POTASSIUM IODATE 85 MG TABLETS

Active substance: POTASSIUM IODATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Potassium Iodate 85mg Tablets
Potassium iodate
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 doctor or 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.
- You must talk to a doctor if you do not feel better or if you feel worse.
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

GEN/POT/PIL/220_06
30/08/2013

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:

½ tablet

25mg

Newborn Babies
aged up to
1 month:

¼ tablet

(or 12.5mg iodine
equivalent as standard
solution)

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

- 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.
5. How to store Potassium Iodate

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 ¼ 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.

Keep this medicine 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.

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.

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.

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.

6. Contents of the pack and other information

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.
P
PL 06831/0275

Potassium Iodate 85mg Tablets

Marketing Authorisation Holder and Manufacturer
MA holder:
Genus Pharmaceuticals, Park View House, 65 London Road,
Newbury, Berkshire RG14 1JN, UK.
Manufacturer:
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel,
Germany.
This leaflet was last revised in September 2013.

4. Possible side-effects
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:

*Trademark

xxxxxxx xxxx

GEN/POT/PIL/220_06
30/08/2013

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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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