DAKTARIN 20 mg /G Topical Powder

Зміст інструкції

1. DAKTARIN DERMATOLOGICO 20 mg/g cutaneous spray, powder
2. DAKTARIN 20 mg/g vaginal cream
   1. What is Daktarin and what is it used for
   2. What you need to know before using Daktarin
   3. How to use Daktarin
   4. Possible side effects
   5. How to store Daktarin
   6. Contents of the pack and other information

DAKTARIN DERMATOLOGICO 20 mg/g cutaneous spray, powder

miconazole nitrate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your pharmacist.
If any side effects occur, including those not listed in this leaflet, tell your doctor or
pharmacist. See section 4.
If your symptoms do not improve or get worse, see your doctor.

Contents of this leaflet:
What DAKTARIN DERMATOLOGICO cutaneous spray, powder is and what it is used for
What you need to know before you use DAKTARIN DERMATOLOGICO cutaneous spray, powder
How to use DAKTARIN DERMATOLOGICO cutaneous spray, powder
Possible side effects
How to store DAKTARIN DERMATOLOGICO cutaneous spray, powder
Contents of the pack and other information

What DAKTARIN DERMATOLOGICO cutaneous spray, powder is and what it is used for
DAKTARIN DERMATOLOGICO cutaneous spray, powder contains miconazole nitrate, which belongs to
a group of medicines called “antifungals” used to treat fungal infections.
DAKTARIN DERMATOLOGICO cutaneous spray, powder is a medicine for dermatological use indicated for
the treatment of skin infections caused by fungi (dermatophytes) or yeasts (Candida) possibly
complicated by bacterial infections.
See your doctor if you do not feel better or if you feel worse.

What you need to know before you use DAKTARIN DERMATOLOGICO cutaneous spray,
powder
Do not use DAKTARIN DERMATOLOGICO cutaneous spray, powder
if you are allergic to miconazole, or other similar antifungal medicines or to any of the other
ingredients of this medicine (listed in section 6).
In infants and children, up to 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using DAKTARIN DERMATOLOGICO cutaneous spray,
powder.
If sensitization or irritation occurs, especially with prolonged use, stop treatment and contact your
doctor.
Avoid contact with eyes. Wash your hands carefully after each application, unless the
treatment concerns the same hands.
DAKTARIN DERMATOLOGICO cutaneous spray, powder contains talc: avoid inhaling the powder which
may cause irritation of the respiratory tract.
It is advisable to apply the following hygiene measures to avoid sources of infection or reinfection (new
infections by the same fungus):
keep towels and underwear separate for personal use to avoid
infection of other people;
change clothes regularly that come into contact with the infected area to
avoid reinfection. DAKTARIN DERMATOLOGICO cutaneous spray, powder does
not stain the skin or clothing.

Other medicines and DAKTARIN DERMATOLOGICO cutaneous spray, powder
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
As with other topical medicines, clinically relevant interactions are very
rare. Tell your doctor or pharmacist if you are taking:
oral anticoagulants (medicines that prevent blood clotting) such as warfarin:
DAKTARIN DERMATOLOGICO cutaneous spray, powder may alter its effect. Other
oral hypoglycemic medicines (medicines used to treat diabetes) and phenytoin (an
antiepileptic medicine): the effectiveness and side effects may be increased if
administered simultaneously with miconazole.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If pregnancy is confirmed or suspected, consult your doctor who will assess whether to prescribe DAKTARIN
DERMATOLOGICO cutaneous spray, powder.
Use DAKTARIN DERMATOLOGICO cutaneous spray, powder with caution during breastfeeding.

Driving and using machines
DAKTARIN DERMATOLOGICO cutaneous spray, powder does not affect the ability to drive vehicles or operate
machinery.

DAKTARIN DERMATOLOGICO cutaneous spray, powdercontains ethanol.
This medicine contains 105 mg of alcohol (ethanol) in each dose (1050 mg) which is equivalent to 100 mg/g
(10% w/w).
May cause a burning sensation on damaged skin.
This medicine is flammable, do not bring it near flames.

How to use DAKTARIN DERMATOLOGICO cutaneous spray, powder
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
If you have doubts, ask your doctor or pharmacist.
FOR EXTERNAL USE ONLY.
Use DAKTARIN DERMATOLOGICO cutaneous spray, powder only following the instructions.
Use DAKTARIN DERMATOLOGICO cutaneous spray, powder every day to get the best
results.
DAKTARIN DERMATOLOGICO cutaneous spray, powder is particularly indicated for the treatment of
moist lesions. Generally, Daktarin Dermatologico spray powder is used in combination with
Daktarin Dermatologico cream.

How much:Apply an amount of powder sufficient to cover the affected area.

When and for how long:Apply the powder 2 times a day.
Treatment should be continued uninterruptedly for at least one week after the disappearance
of symptoms, and may last from 2 to 6 weeks, depending on the type and extent
of the infection.
If you are also using Daktarin Dermatologico cream in combination, it is sufficient to use
both the powder and the cream once a day.

How:
Wash the affected area and dry well. Treat not only the infected part, but also the area around
it. Wash your hands thoroughly after each application to avoid transferring germs to
other parts of the body or to other people.
For foot infections, it is recommended to sprinkle your feet daily with
DAKTARINDERMATOLOGICO spray powder during and after treatment with another
local formulation (DAKTARIN DERMATOLOGICO cream), in particular between the toes, and also socks and shoes.

If you use more DAKTARIN DERMATOLOGICO cutaneous spray, powder than you should
Excessive use of the medicine may cause redness, swelling or a burning sensation. In this case
stop treatment and consult your doctor.
Accidental ingestion: DAKTARIN DERMATOLOGICO cutaneous spray, powder is for topical
application only and not for oral use. If you accidentally ingest a large amount of DAKTARIN
DERMATOLOGICO spray powder, immediately tell your doctor or go to the nearest
hospital.
DAKTARIN DERMATOLOGICO cutaneous spray, powder contains talc: accidental inhalation of large
quantities of medicine may cause airway obstruction. In this case, contact your doctor immediately.

Possible side effects
Like all medicines, DAKTARIN DERMATOLOGICO cutaneous spray, powder can cause side
effects, although not everybody gets them.
In rare cases, redness, a feeling of
irritation, mild burning or itching may occur at the site of application. In these cases, stop treatment and consult your doctor or
pharmacist.
The following other side effects have been reported.

Very rare side effects (may affect up to 1 in 10,000 people):
severe allergic reaction that appears quickly (anaphylactic reactions)
Allergy
Swelling of the face, mouth, lips and/or tongue (angioedema)
Skin rash (urticaria; rash)
Contact dermatitis (skin inflammation)
Erythema
Pruritus
Burning sensation of the skin
Irritations
Other reactions at the application site

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects 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.

How to store DAKTARIN DERMATOLOGICO cutaneous spray, powder
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after the word Scad.. The
expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, properly stored.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Contents of the pack and other information
What DAKTARIN DERMATOLOGICO cutaneous spray, powder contains
The active ingredient is miconazole nitrate. 100g of powder contains 2 g of miconazole nitrate.
The other ingredients are: talc, sorbitan sesquioleate, anhydrous ethanol, stearalkonium hectorite,
propellant (mixture of propane and butane).

Description of the appearance of DAKTARIN DERMATOLOGICO cutaneous spray, powder and contents
of the pack
Cutaneous spray, powder: container with spray valve of 100 g of 2% powder

Marketing Authorisation Holder
Johnson & Johnson S.p.A., Via Ardeatina, km 23,500 - 00071 Santa Palomba – Pomezia - Roma

Manufacturer
JANSSEN-CILAG S.p.A.
Via C. Janssen – Borgo S. Michele - Latina

JNTL Consumer Health(France) SAS
Domaine de Maigremont - 27100 Val de Reuil - France

DAKTARIN 20 mg/g vaginal cream

Miconazole nitrate

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen

Contents of this leaflet:

• 1. What Daktarin is and what it is used for
• 2. What you need to know before you use Daktarin
• 3. How to use Daktarin
• 4. Possible side effects
• 5. How to store Daktarin
• 6. Contents of the pack and other information

1. What is Daktarin and what is it used for

Daktarin contains miconazole nitrate which belongs to a group of medicines called antifungals and
antiseptics, used to treat infections.
Daktarin is a gynecological medicine indicated for the local treatment of vulvovaginal candidiasis (infections caused by fungi of the Candida type) and superinfections (new infections
that occur on top of an existing infection) due to Gram-positive bacteria.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Daktarin

DO NOT use Daktarin

• if you are allergic to miconazole or other similar antifungal medicines or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Daktarin.
It is advisable to apply the following hygiene measures to avoid sources of infection or
reinfection (new infections by the same fungus):

• keep towels and underwear for personal use in order to avoid infecting other people;
• change underwear regularly to avoid reinfection. Your sexual partner may also need treatment if they have been infected. If in doubt, consult your doctor. Daktarin does not stain the skin or clothing. Daktarin vaginal cream should not be used simultaneously with latex condoms or diaphragms. Daktarin vaginal cream may damage latex-based products and prevent them from working correctly.

If sensitization or an allergic reaction should occur, treatment must be
discontinued.
Daktarin should not be used simultaneously with latex condoms or diaphragms.
Avoid contact of Daktarin with rubber (latex) contraceptives such as condoms or
diaphragms, as the components of Daktarin may damage the latex compromising
contraceptive and protective effectiveness against sexually transmitted diseases.

Children and adolescents:
The safety and efficacy of Daktarin have not been established in children and adolescents (under
18 years of age).

Other medicines and Daktarin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor or pharmacist if you are taking:

• oral anticoagulants (medicines that prevent blood clotting) such as warfarin: Daktarin may alter its effect;
• other medicines, for example oral hypoglycemic agents (medicines used in the treatment of diabetes) and phenytoin (an antiepileptic medicine): efficacy and undesirable effects may be increased if administered simultaneously with miconazole.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
In the first trimester of pregnancy, this medicine should only be used at the doctor's discretion
and only if absolutely necessary.
No data are available regarding the excretion of miconazole nitrate into breast milk. Use Daktarin with
great caution during breastfeeding.

Driving and using machines
Not applicable.

Daktarincontains benzoic acid and butylhydroxyanisole

• Benzoic acid may cause local irritation.
• Butylhydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Daktarin

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is the contents of one applicator (approximately 5 g of cream) to be inserted
deeply into the vagina once a day (in the evening before going to bed)
Treatment should be continued for at least 10 days, even if the itching and whitish discharge
(leucorrhoea) have disappeared after 3 days. If there is no effect, consult your doctor who may
decide to repeat microbiological tests to confirm the diagnosis.

How to use
Perform the following operations:

• 1. To open the tube, unscrew the cap and turn it over, pierce the aluminum seal with the piercing wedge.
• 2. Screw the applicator onto the tube in place of the cap.
• 3. Gently press the tube at its lower end to allow the cream to enter the applicator. If the plunger offers some resistance, pull it gently. Unless otherwise prescribed by your doctor, the applicator should be filled completely.
• 4. Remove the applicator from the tube, which must be closed with the cap.
• 5. In a lying position, keep your knees raised and spread, gently insert the applicator into the vagina as deeply as possible. Push the plunger completely. Then remove the applicator and discard it.

Local treatment with Daktarin is generally well tolerated.
Insertion of the vaginal applicator is painless and easy to perform.

If you use more Daktarinthan you should
Daktarin is intended for local application and not for oral use.
In case of accidental ingestion of large quantities of Daktarin, immediately inform your
doctor or go to the nearest hospital.
The use of Daktarin in quantities higher than prescribed should not cause alarm,
it is generally not dangerous; in this case, as well as for accidental ingestion of the
medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below is a list of side effects that have occurred with Daktarin vaginal cream:

Very rare (may affect up to 1 in 10,000 people):

• Allergy, including severe allergic reaction that appears rapidly (anaphylactic and anaphylactoid reaction)
• Swelling of the face, mouth, lips and/or tongue (angioedema) Stop taking Daktarin and seek immediate medical attention if you notice or suspect any of these very rare side effects:
• Itching
• Vaginal irritation
• Reaction at the application site

Not known (frequency cannot be estimated from available data)

• Itching of the female genital organs
• Vaginal burning sensation
• Vulvovaginal discomfort
• Headache
• Painful periods (dysmenorrhea)
• Abdominal pain
• Pain in the upper abdomen
• Nausea
• Vaginal discharge
• Vaginal bleeding
• Vaginal pain
• Urinary tract infection
• Difficult or painful urination (dysuria)
• Itchy skin rash (pruritic rash)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Daktarin

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after the word
Exp. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging and correctly
stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Daktarin contains
The active ingredient is miconazole nitrate 20 mg. One gram of vaginal cream contains 20 mg of
miconazole nitrate.

• The other ingredients are: polyethylene glycol palmitostearate, macrogol, glyceryl oleate, liquid paraffin, butylated hydroxyanisole, benzoic acid,purified water

Description of the appearance of Daktarinand contents of the pack
2% vaginal cream - tube of 78 grams with 16 single-use applicators

Marketing Authorisation Holder
Johnson & Johnson S.p.A., Via Ardeatina, km 23,500 - 00071 Santa Palomba – Pomezia - Rome

MANUFACTURER
JANSSEN PHARMACEUTICA N.V.
Turnhoutseweg, 30
B-2340 Beerse (Belgium)