Daktarin-oral

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Daktarin-oral (Daktarin)

20 mg/g, gel for oral use

Miconazole
Daktarin-oral and Daktarin are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Daktarin-oral gel and what is it used for
• 2. Important information before using Daktarin-oral gel
• 3. How to use Daktarin-oral gel
• 4. Possible side effects
• 5. How to store Daktarin-oral gel
• 6. Contents of the packaging and other information

1. What is Daktarin-oral gel and what is it used for

Daktarin-oral gel for oral use contains the active substance miconazole, which belongs to a group of medicines called antifungal medicines.
Miconazole has an antifungal effect on dermatophytes and yeasts, and an antibacterial effect on some Gram-positive rods and cocci.
Daktarin-oral gel is used to treat yeast infections of the mouth and throat, as well as the gastrointestinal tract in adults and children aged at least 4 months. In infants aged between 4 and 6 months, it should be ensured before administering the gel that they do not have swallowing problems (see section "When not to use Daktarin-oral gel").

2. Important information before using Daktarin-oral gel

When not to use Daktarin-oral gel:

• if the patient is allergic to miconazole, other similar antifungal medicines, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has liver function disorders,
• in infants under 4 months of age or in infants under 5-6 months of age who were born prematurely or do not have a sufficiently developed swallowing reflex, due to the risk of choking,
• if the patient is taking any of the following medicines (see also section "Daktarin-oral gel and other medicines"):
• certain medicines used for hypersensitivity (allergy), such as terfenadine, astemizole, mizolastine;
• cisapride, a medicine used for digestive disorders;
• certain medicines that lower cholesterol levels, such as simvastatin or lovastatin;
• midazolam (given orally) or triazolam - medicines used for anxiety or sleep disorders;
• pimozide and sertindole, medicines used to treat certain mental disorders;
• halofantrine - an antimalarial medicine;
• certain medicines used to treat migraines, such as ergot alkaloids;
• certain medicines used to treat heart rhythm disorders, such as bepridil, quinidine, and dofetilide.

Do not use the medicine if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using Daktarin-oral gel.

Warnings and precautions

Before starting to use Daktarin-oral gel, discuss it with your doctor.
Daktarin-oral gel may cause severe allergic reactions. You should familiarize yourself with the symptoms of these allergic reactions, which are described in section 4. Possible side effects.
Particular caution should be exercised when using Daktarin-oral gel, especially in infants and young children, as it may cause choking. To avoid this, do not apply the medicine to the back of the throat, and divide each dose into smaller portions. Apply the gel to the affected areas (white patches) with a clean finger, following the doctor's or pharmacist's instructions. A breastfeeding woman should not apply the gel to the nipple to treat the child.
If the patient is taking anticoagulant medicines, such as warfarin, it is necessary to monitor blood clotting parameters and adjust the dose of the anticoagulant medicine by the doctor.
During concurrent use of Daktarin-oral gel and phenytoin, it is necessary to monitor the blood levels of both medicines.
In patients taking certain oral antidiabetic medicines, an excessive decrease in blood sugar levels may occur.
If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before using Daktarin-oral gel.

Daktarin-oral gel and other medicines

Tell your doctor about all medicines you are currently taking, or have recently taken, as well as any medicines you plan to take.
The effects of many medicines, including their side effects, may be enhanced or weakened during concurrent use with Daktarin-oral gel.
During treatment with Daktarin-oral gel, certain medicines should not be used, and the use of certain medicines may require dose adjustment by the doctor (see "When not to use Daktarin-oral gel").
Medicines whose use is contraindicated with Daktarin-oral gel:

• certain medicines used for hypersensitivity (allergy), such as terfenadine, astemizole, mizolastine;
• cisapride, a medicine used for digestive disorders;
• certain medicines that lower cholesterol levels, such as simvastatin or lovastatin;
• midazolam (given orally) or triazolam - medicines used for anxiety or sleep disorders;
• pimozide and sertindole, medicines used to treat certain mental disorders;
• halofantrine - an antimalarial medicine;
• certain medicines used to treat migraines, such as ergot alkaloids;
• certain medicines used to treat heart rhythm disorders, such as bepridil, quinidine, and dofetilide.

Concurrent use of certain medicines may require close monitoring or dose adjustment of Daktarin-oral gel, or the medicine used concomitantly. These include:

• anticoagulant medicines, such as warfarin;
• certain oral antidiabetic medicines;
• certain medicines used for AIDS, such as HIV protease inhibitors (e.g., saquinavir);
• certain medicines used for cancer, such as vinca alkaloids, busulfan, and docetaxel;
• certain medicines used for cardiovascular diseases (calcium channel blockers, such as dihydropyridine derivatives and verapamil);
• cyclosporine, tacrolimus, and sirolimus - medicines usually given after transplants;
• phenytoin, carbamazepine - medicines used to treat epilepsy;
• certain medicines used in hospitals for anesthesia, such as alfentanil;
• sildenafil - a medicine used to treat impotence;
• certain medicines used for anxiety and sleep disorders, such as alprazolam, brotizolam, buspirone;
• certain medicines used to treat tuberculosis, such as rifabutin;
• methylprednisolone - an anti-inflammatory medicine used orally or by injection;
• trimethoprim - a medicine used to treat certain types of pneumonia;
• ebastine - a medicine used for hypersensitivity (allergy);
• reboxetine - a medicine used to treat depression;
• midazolam given intravenously;
• cilostazol - a medicine used to treat atherosclerosis of the arteries;
• disopyramide - a medicine used to treat heart rhythm disorders.

You must inform your doctor about the use of any of the above medicines or if you are using any other prescription medicine.
When using Daktarin-oral gel, never start treatment with a new medicine without consulting your doctor.

Pregnancy and breastfeeding

Before using any medicine, consult a doctor or pharmacist.
If the patient is pregnant, suspects she may be pregnant, or plans to have a child, she should inform her doctor before using Daktarin-oral gel. The doctor will decide whether to use Daktarin-oral gel after weighing the risks and benefits of using the medicine.
Breastfeeding women should consult a doctor before using the medicine, who will decide whether to use Daktarin-oral gel. A breastfeeding woman should not apply the gel to the nipple to treat the child.

Driving and operating machinery

Daktarin-oral gel does not affect the ability to drive or operate machinery.

Daktarin-oral gel contains alcohol (ethanol), orange flavor, cocoa flavor, ethanol, and sodium

Alcohol (ethanol)

This medicine contains 7.85 mg of alcohol (ethanol) per gram of gel for oral use, which is equivalent to 0.00785 mg/mg (0.785% w/w).
The amount in a single maximum dose of this medicine for an adult (2 scoops or 10 ml of gel for oral use) is equivalent to less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml dose (maximum single dose for an adult), i.e., the medicine is considered "sodium-free".

3. How to use Daktarin-oral gel

This medicine should always be used as directed by your doctor. If in doubt, consult a doctor or pharmacist.
Daktarin-oral gel, in the form of a gel for oral use, should be taken after a meal. The doctor will determine the exact treatment regimen.
The gel should not be swallowed immediately, but kept in the mouth for as long as possible.
Treatment should be continued for at least a week after the symptoms have disappeared.
The measuring spoon provided with the packaging allows for measuring a dose of 124 mg/5 ml.

The following is a description of the usual recommended dosage

Yeast infections of the mouth and throat
Infants aged 4 to 24 months: 1.25 ml (1/4 scoop) of gel four times a day after eating.
Each dose should be divided into smaller portions and the gel applied to the affected areas with a clean finger. The gel should not be applied to the back of the throat due to the risk of choking. The gel should not be swallowed immediately, but kept in the mouth for as long as possible.
Adults and children over 2 years: 2.5 ml (1/2 scoop) of gel four times a day after eating. The gel should not be swallowed immediately, but kept in the mouth for as long as possible.
Treatment should be continued for at least a week after the symptoms have disappeared.
People wearing dentures should remove them at night and brush them with a toothbrush with the gel applied. This prevents the denture from becoming infected.
Yeast infections of the gastrointestinal tract
The medicine can be used in infants aged 4 months, children, and adults.
The dose depends on body weight. The daily dose should not exceed 250 mg (10 ml of gel) four times a day, i.e.

• up to 12 kilograms: ¼ scoop (1.25 ml) of gel four times a day;
• 12 to 25 kilograms: ½ scoop (2.5 ml) of gel four times a day;
• 25 to 37 kilograms: 1 scoop (5 ml) of gel four times a day;
• 37 to 50 kilograms: 1 and ½ scoops (7.5 ml) of gel four times a day;
• 50 kilograms or more: 2 scoops (10 ml) of gel four times a day.

Treatment should be continued for at least a week after the symptoms have disappeared.
To open the tube, unscrew the cap. Then, pierce the tube seal with the piercer located on the top of the cap.

Using more than the recommended dose of Daktarin-oral gel

In case of using more than the recommended dose of Daktarin-oral gel, contact a doctor or go to the emergency room at the nearest hospital. Vomiting and diarrhea may occur. If the patient is also taking other medicines (e.g., warfarin, oral antidiabetic medicines, or phenytoin), the effects of these medicines, including their side effects, may be enhanced.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur, stop taking Daktarin-oral gel and contact a doctor immediately:

• swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing (angioedema, anaphylactic reactions).
• toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms - these are severe skin reactions with symptoms such as: rash, skin peeling, blisters, pustules all over the body, especially in the mouth, eyes, and genital areas, fever, and lymph node enlargement.
• acute generalized exanthematous pustulosis - a rash with pustules/blisters filled with pus.
• hepatitis, which may be accompanied by the following symptoms: loss of appetite, nausea, vomiting, fatigue, abdominal pain, jaundice, very dark urine, and pale stools. The frequency of the above side effects is unknown (cannot be determined from available data).

If you notice any of the following side effects, inform your doctor or pharmacist:

Common (occurring in less than 1 in 10 people):

• taste disorders,
• dryness of the oral mucosa, discomfort in the mouth,
• nausea,
• vomiting,
• abnormal taste of products.

Frequency not known (frequency cannot be determined from available data):

• choking,
• diarrhea,
• stomatitis,
• discoloration of the tongue,
• hives,
• rash.

In children, nausea and vomiting are very common side effects(may occur in more than 1 in 10 people), and regurgitationis a common side effect.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Daktarin-oral gel

Store in a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Before using the medicine, check the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Daktarin-oral gel contains

What Daktarin-oral gel contains

• The active substance of the medicine is miconazole. 1 g of gel contains 20 mg of miconazole.
• The other excipients are: cornstarch, sodium saccharin, polysorbate 20, orange flavor, cocoa flavor, ethanol 96%, glycerol, purified water.

What Daktarin-oral gel looks like and what the packaging contains

An aluminum tube containing 40 g of white, homogeneous gel, with a measuring spoon of 5 ml capacity, with a 1.25 ml graduation, in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Johnson & Johnson Hellas Consumer AE
Aigialeias & Epidavrou 4
15125 Marousi
Athens
Greece

Manufacturer:

Janssen Pharmaceutica NV
Beerse, Belgium

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź

Marketing authorization number in Greece, the country of export: 85250/12-11-2013

Parallel import authorization number: 172/18 Date of approval of the leaflet: 24.04.2023

[Information about the trademark]