METIZOL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Metizol
5 mg, tablets
Thiamazolum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Metizol is and what it is used for

Metizol is a medicine that inhibits the production of thyroid hormones. However, it does not affect the amount of hormones already produced or their release; therefore, its effects become apparent only after several days of treatment.
Due to these properties, Metizol is used in hyperthyroidism (regardless of type), thyroid storm, preparation for thyroidectomy, and as a supportive agent in radioactive iodine therapy.

2. Important information before using Metizol

When not to use Metizol

• if the patient is allergic to thiamazole, substances with a similar structure to thiamazole (thiourea derivatives), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a reduced number of certain blood cells (granulocytopenia);
• if the patient has cholestatic jaundice before starting treatment with Metizol;
• if the patient has previously experienced bone marrow damage after treatment with thiamazole or carbimazole;
• if the patient has previously experienced pancreatitis (acute pancreatitis) after administration of thiamazole or carbimazole.
  Thiamazole and thyroid hormones should not be used concomitantly in pregnant women.

Warnings and precautions
Before starting to take Metizol, discuss this with your doctor.
If the patient previously experienced mild allergic reactions to thiamazole, such as skin rashes or itching, inform the doctor – the doctor will decide whether the patient can take Metizol.
In case of a large goitre causing breathing difficulties, discuss this with the doctor, as the goitre may enlarge during treatment with Metizol. The doctor may decide to administer the medicine for a shorter duration and will regularly monitor the patient during treatment.
Before starting treatment, the doctor will order blood count tests.
Immediately consult a doctor if symptoms such as oral mucosal inflammation, sore throat, or fever occur. These symptoms may indicate a serious adverse effect of the medicine – agranulocytosis (a marked deficiency of certain types of white blood cells responsible for immune responses in the body). These symptoms usually occur within the first weeks of treatment but may appear even after several months of starting therapy or when restarting treatment. If such symptoms occur, the doctor will order a blood count test and may decide to discontinue Metizol.
Immediately consult a doctor if the patient develops fever or abdominal pain, as these may be symptoms of pancreatitis (acute pancreatitis). Discontinuation of Metizol may be necessary.
If very high doses of Metizol (approximately 120 mg per day) are required, the doctor will order regular blood tests, as bone marrow damage is possible. If toxic effects on the bone marrow occur, the doctor may decide to discontinue treatment and, if necessary, prescribe another medicine.
If the goitre enlarges during treatment with Metizol or if thyroid function becomes excessively reduced, the doctor may modify the dose of Metizol and, if needed, additionally prescribe thyroid hormones.
Metizol may harm the unborn child. If the patient could become pregnant, she should use a reliable method of contraception from the start of treatment and throughout therapy.
During treatment, the occurrence or worsening of a condition known as endocrine ophthalmopathy may occur; this is unrelated to treatment with Metizol.
Weight gain may occur during treatment with Metizol. This is a normal bodily response. Metizol affects thyroid hormones, which regulate energy expenditure in the body.

Children and adolescents
The safety and efficacy of Metizol have not been studied in children under 2 years of age.
Metizol may be used in children and adolescents aged 3 to 17 years (see section 3). For additional information, consult your doctor.

Metizol with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without a prescription.
The effect of thiamazole is reduced by:

• iodine;
• medicines containing iodine (e.g. amiodarone – a medicine used to treat heart rhythm disorders);
• radiographic contrast agents.

Thiamazole reduces the uptake of radioactive iodine by the thyroid gland.
If anticoagulant medicines (preventing blood clotting) are being used, inform the doctor, as normalization of thyroid function due to Metizol may affect the action of these medicines.
This may also apply to other medicines. As thyroid hormone levels return to normal due to treatment with Metizol, blood concentrations of certain concomitantly administered medicines may change. Therefore, dosage adjustment of concomitantly used medicines may be necessary.

Metizol with food and drink
Metizol may be taken independently of meals.

Pregnancy, breastfeeding, and fertility
Metizol may harm the unborn child.
If the patient could 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 is planning a pregnancy, she should consult her doctor immediately.
Continuation of Metizol treatment during pregnancy may be necessary if potential benefits outweigh risks to the mother and fetus. During pregnancy, Metizol and thyroid hormones must not be used concomitantly.
During breastfeeding, Metizol may be used only in low doses, up to 10 mg per day. However, thyroid hormones must not be taken simultaneously. The infant of a patient treated with Metizol who is breastfeeding should be regularly examined by a doctor who will monitor thyroid function in the infant.
Patients taking high doses of Metizol must not breastfeed.

Driving and operating machinery
Metizol has a minor influence on the ability to drive and operate machinery.
This medicine may cause dizziness (see section 4). Patients experiencing this adverse effect should not drive motor vehicles or operate machinery until the symptom has completely resolved.

Metizol contains monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Metizol

This medicine should always be taken as directed by the physician. In case of doubt, consult a doctor or pharmacist.

Recommended dosage
The physician determines the dosage individually for each patient depending on the severity of hyperthyroidism and goitre size.
The initial daily dose is usually 40 mg to 60 mg (8 to 12 tablets), administered in 3 or 4 divided doses. This dosage is maintained until thyroid function is suppressed (usually 2–3 weeks, although in some cases such dosing may need to be continued for up to 8 weeks or longer).
Subsequently, the dose should be gradually reduced to a maintenance dose, usually 5 mg to 20 mg (1 to 4 tablets) per day.
This dose may be taken as a single daily dose or divided into 2 doses.
In the treatment of thyroid storm, the medicine is initially administered at a dose of 100 mg (20 tablets), followed by 30 mg (6 tablets) every 8 hours.
Treatment of hyperthyroidism with Metizol usually lasts from 6 months to 2 years.
In preparation for thyroidectomy, the medicine is usually administered for 3–4 weeks preceding the procedure.

Elderly patients:
Dosage adjustment is not necessary.

Use in children and adolescents (aged 3 to 17 years)
In children and adolescents aged 3 years and older, the dose is adjusted according to body weight.
At the beginning of treatment, the usual dose is 0.5 mg/kg body weight, divided into 2 or 3 equal doses.
Later, the physician may recommend reducing the dose.
The total daily dose should not exceed 40 mg.
Use is not recommended in children under 2 years of age.

Patients with renal function impairment:
Dosage adjustment is not necessary.

Patients with hepatic function impairment:
If there are impairments in liver function or liver disease, inform the physician.
In such cases, a reduction in the dose of Metizol may be necessary.

Metizol should be taken regularly.

Use of a higher than recommended dose of Metizol
If a higher than recommended dose of Metizol is taken, consult a physician immediately. The physician will initiate appropriate management, including, among others, induction of vomiting, gastric lavage, administration of activated charcoal, and symptomatic treatment.
Symptoms of overdose may include, among others: nausea, vomiting, muscle pain, constipation, headache, menstrual disorders in women, decreased body temperature, enlargement or appearance of goitre (swelling in the front of the neck), excessive drowsiness or lethargy, fatigue, weight gain, excessive dryness of the skin, and insomnia.

Missed dose of Metizol
If a dose of Metizol is missed at the scheduled time, take it as soon as possible. However, if the next dose is due soon, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Discontinuation of Metizol
Premature discontinuation of treatment with Metizol may result in worsening of hyperthyroidism.
In case of any doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects may occur:
Very commonly (may occur in more than 1 in 10 people)
Commonly (may occur in up to 1 in 10 people)
Uncommonly (may occur in less than 1 in 100 people)
Rarely (may occur in up to 1 in 1000 people)
Very rarely (may occur in up to 1 in 10,000 people)
Frequency not known (frequency cannot be estimated from available data)
If any of the following adverse effects occur, stop taking the medicine and
contact your doctor immediately:

• Symptoms such as: inflammation of the oral mucosa, sore throat, fever, which may indicate an uncommon adverse effect – agranulocytosis (a marked decrease in the number of certain types of white blood cells). These symptoms may appear within the first weeks of treatment or only after several weeks or months of taking the medicine. Additionally, the following adverse effects may occur:

Very commonly occurring adverse effects:

• Allergic skin reactions of varying severity (itching, rash, urticaria) – usually mild and resolve during continued treatment.

Commonly occurring adverse effects:

• Joint pain, which may appear even after several months of treatment;

Uncommonly occurring adverse effects:

• Taste disturbances (altered sense of taste, loss of taste) – these symptoms may resolve after discontinuation of treatment, although this may take several weeks;
• Fever.

Rarely occurring adverse effects:

• Thrombocytopenia (reduced number of platelets; may manifest as excessive bleeding, e.g. after procedures, nosebleeds, frequent bruising, presence of blood in stool or urine, petechial rash);
• Pancytopenia (reduction in all blood cells);
• Generalized lymphadenopathy (enlarged lymph nodes), decreased blood glucose concentration (caused by disturbances in glucose regulation processes);
• Neuritis, polyneuropathy (nerve damage, may manifest as numbness and tingling in hands, feet, and face);
• Salivary gland swelling;
• Cholestatic jaundice (manifested by yellowing of the skin, mucous membranes, and whites of the eyes) and toxic hepatitis – these symptoms usually resolve after discontinuation of the medicine;
• Severe forms of skin allergic reactions, including generalized dermatitis;
• Hair loss;
• Drug-induced lupus erythematosus (an immunologically based disease; may manifest, among others, as fatigue, loss of appetite, and characteristic butterfly-shaped facial rash).

Frequency not known:

• Dizziness,
• Pancreatitis (acute inflammation of the pancreas).

Children and adolescents
The type, frequency, and severity of adverse effects in children and adolescents are similar to those observed in adults.
Reporting of adverse effects
If any adverse effects occur, including any 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 181 C, 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 gather more information on the safety of the medicine.

5. How to store Metizol
Keep in the original packaging.
The medicine should be stored 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.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Metizol contains

• The active substance is thiamazole.
• The other ingredients are: monohydrate lactose, potato starch, povidone, talc, magnesium stearate.

What Metizol looks like and contents of the pack
Metizol is a white, round, biconvex tablet, embossed with the mark "M" on one side and smooth on the other. The pack contains 50 tablets (2 blisters of 25 tablets each). For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
Mylan EOOD
Office building „Serdika Offices”
Sitnyakovo Blvd., No.48, fl. 7
1505 Sofia
Bulgaria

Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
Poland

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

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

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland

SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Poland

CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Bulgaria (country of export): 9900341
Parallel Import Authorisation Number: 315/22