Daktarin-oral

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Daktarin-oral (Daktarin)

20 mg/g, oral gel

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

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This drug has been prescribed for a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Daktarin-oral is an oral gel. The active substance is miconazole, which belongs to a group of drugs called antifungals. Miconazole has antifungal effects on dermatophytes and yeasts, as well as antibacterial effects on some Gram-positive bacilli and cocci. Daktarin-oral is used to treat yeast infections of the mouth and throat, as well as the gastrointestinal tract in adults and children over 4 months old. In infants between 4 and 6 months old, it is necessary to ensure that they do not have swallowing problems before administering the gel (see "When not to use Daktarin-oral").

2. Important information before using Daktarin-oral

When not to use Daktarin-oral:

• if the patient is allergic to miconazole, other similar antifungal drugs, or any of the other ingredients of this drug (listed in section 6),
• if the patient has liver function disorders,
• in infants under 4 months old or in infants under 5-6 months old 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 drugs (see also "Daktarin-oral and other drugs"):
• certain drugs used for allergies, such as terfenadine, astemizole, mizolastine;
• cisapride, a drug used for digestive disorders;

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• certain cholesterol-lowering drugs, such as simvastatin or lovastatin;
• midazolam (taken orally) or triazolam - drugs used for anxiety or sleep disorders;
• pimozide and sertindole, drugs used to treat certain mental disorders;
• halofantrine - an antimalarial drug;
• certain drugs used to treat migraines, such as ergot alkaloids;
• certain drugs used to treat heart rhythm disorders, such as bepridil, quinidine, and dofetilide.

Do not use the drug if any of the above situations apply to the patient. In case of any doubts, consult a doctor or pharmacist before using Daktarin-oral.

Warnings and precautions

Before starting to use Daktarin-oral, you should discuss it with your doctor. Daktarin-oral 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". Special caution should be exercised when using Daktarin-oral, especially in infants and young children, as it may cause throat obstruction. To avoid this, do not apply the drug 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 drugs, such as warfarin, it is necessary to monitor blood clotting indicators and adjust the dose of the anticoagulant drug by the doctor. When using Daktarin-oral and phenytoin together, it is necessary to monitor the concentration of both drugs in the blood. In patients taking certain oral antidiabetic drugs, an excessive decrease in blood sugar levels may occur. In case of any doubts about whether any of the above situations apply to the patient, consult a doctor or pharmacist before using Daktarin-oral.

Daktarin-oral and other drugs

Tell your doctor about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take. The effects of many drugs, including their side effects, may be enhanced or weakened when used together with Daktarin-oral. During treatment with Daktarin-oral, some drugs should not be used, and the use of some drugs may require dose adjustment by the doctor (see "When not to use Daktarin-oral"). Drugs that should not be used together with Daktarin-oral include:

• certain drugs used for allergies, such as terfenadine, astemizole, mizolastine;
• cisapride, a drug used for digestive disorders;
• certain cholesterol-lowering drugs, such as simvastatin or lovastatin;
• midazolam (taken orally) or triazolam - drugs used for anxiety or sleep disorders;

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• pimozide and sertindole, drugs used to treat certain mental disorders;
• halofantrine - an antimalarial drug;
• certain drugs used to treat migraines, such as ergot alkaloids;
• certain drugs used to treat heart rhythm disorders, such as bepridil, quinidine, and dofetilide.

Concomitant use of some drugs may require close monitoring or dose adjustment of Daktarin-oral or the concomitantly used drug. These include:

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

It is essential to inform the doctor about the use of any of the above-mentioned drugs or in case of using any other prescription drug. When using Daktarin-oral, an oral gel, never start treatment with a new drug without consulting a doctor.

Pregnancy and breastfeeding

Before using any drug, 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. The doctor will decide whether to use Daktarin-oral after weighing the risks and benefits of using the drug. Breastfeeding women should consult a doctor before using the drug, who will decide whether to use Daktarin-oral. A breastfeeding woman should not apply the gel to the nipple to treat the child.

Driving and operating machinery

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

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

Alcohol (ethanol)

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

Orange flavor and chocolate flavor

This drug contains orange flavor (containing: citral, citronellol, linalol, geraniol, d-limonene) and chocolate flavor (containing: benzyl alcohol, benzyl benzoate, ethanol), which may cause allergic reactions. This drug contains 0.017 nanograms of benzyl benzoate in each single maximum dose for an adult (10 ml of oral gel). Benzyl benzoate may cause mild local irritation.

Benzyl alcohol

The drug contains 0.0285 nanograms of benzyl alcohol in each single maximum dose for an adult (10 ml of oral gel). Benzyl alcohol may cause allergic reactions. Administering benzyl alcohol to small children is associated with a risk of severe side effects, including breathing disorders (so-called "gasping syndrome"). There is an increased risk in small children due to accumulation. Pregnant or breastfeeding women should consult a doctor before using the drug, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). Patients with kidney disease should consult a doctor before using the drug, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). Benzyl alcohol may cause mild local irritation.

Sodium

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

3. How to use Daktarin-oral

This drug should always be used according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist. Daktarin-oral, an oral gel, should be taken after a meal. The doctor will determine the exact treatment method. 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 attached to 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 from 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 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. Patients with 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 drug can be used in infants from 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: 1/4 scoop (1.25 ml) of gel four times a day;
• from 12 to 25 kilograms: 1/2 scoop (2.5 ml) of gel four times a day;
• from 25 to 37 kilograms: 1 scoop (5 ml) of gel four times a day;
• from 37 to 50 kilograms: 1 and 1/2 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 on the top of the cap.

Using a higher dose of Daktarin-oral than recommended

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

4. Possible side effects

Like all drugs, this drug may cause side effects, although not everyone will experience them. If any of the following side effects occur, stop taking Daktarin-oral and consult 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 based on 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,

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

Frequency unknown (frequency cannot be determined based on 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, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. 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 drug.

5. How to store Daktarin-oral

Store at a temperature below 30°C. The drug should be stored in a place that is invisible and inaccessible to children. Do not use this drug after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month. Before using the drug, check the expiration date on the packaging. Drugs should not be disposed of in the sewage system or household waste containers. Ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Daktarin-oral contains

• The active substance of the drug is miconazole. 1 g of gel contains 20 mg of miconazole.
• The other ingredients (excipients) are: gelatinized starch, potato starch, sodium saccharin (E 954), polysorbate 20, orange flavor (987431) (contains: citral, citronellol, d-limonene, geraniol, linalol), chocolate flavor (14.31.6296) (contains: benzyl alcohol, benzyl benzoate, ethanol), ethanol 96%, glycerol, purified water.

What Daktarin-oral looks like and what the packaging contains

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

Marketing authorization holder in Greece, the country of export:

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

Manufacturer:

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 1356/15.1.1996
8533/6-2-2007
85250/12-11-2013

Parallel import authorization number: 307/09

Date of leaflet approval: 08.01.2025

[Information about the trademark]
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