TIROSINT 100 MICROGRAMMI/ML Oral drops, solution

Содержание инструкции

1. TIROSINT 100 micrograms/ml oral drops, solution
   1. What is TIROSINT and what is it used for
   2. What you need to know before taking TIROSINT
2. TIROSINT may reduce the effect of the antidiabetic medicine you are taking. It may be
   1. How to take TIROSINT
   2. Possible side effects
   3. How to store TIROSINT
   4. Contents of the pack and other information
3. TIROSINT 25 micrograms/1 ml oral solution
   1. What is TIROSINT and what is it used for
   2. Cosa deve sapere prima di prendere TIROSINT
   3. How to take TIROSINT
   4. Possible side effects
   5. How to store TIROSINT
   6. Contents of the pack and other information

TIROSINT 100 micrograms/ml oral drops, solution

Sodium levothyroxine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is TIROSINT and what is it used for

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

TIROSINT is used:

• as replacement therapy in case of thyroid hormone deficiency (hypothyroidism) due to a decrease in thyroid activity (thyroid hypofunction) or thyroid inflammation (thyroid inflammation) or goiter;
• for the prevention of tumor growth (recurrence) of the thyroid after surgical intervention (strumectomy);
• during therapy with antithyroid drugs.

2. What you need to know before taking TIROSINT

Do not take TIROSINT if:

• you are allergic to levothyroxine sodium or any of the other ingredients of this medicine (listed in section 6);
• you have recently had a heart attack (acute myocardial infarction), an acute inflammation of the heart muscle (acute myocarditis) and/or an acute inflammation of all layers of the heart wall (pancarditis);
• you are pregnant and are simultaneously taking medicines for hyperthyroidism (thyrostatic drugs);
• you have untreated adrenocortical insufficiency (adrenal insufficiency) or untreated pituitary gland dysfunction (pituitary insufficiency);
• 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);
• fast 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 to the coronary arteries (coronary insufficiency). Before taking TIROSINTthese conditions must be treated with medication; if you are taking TIROSINT, thyroid hormone levels must be checked frequently.

Tell your doctor if you suspect you have any of these conditions, or if you have been diagnosed with any of them and
have 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 personnel that you are taking or have recently taken
biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin can affect the
results of laboratory tests. Depending on the test, the 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 know that other products you
may be taking, such as multivitamin complexes or supplements for hair, skin and nails,
may contain biotin. This could affect the results of laboratory tests. Inform
your doctor and/or laboratory personnel if you are taking such products (please note the information
in the Other medicines and TIROSINTsection).

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

• you are postmenopausal or if you have a high risk of osteoporosis;
• you have an alteration of blood glucose (diabetes);
• you have liver problems. If during treatment with TIROSINTyou notice fever, muscle weakness or changes in liver function tests, contact your doctor as your therapy may need to be modified;
• you suffer from adrenal gland dysfunction (adrenal insufficiency).;

Elderly patients
Careful dosage and frequent medical check-ups are necessary in elderly patients.

Premature infants
Blood pressure will be checked regularly when starting treatment with levothyroxine
in premature infants with very low birth weight, as a rapid drop in
blood pressure (circulatory collapse) may occur.
If switching to another levothyroxine-based product, thyroid imbalance may occur. Consult
your doctor for any questions regarding the change of medication. 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 should not be used for weight loss. If your thyroid hormone levels are normal, taking thyroid hormones will not cause you to lose weight. If you increase the dose without specific
consultation with your doctor, serious or even life-threatening side effects may occur, in
particular in combination with certain substances used for weight loss.

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

Tell 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. It may be

necessary to perform additional tests to measure blood glucose levels (glycemia), in
particular at the beginning of therapy with TIROSINT. During treatment with TIROSINT, it
may be necessary to adjust the dosage of the antidiabetic medicine.

• Medicines that delay blood coagulation (coumarin derivatives):TIROSINT may increasethe effect of these medicines. It may be necessary to regularly monitor blood coagulation, particularly at the beginning of therapy with TIROSINT. During treatment with TIROSINT, it may be necessary to adjust the dosage of the coumarin medicine.
• Propylthiouracil(medicine for the treatment of hyperthyroidism);
• Glucocorticoids(anti-allergic and anti-inflammatory medicines);
• Beta-blockers(medicines used in the treatment of heart disease);
• Sertraline(medicine for the treatment of depression);
• Chloroquineor proguanil(medicine for the prevention or treatment of malaria);
• Rifampicin(an antibiotic);
• Carbamazepine, phenytoin(medicines for the treatment of epilepsy);
• Barbiturates(sedatives);
• Medicines containing estrogensused as contraceptives or for hormone replacement therapy after menopause;
• Salicylates(medicines used to relieve pain or lower fever);
• Furosemideat high doses (250 mg) (medicine used to increase urine production);
• Clofibrate(medicine used to reduce fats in the blood);
• Amiodarone(medicine for the treatment of 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 the amount of acid produced by the stomach, which can decrease the absorption of levothyroxine from the intestine and therefore make it less effective. If you are taking levothyroxine during treatment with proton pump inhibitors, your doctor should monitor your thyroid function and may need to adjust the dose of TIROSINT;
• Biotin: if you are taking or have recently taken biotin, you should inform your doctor and/or laboratory staff when you are about to undergo laboratory tests to monitor thyroid hormone levels. Biotin can affect the results of laboratory tests (see the section “Warnings and precautions”).

If you are taking any of the following medicines, make sure to respect the recommended time
interval:

• Antacids(medicines used to relieve stomach symptoms and heartburn), sucralfate(for the treatment of peptic ulcers), and medicines containing aluminum, iron or calcium carbonate: take TIROSINT at least 4 hours beforeany of these medicines, as the effect of TIROSINT may be reduced.
• Medicines used to bind bile acids and lower high cholesterol levels (such as cholestyramineor colestipol): take TIROSINT 4 - 5 hours beforethese medicines, as they can inhibit the absorption of TIROSINT in the intestine.

Also be careful when taking TIROSINT with other medicines
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If you need to undergo an examination that exposes you to X-raysor other diagnostic testsin which a contrast agentis used, tell your doctor that you are taking TIROSINT, as the
substance to be injected may affect thyroid function.

TIROSINT with food and drinks
Tell your doctor if you consume soy products, especially if you change the proportion of the amount
of soy products in your diet. Soy products can reduce the absorption of
levothyroxine in the intestine; for this reason, the dose of TIROSINT may need to be
adjusted.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

• Treatment with TIROSINTduring pregnancy should not be interrupted, it should only be carried out if absolutely necessary and under the direct control of the doctor.
• TIROSINT should not be used during pregnancy together with medicines for the treatment of hyperthyroidism (thyreostatics).

Breastfeeding

• TIROSINT can be used during breastfeeding.
• Levothyroxine is secreted in breast milk during breastfeeding, but the concentrations reached at recommended therapeutic doses are not sufficient to cause harm to the newborn.

Driving and operating machinery
As TIROSINT can cause headache, be careful if you need to drive vehicles or operate machinery.

TIROSINT contains Ethanol and Sodium:

• This medicine contains 243 mg of alcohol (ethanol) in each 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 small children, for example feeling sleepy. 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 to alcoholics. If you have an alcohol dependence, talk to your doctor before taking this medicine. To be taken into consideration 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, that is to say essentially ‘sodium-free’.

3. How to take TIROSINT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The doctor will establish the dose and duration of therapy according to your needs.

Dosage

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Adults

• Hypothyroidism due to decreased thyroid activity (thyroid underfunction): Initially, adults should take 50 micrograms of sodium levothyroxine per day, equivalent to 14 drops per day. The 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 goiter: The daily dose is 100-150 (200) micrograms of sodium levothyroxine, equivalent to 28-42 drops per day.
• Prevention of thyroid tumor growth (recurrence) after surgical intervention (thyroidectomy): The daily dose is 100 micrograms of sodium levothyroxine, equivalent to 28 drops per day.
• Supportive therapy during antithyroid drug therapy: 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 hypothyroidism
Treatment with thyroid hormones must be started with particular caution. This means
that treatment should be started with a low initial dose, gradually increased at
prolonged intervals, with frequent monitoring by 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 little water).
• Before taking TIROSINT, test the correct functioning of the dropper: draw the solution from the bottle with the dropper and check the dispensing in drops.
• To dose the medicine correctly, keep the dropper in a vertical position.
• Take the daily dose in a single dose, in the morning and on an empty stomach.

If you take more TIROSINT than you should
If you take a dose higher than prescribed, symptoms due to
thyroid hyperactivity may occur, such as chest pain (anginal manifestations), irregular heartbeat (cardiac arrhythmias), perception of the heartbeat (palpitations), cramps, increased
heart rate (tachycardia), insomnia, diarrhea, excitability, headache,
hot flashes, muscle weakness, weight loss, fever, vomiting, changes in the menstrual cycle,
tremor, restlessness, increased sweating (hyperhidrosis) (see paragraph 4 – "Possible
side effects").
In case of accidental ingestion of an excessive dose of TIROSINT, immediately notify your
doctor or go to the nearest hospital.
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If you forget to take TIROSINT
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

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, increased benign intracranial pressure, tremor;
• increased heart rate (tachycardia), awareness of heartbeat (palpitations), irregular heartbeat (arrhythmia), chest pain (angina pectoris);
• vomiting, diarrhea;
• weight loss;
• muscle weakness and muscle cramps;
• irregular menstruation;
• excessive sweating (hyperhidrosis), hot flashes, fever (pyrexia);
• allergic reactions.

The following side effects can occur with unknown frequency: angioedema, skin rash, urticaria

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 sight and reach of children.
Do not use this medicine after the expiry date which is 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 in wastewater or household waste. 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 contains
The active ingredient is: levothyroxine sodium.
1 ml of TIROSINT (equivalent to 28 drops) contains: 100 micrograms of levothyroxine sodium, equivalent to 97.24
micrograms of levothyroxine.
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The other ingredients are: ethanol, glycerol.

Description of the appearance of TIROSINT and contents of the pack
TIROSINT is available in 20 ml bottles equipped with a dropper.

Marketing Authorisation 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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TIROSINT 25 micrograms/1 ml oral solution

TIROSINT 50 micrograms/1 ml oral solution
TIROSINT 75 micrograms/1 ml oral solution
TIROSINT 100 micrograms/1 ml oral solution
Sodium levothyroxine

Read this leaflet carefully before you take 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is TIROSINT and what is it used for

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

TIROSINT is used:

• as replacement therapy in case of thyroid hormone deficiency (hypothyroidism) due to a decrease in thyroid activity (thyroid hypofunction) or thyroid inflammation (thyroid inflammation) or goiter;
• for the prevention of tumor growth (recurrence) of the thyroid after surgical intervention (strumectomy);
• during therapy with antithyroid drugs.

2. Cosa deve sapere prima di prendere TIROSINT

Non prenda TIROSINT se:

• è allergico alla levotiroxina sodica o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6);
• ha recentemente avuto un attacco di cuore (infarto miocardico acuto), un’infiammazione acuta del muscolo del cuore (miocardite acuta) e / o una infiammazione acuta di tutti gli strati della parete cardiaca (pancardite);
• è incinta e se assume contemporaneamente medicinali per la tiroide iperattiva (tireostatici)
• ha un’insufficienza adrenocorticale (insufficienza surrenalica) non trattata o un’ipofunzione della ghiandola ipofisaria (insufficienza ipofisaria) non trattata;
• ha un eccesso di ormoni tiroidei nel sangue (tireotossicosi). 8 di 14

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere TIROSINT.
Contatti il suo medico se ha uno dei seguenti disturbi cardiaci:

• alta pressione sanguigna (ipertensione);
• battito cardiaco accelerato (tachicardia);
• depositi grassi sulle pareti delle arterie (arteriosclerosi);
• dolore toracico (angina pectoris);
• infiammazione del cuore (miocardite);
• attacco di cuore (infarto del miocardio);
• inadeguata funzione del cuore (insufficienza cardiaca);
• insufficiente flusso del sangue nelle coronarie (insufficienza coronarica). Prima di prendere TIROSINTquesti disturbi devono essere trattati con dei farmaci; se sta prendendo TIROSINT, è necessario controllare frequentemente i valori degli ormoni tiroidei.

Informi il medico se sospetta di avere uno di questi disturbi, o se le è stato diagnosticato uno di essi e
non è ancora stato trattato.
Se sta per sottoporsi a esami di laboratorio per monitorare i livelli di ormoni della tiroide, deve
informare il medico e/o il personale di laboratorio che sta assumendo o ha recentemente assunto
biotina (nota anche come vitamina H, vitamina B7 o vitamina B8). La biotina può influenzare i
risultati degli esami di laboratorio. A seconda dell’esame, i risultati possono essere falsamente alti o
falsamente bassi a causa della biotina. Il medico può chiederle di interrompere l’assunzione di biotina
prima di eseguire gli esami di laboratorio. Deve inoltre sapere che anche altri prodotti che potrebbe
assumere, quali complessi multivitaminici o integratori per capelli, pelle e unghie, potrebbero
contenere biotina. Ciò potrebbe influenzare i risultati degli esami di laboratorio. Informi il medico e/o
il personale di laboratorio se sta assumendo tali prodotti (tenga presente le informazioni di cui al
paragrafo Altri medicinali e TIROSINT).

Prima di iniziare il trattamento
Il suo medico eseguirà degli esami per controllare se è affetto da un disturbo della ghiandola surrenale
(insufficienza surrenalica), ipofisaria (insufficienza ipofisaria) o della ghiandola tiroidea.
Informi il suo medico se:

• è in post-menopausa o se ha un elevato rischio di osteoporosi;
• presenta un’ alterazione della glicemia(diabete);
• ha problemi al fegato. Se durante il trattamento con TIROSINTnota febbre, debolezza ai muscoli o alterazioni degli esami del fegato, contatti il medico poiché è necessario modificare la sua terapia;
• è affetto da un’ipofunzione della ghiandola surrenale (insufficienza surrenalica).

Pazienti anziani
Un dosaggio attento e controlli medici frequenti sono necessari nei pazienti anziani.

Neonati pretermine
La pressione sanguigna verrà controllata regolarmente quando si inizia un trattamento con levotiroxina
in neonati pretermine con peso alla nascita molto basso, poiché può verificarsi un rapido calo della
pressione sanguigna (collasso circolatorio).
In caso di passaggio ad altro prodotto a base di levotiroxina, può verificarsi uno squilibrio tiroideo. Si rivolga
al medico per qualsiasi domanda che riguarda il cambio di farmaco. È necessario un attento monitoraggio
(biologico e clinico) durante il periodo di transizione. Si rivolga al medico se accusa qualsiasi effetto
indesiderato, poiché in tal caso potrebbe essere necessario aumentare o diminuire la dose.
Gli ormoni tiroidei non devono essere usati per dimagrire. Se i suoi livelli di ormoni tiroidei sono nella
norma, l’assunzione di ormoni tiroidei non le farà perdere peso. Se aumenta la dose senza specifico
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consulto del medico, possono verificarsi effetti indesiderati seri o addirittura pericolosi per la vita, in
particolare in combinazione con determinate sostanze usate per perdere peso.

Altri medicinali e TIROSINT
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere
qualsiasi altro medicinale.
L’assunzione di altri medicinali insieme a TIROSINT può influenzare la sua azione o quella dell’altro
medicinale.

Informi il medico se sta assumendo i seguenti medicinali.

• Medicinali per diminuire la glicemia (antidiabetici):TIROSINT può ridurrel’effetto del medicinale antidiabetico che assume. Può rendersi necessario effettuare esami aggiuntivi per misurare i livelli di glucosio nel sangue (glicemia), in particolare all’inizio della terapia con TIROSINT. Durante il trattamento con TIROSINT, è possibile che debba essere aggiustato il dosaggio del medicinale antidiabetico.
• Medicinali che ritardano la coagulazione del sangue (derivati cumarinici):TIROSINT può aumentarel’effetto di questi medicinali. Può rendersi necessario controllare regolarmente la coagulazione del sangue, in particolare all’inizio della terapia con TIROSINT. Durante il trattamento con TIROSINT, è possibile che debba essere aggiustato il dosaggio del medicinale cumarinico.
• Propiltiouracile(medicinale per il trattamento della tiroide iperattiva);
• Glucocorticoidi(medicinali antiallergici e antinfiammatori);
• Beta-bloccanti(medicinali utilizzati nel trattamento delle malattie cardiache);
• Sertralina(medicinale per il trattamento della depressione);
• Clorochinao proguanile(medicinale per la prevenzione o il trattamento della malaria);
• Rifampicina(un antibiotico);
• Carbamazepina, fenitoina (medicinali per il trattamento dell’epilessia);
• Barbiturici(sedativi);
• Medicinali contenenti estrogeniusati come contraccettivi o per la terapia ormonale sostitutiva dopo la menopausa;
• Salicilati(medicinali utilizzati per alleviare il dolore o per abbassare la febbre);
• Furosemidead alte dosi (250 mg) (medicinale utilizzato per aumentare la produzione di urina);
• Clofibrato(medicinale utilizzato per ridurre i grassi nel sangue);
• Amiodarone(medicinale per il trattamento dei disturbi del ritmo cardiaco);
• Propranololo(medicinale usato per trattare la pressione alta);
• Orlistat(medicinale utilizzato per dimagrire);
• Ritonavir(usato per il controllo dei virus dell’HIV e dell’epatite C cronica);
• Prodotti contenenti erba di San Giovanni(un medicinale di origine vegetale);
• Inibitori della pompa protonica:gli inibitori della pompa protonica (come omeprazolo, esomeprazolo, pantoprazolo, rabeprazolo e lansoprazolo) sono utilizzati per ridurre la quantità di acido prodotta dallo stomaco, che può diminuire l’assorbimento di levotiroxina dall’intestino e quindi renderla meno efficace. Se sta assumendo levotiroxina durante il trattamento con inibitori della pompa protonica, il medico deve monitorare la sua funzionalità tiroidea e potrebbe dover modificare la dose di TIROSINT;
• Biotina: se sta assumendo o ha recentemente assunto biotina, deve informare il medico e/o il personale di laboratorio quando sta per sottoporsi a esami di laboratorio per monitorare i livelli di ormoni della tiroide. La biotina può influenzare i risultati degli esami di laboratorio (vedere il paragrafo “ Avvertenze e precauzioni”).

Se assume uno dei seguenti medicinali, si assicuri di rispettare l’intervallo di tempo
raccomandato:

• Antiacidi(medicinali utilizzati per alleviare i sintomi gastrici e bruciore di stomaco), sucralfato(per il trattamento delle ulcere peptiche), e i medicinali contenenti alluminio, ferro o carbonatodi calcio: prenda TIROSINT almeno 4 ore primadi uno qualsiasi di questi medicinali, poiché l’effetto di TIROSINT potrebbe essere ridotto. 10 di 14
• Medicinali utilizzati per legare gli acidi biliari ed abbassare elevati valori di colesterolo (come colestiraminao colestipolo): prenda TIROSINT 4 - 5 ore primadi questi medicinali, poiché possono inibire l’assorbimento di TIROSINT nell’intestino.

Faccia inoltre attenzione quando prende TIROSINT con altri medicinali
Se deve effettuare un esame che la espone ai raggi Xo altri esami diagnosticiin cui viene utilizzato
un mezzo di contrasto, informi il medico che sta assumendo TIROSINT, poiché la sostanza da
iniettare può influenzare la funzionalità tiroidea.

TIROSINT con cibi e bevande
Informi il medico se consuma prodotti di soya, in particolare se cambia la proporzione della quantità
dei prodotti di soya contenuti nella sua dieta. I prodotti di soya possono ridurre l’assorbimento della
levotiroxina nell’intestino; per questo motivo è possibile che la dose di TIROSINT debba essere
aggiustata.

Gravidanza e allattamento
Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza, o se sta allattando con latte
materno chieda consiglio al medico o al farmacista prima di prendere questo medicinale.

Gravidanza

• Il trattamento con TIROSINTdurante la gravidanza non andrebbe interrotto, andrebbe effettuato solo in caso di effettiva necessità e sotto il diretto controllo del medico.
• TIROSINT non deve essere usato durante la gravidanza insieme ai medicinali per iltrattamento della tiroide iperattiva (tireostatici).

Allattamento

• TIROSINT può essere utilizzato durante l’allattamento.
• La levotiroxina è secreta nel latte materno durante l’allattamento ma le concentrazioni raggiunte alle dosi terapeutiche raccomandate non sono sufficienti a causare danni nel neonato.

Guida di veicoli e utilizzo di macchinari
Poiché TIROSINT può causare mal di testa (cefalea), faccia attenzione se deve mettersi alla guida di
veicoli o utilizzare macchinari.

TIROSINT contiene Etanolo e Sodio:

• Questo medicinale contiene 243 mg di alcol (etanolo) in ciascun ml di soluzione (28,8 vol %). La quantità in 1 ml di questo medicinale è equivalente a 6 ml di birra o 2,4 ml di vino. La quantità di alcol in questo medicinale non sembra avere effetto su adulti e adolescenti e i suoi effetti nei bambini non sono evidenti. Potrebbero verificarsi alcuni effetti nei bambini piccoli, per esempio sentirsi assonnati. L'alcol in questo medicinale può alterare gli effetti di altri medicinali. Parli con il medico o il farmacista se sta assumendo altri medicinali. Se è incinta o sta allattando al seno, parli con il medico o il farmacista prima di assumere questo medicinale. Può essere dannoso per gli alcolisti. Se ha una dipendenza da alcol, parli con il medico prima di assumere questo medicinale. Da tenere in considerazione nei bambini e nei gruppi ad alto rischio, come le persone affette da patologie epatiche o epilessia.
• Questo medicinale contiene meno di 1 mmol (23 mg) di sodio per dose, cioè essenzialmente ‘senza sodio’.

3. How to take TIROSINT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The doctor will establish the dose and duration of therapy according to your needs.

Dosage
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Adults

• Hypothyroidism due to decreased thyroid activity (thyroid underfunction): Initially, adults should take 50 micrograms of sodium levothyroxine per day. The 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 inflammation of the thyroid (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 tumor growth (recurrence) of the thyroid after surgical intervention (thyroidectomy): The daily dose is 100 micrograms of sodium levothyroxine.
• Supportive therapy during therapy with antithyroid drugs: The daily dose is 50-100 micrograms of sodium levothyroxine.

Elderly patients, patients with coronary artery disease and patients with chronic thyroid underfunction
Treatment with thyroid hormones must be started with particular caution. This means that
treatment should be started with a low initial dose, gradually increased at prolonged
intervals, with frequent monitoring by 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 (with a little water).
• Take the daily dose in a single dose, in the morning and on an empty stomach.

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

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

4. Possible side effects

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 which is 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 sachet, the single-dose containers must be used within 15 days; keep the remaining containers inside the sachet.
Each single-dose container must be used immediately after opening. Any unused solution must be discarded.
Do not dispose of any medicine in the wastewater or household waste. 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 contains
The active ingredient is: sodium levothyroxine.
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 ingredients are: ethanol, glycerol.

Description of the appearance of TIROSINT and contents of the pack
TIROSINT is available in packs of 30 single-dose containers, packaged in 6 sachets each containing 5 single-dose containers.

Marketing authorisation holder and manufacturer
IBSA Farmaceutici Italia Srl, via Martiri di Cefalonia, 2, 26900 Lodi
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