TIRODRIL 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Tirodril 10 mg Tablets

Thiamazol (Methimazole)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Tirodril and what is it used for
2. What you need to know before you take Tirodril
3. How to take Tirodril
4. Possible side effects
5. Storage of Tirodril
6. Contents of the pack and other information

1. What is Tirodril and what is it used for

Tirodril is a medicine (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 over 3 years:

• Sudden worsening of hyperthyroidism symptoms (thyrotoxic crisis or thyroid storm)
• If you need to take medicine to treat the overproduction of thyroid hormones by the thyroid gland (hyperthyroidism),
• If you are going to undergo thyroid surgery,
• If you are going to receive radioactive iodine treatment, or after treatment with it until its effect is fully established.

Tirodril is also used for:

• Preventing overproduction of thyroid hormones before exposure to iodine, such as in an examination with iodine contrast medium,
• If you have 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 had overproduction of thyroid hormones at some point in your life.

2. What you need to know before you take Tirodril

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 bile flow obstruction (cholestasis) not caused by hyperthyroidism.
• If you have suffered bone marrow damage during previous treatments with thiamazol or carbimazol.
• The combined therapy of thiamazol and thyroid hormones is contraindicated during pregnancy.
• If you have had pancreatitis after administration of thiamazol or carbimazol 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, you may experience weight gain 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 interrupt 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 of these may be necessary:

• Drugs used for hypertension, heart failure (propranolol or other beta-blockers).
• Drugs that increase the strength of heart contractions (digoxin).
• Drugs 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 drug for heart arrhythmias) may enhance the effect of Tirodril.

Antithyroid drugs may decrease the thyroid uptake of radioactive iodine 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 plan to become pregnant, consult your doctor before using this medicine.

Pregnancy:

During pregnancy, Tirodril should be administered at the lowest possible dose. Thiamazol (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 severe congenital anomalies is low, especially if the dose administered to the mother is the lowest possible dose. Fetal risks increase when antithyroid drugs are used near the end of pregnancy. The possible risks of adverse effects and fetal damage must be weighed against those due to continued hyperthyroidism during pregnancy.

In many pregnant women, poor thyroid function improves throughout pregnancy, so it may be necessary to decrease the dose. During the last trimester of pregnancy, half of 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, but only low doses of up to 10 mg per day can 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 negligible.

3. How to take Tirodril

Follow the instructions for administration of Tirodril indicated by your doctor. If in doubt, consult your doctor or pharmacist.

The tablet can be divided into equal doses. It can be crushed or swallowed whole or fractionated 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 (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 done in fractionated doses and at intervals of 6-8 hours orally until thyroid hormones are normalized. At this time, the dose will be gradually reduced to 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 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.

Sudden 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.

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

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

Prevention of overproduction of thyroid hormones before exposure to iodine:

Generally, daily doses of 10-20 mg of thiamazol 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 interrupted immediately and, if necessary, antibiotic administration, blood transfusions, and corticosteroids should be started.

For the treatment of mild skin allergic reactions produced by thiamazol, 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 your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

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 further questions 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 everybody gets them.

Very common side effects (may affect more than 1 in 10 people): 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 people): nausea, vomiting, stomach pain, joint pain, and muscle pain.

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

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

Very rare side effects (may affect up to 1 in 10,000 people): decrease in the number of some 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, hair loss, tissue inflammation and damage (lupus erythematosus medicamentoso), kidney inflammation (nephritis).

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://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 in the original packaging to protect it from light.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry 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 medicine in the SIGRE point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tirodril

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

Appearance of the product and contents of the pack

Tirodril tablets are presented in a pack 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 and manufacturer

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-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona (Spain)

Date of the last revision of this leaflet:February 2020

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