Daktarin-oral

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging 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 necessary.
• In case of 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 inform their doctor or pharmacist. 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 agents.
Miconazole has antifungal effects on dermatophytes and yeasts, as well as antibacterial effects on some Gram-positive bacilli 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 4 to 6 months, it should be ensured before administering the gel that they do not have swallowing problems (see "When not to use Daktarin-oral gel").

2. Important information before using Daktarin-oral gel

When not to use Daktarin-oral gel:

• 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,
• 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.

You should not use the medicine if any of the above situations apply to the patient. In case of any doubts, you should consult a doctor or pharmacist before using Daktarin-oral gel.

Warnings and precautions

Before starting to use Daktarin-oral gel, you should 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.
Special caution should be exercised when using Daktarin-oral gel, especially in infants and young children, as it may cause choking. To avoid this, you should not apply the medicine to the back of the throat, and each dose should be divided into smaller portions. You should apply the gel to the affected areas (white patches) with a clean finger, in accordance with the doctor's or pharmacist's recommendations. A breastfeeding woman should not apply the gel to the nipple to treat the child.
If the patient is using anticoagulant medicines, such as warfarin, it is necessary to monitor blood clotting parameters and adjust the dose of the anticoagulant medicine by the doctor.
When using Daktarin-oral gel and phenytoin at the same time, it is necessary to monitor the blood levels of both medicines.
In patients using certain oral antidiabetic medicines at the same time, an excessive decrease in blood sugar levels may occur.
In case of any doubts as to whether any of the above situations apply to the patient, you should consult a doctor or pharmacist before using Daktarin-oral gel.

Daktarin-oral gel and other medicines

You should 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 when used at the same time as 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 at the same time as Daktarin-oral gel is contraindicated:

• 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.

Concomitant use of certain medicines may require close monitoring or dose adjustment of Daktarin-oral gel or the concomitantly used medicine. 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 should necessarily inform your doctor about the use of any of the above medicines or in case of using any other prescription medicine.
When using Daktarin-oral gel, you should never start treatment with a new medicine without consulting your doctor.

Pregnancy and breastfeeding

Before using any medicine, you should 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 their 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 using machines

Daktarin-oral gel does not affect the ability to drive and use machines.

Daktarin-oral gel contains alcohol (ethanol), orange flavor, cocoa flavor (containing, among others, benzyl alcohol), 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 an amount less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

Orange flavor and cocoa flavor

This medicine contains orange flavor (containing: citral, citronellol, linalol, geraniol, d-limonene) and cocoa flavor (containing: benzyl alcohol, benzyl benzoate), which may cause allergic reactions.

Benzyl alcohol

The medicine contains 0.0000000285 mg of benzyl alcohol in each single maximum dose for an adult (10 ml of gel for oral use). Benzyl alcohol may cause allergic reactions.
Administering benzyl alcohol to small children is associated with a risk of severe side effects, including respiratory disorders (so-called "gasping syndrome"). There is an increased risk in small children due to accumulation.
Pregnant or breastfeeding women should contact their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with kidney diseases should contact their doctor before using the medicine, 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 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 in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Daktarin-oral gel for oral use 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 usually recommended dosage

Fungal 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 should be 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.
Fungal infections of the gastrointestinal tract
The medicine can be used in infants from 4 months of age, children, and adults.
The dose depends on body weight. The daily dose should not be higher than 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;
• from 12 to 25 kilograms: ½ 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 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, you should unscrew the cap. Then, pierce the tube seal with the piercer located on the top of the cap.

Using a higher dose of Daktarin-oral gel than recommended

In case of using a higher dose of Daktarin-oral gel than recommended, you should 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.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.
In case of experiencing any of the following side effects, you should stop taking Daktarin-oral gel and immediately contact your doctor:

• 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).

In case of noticing any of the following side effects, you should 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 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 reflux is a common side effect.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Daktarin-oral gel

Store at a temperature below 30°C.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Before using the medicine, you should check the expiration date on the packaging.
Medicines should not be disposed of in wastewater or household waste. You should 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 does Daktarin-oral gel contain

• The active substance of the medicine is miconazole. 1 g of gel contains 20 mg of miconazole.
• The other ingredients (excipients) are: potato starch, sodium saccharin (E 954), polysorbate 20 (E 432), orange flavor (containing allergens: citral, citronellol, linalol, geraniol, d-limonene), cocoa flavor (containing allergens: benzyl alcohol, benzyl benzoate), ethanol 96%, glycerol (E 422), purified water.

What does Daktarin-oral gel look like and what does the packaging contain

A tube with a cap and a measuring spoon with a capacity of 5 ml, with a scale of 1.25 ml and 2.5 ml, in a cardboard box. The tube contains 40 g of white, homogeneous gel.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Janssen-Cilag NV
Antwerpseweg 15-17
B-2340 Beerse, Belgium

Manufacturer:

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse, Belgium

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE108087

Parallel import authorization number: 363/22 Date of leaflet approval: 26.09.2022

[Information about the trademark]