Iodek potasu G.l. Pharma

Leaflet included in the packaging: information for the user

Potassium Iodide G.L. Pharma, 65 mg, tablets
Potassium Iodide
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Potassium Iodide G.L. Pharma and what is it used for
• 2. Important information before taking Potassium Iodide G.L. Pharma
• 3. How to take Potassium Iodide G.L. Pharma
• 4. Possible side effects
• 5. How to store Potassium Iodide G.L. Pharma
• 6. Contents of the packaging and other information

1. What is Potassium Iodide G.L. Pharma and what is it used for

Potassium iodide is used in the event of nuclear accidents or damage to nuclear reactors
to prevent the uptake of radioactive iodine by the thyroid gland.
During damage to nuclear reactors, radioactive iodine may be emitted. In the event of
contamination, radioactive iodine is absorbed by the thyroid gland. Taking non-radioactive iodine
(e.g. in the form of potassium iodide) prevents the uptake of radioactive iodine by the thyroid gland before or after
exposure.

2. Important information before taking Potassium Iodide G.L. Pharma

When not to take Potassium Iodide G.L. Pharma

• if the patient is allergic to potassium iodide or any of the other ingredients of this medicine (listed in section 6),
• if the patient has autoimmune diseases associated with skin lesions and blisters (Dühring's dermatitis herpetiformis),
• 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 Potassium Iodide G.L. Pharma, you should consult a doctor or
pharmacist:

• in the event of suspected or confirmed thyroid cancer,
• in the event of respiratory tract narrowing (causing breathing difficulties). Taking Potassium Iodide G.L. Pharma may worsen this condition,
• if the patient is being treated for thyroid diseases or has been treated in the past,
• if the patient has untreated thyroid autonomy,
• if the patient has kidney function disorders,
• in the event of adrenal function disorders and related treatment,
• if the patient is dehydrated or has heat-related cramps,
• when taking other medicines listed in the section "Other medicines and Potassium Iodide G.L. Pharma".

Children

In newborns a few weeks old, after taking Potassium Iodide G.L. Pharma, you should consult a doctor as soon as possible to check thyroid function.

Other medicines and Potassium Iodide G.L. Pharma

You should tell your doctor or pharmacist about all medicines you are currently taking or
have recently taken, as well as any medicines you plan to take.
You should remember that this information also applies to medicines taken recently.
You should inform your doctor if you are taking:

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

Taking Potassium Iodide G.L. Pharma may affect therapy with radioactive iodine and thyroid function tests.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, you should 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 G.L. Pharma 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 in breast milk, but the amount is not sufficient to fully protect the child. Therefore, iodine tablets should also be given to the child (see section "How to take Potassium Iodide G.L. Pharma").

Driving and using machines

Potassium iodide does not affect the ability to drive and use machines.

Potassium Iodide G.L. Pharma contains lactose.

This medicine contains lactose. If you have intolerance to some sugars, you should consult a doctor before taking this medicine.

3. How to take Potassium Iodide G.L. Pharma

Iodine-containing tablets should only be taken in the event of nuclear accidents and after
communication from the relevant authorities, e.g. via radio or television.

Do not take the medicine on your own initiative.

The medicine should be taken according to the instructions provided in this leaflet or according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
To ensure adequate protection, the medicine should be taken as soon as possible (preferably within 2 hours) after the announcement that radioactive iodine exposure has occurred.
However, taking the tablets within 8 hours of exposure to radioactive iodine is still beneficial.
The tablets can be chewed or swallowed whole. For breastfed children, the tablets can be crushed and mixed with water, syrup, or other liquid. Complete dissolution of the tablet may take up to 6 minutes. You should make sure that the tablet is completely dissolved before giving it to the child.
Recommended dosage:
Adults and children over 12 years:
2 tablets
Children from 3 to 12 years:
1 tablet
Children from 1 month to 3 years:
½ tablet
Newborns and infants under 1 month:
¼ tablet
Pregnant women:
2 tablets.
This is a dose that also provides protection for the child.
Breastfeeding women:
2 tablets
Newborns, pregnant women, and breastfeeding women, as well as adults over 60 years, should not take more than one dose.
Potassium Iodide G.L. Pharma is not recommended for people over 40 years, 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 cleaning actions) are likely to benefit from treatment.
Taking the above-mentioned doses once provides protection against possible radioactive iodine absorption.
If the exposure to radioactive iodine is prolonged (>24 hours) and repeated, and it is not possible to avoid contaminated food or water, or if evacuation is not possible, repeated administration may be necessary.
The tablet can be divided into four equal doses.

Taking a higher dose of Potassium Iodide G.L. Pharma than recommended

Taking a higher dose of Potassium Iodide G.L. Pharma than recommended does not increase the protective effect.
If you take too much Potassium Iodide G.L. Pharma, you may experience iodine poisoning with serious side effects, such as respiratory and heart problems.
If you take too much Potassium Iodide G.L. Pharma, you should contact 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 1000 people):

• Temporary skin rash

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

• Allergic reactions, such as swelling of the salivary glands, headache, wheezing, cough, or gastrointestinal disorders
• 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, goiter with or without myxedema (thickening of the skin and tissues, especially on the face)
• Depression, nervousness, impotence, insomnia (after repeated administration)
• Sialadenitis, gastrointestinal disorders

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
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 helps to gather more information on the safety of the medicine.

5. How to store Potassium Iodide G.L. Pharma

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
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 month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Potassium Iodide G.L. Pharma contains

• The active substance of the medicine is potassium iodide. One tablet contains 65 mg of potassium iodide, which corresponds to 50 mg of iodine.
• The other ingredients of the medicine are: cornstarch, lactose monohydrate, microcrystalline cellulose (E 460), butyl methacrylate copolymer, magnesium stearate (E 572).

What Potassium Iodide G.L. Pharma looks like and what the packaging contains

White to light brown, round, convex tablet with a cross-shaped break line on the inner side and notches on the outer side.
The packaging contains a blister pack with 2, 4, 6, 10, or 20 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
[email protected]

This medicinal product is registered in the Member States of the European Union under the following names:

Netherlands:
Kajodan 65 mg tablets
Bulgaria:
калиев йодид G.L. Pharma 65 mg tablets
Cyprus:
ιωδιούχο κάλιο G.L. Pharma 65 mg tablets
Czech Republic:
Jodid draselný G.L. Pharma 65 mg tablets
Estonia:
Potassium iodide G.L. Pharma
Finland:
Kaliumjodidi G.L. Pharma 65 mg tablets
Ireland:
Potassium iodide G.L. Pharma 65 mg tablets
Iceland:
Kalíumjoðíði G.L. Pharma 65 mg tablets
Latvia:
Potassium iodide G.L. Pharma 65 mg tablets
Lithuania:
Potassium iodide G.L. Pharma 65 mg tablets
Malta:
Potassium iodide G.L. Pharma 65 mg tablets
Poland:
Jodek potasu G.L. Pharma
Portugal:
Iodeto de potássio G.L. Pharma 65 mg tablets
Romania:
Iodură de potasiu G.L. Pharma 65 mg tablets
Sweden:
Kaliumjodid G.L. Pharma 65 mg tablets
Slovakia:
Jodid draselný G.L. Pharma 65 mg tablets
Slovenia:
Kalijev jodid G.L. Pharma 65 mg tablets
United Kingdom:
Potassium iodide 65 mg tablets
Date of last revision of the leaflet:09.11.2021