Package leaflet: Information for the user

Jodek potasu G.L. Pharma, 65 mg, tablets
Kalii iodidum
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any side effects occur, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Jodek potasu G.L. Pharma is and what it is used for
Important information before taking Jodek potasu G.L. Pharma
How to take Jodek potasu G.L. Pharma
Possible side effects
How to store Jodek potasu G.L. Pharma
Contents of the pack and other information

1. What Jodek potasu G.L. Pharma is and what it is used for
Jodek potasu is used in nuclear accidents or damage to nuclear reactors to prevent the thyroid gland from absorbing radioactive iodine.
During nuclear reactor damage, radioactive iodine may be released. In case of exposure, radioactive iodine is taken up 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, either before or after exposure occurs.

2. Important information before taking Jodek potasu G.L. Pharma

When not to take Jodek potasu G.L. Pharma

if you are allergic to potassium iodide or any of the other ingredients of this medicine (listed in section 6),
if you have autoimmune diseases associated with blisters and skin lesions (dermatitis herpetiformis),
if you have hyperthyroidism, characterized by excessive production of thyroid hormones,
if you have a blood vessel disorder (hypocomplementemic vasculitis),

Warnings and precautions
Before starting treatment with Jodek potasu G.L. Pharma, consult your doctor or pharmacist:

if you have or are suspected of having malignant thyroid tumour,
if you have airway obstruction (causing breathing difficulties). Administration of Jodek potasu G.L. Pharma may worsen this condition.
if you are currently or have previously been treated for thyroid disorders,
if you have untreated autonomous thyroid function,
if you have impaired kidney function,
if you have adrenal insufficiency or are receiving treatment related to it,
if you are dehydrated or have heat cramps,
if you are taking any of the medicines listed under the section "Other medicines and Jodek potasu G.L. Pharma".

Children
After administering Jodek potasu G.L. Pharma to a newborn, consult a doctor as soon as possible to monitor thyroid function.

Other medicines and Jodek potasu G.L. Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Please remember that this includes medicines taken recently.
Inform your doctor if you are taking:

medicines that suppress thyroid function; if used concomitantly with Jodek potasu G.L. Pharma, your condition must be closely monitored by a doctor,
captopril or enalapril; these medicines may increase potassium levels in the blood,
quinidine; the cardiac effect of quinidine may be enhanced by Jodek potasu G.L. Pharma,
potassium-sparing diuretics such as amiloride or triamterene; these medicines may increase potassium levels in the blood.

The use of Jodek potasu G.L. Pharma may affect therapy involving radioactive iodine and the results of thyroid function tests.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnant women should not take more than one dose, i.e. 2 tablets. If Jodek potasu G.L. Pharma is administered in late pregnancy, thyroid function in the newborn should be tested.
Breastfeeding women should not take more than one dose, i.e. 2 tablets.
Iodine is excreted in breast milk, but the amount is insufficient to fully protect the infant. Therefore, iodine tablets should also be given to the child (see section "How to take Jodek potasu G.L. Pharma").

Driving and operating machinery
Potassium iodide has no effect on the ability to drive or operate machinery.

Jodek potasu G.L. Pharma contains lactose.
This medicine contains lactose. If you have intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Jodek potasu G.L. Pharma

Tablets containing iodine should only be taken in the event of a nuclear disaster and after an official announcement by the competent authorities, e.g. via radio or television.
Do not make an independent decision to take this medicine.
This medicine should always be taken in accordance with the instructions provided in this leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
To ensure adequate protection, the medicine should be taken as soon as possible (ideally within 2 hours) after an announcement that radioactive iodine contamination has occurred.
However, taking the tablets within 8 hours after exposure to radioactive iodine is still beneficial.
The tablets may be chewed or swallowed whole. For breastfed infants, the tablets may be crushed and dispersed in water, syrup, or another liquid. Complete dissolution of the tablet may take up to 6 minutes. Ensure that the tablet is completely dissolved before administering 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 younger than 1 month: ¼ tablet
Pregnant women: 2 tablets.
This dose provides
protection also for the unborn child.
Breastfeeding women: 2 tablets

Newborns, pregnant and breastfeeding women, and adults over 60 years of age should not take more than one dose.

Jodek potasu G.L. Pharma is not recommended for individuals over 40 years of age, as it is less likely that this age group will benefit from iodine treatment following exposure to radioactive iodine. However, individuals exposed to high doses of radioactive iodine (e.g. emergency workers involved in rescue or cleanup operations) may still benefit from treatment.

A single intake of the above-specified doses provides protection against possible absorption of radioactive iodine.

If exposure to radioactive iodine is prolonged (>24 hours), repeated exposure occurs, contaminated food or water is consumed, or evacuation is not possible, repeated dosing may be necessary.

The tablet may be divided into four equal doses.

Taking more than the recommended dose of Jodek potasu G.L. Pharma
Taking more than the recommended dose of Jodek potasu G.L. Pharma does not increase protective effect.
If a patient takes too high a dose of Jodek potasu G.L. Pharma, iodine poisoning may occur, with severe adverse effects such as respiratory disorders and cardiac disturbances.
In case of accidental overdose of Jodek potasu G.L. Pharma, seek immediate medical advice from a doctor.

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not everyone experiences them.

Rare (may affect more than 1 in 1,000 patients):

Transient skin rash

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

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

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Jodek potasu G.L. Pharma

Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater 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 pack and other information

What Jodek potasu G.L. Pharma contains

The active substance is potassium iodide. One tablet contains 65 mg of potassium iodide, corresponding to 50 mg of iodine.
The other ingredients are: maize starch, monohydrate lactose, microcrystalline cellulose (E 460), basic butyl methacrylate copolymer, magnesium stearate (E 572).

What Jodek potasu G.L. Pharma looks like and contents of the pack
White to off-white, round, convex tablet with a cross-shaped break line on the inner side and notches on the outer side.
The pack contains a blister with 2, 4, 6, 10 or 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
For further information, contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Sienna 75 Street; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]
This medicinal product is registered in the European Union Member States under the
following names:
Netherlands: Kajodan 65 mg tabletten
Bulgaria: калиев йодид G.L. Pharma 65 mg таблетки
Cyprus: ιωδιούχο κάλιο G.L. Pharma 65 mg δισκία
Czech Republic: Jodid draselný G.L. Pharma 65 mg tablety
Estonia: Potassium iodide G.L. Pharma
Finland: Kaliumjodidi G.L. Pharma 65 mg tablettia
Ireland: Potassium iodide G.L. Pharma 65 mg tablets
Iceland: Kalíumjoðíði G.L. Pharma 65 mg töflur
Latvia: Potassium iodide G.L. Pharma 65 mg tabletes
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 comprimidos
Romania: Iodură de potasiu G.L. Pharma 65 mg comprimate
Sweden: Kaliumjodid G.L. Pharma 65 mg tabletter
Slovakia: Jodid draselný G.L. Pharma 65 mg tablet
Slovenia: Kalijev jodid G.L. Pharma 65 mg tablete
United Kingdom: Potassium iodide 65 mg tablets