ThySat 65mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Potassium iodide

Available from:

hameln pharma Ltd

INN (International Name):

Potassium iodide

Dosage:

65mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06020200; GTIN: 5016386008214 5016386008221 5016386008238

Patient Information leaflet

N504376.01-UK
504376
SAP No
Artwork No
145X300 MM
COLOURS
APPROVED
LEAFLET THYSAT 65 MG TBL UK (HBM/GALVEX - USE)
Pharmacode
6071
WHITE PAPER, 50 G/M²
Quality
Prepared
Dimensions
Leaflets must comply with
PNOM-OD 9
Leaflets developed by HBM Pharma.
Folded leaflet size
145X150 MM / PHARMACODES OUTSIDE
REPLACES SAP NO. HBM - 56961, GALVEX - 58043
Checked
PACKAGE LEAFLET: INFORMATION FOR THE USER
ThySat
®
65 mg tablets
Potassium iodide
HAMELN
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 other information
1. What ThySat is and what it is used for
Potassium iodide is a thyroid blocking agent
used to prevent harm caused by radioactive
iodine.
When taken by someone exposed to radioactive
iodine, potassium iodide 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 to potassium
iodide or any of the other ingredients of this
medicine (listed in section 6).
If you are allergic to potassium iodide or any of
the ingredients listed in section 6 consult your
doctor.
Warnings and precautions
Talk to your doctor or pharmacist before
taking 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 you are being treated for
problems with your adrenal glands
-
are suffering from dehydration or cramp due
to extreme heat.
If you are uncertain about any of the above you
may want to ask your doctor or pharmacist for
advice before taking this medicine.
Other medicines and ThySat
Tell your doctor or pharmacist if you are taking,
ha

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
THYSAT 65 MG TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 65.00 mg potassium iodide equivalent to 50.00 mg
iodine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
The tablets are white to yellowish slightly marbled round tablets,
with a smooth surface without any
defects, cross-scored for ease of breaking.
The tablet can be divided into equal quarters.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Potassium iodide is indicated as a thyroid-blocking agent to prevent
the uptake of radioactive
iodine, for example after a nuclear accident or during a nuclear
medicine investigation before
administering a radioiodinated compound, which is metabolised to
iodide or which contains
radioiodine impurities.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_NUCLEAR ACCIDENT _
Iodine prophylaxis should be performed in case of a nuclear accident,
when radioactive iodine is
released, in all people involved including children and pregnant and
breastfeeding women located in
the endangered area. People with known iodine sensitivity or with a
history of active treatment of
thyroid disorders should consult their physician. When the nuclear
accident is announced the required
doses of potassium iodide are as follows:
Age group
Tablets
Iodine equivalent
Neonates up to 1 month of age
Quarter of a tablet
16 mg potassium iodide equivalent
to 12.5 mg iodine
Children
from
1
month
to
3
years of age
Half a tablet
32 mg potassium iodide equivalent
to 25 mg iodine
Children from 3 to 12 years of
age
1 tablet
65 mg potassium iodide equivalent
to 50 mg iodine
Children from 12 years of age,
adults and elderly
2 tablets
130 mg potassium iodide
equivalent to 100 mg iodine
A single daily dose should be administered. This will protect against
exposure lasting up to 24 hours
(see section 4.4).
Owing to the sensitivity of the neonate and foetus thyroid to large
doses of iodine, repeated
administration of stable iodine should be avoided for neonates and
pregnan