Daktarin-oral

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Daktarin-oral (Daktarin)
20 mg/g, oral gel
Miconazolum
Daktarin-oral and Daktarin are different trade names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Daktarin-oral gel is and what it is 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 pack and other information

1. What Daktarin-oral gel is and what it is used for
Daktarin-oral oral gel contains the active substance miconazole, which
belongs to a group of medicines called antifungal agents.
Miconazole has antifungal activity against dermatophytes and yeasts, and antibacterial activity against certain
Gram-positive bacilli and cocci.
Daktarin-oral gel is used to treat oral and pharyngeal candidiasis, as well as gastrointestinal tract candidiasis in adults and children aged at least 4 months. In infants aged 4 to 6 months, ensure prior to administering the gel that they do not have swallowing difficulties (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 you are allergic to miconazole, to other similar antifungal medicines, or to any of the other ingredients of this medicine (listed in section 6),
• if you have liver function disorders,
• in infants under 4 months of age, or in infants under 5-6 months of age born prematurely or with insufficiently developed swallowing reflex, due to the risk of choking,
• if you are taking any of the following medicines (see also section "Daktarin-oral gel and other medicines"):
• certain antihistamines (used for allergies), such as terfenadine, astemizole, mizolastine;
• cisapride, a medicine used for digestive disorders;
• certain cholesterol-lowering medicines, for example simvastatin or lovastatin;
• midazolam (administered orally) or triazolam – medicines used for anxiety or sleep disorders;
• pimozide and sertindole, medicines used in the treatment of certain psychiatric disorders;
• halofantrine – an antimalarial medicine;
• certain medicines used to treat migraine, such as ergot alkaloids;
• certain medicines used to treat cardiac arrhythmias, such as bepridil, quinidine, and dofetilide.

Do not use this medicine if any of the above situations apply to you. If you have any
doubts, consult your doctor or pharmacist before using Daktarin-oral gel.
Warnings and precautions
Before starting treatment with Daktarin-oral gel, discuss it with your doctor.
Daktarin-oral may cause severe allergic reactions. Please read about the symptoms of these
allergic reactions described in section 4. Possible side effects.
Particular caution should be exercised when using Daktarin-oral gel, especially in infants and
young children, as the gel may obstruct the throat. To prevent this, do not apply the gel to the
posterior pharyngeal wall, and divide each dose into smaller portions. Apply the gel to the affected
areas (white coating) with a clean finger, according to your doctor's or pharmacist's instructions.
A breastfeeding woman should not apply the gel to the nipple to treat her infant.
If you are taking anticoagulant medicines such as warfarin, blood clotting parameters should be
monitored and the anticoagulant dose adjusted by your doctor.
When Daktarin-oral gel is used concomitantly with phenytoin, blood levels of both medicines should be monitored.
In patients taking certain oral antidiabetic medicines simultaneously, excessive reduction in blood glucose levels may occur.
If you have any doubts whether any of the above situations apply to you, consult your 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 intensified or weakened when used concomitantly with Daktarin-oral gel.
During treatment with Daktarin-oral gel, certain medicines must not be used, and the use of some medicines may require dose adjustment by your doctor (see "When not to use Daktarin-oral gel").
Medicines whose concomitant use with Daktarin-oral gel is contraindicated:

• certain antihistamines (used for allergies), such as terfenadine, astemizole, mizolastine;
• cisapride, a medicine used for digestive disorders;
• certain cholesterol-lowering medicines, for example simvastatin or lovastatin;
• midazolam (administered orally) or triazolam – medicines used for anxiety or sleep disorders;
• pimozide and sertindole, medicines used in the treatment of certain psychiatric disorders;
• halofantrine – an antimalarial medicine;
• certain medicines used to treat migraine, such as ergot alkaloids;
• certain medicines used to treat cardiac arrhythmias, such as bepridil, quinidine, and dofetilide.

Concomitant use of certain medicines may require close monitoring or dose adjustments of Daktarin-oral gel or the co-administered medicine. These include:

• anticoagulants such as warfarin;
• certain oral antidiabetic medicines;
• certain medicines used in AIDS, such as HIV protease inhibitors (e.g. saquinavir);
• certain medicines used in cancer treatment, 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 organ transplantation;
• phenytoin, carbamazepine – medicines used in epilepsy treatment;
• certain medicines used in hospitals for anaesthesia, 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 taken orally or by injection;
• trimetrexate – a medicine used to treat certain types of pneumonia;
• ebastine – an antihistamine (used for allergies);
• reboxetine – a medicine used to treat depression;
• intravenous midazolam;
• cilostazol – a medicine used to treat atherosclerosis;
• disopyramide – a medicine used to treat cardiac arrhythmias.

You must inform your doctor if you are taking any of the medicines listed above
or if you are taking any other prescription medicine.
While using Daktarin-oral oral gel, never start treatment with a new medicine without consulting your doctor.
Pregnancy and breastfeeding
Before using any medicine, consult your doctor or pharmacist.
If you are pregnant, suspect you may be pregnant, or are planning to have a child, inform your doctor before using Daktarin-oral gel. Your doctor will decide whether to use Daktarin-oral gel after weighing the risks and benefits.
Breastfeeding women should consult their doctor, who will decide whether to use Daktarin-oral gel. A breastfeeding woman should not apply the gel to the nipple to treat her infant.
Driving and operating machinery
Daktarin-oral does not affect the ability to drive or operate machinery.
Daktarin-oral gel contains alcohol (ethanol), orange flavouring, cocoa flavouring (containing, among others, benzyl alcohol), and sodium
Alcohol (ethanol)
This medicine contains 7.85 mg of alcohol (ethanol) in each gram of oral gel, equivalent to 0.00785 mg/mg (0.785% w/w).
The amount in a single maximum dose for an adult (2 measuring spoons 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 medicine will not cause noticeable effects.
Orange flavouring and cocoa flavouring
This medicine contains orange flavouring (containing: citral, citronellol, linalool, geraniol, d-limonene) and cocoa flavouring (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 oral gel). Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with the risk of severe adverse effects, including respiratory disorders (so-called "gasping syndrome"). The risk is increased in young children due to accumulation.
Pregnant or breastfeeding women should contact their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with kidney disease should contact their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse 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), meaning the medicine is considered "sodium-free".

3. How to use Daktarin-oral gel

This medicine should always be used as directed by the physician. In case of doubts, consult a
doctor or pharmacist.
Daktarin-oral, in the form of an oral gel, should be taken after meals.
The physician will determine the exact treatment regimen.
The gel should not be swallowed immediately, but held in the mouth as long as possible.
Treatment should be continued for at least one week after symptoms have subsided.
The dosing spoon provided with the package allows measurement of the 124 mg/5 ml dose.
The usual recommended dosing is described below
Fungal infections of the mouth and throat
Infants aged 4 to 24 months: 1.25 ml (1/4 spoon) of gel four times daily after meals.
Each dose should be divided into smaller portions and applied to the affected areas using a clean finger.
The gel should not be applied to the back wall of the throat due to the risk of choking.
The gel should not be swallowed immediately, but held in the mouth as long as possible.
Adults and children over 2 years of age: 2.5 ml (1/2 spoon) of gel four times daily after meals.
The gel should not be swallowed immediately, but held in the mouth as long as possible.
Treatment should be continued for at least one week after symptoms have subsided.
Patients wearing dentures should remove them at night and clean them with a toothbrush using the gel.
This helps prevent denture infection.
Fungal infections of the gastrointestinal tract
The medicine may be used in infants from 4 months of age, children, and adults.
The dose depends on body weight. The daily dose should not exceed 250 mg (10 ml of gel)
four times daily, i.e.:

• up to 12 kilograms: ¼ spoon (1.25 ml) of gel four times daily;
• from 12 to 25 kilograms: ½ spoon (2.5 ml) of gel four times daily;
• from 25 to 37 kilograms: 1 spoon (5 ml) of gel four times daily;
• from 37 to 50 kilograms: 1\½ spoons (7.5 ml) of gel four times daily;
• 50 kilograms or more: 2 spoons (10 ml) of gel four times daily.

Treatment should be continued for at least one week after symptoms have subsided.
To open the tube, unscrew the cap. Then pierce the tube seal using the piercing tool located on top of the cap.
Use of a higher than recommended dose of Daktarin-oral gel
If a higher than recommended dose of Daktarin-oral gel is used, contact a doctor or go to the emergency room at the nearest hospital.
Vomiting and diarrhoea may occur.
If the patient is also taking certain other medicines (e.g. warfarin, oral antidiabetic drugs,
or phenytoin), the effects of these medicines, including their adverse effects, may be intensified.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, discontinue use of Daktarin-oral gel immediately and contact your doctor without delay:

• swelling of the face, tongue or throat; difficulty swallowing; urticaria and breathing difficulties (angioedema, anaphylactic reactions);
• toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) – these are severe skin reactions presenting with symptoms such as rash, skin peeling, blisters, pustules, particularly affecting the mouth, eyes and genital areas, fever and swollen lymph nodes;
• acute generalized exanthematous pustulosis – rash with pustules or 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-mentioned adverse reactions is unknown (cannot be estimated from available data).

If any of the following adverse reactions are observed, inform your doctor or pharmacist:
Common (may affect up to 1 in 10 people):

• taste disturbances,
• dryness of the oral mucosa, discomfort in the mouth,
• nausea,
• vomiting,
• altered taste perception of food.

Frequency unknown (cannot be estimated from available data):

• choking,
• diarrhoea,
• stomatitis,
• tongue discoloration,
• urticaria,
• rash.

In children, nausea and vomiting are very common adverse reactions (may affect more than 1 in 10 people), and regurgitation is a common adverse reaction.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Daktarin-oral gel

Store below 30°C.
Keep the medicine out of the 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 stated month.
Check the expiry date on the packaging before using the medicine.
Medicines must not be disposed of via 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 packaging and other information

What the medicine Daktarin-oral gel contains

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

What Daktarin-oral gel looks like and contents of the pack
Tub with a cap and a measuring spoon with a capacity of 5 ml, marked at 1.25 ml and 2.5 ml, in a cardboard box. The tub contains 40 g of white, homogeneous gel.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Belgium, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Belgium, country of export: BE108087
Parallel import licence number: 363/22