Package Insert: Information for the User

Tirodril 10 mg Tablets

Tiamazol (Metimazol)

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What is Tirodril and for what it is used

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

3. How to take Tirodril

4. Possible adverse effects

5. Storage of Tirodril

6. Contents of the package and additional information

Tirodril is a medication (antithyroid) that acts by controlling the overproduction of thyroid hormones.in the thyroid gland.

It is indicated for the treatment of the following diseases in adults and children 3 years orolder:

• acute worsening of symptoms of hyperthyroidism (thyrotoxic crisis or thyroid storm)
• if you need to take a medication to treat the overproduction of thyroid hormones by thethyroid gland (hyperthyroidism),
• if you are to undergo thyroid gland surgery,
• if you are to receive radioactive iodine treatment, or after treatment with this until its effectis fully established.

Tirodril is also used for:

• preventing the overproduction of thyroid hormones before undergoing exposure to iodine,such as in an iodine-based contrast medium examination,
• if you present a mild overproduction of thyroid hormones without additional symptoms(subclinical hyperthyroidism),
• if your thyroid gland has certain hormone-producing areas (autonomous adenoma),
• if you have previously experienced overproduction of thyroid hormones at some point in your life.

Do not take Tirodril

• if you are allergic to the active ingredient or any of the other components of thismedication (listed in section 6).

• if you have a low count of certain blood cells such as leukocytes or neutrophils
• if you have a bile duct blockage (cholestasis) not caused by hyperthyroidism
• if you have suffered bone marrow damage during previous treatments with tiamazol orcarbimazol.
• if the combined therapy of tiamazol and thyroid hormones is contraindicated duringpregnancy.
• if you have had acute pancreatitis after the administration of tiamazol or carbimazol in the past.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tirodril.

If symptoms worsen or persist, consult your doctor.

• During treatment with Tirodril, inform your doctor of any illness that you may present, especially angina, fever, chills, cough, mouth sores or hoarseness, as they could be the initial symptom of a blood disorder (agranulocytosis) that could have serious consequences.

• During treatment with Tirodril, inform your doctor if you lose your appetite, have itching or abdominal pain as they could be the initial symptom of liver damage.

• If you have a goiter (swelling of the anterior part of the neck), treatment with Tirodril should be carried out under strict medical control.

• During treatment with Tirodril, weight gain may occur as a consequence of an improvement in the clinical picture.

• Inform your doctor if you have had allergic reactions on the skin (allergic dermatitis, itching) before starting treatment with Tirodril.

• During treatment with Tirodril, a certain type of eye disease called endocrine orbitopathy may worsen, which is not related to treatment with Tirodril.

• Informe to your doctor immediately if you present fever or abdominal pain, as they may be signs of acute pancreatitis. It may be necessary to interrupt the administration of Tirodril.

• Tirodril may cause damage to the fetus. If you can become pregnant, use a reliable contraceptive method from the start of treatment and during the same.

Pregnancy

Tirodril may cause damage to the fetus.

If you can become pregnant, use a reliable contraceptive method from the start of treatment and during the same.

If you are pregnant, think you may be pregnant or intend to become pregnant, inform your doctor immediately. It may be necessary to continue treatment with Tirodril during pregnancy if the potential benefit outweighs the potential risk to you and the fetus.

Taking Tirodril with other medications

Inform your doctor if you are taking, have taken recently or may have to take any other medication.

Tirodril may potentiate the effects of the following drugs, requiring a reduction in the dose of the same:

Tirodril may decrease the effects of oral anticoagulants.

The administration of glycerol iodide, iodine or potassium iodide may decrease the response to Tirodril.

The administration of amiodarone (drug for heart arrhythmias) may potentiate the effect of Tirodril.

Antithyroid drugs may decrease the capture of iodine-labeled thyroid hormone used in some tests ([131I]).

Taking Tirodril with food and drinks

Tirodril has no known effects of interaction with food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

Pregnancy:

During pregnancy, Tirodril should be administered at the lowest possible dose. Tiamazol (methimazole) may cross the placental barrier and may cause hypothyroidism and goiter in the fetus. The real risk of fetal death, goiter, hypothyroidism or certain congenital anomalies is low, especially if the dose administered to the mother is the lowest possible. Fetal risks increase when antithyroid drugs are used near the end of pregnancy. The potential risks of adverse effects and fetal damage that its administration represents should be weighed against those due to continued hyperthyroidism during pregnancy.

In many pregnant women, the poor function of the thyroid gland improves over the course of pregnancy, so it may be necessary to reduce the dose. During the last trimester of pregnancy, half the usual daily dose is administered. In some cases, treatment may be interrupted during the last 2-3 weeks.

Breastfeeding::

Tirodril is excreted in breast milk, so there is a risk of hypothyroidism in the baby. Breastfeeding is possible during treatment with Tirodril, although only low doses of up to 10 mg per day can be used without additional administration of thyroid hormones.

Driving and operating machinery

The influence of Tirodril on the ability to drive or operate machinery is negligible or insignificant.

Follow exactly the administration instructions for Tirodril indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The tablet can be divided into equal doses. It can be crushed or taken whole or in fractions with a sufficient amount of liquid.

It is recommended to take this medication every day at the same time in relation to meals. If you take more than one tablet daily, you can also take it in several doses and at regular intervals throughout the day.

Dose recommended:

Treatment of hyperthyroidism (increase in thyroid hormone production):

Adults and adolescents (12 to 17 years):The initial dose of Tirodril is 15 mg (1 and a half tablets) in case of moderate hyperthyroidism, 30-40 mg (3-4 tablets) in moderate to severe hyperthyroidism, or 60 mg (6 tablets) in severe hyperthyroidism. Treatment will be carried out in divided doses and at intervals of 6-8 hours orally until thyroid hormones normalize. At this time, the dose is gradually reduced to reach a maintenance dose of 5-15 mg per day.

Children (3 to 11 years): The initial dose is 0.4 mg/kg in divided doses that will be administered every 8 hours. The maintenance dose is approximately half the initial dose (0.2 mg/kg).

Tirodril is not recommended for children under 3 years old.

Acute worsening of hyperthyroidism symptoms (thyrotoxic crisis or thyroid storm):

Adults: The initial dose is 30 mg (3 tablets) followed by 30 mg every 4-6 hours.

Treatment prior to thyroid surgery in patients with hyperthyroidism:

Use the same doses used for the treatment of hyperthyroidism until the patient is euthyroid.

Before receiving radioactive iodine treatment, or after treatment with this for the treatment of hyperthyroidism:Treatment of hyperthyroidism:

The same doses used in the treatment of hyperthyroidism are used.

Prevention of excessive thyroid hormone production before exposure to iodine:

Generally, daily doses of 10-20 mg of thiamazole are administered for approximately 10 days. The duration of treatment depends on the time the substance with iodine remains in the body.

If you take more Tirodril than you should

If blood disorders occur, treatment should be stopped immediately and, if necessary, the administration of antibiotics, blood transfusions, and corticosteroids should be initiated.

For the treatment of mild skin allergic reactions caused by thiamazole, antihistamines may be useful.

Overdose causes hypothyroidism, with the corresponding symptoms of reduced metabolism and goiter growth. This can be prevented by reducing the dose as soon as normal thyroid hormone levels are achieved, and, if necessary, by administering additional levothyroxine (thyroid hormone).

In case of acute intoxication, the usual treatment will be performed: gastric lavage, intravenous fluids, rest, analgesics, and mild sedation.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tirodril

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tirodril

Do not stop treatment with Tirodril without consulting your doctor first.

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

Like all medications, this medication may produce adverse effects, althoughnot all people will experience them.

Very common adverse effects(may affect more than 1 in 10 patients) :hives, urticaria, itching, and skin darkening. Most are mild in nature anddisappear during treatment with Tirodril.

Common adverse effects(may affect up to 1 in 10 patients): nausea,vomiting, stomach pain, joint pain, and muscle pain.

Uncommon adverse effects(may affect up to 1 in 100 patients): agranulocytosis (decrease in white blood cells in the blood).

Rare adverse effects(may affect up to 1 in 1,000 patients): loss of taste,tingling or numbness in any part of the body, dizziness, swelling,fever, headache, and tendency to sleep.

Very rare adverse effects(may affect up to 1 in 10,000 patients): decreasein the number of some blood cells (granulocytopenia, thrombocytopenia, pancitopenia),lymph node disorders (generalized lymphadenopathy), a type of anemia (aplastic anemia),inflammation of the arteries (periarteritis), coagulation problems (hypoprothrombinemia),hypoglycemic coma (autoimmune insulin syndrome), inflammation of the nerves (neuritis),affection of multiple nerves (polyneuropathy), salivary gland disease(sialoadenopathy), biliary or liver affection (jaundice, fulminant hepatitis,hepatic necrosis), allergic reaction called Stevens-Johnson syndrome, alopecia, inflammation and damageof cellular tissues (lupus erythematosus), kidney inflammation (nephritis).

Adverse effects of unknown frequency(cannot be estimated from available data): acute pancreatitis.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it ispossible adverse effects that do not appear in this prospectus. You can also report them directly tothrough the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute toproviding more information on the safety of this medication.

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

Store in the original packaging to protect it from light.

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

Medicines should not be thrown into the drains or trash. Dispose of the containers andmedicines you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Tirodril

• The active principle is thiamazol (metimazol).Each tablet contains 10 mg of thiamazol.
• The other components are: cornstarch, calcium dihydrate sulfate, talc, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

Tirodril tablets are presented in a package of 40 tablets.

The tablets are round, flat, white in color, and have a groove. The tablet can be divided into equal doses. They are packaged in PVC/aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Estedi Laboratory, S.L.

Montseny, 41

08012 Barcelona (Spain)

Responsible for manufacturing:

Estedi Laboratory, S.L.

Leopoldo Alas, 7

08012 Barcelona (Spain)

Local representative:

Aldo-Unión Laboratory, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona (Spain)

Last review date of this leaflet:February 2020

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.