13 micrograms, 25 micrograms, 50 micrograms, 75 micrograms, 88 micrograms, 100 micrograms, 112 micrograms, 125 micrograms, 137 micrograms, 150 micrograms, 175 micrograms, and 200 micrograms oral solution in single-dose containers
Levothyroxine sodium
What Tirosintsol is and what it is used for
The active substance in Tirosintsol is the synthetically produced thyroid hormone levothyroxine sodium (T4), whose structure and effect are identical to the naturally occurring thyroid hormone.
Tyrosine is used:
- to replace thyroid hormones when the thyroid gland does not produce enough,
- to prevent recurrent goiter after surgery in patients with normal thyroid function,
- to treat benign goiter in patients with normal thyroid function,
- to inhibit renewed tumor growth (malignant disease) in the thyroid gland, especially after surgery, and as a replacement for thyroid hormone deficiency,
- as supportive treatment in the treatment of overactive thyroid gland,
- during thyroid function tests.
Levothyroxine sodium contained in Tirosintsol may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Tirosintsol
Do not take Tyrosinsol:
- if you are allergic to levothyroxine sodium or any of the other ingredients of this medicine (listed in section 6),
- if you have recently suffered 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 at the same time taking medication for an overactive thyroid gland (hydrostatics) (see “Pregnancy and breast-feeding”)
- if you have untreated adrenal insufficiency, untreated underactive pituitary gland ( hypopituitarism ), and/or untreated overactive thyroid gland.
Be careful with Tirosinsol
Talk to your doctor or pharmacist before taking Tirosintsol.
Be careful with Tirosintsol if you have any of the following heart conditions :
- Hypertension,
- fast or irregular heartbeats,
- fatty deposits on the artery walls (atherosclerosis),
- chest pain with a feeling of contractions (angina),
- insufficient blood flow in the coronary arteries (coronary insufficiency).
These diseases must be treated with drugs before taking Tirosintsol, and during the time you are taking Tirosintsol, you must undergo frequent checks of the levels of thyroid hormones.
If you are unsure whether you have any of these conditions, or if they are untreated, see your doctor.
Before starting treatment
- Your doctor will carry out tests to see if you have any problems with the adrenal gland, pituitary gland, or thyroid gland due to uncontrolled overproduction of thyroid hormones (autonomic thyroid function) as this requires medical treatment before taking Tirosintsol.
- Inform the doctor if you are in or after menopause. Regular checks of thyroid function may be required due to the risk of osteoporosis.
- Inform the doctor if you experience signs of psychotic disorders (you may need closer monitoring and dose adjustment).
- Inform the doctor before you start or stop taking orlistat or change treatment with orlistat (medicine to treat obesity as you may need closer monitoring and dose adjustment).
- Certain heart conditions must be treated before taking Tirosintsol, read carefully the information in the section “Take care with Tirosintsol”.
- If you have a blood sugar disease ( diabetes ) or are treated with special blood-thinning drugs, you should carefully read the information in the section “Other drugs and Tyrosinsol”.
- Thyroid imbalance may occur if you need to change your medication to another levothyroxine-containing product. Talk to your doctor if you have any questions about changing your medicine. Careful monitoring (clinical examination and laboratory tests) is required during the transition period. You should tell your doctor if you experience any side effects as this may be a sign that your dose needs to be adjusted up or down.
- Do not take Tirosintsol to lose weight. If your blood thyroid hormone levels are normal, you will not lose weight by taking additional thyroid hormones. Taking additional thyroid hormones without a specific recommendations from your doctor can cause serious or even life-threatening side effects, especially in combination with certain weight loss products.
- Be especially careful if you have epilepsy. In rare cases, seizures have been reported in patients with a known history of epilepsy when treatment with levothyroxine is initiated.
Elderly patients:
For elderly patients, careful dosing and regular medical examinations are required.
For premature babies:
Blood pressure will be checked regularly when treatment with levothyroxine is started in premature babies with very low birth weight as a rapid drop in blood pressure (called circulatory collapse) may occur.
Other medicines and Tirosintsol
If you take other medicines at the same time as Tirosintsol, it may affect how this or the other medicines work. Make sure your doctor knows what other medicines you are taking.
Do not take any other medicines while you are taking Tirosintsol unless you have asked your doctor or pharmacist for advice. This includes over-the-counter medicines.
Tell your doctor if you are taking any of the following medicines:
- Medicines that lower the blood sugar level (antidiabetics): Tyrosinsol can reduce the effect of medicines that lower blood sugar levels. You may need extra checks on your blood sugar levels, especially at the start of treatment with Tirosintsol. While you are taking Tirosintsol, it may be necessary to adjust the dose of a medicine that lowers the blood sugar level.
- Blood-thinning drugs (coumarin derivatives): Tyrosinsol may increase the effect of these medicines. You may need regular checks of your blood clotting, especially at the start of treatment with Tirosintsol. While taking Tirosintsol, it may be necessary to adjust the dose of one of the coumarin drugs.
- Propylthiouracil (for the treatment of overactive thyroid ).
- Glucocorticoid er (against allergy and inflammation ).
- Beta-blockers (blood pressure-lowering drugs also used to treat heart disease).
- Sertraline (for treating depression).
- Chloroquine or proguanil (to prevent or treat malaria ).
- Medicines for the treatment of epilepsy, for example, carbamazepine, phenytoin, phenobarbital, and primidone.
- Medicines containing estrogen that is used as hormone replacement during and after menopause or to prevent pregnancy.
- Salicylates (used to relieve pain and reduce fever).
- Dicoumarol (inhibits blood clotting).
- Furosemide in high doses of 250 mg or more ( diuretics ).
- Clofibrate (lowers blood fat levels).
- Amiodarone (used to treat heart rhythm disorders).
- Ritonavir, indinavir, and lopinavir – are used to control HIV and chronic hepatitis C virus.
- Sevelamer (a medicine used by patients receiving dialysis or patients with chronic kidney disease not receiving dialysis ).
- Tyrosine kinase inhibitors (against cancer and inflammation ).
- Orlistat (used for weight loss).
Make sure you follow the recommended time intervals if you have to take any of the following medicines:
- Antacids (medicines to relieve acid reflux and heartburn), sucralfate (for treating stomach ulcers ), and medicines containing aluminum, iron, or calcium: Take Tirosintsol at least 2 hours before taking these medicines, as they may otherwise reduce the effect of Tirosintsol.
- Medicines used to bind bile acids and to lower high cholesterol (such as cholestyramine or colestipol ): Take Tirosintsol 4-5 hours before taking these medicines, as they can inhibit the absorption of Tirosintsol from the gut.
Other things to keep an eye on when using other medicines at the same time:
If you have to have X-rays or other diagnostic tests where contrast agents are used, you must tell the doctor that you are taking Tirosintsol, as you may be receiving an injection of a substance that can affect the function of the thyroid gland.
Tyrosine with food and drink
Tell your doctor if you eat soy products, especially if you change the number of soy products in your diet. Soy products can lower the absorption of levothyroxine from the intestine and therefore it may be necessary to adjust the dose of Tirosintsol.
Pregnancy and breastfeeding
Consult a doctor or pharmacist before using this medicine.
Pregnancy
- Treatment with Tirosintsol is particularly important during pregnancy and should therefore not be interrupted. This is important for the unborn child to develop normally. Consult a doctor as the dose may need to be adjusted as the need for levothyroxine may increase during pregnancy. Thyroid function needs to be closely monitored.
- During pregnancy, Tirosintsol must not be used at the same time as medicines against an overactive thyroid gland (thyrostatic medicines). During pregnancy, overactive thyroid should only be treated with low doses of thyrostatic drugs (see “Do not take Tirosintsol”).
Breast-feeding
- Tyrosine can be used during breastfeeding. There is no information that a child with normal thyroid function is harmed if the nursing mother uses Tirosintsol.
Driving ability and use of machinery
There is no evidence to suggest that Tirosintsol limits the ability to drive or use machines, as levothyroxine is identical to the naturally occurring thyroid hormone.
Tyrosine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of oral solution, i.e. it is almost “sodium-free”.
How to take Tirosintsol
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The doctor determines your dose based on the results of your laboratory tests.
Dosage:
For individual treatment, single-dose containers of Tirosintsol are available with a levothyroxine sodium content of 13 to 200 micrograms, so as a rule you only need to take one single-dose container a day.
Adults:
- To treat an underactive thyroid: Adults should initially take 25–50 micrograms of levothyroxine sodium a day. The doctor may tell you to increase this dose by 25-50 micrograms of levothyroxine sodium every two to four weeks, up to a daily dose of 100-200 micrograms of levothyroxine sodium (equivalent to 1 to 2 single-dose containers of Tirosintsol).
- To prevent the recurrence of goiter after it has been surgically removed and treatment of benign goiter: The daily dose is 75-200 micrograms of levothyroxine sodium.
- As supportive treatment in the thyrostatic treatment of overactive thyroid gland: The daily dose is 50-100 micrograms of levothyroxine sodium.
- After surgery for a malignant tumor in the thyroid gland: The daily dose is 150-300 micrograms of levothyroxine. For diagnostic use in tests of thyroid suppression: The daily dose is 200 micrograms of levothyroxine sodium for 14 days before the X-ray examination ( scintigraphy ) is carried out.
If you are elderly, have heart problems, or have severe or long-term thyroid problems:
Special care must be taken when starting treatment with thyroid hormones. This means that a lower starting dose must be chosen which is then gradually increased at extended intervals, and in addition, regular monitoring must be carried out using laboratory tests.
Children
The dose for children depends on the child’s age, weight, and the condition being treated. The child will be monitored to ensure that he/she receives the correct dose.
- Congenital underactive thyroid in infants:
Initially 10 to 15 micrograms per kg of body weight per day for the first 3 months. The dose will then be adjusted depending on how the child responds to the treatment. - Acquired underactive thyroid in children:
Initially 13 to 50 micrograms a day. Does one should be gradually increased every two to four weeks, depending on how the child responds to treatment.
Tell your doctor or pharmacist if you feel that the effects of Tirosintsol are too strong or too weak.
How to take the medicine:
- Take the entire daily dose on an empty stomach in the morning, at least half an hour before breakfast. The active substance is better absorbed on an empty stomach rather than before or after a meal.
- Give the child the medicine at least half an hour before the first meal of the day.
- Tyrosine can be taken:
- by first diluting or mixing with water, or
- by being pushed directly into the mouth or onto a spoon
- Tyrosine must not be diluted or mixed with any liquid other than water
- Open the single-dose container and prepare the solution just before you take Tirosintsol
- Once you have diluted or mixed Tirosintsol, it must be taken or thrown away.
- Open the aluminum sachet by tearing off the edge along the perforated line.
- Remove a single-dose container to be used immediately from the strip. Return unused containers to the dosage bag before putting them away for storage.
- Hold the container upright (lid side up) between your index finger and thumb without squeezing it. Open the container by unscrewing the lid.
- Take Tyrosinsol by diluting or mixing:
- Turn the single-dose container upside down.
- Squeeze the softer center of the container between your index finger and thumb slowly to empty the liquid medicine into a glass or cup of water, stop squeezing and wait a few seconds.
- Hold the container upside down and repeat this step at least 5 times until no more liquid medicine comes out of the container.
- Stir the solution.
- Drink all liquid medicine immediately.
- Rinse the glass or cup with more water and drink it to make sure you have taken all the medicine. Take Tirosintsol directly by mouth or with a spoon:
- Turn the single-dose container upside down.
- Squeeze the softer center of the container between your index finger and thumb slowly to empty the liquid medicine into your mouth or onto a spoon, stop squeezing and wait a few seconds.
- For newborns and infants, the contents of the single-dose container should be pushed out against the inside of the cheek or onto a spoon.
- Hold the container upside down and repeat this step at least 5 times until no more liquid medicine comes out of the container.
- Throw away (discard) the empty container.
Length of treatment:
You must take the medicine for as long as the doctor tells you.
- If you have an underactive thyroid gland or have had surgery for a malignant thyroid tumor, you will usually take Tirosintsol for life.
- For benign goiter and to prevent the recurrence of the goiter, you must take Tirosintsol for anything from several months to years to a lifetime.
- When supporting treatment for an overactive thyroid gland, you must take Tirosintsol as long as you are taking a thyrostatic medicine.
- When treating benign goiter with normal thyroid function, a treatment period of between 6 months and 2 years is required. If the treatment with Tirosintsol has not produced the desired results during this period, other treatment options should be considered.
If you have taken too much Tirosintsol
If you have taken a higher dose than prescribed, you may experience symptoms of an overactive thyroid gland, such as palpitations, anxiety, agitation, sweating, or tremors (see “4. Possible side effects”). If any of this happens, contact a doctor.
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Tirosintsol
If you forget to take a dose, do not take it when you remember, but instead skip it and take the normal dose, as usual, the next day.
If you stop taking Tirosintsol
For the treatment to work, Tirosintsol must be taken regularly in the dose prescribed by the doctor. You should not change or stop treatment, either temporarily or permanently, without consulting a doctor. Discontinuing treatment temporarily or permanently may cause your symptoms to return.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Tirosintsol can cause side effects, although not everybody gets them.
The risk of side effects is negligible if you follow the prescription and go to your doctor’s appointments for laboratory tests.
This is because levothyroxine, the active substance in Tyrosintsol, corresponds to the natural thyroid hormone.
The following side effects may occur with an unknown frequency: angioedema, rash, and hives.
If you are hypersensitive, allergic reactions can affect your skin and breathing. If this happens, contact a doctor immediately.
If you take more Tirosintsol than the prescribed dose or if you do not tolerate the dose strength (eg if the dose is too high for your needs) the same symptoms as for an overactive thyroid may occur, for example:
- weight loss, increased appetite
- trembling ( tremor ), agitation, sleep disturbances, headache, increased intracranial pressure with swollen eyes (especially in children)
- palpitations, heart rhythm disturbances, especially fast heartbeats, chest pain with a feeling of contractions ( angina pectoris )
- increased blood pressure
- vomiting, diarrhea
- muscle weakness and muscle cramps
- irregular menstruation
- sweating, hair loss, hot feeling ( redness of the face), fever.
Tell your doctor if you experience any of these symptoms. The doctor decides whether the treatment should be interrupted for a few days or whether the dose should be reduced until the side effects have disappeared.
How Tirosintsol should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 °C.
Store in the original packaging. Light sensitive.
After opening the sachet: use the single-dose containers within 15 days.
After opening the single-dose container or after dilution: the medicine must be used immediately.
Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
Medicines should not be thrown down the drain. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is levothyroxine sodium.
1 ml oral solution Tirosintsol 13 micrograms contains 13 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 25 micrograms contains 25 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 50 micrograms contains 50 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 75 micrograms contains 75 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 88 micrograms contains 88 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 100 micrograms contain 100 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 112 micrograms contain 112 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 125 micrograms contain 125 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 137 micrograms contain 137 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 150 micrograms contain 150 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 175 micrograms contain 175 micrograms of levothyroxine sodium.
1 ml oral solution Tirosintsol 200 micrograms contain 200 micrograms of levothyroxine sodium.
Another ingredient is glycerol 85%.
Appearance and package sizes of the medicine
A clear, colorless slightly yellowish liquid is supplied in a white, non – transparent 1 ml single-dose container. Each single-dose container has a colored label with dosage strength and product name (Tirosintsol).
| Strength [micrograms] | Color |
| 13 | Green |
| 25 | Orange |
| 50 | White |
| 75 | Dark purple |
| 88 | Olive green |
| 100 | Yellow |
| 112 | Fuchsia |
| 125 | Brown |
| 137 | Turquoise |
| 150 | Light blue |
| 175 | Light Purple |
| 200 | Pink |
Tyrosine is supplied in polyethylene terephthalate/aluminum/polyethylene (PET/Alu/PE) sachets containing 5 single-dose containers each.
Tyrosine is available in the pack size of 30 x 1 ml single-dose containers.
Marketing Authorisation Holder
IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
I-26900 Lodi
Italy
Manufacturer
IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
I-26900 Lodi
Italy