MONICURE 400 mg

Miconazole Nitrate 400 mg

Vaginal Suppositories – 3 Suppositories

Medical Description:
MONICURE 400 mg contains miconazole nitrate 400 mg, an imidazole antifungal formulated for intravaginal treatment of vulvovaginal candidiasis (vaginal yeast infection) caused by susceptible Candida species.

Miconazole acts locally in the vagina by interfering with fungal cell-membrane formation, helping eliminate susceptible Candida organisms and relieve associated symptoms such as vaginal/vulvar itching, irritation, redness and soreness.

Active Ingredient

• Miconazole nitrate: 400 mg per vaginal suppository
• Dosage form: Vaginal suppository
• Pack size: 3 suppositories
• Pharmacological class: Imidazole antifungal

Indications

MONICURE 400 mg is indicated for the treatment of vulvovaginal candidiasis, commonly known as vaginal thrush.

Symptoms may include:

• Vaginal and vulvar itching
• Burning or irritation
• Vulvar redness and soreness
• Thick, white vaginal discharge
• Vaginal discomfort
• Discomfort during sexual intercourse
• Burning during urination when the external tissues are affected

Mechanism of Action

Miconazole inhibits the synthesis of ergosterol, an essential component of the fungal cell membrane. This causes alteration of fungal membrane structure and permeability, inhibiting fungal growth and contributing to the elimination of susceptible Candida species.

When administered intravaginally, miconazole provides antifungal activity directly at the site of infection.

Clinical Benefits

MONICURE 400 mg may:

• Treat susceptible vaginal Candida infections.
• Inhibit fungal growth within the vagina.
• Help relieve vaginal and vulvar itching and irritation.
• Reduce redness, soreness and burning associated with candidiasis.
• Provide localized antifungal therapy directly to the affected vaginal tissues.
• Offer a convenient 3-day treatment course.

Dosage & Administration

Adults and adolescents for whom this formulation is appropriate:

Insert ONE 400 mg vaginal suppository deeply into the vagina once daily for 3 consecutive days, preferably at bedtime, or according to the physician's instructions.

Directions:

1. Wash hands before and after administration.
2. Remove one suppository from its packaging immediately before use.
3. Gently insert the suppository deeply into the vagina, preferably while lying down at bedtime.
4. Repeat once daily for 3 consecutive days.
5. A sanitary pad may be used because some leakage of the melted suppository may occur.
6. Complete the prescribed course even if symptoms improve before treatment is finished.

Important: Treatment duration can vary according to the specific formulation and approved product information. The MONICURE package leaflet should be followed for the exact dosing instructions.

Important Warnings & Precautions

• For vaginal use only.
• Do not swallow the suppository.
• Do not use if you have never previously experienced a medically diagnosed vaginal yeast infection without consulting a healthcare professional.
• Seek medical advice if this is the first episode of suspected vaginal candidiasis.
• Consult a physician if there is fever, chills, lower abdominal/pelvic pain, nausea, vomiting or foul-smelling vaginal discharge.
• Seek medical advice if symptoms worsen or fail to improve following treatment.
• Recurrent infections require medical evaluation to confirm the diagnosis and identify possible underlying causes.
• Do not use in case of known hypersensitivity to miconazole, other imidazole antifungals, or any component of the formulation.

Contraceptive Precaution

Some vaginal miconazole preparations contain oily excipients that may damage latex condoms and diaphragms, potentially reducing their contraceptive effectiveness.

Patients should check the MONICURE package leaflet regarding compatibility with latex contraceptive devices and use appropriate alternative contraception when necessary.

Possible Side Effects

Possible local adverse effects include:

• Vaginal burning or irritation
• Increased itching
• Vulvar irritation or redness
• Vaginal discomfort
• Pelvic or abdominal discomfort
• Hypersensitivity or allergic reactions, rarely

Discontinue treatment and seek medical attention if severe irritation, swelling, rash or other signs of a significant allergic reaction develop.

Drug Interactions

Systemic absorption following vaginal administration is generally limited; however, clinically relevant interactions may occur in some patients.

Particular caution is recommended in patients receiving warfarin or other vitamin K antagonists, because azole antifungals may increase anticoagulant effects in susceptible patients.

Patients should inform their healthcare professional about all prescription medicines, OTC medicines, vitamins and supplements they are taking.

Pregnancy & Breastfeeding

Pregnancy or suspected pregnancy should be discussed with a healthcare professional before treatment.

For pregnant women with vulvovaginal candidiasis, treatment recommendations differ from those for non-pregnant women. Topical vaginal azole therapy is generally preferred during pregnancy, while oral fluconazole is not recommended by WHO for pregnant women.

Breastfeeding patients should consult a healthcare professional before use.

When to Seek Medical Advice

Medical evaluation is recommended if:

• Symptoms occur for the first time.
• Symptoms are severe or unusual.
• There is fever or pelvic/lower abdominal pain.
• Vaginal discharge has a foul odor.
• Symptoms do not improve after treatment.
• Symptoms recur frequently.
• Pregnancy is suspected.
• There is concern about a sexually transmitted infection.

Not all vaginal itching or discharge is caused by Candida. Conditions such as bacterial vaginosis and trichomoniasis require different treatment.

Storage

• Store according to the manufacturer's labeled conditions.
• Keep in the original package until use.
• Protect from excessive heat and moisture.
• Keep out of reach of children.
• Do not use after the expiry date.

Key Product Advantages

MONICURE 400 mg Vaginal Suppositories provide:

• 400 mg miconazole nitrate per suppository
• Targeted intravaginal antifungal therapy
• Activity against susceptible Candida species
• Direct delivery to the site of vaginal infection
• Convenient 3-suppository treatment pack
• Once-daily administration for 3 consecutive days

Patient Disclaimer

This information is provided for educational purposes only and does not replace the advice of a qualified healthcare professional. MONICURE 400 mg Vaginal Suppositories should be used according to the approved product information and/or as directed by a physician. This product is intended for the treatment of susceptible vaginal fungal infections and is not intended to diagnose, treat, cure, or prevent other causes of vaginal symptoms. Consult a healthcare professional if symptoms are severe, recurrent, unusual, do not improve, or if pregnancy is suspected.