TIRODRIL 5mg TABLETS

2. What you need to know before taking Tirodril 5 mg tablets

Do not take Tirodril

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• if you have a low number of certain blood cells such as leukocytes or neutrophils if you have biliary flow obstruction (cholestasis) not caused by hyperthyroidism.
• if you have suffered bone marrow damage during previous treatments with thiamazole or carbimazole.
• Combined therapy with thiamazole and thyroid hormones is contraindicated during pregnancy.
• if you have had acute pancreatitis after administration of thiamazole or carbimazole in the past.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tirodril.

If your symptoms worsen or persist, consult your doctor.

• During treatment with Tirodril, inform your doctor of any illness that occurs, especially angina, fever, chills, cough, mouth sores, or hoarseness, as they may 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, experience itching, or abdominal pain, as they may be the initial symptom of liver damage.

• If you have a goiter (swelling of the front of the neck), treatment with Tirodril should be done under strict medical control.

• During treatment with Tirodril, weight gain may occur as a result of 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.

• Inform your doctor immediately if you experience fever or abdominal pain, as they may be signs of pancreatitis (acute pancreatitis). It may be necessary to discontinue the administration of Tirodril.

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

Pregnancy

Tirodril may cause harm to the fetus.

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

If you are pregnant, think you may be pregnant, or plan 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 medicines

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

Tirodril may enhance the effects of the following drugs, and a dose reduction may be necessary:

• Medicines used for hypertension, heart failure (propranolol or other beta-blockers).
• Medicines that increase the heart's contractile force (digoxin).
• Medicines for the treatment of asthma (theophylline).

Tirodril may decrease the effects of oral anticoagulants.

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

The administration of amiodarone (a medicine for heart arrhythmias) may enhance the effect of Tirodril.

Antithyroid medicines may decrease the thyroid uptake of radioactive iodine used in some tests ([131I]).

Taking Tirodril with food and drinks

Tirodril has no known interactions with food or drinks.

Pregnancy and breastfeeding

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

Pregnancy:

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

In many pregnant women, thyroid dysfunction improves throughout pregnancy, so a dose reduction may be necessary. During the last trimester of pregnancy, half of the usual daily dose is administered. In some cases, treatment may be discontinued 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, but only low doses of up to 10 mg per day should be used without additional administration of thyroid hormones.

Driving and using machines

The influence of Tirodril on the ability to drive or use machines is nil or insignificant.

3. How to take Tirodril

Follow your doctor's instructions for taking Tirodril exactly. If in doubt, consult your doctor or pharmacist.

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

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

The recommended dose is:

Treatment of hyperthyroidism (increased production of thyroid hormones):

Adults and adolescents (12 to 17 years):the initial dose of Tirodril is 15 mg (3 tablets) in case of moderate hyperthyroidism, 30-40 mg (6-8 tablets) in moderate to severe hyperthyroidism, or 60 mg (12 tablets) in severe hyperthyroidism. Treatment will be done in divided doses and at 6-8 hour intervals orally until thyroid hormones are normalized. At this point, the dose will be gradually reduced to a maintenance dose of 5-15 mg (1-3 tablets) per day.

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

Tirodril is not recommended for children under 3 years of age.

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

Adults:The initial dose is 30 mg (6 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.

Prior to receiving radioactive iodine treatment, or after treatment with this for the treatment of hyperthyroidism:

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

Prevention of thyroid hormone overproduction 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 iodine substance remains in the body.

If you take more Tirodril than you should

If blood disorders occur, treatment should be discontinued immediately, and if necessary, antibiotic administration, blood transfusions, and corticosteroids should be started.

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

Overdose causes hypothyroidism, with corresponding symptoms of reduced metabolism and goiter growth. This can be avoided 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 poisoning, the usual treatment will be performed: gastric lavage, intravenous fluids, rest, analgesics, and mild sedation.

In case of overdose or accidental ingestion, consult the Toxicology Information Service.

Phone 91 562 04 20.

If you forget to take Tirodril

Do not take a double dose to make up for forgotten doses.

If you stop taking Tirodril

Do not stop taking Tirodril without consulting your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The most common side effects (may affect more than 1 in 10 patients) are: rash, urticaria, itching, and skin darkening. Most are mild and disappear during treatment with Tirodril.

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

Uncommon but serious side effects (may affect up to 1 in 100 patients) are agranulocytosis.

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

Very rare side effects (may affect up to 1 in 10,000 patients) are decreased number of certain blood cells (granulocytopenia, thrombocytopenia, pancytopenia), lymph node disorders (generalized lymphadenopathy), a type of anemia (aplastic anemia), artery inflammation (periarteritis), coagulation problems (hypoprothrombinemia), hypoglycemic coma (insulin autoimmune syndrome), nerve inflammation (neuritis), multiple nerve damage (polyneuropathy), salivary gland disease (sialadenopathy), liver or bile damage (cholestatic jaundice, fulminant hepatitis, liver necrosis), allergic reaction called Stevens-Johnson syndrome, tissue inflammation and damage (lupus erythematosus medicamentoso), kidney inflammation (nephritis).

Side effects with unknown frequency (cannot be estimated from available data) are acute pancreatitis.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tirodril

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

Store this medicine in its original packaging to protect it from light.

Do not use this medicine after the expiration date stated on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Tirodril composition

• The active ingredient is thiamazole (methimazole). Each tablet contains 5mg of thiamazole.
• The other ingredients are: cornstarch, calcium sulfate, talc, colloidal silica, and magnesium stearate.

Product appearance and packaging contents

Tirodril tablets are presented in a package of 40 tablets.

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

Marketing authorization holder

LABORATORIO ESTEDI S.L.

Montseny 41

08012 Barcelona (Spain)

Manufacturer:

LABORATORIO ESTEDI S.L.

Leopoldo Alas 7

08012 Barcelona (Spain)

Local representative:

LABORATORIO ALDO-UNION S.L.

Baronesa de Maldà, 73

08950 Esplugues de Llobregat

Barcelona (Spain)

Date of last revision of this leaflet: March 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.