Potassium iodate 85mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Potassium iodate

Available from:

Alliance Pharmaceuticals Ltd

INN (International Name):

Potassium iodate

Dosage:

85mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06020200; GTIN: 5024403001131 5024403001124

Patient Information leaflet

Artwork Information
Product Title:
Potassium Iodate 85mg Tablets
Date:
13.05.2013
Product Size:
Finished size: 148mm x 210mm
Label Number:
13-182
Colours Used:
Black
Fonts Used:
Bosis
Font size: (min/max)
7.5pt / 24pt
Artwork by:
PATIENT INFORMATION LEAFLET
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. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Potassium Iodate 85mg Tablets are and what they are used for
2. What you need to know before you take Potassium Iodate 85mg Tablets
3. How to take Potassium Iodate 85mg Tablets
4.
Possible side effects
5.
How to store Potassium Iodate 85mg Tablets
6.
Contents of the pack and other information
1. WHAT POTASSIUM IODATE 85MG TABLETS ARE AND WHAT THEY ARE USED FOR
Potassium Iodate is a thyroid blocking agent, and is used for example
after a nuclear accident.
Potassium Iodate tablets are used at the time of a nuclear emergency;
the tablets stop the thyroid gland (situated in your neck)
taking up radioactive iodine, which may be released into the
environment following a nuclear accident.
Radioactive Iodine is harmful and especially dangerous to babies and
children. Ask your doctor, pharmacist or emergency
co-ordinator if you need additional information especially concerning
the correct use of this product.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE POTASSIUM IODATE 85MG TABLETS
DO NOT TAKE POTASSIUM IODATE IF:
%
you are allergic to potassium iodate, iodine or any of the other
ingredients of this medicine (listed in section 6).
KEEP IN MIND THAT IF YOU ARE ALLERGIC TO ANY IODINE PRODUCT, THEN YOU

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Potassium Iodate 85mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 85mg Potassium Iodate equivalent to 50mg iodine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Off white, round tablet with star shaped double breakline, engraved
2202 on
the obverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Potassium iodate is indicated as a thyroid blocking agent to prevent
the uptake
of radioactive iodine, for example after a nuclear accident.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Administration should take place within 3 hours of a nuclear accident,
or up to
10 hours after an accident, however, this is less effective.
A single daily dose should be administered. This will protect against
exposure
lasting up to 24 hours. (see Section 4.4).
For neonates living at home a dosage of ¼ tablet is satisfactory. The
dosage
can be crushed and mixed with milk or water.
For neonates in hospital a dosage of 12.5 mg iodine equivalent can be
given as
a standard solution freshly prepared from KI crystals. It is
recommended that
maternity wards store KI crystals.
For babies the dose may be crushed and mixed with milk or juice before
administration. For children the dose may be crushed and mixed with
eg. jam,
honey or yoghurt.
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 pregnant and lactating women.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance, to iodine or to any of the
excipients listed in section 6.1
•
Renal failure
•
Hypocomplementaemic vasculitis
•
Dermatitis herpetiformis.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In cases of exposure to radioiodine from nuclear accidents, dosing of
potassium iodate should be based on emergency plans and predetermined
operational intervention levels. Risk benefit of administration of
stable
radioi