Informations for option: Thysat 65 Mg Tablets, show other option

Select option:

1. Thysat 65 Mg Tablets
2. Thysat 65 Mg Tablets

<§>

PACKAGE LEAFLET: INFORMATION FOR THE USER _w 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.

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

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.

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.

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.

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.

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.

Horna 36

900 01 Modra, SR

This leaflet was last revised in March 2013

56961/29/13

56407_29_13_PL_ThySat_65mg.indd 2 22/07/2013 10:13:07