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

Source: Medicines Authority (MT)  Revision Year: 2019  Publisher: BIAL โ€“ Portela & Cยช, S.Aร€ Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

4.1. Therapeutic indications

Yodafar is a supplement of potassium iodide indicated in:

Adults: Correction of nutritional deficiencies.

Pregnancy and lactation: Correction of nutritional deficiencies and the prevention of neural tube defects as well as fetal neurological disorders.

4.2. Posology and method of administration

Posology

The recommended iodine dose is:

  • Adults: 120-150 micrograms daily.
  • Pregnant and lactation: 200-300 micrograms daily.

At the time of establishing the appropriate dose, the doctor will consider iodine needs and the use of potassium iodide in multivitamins.

Paediatric population

It is not suitable for children under 12 years.

Method of administration

Administer the tablet orally, after meal with enough amount of liquid.

4.9. Overdose

Deliberate or accidental intoxication with potassium iodide is unlikely. However, may occur iodism manifestations as metallic taste, burning mouth and throat, soreness in your teeth and gums, increased salivation, coryza, sneezes and eye irritation with swelling of the eyelids when are given high doses of potassium iodide (milligram range) or during long periods of time. It can also develop severe headache, productive cough, pulmonary oedema and swelling and awareness of the parotid and submaxillary glands. The pharynx, larynx and tonsils can become inflamed.

In seborrheic areas may appear moderate acneiform rashes, seldom severe rashes may occur (ioderma) and sometimes fatal.

If much higher doses than recommended are ingested the gastric irritation is common and can cause diarrhoea, sometimes bloody.

Signs and symptoms of iodism usually disappear spontaneously after a few days following withdrawal of treatment.

The use of excessive doses or for long periods of iodides may produce hyperplasia of the thyroid gland, thyroid adenoma, goitre and serious hypothyroidism.

6.3. Shelf life

4 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

YODAFAR 200 micrograms tablets: pack with 50 tablets in PVC-PVDC/Aluminium blister.

YODAFAR 300 micrograms tablets: pack with 50 tablets in PVC-PVDC/Aluminium blister.

6.6. Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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