and precautions”).

If you take any of the following medicines, ensure you observe the recommended time interval:

• Antacids (medicines used to relieve gastric symptoms and heartburn), sucralfate (for treating peptic ulcers), and medicines containing aluminium, iron, or calcium carbonate: take TIROSINT at least 4 hours before taking any of these medicines, as they may reduce the effect of TIROSINT.
• Medicines used to bind bile acids and lower high cholesterol levels (such as cholestyramine or colestipol): take TIROSINT 4–5 hours before these medicines, as they may inhibit the intestinal absorption of TIROSINT.

Also be cautious when taking TIROSINT with other medicines
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If you are scheduled for an X-ray examination or other diagnostic tests involving the use of a contrast agent, inform your doctor that you are taking TIROSINT, as the injected substance may affect thyroid function.

TIROSINT with food and drinks
Inform your doctor if you consume soy products, especially if you change the proportion of soy products in your diet. Soy products may reduce intestinal absorption of levothyroxine; therefore, the TIROSINT dose may need to be adjusted.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

• Treatment with TIROSINT during pregnancy should not be discontinued, but should only be carried out when strictly necessary and under direct medical supervision.
• TIROSINT must not be used during pregnancy together with medicines for treating hyperthyroidism (thyroid inhibitors).

Breastfeeding

• TIROSINT may be used during breastfeeding.
• Levothyroxine is excreted in breast milk during lactation, but concentrations achieved at recommended therapeutic doses are not sufficient to cause harm to the infant.

Driving and using machines
Since TIROSINT may cause headache (cephalalgia), exercise caution if you intend to drive vehicles or operate machinery.

TIROSINT contains Ethanol and Sodium:

• This medicine contains 243 mg of alcohol (ethanol) per ml of solution (28.8 vol %). The amount in 1 ml of this medicine is equivalent to 6 ml of beer or 2.4 ml of wine. The amount of alcohol in this medicine does not appear to have an effect in adults and adolescents, and its effects in children are not evident. Some effects may occur in young children, for example drowsiness. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. It may be harmful for alcoholics. If you have alcohol dependence, talk to your doctor before taking this medicine. This should be considered in children and high-risk groups, such as people with liver disease or epilepsy.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take TIROSINT

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment according to your individual needs.
Dosage

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Adults

• Hypothyroidism due to reduced thyroid activity (thyroid hypofunction): Initially, adults should take 50 micrograms of sodium levothyroxine per day, equivalent to 14 drops per day. Your doctor may prescribe increasing this dose by 50 micrograms of sodium levothyroxine every 2 weeks, up to a daily dose of 100–200 (300) micrograms of sodium levothyroxine, equivalent to 28–56 (84) drops per day.
• Hypothyroidism due to thyroid inflammation (thyroiditis): The daily dose is 100–150 micrograms of sodium levothyroxine, equivalent to 28–42 drops per day.
• Hypothyroidism due to goitre: The daily dose is 100–150 (200) micrograms of sodium levothyroxine, equivalent to 28–42 (56) drops per day.
• Prevention of tumour growth (recurrence) of the thyroid after surgery (thyroidectomy): The daily dose is 100 micrograms of sodium levothyroxine, equivalent to 28 drops per day.
• Adjunctive therapy during antithyroid treatment: The daily dose is 50–100 micrograms of sodium levothyroxine, equivalent to 14–28 drops per day.

Elderly patients, patients with coronary heart disease, and patients with chronic thyroid hypofunction
Treatment with thyroid hormones must be initiated with particular caution. This means that treatment should start with a low initial dose, gradually increased at prolonged intervals, with frequent monitoring through laboratory tests.

Children

• In newborns and infants, treatment of congenital hypothyroidism should be started with a daily dose of 10–15 micrograms of sodium levothyroxine per kilogram of body weight.
• In children, treatment of acquired hypothyroidism should be started with a daily dose of 12.5–50 micrograms of sodium levothyroxine.
• The entire daily dose should be taken at least 30 minutes before the first meal of the day.

How to take the medicine:

• Take the drops with an adequate amount of liquid (with a small amount of water).
• Before taking TIROSINT, check the correct functioning of the dropper: draw the solution from the bottle using the pipette and verify that drops are properly dispensed.
• To correctly measure the dose, hold the dropper in a vertical position.
• Take the daily dose as a single administration, in the morning and on an empty stomach.

If you take more TIROSINT than you should
If you take a higher dose than prescribed, symptoms due to overactivity of the thyroid gland may occur, such as chest pain (angina-like symptoms), irregular heartbeat (cardiac arrhythmias), awareness of heartbeat (palpitations), cramps, increased heart rate (tachycardia), insomnia, diarrhoea, excitability, headache (cephalalgia), hot flushes, muscle weakness, weight loss, fever, vomiting, menstrual cycle disturbances, tremor, restlessness, increased sweating (hyperhidrosis) (see section 4 – "Possible side effects").
In case of accidental ingestion of an excessive dose of TIROSINT, contact your doctor immediately or go to the nearest hospital.

If you forget to take TIROSINT
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• restlessness, agitation, insomnia, headache (cephalalgia), increased benign intracranial pressure, tremor;
• increased heart rate (tachycardia), awareness of heartbeat (palpitations), heart rhythm disorders (arrhythmia), chest pain (angina pectoris);
• vomiting, diarrhoea;
• weight loss;
• muscle weakness and muscle cramps;
• irregular menstruation;
• excessive sweating (hyperhidrosis), hot flushes, fever (pyrexia);
• allergic reactions.

The following side effects may occur with unknown frequency: angioedema, rash, urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TIROSINT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store the medicine at a temperature not exceeding 25°C. After opening the bottle, use this medicine within 1 month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TIROSINT contains
The active substance is: sodium levothyroxine.
1 ml of TIROSINT (equal to 28 drops) contains: 100 micrograms of sodium levothyroxine, equivalent to 97.24 micrograms of levothyroxine.
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The other components are: ethanol, glycerol.

Description of the appearance of TIROSINT and package contents
TIROSINT is available in a 20 ml bottle with a dropper.

Marketing Authorization Holder
IBSA Farmaceutici Italia Srl, via Martiri di Cefalonia, 2, 26900 Lodi

Manufacturer
IBSA Farmaceutici Italia Srl, via Martiri di Cefalonia, 2, 26900 Lodi
IBI Istituto Biochimico Italiano Giovanni Lorenzini S.p.a. - Via Fossignano, 2, Aprilia (Italy)
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Package leaflet: information for the patient

TIROSINT 25 micrograms/1 ml oral solution, 50 micrograms/1 ml oral solution, 75 micrograms/1 ml oral solution, 100 micrograms/1 ml oral solution

Levothyroxine sodium
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TIROSINT is and what it is used for

The active substance of TIROSINT is sodium levothyroxine (T4), a thyroid hormone produced in the laboratory (synthetic), whose structure and action are identical to those of natural thyroid hormone.
TIROSINT is used:

• as replacement therapy in case of thyroid hormone deficiency (hypothyroidism) due to reduced thyroid activity (hypothyroidism), or thyroid inflammation (thyroiditis), or goitre;
• to prevent tumour regrowth (recurrence) of the thyroid after surgical intervention (thyroidectomy);
• during treatment with antithyroid drugs.

2. What you should know before taking TIROSINT

Do not take TIROSINT if:

• you are allergic to sodium levothyroxine or to any of the other ingredients of this medicine (listed in section 6);
• you have recently had a heart attack (acute myocardial infarction), acute inflammation of the heart muscle (acute myocarditis), and/or acute inflammation of all layers of the heart wall (acute pancarditis);
• you are pregnant and are simultaneously taking medications for hyperthyroidism (thyroid suppressants);
• you have untreated adrenal insufficiency (adrenocortical insufficiency) or untreated pituitary gland underactivity (hypopituitarism);
• you have an excess of thyroid hormones in the blood (thyrotoxicosis). 8 of 14

Warnings and precautions
Talk to your doctor or pharmacist before taking TIROSINT.
Contact your doctor if you have any of the following heart conditions:

• high blood pressure (hypertension);
• rapid heartbeat (tachycardia);
• fatty deposits on the walls of arteries (arteriosclerosis);
• chest pain (angina pectoris);
• inflammation of the heart (myocarditis);
• heart attack (myocardial infarction);
• inadequate heart function (heart failure);
• insufficient blood flow in the coronary arteries (coronary insufficiency). Before taking TIROSINT, these conditions must be treated with medication; if you are already taking TIROSINT, thyroid hormone levels must be monitored frequently.

Inform your doctor if you suspect you have any of these conditions, or if you have been diagnosed with one of them and it has not yet been treated.
If you are about to undergo laboratory tests to monitor thyroid hormone levels, you must inform your doctor and/or laboratory staff that you are taking or have recently taken biotin (also known as vitamin H, vitamin B7, or vitamin B8). Biotin can affect laboratory test results. Depending on the test, results may be falsely high or falsely low due to biotin. Your doctor may ask you to stop taking biotin before undergoing laboratory tests. You should also be aware that other products you may be taking, such as multivitamin complexes or supplements for hair, skin, and nails, might contain biotin. This could affect laboratory test results. Inform your doctor and/or laboratory staff if you are taking such products (refer to the section Other medicines and TIROSINT).

Before starting treatment
Your doctor will perform tests to check whether you have an adrenal gland disorder (adrenal insufficiency), pituitary gland disorder (hypopituitarism), or thyroid gland disorder.
Inform your doctor if:

• you are postmenopausal or at high risk of osteoporosis;
• you have blood sugar disorders (diabetes);
• you have liver problems. If, during treatment with TIROSINT, you experience fever, muscle weakness, or abnormal liver function tests, contact your doctor, as your therapy may need to be adjusted;
• you have adrenal gland underactivity (adrenal insufficiency).

Elderly patients
Careful dosing and frequent medical monitoring are required in elderly patients.
Premature neonates
Blood pressure will be monitored regularly when starting levothyroxine treatment in premature neonates with very low birth weight, as a rapid drop in blood pressure (circulatory collapse) may occur.
When switching to another levothyroxine-containing product, thyroid imbalance may occur. Consult your doctor for any questions regarding a medication change. Careful monitoring (biological and clinical) is necessary during the transition period. Contact your doctor if you experience any adverse effects, as the dose may need to be increased or decreased.
Thyroid hormones must not be used for weight loss. If your thyroid hormone levels are normal, taking thyroid hormones will not cause weight loss. Increasing the dose without specific medical advice may lead to serious or even life-threatening adverse effects, particularly when combined with certain substances used for weight loss.
Other medicines and TIROSINT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking other medicines together with TIROSINT may affect its action or the action of the other medicine.
Inform your doctor if you are taking the following medicines.

• Medicines to lower blood sugar (antidiabetics): TIROSINT may reduce the effect of the antidiabetic medicine you are taking. Additional tests to measure blood glucose levels (blood sugar) may be necessary, especially at the beginning of TIROSINT therapy. During treatment with TIROSINT, the dosage of your antidiabetic medicine may need to be adjusted.
• Medicines that delay blood clotting (coumarin derivatives): TIROSINT may increase the effect of these medicines. Regular monitoring of blood clotting may be necessary, especially at the beginning of TIROSINT therapy. During treatment with TIROSINT, the dosage of your coumarin medicine may need to be adjusted.
• Propylthiouracil (a medicine for treating hyperthyroidism);
• Glucocorticoids (anti-allergic and anti-inflammatory medicines);
• Beta-blockers (medicines used in the treatment of heart conditions);
• Sertraline (a medicine for treating depression);
• Chloroquine or proguanil (medicines for prevention or treatment of malaria);
• Rifampicin (an antibiotic);
• Carbamazepine, phenytoin (medicines for treating epilepsy);
• Barbiturates (sedatives);
• Medicines containing estrogens used as contraceptives or for hormone replacement therapy after menopause;
• Salicylates (medicines used to relieve pain or reduce fever);
• Furosemide at high doses (250 mg) (a medicine used to increase urine production);
• Clofibrate (a medicine used to reduce fats in the blood);
• Amiodarone (a medicine for treating heart rhythm disorders);
• Propranolol (a medicine used to treat high blood pressure);
• Orlistat (a medicine used for weight loss);
• Ritonavir (used to control HIV virus and chronic hepatitis C);
• Products containing St. John's wort (a herbal medicine);
• Proton pump inhibitors: proton pump inhibitors (such as omeprazole, esomeprazole, pantoprazole, rabeprazole, and lansoprazole) are used to reduce stomach acid production, which may decrease levothyroxine absorption from the intestine and thus reduce its effectiveness. If you are taking levothyroxine during treatment with proton pump inhibitors, your doctor must monitor your thyroid function and may need to adjust the dose of TIROSINT;
• Biotin: if you are taking or have recently taken biotin, you must inform your doctor and/or laboratory staff when undergoing laboratory tests to monitor thyroid hormone levels. Biotin can affect laboratory test results (see section "Warnings and precautions").

If you take any of the following medicines, ensure you observe the recommended time interval:

• Antacids (medicines used to relieve gastric symptoms and heartburn), sucralfate (for treatment of peptic ulcers), and medicines containing aluminum, iron, or calcium carbonate: take TIROSINT at least 4 hours before taking any of these medicines, as the effect of TIROSINT may be reduced. 10 of 14
• Medicines used to bind bile acids and lower high cholesterol levels (such as cholestyramine or colestipol): take TIROSINT 4–5 hours before these medicines, as they may inhibit the intestinal absorption of TIROSINT.

Also be cautious when taking TIROSINT with other medicines
If you need to undergo an X-ray examination or other diagnostic tests involving the use of a contrast agent, inform your doctor that you are taking TIROSINT, as the injected substance may affect thyroid function.
TIROSINT with food and drinks
Inform your doctor if you consume soy products, especially if you change the proportion of soy products in your diet. Soy products may reduce levothyroxine absorption in the intestine; therefore, the dose of TIROSINT may need to be adjusted.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy

• Treatment with TIROSINT during pregnancy should not be interrupted, but should only be carried out when strictly necessary and under direct medical supervision.
• TIROSINT must not be used during pregnancy together with medicines for treating hyperthyroidism (thyroid suppressants).

Breastfeeding

• TIROSINT may be used during breastfeeding.
• Levothyroxine is excreted in breast milk during lactation, but concentrations achieved at recommended therapeutic doses are not sufficient to cause harm to the infant.

Driving and using machines
Since TIROSINT may cause headache (cephalalgia), exercise caution if you intend to drive vehicles or operate machinery.
TIROSINT contains Ethanol and Sodium:

• This medicine contains 243 mg of alcohol (ethanol) per ml of solution (28.8 vol %). The amount in 1 ml of this medicine is equivalent to 6 ml of beer or 2.4 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effects in children are not evident. Some effects may occur in young children, for example drowsiness. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. It may be harmful for alcoholics. If you have alcohol dependence, talk to your doctor before taking this medicine. This should be taken into account in children and high-risk groups, such as people with liver disease or epilepsy.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take TIROSINT

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment according to your individual needs.

Dosage

Adults

• Hypothyroidism due to reduced thyroid activity (thyroid hypofunction): Initially, adults should take 50 micrograms of sodium levothyroxine daily. Your doctor may prescribe increasing this dose by 50 micrograms of sodium levothyroxine every 2 weeks, up to a daily dose of 100–200 (300) micrograms of sodium levothyroxine.
• Hypothyroidism due to thyroid inflammation (thyroiditis): The daily dose is 100–150 micrograms of sodium levothyroxine.
• Hypothyroidism due to goiter: The daily dose is 100–150 (200) micrograms of sodium levothyroxine.
• Prevention of thyroid tumor growth (recurrence) after surgery (thyroidectomy): The daily dose is 100 micrograms of sodium levothyroxine.
• Adjunctive therapy during antithyroid treatment: The daily dose is 50–100 micrograms of sodium levothyroxine.

Elderly patients, patients with coronary heart disease, and patients with chronic hypothyroidism
Treatment with thyroid hormones must be initiated with particular caution. This means starting with a low initial dose, gradually increasing it at prolonged intervals, with frequent monitoring through laboratory tests.

Children

• In newborns and infants, treatment of congenital hypothyroidism should be started with a daily dose of 10–15 micrograms of sodium levothyroxine per kilogram of body weight.
• In children, treatment of acquired hypothyroidism should be started with a daily dose of 12.5–50 micrograms of sodium levothyroxine.
• The entire daily dose should be taken at least 30 minutes before the first meal of the day.

How to take the medicine:

• Take the dose with an adequate amount of liquid (e.g. a small amount of water).
• Take the daily dose as a single dose in the morning, on an empty stomach.

If you take more TIROSINT than you should
If you take a higher dose than prescribed, symptoms of thyroid overactivity may occur, such as chest pain (anginal symptoms), irregular heartbeat (cardiac arrhythmias), awareness of heartbeat (palpitations), cramps, increased heart rate (tachycardia), insomnia, diarrhoea, excitability, headache (cephalalgia), hot flushes, muscle weakness, weight loss, fever, vomiting, menstrual cycle disturbances, tremor, restlessness, increased sweating (hyperhidrosis) (see section 4 – "Possible side effects").
In case of accidental ingestion of an excessive dose of TIROSINT, contact your doctor immediately or go to the nearest hospital.

If you forget to take TIROSINT
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
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• restlessness, agitation, insomnia, headache (cephalalgia), increased benign intracranial pressure, tremor;
• increased heart rate (tachycardia), awareness of heartbeat (palpitations), heart rhythm disorders (arrhythmia), chest pain (angina pectoris);
• vomiting, diarrhoea;
• weight loss;
• muscle weakness and muscle cramps;
• irregular menstruation;
• excessive sweating (hyperhidrosis), hot flushes, fever (pyrexia);
• allergic reactions.

The following side effects may occur with unknown frequency: angioedema, skin rash, urticaria.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TIROSINT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store the medicine at a temperature not exceeding 25°C. After opening the protective pouch, the single-dose containers must be used within 15 days; store the remaining containers inside the pouch.
Each single-dose container must be used immediately after opening. Any unused solution should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TIROSINT contains
The active substance is: levothyroxine sodium.
1 single-dose container of TIROSINT 25 micrograms contains: 25 micrograms of levothyroxine
sodium, equivalent to 24.31 micrograms of levothyroxine.
1 single-dose container of TIROSINT 50 micrograms contains: 50 micrograms of levothyroxine
sodium, equivalent to 48.62 micrograms of levothyroxine.
1 single-dose container of TIROSINT 75 micrograms contains: 75 micrograms of levothyroxine
sodium, equivalent to 72.96 micrograms of levothyroxine.
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1 single-dose container of TIROSINT 100 micrograms contains: 100 micrograms of levothyroxine
sodium, equivalent to 97.24 micrograms of levothyroxine.
The other components are: ethanol, glycerol.
Description of the appearance of TIROSINT and package contents
TIROSINT is available in a carton containing 30 single-dose containers, packaged in 6 sachets with
5 single-dose containers each.
Marketing Authorization Holder and Manufacturer
IBSA Farmaceutici Italia Srl, via Martiri di Cefalonia, 2, 26900 Lodi
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