POTASSIUM IODIDE 65MG TABLETS

Active substance: POTASSIUM IODIDE

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Package Leaflet for
Emergency Supplies
Iosat 65mg Tablets

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

This medicine should be taken if there is a radiation
accident involving the release of radioactive iodine.
Only take this medicine if a doctor tells you to.
Iosat tablets stop the thyroid gland from absorbing
radioactive iodine.

Do




not take this medicine if you have:
an over-active thyroid
a known allergy to iodine or to any of the other ingredients
a skin condition that causes blisters known as Duhring’s
disease (dermatitis herpetiformis)
• an itchy skin rash known as hypocomplementaemic vasculitis

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.

• 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.

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 Iosat
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 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.

The usual dose is:

Please follow the directions for use exactly, or Iosat may not
work properly.

4. Possible Side Effects

Age

Dose

Newborn (less than
1 month)

¼ tablet (equivalent to 12.5 mg iodine)

Like all medicines, Iosat can cause side effects, although not
everybody gets them.

1 month to under
36 months

½ tablet (equivalent to 25 mg iodine)

The side effects may be:

3 to under 13 years

1 tablet (equivalent to 50 mg iodine)

13 to 45 years

2 tablets (equivalent to 100 mg iodine)

Over 45 years

Not recommended

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.

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

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

• llergic reaction such as redness of the skin, itching and
A
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

• odine-induced over-active thyroid. Signs of an over-active
I
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 Iosat
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.

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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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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