GYNO-PEVARYL

Route of Administration For vaginal/penile administration.

Females:

One applicator full (approximately 5 g) intravaginally once daily at night for not less than 14 days. The cream should also be applied to the vulva. The full 14 days treatment should be carried out even if the symptoms of vaginal itching or discharge have disappeared.

In pregnant women, it is recommended that administration takes place without the use of an applicator, or is performed by a physician. Pregnant women should thoroughly wash their hands before self-administering Gyno-Pevaryl cream.

Males:

Apply the cream to the penis, including under the foreskin, once daily for not less than 14 days. The sexual partner should also be treated.

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). 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

Not for ophthalmic or 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 Cream should not be used in conjunction with other internal or external treatment of the genitalia. Gyno-Pevaryl Cream is not indicated for use in children under the age of 16 years. Excipients This medicine contains 30 mg benzoic acid in each tube of 15 g which is equivalent to 2 mg/g cream.

This medicine contains 60 mg benzoic acid in each tube of 30 g which is equivalent to 2 mg/g cream. Benzoic acid may cause local irritation. g. contact dermatitis) or irritation to the eyes and mucous membranes.

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