GYNOCANESTEN MONO*1VAGCPS500MG

Gyno-Canesten single dose 500 mg
soft capsule
vaginal
clotrimazole

What it is and what it is used for
The active ingredient in Gyno-Canesten single dose is clotrimazole, which belongs to the imidazole group. It has a broad-spectrum effect against fungi, meaning it destroys them and inhibits their growth. It is also effective against microorganisms such as dermatophytes, yeasts, and molds.

Gyno-Canesten single dose is used for the treatment of infections of the vagina and external female genital organs caused by microorganisms sensitive to clotrimazole. The infections are generally caused by Candida, a fungus belonging to the yeast type. Symptoms include itching, burning, thick, white to yellow, odorless vaginal discharge (similar to cottage cheese), redness, swelling, and soreness.

This medicine is suitable for adults and adolescents aged 16 and over.

What you need to know before taking the medicine
Do not use Gyno-Canesten single dose:
• if you are allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Gyno-Canesten single dose if: • this is the first time you have a vaginal infection;
• you have a vaginal infection during the first trimester of pregnancy;
• you have recurrent infections, i.e., more than two infections within the preceding six months;
• you have a fever of 38 °C or higher;
• you have lower abdominal pain, back pain;
• you have foul-smelling vaginal discharge;
• you have nausea;
• you have vaginal bleeding and/or simultaneous shoulder pain.

Gyno-Canesten single dose soft vaginal capsule is not recommended during menstruation. Treatment should be completed before the start of menstruation.

Do not use tampons, vaginal douches, spermicides, or other products intended for vaginal use concomitantly with Gyno-Canesten single dose.

During the use of this medicine, avoid sexual intercourse, as the infection could be transmitted to your partner.

If your partner also has symptoms of a fungal infection, they should be treated simultaneously. Treating your partner can help prevent reinfection.

The contraceptive properties of latex contraceptives such as condoms and diaphragms may be reduced.

Do not swallow Gyno-Canesten single dose.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects can occur with the following frequencies:
Common, may affect 1 in 10 people:
• burning

Uncommon, may affect 1 in 100 people:
• abdominal pain
• itching
• skin redness/irritation

Rare, may affect 1 in 1000 people:
• allergic reactions
• swelling
• skin rash
• vaginal bleeding

Frequency not known, based on available data
• vaginal peeling
• vaginal discomfort
• vaginal pain
• nausea
• hives
• vaginal discharge
• pain

Stop treatment if localized side effects or allergic reactions occur (including anaphylactic reactions, angioedema (swelling), low blood pressure, shortness of breath, and/or fainting).

Local reactions may be similar to the symptoms of the disease. Therefore, it can sometimes be difficult to distinguish infection symptoms from side effects caused by the medicine.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.