ITAMELAGIN – Vaginal Suppository

Itamelagin

ITAMELAGIN Vaginal Suppository

COMPOSITION

Each suppository contains:

Metronidazole …………………………… 500 mg

Miconazole nitrate……………………… 100 mg

Lactobacillus acidophilus……………. 50 mg

Excipients:  Solid semisynthetic glycerides.

Description: Vaginal suppository , opalescent white colour with brown spots

INDICATIONS

– Itamelagin is a broad spectrum antifungal combined preparation which also exhibits activity against Trichomonas spp. Itamelagin is indicated for the treatment of candidal vaginitis and mixed vaginal infections due to Gram+ and Gram- bacteria. Lactobacillus spp. activity promotes the restoration of the physiological conditions of the vagina.

DOSAGE & ADMINISTRATIONS

– One vaginal suppository should be inserted daily, preferably at night, for 10 days or 14 days.

* Not To Be Taken Orally. This drug should be used only under prescription.

CONTRAINDICATIONS

– Known hypersensitivity to Metronidazole, Miconazole nitrate, and Lactobacillus acidophilus or to any of the components of the vaginal suppositories.

SIDE EFFECTS

– Rarely patients may experience local mild burning or irritation immediately after inserting the vaginal suppository.

– Rarely hypersensitivity reactions have occurred.

- Inform your doctor in case of any adverse reactions related to drug use.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

– Disulfiram-like reaction to alcohol has been reported with oral Metronidazole, thus the patient should be cautioned with drinking alcohol while being treated with Metronidazole.

– The treatment duration must be limited due to the danger of selection of resistant micro-organisms and the risk of superinfection by these micro-organisms.

WARNING

– Do not interrupt treatment even during menstrual period.

– Do not douche unless the doctor says so. Douching may disturb the vaginal bacterial balance

– Dry the outside vaginal area thoroughly after a shower, bath or swim. Change out of a wet bathing suit or damp workout clothes as soon as possible. A dry place is less likely to encourage the growth of yeast.

DRUG INTERACTIONS

– Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time.

– In patients stabilized on relatively high doses of lithium, short-term Metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.

– Miconazole may increase the plasma concentration of phenytoin so far that may harm to the hepatic metabolism of phenytoin.

– Miconazole may increase the effect of oral anticoagulants (coumarin and warfarin).

– In patients stabilized on relatively high doses of lithium, short-term Metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.

– The use of other local drugs on the same area should be avoided during treatment with Itamelagin, since interactions cannot be ruled out.

USE IN PREGNANCY AND LACTATION

– Itamelagin is not indicated in the first three months of pregnancy.

– Use in pregnant women should be carefully considered. Itamelagin should be administered only if evidently necessary.

Effects on ability to drive and operate machine

– Itamelagin has no significant effects on ability to drive and operate machine.

OVERDOSAGE

– Overdosage of miconazole nitrate, metronidazole and Lactobacillus acidophilus vaginal suppositories in humans has not been reported to date.

SHELF LIFE

– 36 months from the manufacturing date.

STORAGE

– Store in a dry place below 250C, protect from light.

SPECIFICATION

– Manufacturer.

PACKAGING

– Box of 2 trips of 5 suppositories.

Keep all medicines out of the reach of children.

Read carefully the leaflet before use.

This drug is dispensed on prescription only.

For further information, please contact your doctor.

MANUFACTURED by: Via Marconi

28/9-20020Arese (Milano), Italy

FAX (02) 93589162– TEL (02) 93823/63/71

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