INTRODUCTION

FENTISAFE contains Fenticonazole which belongs to the group of medicines called Antifungals. It is used in adults and adolescents to manage genital candidiasis (fungal infection of the vagina and tissues at the opening of the vagina (vulva) that results in inflammation, intense itchiness, and a thick, white discharge from the vagina) and mixed vaginal infections (a change in the characteristics of vaginal discharge along with genital itching and burning pain).

Fenticonazole works by interfering with the fungi cell membrane by inhibiting the production of a substance called ergosterol (a type of fat that provides the ability to flow easily to the cell membrane). This type of action prevents the growth of the fungi by forming holes in the membrane and helps in manageing vaginal fungal infections.

Before using FENTISAFE, 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 or difficult urination), using a latex made contraceptive method and a history of a sexually transmitted disease or exposure to partner with the sexually transmitted disease. FENTISAFE is generally not recommended for use in pregnant and breastfeeding women unless clearly advised by your doctor. FENTISAFE is not recommended for use in children and adolescents (below 16 years of age) and it should be used with caution in adolescents (above 16 years of age) and elderly patients. Therefore, consult your doctor before using it. The most common side effects of using FENTISAFE are irritation, itching, and burning sensation. Contact your doctor for advice if any of the symptoms worsen.

USES OF FENTISAFE

• Manages genital candidiasis and mixed vaginal infections

HOW FENTISAFE WORKS

FENTISAFE works by interfering with the fungi cell membrane by inhibiting the production of a substance called ergosterol (a type of fat that provides the ability to flow easily to the cell membrane). This type of action prevents the growth of the fungi by forming holes in the membrane and helps manageing vaginal fungal infections.

DIRECTIONS FOR USE

Apply FENTISAFE as advised by your physician. It is for vaginal use only. Wash your hands before use. Use the applicator provided for applying the cream into the vagina. To do this, the applicator is to be attached to the tube. Squeeze the cream into the applicator until it is full. Remove the applicator from the tube, and then gently insert the cream-filled end of the applicator into the vagina as high as it is comfortable for you. Push the plunger to release the cream into the vagina. Remove the applicator and wash it with warm water and soap, to ready for your next dose. The correct dose and duration will be decided by the doctor depending on your age, body weight, and disease condition.

SIDE EFFECTS OF FENTISAFE

HOW TO MANAGE SIDE EFFECTS

Itching:

Try using warm water and gentle cleanser to wash your genital area. Avoid using scented soaps, lotions, and bubble baths. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interaction:

Before using FENTISAFE, inform your doctor if you are using latex made barrier contraceptives, spermicides, intravaginal douches, and other vaginal products.

Overdosage:

If you use more FENTISAFE than you should, consult your doctor for advice.

SYNOPSIS

MORE INFORMATION

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

FAQs ABOUT FENTISAFE

Is it safe to use FENTISAFE in children?

FENTISAFE is generally not recommended for use in children and adolescents (below 16 years of age). It should be used with caution in adolescents (above 16 years of age). Therefore, consult your doctor before using it.

Can I stop using FENTISAFE if my condition improves?

Do not stop using FENTISAFE without contacting 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 FENTISAFE.

What is FENTISAFE used for?

FENTISAFE is used to manage genital candidiasis (fungal infection of the vagina and tissues at the opening of the vagina (vulva) that results in inflammation, intense itchiness and a thick, white discharge from the vagina) and mixed vaginal infections (a change in the characteristics of vaginal discharge along with genital itching and burning pain) in adults and adolescents.

What precautions to be followed before using FENTISAFE?

Before using FENTISAFE, 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 or difficult urination), and a history of sexually transmitted disease or exposure to partner with the sexually transmitted disease. Consult your doctor for advice before using FENTISAFE.

How does FENTISAFE work?

FENTISAFE 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 as a result it helps to manage vaginal fungal infections.

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 Gonzalez, 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. Recordati Industria Chimica e Farmaceutica S.p.A. Gynoxin Vaginal Cream. [Revised in March 2020] [Accessed on 30th June 2022] http://recordati.pl/produkty_upload/gynoxin_krem_dopochwowy/File/Gynoxin_cream_leaflet.pdf

5. Recordati Industria Chimica e Farmaceutica SpA. Health Products Regulatory Authority (HPRA) [Revised in January 2010] [Accessed on 30th June 2022] https://www.hpra.ie/img/uploaded/swedocuments/LicenseSPC_PA0812-002-001_30012010225621.pdf

6. Leeford pharmaceuticals limited. Fenzitop Cream [Accessed on 30th June 2022] https://www.leeford.in/product/1495/fenzitop-cream