CANDID-V6 Vaginal tablet

For the treatment of candidal vaginitis.

Posology and Method of administration

The tablets should be inserted into the vagina, as high as possible, using the applicator provided. This is best achieved when lying back with legs bent up.

Adults

2 tablets should be insert daily (preferably at night) for 3 consecutive days. Alternatively, 1 tablet may be inserted daily for 6 days, preferably at night. A second treatment may be carried out if necessary in the treatment of severe candidal vaginitis, non-albicans candida vaginitis, candidal vaginitis in Immunocompromised host and in the maintenance treatment of recurrent candidal vaginitis.

There is no separate dosage schedule for the elderly.

Candid tablets need moisture in the vagina in order to dissolve completely; otherwise undissolved pieces of the tablet might crumble out of the vagina. Pieces of undissolved tablet may be noticed by women who experience vaginal dryness. To help prevent this it is important that the tablet is inserted as high as possible into the vagina at bedtime.

Generally

Treatment during the menstrual period should not be performed due to the risk of the tablet being washed out by the menstrual flow. 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.

Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.

For the prevention of reinfection, the partner should be treated locally with CANDID Cream if he is diagnosed with candidal balanitis.

Children

Not for use in children under 16.

Hypersensitivity to clotrimazole or any of the excipients in this product.

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

Immune system disorders: Allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus)

Reproductive system and breast disorders: Genital peeling, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.

Gastrointestinal disorders: Abdominal pain.

When used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least 5 days after using this product. Concomitant medication with vaginal clotrimazole and oral tacrolimus might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

Pregnancy

There are limited amount of data from the use of clotrimazole in pregnant women.

During pregnancy the tablet should be inserted without using an applicator.

Lactation

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration. A risk to the suckling child cannot be excluded. 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.

For vaginal use only: Not to be taken orally.

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.

Before using Candid 100mg tablets, medical advice must be sought if any of the following are applicable:

- More than two infections of candidal vaginitis in the last 6 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.

Candid 100mg tablets 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 1 week of using Candid 100mg tablets. The tablets can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within 6 months, patients should be advised to consult their physician.

If there is a lack of response of Candid-V6, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.

Pharmacotherapeutic group: Gynaecological anti-infective and antiseptics imidazole derivatives.

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

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

(See the package insert about more information.)