PACKAGE LEAFLET: INFORMATION FOR THE USER ThySat® 65 mg tablets
ThySat should only be taken when there is a risk of exposure to nuclear STOP 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 What is in this leaflet:
may want to ask your doctor or pharmacist for
1. What ThySat is and what it is used for 2. What you need to know before you take 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
Contents of the pack and further information
in endangered area. If you are pregnant or
1. What ThySat is and what it is used for
breastfeeding, this medicine can be taken over
ThySat is a thyroid blocking agent used to a short period of time. You should continue to prevent contamination with radioactive iodine.
breast feed if you are taking this medicine.
When taken by someone exposed to radioactive
Driving and using machines
iodine, ThySat may prevent damage to the ThySat has little or no influence on the ability to
thyroid gland by saturating it with non-radioactive
iodine blocking the uptake of radioactive iodine from contaminated air, water, milk and other
3. How to take ThySat
The standard dose of ThySat is listed in the
2. What you need to know before you table below. You should check with your doctor take ThySat
or pharmacist if you are not sure about the dose you require. Do not take ThySat if you: Quantity of
- are, or think you may be, allergic (sensitive)
potassium
to potassium iodide or any other ingredients
listed in section 6 of this leaflet. Neonates
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: Children
- are being treated for a thyroid problem
- suffer from dermatitis herpetiformis (a skin
Children
- suffer from hypocomplementaemic vasculitis
(a disease causing inflammation of the blood
Adults and
- have problems or are you are being treated for
children from 2 tablets
- are suffering from dehydration or cramp due
The tablets should be taken as a single dose or
- are taking quinidine, captopril or enalapril
as soon as you are advised to do so. Delay may
- are currently taking a diuretic (“water tablets”)
For children the dose may be crushed and mixed
If you are uncertain about any of the above you
with milk, water or juice before administration.
In case of prolonged exposure, repeat dosing
5. How to store ThySat
may be necessary although if you are pregnant
or breastfeeding you should normally not take
Keep the blister in the outer carton in order to
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
Keep out of the reach and sight of children.
establish and correct this. Babies up to a month
Do not use ThySat after the expiry date which is
old should only receive one dose and should
stated on the label. The expiry date refers to the
have their thyroid function assessed by their
Do not throw away any medicines. Ask your
After taking ThySat babies under the age of 3
pharmacist how to throw away medicines you no
months should be taken to see their doctor as
soon as possible so that their thyroid function
6. Contents of the pack and further information
Women in the last 3 months of pregnancy should inform their doctor and other healthcare
What ThySat contains:
professionals that they have taken ThySat, as a
- The active substance is 65 mg potassium
blood sample from the umbilical cord should be
iodide which is equivalent to 50 mg of iodine
taken to measure the baby’s thyroid function.
- The other ingredients are microcrystalline
If you take more ThySat than you should
cellulose, talc, macrogol 6000, colloidal anhydrous silica.
Taking higher doses of ThySat does not increase the protective effect. If you (or someone else)
What ThySat looks like and contents of the
swallow lots of the tablets all together, or if you
think a child has accidentally swallowed any
The tablets are white to yellowish slightly
of the tablets, contact your nearest hospital marbled round tablets with a smooth surface
casualty department or a doctor immediately.
without any defects, cross-scored for ease of breaking. 4. Possible side effects
ThySat is taken by the majority of patients Not all pack sizes may be marketed.
without any problems. However, like many other medicines, it may occasionally cause side
Marketing Authorisation Holder
effects in some people. These may include:
- an overactive thyroid gland (characterised by
weight loss, increased appetite, intolerance to
- an enlarged thyroid gland with or without the
Manufacturer
development of myxoedema (a condition in
which there is a thickening of the skin and
- occasionally hypersensitive reactions such
as a rash, swollen salivary glands, headache,
This leaflet was last revised in March 2013
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.
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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