Propicil 50 mg

Package Leaflet: Information for the User

Propycil 50 mg, 50 mg, Tablets

Propylthiouracil

Read the package leaflet carefully before taking the medicine, 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 only. 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 Propycil 50 mg and what is it used for
• 2. Important information before taking Propycil 50 mg
• 3. How to take Propycil 50 mg
• 4. Possible side effects
• 5. How to store Propycil 50 mg
• 6. Contents of the pack and other information

1. What is Propycil 50 mg and what is it used for

The active substance of Propycil 50 mg is propylthiouracil.
Indications for use:

• Hyperthyroidism (including Graves' disease and autonomous thyroid nodules).
• Preparation for thyroid surgery or radioactive iodine treatment, to achieve normal thyroid function.

2. Important information before taking Propycil 50 mg

When not to take Propycil 50 mg

• if you are allergic to propylthiouracil or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other anti-thyroid medicines
• if you have previously experienced severe side effects due to propylthiouracil treatment (especially agranulocytosis and liver failure).

Warnings and precautions

Before starting treatment with Propycil 50 mg, discuss it with your doctor.
If you experience fever, feeling unwell, sore throat, or mouth ulcers during treatment, you should immediately consult your doctor, as it may be necessary to stop taking the medicine. You should immediately have a blood test, as these symptoms may indicate agranulocytosis - a life-threatening severe lack of white blood cells.
You should immediately consult your doctor if you experience symptoms of liver damage, such as nausea, vomiting, yellowing of the skin or eyes, dark urine, pale stools, bleeding, itching, or chills. After taking the medicine, severe liver damage and acute liver failure have been observed, in some cases resulting in death, both in adults and children.
Propycil 50 mg may only be used in children if other treatments for hyperthyroidism have failed.
If symptoms of vasculitis occur, your doctor will perform immunological tests and consider discontinuing Propycil 50 mg. These symptoms usually resolve after treatment is stopped. Single cases leading to death have been reported, which may have been contributed to by additional complications. (see section 4).
During treatment with Propycil 50 mg, hypothyroidism may occur. Regular monitoring of thyroid function is necessary during treatment with Propycil 50 mg.
A blood test (complete blood count with smear) should be performed before starting treatment with Propycil 50 mg.
During treatment with Propycil 50 mg, regular blood tests should be performed, such as blood count with smear, liver enzyme tests (aminotransferases) and enzymes indicating bile stasis.
The possibility of further enlargement of the goiter (risk of increased volume in nodular goiter) should also be considered.

Propycil 50 mg and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Effect of other medicines on Propycil 50 mg
Concomitant administration of thyroxine reduces the uptake of propylthiouracil by the thyroid gland and weakens its effect.
Administration of iodine or prior use of iodine-containing agents (e.g., contrast agents used in radiodiagnosis) may reduce the effectiveness 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 Propycil 50 mg.
Effect of Propycil 50 mg on other medicines
Under the influence of Propycil 50 mg, the effect of propranolol, coumarin derivatives (anticoagulant medicines, e.g., warfarin), and theophylline (used in asthma) may change.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The potential harm of Propycil 50 mg to the unborn child is unknown.
If you are pregnant, think you may be pregnant, or plan to have a child, you should immediately consult your doctor. During pregnancy, it may be necessary to treat you with Propycil 50 mg if the expected benefits outweigh the potential risk to you and your unborn child.
Propycil 50 mg should not be used during pregnancy unless your doctor considers it absolutely necessary. If your doctor decides that it is necessary to use Propycil 50 mg, they may limit its use and prescribe the smallest effective dose. The use of propylthiouracil during pregnancy does not lead to the development of severe congenital defects; however, the risk of certain congenital defects in the child cannot be ruled out.
Breastfeeding
If your doctor decides that you need to take Propycil 50 mg during breastfeeding, it is necessary to monitor the newborn due to the risk of hypothyroidism in newborns.

Driving and using machines

Be careful when driving or operating machinery, as side effects of the medicine may affect your concentration.

Propycil 50 mg contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Propycil 50 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Propycil 50 mg is usually taken every 6 to 8 hours, as described below.
Adults, adolescents, and children over 10 years:
Typically, the initial daily dose used in moderate hyperthyroidism is 100 mg to 300 mg of propylthiouracil, given in 2-3 divided doses, each 50 mg-100 mg (1 to 2 tablets). The maintenance dose is 50 mg to 150 mg of propylthiouracil (1 to 3 tablets) per day. In more severe cases and due to iodine contamination, higher initial doses are recommended, i.e., 300 mg to 600 mg of propylthiouracil (6 to 12 tablets) per day, in 4-6 divided doses.

Use in children over 6 to 10 years

Typically, the initial dose is 50 mg to 150 mg of propylthiouracil (1 to 3 tablets) per day, in 1-3 divided doses, while the maintenance dose is approximately 25 mg to 50 mg of propylthiouracil (1/2 to 1 tablet) per day, in 1-2 divided doses.
Propycil 50 mg may only be used in children if other treatments for hyperthyroidism have failed.
Elderly patients:
Your doctor will prescribe a lower dose than usual.
Patients with renal impairment:
The dose of Propycil 50 mg should be reduced by 25% in mild to moderate renal impairment, and by 50% in severe impairment.
Patients with hepatic impairment:
Your doctor will consider reducing the dose of Propycil 50 mg in patients with hepatic impairment. It is recommended to check renal and hepatic function before starting therapy with Propycil 50 mg.

Overdose of Propycil 50 mg

If you experience symptoms of overdose, seek medical attention immediately.
After an overdose, the following symptoms may occur: muscle pain, nausea or vomiting, fatigue or weakness, menstrual disorders, increased sensitivity to cold, constipation, dry, swollen skin, headache, apathy, drowsiness, weight gain.
In the case of prolonged use or incorrect dosing of the medicine, symptoms of overdose may appear, leading to the development of goiter (thyroid enlargement) or hypothyroidism, which requires discontinuation of Propycil 50 mg.

Missed dose of Propycil 50 mg

Do not take a double dose to make up for a missed dose.

Stopping treatment with Propycil 50 mg

Only your doctor can decide to stop treatment with Propycil 50 mg.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Propycil 50 mg can cause side effects, although not everybody gets them.
During treatment with Propycil 50 mg, the following side effects may occur:
Very common (occurring in more than 1 in 10 patients):
transient increase in liver enzyme activity.
Common (occurring in less than 1 in 10 and more than 1 in 100 patients):
significant decrease in white blood cell count - granulocytopenia, allergic skin rashes (itching, rash, hives), gastrointestinal disorders, nausea, vomiting.
Uncommon (occurring in less than 1 in 100 and more than 1 in 1000 patients):
severe, life-threatening agranulocytosis, transient taste and smell disorders after treatment is stopped.
Rare (occurring in less than 1 in 1000 and more than 1 in 10,000 patients):
liver damage, drug fever, dizziness, neuromuscular disorders.
Very rare (occurring in less than 1 in 10,000 patients):
general blood morphology disorders, e.g., disorders of red blood cell production, thrombocytopenia, decrease in all blood cell elements, positive Coombs test (detection of antibodies in pregnant women that can cross the placenta and attack the baby's red blood cells), lymphadenopathy, arthralgia, vasculitis, including vasculitis manifesting as renal dysfunction, glomerulonephritis, and, in single cases, acute renal failure, nodular vasculitis, a clinical syndrome resembling lupus erythematosus (e.g., fever, muscle and joint pain, skin changes), hair loss, peripheral edema, pneumonitis, severe liver disease, goiter in newborns, hearing loss, hemoptysis, disseminated or generalized purpura, asthma, urticaria, leukocytoclastic vasculitis (vasculitis in the skin). In patients with Graves' disease treated with propylthiouracil, antibodies may appear that react with neutrophils (a type of white blood cell) in the blood. In some patients, the presence of these antibodies is associated with the development of vasculitis, which, in addition to joint and muscle pain, and flu-like symptoms, can also cause symptoms from the following organs: skin (e.g., rash, purpura, leukocytoclastic vasculitis), kidneys (e.g., glomerulonephritis, in single cases, acute renal failure), lungs (e.g., interstitial pneumonitis, disseminated or generalized purpura), and other organs.
If you experience any of the above symptoms of vasculitis, you should immediately consult your doctor. Your doctor will then order immunological tests and may decide to discontinue Propycil 50 mg. These symptoms usually resolve after treatment is stopped. Single cases leading to death have been reported, which may have been contributed to by additional complications.
During treatment with Propycil 50 mg, transient weight gain may also occur.
Existing goiter may enlarge due to treatment with Propycil 50 mg.
Despite proper treatment of the mother, goiter has been reported to occur in newborns.

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
PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Propycil 50 mg

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 Propycil 50 mg contains

• The active substance is propylthiouracil.
• The other ingredients are: lactose monohydrate, cornstarch, magnesium stearate (E 572), colloidal silica, povidone K 30, pregelatinized starch.

What Propycil 50 mg looks like and contents of the pack

Propycil 50 mg is a white, round, biconvex tablet with a dividing line.
The packaging is a glass bottle with a low-density polyethylene (LDPE) cap and a high-density polyethylene (HDPE) insert, placed in a cardboard box.
The pack contains 20 or 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Admeda Arzneimittel GmbH
Tönsfeldtstraße 16, 22763 Hamburg
Germany
Manufacturer:
Haupt Pharma Berlin GmbH
Moosrosenstraße 7
12347 Berlin, Germany

Date of last revision of the leaflet: