Romazol Tablets 100mg (Clotrimazole)

Adult use

Typically, 100 mg of clotrimazole is deeply inserted vaginally at bedtime once daily for 6 consecutive days. In short-term therapy, typically, 200 mg of clotrimazole is deeply inserted vaginally at bedtime once daily for 3 consecutive days. Typically, 500 mg of clotrimazole is deeply inserted vaginally at bedtime once daily for 1 day.

This medicine should not be used by individuals who have had allergic reactions to its active or inactive ingredients. It is important not to use this medication simultaneously with certain immunosuppressants such as tacrolimus or sirolimus during treatment. Co-administration may increase the serum concentration of these drugs, leading to a higher risk of side effects, so serum levels should be monitored periodically as directed by a doctor. Women who are pregnant or may become pregnant must consult a physician before using this medication. Animal studies have shown no significant issues regarding reproductive ability or malformation, but it is advisable to avoid the use of insertion devices during pregnancy. It is also advisable for breastfeeding women to consult a physician before using this medication. This medicine acts locally and has a low likelihood of being absorbed systemically into breast milk, but it's prudent to discuss this with a healthcare professional for safety. If allergic reactions, breathing difficulties, abdominal pain, skin rashes, or vaginal bleeding occur while using this medication, it should be stopped immediately, and a physician or pharmacist should be consulted. It is advisable not to use this medicine during menstruation, and treatment for any oral infections should also be performed to ensure complete eradication of the infection. If vulvitis or Candida balanitis is also present, using additional cream preparations may be beneficial. It is essential for sexual partners to be treated as well if there are itching or inflammation symptoms. To prevent re-infection, it is recommended to change and wash personal towels or underwear daily. During the use of this medication, tampons, vaginal cleansers, or other vaginal insert products should not be used, and vaginal intercourse should be avoided as it helps prevent the spread of infection. Care should be taken to avoid contact with the eyes, and this product should never be swallowed. If symptoms such as high fever, lower abdominal pain, foul-smelling vaginal discharge, nausea, or vaginal bleeding occur, immediate consultation with a physician is necessary. No cases of overdose have been reported, but if a significant amount is accidentally ingested, appropriate measures such as gastric lavage should be taken. This medication may weaken rubber products such as condoms or diaphragm contraceptives, so caution is necessary during use. This product is only for use in the vagina and is recommended for children aged 12 and older and adults only. When storing, keep the medication out of reach of children, in its original packaging, away from direct sunlight, and in a cool, dry place.

Serious side effects

• Hives
• severe swelling (edema)
• difficulty breathing

Mild side effects

• Abdominal pain
• nausea
• rash
• urticaria (hives)
• pruritus
• vaginal peeling
• vaginal discharge
• vaginal bleeding
• vulvar discomfort
• vulvar erythema (red spots)

Drug interactions

Do not use this medication concurrently with oral tacrolimus.

This medication is sensitive to light and should be stored in a container that prevents light exposure. Additionally, it is recommended to store the medication at room temperature between 1°C and 30°C. This will safely maintain the effectiveness of the drug.

Appearance

White rectangular vaginal tablet

Package unit

1 tablet/foil packaging*6 pieces