YODAFAR Tablet Ref.[51122] Active ingredients: Potassium iodide

Urinary iodine should be used to evaluate the degree of iodine deficiency as well as monitoring and evaluating its correction. The adequate supply of iodine in the diet should be at least 150-300 micrograms daily.

Since some people are very sensitive to iodine, the potassium iodide should be used with caution at the beginning of the treatment. Patients at risk for adverse effects of iodine administration include those with hypocomplementemic vasculitis, goitre or thyroid autoimmune disease.

Caution should be exercised when initiating treatment in: kidney disease, hyperkalemia, goitre or active tuberculosis.

Care should be exercised if potassium salts are given concomitantly with potassium-sparing diuretics, as hyperkalaemia may result.

Iodides can affect the thyroid gland, so the administration of these agents may interfere with thyroid function tests.

The following interactions are known for potassium iodide:

Potassium-sparing diuretics: Concomitant use of potassium iodide and potassium-sparing diuretics produces a reduction in renal excretion of potassium that can lead to serious hyperkalemia (arrhythmias) or even fatal (heart attack), being the existence of reduced kidney function a predisposing factor for the occurrence of this complication.

If you have to administer both drugs at the same time, it is necessary to monitor potassium levels and adjust dose accordingly. In any case, should be avoided this type of combination.

Lithium salts: Concomitant use of lithium salts with potassium salts may result in hypothyroidism. Therefore, this combination should be avoided whenever possible. However, in case it is necessary to administer both drugs and develop hypothyroidism, thyroid hormone can be used to treat symptoms.

Antithyroidal drugs: Concomitant use of antithyroidal agents and potassium iodide can produce additive hypothyroid effects.

Pregnancy

In pregnancy there is an increased need for iodine. The administration of iodine and preparations containing iodine should be expressly provided by the physician based on risk-benefit assessment.

Since iodine crosses the placenta barrier and the foetus is sensitive to pharmacologically active dose of iodine, doses of iodine on milligram level should not be given. Reproductive toxicity has been observed in animal studies (see section 5.3).

Lactation

Potassium iodide is excreted in human milk and may cause rashes or thyroid suppression in the infant. Therefore, the physician should individually assess the administration of potassium iodide in the lactation period.

Yodafar has no or negligible influence on the ability to drive and use machines.

The following uncommon side effects have been observed (between 1 and 10 in 1,000):

Endocrine disorders: goitre, hyperthyroidism and hypothyroidism.

Blood and lymphatic system disorders: thrombotic thrombocytopenic purpura.

Gastrointestinal disorders: nausea and abdominal pain, metallic taste and increased salivation.

Skin and subcutaneous tissue disorders: hives, angioedema and exanthematous rash.

Vascular disorders: vasculitis, fatal periarteritis.

Immune system disorders: oedema (including facial and glottis oedema)

General disorders and administration site conditions: hypersensitivity reactions, signs and symptoms resembling serum sickness: fever, arthralgia, enlarged lymph nodes and eosinophilia.

See section 4.5 (Interaction with other medicinal products and other forms of interaction).