Leidapharm Miconazolnitraat

For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria.

For the local treatment of vulvovaginal candidosis and superinfections due to Gram-positive bacteria.

For the treatment of vaginal yeast infections and the relief of external vulvar itching and irritation associated with a yeast infection. If you have any or all of the symptoms of a yeast infection (vaginal itching, burning, discharge) and if at sometime in the past your doctor has told you that these symptoms are due to a yeast infection, then miconazole nitrate vaginal cream should work for you. If, however, you have never had these symptoms before, you should see your doctor before using miconazole nitrate vaginal cream. MICONAZOLE VAGINAL CREAM IS FOR THE TREATMENT OF VAGINAL YEAST INFECTIONS AND FOR THE RELIEF OF EXTERNAL VULVAR ITCHING AND IRRITATION ASSOCIATED WITH A YEAST INFECTION. IT DOES NOT TREAT OTHER INFECTIONS OR EXTERNAL ITCHING AND IRRITATION DUE TO CAUSES OTHER THAN YEAST INFECTIONS. IT DOES NOT PREVENT PREGNANCY.

Route of administration: Cutaneous use.

Recommended dosage:

For all ages:

Fungal infections of the skin: Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully penetrated. If the powder is used with the cream, a once daily application of both formulations is recommended. The duration of therapy varies from 2 to 6 weeks depending on the localisation and the severity of the lesion. Treatment should be continued at least one week after disappearance of all signs and symptoms.

Nail infections: Apply the cream once or twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

Leidapharm Miconazolnitraat vaginal capsules are for intravaginal administration.

Adults (aged 18 years and older)

One soft vaginal capsule to be inserted high in the vagina at bedtime, as a single dose. This is best done in the reclining position.

Paediatrics (aged under 18 years)

The safety and efficacy of Leidapharm Miconazolnitraat vaginal capsule in children and adolescents has not been studied.

No information provided.

No information provided.

Daktarin Cream must not come into contact with the mucosa of the eyes.

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Cream and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.

Benzoic acid (E210) is mildly irritant to the skin, eyes and mucous membranes.

Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Leidapharm Miconazolnitraat vaginal capsule and with other miconazole formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.

Appropriate therapy is indicated when the sexual partner is also infected.

Leidapharm Miconazolnitraat vaginal capsules do not stain skin or clothes.

The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents. Therefore Leidapharm Miconazolnitraat vaginal capsules should not be used concurrently with a latex condom or latex diaphragm.

WARNINGS

·This product is only effective in treating vaginal infection caused by yeast and in relieving vulvar itching and irritation associated with a yeast infection. Do not use in the eyes or take by mouth.

·Do not use miconazole nitrate vaginal cream if  you have any of  the following signs and symptoms. Also, if they occur while using miconazole nitrate vaginal cream, STOP using the product and contact your doctor right away. You may have a  more serious illness.

Fever (Above 100°F orally)

Pain in the lower abdomen, back or either shoulder.  A vaginal discharge that smells bad

· If  there is no improvement or if the infection worsens within 3 days, or complete relief is not felt within 7 days, or your symptoms return within two months, then you may have something other than a yeast infection. You should consult your doctor.

· If you may have been exposed to the human immunodeficiency virus (HIV, the virus that causes AIDS) and are now having recurrent vaginal infections, especially infections that don't clear up easily with proper treatment, see your doctor promptly to determine the cause of your symptoms and to receive proper medical care. 

· Mineral oil may weaken latex in condoms or in diaphragms. This cream contains mineral oil. Do not  rely on condoms or diaphragms to prevent sexually transmitted diseases or pregnancy while using miconazole nitrate vaginal cream.

· Do not use tampons while using this medication.

· Do not use in girls less than 12 years of age. 

· If you are pregnant or think you may be, do not use this product except under the advice and supervision of a doctor. 

· Keep this and all drugs out of the reach of children. 

· In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

IMPORTANT: DO NOT USE IF CARTON WAS OPENED. THE TUBE OPENING SHOULD BE SEALED. IF SEAL HAS BEEN PUNCTURED OR IS NOT VISIBLE, DO NOT USE. RETURN THE PRODUCT TO THE STORE WHERE YOU BOUGHT IT.

PRECAUTIONS

NOT SUPPLIED

Not relevant.

None known.

Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in Table 1 below. Moreover, adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet threshold criteria are included in Table 1. The adverse drug reactions are ranked by frequency, using the following convention:

Very common >1/10

Common >1/100 and <1/10

Uncommon >1/1,000 and <1/100

Rare >1/10,000 and <1/1,000

Very rare <1/10,000, including isolated reports

Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by frequency category based on incidence in clinical trials or epidemiology studies, when known.

Table 1: Adverse reactions reported in clinical trials and post-marketing experience

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

The safety of Leidapharm Miconazolnitraat was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g., vulvovaginal itching, burning/irritation), or signs of vulvar erythema, edema, excoriation, or vaginal erythema or edema who participated in 2 single-blind clinical trials. Subjects were treated with miconazole intravaginally, randomly assigned to either a single 1,200 mg capsule, or a 7-day application of 2% vaginal cream. Adverse reactions reported by >1% of Leidapharm Miconazolnitraat-treated subjects in these trials are shown in Table 1.

In the table, the frequencies are provided according to the following convention:

Table 1. Adverse Reactions Reported by Leidapharm Miconazolnitraat-treated Subjects in 2 Single Blind Clinical Trials

A range of additional reactions were reported during the clinical trials, such as: vaginal discharge, vaginal haemorrhage, vaginal pain, headache, dysuria, urinary tract infection, abdominal pain, rosacea, swelling of the face and nausea. However due to the design of these studies, a definitive causal relationship could not be established.

Table 2. Adverse Reactions Identified During Postmarketing Experience with Leidapharm Miconazolnitraat by Frequency Category Estimated from Spontaneous Reporting Rates

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

The following side effects have been reported with the use of miconazole nitrate vaginal cream; a temporary increase in burning, itching, and/or irritation when the cream is inserted. Abdominal cramping, headaches, hives, and skin rash have also been reported. If any of these occur, stop using miconazole nitrate vaginal cream and consult your doctor.

Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment

Daktarin cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care

Symptoms

Leidapharm Miconazolnitraat vaginal capsules are intended for local application and not for oral use. In case of accidental ingestion, no problems are expected.

Treatment

In the event of accidental ingestion of large quantities, use appropriate supportive care.

No information provided.

Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.

Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

Pharmacotherapeutic classification:

(Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivative)

ATC code: G01A F04

Miconazole is a synthetic imidazole antifungal agent with a broad spectrum of activity against pathogenic fungi (including yeasts and dermatophytes) and gram-positive bacteria (staphylococcus and streptococcus spp). Miconazole combines a potent antifungal activity against common dermatophytes and yeasts with an antibacterial activity against certain gram-positive bacilli and cocci.

Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.

In general, miconazole exerts a very rapid effect on pruritus, a symptom that frequently accompanies dermatophyte and yeast infections.

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.

After the capsule has been inserted into the vagina, the outer covering rapidly disintegrates and the active suspension is almost instantaneously released.

Absorption: Miconazole persists in the vagina for up to 72 hours after a single dose. Systemic absorption of miconazole after intravaginal administration is limited, with a bioavailability of 1 to 2% following intravaginal administration of a 1200 mg dose. Plasma concentrations of miconazole are measurable within 2 hours of administration in some subjects, with maximal levels seen 12 to 24 hours after administration. Plasma concentrations decline slowly thereafter and were still measurable in most subjects 96 hours post-dose. A second dose administered 48 hours later resulted in a plasma profile similar to that of the first dose.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine. The apparent elimination half-life ranges from 15 to 49 hours in most subjects and likely reflects both absorption from the site of application and metabolism/excretion of the drug.

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

Preclinical data reveal no special hazard for humans based on studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

Not applicable.

None known.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

No special requirements.