Thyrozol

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

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

• when treatment is required for a thyroid gland producing excess hormones, particularly in cases of a small goitre (swelling at the front of the neck) or absence of goitre,
• prior to planned thyroid surgery,
• prior to radioactive iodine therapy, 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 using iodine-containing contrast agents:

• when a slight increase in thyroid hormone production is detected without associated symptoms,
• when certain hormone-producing areas are present in the thyroid gland (autonomous adenomas),
• when excessive thyroid hormone production has occurred previously.

2. Important information before taking Thyrozol

When not to take Thyrozol

• if the patient is allergic (hypersensitive) to thiamazole, substances related to thiamazole (thiourea 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 has been diagnosed prior to 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 inflammation of the pancreas) 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 there is a large goitre (swelling at the front of the neck) causing breathing difficulties, consult your doctor, as the goitre may enlarge during treatment with Thyrozol.
Your doctor may decide to prescribe the medicine for a short period only and with regular monitoring during treatment.
Immediately consult your 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 a case, your doctor may discontinue treatment if necessary. Usually, these symptoms resolve after stopping the medication.
Stop taking Thyrozol and immediately contact your 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 especially during the first weeks of treatment and may lead to serious consequences.
Immediately contact your doctor if the patient develops fever or abdominal pain, as these may be symptoms of pancreatitis (acute inflammation of the pancreas). It may be necessary to discontinue treatment with Thyrozol.
Thyrozol may harm the unborn child. If the patient can become pregnant, she should use a reliable method of contraception from the start of treatment and throughout therapy.
In cases of very high production of thyroid hormones, very high doses of Thyrozol (over 120 mg per day) may be required. In such cases, your doctor will periodically perform blood tests, as there is a risk of bone marrow damage. If this occurs, your 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, your 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 develop or worsen, which 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. Your doctor will determine the dose of Thyrozol taking into account iodine intake and thyroid function in the individual patient.
If you are taking anticoagulant medicines (preventing blood clotting), inform your doctor, as normalization of thyroid function due to Thyrozol may affect the action of these medicines. The same may apply to other medicines.
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding
Thyrozol may harm the unborn child.
If the patient can become 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 plans to become pregnant, she should immediately consult her doctor. Continuing treatment with Thyrozol during pregnancy may be necessary if the potential benefits outweigh the risks to the mother and fetus.
Thyrozol passes into human milk. Your doctor will decide whether taking Thyrozol during breastfeeding is necessary. If so, only a low dose of up to 10 mg of thiamazole should be taken.
Your doctor will regularly monitor the newborn's thyroid function.

Driving and operating machinery
Thyrozol has no influence 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; therefore, the medicine is considered "sodium-free".

3. How to use Thyrozol

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor.
Thyrozol is available in the following strengths: 5 mg, 10 mg, 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 given 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 of body weight per day. Then your doctor will decide whether a lower maintenance dose is sufficient and whether additional thyroid hormones are necessary.*

Use in children (under 2 years of age)
Thyrozol is not recommended for use in children under 2 years of age.
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 disorders
If you have impaired liver function or liver disease, inform your doctor. In such cases, the dose of
Thyrozol may need to be reduced.
Patients with kidney disorders
If you have impaired kidney function or kidney disease, inform your doctor. In such cases, the dose of
Thyrozol may 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 duration of treatment 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 radioactive iodine administration: until thyroid function normalizes,
• treatment after radioactive iodine administration: 4-6 months, until the effects of radioactive iodine therapy become apparent.

Administration
Tablets should be taken in the morning, after breakfast, with a small amount of liquid, e.g. half a
glass of water. The tablet may be divided into equal doses.
If more than one tablet per day is prescribed, they may be divided into several portions and taken at
regular intervals throughout the day.
Taking more Thyrozol than prescribed
Accidentally taking more medicine than prescribed should not cause problems. However, if higher
doses have been taken repeatedly, contact your doctor as soon as possible.
The patient may experience cold intolerance, fatigue, dry skin, constipation, weight gain, slow
heartbeat, and goitre. Your doctor may recommend adjusting the dose of Thyrozol or may prescribe
additional thyroid hormones to prevent goitre.
Missed 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 effects

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

Very common (may occur in 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 occur in up to 1 in 10 people)

• Joint pain.

Uncommon (may occur in up to 1 in 100 people)

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

Rare (may occur in up to 1 in 1000 people)

• Taste disturbances or loss of taste.
• Fever.

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

• Decreased number of platelets (thrombocytopenia), decreased number of all blood cells (pancytopenia), lymph node disease (generalized lymphadenopathy).
• A disorder affecting hormones that regulate blood glucose concentration, manifesting as reduced 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.
• Severe 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 effects in children and adolescents are similar to those observed in adults.

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

5. How to store Thyrozol

Keep this medicine out of 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:
Verwendbar bis und Ch.-B. siehe Randprägung – expiry date and batch number, see edge embossing.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Thyrozol contains
The active substance is thiamazole. Each coated tablet contains 5 mg of thiamazole.
The other components are:
tablet core: anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, talc, microcrystalline cellulose, corn starch, lactose monohydrate, sodium carboxymethyl starch;
coating: dimethicone 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 tablets 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 the Parallel Importer.

Marketing Authorisation Holder in Germany, the country of export:
Merck Healthcare Germany GmbH
Waldstraße 3
64331 Weiterstadt
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Germany, the country of export: 13478.00.00
Marketing Authorisation Number for Parallel Import: 245/25

This medicinal product is authorised for sale 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