INTRODUCTION

FENTISPOR contains Fenticonazole which belongs to the group of medicines called Antifungals. It is used to manage vulvovaginal candidiasis (fungal infection of the vagina and tissues at the opening of the vagina (vulva) caused by the fungus candida albicans, resulting in pain in the vaginal area, pain that occurs during sexual intercourse or during urination, white vaginal discharge, vaginal itching, and redness in the affected area).

Fenticonazole works by interfering with the cell membrane of the fungi by inhibiting the production of a substance called ergosterol. This type of action prevents the growth of the fungi by forming holes in the membrane and helps in manageing various fungal infections.

Before using FENTISPOR, inform your doctor if you have or ever had abnormal or irregular vaginal bleeding, blood staining in the vaginal discharge, vulval or vaginal sores, ulcers or blisters, lower abdominal pain or dysuria (painful and difficult urination), and a history of a sexually transmitted disease or exposure to a partner with sexually transmitted disease. FENTISPOR should be used with caution among pregnant or breastfeeding women, therefore consult your doctor before using it. The most common side effects of using FENTISPOR are mild irritation, itching of the skin and a burning sensation. Contact your physician if any of the symptoms worsen.

USES OF FENTISPOR

• Manages vulvovaginal candidiasis

HOW FENTISPOR WORKS

FENTISPOR works by interfering with the cell membrane of the fungi by inhibiting the production of a substance called ergosterol. Thereby preventing the growth of the fungi by forming holes in the membrane and helps in manageing various fungal infections.

DIRECTIONS FOR USE

Use FENTISPOR as advised by your physician. It is for vaginal use only. Wash and dry your vaginal area, then lie down in comfortable position and push the vaginal capsule deeply as it is comfortable. Your doctor will decide the correct dose and duration for you depending upon the severity of the infection.

SIDE EFFECTS OF FENTISPOR

HOW TO MANAGE SIDE EFFECTS

Skin itching:

Avoid hot showers because hot water can irritate the skin. Do not scratch the affected area. Use sunscreen, moisturizer, and protective clothing to soothe and hydrate the affected area. If there is no improvement, consult your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before using FENTISPOR, inform your doctor if you are applying or have recently taken any other medicines, including medicines obtained without a prescription, vitamin supplements or herbal products.

Overdosage:

If you or anyone else accidentally swallow FENTISPOR, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are abdominal pain and vomiting.

SYNOPSIS

MORE INFORMATION

• Keep FENTISPOR out of reach of children
• Store at a room temperature

FAQs ABOUT FENTISPOR

Is it safe to use FENTISPOR in children?

FENTISPOR is generally not recommended to use in children and adolescents of age 16 years and below. FENTISPOR should be used with caution in adolescents aged 16 years and older. Consult your doctor before using FENTISPOR.

Can I stop using FENTISPOR if my condition improves?

Do not stop using FENTISPOR without consulting your physician. Remember to complete the course of management as this will help to prevent the infection from coming back even if you feel your condition is improved. Contact your doctor if the symptoms do not improve after using FENTISPOR.

What is FENTISPOR used for?

FENTISPOR is used to manage fungal infections of the vagina, also called as vaginal candidiasis. Vaginal candidiasis is a fungal infection that causes irritation, discharge, and intense itchiness of the vagina and the vulva (tissues at the vaginal opening).

When not to use FENTISPOR?

FENTISPOR is not recommended for use if it is used in conjunction with barrier contraceptives, spermicides, intravaginal douches, or other vaginal products. Consult your physician before using it.

Can FENTISPOR be used in pregnant or breast-feeding women?

FENTISPOR should be used with caution in pregnant and breast-feeding women unless clearly advised by your doctor. Consult your doctor before using FENTISPOR if you are pregnant or about to start breast-feeding.

REFERENCES

1. Kubra Saygisever-Faikoglu, Gokhan Faikoglu, Fatmanur Otmar Ozcan, Tugce Uskur, Dundar Okan Yillar, Barkin Berk, Pelin Kelicen Ugur. The efficacy and safety of fenticonazole in the management of mixed vaginitis. Pharmacy & Pharmacology International Journal. January 2022. [Accessed on 30th June 2022] https://medcraveonline.com/PPIJ/the-efficacy-and-safety-of-fenticonazole-in-the-management-of-mixed-vaginitis.html

2. Stefano Veraldi, Rodolfo Milani. Topical fenticonazole in dermatology and gynaecology: current role in therapy. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. 2008 [Accessed on 30th June 2022] https://pubmed.ncbi.nlm.nih.gov/18840006/

3. J Fernandez-Alba, A Valle-Gay, M Dibildox, J A Vargas, J González, M Garcia, L H Lopez. Fenticonazole nitrate for management of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen. Journal of Chemotherapy. April 2004 [Accessed on 30th June 2022] https://pubmed.ncbi.nlm.nih.gov/15216954/

4. Fenticonazole Nitrate Soft Gelatin Capsule. DM pharma. [Accessed on 30th June 2022] http://dmpharma.co.in/Fenticonazole%20Nitrate%20Soft%20Gelatin%20Capsule.html

5. Recordati Industria Chimica e Farmaceutica SpA. Health Products Regulatory Authority (HPRA). [Revised in September 2020] [Accessed on 30th June 2022] http://www.hpra.ie/img/uploaded/swedocuments/Licence_PA0812-004-001_23092020150729.pdf