Miconal

Italy
Brand name Miconal
Form cream
Active substance / Dosage
MICONAZOLE NITRATE
Prescription type Non-prescription – not available over the counter
ATC code
D01AC02
Registration number 024625
Manufacturer MORGAN S.R.L.
Miconal cream

Table of Contents

Package leaflet

MICONAL

Miconazole
2% Dermatological cream
2% Dermatological powder
2% Vaginal cream
Vaginal ovules 50 mg
Vaginal capsules 1200 mg
0.2% Vaginal wash
PHARMACOTHERAPEUTIC CATEGORY:
Vaginal cream, Vaginal ovules, Vaginal capsules, Vaginal wash: G01AF04
Dermatological cream, Dermatological powder: D01AC02.
Miconazole is an antifungal agent. It is used for the treatment of fungal skin infections.
THERAPEUTIC INDICATIONS
2% Dermatological cream and 2% dermatological powder
Local treatment of skin and nail infections caused by dermatophytes or Candida.
2% Vaginal cream, 50 mg vaginal ovules, 1200 mg vaginal capsules, 0.2% vaginal wash
Treatment of vaginal or vulvo-vaginal fungal infections, particularly those caused by Candida.
BEFORE USING MICONAL
Contraindications
Proven hypersensitivity to the product or to other compounds closely related from a chemical point of view.
Interactions with other medicinal products
None known.
Use during pregnancy and breastfeeding
In pregnant women, the product should be used only if clearly needed and under direct medical supervision.
Effects on ability to drive and use machines
No negative effects of miconazole on the ability to drive or use machines are known.
Special warnings
Prolonged use of the drug may lead to sensitization phenomena.
In such cases, treatment must be discontinued and appropriate therapy initiated.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Posology and method of administration
2% Dermatological powder: 1–2 applications/day
2% Dermatological cream: 1–2 applications/day
50 mg vaginal ovules: 2 vaginal ovules/day (equivalent to 100 mg/day)
1200 mg vaginal capsules: 1 capsule as a single application for 2 consecutive days
2% Vaginal cream: content of one single-use vaginal applicator (5 g of cream), twice daily
0.2% Vaginal wash: 1 wash for 5 consecutive days
Skin infections. Before applying MICONAL (miconazole nitrate) to skin lesions, the affected area must be washed and thoroughly dried. Then, apply 1 cm or more of cream to the affected area, once or twice daily, gently spreading and rubbing until completely absorbed. After the lesions have disappeared, usually within 2 to 5 weeks, treatment should continue for at least 2 additional days to prevent possible relapses. If lesions are exudative, MICONAL powder (miconazole nitrate) should also be used.
Nail infections. Infected nails should first be trimmed as short as possible, then washed and dried before applying MICONAL cream (miconazole nitrate). Apply a small amount of cream 1–2 times daily to the infected nail, then massage gently with fingers. Cover the area with a non-perforated occlusive dressing. It is necessary to regularly cut and remove dead portions using nail clippers, keeping the nail bed and nail edges clean. Treatment must continue uninterrupted even after the infected nail has fallen off (usually after 2–3 weeks) and throughout the entire period of new nail growth (2–3 months), until complete clinical and mycological healing is achieved. Concurrent or separate use of the powder is particularly indicated for the treatment of moist lesions. Sprinkle the lesions 1–2 times daily with MICONAL (miconazole nitrate) powder, continuing treatment uninterrupted until complete resolution of the lesions.
Instructions for use of the vaginal cream applicator.

  1. Open the cream tube by piercing the aluminum seal with the tip of the closure cap.
  2. Screw the single-use applicator onto the tube.
  3. Press the end of the tube to fill the applicator with cream. If resistance is encountered with the plunger, gently move it to loosen.
  4. Remove the applicator and close the tube.
  5. In a supine position, with knees raised and apart, gently insert the applicator into the vagina. Push the plunger fully to complete extrusion of the cream. Remove the applicator without touching the plunger.
    The applicator is for single use only. Use a new cannula for each application.
    Instructions for use of the vaginal wash bottle.
    Break the terminal portion of the closure cap. Insert the cannula into the opening in the correct position. Gently insert the cannula into the vagina and gradually press the bottle while simultaneously performing a slight rotating movement to ensure slow and as uniform as possible irrigation of the vaginal walls.
    If you use more MICONAL than prescribed.
    No adverse effects due to overdose have been reported.
    If you forget to apply MICONAL
    Do not apply a double dose. Apply a normal dose as soon as possible.
    If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
    POSSIBLE ADVERSE EFFECTS
    Topical use: Occasionally, local sensitization or irritant reactions may occur, requiring discontinuation of treatment.
    Vaginal use: Various disturbances have been reported during the first weeks of treatment with miconazole: vaginal burning and irritation, pelvic cramps, and more rarely skin rashes and headache. In such cases, treatment must be discontinued and appropriate therapy initiated.
    If you notice any adverse effect not listed in this leaflet, or if any of the listed adverse effects worsen, inform your doctor or pharmacist.
    HOW TO STORE MICONAL
    Keep out of the reach and sight of children.
    Do not use the medicine after the expiry date stated on the packaging.
    This medicine does not require any special storage conditions.
    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required: this will help protect the environment.
    COMPOSITION
    100 g of dermatological or vaginal cream contain:
    Active ingredient: MICONAZOLE NITRATE 2 g
    Excipients: Glycol palmitostearate, polyoxyethylene glycerides, liquid paraffin, sodium hydroxyethylidenemethylpyranedione, butylated hydroxyanisole, butylated hydroxytoluene, ascorbyl palmitate, purified water.
    100 g of powder contain:
    Active ingredient: MICONAZOLE NITRATE 2 g
    Excipients: Talc, zinc oxide, precipitated silica.
    Each ovule contains:
    Active ingredient: MICONAZOLE NITRATE 50 mg
    Excipients: Partially polyoxyethylene glycolated mono-di-glycerides of natural fatty acids, polyoxyethylene sorbitan monostearate, ethyldiethylene glycol.
    Each vaginal capsule contains:
    Active ingredient: MICONAZOLE NITRATE 1200 mg
    Excipients: Liquid paraffin, white vaseline, gelatin, glycerol, soy lecithin, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium, titanium dioxide.
    100 ml of vaginal wash contain:
    Active ingredient: MICONAZOLE 200 mg
    Excipients: Propylene glycol, lactic acid, ethylene glycol phenylundecyl ether p-hydroxybenzoate, polyoxyethylene derivative of hydrogenated ricinoleic triglyceride, purified water.
    PHARMACEUTICAL FORM
    2% Dermatological cream (tube 30 g)
    2% Dermatological powder (bottle 20 g)
    2% Vaginal cream (tube 78 g with 16 single-use applicators)
    50 mg vaginal ovules (pack of 15 ovules)
    1500 mg vaginal capsules (pack of 2 capsules)
    0.2% Vaginal wash (5 single-use bottles of 150 ml each)
    MARKETING AUTHORISATION HOLDER
    MORGAN Srl
    Via Divisione Folgore 46
    36100 VICENZA
    Manufacturer and responsible for batch release
    Cream, Vaginal cream, Powder, Vaginal ovules, Vaginal wash:
    INDUSTRIA FARMACEUTICA NOVA ARGENTIA Spa
    Via Pascoli 1
    20064 GORGONZOLA MI
    FULTON MEDICINALI Spa
    Via Marconi, 28/9
    20020 ARESE MI
    Vaginal capsules:
    CATALENT ITALY Spa
    Via Nettunense km 20,100
    04011 APRILIA LT