Potassium iodide G.L. Pharma 65 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium iodide

Available from:

G.L. Pharma GmbH

ATC code:

V03AB; V03AB21

INN (International Name):

Potassium iodide

Dosage:

65 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antidotes; potassium iodide

Authorization status:

Not marketed

Authorization date:

2012-08-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
POTASSIUM IODIDE G.L. PHARMA 65 MG TABLETS
Potassium iodide
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. See section 4.
WHAT IS IN THIS LEAFLET
1. What Potassium iodide G.L. Pharma is and what it is used for
2. What you need to know before you take Potassium iodide G.L. Pharma
3. How to take Potassium iodide G.L. Pharma
4. Possible side effects
5. How to store Potassium iodide G.L. Pharma
6. Contents of the pack and other information
1.
WHAT POTASSIUM IODIDE G.L. PHARMA IS AND WHAT IT IS USED FOR
Potassium iodide is used in cases of nuclear accidents or nuclear
reactor accidents to
prevent the uptake of radioactive iodine by the thyroid.
In the event of nuclear reactor accidents, there may be an emission of
radioactive iodine. In
case of contamination, the radioactive iodine is taken up by the
thyroid. The uptake of
radioactive iodine by the thyroid is prevented by the intake of
non-radioactive iodine (e.g. in
the form of potassium iodide) before or during the contamination.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE POTASSIUM IODIDE G.L. PHARMA
DO NOT TAKE POTASSIUM IODIDE G.L. PHARMA

if you are allergic to potassium iodide or any of the other
ingredients of this medicine
(listed in section 6).

if you have an autoimmune disease involving itching and blisters of
your skin (dermatitis
herpetiformis van Dühring).

if
you
have
an
overactive
thyroid
producing
too
much
of
thyroid
hormones
(hyperthyreosis).

if
you
have
a
certain
disorder
of
your
blood
vessel
walls
(hypocomplementaemic
vasculitis).
WARNINGS AND PRECAUTIONS
Talk to your doctor or p

Summary of Product characteristics

Health Products Regulatory Authority
22 December 2021
CRN00CMFW
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Potassium iodide G.L. Pharma 65 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains65 mg potassium iodide, equivalent to 50 mg iodine.
Excipient with known effect:
1 tablet contains 80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Diameter: about 8.3 mm
Thickness: 3.2 – 3.8 mm
White to brown-white, round, curved tablet with a pressure-sensitive
cross break line on the inner side and notches on the
outer side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use after nuclear accidents with release of radioactive iodine
isotopes to prevent the uptake of radioactive iodine in the
thyroid after intake or inhalation of this substance.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Iodine tablets may only be taken after explicit appeal by the
authority, for example via radio or television.
Timing of administration
It is recommended to use the tablets as soon as possible and
preferably within 2 hours after the expected onset of exposure.
However, an administration up to 8 hours after the estimated onset of
exposure is still useful.
Posology
Adults and children above 12 years: 100 mg iodine (2 tablets)
Children from 3 to 12 years: 50 mg iodine (1 tablet)
Children from 1 month to 3 years: 25 mg iodine (½ tablet)
Newborns and babies younger than a month: 12.5 mg iodine (¼ tablet)
Pregnant and breast-feeding women (all ages): 100 mg iodine (2
tablets)
Duration of administration
A single administration is usually sufficient.
If the release of radioactive iodine continues (> 24 hours), with
repeated exposure, intake of contaminated food or drinking
water and if evacuation is not possible, a repeated administration may
be necessary.
_Special populations_
Neonates, pregnant and breast-feeding women and older adults (> 60
years) should not receive more than one do