Iodek Potasu Tzf

Leaflet attached to the packaging: patient information

Potassium Iodide TZF, 65 mg, tablets

Potassium iodide
The Potassium Iodide TZF medicine should only be taken in the event of a risk of exposure to nuclear radiation.
Potassium Iodide TZF medicine contains potassium iodide, which, when taken in the correct dose, saturates the thyroid gland with iodine and, by blocking the uptake of radioactive iodine isotopes, prevents thyroid cancer.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Potassium Iodide TZF and what is it used for
• 2. Important information before taking Potassium Iodide TZF
• 3. How to take Potassium Iodide TZF
• 4. Possible side effects
• 5. How to store Potassium Iodide TZF
• 6. Package contents and other information

1. What is Potassium Iodide TZF and what is it used for

Potassium Iodide TZF is a medicine that blocks the function of the thyroid gland and prevents its damage due to the action of radioactive iodine isotopes.
Potassium Iodide TZF, when taken by a person exposed to radioactive iodine, prevents thyroid damage, as it saturates the thyroid gland with non-radioactive iodine, blocking the absorption of radioactive iodine from contaminated air, water, milk, and other sources.

2. Important information before taking Potassium Iodide TZF

When not to take Potassium Iodide TZF:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient has autoimmune diseases associated with itching and blisters on the skin (pemphigoid dermatitis, Duhring's disease),
• if the patient has hyperthyroidism, characterized by the production of too much thyroid hormone,
• if the patient has a blood vessel disorder (vasculitis with hypocomplementemia).

Warnings and precautions

Before starting to take Potassium Iodide TZF, consult a doctor or pharmacist:

• in case of suspected or confirmed thyroid cancer,
• in case of respiratory tract narrowing (causing breathing difficulties). Administration of Potassium Iodide TZF may worsen this condition,
• if the patient is being treated or has been treated in the past for thyroid diseases,
• if the patient is being treated or has been treated in the past for thyrotoxicosis (excess of thyroid hormones in the body),
• if the patient has kidney function disorders,
• in case of adrenal function disorders and related treatment,
• if the patient is dehydrated or has heat-induced cramps,
• in case of taking medicines listed in the section "Potassium Iodide TZF and other medicines".

Children

If Potassium Iodide TZF is given to a newborn, the doctor should be consulted as soon as possible to check the thyroid function.

Potassium Iodide TZF and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those taken without a prescription.
In particular, when taking Potassium Iodide TZF, it may not be possible to take the following medicines:

• medicines that inhibit thyroid function; when taken together with Potassium Iodide TZF, the patient's condition must be closely monitored by a doctor,
• certain medicines, such as captopril or enalapril; concurrent use may increase potassium levels in the blood,
• quinidine; the effect of quinidine on the heart may be increased by Potassium Iodide TZF,
• potassium-sparing diuretics such as amiloride or triamterene; concurrent use may lead to increased potassium levels in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Pregnant women should not take more than one dose, i.e., 2 tablets. If Potassium Iodide TZF is given in late pregnancy, it is recommended to check the thyroid function of the newborn.
Breastfeeding women should not take more than one dose, i.e., 2 tablets. Iodine is excreted into human milk, but its amount is not sufficient to fully protect the child. Therefore, iodine tablets should also be given to the child (see the section "How to take Potassium Iodide TZF").

Driving and using machines

Potassium Iodide TZF has no effect or negligible effect on the ability to drive and use machines.

3. How to take Potassium Iodide TZF

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If in doubt, consult a doctor or pharmacist.
Iodine tablets should only be taken in the event of nuclear disasters, after a message from the relevant authorities, e.g., via radio or television, and in the case of nuclear medicine tests.

Do not take the decision to take the medicine on your own.

To ensure adequate protection, Potassium Iodide TZF should be taken as soon as possible (preferably within 2 hours) after the announcement of radioactive iodine contamination.
However, taking the tablets within 8 hours of 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.
Potassium Iodide TZF is not recommended for people over 40 years of age, as it is less likely that this age group will benefit from iodine treatment after exposure to radioactive iodine. However, people exposed to high doses of radioactive iodine (e.g., rescue workers involved in rescue or security operations) are likely to benefit from treatment.
Usually, a single dose is sufficient.
If the action of radioactive iodine is prolonged (>24 hours) and re-exposure occurs, contaminated food or water is consumed, and evacuation is not possible, a second dose may be necessary.
Method of administration
The tablet can be divided into four equal doses.
The tablets can be swallowed whole, chewed, or dissolved in a tablespoon of water at room temperature. The resulting suspension (without changing color) should be taken immediately after preparation.
Wash down with a small amount of water.

Taking a higher dose of Potassium Iodide TZF than recommended

Taking higher doses of the medicine does not increase its protective effect.
If the patient takes too much Potassium Iodide TZF, iodine poisoning may occur with severe side effects, such as respiratory and heart disorders.
In case of taking too much Potassium Iodide TZF, consult a doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):

• Transient skin rash

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

• Hypersensitivity reactions, such as salivary gland swelling, headache, wheezing, or cough, gastrointestinal disorders of varying severity
• Iodine-induced autoimmune diseases (Graves' disease, Hashimoto's disease), nodular goiter, 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 myxedema (thickening of the skin and tissues, especially on the face)
• Depression, nervousness, impotence, insomnia (after repeated administration)
• Salivary gland inflammation, gastrointestinal disorders

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Potassium Iodide TZF

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

6. Package contents and other information

What Potassium Iodide TZF contains

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

What Potassium Iodide TZF looks like and what the package contains

The tablet is white to yellowish, slightly marbled, round, flat on both sides, with slightly beveled edges, with a cross-shaped notch on one side to facilitate breaking into two or four equal parts, with a diameter of 7 mm. The tablet can be divided into two or four equal doses.
Packagecontains a blister pack of 30 tablets.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information about this medicine, contact the marketing authorization holder.

Date of the last update of the leaflet: