PROSPECTO: information for the user

Solsint 13 micrograms oral solution in single-dose packaging

Solsint 25 micrograms oral solution in single-dose packaging

Solsint 50 micrograms oral solution in single-dose packaging

Solsint 75 micrograms oral solution in single-dose packaging

Solsint 88 micrograms oral solution in single-dose packaging

Solsint 100 micrograms oral solution in single-dose packaging

Solsint 112 micrograms oral solution in single-dose packaging

Solsint 125 micrograms oral solution in single-dose packaging

Solsint 137 micrograms oral solution in single-dose packaging

Solsint 150 micrograms oral solution in single-dose packaging

Solsint 175 micrograms oral solution in single-dose packaging

Solsint 200 micrograms oral solution in single-dose packaging

Levotiroxina sódica

Read this prospectus carefully before starting to take this medication because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Solsint and for what it is used

2. What you need to know before starting to take Solsint

3. How to take Solsint

4. Possible adverse effects

5. Storage of Solsint

6. Contents of the package and additional information

The active ingredient of Solsint is synthetic levothyroxine sodium hormone (T4), whose action and structure are identical to the naturally produced thyroid hormone.

Solsint is used as:

• replacement therapy for thyroid hormone deficiency in cases of a less active thyroid gland (hypothyroidism);
• prevention of the recurrence of goiter after surgery in patients with normal thyroid function;
• treatment of benign goiter in patients with normal thyroid function;
• treatment of malignant thyroid tumors, especially after surgery to suppress the growth of a new tumor, and as a supplement for the lack of thyroid hormones;
• concomitant therapy during the treatment of excessive thyroid hormones (hyperthyroidism);
• diagnostic use for the thyroid suppression test.

Do not take Solsint

• if you are allergic to levothyroxine sodium or any of the other ingredients of this medicine (listed in section 6);
• if you have recently had a heart attack, acute myocarditis or acute pancarditis;
• if you are pregnant and taking antithyroid medication at the same time (see section "Pregnancy and breastfeeding");
• if you have untreated adrenal insufficiency or untreated functional disorders of the pituitary gland (hypopituitarism) and/or an overactive thyroid gland.

Be especially careful with Solsint

Consult your doctor or pharmacist before starting to take this medicine.

Be especially careful with this medicine if you have any of the following heart conditions:cardiac disorders:

• high blood pressure;
• arrhythmias or tachycardia;
• accumulation of fat in the arteries (arteriosclerosis);
• chest pain with a feeling of oppression (angina pectoris);
• inadequate blood flow in the coronary arteries (coronary insufficiency).

These conditionsmust be treatedwith medicationbefore takingthis medicineand, while taking this medicine,you should undergo more frequent checks of thyroid hormone levels.

Consult your doctor if you are unsure whether you have any of these conditions or if you have any of them but are not yet receiving treatment.

If you are to have laboratory tests to control your thyroid hormone levels, you must inform your doctor or the laboratory staff that you are taking or have recently taken biotin (also known as vitamin H, vitamin B7 or vitamin B8). Biotin may affect the results of laboratory tests. Depending on the test, the results may be falsely elevated or falsely reduced due to biotin. Your doctor may instruct you to stop taking biotin before the tests are performed. You should also be aware that other products you may be taking, such as multivitamin preparations or supplements for hair, skin and nails, may also contain biotin. This could affect the results of laboratory tests. Inform your doctor or the laboratory staff if you are taking these products (see the information in the sectionOther medicines and Solsint).

Before starting treatment

• Your doctor will perform tests to determine if you have a disorder in the functioning of the adrenal, pituitary or thyroid gland due to uncontrolled overproduction of thyroid hormones (autonomous thyroid function), as you must receive medical treatment before taking this medicine.
• Inform your doctor if you are currently experiencing symptoms of menopause or are postmenopausal. Due to the risk of osteoporosis, thyroid function must be controlled more frequently.

• Inform your doctor if you havepsychotic symptoms(you may need closer monitoring and a dose adjustment).
• Inform your doctor before starting or stoppingorlistat, or changing treatment with orlistat (a medicine for weight loss; you may need closer monitoring and a dose adjustment).
• Certaincardiac disordersmust be treated before taking this medicine. Read the information in the sectionBe especially careful with Solsintcarefully.
• If you havediabetesor are being treated with certainanticoagulants, please see the information provided in the sectionOther medicines and Solsint.
• A thyroid imbalance may occur if you need to change your current medication to one containing levothyroxine. Consult your doctor if you have any doubts about the change in treatment. Comprehensive checks (clinical and biological) must be performed during the transition period. Inform your doctor if you experience any adverse effects, as this may indicate that your current dose needs to be increased or decreased.
• Do not take this medicine for weight loss.The intake of thyroid hormones will not reduce your weight if you have a normal thyroid hormone level. If you increase the dose of thyroid hormones without any special control by your doctor, serious adverse effects may occur or even put your life at risk, especially if taken with other weight loss medications.
• Be especially careful if you haveepilepsy. Rarely, seizures may occur in patients with a known history of epilepsy when starting treatment with levothyroxine.

Older people:

In elderly patients, the doses must be carefully calculated and frequent medical checks must be performed.

Preterm neonates

The blood pressure will be monitored regularly when starting treatment with levothyroxine in very low birth weight preterm infants, as a rapid drop in blood pressure (known as circulatory collapse) may occur.

Use of Solsint with other medicines

Taking other medicines while taking levothyroxine sodium may affect the functioning of this or the other medicine. Make sure your doctor knows what other medicines you are taking.

Do not take any other medicine while taking Solsint, unless you have consulted your doctor or pharmacist,including medicines obtained without a prescription.

Consult your doctorif you are taking one of the following medicines:

• Medicines to reduce blood sugar levels (antidiabetic medicines):

This medicine mayreducethe hypoglycaemic effect of antidiabetic medicines. You may need additional checks of your blood sugar levels, especially when starting treatment with this medicine and, if necessary, the dose of antidiabetic medicines may be adjusted during treatment with this medicine.

• Anticoagulant medicines (cumarinic derivatives):

This medicine mayincreasethe effect of these medicines. You may need frequent monitoring of blood coagulation, especially when starting treatment with this medicine and, if necessary, the dose of your coumarinic medicine may be adjusted during treatment with this medicine.

• Propylthiouracil(a medicine used to treat hyperthyroidism).
• Glucocorticoids(medicines used to treat allergies and as anti-inflammatory agents).
• Beta-blockers(medicines to reduce blood pressure, also used to treat heart disease).
• Sertraline(a medicine used to treat depression).
• Chloroquine or proguanil(a medicine used to prevent or treat malaria).
• Medicines used to treat epilepsy, such ascarbamazepine, phenytoin, phenobarbital or primidone.
• Medicines containing oestrogensused in hormone replacement therapy during and after menopause or to prevent pregnancy.
• Salicylates(medicines used to relieve pain and reduce fever).
• Dicumarol(a medicine used to prevent blood coagulation).
• Furosemidein doses of 250 mg or more (a diuretic medicine).
• Clofibrate(a medicine used to reduce blood lipid levels).
• Amiodarone(a medicine used to treat cardiac arrhythmias).
• Ritonavir, indinavir, lopinavir(medicines used to control HIV infection and chronic hepatitis C infection).
• Sevelamer(a medicine used in patients with dialysis or chronic kidney disease without dialysis).
• Tyrosine kinase inhibitors(medicines used to treat cancer and inflammation).
• Orlistat(a 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 reduce the intestinal absorption of levothyroxine and make it less effective. If you are taking levothyroxine at the same time as a proton pump inhibitor, your doctor will need to monitor your thyroid function and may need to adjust the dose of Solsint.
• Biotin: if you are taking or have recently taken biotin, you must inform your doctor or the laboratory staff when they are to perform laboratory tests to control your thyroid hormone levels. Biotin may affect the results of laboratory tests (seeBe especially careful with Solsint).

Make sure tofollow the recommended intervalsif you have to take one of the following medicines:

• Antacids(medicines to relieve stomach symptoms and acid reflux),sucralfate(used to treat peptic ulcers) andmedicines containing aluminium, iron or calcium:
  Take this medicine at least2hours beforetaking these medicines, as they may reduce the effect of levothyroxine sodium.
• Medicines for bile acid binding and cholesterol treatment (such ascholestyramineandcolestipol):

Take this medicine4-5hoursbefore taking these medicines, as they may inhibit the intestinal absorption of levothyroxine sodium.

What else you should know if you take Solsint with other medicines:

If you need to have anX-ray examinationor any otherdiagnostic testthat usescontrast media, inform your doctor that you are taking this medicine, as they may inject a substance that may affect thyroid function.

Solsint with food and drinks

Inform your doctor if you consume soy products, especially if you modify the proportion of soy products in your diet. Soy products may reduce the intestinal absorption of levothyroxine, so you may need to adjust your dose of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

• This medicine is especially important during pregnancy and, therefore,should not be interrupted. It is essential for the proper development of the fetus. Consult your doctor, as you may need to adjust your dose, as during pregnancy, your need for levothyroxine may increase. Your thyroid function must be closely monitored.
• During pregnancy, this medicine should not be taken at the same time as other medicines for treating hyperthyroidism (antithyroid medicines).During pregnancy, hyperthyroidism should only be treated with low-dose antithyroid medicines (see the sectionDo not take Solsint).

Lactation

• This medicine can be used during breastfeeding.There is no information to indicate that the use of this medicine in a breastfeeding woman may harm the baby with normal thyroid function.

Driving and operating machinery

There is no evidence to suggest that this medicine affects your ability to drive and use machinery, as levothyroxine is identical to the naturally produced thyroid hormone.

This medicine contains less than 23 mg of sodium (1 mmol) per 1 ml of oral solution; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine your individual dose based on the tests and laboratory analyses that have been performed on you.

Dose:

For individual treatment, Solsint single-dose vials are available in different doses of 13-200 micrograms of levothyroxine sodium. In most cases, only one single-dose vial will be taken per day.

Adults:

– Treatment for hypothyroidism:

Adult patients will start with 25-50 micrograms of levothyroxine sodium per day. This dose will be increased following the doctor's instructions in 25-50 micrograms of levothyroxine sodium at intervals of 2 to 4 weeks, until reaching a daily dose of 100-200 micrograms of levothyroxine sodium (equivalent to 1-2 single-dose vials of Solsint).

– Prevention of recurrence of goiter after surgical removal and treatment of benign goiter: The daily dose is 75-200 micrograms of levothyroxine sodium.

− Concurrent therapy during antithyroid treatment of hyperthyroidism: The daily dose is 50-100 micrograms of levothyroxine sodium.

– After thyroid surgery to remove a malignant tumor of the thyroid gland: The daily dose is 150-300 micrograms of levothyroxine.

– For diagnostic use in thyroid suppression test: The daily dose is 200 micrograms of levothyroxine sodium for 14 days prior to the radiological examination (scintigraphy).

Older adults, patients with coronary disease, and patients with severe or chronic hypothyroidism:

Treatment with thyroid hormones will be started with special caution. This means that initially a lower dose will be administered, which will be gradually increased at longer intervals with frequent monitoring through laboratory tests.

Children:

The dose in children depends on the child's age, weight, and the condition to be treated. The doctor will monitor the child's treatment to ensure that the child takes the correct dose.

• Congenital hypothyroidism in infants:
  Initially 10-15 micrograms/kg of body weight per day for the first 3 months. Once that period has passed, the dose will be adjusted based on the response to treatment.
• Acquired hypothyroidism in children:
  Initially 13-50 micrograms per day. The dose must be gradually increased at intervals of 2-4 weeks based on the response to treatment.

Consult your doctor or pharmacist if you think the effects of this medication are too intense or too weak.

Administration form:

• Take a complete daily dose with an empty stomach in the morning, at least 30 minutes before breakfast, as the active principle is better absorbed with an empty stomach than before or after meals.
• Children should take the entire daily dose at least 30 minutes before the first meal of the day.
• This medication can be taken:
  • Diluting or mixing it first with water or
  • Pouring the contents of the single-dose vial directly into the mouth or into a spoon.
• Do notdilute or mix this medication with another liquid that is not water.
• Open the single-dose vial and prepare the solution immediately before taking this medication.
• After diluting or mixing this medication, it must be taken or discarded.

1. Open the aluminum foil package by pulling the edge along the dotted line.
2. Remove a single-dose vial from the strip and use it immediately. Insert the unused vials back into the package before storing the medication.
3. Hold the vial vertically (with the cap facing up) between the index finger and thumb without tightening it. Open the vial by unscrewing the cap.
   

Administration of Solsint with dilution or mixing:

• Place the single-dose vial upside down.
• Press with the index finger and thumb in the middle of the vial, in the softest part, to slowly release the liquid into a glass of water; then stop pressing andwait a few seconds.
• Keep the vial upside down and repeat this stepat least 5 times, until there is no more liquid left in the vial.
• Mix the solution.
• Drinkimmediatelyall the medicinal liquid.
• Wash the glass with more water and drink the contents again to ensure that all the medication has been taken.

Administration of Solsint directly into the mouth or with a spoon:

• Place the single-dose vial upside down.
• Press with the index finger and thumb in the middle of the vial, in the softest part, to slowly release the liquid into the mouth or into a spoon; then stop pressing andwait a few seconds.
• In neonates and children, pour the contents of the single-dose vial into the cheek or into a spoon.
• Keep the vial upside down and repeat this stepat least 5 times, until there is no more liquid left in the vial.

Discard the empty vial.

Treatment duration:

You should take this medication for the time indicated by your doctor.

• If you have hypothyroidism or have undergone surgical removal of a malignant tumor in the thyroid gland, you will take this medication for the rest of your life.
• To treat benign goiter and prevent the recurrence of goiter after surgery, the treatment duration with this medication may range from several months to years until the end of your life.
• During concurrent therapy with antithyroid medication for hyperthyroidism, you should take this medication for the period during which the antithyroid medication is administered.
• To treat benign goiter with normalized thyroid function, the necessary treatment duration is 6 months to 2 years. If this medication treatment does not produce the expected result within this time period, other treatments should be considered.

If you take more Solsint than you should:

If you ingest a higher dose than prescribed, you may experience symptoms of hyperthyroidism, such as palpitations, anxiety, agitation, excessive sweating, or tremors (see section "4. Possible adverse effects"). Contact your doctor if these effects occur.

If you forget to take Solsint:

If you forget to take a dose, do not take it when you remember and continue taking your regular daily dose the next day.

If you interrupt treatment with Solsint:

To be successful, you must take the prescribed dose of Solsint regularly. Do not change, suspend, or interrupt treatment without consulting your doctor. Symptoms may reappear if you suspend or interrupt treatment.

If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, Solsint may produce adverse effects, although not everyone will experience them.

The risk of experiencing adverse effects is insignificant if you follow the instructions and undergo the laboratory tests prescribed by your doctor, as levotiroxine, the active principle of this medication, is equivalent to the natural thyroid hormone.

The following adverse effects occur with an unknown frequency: angioedema, skin rash, urticaria.

In case of hypersensitivity , allergic reactions may affect the skin and respiratory tract. Contact your doctor immediately if you observe these effects.

If you take more Solsint than prescribed or do not tolerate the intensity of the dose (for example, if the dose is too high for your needs), you may experience typical symptoms of hyperthyroidism, such as:

– weight loss and increased appetite;

– tremors, agitation, difficulty sleeping, headache, increased intracranial pressure with swelling of the eyes (especially in children);

– palpitations, cardiac rhythm disturbances, especially tachycardia, chest pain with a feeling of constriction (angina pectoris);

– high blood pressure;

– vomiting, diarrhea;

– muscle weakness and muscle cramps;

– irregular menstruation;

– excessive sweating, hair loss, feeling of burning (redness of the face), fever.

Consult your doctor if you observe any of these effects. Your doctor will decide whether to interrupt treatment for several days or reduce the dose until the adverse effects have disappeared.

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es . By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from light.

After opening the first package: use the single-dose containers within the next 15días.

After opening a single-dose container or after diluting its contents: use immediately.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Solsint

The active principle is levothyroxine sodium.

1 ml of oral solution of Solsint 13 micrograms contains 13 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 25 micrograms contains 25 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 50 micrograms contains 50 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 75 micrograms contains 75 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 88 micrograms contains 88 micrograms of levothyroxine sodium.

1ml of oral solution of Solsint 100 micrograms contains 100 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 112 micrograms contains 112 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 125 micrograms contains 125 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 137 micrograms contains 137 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 150 micrograms contains 150 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 175 micrograms contains 175 micrograms of levothyroxine sodium.

1 ml of oral solution of Solsint 200 micrograms contains 200 micrograms of levothyroxine sodium.

The other component is glycerol 85%.

Appearance of the product and contents of the package

Transparent and colorless solution that tends slightly to yellow supplied in a single-dose vial of 1ml of white non-transparent color. Each single-dose vial carries a label with a color indicating the concentration of the dose and the name of the product (Solsint).

This medicine is supplied in blister packs of polyethylene terephthalate/aluminium/polyethylene (PET/Alu/PE) with 5 single-dose vials each.

This medicine is available in formats of 30single-dose vials of 1ml.

Only some sizes of packaging may be marketed.

Marketing authorization holder and responsible manufacturer

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia, 2,

26900 Lodi

Italy

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

8th floor, Local 1,

08028 Barcelona (Spain)

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany, Netherlands, Poland: Tirosint SOL Austria: Syntroxine SOL

Denmark, Norway, Sweden, Slovakia: Tirosintsol Spain: Solsint

Greece: Tirosol

Hungary, Czech Republic: Synotirex Italy: Levotirsol

Last review date of this leaflet: February 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)