CLOTRIMAZOLE

Posology:

The treatment consists of one vaginal tablet to be inserted in the evening.

Method of administration Adults:

One 500mg vaginal tablet should be inserted as a single dose at night. Using the applicator provided, the tablet should be inserted as high as possible into the vagina. The vaginal tablet is placed into the holder of the applicator provided.

The applicator is inserted into the vagina as deeply as comfortable. This is best achieved when lying on the back with the legs slightly bent. The plunger is slowly pushed in as far as it will go depositing the tablet in the vagina. The applicator should then be removed from the vagina and disposed of carefully, out of the reach of children.

A second treatment may be carried out, if necessary. Clotrimazole vaginal tablets need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the vaginal tablet might crumble out of the vagina. Pieces of undissolved vaginal tablet may be noticed by women who experience vaginal dryness.

To help prevent this it is important that the vaginal tablet is inserted as high as possible into the vagina at bedtime. As a matter of practicality the treatment should not be undertaken during menstruation. 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.

g. discharge, itching) have not subsided completely within three days after termination of therapy, treatment should be continued only after consulting the attending doctor.

Children:

Not for use in children under 16 .

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible. The frequency of adverse events listed below is defined using the following convention: 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).

Tabulated summary of adverse reactions System Organ Class Frequency Adverse reaction Reproductive system and breast disorders Not known vaginal exfoliation, vaginal discharge, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain.

Immune system disorders Not known allergic reaction (syncope, hypotension, dyspnea, urticaria, pruritus, anaphylactic reaction, angioedema, hypersensitivity) Vascular disorder Not known syncope, hypotension Respiratory, thoracic and mediastinal disorders Not known dyspnea Gastrointestinal disorders Not known abdominal pain, Nausea Skin and Subcutaneous Tissue Disorders Not known rash, urticaria, pruritus General disorders and administration site conditions Not known application site irritation, oedema, pain.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis. Before using Clotrimazole vaginal tablet, medical advice must be sought if any of the following are applicable: • previous history of sexually transmitted disease or exposure to partner with sexually transmitted disease.

• more than two infections of candidal vaginitis in the last 6 months. • pregnancy or suspected pregnancy. • known hypersensitivity to imidazoles or other vaginal antifungal products. • aged under 16 or over 60 years. Clotrimazole vaginal tablets should not be used if the patient has any of the following symptoms where upon medical advice should be sought: • abnormal vaginal bleeding or a blood-stained discharge.

• irregular vaginal bleeding. • vulval or vaginal ulcers, blisters or sores. • lower abdominal pain or dysuria. • fever or chills. • diarrhoea. • nausea or vomiting. • foul smelling vaginal discharge. • any adverse events such as redness, irritation or swelling associated with the treatment.

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. When used in pregnancy, the tablet should be inserted without using an applicator (see “Pregnancy”).

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Clotrimazole vaginal tablet. Clotrimazole vaginal tablet 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.

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