Thyrozol

Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Thyrozol
5 mg, coated tablets
Thiamazolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Thyrozol is and what it is used for
2. Important information before taking Thyrozol
3. How to take Thyrozol
4. Possible side effects
5. How to store Thyrozol
6. Contents of the pack and other information

1. What Thyrozol is and what it is used for

The medicine contains thiamazole. It inhibits the excessive production of thyroid hormones in the thyroid gland, regardless of the cause.
Thyrozol is used to treat excessive production of thyroid hormones:

• when it is necessary to take the medicine to treat an overactive thyroid gland, particularly in cases of a small goitre (swelling at the front of the neck) or absence of goitre,
• when thyroid surgery is planned,
• when radioactive iodine therapy is planned, especially in cases of very high thyroid hormone production,
• after radioactive iodine therapy, until the full effects of treatment become apparent.
  Thyrozol is also used to prevent excessive thyroid hormone production prior to planned exposure to iodine, for example, before diagnostic imaging procedures using iodine-containing contrast agents:
• when a slight increase in thyroid hormone production is detected without accompanying symptoms,
• when certain areas within the thyroid gland produce hormones autonomously (autonomous adenomas),
• when excessive thyroid hormone production has occurred previously.

2. Important information before using Thyrozol

When not to use Thyrozol

• if the patient is allergic (hypersensitive) to thiamazole, substances related to thiamazole (thionamide derivatives), or any of the other ingredients of this medicine (listed in section 6),
• if laboratory tests show a reduced number of certain blood cells (granulocytopenia),
• if cholestasis (impaired bile flow) is detected before starting treatment with Thyrozol,
• if bone marrow damage occurred in the past during treatment with thiamazole or carbimazole,
• if the patient previously experienced pancreatitis (acute pancreatitis) after administration of thiamazole or carbimazole.

Warnings and precautions
Before starting treatment with Thyrozol, discuss this with your doctor or pharmacist.
If mild allergic reactions to thiamazole occurred in the past, such as skin rash or itching, speak with your doctor, who will decide whether it is safe to take Thyrozol.
If the patient has a large goitre (swelling at the front of the neck) causing breathing difficulties, consult a doctor, as the goitre may enlarge during treatment with Thyrozol.
The doctor may decide to use the medicine for a short period only, with regular monitoring during treatment.
Immediately consult a doctor if symptoms such as fever, fatigue, weight loss, or muscle and joint pain occur. These may be symptoms of blood vessel inflammation (vasculitis). In such cases, the doctor may need to discontinue treatment. Usually, these symptoms resolve after stopping the medicine.
Stop taking Thyrozol and immediately contact a doctor if symptoms such as inflammation of the mucous membranes in the mouth, sore throat, or fever occur. These may indicate a serious reduction in certain blood cells (agranulocytosis). This may occur particularly during the first weeks of treatment and may lead to serious consequences.
Immediately contact a doctor if the patient develops fever or abdominal pain, as these may be symptoms of pancreatitis (acute pancreatitis). It may be necessary to stop using Thyrozol.
Thyrozol may harm an unborn child. If the patient is capable of becoming pregnant, she should use a reliable method of contraception from the start of treatment and throughout therapy.
In cases of very severe overproduction of thyroid hormones, very high doses of Thyrozol (above 120 mg per day) may be required. In such cases, the doctor will periodically perform blood tests, as there is a risk of bone marrow damage. If this occurs, the doctor may decide to discontinue treatment and, if necessary, prescribe another medicine.
If the goitre enlarges during treatment with Thyrozol, or if thyroid function becomes excessively reduced, the doctor may adjust the dose of Thyrozol. However, such situations may also occur naturally during the course of the disease. Similarly, eye disease (endocrine ophthalmopathy) may appear or worsen, but this is unrelated to treatment with Thyrozol.
During treatment with Thyrozol, weight gain may occur. This is a normal bodily response. Thyrozol affects thyroid hormones, which regulate energy consumption in the body.

Thyrozol and other medicines
Iodine intake affects the action of Thyrozol. The doctor will determine the dose of Thyrozol taking into account iodine intake and thyroid function in the individual patient.
If anticoagulant medicines (preventing blood clotting) are being used, inform the doctor, as normalization of thyroid function due to Thyrozol may affect the action of these medicines. The same may apply to other medicines.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding
Thyrozol may harm an unborn child.
If the patient is capable of becoming pregnant, she should use a reliable method of contraception from the start of treatment and throughout therapy.
If the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy, she should immediately consult a doctor. Continuing treatment with Thyrozol during pregnancy may be necessary if potential benefits outweigh the risks to the mother and fetus.
Thyrozol passes into human milk. The doctor will decide whether it is necessary to take Thyrozol during breastfeeding. If so, only a low dose of up to 10 mg of thiamazole should be taken.
The doctor will regularly monitor the newborn's thyroid function.

Driving and operating machinery
Thyrozol has no effect on the ability to drive or operate machinery.

Important information about certain ingredients of Thyrozol
If the patient has an intolerance to certain sugars, inform the doctor, as Thyrozol contains lactose.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Thyrozol

This medicine should always be taken exactly as your doctor has instructed. If you are unsure,
you should consult your doctor.
Thyrozol is available in the following strengths: 5 mg, 10 mg, or 20 mg.
Recommended dose
Your doctor will determine the dose individually depending on the severity of the disease. The
following doses are usually recommended.

• Adults The initial dose is 10 mg to 40 mg of Thyrozol per day (or more in some patients) and is administered until the thyroid gland begins to function normally. The maintenance dose is either 5 mg to 20 mg of Thyrozol per day in combination with thyroid hormones or 2.5 mg to 10 mg of Thyrozol per day without thyroid hormones.*
• Use in children and adolescents (from 3 to 17 years of age) The initial dose is 0.5 mg of Thyrozol per kg body weight per day. Afterwards, your doctor will decide whether a lower maintenance dose is sufficient and whether additional thyroid hormones are necessary.* Use in children (aged 2 years and younger)

Thyrozol is not recommended for use in children aged 2 years and younger.
If there is a risk of excessive thyroid hormone production following a diagnostic procedure using
an iodine-containing contrast agent, your doctor may recommend taking 10 mg to 20 mg of
Thyrozol per day in combination with perchlorate for approximately 10 days (until the iodine-containing contrast agent has been eliminated from the body).*
*If small doses are required, tablets containing 5 mg of the medicine are available.
Patients with liver disease
If you have impaired liver function or liver disease, you must inform your doctor. In such cases,
the dose of Thyrozol will need to be reduced.
Patients with kidney disease
If you have impaired kidney function or kidney disease, you must inform your doctor. In such
cases, the dose of Thyrozol will need to be reduced.
Duration of treatment
The duration of treatment may vary depending on the reason for using Thyrozol. Your doctor
will explain how long you should take the medicine. Usually, the treatment duration is as follows:

• treatment of excessive thyroid hormone production (without surgery): 6 months to 2 years,
• treatment prior to surgical procedure: 3-4 weeks before surgery,
• treatment before administration of radioactive iodine: until thyroid function normalizes,
• treatment after administration of radioactive iodine: 4-6 months, until the effects of radioactive iodine therapy become apparent. Administration Tablets should be taken in the morning, after breakfast, and swallowed with a small amount of liquid, e.g. half a glass of water. Tablets may be divided into equal doses. If a higher number of tablets per day is required, they may also be divided into several portions and taken at regular intervals throughout the day.

Taking more than the recommended dose of Thyrozol
If you accidentally take more medicine than you should, it is unlikely to cause problems. However,
if you have repeatedly taken more than the recommended dose, you should contact your doctor
as soon as possible.
You may experience cold intolerance, fatigue, dry skin, constipation, weight gain, slow heartbeat,
and goitre enlargement. Your doctor may recommend adjusting the dose of Thyrozol or may
prescribe additional thyroid hormones to prevent goitre enlargement.
Missing a dose of Thyrozol
Do not take a double dose to make up for a missed dose.
On the following day, take the same dose as usual.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse effects may occur during treatment with Thyrozol, sometimes even after several months of treatment.

Very common (may affect more than 1 in 10 people)

• Skin reactions of varying severity (rash, itching, itchy hives). In most cases, these are mild and resolve during continued treatment with Thyrozol.

Common (may affect up to 1 in 10 people)

• Joint pain.

Uncommon (may affect up to 1 in 100 people)

• If symptoms such as inflammation of the mucous membranes of the mouth, sore throat, or fever occur, contact your doctor immediately. These may be signs of a serious reduction in the number of certain blood cells (agranulocytosis).

Rare (may affect up to 1 in 1,000 people)

• Taste disturbances or loss of taste.
• Fever.

Very rare (may affect up to 1 in 10,000 people)

• Decrease in the number of platelets (thrombocytopenia), decrease in the number of all blood cells (pancytopenia), lymph node disorder (generalized lymphadenopathy).
• Hormonal disorder affecting hormones regulating blood glucose levels, manifested by decreased blood sugar (autoimmune insulin syndrome).
• Inflammation or irritation of nerves (neuritis, polyneuropathy).
• Swelling of the salivary glands.
• Liver function disorders or hepatitis (cholestatic jaundice, toxic hepatitis). Symptoms usually resolve after discontinuation of treatment.
• Acute allergic skin reactions affecting the entire body, including blistering skin reactions (Stevens-Johnson syndrome), hair loss, inflammatory autoimmune disease of the skin and connective tissue (lupus erythematosus).

Frequency not known (frequency cannot be estimated from available data)

• Inflammation of the pancreas (acute pancreatitis).
• Inflammation of blood vessels (vasculitis).

Children and adolescents
Adverse reactions in children and adolescents are similar to those observed in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Thyrozol

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Translation of some information on the immediate packaging:
Ch.-B./Verwendbar bis - siehe Randprägung - batch number / expiry date – see embossing
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices help protect the environment.

6. Contents of the pack and other information

What Thyrozol contains

• The active substance is tiamazole. Each coated tablet contains 5 mg of tiamazole.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, hypromellose, talc, microcrystalline cellulose, corn starch, lactose monohydrate, sodium carboxymethyl starch; coating: simethicone 100, polyethylene glycol 400, hypromellose, titanium dioxide (E 171), and iron oxide (E 172).

What Thyrozol looks like and contents of the pack
Thyrozol 5 mg coated tablets are yellow, biconvex, round, with a score line on both sides.
Thyrozol 5 mg coated tablets are available in packs containing 25, 50, 75 or 100 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Germany, country of export:
Merck Healthcare Germany GmbH
Waldstraße 3
64331 Weiterstadt
Hessen, Germany

Manufacturer:
Merck Healthcare KGaA
Frankfurter Straße 250
64293 Darmstadt
Germany
P&G Health Austria GmbH & Co. OG
Hösslgasse 20
9800 Spittal/Drau
Austria

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Relabelled in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

This medicinal product is authorised in the European Economic Area member states under the following names:
Bulgaria: Thyrozol
Czech Republic: Thyrozol
Estonia: Thyrozol
France: Thyrozol
Germany: Thyrozol
Latvia: Thyrozol
Lithuania: Thyrozol
Poland: Thyrozol
Romania: Thyrozol
Slovakia: Thyrozol

Marketing Authorisation number in Germany, country of export: 13478.00.00
Parallel import authorisation number: 176/25