Daktarin-oral

Package Leaflet: Information for the Patient

Daktarin-oral, 20 mg/g, Oral Gel

Miconazole

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package and other information

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

Daktarin-oral gel 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 rods and cocci. Daktarin-oral gel is used to treat fungal infections of the mouth and throat, as well as the gastrointestinal tract in adults and children aged 4 months and older. In infants aged 4 to 6 months, ensure they do not have swallowing problems before administering the gel (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, other similar antifungal agents, or 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 who were born prematurely or do not have a sufficiently 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 medicines used for allergies, such as terfenadine, astemizole, mizolastine;
• cisapride, a medicine used for digestive disorders;
• certain cholesterol-lowering medicines, such as simvastatin or lovastatin;
• midazolam (given orally) or triazolam - medicines used for anxiety or sleep disorders;
• pimozide and sertindole, medicines used for certain mental disorders;
• halofantrine - an antimalarial medicine;
• certain medicines used for migraine, such as ergot alkaloids;
• certain medicines used for heart rhythm disorders, 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 to use Daktarin-oral gel, discuss it with your doctor. Daktarin-oral gel may cause severe allergic reactions. 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 gel, especially in infants and young children, as it may cause choking. To avoid 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 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.

Daktarin-oral gel and other medicines

Tell your doctor about all medicines you are 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 increased or decreased when used with Daktarin-oral gel. During treatment with Daktarin-oral gel, some medicines should 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 use with Daktarin-oral gel is contraindicated:

• certain medicines used for allergies, such as terfenadine, astemizole, mizolastine;
• cisapride, a medicine used for digestive disorders;
• certain cholesterol-lowering medicines, such as simvastatin or lovastatin;
• midazolam (given orally) or triazolam - medicines used for anxiety or sleep disorders;
• pimozide and sertindole, medicines used for certain mental disorders;
• halofantrine - an antimalarial medicine;
• certain medicines used for migraine, such as ergot alkaloids;
• certain medicines used for 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:

• blood thinners, such as warfarin;
• certain oral diabetes medicines;
• certain AIDS medicines, such as HIV protease inhibitors (e.g., saquinavir);
• certain cancer medicines, such as vinca alkaloids, busulfan, and docetaxel;
• certain cardiovascular medicines (calcium channel blockers, such as dihydropyridine derivatives and verapamil);
• cyclosporine, tacrolimus, and sirolimus - medicines usually given after transplants;
• phenytoin, carbamazepine - medicines used for epilepsy;
• certain hospital anesthetics, such as alfentanil;
• sildenafil - a medicine used for impotence;
• certain medicines used for anxiety and sleep disorders, such as alprazolam, brotizolam, buspirone;
• certain medicines used for tuberculosis, such as rifabutin;
• methylprednisolone - an anti-inflammatory medicine given orally or by injection;
• trimethoprim - a medicine used for certain types of pneumonia;
• ebastine - a medicine used for allergies;
• reboxetine - a medicine used for depression;
• midazolam given intravenously;
• cilostazol - a medicine used for atherosclerosis of the blood vessels;
• disopyramide - a medicine used for heart rhythm disorders.

Be sure to inform your doctor about the use of any of the above medicines or if you are using any other prescription medicine. When using Daktarin-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, think you may be pregnant, or plan to have a baby, inform your doctor before using Daktarin-oral gel. Your 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 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 or use machines.

Daktarin-oral gel contains alcohol (ethanol), orange flavor, cocoa flavor (containing, among others, benzyl alcohol and ethanol), and sodium

Alcohol (ethanol)

This medicine 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 medicine 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 medicine will not have noticeable effects.

Orange flavor and cocoa flavor

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

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Daktarin-oral gel should be used after meals. Your doctor will determine the exact treatment. Do not swallow the gel immediately, but keep it in your mouth for as long as possible. Treatment should be continued for at least one week after the symptoms have disappeared.

Below 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 meals. Each dose should be divided into smaller portions and the gel applied to the affected areas with 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, but keep it in your 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 meals. Do not swallow the gel immediately, but keep it in your mouth for as long as possible. Treatment should be continued for at least one week after the symptoms have disappeared. People wearing dentures should remove them at night and brush them with a toothbrush with the gel. This prevents the denture from becoming infected.

Using more than the recommended dose of Daktarin-oral gel

If you use more than the recommended dose of Daktarin-oral gel, contact your doctor or go to the emergency room at the nearest hospital. Vomiting and diarrhea may occur. If you are also taking other medicines (e.g., warfarin, oral diabetes medicines, or phenytoin), the effects of these medicines, including their side effects, may be increased. If you have any further doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop using Daktarin-oral gel and contact your 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 swollen lymph nodes.
• 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 from available data).

If you notice any of the following side effects, tell 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 of products.

Frequency not known (frequency cannot be determined from 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 those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daktarin-oral gel

Store in a temperature below 30°C. Keep this 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 month stated. Before using the medicine, check the expiry date on the packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Daktarin-oral gel contains

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

What Daktarin-oral gel looks like and what the package contains

A tube containing 40 g of white, homogeneous gel, with a measuring spoon of 5 ml capacity, with a 1.25 ml graduation, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

McNeil Healthcare (Ireland) Limited, Office 5, 6 & 7, Block 5, High Street, Tallaght, Dublin 24, D24 YK8N, Ireland

Manufacturer:

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

Date of last revision of the package leaflet: