Thirosan

Package Leaflet: Information for the User

Thyrosan, 50 mg, Tablets

Propylthiouracil

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Thyrosan and what is it used for

Thyrosan contains the active substance propylthiouracil, which belongs to a group of medicines called antithyroid medicines. Antithyroid medicines inhibit the production of hormones

• triiodothyronine and thyroxine - in the thyroid gland (a gland located below the larynx, where hormones regulating growth and metabolism are produced).

Thyrosan is used:

• to treat hyperthyroidism, including Graves' disease and autonomous toxic thyroid adenoma,
• to prepare for thyroidectomy or radioactive iodine treatment in cases of hyperthyroidism,
• to treat thyroid crisis (a life-threatening condition for the patient).

2. Important information before taking Thyrosan

When not to take Thyrosan

• if you are allergic to the active substance - propylthiouracil, thiouracil derivatives or any of the other ingredients of this medicine (listed in section 6).
• if you have liver failure.
• if you have hyperthyroidism with a nodular goiter, especially with compression of the thyroid gland.
• if you have hematological disorders (changes in blood test results, such as agranulocytosis, anemia, leukopenia - a decrease in white blood cells).

Warnings and precautions

Before starting treatment with Thyrosan, discuss it with your doctor.
You should be particularly careful:

• if you have liver function disorders;
• if you have kidney function disorders;
• if you are pregnant or breastfeeding,
• if you are taking anticoagulant medications,
• if you are being prepared for surgery.

You should immediately consult a doctor:

• if you experience malaise, fever, sore throat, as it is necessary to stop taking the medicine. You should immediately have a blood morphology test, as these symptoms may indicate agranulocytosis - a life-threatening severe decrease in white blood cells.
• if you experience symptoms of liver damage, such as nausea, vomiting, diarrhea, yellowing of the skin or eyes, dark urine, light-colored stools, tendency to bleed, itching or chills. In patients taking propylthiouracil, both in adults and children, cases of severe liver damage have been reported, including those requiring liver transplantation and resulting in death.

During treatment with Thyrosan, your doctor will recommend regular monitoring of thyroid function to possibly modify the dose, as well as blood tests.

Thyrosan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Concomitant administration of thyroxine reduces the uptake of propylthiouracil by the thyroid gland, weakening its effect.
Administration of iodine or previous use of iodine-containing agents (e.g., contrast agents used in radiodiagnostics) may weaken the effect of propylthiouracil and delay the achievement of normal thyroid function.
Medicines that weaken bone marrow function (affecting the immune system), medicines with hepatotoxic effects, or those containing lithium may potentiate the side effects of Thyrosan.
Thyrosan may interfere with the effects of anticoagulant medications (e.g., warfarin), beta-blockers (e.g., propranolol), and theophylline (a medication used in asthma). Dose adjustment may be necessary.

Thyrosan with food and drink

The medicine should be taken during meals.

Pregnancy and breastfeeding

Pregnancy
The potential harm of Thyrosan to the unborn child is unknown.
If you are pregnant, think you may be pregnant, or plan to have a child, consult your doctor immediately. During pregnancy, it may be necessary to treat you with Thyrosan if the expected benefits outweigh the possible risk to you and your unborn child.
If your doctor decides that you need to take Thyrosan during pregnancy, you must strictly follow your doctor's instructions. Your doctor will recommend the smallest effective dose of the medicine.
Breastfeeding
The medicine passes into breast milk in small amounts.
If you are breastfeeding, consult your doctor immediately.
If your doctor decides that you need to take Thyrosan during breastfeeding, it is necessary to monitor the newborn due to the risk of hypothyroidism in newborns.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

3. How to take Thyrosan

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Your doctor will decide on the initial dose of the medicine and the number of tablets to take each day. Depending on your individual needs, your doctor may reduce or increase the dose.
Tablets can be divided.
Adults
The usual initial dose for adults is 2 tablets every 8 hours (6 tablets per day).
In patients with severe hyperthyroidism, the doctor may increase the dose. Usually, up to 8 tablets per day are used, in divided doses every 8 hours.
After a few weeks of treatment with Thyrosan, the doctor may recommend taking a smaller number of tablets per day (so-called maintenance dose) and this may last for up to 1-2 years.
The usual maintenance dose for adults is 2 to 3 tablets per day, in divided doses.
Use in children
Children over 10 years old
The usual initial dose is 3 to 6 tablets per day, in three divided doses.
Children 6-10 years old
The usual initial dose is 1 to 3 tablets per day, in three divided doses.
Children under 6 years old
Thyrosan should not be used in children under 6 years old due to the lack of data on safety and efficacy.
The maintenance dose in children is usually 1-2 tablets per day, given in one or two doses.
Patients with renal impairment
The dose of Thyrosan should be reduced. The doctor will recommend an appropriate dose depending on the severity of renal impairment.
Thyroid crisis
In adults with thyroid crisis, the doctor will determine the dose individually until the acute condition is controlled.

Overdose of Thyrosan

If you have taken more than the recommended dose of Thyrosan, you may experience nausea, vomiting, gastrointestinal disorders, headache, fever, joint pain, itching, and swelling.
Immediately contact your doctor or go to the nearest hospital. Take the Thyrosan packaging with you.

Missed dose of Thyrosan

If you have missed a dose of Thyrosan, take it as soon as possible. However, if it is almost time for the next dose, wait and take only the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Thyrosan

Take the medicine for as long as your doctor recommends. Do not stop taking the medicine 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, Thyrosan can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people)
Headache, fever, sore throat, paresthesia in the hands and feet, rash, itching, urticaria, skin inflammation, and gastrointestinal disorders, such as nausea, vomiting, loss of appetite, and diarrhea, disturbances in thyroid-stimulating hormone (TSH) secretion (e.g., increased TSH secretion), decreased number of certain types of blood cells, which may cause worsening of general condition (weakness, fatigue).
Rare (may affect up to 1 in 1,000 people)
Visual disturbances, hearing disturbances, liver damage, yellowing of the skin and eyes (jaundice), changes in liver function may manifest as increased liver enzyme activity and increased bilirubin levels in serum.
Very rare (may affect less than 1 in 10,000 people)
Joint pain, arthritis, hair loss, and precocious puberty, symptoms of systemic lupus erythematosus (e.g., fever, muscle pain, skin changes).
Frequency not known (frequency cannot be estimated from available data)
Hepatitis, liver failure.
Some side effects are only visible in blood test results. These include a decrease in the number of certain types of blood cells, which may cause worsening of general condition (weakness, fatigue).
Agranulocytosis, a life-threatening severe decrease in white blood cells, may occur in the initial period of treatment (1-3 months), but also later. It may occur suddenly, without warning signs. Periodic blood tests do not always prevent agranulocytosis, so you should immediately inform your doctor about any side effects, especially sore throat or fever.
There have been reports of vasculitis associated with the presence of a specific type of antibodies in body fluids, called anti-neutrophil cytoplasmic antibodies (ANCA). ANCA-associated vasculitis may manifest as kidney disease, sometimes leading to acute kidney failure, changes in the lungs, skin, and blood vessels.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
e-mail: [email protected]
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Thyrosan

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should 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 pack and other information

What Thyrosan contains:

• The active substance is propylthiouracil. One tablet contains 50 mg of propylthiouracil.
• The other ingredients are: microcrystalline cellulose with silicon dioxide, sodium carboxymethylcellulose, magnesium stearate.

What Thyrosan looks like and contents of the pack

Thyrosan is a round, flat tablet with a dividing line.
Pack sizes: 20 or 90 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

SUN–FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
mibe GmbH Arzneimittel
Münchener Straβe 15
06796 Brehna
Germany

Date of last revision of the leaflet: