BETAISODONA Cream Ref.[49797] Active ingredients: Povidone iodine

Patients with goitre, thyroid nodules, or other non-acute thyroid diseases are at risk of developing thyroid hyperfunction (hyperthyroidism) from the administration of large amounts of iodine. In this patient population, povidone-iodine should not cover for a long period large areas of the skin (e.g., not to more than 10% of the total body surface and for not longer than 14 days) unless strictly indicated. Even after the end of the treatment (up to 3 months) one should look for the early symptoms of possible hyperthyroidism and if necessary the thyroid function should be monitored.

It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.

Newborns and small infants are at increased risk of developing hypothyroidism from the administration of large amounts of iodine. Because of the permeable nature of their skin and their increased sensitivity to iodine, the use of povidone-iodine should be kept to the absolute minimum. A check of the child’s thyroid function (e.g. T4 levels and TSH levels) may be necessary. Any possible oral ingestion of the product by the infant must be absolutely avoided.

Special caution is required when regular applications to broken skin are made to patients with pre-existing renal insufficiency.

For external use only.

Prolonged exposure to the cream may cause allergy or contact dermatitis or rarely, severe skin reactions. In instances of skin irritation, contact dermatitis or hypersensitivity discontinue use.

Keep out of the reach of children

Special caution is needed in pregnant and brest-feeding patients. In such cases benefit/risk assessment should be performed and povidone-iodine should only be administered if clearly necessary (see section 4.6).

The PVP-Iodine complex is effective at pH values of between 2.0 and 7.0. It has to be expected that the complex will react with protein and other unsaturated organic compounds, leading to impairment of its effectiveness.

The concomitant use of wound-treatment preparations containing enzymatic components leads to a weakening effect of both substances. Products containing silver, hydrogen peroxide, and taurolidine may interact with povidone-iodine and cause mutual reduction of effects.

Povidone-iodine products when used before or after application of octenidine may lead to transient dark discolourations at the application site.

Due to the oxidative effect of povidone-iodine preparations various diagnostic agents can show false-positive lab results (e.g., tests with toluidine or gum guaiac for the determination of haemoglobin or glucose in the stool or the urine).

Absorption of iodine from povidone iodine products may lower the iodine uptake of the thyroid. This can lead to interference with various investigations (thyroid scintigraphy, determination of protein-bound iodine (PBI), radioiodine diagnostics) and can make a planned treatment of the thyroid with iodine (radioiodine therapy) impossible. After the end of the treatment, an appropriate interval should be allowed before a new scintigram is carried out (see section 4.3).

Povidone Iodine passes into the placenta and is secreted in breast milk. Thyroid function disorders including congenital hypothyroidism have been reported in the offspring of mothers who have received Iodine.

Povidone Iodine use should be avoided unless the potential benefit to the mother justifies the potential risk to the foetus and neonate or if a safer alternative is unavailable.

BETAISODONA Cream has no influence on the ability to drive and use machines.

The following frequencies are the basis for assessing undesirable effects: 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).

Immune system disorders

Rare: Hypersensitivity

Very rare: Anaphylactic reaction

Endocrine disorders

Very rare: Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness)*

Unknown: Hypothyroidism****

Metabolism and nutrition disorders

Unknown: Electrolyte imbalance**, Metabolic acidosis**

Skin and subcutaneous disorders

Rare: Contact dermatitis (with symptoms such as erythema, small blisters and pruritus)

Very rare: Angioedema

Renal and urinary disorders

Unknown: Acute renal failure**, Blood osmolarity abnormal**

Injury poisoning and procedural complications

Unknown: Chemical burn of skin***

^* In patients with a history of thyroid disease (see under Special Warnings and Special Precautions for Use) following a notable uptake of iodine e.g. following long-term use of povidone–iodine solution for the treatment of wounds and burns over extensive areas of the skin
^** May occur following uptake of large amounts of povidone iodine (e.g. in the treatment of burns)
^*** May occur due to “pooling” beneath the patient in pre-operative preparation
^**** Hypothyroidism following prolonged or extensive use of povidone iodine

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. Healthcare professionals are asked to report any suspected adverse reactions to the: Pharmaceutical Services, Ministry of Health, CY-1475, Nicosia, Tel: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs.

Povidone-Iodine should not be used together with alkali, hydrogen peroxide, taurolidine, tannic acid, and silver and mercury salts.