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THYSAT 65 MG TABLETS

Active substance(s): POTASSIUM IODIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

hameln

ThySat® 65 mg tablets
Potassium iodide

STOP

!

ThySat should only be taken when there is a risk of exposure to nuclear
radiation. ThySat contains potassium iodide which, when taken at the correct
dosage, saturates your thyroid gland with iodine and blocks it from absorbing
radioactive iodine helping to prevent thyroid cancer.

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 ThySat is and what it is used for
2. What you need to know before you take
ThySat
3. How to take ThySat
4. Possible side effects
5. How to store ThySat
6. Contents of the pack and further information

1. What ThySat is and what it is used for
ThySat is a thyroid blocking agent used to
prevent contamination with radioactive iodine.
When taken by someone exposed to radioactive
iodine, ThySat may prevent damage to the
thyroid gland by saturating it with non-radioactive
iodine blocking the uptake of radioactive iodine
from contaminated air, water, milk and other
sources.

2. What you need to know before you
take ThySat
Do not take ThySat if you:
- are, or think you may be, allergic (sensitive)
to potassium iodide or any other ingredients
listed in section 6 of this leaflet.
If you are allergic to ThySat or any of the
ingredients listed in section 6 consult your doctor.
Take special care with ThySat if you:
- are being treated for a thyroid problem
- suffer from dermatitis herpetiformis (a skin
disease)
- suffer from hypocomplementaemic vasculitis
(a disease causing inflammation of the blood
vessels)
- have problems with your kidneys
- have problems or are you are being treated for
problems with your adrenal glands
- are suffering from dehydration or cramp due
to extreme heat
- are taking quinidine, captopril or enalapril
- are currently taking a diuretic (“water tablets”)
such as amiloride or triamterene.
If you are uncertain about any of the above you

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may want to ask your doctor or pharmacist for
advice before taking this medicine.
Pregnancy and breast-feeding
Iodine prophylaxis should be undertaken in case
of a nuclear accident or when radioactive iodine
is released, in all people involved including
pregnant and breastfeeding women located
in endangered area. If you are pregnant or
breastfeeding, this medicine can be taken over
a short period of time. You should continue to
breast feed if you are taking this medicine.
Driving and using machines
ThySat has little or no influence on the ability to
drive and use machines.

3. How to take ThySat
The standard dose of ThySat is listed in the
table below. You should check with your doctor
or pharmacist if you are not sure about the dose
you require.
Age
Neonates
Babies up to 1
month
Children
from 1 month
to 3 years
Children
from 3 to 12
years
Adults and
children from
12 years

Dose

Quantity of
potassium
iodide

Quarter of a
tablet

16 mg

Half a tablet

32 mg

1 tablet

65 mg

2 tablets

130 mg

The tablets should be taken as a single dose or
as soon as you are advised to do so. Delay may
result in reduced effectiveness.
For children the dose may be crushed and mixed
with milk, water or juice before administration.

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In case of prolonged exposure, repeat dosing
may be necessary although if you are pregnant
or breastfeeding you should normally not take
more than two doses. You must also get medical
advice since ThySat may affect the thyroid
of your child and tests from your doctor can
establish and correct this. Babies up to a month
old should only receive one dose and should
have their thyroid function assessed by their
doctor.
After taking ThySat babies under the age of 3
months should be taken to see their doctor as
soon as possible so that their thyroid function
can be closely monitored.
Women in the last 3 months of pregnancy
should inform their doctor and other healthcare
professionals that they have taken ThySat, as a
blood sample from the umbilical cord should be
taken to measure the baby’s thyroid function.
If you take more ThySat than you should
Taking higher doses of ThySat does not increase
the protective effect. If you (or someone else)
swallow lots of the tablets all together, or if you
think a child has accidentally swallowed any
of the tablets, contact your nearest hospital
casualty department or a doctor immediately.

4. Possible side effects
ThySat is taken by the majority of patients
without any problems. However, like many
other medicines, it may occasionally cause side
effects in some people. These may include:
- 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)
- occasionally hypersensitive reactions such
as a rash, swollen salivary glands, headache,
wheezing or coughing, and stomach upset
may occur.
If you have these or any other effects, whilst
taking ThySat tell your doctor or pharmacist
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.
Continued use may lead to depression,
nervousness, insomnia or impotence.

5. How to store ThySat
Do not store above 25°C.
Keep the blister in the outer carton in order to
protect from light and moisture.
Keep out of the reach and sight of children.
Do not use ThySat after the expiry date which is
stated on the label. The expiry date refers to the
last day of the month.
Do not throw away any medicines. Ask your
pharmacist how to throw away medicines you no
longer use.

6. Contents of the pack and further
information
What ThySat contains:
- The active substance is 65 mg potassium
iodide which is equivalent to 50 mg of iodine
- The other ingredients are microcrystalline
cellulose, talc, macrogol 6000, colloidal
anhydrous silica.
What ThySat looks like and contents of the
pack
The tablets are white to yellowish slightly
marbled round tablets with a smooth surface
without any defects, cross-scored for ease of
breaking.
4, 10 and 100 tablets in one pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder
hameln pharmaceuticals ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG, UK
Manufacturer
hameln rds a.s.
Horná 36
900 01 Modra, SR
This leaflet was last revised in March 2013
56961/29/13

Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at www.
mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.

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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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