GYNO-PEVARYL

For vaginal administration.

Adults:

One pessary should be inserted high into the vagina each evening for three consecutive days. Pregnant women should thoroughly wash their hands before self- administering Gyno-Pevaryl 150 mg vaginal pessaries.

Children:

Gyno-Pevaryl 150 mg vaginal pessaries are not indicated for use in children under the age of 16 years.

Elderly:

No specific dosage recommendations or precautions apply.

The safety of Gyno-Pevaryl Vaginal Cream and Vaginal Pessaries was evaluated in 3630 patients who participated in 32 clinical trials. 2%). Including the above mentioned adverse reactions, the following table displays adverse reactions that have been reported with the use of Gyno-Pevaryl Vaginal Cream and Vaginal Pessaries from either clinical trial or postmarketing experiences.

The displayed frequency categories use 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); and not known (cannot be estimated from the available clinical trial data). All adverse reactions with a known incidence (common or uncommon) are from clinical trial data and all adverse reactions with an unknown incidence are from post- marketing data.

Adverse Reactions Adverse Reactions Frequency CategorySystem Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known Immune System Disorders Hypersensitivity Skin and Subcutaneous Tissue Disorders Pruritus, Skin burning sensation Rash Erythema Angioedema, Urticaria, Contact dermatitis, Skin exfoliation Reproductive System and Breast Disorders Vulvovaginal burning sensation General Disorders and Administrati on Site Conditions Application site pain, Application site irritation, Application site swelling 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.

For intravaginal use only. This preparation is not for oral use. Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued. Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation.

5). Gyno-Pevaryl 150mg vaginal pessaries should not be used in conjunction with other internal or external treatment of the genitalia.

Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any ingredients of Gyno- Pevaryl 150mg vaginal pessaries.