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Package Leaflet for Emergency Supplies losat 65mg Tablets

Package Leaflet: Information For The User

Iosat 65mg Tablets

Active substance: Potassium iodide

Read all of this 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 instructed by a doctor or the competent authorities. ¹

What is in this leaflet:

1.    What Iosat tablets are and what they are used for

2.    What you need to know before you take Iosat

3.    How to take Iosat

4.    Possible side effects

5.    How to store Iosat

6.    Contents of the pack and other information

1. What Iosat Tablets Are and What They Are Used For

Iosat tablets contain the active substance potassium iodide. When nuclear accidents occur radioactive iodine may be released. Radioactive iodine is similar to the natural iodine found in food, and can be stored in your thyroid gland in the same way.

Iosat works by saturating your thyroid with iodine.

Your thyroid gland is therefore prevented from absorbing radioactive iodine.

Iosat is used to stop you absorbing radioactive iodine in nuclear accidents.

2. What You Need To Know Before You Take Iosat

Do NOT take Iosat:

•    if you have an over-active thyroid.

•    if you are allergic (hypersensitive) to iodine. This is very rare. Do not confuse it with the common allergy to what are called x-ray contrast media (medicines which enhance images of structures and functions in the body so that they can be seen more clearly, e.g. on x-rays).

•    if you are allergic (hypersensitive) to any of the other ingredients of Iosat (see Section 6).

•    if you suffer from a disease in which you develop blisters, reddening of the skin and eczema, mainly in the elbows or knees (Duhring's dermatitis herpetiformis).

•    if you know you have an allergy that causes inflammation of the blood vessel walls (hypocomplementaemic vasculitis).

Warnings and precautions

•    if you are over 45 years old, this medicine is not recommended for two reasons:

♦    you have a higher risk of side effects from Iosat as you get older.

♦    you are less likely to get thyroid cancer as you get older.

•    if you have anything wrong with your wind pipe (trachea), this medicine may make it worse.

•    if you have a benign nodule in your thyroid gland which is not being treated, taking this medicine may cause the thyroid to become over-active. If you know that you have an untreated nodule, you should not take Iosat.

•    if you are taking medicine to treat an over-active thyroid, your doctor may want to examine you more often.

•    if it is suspected that you have thyroid cancer you will not usually be given Iosat. Taking this medicine may make radiotherapy impossible. It may also make it hard to tell exactly what is wrong with your thyroid.

Other medicines and Iosat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Iosat and other medicines can affect each other such as:

Medicines which stop your thyroid gland taking up so much iodine (e.g. perchlorate, thiocyanate in concentrations over 5 mg/dl) may prevent Iosat from working effectively.

Medicines that reduce the activity of your thyroid gland may not work as well.

Iosat with food and drink

Food and drink have no effect on how Iosat works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Iosat is not expected to affect your ability to drive or use machines.

3. How to take losat

Always take Iosat exactly as described in this leaflet or as your doctor or the competent authorities have told you. Check with your doctor or pharmacist if you are not sure.

The tablets are most effective if they are taken shortly before or at the same time as you breathe in radioactive iodine. Do not start taking Iosat more than one day after you are exposed to radioactive iodine. Starting the tablets then is likely to be harmful.

How to take the tablets

Swallow tablets whole or dissolve them in a small amount of liquid such as water. Drinking plenty of additional fluid may stop your stomach being irritated.

How to give the medicine to children under 36 months

To obtain the correct dose for children aged under 36 months, dissolve the tablet in water as described below.

1.    Put one tablet into a small bowl and grind it into a fine powder using the back of a metal teaspoon against the inside of the bowl. The powder should not have any large pieces.

2.    Add 4 teaspoonfuls of water to the crushed powder and mix until the powder is dissolved in the water.

For children less than 1 month old, administer 1 teaspoonful.

For children from 1 to 36 months old, administer 2 teaspoonfuls.

In order to make it taste better for the child, you can add the dose to a small amount of flavoured drink and ensure that the child drinks the whole amount.

How long should you take Iosat tablets

You will usually take a single dose of Iosat. Sometimes an additional dose may be given. It is important that:

•    Newborn infants only have one dose.

•    Pregnant and breastfeeding women do not have more than two doses.

If you take more Iosat than you should

Taking very large quantities of iodide may result in skin irritation and stomach pains. The symptoms are similar to the side effects described in section 4. If you have severe problems, your doctor may need to pump your stomach.

4. Possible Side Effects

Like all medicines, Iosat can cause side effects, although not

everybody gets them.

The side effects may be:

Common: may affect up to 1 in 10 people

•    Irritation of the lining of your stomach may occur, especially if Iosat tablets are taken on an empty stomach.

Rare: may affect up to 1 in 1,000 people

•    Inflammation of the blood vessels (e.g. periarteritis nodosa).

•    Allergic reaction such as redness of the skin, itching and burning in the eyes, runny nose, irritant cough, diarrhoea, headaches and similar symptoms. Life-threatening reactions are possible, particularly if you already suffer from Duhring's dermatitis herpetiformis, a disease which causes blisters, reddened skin and eczema, mainly in the elbows or knees (see section 2, "Do not take Iosat").

Very rare: may affect up to 1 in 10,000 people

•    Iodine-induced over-active thyroid. Signs of an over-active thyroid may include problems such as a rapid pulse, sweats, difficulty in sleeping, shaking, diarrhoea and weight loss despite an increased appetite. If you experience problems like these, contact your doctor.

If any of the side effects gets serious, or if you notice any side

effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How To Store losat

Store in the original package in order to protect from light.

Store below 30°C.

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the blister strip and carton. 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 Iosat tablets contain

•    The active substance is potassium iodide. 1 tablet contains 65 mg potassium iodide.

•    The other ingredients are: microcrystalline cellulose, sodium thiosulfate, colloidal anhydrous silica and magnesium stearate.

What Iosat looks like and contents of the pack

The tablets are white, round tablets with IOSAT on one side and a cross-shaped scoreline on the other side.

Iosat is available in packs containing 20 tablets or 100 tablets.

(0) Agropharm¹ Ltd

Marketing Authorisation Holder

Agropharm Limited

IOSAT Division, Buckingham Place, Church Road, Penn,

High Wycombe, Bucks, HP10 8LN United Kingdom.

Manufacturer

Wasdell Packaging Limited

Unit 6, Euroway Industrial Estate, Blagrove, Swindon,

Wiltshire, SN5 8YW, United Kingdom.

This leaflet was last revised in July 2012.

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   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.