Jodek potassium tzf

Package leaflet: Information for the patient

Jodek Potasu TZF, 65 mg, tablets
Kalii iodidum
Jodek Potasu TZF should be taken only in the event of risk of exposure to nuclear radiation.
Jodek Potasu TZF contains potassium iodide, which, when taken at the proper dose, saturates the thyroid gland with iodine and, by blocking the uptake of radioactive iodine isotopes, prevents thyroid cancer.
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, please 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Jodek Potasu TZF is and what it is used for

Jodek Potasu TZF is a medicine that blocks thyroid function and prevents thyroid damage caused by radioactive iodine isotopes.
Jodek Potasu TZF, when taken by a person exposed to radioactive iodine, prevents thyroid damage by saturating the thyroid gland with non-radioactive iodine, thereby blocking the absorption of radioactive iodine from contaminated air, water, milk, and other sources.

2. Information before taking Jodek Potasu TZF

When not to take Jodek Potasu TZF:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has autoimmune skin disorders associated with itching and blistering (dermatitis herpetiformis, Duhring's disease),
• if the patient has hyperthyroidism, characterized by excessive production of thyroid hormones,
• if the patient has a blood vessel disorder (vasculitis with hypocomplementemia).

Warnings and precautions
Before starting to take Jodek Potasu TZF, consult a doctor or pharmacist:

• if there is a malignant tumor of the thyroid gland or suspicion thereof,
• if the patient has narrowing of the airways (causing breathing difficulties). Administration of Jodek Potasu TZF may worsen this condition,
• if the patient is currently undergoing or has previously received treatment for thyroid disorders,
• if the patient is being treated or has previously been treated for thyrotoxicosis (excess thyroid hormones in the body),
• if the patient has impaired kidney function,
• in case of adrenal dysfunction and related treatment,
• if the patient is dehydrated or has heat cramps,
• when taking any of the medicines listed in section "Jodek Potasu TZF and other medicines".

Children
If Jodek Potasu TZF is administered to a newborn infant a few weeks old, the infant should be taken to a doctor as quickly as possible to monitor thyroid function.

Jodek Potasu TZF and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription.
In particular, the following medicines may not be suitable for concomitant use with Jodek Potasu TZF:

• medicines that suppress thyroid function; if used together with Jodek Potasu TZF, the patient's condition must be closely monitored by a doctor,
• certain medicines such as captopril or enalapril; concomitant use may lead to increased potassium levels in the blood,
• quinidine; the cardiac effects of quinidine may be enhanced by Jodek Potasu TZF,
• potassium-sparing diuretics such as amiloride or triamterene; concomitant use may lead to increased potassium levels in the blood.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking this medicine.

Pregnant women should not take more than one dose, i.e. 2 tablets. If Jodek Potasu TZF is administered in the late stages of pregnancy, thyroid function in the newborn should be examined.
Breastfeeding women should not take more than one dose, i.e. 2 tablets. Iodine is excreted into human milk, but the amount is insufficient to fully protect the infant. Therefore, iodine tablets should also be administered to the infant (see section "How to take Jodek Potasu TZF").

Driving and operating machinery
Jodek Potasu TZF has no effect or has negligible effect on the ability to drive and operate machinery.

3. How to take Jodek Potasu TZF

This medicine should always be taken according to the instructions of your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Tablets containing iodine should only be taken in the event of nuclear accidents, following an official announcement
by the relevant authorities, for example via radio or television, or during nuclear medicine examinations.
Do not make an independent decision to take this medicine.
To ensure adequate protection, the medicine Jodek Potasu TZF should be taken as soon as possible
(preferably within 2 hours) after an announcement of radioactive iodine exposure.
However, taking the tablets within 8 hours after exposure to radioactive iodine is still beneficial.
Recommended dosage:

Newborns, pregnant and breastfeeding women, and adults over 60 years of age should not take more than one dose.
The medicinal product Jodek Potasu TZF is not recommended for individuals over 40 years of age, as this age group is less likely to benefit from iodine treatment following exposure to radioactive iodine. However, individuals exposed to high levels of radioactive iodine (e.g. emergency service workers involved in rescue or cleanup operations) are likely to benefit from treatment.
A single dose is usually sufficient.
If exposure to radioactive iodine is prolonged (>24 hours), repeated exposure occurs, contaminated food or water is ingested, and evacuation is not possible, repeated dosing may be necessary.
Method of administration
The tablet may be divided into four equal doses.
Tablets may be swallowed whole, chewed, or dispersed in one tablespoon of water at room temperature. The resulting suspension (without colour change) should be administered entirely immediately after preparation. Follow with a small amount of water.
Administration of a higher than recommended dose of Jodek Potasu TZF
Taking higher than recommended doses does not increase protective effect.
If a patient takes an excessive dose of Jodek Potasu TZF, iodine poisoning with severe adverse reactions such as respiratory disturbances and cardiac disorders may occur.
In case of overdose with Jodek Potasu TZF, medical advice should be sought immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rare (may affect less than 1 in 1,000 patients):

• Skin rash (transient)

Frequency unknown (frequency cannot be estimated from the available data):

• Hypersensitivity reactions such as salivary gland swelling, headache, wheezing or cough, gastrointestinal disturbances of varying severity
• Iodine-induced autoimmune diseases (Graves' disease, Hashimoto's disease), nodular goitre, and iodine-induced transient hyperthyroidism or hypothyroidism
• Hyperthyroidism (characterized by weight loss, increased appetite, heat intolerance and increased sweating), thyroiditis, thyroid enlargement with or without myxoedema (thickening of the skin and tissues, particularly on the face)
• Depression, nervousness, impotence, insomnia (after repeated administration)
• Sialadenitis, gastrointestinal disturbances

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 also 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Jodek Potasu TZF

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Jodek Potasu TZF contains

• The active substance is potassium iodide. One tablet contains 65 mg of potassium iodide, corresponding to 50 mg of iodine.
• The other components are: microcrystalline cellulose type 102, colloidal anhydrous silica, magnesium stearate.

What Jodek Potasu TZF looks like and contents of the pack
The tablet is white to slightly yellowish, slightly mottled, round, flat on both sides, with bevelled edges and a cross-score on one side, facilitating breakage into two or four equal parts, with a diameter of 7 mm. The tablet can be divided into two or four equal doses.
Packaging contains a blister with 30 tablets.
Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: 22 811-18-14
For further information on this medicinal product, please contact the Marketing Authorisation Holder.