Levotirsol

PACKAGE LEAFLET: INFORMATION FOR THE USER

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, 125 micrograms oral solution in single-dose container, 137 micrograms oral solution in single-dose container, 150 micrograms oral solution in single-dose container, 175 micrograms oral solution in single-dose container, 200 micrograms oral solution in single-dose container

Levothyroxine sodium
Please read all of 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 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 LEVOTIRSOL is and what it is 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. Contents of the pack and other information

1. What LEVOTIRSOL is and what it is used for

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

• In thyroid hormone replacement therapy in cases of underactive thyroid gland;
• for the prevention of recurrent goitre after surgical intervention, in patients with normal thyroid function;
• for the treatment of benign goitre in patients with normal thyroid function;
• for suppression of renewed tumour growth (malignant disease) of the thyroid gland, particularly after surgery, and as replacement for thyroid hormone deficiency;
• as adjunctive therapy in the treatment of overactive thyroid;
• in the thyroid suppression test.

2. What you should know before taking LEVOTIRSOL

Do not take LEVOTIRSOL

• if you are allergic to sodium levothyroxine or to any of the other ingredients of this medicinal product (listed in section 6),
• if you have recently had a heart attack, acute inflammation of the heart muscle, and/or acute inflammation of all layers of the heart wall (pancarditis);
• if you are pregnant and are simultaneously taking medications for hyperthyroidism (antithyroid drugs) (see section “Pregnancy and breastfeeding”);
• if you have untreated adrenal insufficiency, untreated pituitary hypofunction (pituitary insufficiency), and/or untreated hyperfunction of the thyroid gland;

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

• high blood pressure,
• rapid or irregular heartbeat,
• fatty deposits on arterial walls (arteriosclerosis),
• chest pain with a feeling of tightness (angina pectoris),
• insufficient blood flow in the coronary arteries (coronary insufficiency).

These conditions must be treated with medications before starting LEVOTIRSOL, and
during LEVOTIRSOL treatment, thyroid hormone levels must be monitored more
frequently.
Inform your doctor if you suspect you have any of the above-mentioned conditions or if you have been diagnosed with one 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 staff that you are currently taking or have recently taken biotin (also known as vitamin H, vitamin B7, or vitamin B8). Biotin may 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 LEVOTIRSOL).

Before starting treatment

• Your doctor will perform tests to check whether you have a disorder of the adrenal gland, pituitary gland, or thyroid gland caused by uncontrolled overproduction of thyroid hormones (thyroid autonomy), as this condition must be pharmacologically treated before starting LEVOTIRSOL.

• Inform your doctor if you are currently in menopause or post-menopause. Regarding the risk of osteoporosis, regular monitoring of thyroid function may be necessary.

• Inform your doctor if you notice the onset of signs of psychotic disorders (closer monitoring and dose adjustment may be required).

• Inform your doctor before starting, stopping, or changing treatment with orlistat (a medicine used to treat obesity; closer monitoring and dose adjustment may be required).

• Some cardiac conditions must be treated before taking LEVOTIRSOL; read carefully the information contained in the section “Take special care with LEVOTIRSOL”.

• If you have altered blood glucose levels (diabetes) or if you are taking certain medicines that help thin the blood, read carefully the section “Other medicines and LEVOTIRSOL”.

• When switching to another product containing levothyroxine, thyroid imbalance may occur. Consult your doctor for any questions regarding a change in medication. Careful monitoring (biological and clinical) is required during the transition period. Contact your doctor if you experience any adverse effects, as this may require increasing or decreasing the dose.

• Do not take LEVOTIRSOL for weight loss. If your thyroid hormone levels are within normal limits, taking additional thyroid hormones will not lead to weight loss. Taking additional thyroid hormones without consulting your doctor may cause serious or even life-threatening side effects, especially if taken together with certain weight-loss agents.

• Be cautious if you suffer from epilepsy. Rare cases of seizures have been reported at the beginning of levothyroxine treatment in patients with a known history of epilepsy.

Elderly patients:
Careful dosing and frequent medical checks are necessary in elderly patients.
Preterm neonates:
Blood pressure will be monitored regularly when starting levothyroxine treatment in preterm neonates 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 may affect its action or that of the other medicine. Make sure your doctor is aware of all medicines you are taking.
Do not take other medicines while taking LEVOTIRSOL unless you have first informed your doctor or pharmacist and obtained their advice. This includes medicines obtained without a prescription.
Inform your doctor if you are taking any of the following medicines:

• Medicines to lower blood glucose (antidiabetics): LEVOTIRSOL may reduce the effect of the antidiabetic medicine you are taking. Additional tests to measure blood glucose levels may be necessary, especially at the beginning of LEVOTIRSOL therapy. During LEVOTIRSOL treatment, the dosage of your antidiabetic medicine may need to be adjusted.
• Medicines that help thin the blood (coumarin derivatives): LEVOTIRSOL may increase the effect of these medicines. Regular monitoring of blood coagulation may be necessary, especially at the beginning of LEVOTIRSOL therapy. During LEVOTIRSOL treatment, the dosage of the coumarin medicine may need to be adjusted.
• Propylthiouracil (medicine for treating hyperthyroidism),
• Glucocorticoids (anti-allergic and anti-inflammatory medicines),
• Beta-blockers (medicines to reduce blood pressure, also used in treating heart diseases),
• Sertraline (medicine for treating depression),
• Chloroquine or proguanil (medicines for prevention or treatment of malaria),
• Medicines for treating epilepsy, such as carbamazepine, phenytoin, phenobarbital, primidone,
• Medicines containing estrogens used for hormone replacement therapy during or after menopause or as contraceptives,
• Salicylates (medicines used to relieve pain or reduce fever),
• Dicumarol (medicine used to inhibit blood coagulation),
• Furosemide at 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 treating cardiac rhythm disorders),
• Ritonavir, indinavir, lopinavir, used to control HIV virus and chronic hepatitis C,
• Sevelamer (medicine used in dialyzed patients or in non-dialyzed patients with chronic kidney disease),
• Tyrosine kinase inhibitors (anticancer and anti-inflammatory medicines),
• Orlistat (medicine used for weight loss),
• 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 LEVOTIRSOL.
• 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 may affect laboratory test results (see section “Take special care with LEVOTIRSOL”).

If you are taking any of the following medicines, ensure you respect the recommended time interval:

• Antacids (medicines used to relieve gastric symptoms and heartburn), sucralfate (for treating peptic ulcers), and medicines containing aluminum, iron, or calcium: Take LEVOTIRSOL at least 2 hours before taking any of these medicines, as they may reduce the effect of LEVOTIRSOL.
• Medicines used to bind bile acids and lower elevated cholesterol levels (such as cholestyramine or colestipol): Take LEVOTIRSOL 4–5 hours before these medicines, as they may inhibit the intestinal absorption of LEVOTIRSOL.

Also take care when taking LEVOTIRSOL with other medicines:
If you are scheduled for an examination involving X-rays or other diagnostic tests using a contrast agent, inform your doctor that you are taking LEVOTIRSOL, as the injected substance may affect thyroid function.

LEVOTIRSOL 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 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 LEVOTIRSOL is particularly important during pregnancy and therefore must not be stopped. This is essential for the normal development of the unborn child. Consult your doctor, as the dose of levothyroxine may need to be adjusted, since your requirement may increase during pregnancy. Careful monitoring of thyroid function is necessary.
• LEVOTIRSOL must not be used during pregnancy together with medicines for treating hyperthyroidism (antithyroid drugs). During pregnancy, hyperthyroidism must be treated exclusively with low-dose antithyroid drugs (see “Do not take LEVOTIRSOL”).

Breastfeeding

• LEVOTIRSOL may be used during breastfeeding. There is no evidence that using LEVOTIRSOL in breastfeeding women may harm an infant with normal thyroid function.

Driving and using machines
There is no evidence suggesting that LEVOTIRSOL impairs the ability to drive vehicles or operate machinery, as levothyroxine is identical to the natural thyroid hormone.
This medicinal product 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 instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine your individual dose based on laboratory test results.
Dosage
For individual treatment, LEVOTIRSOL is available in single-dose containers
containing varying amounts of 13 to 200 micrograms of sodium levothyroxine, so that you can take one single-dose container per day.
Adults

• Treatment of hypothyroidism: Initially, adults should take 25–50 micrograms of sodium levothyroxine daily. Your doctor may prescribe increasing this dose by 25–50 micrograms of sodium levothyroxine every two to 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.
• Adjunctive therapy in antithyroid treatment of hyperthyroidism: The daily dose is 50–100 micrograms of sodium levothyroxine.
• After surgery for malignant thyroid tumor: The daily dose is 150–300 micrograms of sodium levothyroxine.
• For diagnostic use in thyroid suppression testing: The daily dose is 200 micrograms of sodium levothyroxine for 14 days prior to radiological examination (scintigraphy).

Elderly patients, patients with coronary heart disease, and patients with severe or 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
The dose for children depends on age, body 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 body weight per day for the first 3 months. The dose will then be adjusted according to the response to treatment.
• Acquired hypothyroidism in children: Initially, 13 to 50 micrograms per day. The dose should be gradually increased every 2–4 weeks depending on the response to treatment.

Inform 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 least half an hour before breakfast. Absorption of the active ingredient is better on an empty stomach than after a meal.

• Give this medicine to the child at least half an hour before their first meal of the day.
• LEVOTIRSOL may be taken:
  • diluted or mixed beforehand with water, or
  • squeezed directly into the mouth or onto a spoon
• Do not dilute or mix LEVOTIRSOL with liquids other than water.
• Open the single-dose container and prepare the solution immediately before taking LEVOTIRSOL.
• After diluting or mixing, LEVOTIRSOL should be taken immediately or discarded.
  1. Tear open the aluminum pouch along the dotted line.
  2. Immediately remove the single-dose container to be used from the strip. Return any unused containers to the pouch before storing.
  3. Hold the container vertically (cap upwards) between index finger and thumb without squeezing. Open the container by twisting the top part.

Taking LEVOTIRSOL diluted or mixed:

• Invert the single-dose container.
• Slowly press the softer, central part of the container between 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.
• While keeping the container inverted, repeat this step at least 5 times, until no more liquid medicine comes out of the container.
• Mix the solution.
• Drink immediately all of the liquid medicine.
• Rinse the glass or cup with additional water and drink it to ensure the entire dose has been taken.

Taking LEVOTIRSOL directly into the mouth or with a spoon:

• Invert the single-dose container.
• Slowly press the softer, central part of the container between index finger and thumb to release the liquid medicine into the mouth or onto a spoon, then release the pressure and wait a few seconds.
• In newborns and infants, the contents of the single-dose container should be squeezed into the cheek or onto a spoon.
• While keeping the container inverted, repeat this step at least 5 times, until no more liquid medicine comes out of the container. 4. Discard (throw away) the empty container.

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

• If you have hypothyroidism or have undergone surgery for malignant thyroid cancer, you will generally need to take LEVOTIRSOL for life.
• For benign goiter and prevention of recurrent goiter, you must take LEVOTIRSOL for a period ranging from many months to the rest of your life.
• In adjunctive therapy for the treatment of hyperthyroidism, you must take LEVOTIRSOL for as long as you are taking the antithyroid medicine.
• For treatment of benign goiter with normal thyroid function, a treatment period of 6 months to 2 years is required. If treatment with LEVOTIRSOL has not achieved the desired result within this time, alternative 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, restlessness, excessive sweating, or tremor (see “4. Possible side effects”). In such 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 the missed dose and take your next dose as usual the following day.
If you stop taking LEVOTIRSOL
LEVOTIRSOL must be taken regularly at the prescribed dose for the treatment to be effective. Do not change, stop, or interrupt the treatment without consulting your doctor. Stopping or temporarily interrupting treatment may cause symptoms to return.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, LEVOTIRSOL may cause side effects, although not everyone experiences them.
If you follow your doctor's instructions and attend scheduled laboratory check-ups, the risk of
side effects is negligible. Indeed, levotiroxine, the active substance in LEVOTIRSOL, is identical
to the natural thyroid hormone.
The following side effects may occur with unknown frequency: angioedema, skin rash, urticaria.
In case of hypersensitivity , allergic reactions may affect the skin and breathing. In this case, contact 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 an overactive thyroid may occur, such as:

• weight loss, increased appetite,
• tremor, restlessness, difficulty sleeping, headache, increased intracranial pressure with eye swelling (particularly in children),
• palpitations, heart rhythm disturbances, especially tachycardia, chest pain with a feeling of tightness (angina pectoris),
• increased blood pressure,
• vomiting, diarrhoea,
• weakness and muscle cramps,
• irregular menstruation,
• excessive sweating, hair loss, sensation of heat (flushing of the face), fever.

If any of the symptoms listed above occur, inform your doctor . The doctor may decide to
temporarily stop treatment or reduce the dose until the side effects disappear.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or
pharmacist. You can also report side effects directly via the national reporting system at the website 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 above 25 °C.
Keep the medicine in the original packaging to protect it from light.
After first opening of the sachet: use the single-dose containers within 15 days.
After first opening of the single-dose container or after dilution: use immediately.
Do not use this medicine after the expiry date stated on the label after the word
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

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

Description of the appearance of LEVOTIRSOL and pack contents
Clear solution, colourless to slightly yellowish, in 1 ml single-dose containers, white and opaque.
Each single-dose container has a coloured label indicating the dosage and the product name (LEVOTIRSOL).

LEVOTIRSOL is supplied in pouches made of polyethylene terephthalate/aluminum/polyethylene (PET/Alu/PE), each containing 5 single-dose containers.
LEVOTIRSOL is available in packs of 30 single-dose containers of 1 ml.
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 European Economic Area Member States under the
following names:
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