Daktarin-oral

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Daktarin-oral (Daktarin 20 mg/g), 20 mg/g

gel for oral use
Miconazole
Daktarin-oral and Daktarin 20 mg/g are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine.

• 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 tell their doctor or pharmacist. 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. Contents of the packaging and other information

1. What is Daktarin-oral 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 yeast, as well as an antibacterial effect on some Gram-positive rods and cocci.
Daktarin-oral is used to treat yeast infections of the mouth and throat, as well as the digestive tract in adults and children aged at least 4 months. In infants aged 4 to 6 months, it should be ensured before administering the medicine in the form of a gel that they do not have swallowing problems (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 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 "Daktarin-oral 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. In case of any doubts, consult a doctor or pharmacist before using Daktarin-oral.

Warnings and precautions

Before starting to use Daktarin-oral, 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.
Particular caution should be exercised when using Daktarin-oral, especially in infants and young children, as it may cause throat obstruction due to the gel. 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 coating) 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 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.
In case of any doubts as to whether any of the above situations apply to the patient, consult a doctor or pharmacist before using Daktarin-oral.

Daktarin-oral 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 intensified or weakened during concurrent use with Daktarin-oral.
During treatment with Daktarin-oral, 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").
Medicines whose concurrent use with Daktarin-oral 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.

Concurrent use of certain medicines may require close monitoring or dose adjustment of Daktarin-oral or the concurrently 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;
• trimetrexate - 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 in case you are using any other prescription medicine.
During the use of Daktarin-oral, gel for oral use, 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. The doctor will decide whether to use Daktarin-oral 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. A breastfeeding woman should not apply the gel to the nipple to treat the child.

Driving and using machines

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

Daktarin-oral contains alcohol (ethanol), orange flavor, 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.
A small amount of alcohol in this medicine will not cause noticeable effects.

Orange flavor

This medicine contains an orange flavor (containing: linalool, d-limonene), which may cause allergic reactions.

Sodium

This 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

This medicine should always be used in accordance with the doctor's instructions. In case of doubts, consult a doctor or pharmacist.
Daktarin-oral, in the form of a 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 describes 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 digestive 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 more 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, 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 than recommended

In case of using a higher dose of Daktarin-oral than recommended, 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 intensified.
In case of any further doubts related to the use of 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.
In case of any of the following side effects, stop taking Daktarin-oral 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 based on available data).

In case of 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 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 more frequently than in 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, tell 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 can help gather more information on the safety of the medicine.

5. How to store Daktarin-oral

Do not store above 30°C.
Medicines 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 month stated.
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 contains

• 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, orange flavor (containing allergens: linalool and d-limonene and ethanol), cocoa flavor (containing ethanol), ethanol 96%, glycerol, purified water.

What Daktarin-oral looks like and what the packaging contains

Aluminum tube closed with a membrane and a PP cap, with a PP 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.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, the country of export:

Johnson & Johnson (Ireland) Limited
Airton Road, Tallaght
Dublin 24
Ireland

Manufacturer:

Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Pharmapac UK Ltd, Bidston, Wirral, CH41 7EL, United Kingdom
McGregor Cory Ltd, Exel, Middleton Close, Banbury, Oxon, OX16 4RS, United Kingdom

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 Ireland, the country of export:PA 330/048/003

Parallel import authorization number: 45/22 Date of leaflet approval: 19.01.2022

[Information about the trademark]