BETADINE 200MG Vaginal pessary

This product is intended for vaginal use only. For stability reasons, the vaginal pessaries should not be warmed before application. Povidone-iodine is less irritating than iodine; however, it may still cause local reactions (irritation, contact dermatitis, hypersensitivity [including anaphylactic reaction, see section 4.8], local redness, burning, pain or swelling in the vagina or vaginal area, abdominal pain, fever, or chills). If these symptoms occur, treatment must be discontinued.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ Patients should be advised to seek immediate medical attention if symptoms of an anaphylactic reaction occur. Prolonged use may provoke irritation, contact dermatitis, or hypersensitivity. If irritation or hypersensitivity develops, application must be discontinued. Use of povidone-iodine may lead to transient discolouration of the skin at the application site, which is caused by the colour of the medicinal product. The patient should consult a physician before using Betadine in the following cases: if using other vaginal products if the patient or her partner has had a sexually transmitted disease if symptoms recur (if the patient has had two or more infections in the past 6 months) And also if any of the following symptoms occur: irregular vaginal bleeding abnormal vaginal bleeding or blood-stained discharge ulcers or blisters in the vaginal or vulvar area moderate to severe pain in the vaginal or vulvar area lower abdominal pain lumbar pain pain or difficulty urinating, burning during urination fever or chills nausea or vomiting diarrhoea foul-smelling vaginal discharge The patient should consult a physician before using Betadine if trichomonal infection is suspected. It is particularly important that in the case of trichomonal infection, the sexual partner must also be treated. In women, trichomoniasis (caused by the protozoan Trichomonas vaginalis) may manifest with the following symptoms: foul-smelling vaginal discharge – which tends to be thin, frothy, watery, and may be whitish, grey, yellow, or greenish, pain or burning during urination, pain during or after sexual intercourse, bleeding after sexual intercourse. The patient should be advised not to use tampons during treatment with Betadine vaginal pessaries. Patients with thyroid disorders (patients with goitre, thyroid nodules, or other non-acute thyroid disease) are at risk of developing hyperthyroidism as a result of administration of large amounts of iodine. In this patient population, povidone-iodine should not be administered on a long-term basis unless strictly indicated. Even after treatment has ended, early signs of possible hyperthyroidism must be monitored, and thyroid function should be assessed if necessary. Special caution is required with regular application in patients with a history of renal insufficiency. Regular use of Betadine vaginal pessaries should be avoided in patients receiving concomitant lithium therapy. This product must not be used before, during, or after radioactive iodine scintigraphy and before, during, or after radioactive iodine therapy for thyroid carcinoma (see section 4.3).