Daktarin-oral

PACKAGE LEAFLET: 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, oral gel
Miconazole
Daktarin-oral and Daktarin are different brand names for 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 exerts 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 and 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 formulation 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 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 born prematurely who are under 5–6 months of age and who 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 allergies (hypersensitivity), 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 heart rhythm disorders, such as bepridil, quinidine, and dofetilide.

Do not use Daktarin-oral gel if any of the above situations apply. If in doubt, consult a 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 gel may cause severe allergic reactions. Please read about the symptoms of these allergic reactions described in section 4. Possible side effects.

Special caution is required when using Daktarin-oral gel, especially in infants and young children, as the gel may block the throat. To prevent this, do not apply the gel 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, as directed by the doctor or pharmacist. A breastfeeding woman should not apply the gel to the nipple for the purpose of treating the infant.

If the patient is taking anticoagulant medicines such as warfarin, blood clotting parameters must be monitored and the anticoagulant dose adjusted by the doctor as necessary.

When Daktarin-oral gel is used concomitantly with phenytoin, blood levels of both medicines must be monitored.

In patients taking certain oral antidiabetic medicines simultaneously, blood sugar levels may drop excessively.

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, have recently taken, or plan to take.

The effects of many medicines, including their side effects, may be intensified or weakened when used together with Daktarin-oral gel.

Some medicines must not be used during treatment with Daktarin-oral gel, and the use of certain other medicines may require dose adjustments by the doctor (see "When not to use Daktarin-oral gel").

Medicines that must not be used together with Daktarin-oral gel:

• certain medicines used for allergies (hypersensitivity), 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 heart rhythm disorders, 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:

• medicines that reduce blood clotting, 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 the treatment of epilepsy;
• 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 administered by injection;
• trimethoprim – a medicine used to treat certain types of pneumonia;
• ebastine – a medicine used for allergies (hypersensitivity);
• reboxetine – a medicine used to treat depression;
• intravenous midazolam;
• cilostazol – a medicine used to treat atherosclerosis;
• disopyramide – a medicine used to treat heart rhythm disorders.

Always inform your doctor if you are taking any of the medicines listed above, or any other prescription medicine.

When using Daktarin-oral, oral gel, never start treatment with a new medicine without first consulting your doctor.

Pregnancy and breastfeeding

Before using any medicine, consult your doctor or pharmacist.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, 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 for the purpose of treating the infant.

Driving and operating machinery

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

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

Alcohol (ethanol)

This medicine contains 7.85 mg of alcohol (ethanol) per 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 measures 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.

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 a physician. In case of doubt, consult a doctor or pharmacist.
Daktarin-oral gel should be taken after meals. The exact treatment regimen will be determined by the physician.
Do not swallow the gel immediately; keep it in the mouth as long as possible.
Treatment should be continued for at least one week after symptoms have resolved.
The measuring spoon provided with the package allows for accurate dosing of 124 mg/5 ml.
The usual recommended dosages are described below
Oral and pharyngeal candidiasis
Infants aged 4 to 24 months: 1.25 ml (1/4 spoonful) of gel four times daily after meals.
Each dose should be divided into smaller portions and applied directly to the affected areas using a clean finger.
Do not apply the gel to the back of the throat due to the risk of choking. Do not swallow the gel immediately; keep it in the mouth as long as possible.
Adults and children over 2 years of age: 2.5 ml (1/2 spoonful) of gel four times daily after meals. Do not swallow the gel immediately; keep it in the mouth as long as possible.
Treatment should be continued for at least one week after symptoms have resolved.
Patients wearing dentures should remove them at night and clean them with a toothbrush using the gel. This helps prevent denture contamination.
Gastrointestinal tract candidiasis
The medicine may be used in infants from 4 months of age, as well as in children and adults.
Dosage depends on body weight. The daily dose should not exceed 250 mg (10 ml of gel) four times daily, i.e.:

• up to 12 kg: 1/4 spoon (1.25 ml) of gel four times daily;
• 12 to 25 kg: 1/2 spoon (2.5 ml) of gel four times daily;
• 25 to 37 kg: 1 spoon (5 ml) of gel four times daily;
• 37 to 50 kg: 1 and 1/2 spoons (7.5 ml) of gel four times daily;
• 50 kg or more: 2 spoons (10 ml) of gel four times daily.

Treatment should be continued for at least one week after symptoms have resolved.
To open the tube, unscrew the cap. Then pierce the seal of the tube using the spike located on the 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 has been used, contact a doctor or go to the emergency department of the nearest hospital. Symptoms such as vomiting and diarrhoea may occur. If the patient is also taking certain other medicines (e.g. warfarin, oral antidiabetic agents, or phenytoin), the effects of these medicines, including their adverse effects, may be intensified.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any of the following adverse reactions occur, stop taking Daktarin-oral gel immediately and contact your doctor without delay:

• swelling of the face, tongue or throat, difficulty in 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 with symptoms such as: rash, skin peeling, blisters, bullae all over the body, particularly in the oral cavity, eyes and genital areas, fever and swollen lymph nodes.
• acute generalized exanthematous pustulosis – 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-mentioned adverse reactions is unknown (cannot be estimated from the available data).

If any of the following adverse reactions are noticed, inform your doctor or pharmacist:
Common (occur in less than 1 in 10 people):

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

Frequency unknown (cannot be estimated from the available data):

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

In children, nausea and vomiting are very common adverse reactions (may occur in more than 1 in 10 people), and regurgitation is a common adverse reaction.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the Daktarin-oral gel medicine

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 no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Daktarin-oral gel contains
What Daktarin-oral gel contains

• The active substance is miconazole. Each 1 g of gel contains 20 mg of miconazole.
• Other excipients: pregelatinized corn starch, sodium saccharin, polysorbate 20, orange flavoring composition, cocoa flavoring composition, ethanol 96%, glycerol, purified water.

What Daktarin-oral gel looks like and contents of the pack
An aluminium tube containing 40 g of white, homogeneous gel, with a 5 ml measuring spoon graduated at 1.25 ml, in a cardboard box.
For further information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Greece, 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.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in Greece, country of export: 85250/12-11-2013
Parallel Import Licence Number: 172/18