POTASSIUM IODIDE G.L. PHARMA Tablet Ref.[51172] Active ingredients: Potassium iodide

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 at higher risk of adverse health effects if they receive repeated doses of stable iodine (see sections 4.4 and 4.6).

Adults above 40 years of age

The intake of iodine tablets is not recommended for persons above 40 years because they are less likely to benefit from treatment with iodine tablets after exposure to radioactive iodine (see section 4.4).

Hepatic and renal insufficiency

No dosage adjustments are required in special populations such as patients with impaired renal or hepatic function. Iodine elimination occurs mainly via the kidneys; however, renal elimination rate is not influenced by iodine intake or iodine serum levels.

Method of administration

Oral use.

The tablets may be chewed or swallowed whole.

Paediatric population

To be able to provide the proper doses for children more easily, the tablets have got a cross break score. For newborns and babies, the dose may be ground or dispersed in water, syrup or a similar liquid. It may take up to 6 minutes until the tablets are fully dispersed.

Symptoms

In overdose, symptoms of iodism such as headache, pain and swelling of the salivary glands, fever or laryngitis, swelling or inflammation of the throat, gastrointestinal upset and diarrhoea can occur. Pulmonary oedema can also occur.

Acute ingestion of iodine can result in corrosive injury of the gastrointestinal tract and renal damage. Cardiopulmonary collapse due to circulatory failure should be treated by maintenance of airway and stabilisation of the circulation. Oedema of the glottis resulting in asphyxia or aspiration pneumonia can occur. In acute iodine poisoning large quantities of milk and starch mucilage should be given.

Newborns are particularly sensitive to iodine overload, probably by an immature regulation system. For neonates who have been administered potassium iodide in the first few weeks of life TSH levels and, if necessary, T4 levels should be monitored and appropriate replacement therapy given (see also section 4.4).

Treatment

Lavage with starch mucilage or lavage with activated charcoal should be considered if there is no oesophageal damage.

Electrolyte and water losses should be replaced and the circulation should be maintained. Pethidine (100 mg) or morphine sulphate (10 mg) may be given for pain. A tracheostomy may become necessary.

Haemodialysis may reduce excessively elevated serum iodine concentrations.

5 years.

Do not store above 25°C.

Store in the original package in order to protect from light and moisture.

Blister packs: PVC-PVdC/aluminium blister containing 2, 4, 6, 10, and 20 tablets

Not all pack sizes may be marketed.

No special requirements.