LEVOTIRSOL 13 MICROGRAMS Oral solution

Содержание инструкции

1. LEVOTIRSOL 13 micrograms oral solution in single-dose container, 25 micrograms oral solution in single-dose container, 50 micrograms oral solution in single-dose container, 75 micrograms oral solution in single-dose container, 88 micrograms oral solution in single-dose container, 100 micrograms oral solution in single-dose container, 112 micrograms oral solution in single-dose container
   1. What is LEVOTIRSOL and what is it used for
   2. What you need to know before taking LEVOTIRSOL
   3. How to take LEVOTIRSOL
   4. Possible side effects
   5. How to store LEVOTIRSOL
   6. Package contents and other information

LEVOTIRSOL 13 micrograms oral solution in single-dose container, 25 micrograms oral solution in single-dose container, 50 micrograms oral solution in single-dose container, 75 micrograms oral solution in single-dose container, 88 micrograms oral solution in single-dose container, 100 micrograms oral solution in single-dose container, 112 micrograms oral solution in single-dose container

LEVOTIRSOL 125 micrograms oral solution in single-dose container
LEVOTIRSOL 137 micrograms oral solution in single-dose container
LEVOTIRSOL 150 micrograms oral solution in single-dose container
LEVOTIRSOL 175 micrograms oral solution in single-dose container
LEVOTIRSOL 200 micrograms oral solution in single-dose container
Sodium levothyroxine

Read this leaflet carefully before you start 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 their
• symptoms are the same as yours, 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 LEVOTIRSOL is and what it is used for
• 2. What you need to know before you take LEVOTIRSOL
• 3. How to take LEVOTIRSOL
• 4. Possible side effects
• 5. How to store LEVOTIRSOL
• 6. Contents of the pack and other information

1. What is LEVOTIRSOL and what is it used for

The active ingredient of LEVOTIRSOL is sodium levothyroxine (T4) a synthetic thyroid hormone, whose structure and action are identical to the natural thyroid hormone.
LEVOTIRSOL is used:

• In the replacement therapy of thyroid hormone in case of hypothyroidism;
• for the prevention of recurrent goiter after surgical intervention, in patients with normal thyroid function;
• for the treatment of benign goiter in patients with normal thyroid function;
• for the suppression of renewed tumor growth (malignant disease) of the thyroid, particularly after surgical intervention, and as a substitute for thyroid hormone deficiency;
• as accompanying therapy in the treatment of hyperthyroidism,
• in the thyroid suppression test.

2. What you need to know before taking LEVOTIRSOL

Do not take LEVOTIRSOL

• if you are allergic to levothyroxine sodium or any of the other ingredients of this medicine (listed in section 6),

medicinal product (listed in paragraph 6),

• if you have recently had a heart attack, an acute inflammation of the heart muscle and/or an acute inflammation of all layers of the heart wall (pancarditis);
• if you are pregnant and are taking medications for overactive thyroid (thyrostatic drugs) at the same time (see section “Pregnancy and breastfeeding”);
• if you suffer from untreated adrenal insufficiency, untreated pituitary insufficiency (pituitary failure) and/or untreated overactive thyroid gland;

Take special care with LEVOTIRSOL
Talk to your doctor or pharmacist before taking LEVOTIRSOL.
Take special care with LEVOTIRSOL if you suffer from any of the following heart conditions:

• high blood pressure,
• fast or irregular heartbeat,
• fat deposits on the artery walls (arteriosclerosis),
• chest pain with a feeling of tightness (angina pectoris),
• insufficient blood flow to the coronary arteries (coronary insufficiency).

These conditions must be treatedwith medications before takingLEVOTIRSOL and,
while taking LEVOTIRSOL, thyroid hormone levels must be checked more
frequently.
Tell your doctor if you suspect you have any of the above 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 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 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 (please refer to the information in the
section Other medicines and LEVOTIRSOL).

Before starting treatment

• Your doctor will perform tests to check if you suffer from a disorder of the adrenal gland, pituitary gland or thyroid gland caused by the overproduction and uncontrolled production of thyroid hormones (thyroid autonomy), as this condition must be treated pharmacologically before taking LEVOTIRSOL.
• Tell your doctor if you are currently in menopause or post-menopause. Regarding the risk of osteoporosis, it may be necessary to regularly check thyroid function.
• Tell your doctor if you notice the onset of signs of psychotic disorders(more accurate monitoring and dose adjustment may be necessary).
• Tell your doctor before starting or stopping orlistat, or changing the treatment with orlistat (a medicine for treating obesity; more accurate monitoring and dose adjustment may be necessary).
• Some heart conditionsmust be treated before taking LEVOTIRSOL; read the information in the section “Take special care with LEVOTIRSOL” carefully.
• If you have an alteration of blood sugar (diabetes)or are taking some medicines that helptothin the blood, read the section “Other medicines and LEVOTIRSOL” carefully.
• If switching to another product based on levothyroxine, thyroid imbalance may occur. Contact your doctor with 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 undesirable effects, as the dose may need to be increased or
decreased in such cases.

• Do not take LEVOTIRSOL to lose weight. If the level of thyroid hormones in the blood is within the normal range, taking additional thyroid hormones will not lead to weight loss. Taking additional thyroid hormones without consulting a doctor can cause serious or even life-threatening side effects, especially when taken together with some weight-loss agents.
• Be careful if you suffer from epilepsy. Rare cases of seizures have been reported at the start of treatment with levothyroxine in patients with a known history of epilepsy.

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.

Other medicines and LEVOTIRSOL
Taking other medicines together with LEVOTIRSOL can affect its action or that
of the other medicine. Make sure your doctor is aware of the medicines you are taking.

Do not take other medicines while taking LEVOTIRSOL unless you have first
informed your doctor or pharmacist and asked for their advice.This includes medicines obtained
without a prescription.

Tell your doctor if you are taking any of the following medicines:

• Medicines to lower blood sugar (antidiabetics):LEVOTIRSOL canreducethe effect of the antidiabetic medicine you are taking. Additional tests to measure blood sugar levels may be necessary, especially at the beginning of therapy with LEVOTIRSOL. During treatment with LEVOTIRSOL, the dosage of the antidiabetic medicine may need to be adjusted.
• Medicines that help to thin the blood (coumarin derivatives):LEVOTIRSOL canincreasethe effect of these medicines. Regular monitoring of blood coagulation may be necessary, especially at the beginning of therapy with LEVOTIRSOL. During treatment with LEVOTIRSOL, the dosage of the coumarin medicine may need to be adjusted.
• Propylthiouracil(medicine for the treatment of hyperthyroidism),
• Glucocorticoids(anti-allergic and anti-inflammatory medicines),
• Beta-blockers(medicines to reduce blood pressure, also used in the treatment of heart disease),
• Sertraline(medicine for the treatment of depression),
• Chloroquine or proguanil(medicine for the prevention or treatment of malaria),
• Medicines for the treatment of epilepsy, such as carbamazepine, phenytoin, phenobarbital,primidone,
• Medicines containing estrogensused for hormone replacement therapy during or after menopause or as contraceptives.
• Salicylates(medicines used to relieve pain or to reduce fever),
• Dicoumarol(medicine used to inhibit blood coagulation),
• Furosemideat high doses equal to or greater than 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)
• Ritonavir, indinavir, lopinavir,used to control HIV viruses and chronic hepatitis C
• Sevelamer(medicine used in patients undergoing dialysis or those with chronic non-dialyzed kidney disease)
• Tyrosine kinase inhibitors(anticancer and anti-inflammatory medicines)
• Orlistat (medicine used to lose weight)
• 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 LEVOTIRSOL
• Biotin: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 “Take special care with LEVOTIRSOL”).

If you are taking any of the following medicines, make sure you 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:Take LEVOTIRSOL at least 2 hours beforeany of these medicines, as the effect of LEVOTIRSOL may be reduced.
• Medicines used to bind bile acids and lower high cholesterol levels (such as cholestyramine or colestipol): Take LEVOTIRSOL 4 - 5 hours beforethese medicines, as they can inhibit the absorption of LEVOTIRSOL in the intestine.

Also take care when taking LEVOTIRSOL with other medicines:
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 LEVOTIRSOL, as
the substance to be injected may affect thyroid function.

LEVOTIRSOL with food and drink
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 LEVOTIRSOL may need to be
adjusted.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

• Treatment with LEVOTIRSOLis particularly important during pregnancy and, therefore, must not be interrupted. This is essential for the normal development of the unborn child. Consult your doctor, as the dose of levothyroxine may need to be adjusted, as your requirement may increase during pregnancy. Thyroid function must be carefully monitored.
• LEVOTIRSOL must not be used during pregnancy together with medicines for thetreatment of hyperthyroidism (thyrostatic drugs).During pregnancy, hyperthyroidism must be treated exclusively with low-dose thyrostatic drugs (see “Do not take LEVOTIRSOL”). Breastfeeding
• LEVOTIRSOL can be used during breastfeeding. There is no information to suggest that the use of LEVOTIRSOL by women during breastfeeding can harm the baby with normal thyroid function.

Driving and using machines
There is no evidence to suggest that LEVOTIRSOL limits the ability to drive vehicles or
use machines, as levothyroxine is identical to natural thyroid hormone.
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of oral solution, i.e.
essentially ‘sodium-free’.

3. How to take LEVOTIRSOL

Always take this medicine exactly as your doctor has told you. If you have
any doubts, ask your doctor or pharmacist.
The doctor will establish the individual dose based on the results of laboratory tests.

Dosage
For individual treatment, single-dose containers of LEVOTIRSOL are available with a
content varying from 13 to 200 micrograms of sodium levothyroxine, so that you can take one
single-dose container per day.

Adults

• Treatment of thyroid gland hypofunction: Initially, adults should take 25-50 micrograms of sodium levothyroxine per day. The doctor may prescribe increasing this dose by 25-50 micrograms of sodium levothyroxine every two - four weeks, up to a daily dose of 100-200 micrograms of sodium levothyroxine (equivalent to 1 - 2 single-dose containers of LEVOTIRSOL).
• Prevention of recurrent goiter after surgical removal and treatment of benign goiter: The daily dose is 75-200 micrograms of sodium levothyroxine.
• Supportive therapy in the tireostatic treatment of hyperthyroidism: The daily dose is 50-100 micrograms of sodium levothyroxine.
• After surgery to the thyroid for a malignant thyroid tumor: The daily dose is 150-300 micrograms of sodium levothyroxine.
• For diagnostic use in thyroid suppression testing: The daily dose is 200 micrograms of sodium levothyroxine for 14 days before the radiological examination (scintigraphy).

Elderly patients, patients with coronary heart disease and patients suffering from severe
or chronic hypothyroidism:
Treatment with thyroid hormones must be started with particular caution. This means that a
low initial dose must be selected, gradually increased at prolonged intervals, with frequent monitoring by laboratory tests.

Children
The dose for children depends on age, weight and the condition being treated. The child will be
monitored to ensure they receive the correct dose.

• Congenital hypothyroidism in children: Initially 10 to 15 micrograms/kg of body weight per day for the first 3 months. The dose will then be adjusted according to the response to treatment.
• Acquired hypothyroidism in children: Initially 13 to 50 micrograms per day. The dose must be gradually increased every 2-4 weeks depending on the response to treatment.

Tell your doctor or pharmacist if you think the effects of LEVOTIRSOL are too strong or too
weak.

How to take the medicine:
Take the full daily dose in the morning, on an empty stomach, at leasthalf an hour before
breakfast. Absorption of the active ingredient is better on an empty stomach, rather than after a
meal.

• Give this medicine to the child at least half an hour before the first meal of the day.
• LEVOTIRSOL can be taken:
• diluted or mixed first with water, or
• squeezed directly into the mouth or onto a spoon
• Do notdilute or mix LEVOTIRSOL with liquids other than water.
• Open the single-dose container and prepare the solution shortly before taking LEVOTIRSOL.
• After diluting or mixing, LEVOTIRSOL must be taken or discarded.
• 1. Open the aluminum sachet by tearing along the dotted line.
• 2. Immediately remove the single-dose container to be used from the strip. Put the unused containers back into the sachet before storing it.
• 3. Hold the container in an upright position (cap upwards) between your index finger and thumb without squeezing it. Open the container by twisting the top.

Taking LEVOTIRSOL by diluting or mixing it:

• Turn the single-dose container upside down.
• Press slowlyon the softer central part of the container between your index finger and thumb to release the liquid medicine into a glass or cup containing water, then release the pressure and wait a few seconds.
• Keeping the container upside down, repeat this step at least 5 times, untilno more liquid medicine comes out of the container.
• Mix the solution.
• Drink immediatelyall the liquid medicine.
• Rinse the glass or cup with more water and drink to make sure all the medicine has been taken.

Taking LEVOTIRSOL directly into the mouth or with a spoon:

• Turn the single-dose container upside down.
• Press slowlyon the softer central part of the container between your index finger and thumb to release the liquid medicine into your mouth or onto a spoon, then release the pressure and waita few seconds.
• In newborns and infants, the contents of the single-dose container must be squeezed into the cheek or onto a spoon.
• Keeping the container upside down, repeat this step at least 5 times, untilno more liquid medicine comes out of the container.
• 4. Dispose of (waste) the empty container

Duration of treatment:
Take this medicine for as long as your doctor has told you.

• If you have hypothyroidism or have undergone surgery for a malignant thyroid tumor, you will generally need to take LEVOTIRSOL for life.
• For benign goiter and for the prevention of recurrent goiter, you must take LEVOTIRSOL for a period ranging from several months or years to the rest of your life.
• In supportive therapy for the treatment of hyperthyroidism, you must take LEVOTIRSOL for as long as you take the tireostatic medicine.
• For the treatment of benign goiter with normal thyroid function, a treatment period of between 6 months and 2 years is necessary. If treatment with LEVOTIRSOL has not produced the desired result within this period, other therapeutic options should be considered.

If you take more LEVOTIRSOL than you should
If you take a higher dose than prescribed, symptoms of hyperthyroidism may occur,
such as palpitations, anxiety, agitation, excessive sweating or tremors (see “4. Possible side
effects”). In these cases, contact your doctor.

If you forget to take LEVOTIRSOL
If you forget to take a dose, do not take it when you remember, skip it and take the
normal dose the next day, as usual.

If you stop taking LEVOTIRSOL
LEVOTIRSOL must be taken regularly at the dose prescribed by your doctor for the therapy to be
effective. Do not change, interrupt or stop treatment without consulting your doctor. A
suspension or temporary interruption may cause the symptoms to reappear.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, LEVOTIRSOL can cause side effects, although not everybody gets them.
If you follow the prescription and attend the doctor's appointments for laboratory tests, the risk of
side effectsis negligible. In fact, levothyroxine, the active ingredient of LEVOTIRSOL, is identical
to the natural thyroid hormone.
The following side effects can occur with an unknown frequency: angioedema, skin rash,
urticaria.

In case of hypersensitivity, allergic reactions may affect the skin and breathing. In this
case, consult your doctor immediately.

If you take more LEVOTIRSOL than prescribed or if you do not tolerate the dose(e.g. if the dose is too
high for your needs), symptoms characteristic of hyperthyroidism may occur, such as:

• weight loss, increased appetite,
• tremor, agitation, difficulty sleeping, headache, increased intracranial pressure with eye swelling (especially in children),
• palpitations, heart rhythm disturbances, in particular acceleration, chest pain with a feeling of constriction (angina pectoris),
• increased blood pressure,
• vomiting, diarrhea,
• weakness and muscle cramps,
• irregular menstruation,
• excessive sweating, hair loss, feeling of warmth (flushing of the face), fever.

If any of the above symptoms occur, inform your doctor. They may decide to
interrupt treatment for a few days, or reduce the dose until the side effects
disappear.

Reporting of side effects
If you get any side effects, even 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.
safety of this medicine.

5. How to store LEVOTIRSOL

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25 °C.
Keep the medicine in the original package to protect it from light.
After first opening the sachet: use the single-dose containers within 15 days.
After first opening the single-dose container or after dilution: use it immediately.
Do not use this medicine after the expiry date which is stated on the label after the words
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LEVOTIRSOL contains
The active ingredient is sodium levothyroxine.
1 ml of oral solution of LEVOTIRSOL 13 micrograms contains 13 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 25 micrograms contains 25 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 50 micrograms contains 50 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 75 micrograms contains 75 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 88 micrograms contains 88 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 100 micrograms contains 100 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 112 micrograms contains 112 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 125 micrograms contains 125 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 137 micrograms contains 137 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 150 micrograms contains 150 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 175 micrograms contains 175 micrograms of levothyroxine
sodium.
1 ml of oral solution of LEVOTIRSOL 200 micrograms contains 200 micrograms of levothyroxine
sodium.
The other component is 85% glycerol.

Description of the appearance of LEVOTIRSOL and package contents
Clear solution, from colorless to slightly yellowish, in 1 ml single-dose containers, white, non-
transparent.
Each single-dose container has a colored label with the dosage and the product name
(LEVOTIRSOL).
LEVOTIRSOL is supplied in polyethylene terephthalate/aluminum/polyethylene (PET/Alu/PE) pouches
containing 5 single-dose containers each.
LEVOTIRSOL is available in packs of 30 single-dose 1 ml containers.

Marketing authorization holder and manufacturer
IBSA Farmaceutici Italia S.r.l.
Via Martiri di Cefalonia 2
26900 Lodi

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
AT: Syntroxine SOL
CZ: Synotirex
DE: Tirosint SOL
DK: Tirosintsol
EL: Tirosol
HU: Synotirex
IT: Levotirsol
NL: Tirosint SOL
NO: Tirosintsol
PL: Tirosint SOL
SE: Tirosintsol
SK: Tirosintsol