Active ingredients: Miconazole (Miconazole nitrate)
DAKTARIN 100 mg vaginal suppositories
DAKTARIN 400 mg soft vaginal capsules
DAKTARIN 1200 mg soft vaginal capsules
Daktarin package inserts are available for pack sizes: - DAKTARIN 100 mg vaginal suppositories, DAKTARIN 400 mg vaginal soft capsules, DAKTARIN 1200 mg vaginal soft capsules
- DAKTARIN 2% vaginal cream
- DAKTARIN 2% oral gel
- DAKTARIN 0.2% Vaginal solution
Why is Daktarin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antifungal for gynecological use.
THERAPEUTIC INDICATIONS
Local treatment of vulvovaginal candidiasis and superinfections due to Gram positive bacteria.
Contraindications When Daktarin should not be used
Hypersensitivity to the active substance, to other imidazole derivatives or to any of the excipients.
Precautions for use What you need to know before taking Daktarin
It is advisable to apply the following hygiene measures to avoid sources of infections or reinfections:
- keep towels and underwear for personal use in order to avoid infection of other people;
- change your underwear regularly to avoid re-infection.
Your sexual partner may also need treatment if they are infected. If in doubt, consult your doctor.
DAKTARIN does not stain skin or clothing.
Should sensitization or allergic reaction occur, treatment should be discontinued.
DAKTARIN ovules and vaginal soft capsules should not be used at the same time as condoms or latex diaphragms.
Interactions Which drugs or foods can modify the effect of Daktarin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
If you are taking oral anticoagulants, such as warfarin, you should tell your doctor or pharmacist as this medicine may change their effect.
The efficacy and undesirable effects of other drugs (eg oral hypoglycaemics and phenytoin), if given at the same time as miconazole, may be increased, so you should tell your doctor or pharmacist if you are taking other drugs.
Avoid contact of DAKTARIN ovules and vaginal capsules with rubber-based (latex) contraceptives such as condoms or diaphragms. The components of DAKTARIN can damage the rubber (latex) compromising the contraceptive and protective efficacy against sexually transmitted diseases.
Warnings It is important to know that:
Should sensitization or an allergic reaction occur, the treatment should be discontinued.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
During pregnancy or breastfeeding, the product should only be used if clearly needed and under direct medical supervision.
Effects on ability to drive and use machines
Nothing to report.
Important information about some of the ingredients
The soft vaginal capsules contain sodium ethyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate which can cause allergic reactions (possibly delayed).
Dose, Method and Time of Administration How to use Daktarin: Posology
Insert the egg or capsule deeply into the vagina.
The best way to do this is to lie on your back with your knees still and apart. Insertion should be done at bedtime to keep the egg or capsule in place overnight.
Vaginal suppositories 100 mg
Once a day (in the evening before bedtime) introduce an egg as deeply as possible into the vagina.
Treatment should be continued for two weeks, even after the itching, redness or whitish discharge (leucorrhoea) has disappeared.
The treatment can also be continued during the menstrual period.
In case of no effect, consult your doctor.
Soft vaginal capsules 400 mg
Insert one capsule into the vagina as deeply as possible each evening, for 3 consecutive evenings.
If necessary, the treatment can be repeated.
A complete therapeutic course (3 or 6 days according to medical prescription) must always be followed even if the symptoms (itching, redness or leucorrhea) disappear quickly.
The treatment can also be continued during the menstrual period.
Soft vaginal capsules 1200 mg
Insert a capsule into the vagina as deeply as possible, preferably in the evening.
If necessary, the treatment can be repeated.
A complete treatment course (2 days) should always be followed even if the symptoms (itching, redness or leucorrhea) disappear quickly.
The treatment can also be continued during the menstrual period.
Children and adolescents (under 18 years of age):
The safety and efficacy of DAKTARIN ovules and vaginal capsules have not been established in children and adolescents.
Overdose What to do if you have taken too much Daktarin
In case of accidental ingestion / intake of an excessive dose of DAKTARIN, notify your doctor immediately or go to the nearest hospital.
DAKTARIN ovules and vaginal capsules are intended for local application and not for oral use.
The use of DAKTARIN ovules and vaginal capsules in higher quantities than prescribed, should not alarm, is generally not dangerous; in this case, as well as for accidental ingestion of the drug, consult your doctor.
Information for the doctor:
In case of accidental ingestion of DAKTARIN ovules and vaginal capsules, use appropriate supportive therapy. The efficacy and side effects of other drugs (eg oral hypoglycaemics and phenytoin), when taken at the same time as miconazole, may be increased.
If you have any questions about the use of DAKTARIN, ask your doctor or pharmacist.
Side Effects What are the side effects of Daktarin
Like all medicines, DAKTARIN can cause side effects, although not everybody gets them.
Especially at the beginning of the treatment, some disorders have been reported such as redness, vaginal irritation, vulvovaginal discomfort, itching and burning sensation in the genitals, which usually regress spontaneously. If not and if urticaria occurs, skin rashes, pain abdominal, vaginal discharge or headache discontinue treatment and consult your doctor to institute appropriate therapy.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly through the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Do not store above 30 ° C
The expiry date indicated refers to the product in intact and correctly stored packaging.
Warning: do not use medicines after the expiry date indicated on the package.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
COMPOSITION
One vaginal egg contains: 100 mg miconazole nitrate. Excipients: solid semisynthetic glycerides.
One 400 mg vaginal soft capsule contains: 400 mg miconazole nitrate. Excipients: high viscosity mineral oil (liquid paraffin), white petroleum jelly, gelatin, glycerin, titanium dioxide, sodium ethyl-p-hydroxybenzoate, sodium propyl-p-hydroxybenzoate.
One 1200 mg vaginal soft capsule contains: 1200 mg miconazole nitrate. Excipients: high viscosity mineral oil (liquid paraffin), white petroleum jelly, soy lecithin, gelatin, glycerin, titanium dioxide, sodium ethyl-p-hydroxybenzoate, sodium propyl-p-hydroxybenzoate.
PHARMACEUTICAL FORMS AND PACKAGING
100 mg vaginal pessaries - 15 pessaries
400 mg soft vaginal capsules - 3 capsules
1200 mg soft vaginal capsules - 2 capsules
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DAKTARIN® ova
DAKTARIN® vaginal capsules
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
A vaginal ovum 100 mg contains: Miconazole nitrate 100 mg equal to 87 mg of miconazole.
A vaginal soft capsule 400 mg contains: Miconazole nitrate 400 mg equal to 347 mg of miconazole.
A vaginal soft capsule 1200 mg contains: Miconazole nitrate 1200 mg equal to 1042 mg of miconazole.
03.0 PHARMACEUTICAL FORM
100 mg vaginal suppositories.
400 mg soft vaginal capsules.
1200 mg soft vaginal capsules.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Local treatment of vulvovaginal candidiasis and superinfections due to Gram positive bacteria.
04.2 Posology and method of administration
Insert the egg or capsule deeply into the vagina.
The best way to do this is to lie on your back with your knees still and apart. Insertion should be done at bedtime to keep the egg or capsule in place overnight.
100 mg vaginal pessaries:
Once a day (in the evening before bedtime) introduce an egg as deeply as possible into the vagina.
Treatment should be continued for two weeks, even after the itching, redness or leucorrhea has disappeared.
The treatment can also be continued during the menstrual period.
In case of lack of effect, it is advisable to repeat the microbiological tests to confirm the diagnosis.
Soft vaginal capsules of 400 mg:
Insert one capsule into the vagina as deeply as possible each evening, for 3 consecutive evenings.
If necessary, the treatment can be repeated.
In case of pronounced infections it may be preferable to prescribe a treatment of 6 consecutive days from the beginning
A complete therapeutic course (3 or 6 days according to medical prescription) must always be followed even if the symptoms (itching, redness or leucorrhea) disappear quickly.
The treatment can also be continued during the menstrual period.
1200 mg soft vaginal capsules:
Insert a capsule into the vagina as deeply as possible, preferably in the evening.
If necessary, the treatment can be repeated.
In case of pronounced infections it may be preferable to prescribe a longer therapeutic course from the beginning.
A complete treatment course (2 days) should always be followed even if the symptoms (itching, redness or leucorrhea) disappear quickly.
The treatment can also be continued during the menstrual period.
04.3 Contraindications
Hypersensitivity to the components.
04.4 Special warnings and appropriate precautions for use
Should sensitization or an allergic reaction occur, the treatment should be discontinued.
Adequate preventive hygiene measures should be adopted in order to limit the possibility of infection or reinfection.
Adequate therapy should also be followed by the partner if he has been infected.
DAKTARIN does not stain skin or clothing.
04.5 Interactions with other medicinal products and other forms of interaction
Contact with some latex products, such as diaphragm or condom type contraceptives, and DAKTARIN vaginal pessaries and soft capsules should be avoided, as the blanket may be damaged by the emollient base. In such situations the use of gynecological cream can be recommended.
04.6 Pregnancy and lactation
Although intravaginal absorption is limited, DAKTARIN should only be used in the first trimester of pregnancy if, in the judgment of the physician, the expected benefit outweighs the potential risk.
There are no known data on the excretion of miconazole nitrate in breast milk, so great caution should be exercised when administering DAKTARIN during the lactation period.
04.7 Effects on ability to drive and use machines
Nothing to report.
04.8 Undesirable effects
Local treatment with DAKTARIN is usually well tolerated. However, especially at the beginning of the treatment, some disorders have been reported such as vaginal irritation, redness, itching and burning sensation, pelvic cramps, more rarely skin rashes and headache.
04.9 Overdose
Symptoms:
In case of accidental ingestion no particular problems are expected. However, if this occurs concomitantly with the intake of other drugs, such as coumarin derivatives, oral hypoglycemic agents and phenytoin, the action and side effects of the latter can be enhanced.
Treatment:
In case of accidental ingestion of large quantities of the drug, adopt, if necessary, an appropriate method of gastric emptying.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Miconazole combines in itself both a powerful antifungal activity against common dermatophytes and yeasts, and an antibacterial activity against certain Gram positive bacilli and cocci.
Miconazole inhibits, in fungi, the biosynthesis of ergosterol, an essential component for the integrity and functionality of the membrane of the fungal cell, and modifies the composition of other lipid components of the membrane. This mechanism of action involves the necrosis of the fungal cell.
Miconazole exerts a very rapid action on itching that often accompanies infections caused by dermatophytes and yeasts, and this even before the onset of therapeutic action.
05.2 Pharmacokinetic properties
Systemic absorption after intravaginal administration is negligible.
8 hours after application, 90% of the drug is still present in the vagina. There are no traces of unchanged drug in plasma or urine.
As for the soft vaginal capsules, after insertion into the vagina the outer covering rapidly disintegrates and the active suspension is released almost instantly.
05.3 Preclinical safety data
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06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
100 mg vaginal pessaries: solid semisynthetic glycerides.
Soft vaginal capsules of 400 mg: high viscosity mineral oil (liquid paraffin), white petroleum jelly, gelatin, glycerin, titanium dioxide, sodium ethyl-p-hydroxybenzoate, sodium propyl-p-hydroxybenzoate.
1200 mg soft vaginal capsules: high viscosity mineral oil (liquid paraffin), white petroleum jelly, soy lecithin, gelatin, glycerin, titanium dioxide, sodium ethyl p-hydroxybenzoate, sodium propyl-p-hydroxybenzoate.
06.2 Incompatibility
Nothing to report.
06.3 Period of validity
Vaginal suppositories: 3 years
Soft vaginal capsules: 5 years
06.4 Special precautions for storage
Vaginal suppositories: store at a temperature not exceeding 25 ° C
Soft vaginal capsules: 400 mg: store at room temperature (15 ° -30 ° C); 1200 mg: store at a temperature not exceeding 25 ° C
06.5 Nature of the immediate packaging and contents of the package
Vaginal suppositories: blister of 15 impressions. Lithographed cardboard box containing the package leaflet - 15 eggs
Soft vaginal capsules: blisters of 3 and 2 impressions (respectively for the pack of 3 capsules of 400 mg and the pack of 2 capsules of 1200 mg respectively). Lithographed cardboard box containing the package leaflet.
06.6 Instructions for use and handling
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07.0 MARKETING AUTHORIZATION HOLDER
Janssen - Cilag SpA
Via M. Buonarroti, 23
20093 COLOGNO MONZESE (Milan)
08.0 MARKETING AUTHORIZATION NUMBER
100 mg vaginal suppositories AIC 024957211
400 mg soft vaginal capsules AIC 024957312
1200 mg soft vaginal capsules AIC 024957173
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
100 mg vaginal suppositories: June 2, 1979 / June 2005
400 mg soft vaginal capsules: 25 October 1984 / June 2005
1200 mg soft vaginal capsules: 25 October 1984 / June 2005
10.0 DATE OF REVISION OF THE TEXT
01/10/2007
