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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Potassium Iodide 65 mg tablets

Potassium iodide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Potassium Iodide tablets are and what they are used for

2.    What you need to know before you take Potassium Iodide tablets

3.    How to take Potassium Iodide tablets

4.    Possible side effects

5.    How to store Potassium Iodide tablets

6.    Contents of the pack and other information

1. WHAT POTASSIUM IODIDE TABLETS ARE AND WHAT THEY ARE 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 TABLETS

Do not take Potassium Iodide tablets_

•    if you are allergic to potassium iodide or any of the other ingredients of this medicine (listed in section 6).

•    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).

•    if you have an autoimmune disease involving itching and blisters of your skin (dermatitis herpetiformis van Duhring).

Warnings and precautions

Talk to your doctor or pharmacist before using Potassium Iodide tablets 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 tablets 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 tablets”.

Babies until a few weeks of age should be taken to the doctor as soon as possible after being given Potassium Iodide tablets so that their thyroid function can be closely monitored.

Ask your doctor for advice if one of the above mentioned circumstances applies to you.

Other medicines and Potassium Iodide tablets

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 tablets 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 tablets.

•    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 tablets 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 may take a maximum of 2 doses (this is 2 tablets twice). If Potassium Iodide tablets is taken in late pregnancy, it is recommended to check the thyroid function of the newborn.

Breast-feeding women may take a maximum of 2 doses (this is 2 tablets twice).

Iodide is excreted into breast milk, but the amount is not enough for the complete protection of the baby. Therefore, Potassium iodide has to be given to the baby as well.

(See section 3, “How to take Potassium Iodide tablets”).

Driving and using machines

Potassium iodide has no influence on the ability to drive or use machines.

Potassium Iodide tablets contain 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 medicine.

3. HOW TO TAKE POTASSIUM IODIDE TABLETS

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 have 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 (within two hours) after the announcement that radioactive iodine has been released.

If the tablets are taken 4 to 6 hours after the exposure to radioactive iodine, protection is approximately 50%. The intake is useless 12 hours after the exposure, because the thyroid has already taken up 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: a half tablet Newborns and babies younger than 1 month: a quarter tablet

Pregnant women (all ages): 2 tablets. With this dose your unborn child is protected as well. Breast-feeding women (all ages): 2 tablets.

Pregnant and breast-feeding women should take two doses (this is 2 tablets twice) as a maximum. Newborns must not be given more than a single dose. Children developing skin reactions after the first intake must not receive further doses either.

The intake of iodine tablets is not recommended for persons above 40 years, because at this age there is no increased risk for thyroid cancer caused by exposure to radioactive iodine.

The single intake of the above mentioned doses protects against the possible uptake of radioactive iodine if inhaled when the radioactive cloud passes by.

If the release of radioactive iodine continues and thus also the exposure by inhalation, the above mentioned doses should be taken on a daily basis as long as the release of radioactive iodine continues.

If you take more Potassium Iodide tablets than you should

Taking more of Potassium Iodide tablets than described above does not increase the protective effect. If you have taken too much of Potassium Iodide tablets, iodine poisoning may occur with severe side effects such as respiratory and heart problems.

If you have taken too much of Potassium Iodide tablets, 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):

•    An overactive thyroid gland (characterised by weight loss, increased appetite, intolerance to heat and increased sweating).

•    An 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).

•    Hypersensitivity reactions such as swollen salivary glands, headache, wheezing or coughing, and stomach upset may occur.

If you get any side effect talk to your doctor or pharmacist. This includes any side effects not

listed in this leaflet.

5. HOW TO STORE POTASSIUM IODIDE TABLETS

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 waste water 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 tablets contain

•    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 tablets look 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.

The tablet can be divided into equal quarters.

Blister packs containing 2, 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 European Economic Area (EEA) under the following names:

Kajodan 65 mg tabletten KaniueB moama G.L. Pharma 65 mg TaSneTKiu iwbiouxo kOAio G.L. Pharma 65 mg diawa Jodid draselny G.L. Pharma 65 mg tablety Potassium iodide G.L. Pharma Kaliumjodidi G.L. Pharma 65 mg tablettia Potassium iodide G.L. Pharma 65 mg tablets Kaliumjodidi G.L. Pharma 65 mg toflur Potassium iodide G.L. Pharma 65 mg tabletes Potassium iodide G.L. Pharma 65 mg tablets Potassium iodide G.L. Pharma 65 mg tablets Jodek potasu G.L. Pharma

lodeto de potassio G.L. Pharma 65 mg comprimidos lodura de potasiu G.L. Pharma 65 mg comprimate Kaliumjodid G.L. Pharma 65 mg tabletter Jodid draselny G.L. Pharma 65 mg tablet Kalijev jodid G.L. Pharma 65 mg tablete Potassium iodide 65 mg tablets

This leaflet was last revised in May 2012 .