Tirodril 10 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tirodril 10 mg tablets

Thiamazole (Methimazole)

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Tirodril is and what it is used for

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

It is indicated for the treatment of the following conditions in adults and children aged 3 years and older:

• sudden worsening of symptoms of hyperthyroidism (thyrotoxic crisis or thyroid storm)
• when you need to take a medication to treat overproduction of thyroid hormones by the thyroid gland (hyperthyroidism)
• when you are scheduled to undergo thyroid surgery
• when you are about to receive radioactive iodine treatment, or after such treatment until its full effect has been established

Tirodril is also used for:

• preventing overproduction of thyroid hormones prior to exposure to iodine, such as during an imaging procedure with iodine-containing 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 previously experienced overproduction of thyroid hormones at any time in your life

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

Do not take Tirodril

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

• if you have low levels of certain blood cells such as leukocytes or neutrophils.

• if you have biliary flow obstruction (cholestasis) not caused by hyperthyroidism.

• if you have previously experienced bone marrow damage during prior treatment with thiamazole or carbimazole.

• combination therapy with thiamazole and thyroid hormones is contraindicated during pregnancy.

• if you have previously experienced inflammation of the pancreas (acute pancreatitis) after administration of thiamazole or carbimazole.

Warnings and precautions

Talk to 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 sore throats, fever, chills, cough, mouth ulcers, or hoarseness, as these could be early signs of blood disorders (agranulocytosis) which could have serious consequences.

• During treatment with Tirodril, inform your doctor if you lose your appetite or develop itching or abdominal pain, as these could be early signs of liver impairment.

• If you have goiter (swelling in the front of the neck), treatment with Tirodril must be carried out under strict medical supervision.

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

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

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

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

• Tirodril may harm the fetus. If you could become pregnant, use a reliable method of contraception from the start of treatment and throughout treatment.

Pregnancy

Tirodril may harm the fetus.

If you could become pregnant, use a reliable method of contraception from the start of treatment and throughout 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 might need to take any other medicines.

Tirodril may enhance the effects of the following drugs, requiring a reduction in their dosage:

• Drugs used for hypertension, heart failure (propranolol or other β-blockers).
• Drugs that increase the strength of heart contraction (digoxin).
• Drugs for the treatment of asthma (theophylline).

Tirodril may reduce the effects of oral anticoagulants.

Administration of iodinated glycerol, iodine, or potassium iodide may reduce the response to Tirodril.

Administration of amiodarone (a drug for heart arrhythmias) may enhance the effect of Tirodril.

Antithyroid drugs may reduce thyroid uptake of radioactive iodine used in certain diagnostic tests ([131I]).

Taking Tirodril with food and drink

Tirodril has no known interactions with food or beverages.

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) can 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 given to the mother is the lowest possible. Fetal risks increase when antithyroid drugs are used close to the end of pregnancy. The potential risks of adverse effects and fetal harm must be weighed against those due to uncontrolled hyperthyroidism during pregnancy.

In many pregnant women, thyroid gland dysfunction improves during pregnancy, so a dose reduction may be necessary. During the last trimester of pregnancy, half 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 infant. Breastfeeding is possible during treatment with Tirodril, but only low doses of up to 10 mg per day may 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 none or negligible.

3. How to take Tirodril

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

The tablet can be divided into equal doses. It may be crushed or swallowed whole or divided, 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 daily, you may also take it in divided doses 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 cases 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 administered in divided doses every 6–8 hours orally until thyroid hormones normalize. At this point, the dose should be gradually reduced to the maintenance dose of 5–15 mg daily.

Children (3 to 11 years): The initial dose is 0.4 mg/kg given in divided doses 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 of age.

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.

Preoperative treatment for thyroid surgery in patients with hyperthyroidism:

Use the same doses as those used for the treatment of hyperthyroidism until the patient becomes euthyroid.

Prior to receiving radioactive iodine treatment, or after such treatment for hyperthyroidism:

Use the same doses as those used in the treatment of hyperthyroidism.

Prevention of overproduction of thyroid hormones prior to exposure to iodine:

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

If you take more Tirodril than you should

If blood disorders occur, treatment must be stopped immediately and, if necessary, antibiotics, blood transfusions, and corticosteroids should be administered.

For mild skin allergic reactions caused by thiamazole, antihistamines may be helpful.

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

In case of acute intoxication, standard treatment should be administered: gastric lavage, intravenous fluids, rest, analgesics, and mild sedation.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication 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 treatment with Tirodril without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects (may affect more than 1 in 10 patients): rash, urticaria, itching, and darkening of the skin. Most of these are mild and disappear 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 (reduction 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 sensation anywhere in the body, dizziness, swelling, fever, headache, and drowsiness.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tirodril

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect 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. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and other information

Composition of Tirodril

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

Appearance of the product and contents of the pack

Tirodril tablets are supplied in a pack containing 40 tablets.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: February 2020

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