Product Overview
[Drug Name]
Generic Name: Nifuratel Nysfungin Vaginal Soft Capsules
Trade Name: Langyi
English Name: Nifuratel Nysfungin Vaginal Soft Capsules
Chinese Pinyin: Xiaofutai'er Zhimeisu Yindao Ruanjiaonang
[Ingredients]
This product is a compound preparation. Each capsule contains 500 mg of nifuratel and 200,000 units of nystatin. Class A excipients are: the contents contain vaseline, soybean oil, ethylparaben, and the capsule shell contains gelatin, glycerin, water, sunset yellow and titanium dioxide.
[Properties]
This product is an oval soft capsule, and the contents are yellow viscous oil.
[Indications]
This product is an over-the-counter drug for gynecological use. Bacterial vaginosis, Trichomonas vaginitis, Candidal vulvovaginitis, and mixed vaginal infections.
[Usage and Dosage]
Vaginal administration, once a day, after washing the vulva before going to bed at night, put 1 tablet of this product deep into the vagina. Use it for 6 consecutive days as a course of treatment.
[Adverse Reactions]
Reproductive system and breast diseases: vulvovaginal itching, vulvovaginal burning, vulvovaginal pain, vulvovaginal swelling, vulvovaginal dryness, vulvovaginal discomfort, genital itching, vulvar hematoma, vulvar edema, vaginal bleeding, vulvovaginal erythema, vaginal discharge, perineal pain, etc.; Skin and subcutaneous tissue diseases: skin reactions, itching, rash, urticaria, erythema, etc.; Gastrointestinal system diseases: nausea, vomiting, abdominal pain, diarrhea, abdominal discomfort, etc.; Systemic diseases and various reactions at the site of administration: pain, fever, chills, fatigue, chest discomfort, local swelling, etc.; Nervous system: dizziness, headache, burning sensation; Various examinations: positive skin test; Immune system diseases: allergic reaction.
[Contraindications]
People who are allergic to nifuratel and nystatin and any of the ingredients of this product are prohibited.
【Precautions】
1. This product is for vaginal administration only, and should not be taken orally. 2. For better efficacy, try to insert this product deep into the vagina. 3. After 1-2 courses of continuous use of this product, if the symptoms do not ease or disappear, consult a physician. 4. Pregnant women should use this product under the guidance of a physician, and breastfeeding women should use it with caution. 5. Women with no sexual history should use this product under the guidance of a physician. 6. Do not drink alcoholic beverages while using this product. Alcohol may cause discomfort or nausea, but this reaction will disappear on its own. 7. Wash your hands or wear cots or gloves when administering the medicine. 8. Pay attention to personal hygiene during medication, prevent repeated infection, and avoid sexual intercourse. 9. If there is a burning sensation, redness, swelling, etc. at the medication site, stop taking the medicine, wash off the local medicine, and consult a physician if necessary. 10. Avoid using this product during menstruation. 11. It is forbidden for those who are allergic to this product, and should be used with caution by those with allergic constitution. 12. Patients with glucose-6-phosphate dehydrogenase deficiency (commonly known as favism) are prohibited from using this product. 13. Post-marketing data have reported that patients experienced anaphylactic shock after external use of this product. 14. This product is prohibited from use when its properties change. 15. Please keep this product out of reach of children. 16. If you are using other medicines, please consult a doctor or pharmacist before using this product.
[Special population medication]
Children's precautions: There is still a lack of safety and effectiveness data for children.
Precautions for pregnancy and lactation: There is still a lack of safety and effectiveness data for pregnant and lactating women. Pregnant women should use this product under the guidance of a doctor. Lactating women should use it with caution.
Precautions for the elderly: Same as adults, no special.
[Drug interactions]
If used with other drugs at the same time, drug interactions may occur. Please consult a doctor or pharmacist for details.
[Pharmacological action]
Nifuratel is a nitrofuran derivative with a broad-spectrum antimicrobial effect, active against Trichomonas, bacteria, Candida albicans, etc. Nystatin is a polyene antifungal drug with strong activity against Candida. Nifuratel and nystatin have broad-spectrum antifungal, anti-trichomonal and antibacterial activities in vitro. There is no negative interaction between the two components. It can provide a safer effect in the treatment of mixed vaginal infections (Candida, Trichomonas and bacteria), when the pathogens cannot be diagnosed in time, and when the fungal superinfection and recurrence after other drug treatment cannot be prevented. Experiments have shown that this product has mild toxicity in acute toxicological tests on animals.
[Storage] Store in a dark, sealed, cool (not exceeding 20°C) and dry place.
[Specification] Nifuratel 500 mg, nystatin 200,000 units.
[Packing specification] Aluminum-plastic blister packaging, 12 tablets/box.
[Validity period] 24 months
[Approval number] National Medicine Standard H20051563
[Manufacturer] Enterprise name: Beijing Jincheng Taier Pharmaceutical Co., Ltd.