Patient leaflet - Potassium Iodide 65 mg tablets
1. What Potassium Iodide is and what it is used for
Potassium iodide is used in cases of nuclear accidents or nuclear reactor accidents to prevent the uptake of radioactive iodine by the thyroid.
In the event of nuclear reactor accidents, there may be an emission of radioactive iodine. In case of contamination, the radioactive iodine is taken up by the thyroid. The uptake of radioactive iodine by the thyroid is prevented by the intake of non-radioactive iodine (e.g. in the form of potassium iodide) before or during the contamination.
2. What you need to know before you take Potassium Iodide
Do not take Potassium Iodide
if you are allergic to potassium iodide
or any of the other ingredients of this medicine (listed in section 6).
if you have an autoimmune disease
involving itching and blisters of your skin (dermatitis herpetiformis van Dühring).
if you have an overactive thyroid
producing too much of thyroid hormones (hyperthyreosis).
if you have a certain disorder
of your blood vessel walls
(hypocomplementaemic vasculitis).
Warnings and precautions
Talk to your doctor or pharmacist before using Potassium Iodide if you:
have a malign tumor in your thyroid or if
your doctor assumes that you have one.
have a narrowing of your wind-pipe
(causing respiratory problems). The use of Potassium Iodide may worsen this condition.
are being treated or were treated in the
past for a thyroid problem.
have a specific problem with your thyroid
called thyroid autonomy and are not being treated for it.
- have problems with your kidneys.
have problems or are being treated for
problems with your adrenal glands.
are suffering from dehydration or cramp
due to extreme heat.
are taking any of the medicines listed in
section “Other medicines and Potassium Iodide”.
Children
Babies until a few weeks of age should be taken to the doctor as soon as possible after being given Potassium Iodide so that their thyroid function can be closely monitored.
Other medicines and Potassium Iodide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Please remember that this information can also be applicable to medicines which you have taken/used recently.
Tell your doctor if you are taking:
medicines inhibiting the thyroid
function; when taken concomitantly with Potassium Iodide you should be closely monitored by a doctor.
captopril or enalapril; these medicines
may cause an increased potassium level in your blood.
- quinidine; the effect of quinidine on the heart is increased by Potassium Iodide.
- potassium-sparing diuretics (“water tablets”) such as amiloride or triamterene; those medicines may cause an increased potassium level in your blood.
The use of Potassium Iodide may influence radioiodine therapy and the results of thyroid tests.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant women should not take more than one dose of 2 tablets. If Potassium Iodide is taken in late pregnancy, it is recommended to check the thyroid function of the newborn.
Breast-feeding women should not take more than one dose of 2 tablets.
Iodide is excreted into breast milk, but the amount is not enough for the complete protection of the baby. Therefore, iodide tablets have to be given to the baby as well. (See section 3, “How to take Potassium Iodide”).
Driving and using machines
Potassium iodide has no influence on the ability to drive or use machines.
Potassium Iodide contains lactose
This medicine contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Potassium Iodide
Iodine tablets may only be taken in cases of nuclear accidents and if announced by the respective authority, e.g. via radio or television.
Do not take the tablets on your own account.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For best possible protection it is necessary to take the tablets as soon as possible (preferably within two hours) after the announcement that radioactive iodine has been released.
However, it is still useful to take the tablets up to 8 hours after the exposure to radioactive iodine.
The tablets can be chewed or swallowed whole. For sucklings, the tablets can be pulverized or dispersed in water, syrup or similar liquids. It may take up to 6 minutes until the tablets are fully dispersed. Make sure that the tablets are fully dispersed before you give them to your child.
The recommended dose is:
Adults and children 12 years or older: 2 tablets
Children aged 3 to 12 years:
1 tablet
Children aged 1 month to 3 years: ½ tablet
Newborns and babies younger than 1 month:
¼ tablet
Pregnant women (all ages):
2 tablets
With this dose your unborn child is protected as well.
Breast-feeding women (all ages): 2 tablets
Newborns, pregnant and breast-feeding women and adults older than 60 years of should not take more than one single dose.
Potassium Iodide is not recommended for persons above 40 years, because they are less likely to benefit from treatment with iodine tablets after exposure to radioactive iodine. However, individuals at risk of exposure to high doses of radioactive iodine (e.g. emergency workers involved in rescue or clean-up operations) are likely to benefit from iodine thyroid blocking treatment. Package leaflet: Information for the user
Potassium Iodide 65 mg tablets
07.2022/1098/SK GI40000GB, Potassium Iodide 65 mg Tab.
07.2022/1098/SK GI40000GB, Potassium Iodide 65 mg Tab. The single intake of the above mentioned doses protects against the possible uptake of radioactive iodine.
If the release of radioactive iodine continues (over 24 hours), with repeated exposure, intake of contaminated food or drinking water and if evacuation is not possible, a repeated administration may be necessary.
The tablet can be divided into equal doses.
If you take more Potassium Iodide than you should
Taking more of Potassium Iodide than described above does not increase the protective effect. If you have taken too much of Potassium Iodide, iodine poisoning may occur with severe side effects such as respiratory and heart problems.
If you have taken too much of Potassium Iodide, contact your 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):
- Temporary skin rash
Not known (frequency cannot be estimated from the available data):
Hypersensitivity reactions such as
swollen salivary glands, headache, wheezing or coughing, and stomach upset
Iodine-induced autoimmune disorders
(Grave’s disease, Hashimoto’s disease), harmful nodular goitre and iodine-induced temporary thyroid hyperfunction or hypofunction
Overactive thyroid gland (characterised
by weight loss, increased appetite, intolerance to heat and increased sweating), inflammation of the thyroid, enlarged thyroid gland with or without the development of myxoedema (a condition in which there is a thickening of the skin and body tissues, most notably the face)
Depression, nervousness, impotence,
and sleeplessness (after continued administration)
Sialadenitis (an inflammation of the saliva
gland), gastrointestinal disturbances
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Potassium Iodide
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Potassium Iodide contains
The active substance is potassium
iodide. 1 tablet contains
65 mg potassium iodide, equivalent to 50 mg iodine.
The other ingredients are maize starch,
lactose monohydrate, microcrystalline cellulose (E 460), basic butyl methacrylate copolymer, magnesium stearate (E 572).
What Potassium Iodide looks like and contents of the pack
The tablets are white to white-brown in colour, round, curved and have a cross-shaped pressure-sensitive break line on the inner side and notches on the outer side.
Blister packs containing 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
This medicinal product is authorised in the Member States of the EEA under the following names:
The 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
Slovak Republic: Jodid draselný
G.L. Pharma 65 mg tablety
Slovenia: Kalijev jodid
G.L. Pharma 65 mg tablete
United Kingdom: Potassium iodide 65 mg
tablets
This leaflet was last revised in 09/2021.
Präparatenamen/Stärke:
Potassium Iodide 65 mg Darreichungsform:
Tabletten
Abpackungsart:
Blister
Art.-Nr.: GI40000GB
Code-Nr.: 07.2022/1098/SK
Land: Großbritannien / uk
Format: 148 x 420 mm
Packmittelart: Gebrauchsinformation
Produktion: intern
Schrift: Helvetica 9,0 – 22,0 Punkt
Druckfarbe: ♦Schwarz
Version: 3
Datum: 04.12.2022
Uhrzeit: 12:36:05
GEROT •• LANNACH
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