CLOTRIMAZOLE

Posology The treatment consists of one vaginal tablet to be inserted at night, using the applicator provided. Method of administration One 500mg tablet should be placed into the holder of the applicator. The applicator should be inserted as high as possible into the vagina.

This is best achieved when lying back with legs bent up. 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 tablets might crumble out of the vagina. Pieces of undissolved tablets 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. Treatment should not be performed during menstrual period due to the risk of the tablets 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.

Children:

Not for use in children under 16 years of age.

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

Immune system disorders:

Anaphylactic reaction, angioedema, hypersensitivity. Vascular disorder: syncope, hypotension. Respiratory, thoracic and mediastinal disorders: dyspnea. Gastrointestinal disorders: abdominal pain, nausea Skin and Subcutaneous Tissue Disorders: Rash, urticaria, pruritus.

Reproductive system and breast disorders:

Vaginal exfoliation, vaginal discharge, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain. General disorders and administration site conditions: 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: • more than two infections of candidal vaginitis in the last 6 months.

• previous history of 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.

Clotrimazole vaginal tablet should not be used if the patient has any of the following symptoms where upon 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 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. When used in pregnancy, the pessary should be inserted without using an applicator (see “Pregnancy”).

1