EUTIROX 25 MICROGRAMMI Coated tablet

Зміст інструкції

1. Eutirox 25 micrograms tablets, 50 micrograms tablets, 75 micrograms tablets, 88 micrograms tablets, 100 micrograms tablets, 112 micrograms tablets
   1. What is Eutirox and what is it used for
   2. What you need to know before taking Eutirox
   3. How to take Eutirox
   4. Possible side effects
   5. How to store Eutirox
   6. Contents of the pack and other information

Eutirox 25 micrograms tablets, 50 micrograms tablets, 75 micrograms tablets, 88 micrograms tablets, 100 micrograms tablets, 112 micrograms tablets

Eutirox 125 microgramstablets
Eutirox 137 microgramstablets
Eutirox 150 microgramstablets
Eutirox 175 microgramstablets
Eutirox 200 microgramstablets
sodium levothyroxine

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

1. What is Eutirox and what is it used for

Eutirox contains the active ingredient levothyroxine sodium (T4). Levothyroxine sodium is a synthetic hormone,
perfectly identical to that produced by the thyroid gland.
It is obtained in the laboratory through synthetic production and is available in tablet form.
The T4 contained in Eutirox is converted in our body into the hormone triiodothyronine (T3),
which regulates numerous functions of human metabolism.
Eutirox is used to treat conditions of hypothyroidism such as:

• goiter
• prophylaxis of recurrences after total or partial removal of the goiter (thyroidectomy)
• thyroid hypofunction
• thyroid inflammation
• during therapy with antithyroid medications.

2. What you need to know before taking Eutirox

Do not take Eutirox:

• if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6)
• if you have inadequately treated reduced function of the adrenal glands (adrenal insufficiency)
• if you have untreated overactive thyroid (untreated hyperthyroidism)
• if you have an untreated pituitary gland disease (untreated hypopituitarism)
• if you have a disease associated with high levels of thyroid hormones that is not treated (untreated thyrotoxicosis)
• if you have an acute heart attack
• if you have inflammation of the heart or heart muscle (pancarditis, acute myocarditis)
• if you are pregnant and using a medicine for overactive thyroid (hyperthyroidism) (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Before starting treatment with Eutirox, your doctor will exclude the presence and, if necessary,
treat the following clinical conditions:

• reduced blood supply to the heart (coronary insufficiency)
• inability of the heart to provide an adequate amount of blood (heart failure)
• chest pain of cardiac origin (angina pectoris)
• inflammation of the heart muscle (myocarditis)
• necrosis of heart tissue (myocardial infarction)
• presence of plaques in the arteries that decrease blood flow (arteriosclerosis)
• increased blood pressure (hypertension)
• reduced function of the pituitary gland (hypopituitarism)
• reduced function of the adrenal gland (adrenal insufficiency)
• uncontrolled function of the thyroid gland by the pituitary gland (thyroid gland autonomy)
• epilepsy (seizures). Seizures rarely occur at the beginning of treatment with levothyroxine.

Children
Blood pressure will be monitored regularly when starting treatment with
levothyroxine in premature newborns with very low birth weight, as a rapid drop in blood pressure (circulatory collapse) may occur.
If your child is taking this medicine, partial hair loss may occur
in the first few months of therapy, but this effect is generally transient and usually resolves with
subsequent regrowth.
Talk to your doctor or pharmacist before taking Eutirox.
Before prescribing Eutirox, your doctor will:

• establish the cause of secondary hypothyroidism, i.e. insufficient production of TSH hormone, which regulates thyroid function. If necessary, your doctor will prescribe replacement therapy for compensated adrenal insufficiency
• exclude thyroid autonomy. To this end, the doctor will assess the need to perform specific tests (TRH test or a scan during suppression).

Tell your doctor if any of the following conditions apply to you or you think they may apply,
because your doctor will pay particular attention:

• if you are an elderly patient
• if you have heart or blood vessel disease
• if you have heart problems, such as coronary insufficiency or heart failure or abnormal heart rhythm (arrhythmias) in these cases, your doctor will prescribe frequent monitoring of your thyroid hormone levels
• if you have severe or long-lasting hypothyroidism
• if you have psychotic disorders. In this case, your doctor will prescribe a low dose of levothyroxine and will gradually increase the dose at the beginning of therapy. Tell your doctor if psychotic disorder symptoms appear during treatment with Eutirox because they will assess the need to change the dose of levothyroxine
• if you are using medicines for the treatment of obesity that have a hormonal effect on the thyroid because if used together with Eutirox they can cause serious reactions (see section “Other medicines and Eutirox”)
• if you are using medicines that regulate blood clotting (anticoagulants) (see section “Other medicines and Eutirox”)
• if you are using any other medicine and in particular those listed in the section “Other medicines and Eutirox”
• if you have a pituitary gland disease (panhypopituitarism) or other diseases that may predispose to adrenal insufficiency or if your adrenal glands are not functioning properly (adrenal insufficiency), because in these cases your doctor may prescribe corticosteroid therapy before treatment with Eutirox
• if you are a postmenopausal woman and have a high risk of osteoporosis. In this case, your doctor will closely monitor thyroid function
• if you suffer from hyperthyroidism, because Eutirox should not be used unless as a supplement during antithyroid therapy for hyperthyroidism
• if you have diabetes. During treatment with Eutirox, your doctor will check your TSH levels tomonitor therapy. The frequency of checks depends on your clinical condition,generally your doctor will check you at intervals of 6-8 weeks.

Rare cases of liver dysfunction have been reported in subjects treated with thyroid preparations, the
doctor will assess the need to reduce the dose or stop treatment with Eutirox if,
during therapy, fever, muscle weakness or abnormalities in laboratory tests to assess liver function appear. Tell your doctor if you experience these symptoms.
Thyroid imbalance can occur if it is necessary to replace the medicine with another
medicine containing levothyroxine. Talk to your doctor if you have questions about how to replace the
medicine. Careful monitoring (clinical and biological) is necessary during the transition period. You must inform your doctor if you experience adverse effects as this may indicate
that the dose needs to be increased or decreased.
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 performing laboratory tests. You should also know that other products you
may be taking, such as multivitamin complexes or hair, skin and nail supplements,
may contain biotin. This may affect the results of laboratory tests. Inform
your doctor and/or laboratory personnel if you are taking such products (see
information in the section Other medicines and Eutirox).

Other medicines and Eutirox
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking or are going to take the medicines listed below, because Eutirox can
change their effects:

• medicines for diabetes (insulin and oral hypoglycemic agents). Eutirox may reduce the effect of these medicines, so at the beginning of treatment with Eutirox your doctor will ask you to frequently check your blood glucose levels and assess the need to change the dosage of the diabetes medicine.
• medicines that regulate blood clotting (coumarin anticoagulants). Eutirox may intensify the effect of these medicines, especially in the elderly. At the beginning and during therapy with Eutirox, your doctor will have you undergo frequent tests to check the coagulation parameters and assess the need to change the dosage of the anticoagulant.
• tricyclic antidepressant medicines (such as amitriptyline, imipramine). Eutirox may accelerate the response to tricyclic antidepressants.
• digitalis-based preparations. Your doctor may need to adjust your dose of digitalis. As treatment progresses, patients with hyperthyroidism may need a gradual increase in the dose of digoxin as patients are initially relatively sensitive to digoxin.
• sympathomimetic agents. The effects of sympathomimetic agents (such as adrenaline) are potentiated. Be very careful to respect the time intervals indicated if you need to take Eutirox together with the medicines listed below:
• medicines that reduce blood cholesterol levels (hypocholesterolemic agents) based on oral colestyramine and colestipol. In these cases, you must take Eutirox 4-5 hours before taking the medicine based on colestyramine or colestipol.
• medicines that contain iron, aluminum (antacids, sucralfate) or calcium as active ingredients or excipients. In these cases you must take Eutirox at least 2 hours before taking the medicines containing iron, aluminum or calcium. Tell your doctor if you are taking or are going to take the medicines listed below, because they can reduce the effects of Eutirox:
• orlistat (medicine for the treatment of obesity)
• antiepileptic medicines, especially diphenylhydantoin intravenously
• propylthiouracil (antithyroid medicine)
• glucocorticoids (steroidal anti-inflammatory drugs)
• beta-blockers (medicines used to lower blood pressure and treat heart disease)
• sertraline (antidepressant)
• chloroquine, proguanil (medicines for malaria therapy)
• barbiturates (sedatives, hypnotics) and other medicines that can increase the amount of levothyroxine eliminated from the blood through hepatic metabolism or products containing St. John's wort (a herbal medicine)
• medicines containing estrogens. If you are using contraceptives containing estrogens or if you are a postmenopausal woman and are using hormone replacement therapy for estrogen deficiency, you may have a greater need for levothyroxine
• sevelamer (medicine used to treat chronic kidney failure)
• tyrosine kinase inhibitors (anti-inflammatory and anti-cancer medicines)
• selpercatinib (used to treat some cancers)
• 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 Eutirox. Tell your doctor if you are taking or are going to take the medicines listed below, because they can intensify the effects of Eutirox:
• salicylates (anti-inflammatory drugs)
• dicoumarol (anticoagulant)
• furosemide (diuretic) at high doses (250 mg)
• clofibrate (to reduce cholesterol and lipids in the blood). Tell your doctor if you are taking or are going to take the medicines listed below, because they can change the effects of Eutirox:
• protease inhibitors e.g. ritonavir, indinavir and lopinavir;
• phenytoin (antiepileptic).

Tell your doctor if you are taking amiodarone (antiarrhythmic), because this medicine can
affect thyroid activity.
Tell your doctor that you are using Eutirox if you are going to undergo diagnostic tests in which
iodine-containing contrast agents are used, because they can affect thyroid activity.
If you are taking or have recently taken biotin, you must inform your doctor and/or laboratory personnel 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”).
Thyroid hormones should not be used for weight reduction. Taking thyroid hormones will not reduce your weight if your thyroid hormone level is normal. Serious or life-threatening side effects may occur if you increase the dose without a doctor's advice,
especially if taken together with other medicines used for weight reduction.

Eutirox with food and drink
Compounds or foods containing soy can decrease the absorption of Eutirox in the intestine therefore
you must inform your doctor if you use compounds or foods containing soy. In case of concomitant
intake, your doctor will assess whether to modify the dose of Eutirox, especially at the beginning or
end of the period of taking soy-based products.
If you have any doubts, ask your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
Pregnancy
Do not interrupt treatment with Eutirox during pregnancy.
Consult your doctor if you are pregnant, suspect you are pregnant, or are planning a pregnancy because during
pregnancy it may be necessary to increase the dose of Eutirox.
Experience has shown that this medicine does not cause congenital malformations and is not
toxic to the human fetus at the recommended therapeutic dosages.
Very high doses of levothyroxine taken during pregnancy can have a negative effect
on fetal development and in subsequent stages of growth after birth.
If you are pregnant, you should not take levothyroxine in combination with medicines for the treatment
of hyperthyroidism (antithyroid drugs). The use of Eutirox may require a higher dose of
antithyroid drugs. Therefore, if antithyroid drugs are necessary during pregnancy,
they should be taken alone (monotherapy with antithyroid drugs). See paragraph “Do not take
Eutirox”.
Breastfeeding
Do not interrupt treatment with Eutirox during breastfeeding.
Eutirox is found in breast milk during breastfeeding, but the concentrations reached at the recommended therapeutic doses
do not cause effects on the newborn.

Driving and using machines
No effects on the ability to drive vehicles and use machines are known. However, due to
the possible onset of headache, you should be careful when driving vehicles and performing
activities that require particular vigilance.

Eutirox contains sodium
Eutirox 25, 50, 75, 88, 100, 112, 125, 137, 150, 175 and 200 micrograms:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Eutirox

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor.
Take Eutirox preferably with a sip of water in the morning, while fasting.

The doctor will decide the appropriate dose according to your condition.
A lower dose may be sufficient

• if you are an elderly patient,
• if you have heart problems,
• if you have severe or chronic hypothyroidism,
• if you are of low weight and if you have a large goiter

Treatment of goiter
Adults
The recommended dose is 100-150 (200) micrograms per day.
Children (up to 14 years)
The recommended dose is 50-100 (150) micrograms per day.

Prophylaxis of recurrences after total or partial removal of the goiter (strumectomy)
The recommended dose is 100 micrograms per day.

Treatment of thyroid hypofunction
Adults
The recommended dose is 50 micrograms per day as an initial dose for about two weeks.
The doctor may then increase the daily dose by 50 micrograms at intervals of 14-15 days
approximately, up to a maintenance dose of 100-200 (300) micrograms per day; on average 2-2.5
micrograms/kg body weight per day.
Children
If the child was born with hypothyroidism, the doctor may recommend starting with a higher dose
because rapid replacement is important. The recommended initial dose is 10 to 15
micrograms per kg of body weight per day for the first 3 months. Afterwards, the doctor
will adjust the dose individually.
If the child has acquired hypothyroidism, the doctor may recommend an initial dose of 12.5-50
micrograms per day. Afterwards, the doctor will adjust the dose individually.
Method of administration
Infants must be given the entire daily dose of Eutirox at least half an hour before the
first meal of the day. Immediately before use, dissolve the tablet and mix it
with water and administer the mixture to the child with a further addition of liquid.
Prepare the mixture always at the time of use.

Treatment of thyroid inflammation
The recommended dose is 100-150 micrograms per day.

During therapy with antithyroid drugs
The recommended dose is 50-100 micrograms per day.

If you take more Eutirox than you should
In case of accidental ingestion of an excessive dose of Eutirox, immediately inform your
doctor or go to the nearest hospital.
After accidental ingestion of an excessive dose of Eutirox you may experience:

• symptoms of sudden acceleration of metabolism. In these cases, consult your doctor immediately, who may advise you to stop treatment and perform the appropriate tests;
• convulsions, in predisposed patients;
• hyperthyroidism and the appearance of symptoms of acute psychosis, these occur especially in patients at risk of psychotic disorders.

In cases of poisoning that occurred, for example, in suicide attempts, it has been proven that doses equal to 10
mg of levothyroxine can be tolerated without complications.
However, cases of sudden death from cardiac arrest have been reported in patients who have been
abusing this medicine for years.

If you forget to take Eutirox
If you forget to take a dose, do not take a double dose to make up for the missed dose
but take the normal dose the next day, as usual.

If you have any further questions on 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 everyone will experience them.
Occasionally, especially if you exceed your personal tolerance limit to levothyroxine, if you take
too much medicine, or if at the beginning of therapy with thyroid hormones the dose of levothyroxine is
increased too quickly, you may experience the typical symptoms of hyperthyroidism such as:

• increased heart rate (tachycardia)
• palpitations
• heart rhythm changes (cardiac arrhythmias)
• angina pectoris
• heart failure, myocardial infarction
• high blood pressure (hypertension)
• headache
• muscle weakness
• skeletal muscle cramps
• skull deformity due to premature closure of the skull bones in infants and children (craniostenosis)
• hot flashes
• increased appetite
• abdominal pain
• nausea
• fever
• vomiting
• shortness of breath (dyspnea)
• menstrual cycle changes
• pseudotumor cerebri (increased intracranial pressure)
• tremor
• restlessness
• insomnia
• excessive sweating (hyperhidrosis)
• weight loss
• diarrhea
• agitation
• flushing

Heat intolerance and transient hair loss in children have also been reported.
Seizures have been rarely reported in association with levothyroxine therapy.
In these cases, the doctor will assess whether to reduce the daily dose or interrupt treatment
with Eutirox for a few days. When the side effects have resolved, the doctor will assess whether to
resume treatment with caution.

If you are hypersensitive, you may experience allergic reactions. Cases of
angioedema (swelling of the skin or mucous membranes), rash (skin eruption) and urticaria have been
reported with unknown frequency. In this case, consult your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, 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 Eutirox

Do not use this medicine after the expiry date which is reported on the label. The expiry date refers to the last day of that month.
Do not store at a temperature above 25° C. Keep the blisters in the original package to
protect the medicine from light.
Keep this medicine out of the sight and reach of children.
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 Eutirox contains
The active ingredient is sodium levothyroxine
One tablet contains:

• 25 micrograms - 50 micrograms - 75 micrograms - 88 micrograms - 100 micrograms - 112 micrograms - 125 micrograms - 137 micrograms - 150 micrograms - 175 micrograms - 200 micrograms of sodium levothyroxine
• The other ingredients are: Corn starch, Citric acid, Sodium croscarmellose, Gelatin, Magnesium stearate, Mannitol (E421).

Description of the appearance of Eutirox and contents of the pack
Eutirox tablets are whitish, round, flattened on both sides, with a beveled edge,
with a fracture line on both sides and an inscription on one side: EM 25 or EM 50 or EM 75 or EM
88 or EM 100 or EM 112 or EM 125 or EM 137 or EM 150 or EM 175 or EM 200.
Eutirox is available in blisters of 50 tablets

Marketing Authorisation Holder
Merck Serono S.p.A. - Via Casilina 125, 00176 Rome

Manufacturer
Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt (Germany)
Corden Pharma GmbH, Otto-Hahn Straße, 68723 Plankstadt (Germany)
Famar Health Care Services Madrid, S.A.U. Avda. Leganés, 62 Alcorcón, 28923 Madrid (Spain)