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PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Iodate 85mg Tablets

Potassium iodate

What is in this leaflet:

1.    What Potassium Iodate is and what it is used for

2.    What you need to know before you take Potassium Iodate

3.    How to take Potassium Iodate

4.    Possible side-effects

5.    How to store Potassium Iodate

6.    Contents of the pack and other information

1. What Potassium Iodate is and what it is used for

This product contains the active substance potassium iodate.

It is a thyroid blocking agent and is used for example after a nuclear accident.

Potassium Iodate tablets are used during a nuclear emergency, when harmful radioactive iodine has been released into the environment. The tablets saturate your thyroid gland (situated in your neck) with iodine, which means that when you breathe in harmful radioactive iodine no more can be absorbed by your thyroid.

Radioactive iodine is especially dangerous to babies and children as they are at a higher risk of developing thyroid disease and/or cancer from breathing it in.

Ask your doctor, pharmacist or emergency co-ordinator if you need additional information especially with regards to the correct use of this product.

2. What you need to know before you take Potassium Iodate

Do not take Potassium Iodate if you:

-    are allergic to the active substance potassium iodate or any of the other ingredients of this medicine (listed in section 6)

-    suffer from kidney failure

-    suffer from a disease of inflamed blood vessels caused by an allergic reaction (hypo-complementaemic vasculitis)

-    suffer from a blistering skin condition called dermatitis herpetiformis.

Warnings and precautions

Talk to your doctor or pharmacist before taking Potassium Iodate if you answer at least one of the following questions with YES:

•    Have you ever been treated for a condition resulting from an overactive thyroid gland (thyrotoxicosis)?

•    Do you have problems with your kidneys?

Do you have, or are you being treated for problems with your adrenal glands?

Are you suffering from dehydration or cramp due to extreme heat?

If the answer to any of these questions is YES, do not take Potassium Iodate before talking to a doctor or pharmacist. Bear in mind that if you are allergic to any iodine product, then you will also be allergic to radioactive iodine.This means you have an additional risk that should be discussed with your doctor.

Children and adolescents

Potassium Iodate is of greatest benefit to young people, as the thyroid cancer risks associated with absorbing radioactive iodine are much higher in this age group.

Newborns are at risk of developing short term hypothyroidism as their thyroids can absorb relatively more radioactive iodine, and they can also overdose on potassium iodate. This can result in a loss of intellectual capacity. Consequently, their thyroid function should be closely monitored and appropriate replacement therapy administered if necessary.

Other medicines and Potassium Iodate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, do not take and check with your doctor first if you are taking any of the following:

-    certain medicines for treating heart rhythm disturbance, high blood pressure or heart failure (e.g. quinidine, captopril or enalapril)

-    water tablets (diuretics) such as amiloride, triamterene or aldosterone antagonists.

Pregnancy, breast-feeding and fertility

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.

If you are pregnant or breast-feeding low doses over a short period of time can be taken.

If this medicine is administered late in the pregnancy, the thyroid function of the new-born will be monitored.

Pregnant women with active hyperthyroidism must not take potassium iodate.

You can continue to breast-feed if you are taking this medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

3. How to take Potassium Iodate

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.

This medicine should be taken after a nuclear accident. Emergency co-ordinators will advise you on the correct actions to take.

The tablets should be taken as a single dose as soon as you are advised to do so, and usually within three hours of a nuclear accident; delay may reduce their effectiveness.

Please read the back of this leaflet.

*Trademark    GENUS PHARMACEUTICALS

M875

GEN/POT/PIL/275_04

Dose

The usual recommended dose is as follows:

		Iodine Equivalent
Adults (including the elderly) and adolescents:	2 tablets	100mg
Children aged 3-12 years:	1 tablet	50mg
Children aged 1 month - 3 years:	/ tablet	25mg
Newborn Babies aged up to 1 month:	% tablet	(or 12.5mg iodine equivalent as standard solution)

The score lines are there to help you break the tablet into equal doses.

Method of Administration

Children - the dose may be crushed and taken mixed with e.g. jam, honey or yoghurt.

Babies - the dose may be crushed and taken mixed with milk or juice.

Newborn babies at home - a dosage of % tablet is acceptable. This can be crushed and mixed with milk or water.

Newborn babies still in hospital - an exact dosage of 12.5mg iodine equivalent can be prepared from the potassium iodide crystals commonly kept in maternity wards.

Duration of usage

Usually you will only take the tablets once, but in cases of prolonged exposure, more than one dose may be needed.

If you are pregnant or breast-feeding your doctor will check if repeat dosing is necessary. The number of doses should be kept to a minimum.

Babies up to a month old should only receive one dose and should have their thyroid function assessed by their doctor.

After taking Potassium Iodate

If you are pregnant or breast-feeding you must get additional medical advice since this medicine may affect the thyroid of your child and tests from your doctor can establish and correct this. Women in the last 3 months of their pregnancy should inform their doctor and other healthcare professionals that they have taken Potassium Iodate, as a blood sample from the umbilical cord should be taken to measure the baby's thyroid function.

After taking Potassium Iodate, babies under the age of 3 months should be taken to see their doctor as soon as possible so the function of their thyroid can be closely monitored.

If you take more Potassium Iodate than you should

If you (or someone else) swallow a lot of the tablets in one go, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or a doctor immediately. Take the medicine pack with you if you can.

Symptoms of overdose may include the following: headache, pain and swelling of the salivary glands, fever, inflammation of the voice box with difficulty swallowing and hoarseness, swelling or inflammation of the throat, stomach pain, diarrhoea, excessive sweating, coughing, coughing up blood, difficulty breathing, shortness of breath and feeling of suffocation.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

-    Hypersensitive reactions such as a rash, swollen salivary glands, headache, wheezing or coughing, and stomach upsets.

-    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 notable on the face).

-    Continued use may lead to depression, nervousness, insomnia or impotence.

If you have these or any other effects whilst taking Potassium Iodate tell a doctor immediately.

In the event of a nuclear emergency, there are other protective actions you can take against radiation damage. Emergency assistance should be sought in order to avoid further dangerous contamination.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Iodate

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the outside packaging. The expiry date refers to the last day of that month. Store in the original package.

Do not transfer them to another container. 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 Iodate contains

The active substance is potassium iodate. Each tablet contains 85mg of potassium iodate which is equivalent to 50mg of iodine. The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.

What Potassium Iodate looks like and contents of the pack:

Potassium Iodate are white to off white round, biplanar tablets with a cross scored breakline.

The product is available in pack sizes of 10 and 100 tablets.

Not all pack sizes may be marketed.

PL 06831/0275 Potassium Iodate 85mg Tablets Marketing Authorisation Holder and Manufacturer MA holder:

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK Manufacturer:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany.

This leaflet was last revised in November 2014.

Potassium Iodate is taken by the majority of patients without any problems. However, like many other medicines, it may occasionally cause side-effects in some people.

The frequency of likelihood cannot be estimated from the available data, but these side-effects may include:

GEN/POT/PIL/275_04

Product Title	Potassium lodate 85mg Tablets	Colours used		Fonts used
Component	Leaflet		Black	Helvetica Narrow
Pack Size	10's/100's			Optima
CMU No	M875
Dimensions	180 x270mm
Proof No.	04 Date 05/11/2014