Daktarin 20 mg/g oral gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Daktarin 20 mg/g oral gel

Miconazole

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Daktarin is and what it is used for
2. What you need to know before using Daktarin
3. How to use Daktarin
4. Possible side effects
5. How to store Daktarin
6. Contents of the pack and other information

1. What Daktarin is and what it is used for

Daktarin contains the active substance miconazole, which belongs to a group of medicines called antifungals. Miconazole works by preventing the growth of fungi that cause infections.

Daktarin is used to treat fungal infections of the mouth, throat, and gastrointestinal tract caused by a species of fungus called Candida, in adults, adolescents, and children from 4 months of age.

2. What you need to know before using Daktarin

Do not use Daktarin:

• 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);

• in infants under 4 months of age or in infants with swallowing difficulties, due to the risk of choking (see section “Warnings and precautions”);

• if you have liver problems;

• if you are taking any of the following medicines (see section “Using Daktarin with other medicines”):

• certain allergy medications: terfenadine, astemizole, mizolastine;

• cisapride, a medicine used to treat certain digestive problems;

• certain cholesterol-lowering medicines, such as simvastatin and lovastatin;

• oral midazolam and triazolam, medicines used for anxiety or to help sleep (sedatives);

• pimozide and sertindole, medicines used to treat disorders related to disturbances in thoughts, feelings, and behavior;

• halofantrine, an antimalarial medicine;

• certain migraine treatments such as ergot alkaloids: ergotamine, dihydroergotamine, ergometrine;

• certain medicines used to treat irregular heartbeats: bepridil, quinidine, dofetilide;

• warfarin, an anticoagulant medicine used to prevent blood clots from forming or growing larger in the blood and blood vessels.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use this medicine.

Daktarin may cause serious allergic reactions. You should be aware of the signs of an allergic reaction when taking or administering this medicine (see section “Possible side effects”).

Infants (28 days to 23 months of age) and Children (2 to 11 years of age)

Daktarin must not be given to infants under 4 months of age.

In premature infants or infants showing delayed neuromuscular development, this medicine should not be administered until 5 or 6 months of age.

Choking risk in infants and children

Daktarin is a thick gel. This ensures it remains in the mouth for as long as possible. It is important to ensure the gel does not block the child's throat, as this could cause choking.

Due to the risk of choking, Daktarin must not be given to infants under 4 months of age or to infants with swallowing difficulties.

Take the following precautions:

• administer the gel at the front of the mouth; never place it at the back of the throat;
• the total amount of gel to be administered should be divided into small portions (never administer the full dose at once into the child’s mouth);
• apply the gel to the affected areas of the mouth (white patches) with a clean finger, as directed by your doctor or pharmacist;
• if the child is being treated with Daktarin and you are breastfeeding, never apply the gel to the nipple to administer it to the child.

Using Daktarin with other medicines

Inform your doctor, dentist, or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may affect how Daktarin works or increase the likelihood of side effects. Daktarin may also affect how other medicines work.

If you are taking any of the following medicines or others, consult your doctor or pharmacist before starting to use Daktarin:

• the anticoagulant medicine warfarin;
• certain oral medicines for diabetes: sulfonylureas (e.g., tolbutamide, gliclazide, glipizide, glyburide);
• certain cancer treatments: busulfan, docetaxel;
• certain medicines used to treat heart and blood vessel conditions (calcium channel blockers), e.g., dihydropyridines and verapamil;
• medicines commonly used after organ transplantation;
• certain medicines for HIV infection: HIV protease inhibitors (e.g., lopinavir, saquinavir, amprenavir, nelfinavir);
• phenytoin, a medicine used to treat epilepsy;
• certain hospital-used anesthetics such as alfentanil;
• sildenafil, a medicine used to treat male impotence;
• certain medicines for anxiety or to help sleep (sedatives);
• certain medicines for tuberculosis;
• oral or injectable methylprednisolone, a medicine used for inflammation;
• trimetrexate, a medicine used to treat certain types of pneumonia;
• ebastine, a medicine used for allergies;
• reboxetine, a medicine used to treat depression.

While using Daktarin, do not start taking any new medicine without first informing your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Daktarin should not be used during pregnancy unless your doctor considers it necessary.

It is unknown whether miconazole or its components pass into breast milk.

Due to the risk of choking when administering the gel to young children, this medicine must not be applied to the nipple of a woman who is breastfeeding (see section “Warnings and precautions”).

Driving and using machines

Daktarin is not expected to affect your ability to drive or operate machinery.

Daktarin contains ethanol and orange flavour

This medicine contains 7.47 mg of alcohol (ethanol) per gram, equivalent to 0.00747 mg/mg (0.747% w/w). The amount in a single maximum adult dose of this medicine (10 ml) is equivalent to less than 3 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains orange flavour with the following allergens: limonene, linalool, citral, citronellol, and geraniol, which may cause allergic reactions.

3. How to use Daktarin

This medicine is for oral use. The amount to be used and the duration of treatment will depend on the type and location of the infection.

Always follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Infection of the mouth or throat

The recommended dose for the treatment of infections in the mouth or throat is:

Adults: apply 2.5 ml of gel (the contents of the large dosing spoon provided in the package; equivalent to 61 mg of miconazole), four times daily after meals. The gel should not be swallowed immediately; it should be held in the mouth for as long as possible before swallowing.

Treatment should continue for at least 1 week after symptoms have disappeared.

If you wear dentures, you should remove them at night and brush them with the gel, leaving them out overnight. This may help prevent possible infections in your dentures.

Use in children and adolescents

Children over 2 years of age and adolescents: the same dose as in adults should be used.

Infants over 4 months of age and children up to 2 years of age: apply 1.25 ml of gel (the contents of the small dosing spoon provided in the package; approximately equivalent to 30.5 mg of miconazole), four times daily after meals. Each dose should be divided into small portions and the gel should be applied to the affected area with a clean finger. The gel should not be applied to the throat due to the possible risk of choking. The gel should not be swallowed immediately; it should be held in the mouth for as long as possible before swallowing.

Daktarin must not be administered to infants under 4 months of age or to infants who have difficulty swallowing (see section "Do not use Daktarin").

Infection of the stomach or intestine

For the treatment of infections in the stomach or intestine, with or without infections of the mouth or throat: the dose depends on body weight.

Adults, adolescents, children and infants over 4 months of age: the dose to be administered is 20 mg/kg body weight per day, divided into four doses. The daily dose must not exceed 250 mg or 10 ml of oral gel four times daily.

Daktarin must not be administered to infants under 4 months of age or to infants who have difficulty swallowing (see section "Do not use Daktarin").

Treatment should continue for at least 1 week after symptoms have disappeared.

Daktarin should be taken or administered orally.

Unscrew the cap and pierce the seal of the tube opening by inserting the back of the cap into the tube opening.

If you use more Daktarin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose or accidental ingestion, vomiting and diarrhea may occur.

Symptomatic and supportive treatment will be administered. There is no known specific antidote for miconazole.

If you forget to use Daktarin

Do not take a double dose to make up for forgotten doses.

If you stop using Daktarin

Do not stop treatment with Daktarin unless instructed by your doctor. If treatment is stopped prematurely, it may not be effective.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking Daktarin and contact your doctor immediately:

• Swelling of the face, tongue or throat; difficulty swallowing; hives; and breathing difficulties (angioedema, anaphylactic reactions).

Inform your doctor or pharmacist if you experience any of the following adverse effects:

Frequent adverse effects (may affect up to 1 in 10 people) may include:

• Dry mouth
• Nausea
• Mouth discomfort
• Vomiting
• Regurgitation of stomach contents into the mouth without effort (regurgitation)
• Unusual taste of the medicine

Uncommon adverse effects (may affect up to 1 in 100 people) may include:

• Dysgeusia (altered taste)

Adverse effects with unknown frequency (cannot be estimated from available data) may include:

• Pustular rash or blisters filled with pus that may spread across the body, sometimes accompanied by fever (acute generalized exanthematous pustulosis).
• Life-threatening rash with blisters and extensive skin peeling (toxic epidermal necrolysis).
• Severe rash with blisters and skin peeling, particularly affecting the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• Urticaria (hives, itching, and redness).
• Skin rash.
• Severe systemic rash, usually with fever and swollen lymph nodes, and effects on blood cells and organs (drug reaction with eosinophilia and systemic symptoms or DRESS).
• Suffocation.
• Diarrhea.
• Mouth ulcers.
• Discoloration of the tongue.
• Hepatitis (inflammation of the liver).
• You must stop using Daktarin and see your doctor immediately if you develop any of the following symptoms:

Skin allergic reaction, which may include round or oval-shaped red and swollen skin patches, blisters, and itching (drug-induced fixed eruption). Darkening of the skin in affected areas may also occur, which could persist after healing. Drug-induced fixed eruption usually recurs in the same location(s) if the medicine is taken again.

Additional adverse effects in children

Adverse effects observed in children are similar to those observed in adults and adolescents.

Suffocation in infants and children

(see sections “Do not use Daktarin” and “Warnings and precautions”).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Daktarin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Daktarin

• The active substance is miconazole. Each gram of gel contains 20 mg of miconazole.
• The other components (excipients) are: sodium saccharin, pregelatinized potato starch, polysorbate 20, orange flavour (containing limonene, linalool, citral, citronellol and geraniol), cocoa flavour (containing ethanol), glycerol, ethanol and purified water.

Appearance of the product and contents of the pack

Daktarin is a homogeneous white gel, supplied in an aluminium tube with a white high-density polyethylene cap containing 40 g of gel, together with a polystyrene double spoon, each spoon having its volume engraved: the small spoon has a volume of 1.25 ml and the large spoon a volume of 2.5 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

EstevePharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona (Spain)

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: August 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)