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Stadmazol 500
OTC

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane.

Pack size Box of 1 tablet
Shelf-life 36 months
Composition Clotrimazole
Dosage forms and strengths Vaginal tablet 500 mg
Product code :

PRESCRIBING INFORMATION

Indications

Stadmazol 500 is recommended for the treatment of infections of the genital region (vaginitis) caused by:

  • Fungi (usually Candida).
  • Superinfections caused by clotrimazole-sensitive bacteria.

Dosage

  • Single-dose treatment with 1 vaginal tablet to be introduced in the evening.
  • If symptoms persist for more than 7 days, the patient may have a medical condition that requires treatment by a doctor.
  • The treatment can be repeated if necessary, however, patient should seek medical advice if symptoms return within 2 months.
  • If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given in addition to the intravaginal treatment (combination treatment). The sexual partner should also undergo local treatment if symptoms, e.g. pruritus, inflammation, etc. are present.
  • Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation.
  • Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.
  • Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using this product because the partner could become infected.
  • Intended for use by adults and children 12 years of age and older.

Usage

  • The vaginal tablet should be inserted as deeply as possible into the vagina in the evening before going to bed. Insertion is best achieved when lying back with the legs slightly drawn up.
  • Should the vagina tablet not dissolve completely within one night, the use of a vagina cream should be considered.

Hypersensitivity to clotrimazole or to any of the ingredients.

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.

  • Allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus).
  • Genital peeling, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.
  • Abdominal pain.
  • Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
  • Before using vaginal tablet, medical advice must be sought if any of the following are applicable:
    + More than two infections of candidal vaginitis in the last six months.
    + Previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease.
    + Pregnancy or suspected pregnancy.
    + Aged under 16 or over 60 years.
  • Known hypersensitivity to imidazoles or other vaginal antifungal products.
  • Vaginal tablet should not be used if the patient has any of the following symptoms whereupon medical advice should be sought:
    + Irregular vaginal bleeding.
    + Abnormal vaginal bleeding or a blood-stained discharge.
    + Vulval or vaginal ulcers, blisters or sores.
    + Lower abdominal pain or dysuria.
    + Any adverse events such as redness, irritation or swelling associated with the treatment.
    + Fever or chills.
    + Nausea or vomiting.
    + Diarrhoea.
    + Foul smelling vaginal discharge.
  • Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using vaginal tablets. The vaginal tablets can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician.
  • Clotrimazole vaginal tablet can be used during pregnancy, but only under the supervision of a physician or midwife without using an applicator.
  • A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
  • The drug has no or negligible influence on the ability to drive or use machinery.