Potassium iodide G.L. Pharma 65mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

POTASSIUM IODIDE

Available from:

G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach, Austria

ATC code:

V03AB21

INN (International Name):

POTASSIUM IODIDE 65 mg

Pharmaceutical form:

TABLET

Composition:

POTASSIUM IODIDE 65 mg

Prescription type:

OTC

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2014-02-17

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

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 contains
_ _
65 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 dose (see section 4.6). Neonates and older people (> 60
years) are a