POTASSIUM IODIDE SERB

This medicinal product should only be taken after explicit instructions of the national competent authorities. The protocol of administration is in line with the latest WHO recommendations for Iodine Prophylaxis following Nuclear Accidents (2017).

Posology People living in iodine deficient areas are more likely to be affected by exposure to radioactive iodine. In such places, national or regional programmes targeting iodine deficiency should be considered. Time of administration - The optimal period of administration of potassium iodide is less than 24 hours prior to, and up to 2 hours after, the expected onset of exposure.

It would still be reasonable to administer potassium iodide up to 8 hours after the estimated onset of exposure. 4. - Potassium iodide should not be administered later than 24 hours following exposure. Recommended single dosage by age • Adults including pregnant and breastfeeding women.

The standard dose is detailed below:

Potassium iodide dose Potassium iodide 65 mg tablet Adults 130 mg 2 • Paediatric population The standard dose is defined according to the age of the patient: Potassium iodide dose Potassium iodide 65 mg tablet Adolescents (above 12 years old) 130 mg 2 Children (from 3 to 12 years old) 65 mg 1 Infants (from 1 month to 3 years old) 32 mg 1/2 Newborns (<1 month) 16 mg 1/4 Repeated doses in case of prolonged exposure A single administration of stable iodine is usually sufficient.

In case of prolonged exposure, additional doses may be administered following explicit instructions of the competent authorities. New-borns (<1 month), pregnant and breastfeeding women and older adults (over 60 years) should not receive repeated doses of potassium iodide.

Renal impairment There are no available information that suggests that a dose reduction is necessary. However, due to the decrease in renal excretion, there is a risk of accumulation of drug in the body. Hepatic impairment There are no available information that suggests that a dose reduction is necessary.

However, due to the decrease in liver detoxification, there is a risk of accumulation of drug in the body. Elderly population There are no available information that suggests that a dose reduction is necessary. However, because this population is at higher risk of liver and/or renal impairment, there is a risk of accumulation of drug in the body.

The undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥1/10,000 to <1/1,000 Very rare: <1/10,000 Not known: cannot be estimated from the available data Systeme Organ class Undesirable effect Frequency Immune system disorders Hypersensitivity reactions Not known* Endocrine disorders Hyperthyroidism Goitre Hypothyroidism Not known Vomiting Diarrhoea Gastric pain CommonGastrointestinal disorders Metallic taste Thirst Abdominal pain Bloody diarrhoea Not known Skin disorders Skin rash Common *Hypersensitivity reactions to iodides are exceptional.

Those may include bronchospasm, urticaria, angioedema, cutaneous haemorrhage or purpuras, fever, arthralgia, lymphadenopathy, and eosinophilia. 37% of newborns who received potassium iodide prophylaxis on the second day of life (uncommon).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

2). The late intake of potassium iodide tablets (24 hours after exposure) may be harmful as it would prolong the half-life of radioactive iodine that has accumulated in the thyroid leading to possible hypothyroidism by thyroid-cell destruction and to thyroid cancer.

Precautions for use - The groups most likely to benefit from treatment with iodine tablets after exposure to radioactive iodine are children, adolescents, and pregnant and lactating women, as well as those living in iodine-poor areas (who are more likely to be affected by exposure to radioactive iodine).

If the supply of stable iodine is limited, preference should be given to children and young adults. - Adults over 40 years of age are less likely to benefit from treatment with iodine tablets after exposure to radioactive iodine. g. workers involved in rescue or cleaning operations) are more likely to benefit from treatment regardless of age and should be given priority.

- Prophylaxis with iodine protects against inhaled or ingested radioiodine, but has no effect on other ingested radionuclides. e. 8). It can subsequently lead to difficulties to breath or to swallow by pressure on adjacent tissues. g. hyperthyroidism) especially with repeated administration.

Patients should continue their thyroid therapy and regularly undergo medical examinations and biological tests at short intervals. - The administration of iodine interferes with radioiodine therapy and thyroid diagnostics. - In the presence of known or suspected thyroid cancer, iodine should generally not be administered.

Paediatric population - The risk of thyroid carcinoma after exposure to radiations is higher in younger children at the time of exposure. As their thyroid gland is still growing, new-borns and children are more susceptible to the dangerous effects of radioactive iodide than adults and should be treated with potassium iodide in priority.

1 - Dermatitis herpetiformis (Duhring-Brocq disease) - Hypocomplementaemic urticarial vasculitis (Mac Duffie syndrome)