Leaflet: information for the patient

Daktarin 20 mg/g oral gel

Miconazole

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Daktarin is and for what it is used

2. What you need to know before starting to use Daktarin

3. How to use Daktarin

4. Possible side effects

5. Storage of Daktarin

6. Contents of the pack and additional information

Daktarin contains the active ingredient 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 infections of the mouth and throat, and the digestive tract caused by a type of fungus calledCandida, in adults, adolescents, and children aged 4 months and above.

No use Daktarin:

-if you are allergic to miconazole, other similar antifungals, or any of the other components of this medication (listed in section 6);

-in infants under 4 months of age or in those infants with difficulty swallowing, as there is a risk of asphyxiation (see section “Warnings and Precautions”);

-if you have liver problems;

-if you are taking any of the following medications (see section “Use of Daktarin with other medications”):

• some allergy medications: terfenadine, astemizole, mizolastine;
• cisapride, a medication used to treat some digestive problems;
• some cholesterol-lowering medications, for example simvastatin and lovastatin;
• midazolam administered orally and triazolam, medications used to treat anxiety or help with sleep (tranquilizers);
• pimozide and sertindole, medications used to treat diseases related to thought, feeling, and behavior alterations;
• halofantrine, an antimalarial medication;
• some medications used to treat migraines, such as ergot alkaloids: ergotamine, dihydroergotamine, ergometrine;
• some medications used to treat heart rhythm alterations: bepridil, quinidine, dofetilide;
• warfarin, an anticoagulant medication used to prevent blood clots or make them larger in the blood and blood vessels.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

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

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

This medication should not be administered to infants under 4 months of age.

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

Asphyxiation in Infants and Children

Daktarin is a thick gel. This ensures that it stays in the mouth for as long as possible. It is essential to ensure that the gel does not obstruct the child's throat, as they could asphyxiate.

Due to the risk of asphyxiation, Daktarin should not be administered to infants under 4 months of age, nor to infants with difficulty swallowing.

Take the following precautions:

• you must administer the gel to the front of the mouth, never place it in the back of the throat;
• the total amount of gel to be administered must be divided into small portions (never place the entire amount at once in the child's mouth);
• apply the gel to the affected areas of the mouth (white patches) with a clean finger and according to the instructions of 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 the gel to the child.

Use of Daktarin with other medications

Inform your doctor, dentist, or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may affect the way Daktarin works or make it more likely to cause side effects. Daktarin may also affect the way other medications work.

If you are taking any of these medications or others, consult your doctor or pharmacist before starting to use Daktarin:

• the anticoagulant medication warfarin;
• some oral medications used to treat diabetes: sulfonylureas (e.g., tolbutamide, gliclazide, glipizide, glibenclamide);
• some medications used to treat cancer: busulfan, docetaxel;
• some medications used to treat heart and blood vessel diseases (calcium channel blockers), e.g., dihydropyridines and verapamil;
• medications used after an organ transplant;
• some medications used to treat HIV infection. HIV protease inhibitors (e.g., lopinavir, saquinavir, amprenavir, and nelfinavir);
• phenytoin, a medication used to treat epilepsy;
• some hospital anesthetics, such as alfentanil;
• sildenafil, a medication used to treat male impotence;
• some medications used to treat anxiety or help with sleep (tranquilizers);
• some medications used to treat tuberculosis;
• oral or injectable methylprednisolone, a medication used for inflammation;
• trimetrexate, a medication used to treat certain types of pneumonia;
• ebastine, an allergy medication;
• reboxetine, a medication used to treat depression.

Do not start taking a new medication without informing your doctor or pharmacist while using Daktarin.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

The passage of miconazole or its components into breast milk is unknown.

Since there is a risk of asphyxiation when administering the gel to young children, this medication should not be applied to the nipple of a breastfeeding woman (see section “Warnings and Precautions”).

Driving and Operating Machines

Daktarin is not expected to affect the ability to drive or use machines.

Daktarin contains ethanol and orange aroma

This medication contains 7.47 mg of alcohol (ethanol) per gram, equivalent to 0.00747 mg/mg (0.747% p/p). The maximum single dose of this medication for an adult (10ml) is equivalent to less than 3ml of beer or 1ml of wine.

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

This medication containsorange aromawith the following allergens: limonene, linalool, citral, citronellol, and geraniol, which may cause allergic reactions.

This medication is taken orally. The amount to be used and the duration of treatment will depend on the type and location of the infection.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Throat or mouth infection

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

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

Treatment should be continued for at least 1 week after the disappearance of symptoms.

If you use dental prostheses, you should remove them at night and brush them with the gel, staying without them during the night. This may 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 content of the small dosing spoon included in the package; approximately equivalent to 30.5 mg of miconazole), four times a day 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 for possible risk of asphyxiation. The gel should not be swallowed immediately, it should be kept in the mouth as long as possible before swallowing.

It should not be administered to infants under 4 months of age or to those infants with difficulty swallowing (see section "Do not use Daktarin").

Stomach or intestine infection

For the treatment of infections in the stomach or intestine with or without throat or mouth infections: 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 of body weight per day, divided into four doses. The daily dose should not exceed 250 mg or 10 ml of oral gel four times a day.

It should not be administered to infants under 4 months of age or to those infants with difficulty swallowing (see section "Do not use Daktarin").

Treatment should be continued for at least 1 week after the disappearance of symptoms.

Daktarin should be taken or administered orally.

Remove the cap and pierce the mouth seal of the tube by inserting the back of the cap into the mouth of the tube.

If you use more Daktarin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Supportive and symptomatic treatment will be applied. No specific antidote is known for miconazole.

If you forgot to useDaktarin

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withDaktarin

Do not interrupt the treatment with Daktarin unless your doctor tells you to. If you interrupt the treatment prematurely, it may not be effective.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

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

Inform your doctor or pharmacist if you have any of the following side effects:

The side effectsfrequent(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
• unusual taste of the medicine

The side effectsinfrequent(may affect up to 1 in 100 people) may include:

• disgeusia (alteration of taste)

The side effectsof unknown frequency(cannot be estimated from available data) may include:

• eruption with pustules or blisters filled with pus that may spread over the body, sometimes with fever (acute generalized pustular psoriasis).
• eruption that threatens life, with blisters and skin peeling on most of the body (toxic epidermal necrolysis).
• severe eruption with blisters and skin peeling particularly in the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• urticaria (hives, itching, and redness).
• skin eruption.
• severe eruption on the body, usually with fever and swelling of lymph nodes, and effects on blood cells and organs (pharmacological reaction with eosinophilia and systemic symptoms or DRESS).
• asphyxia.
• diarrhea.
• mouth ulcers.
• lingual discoloration.
• hepatitis (inflammation of the liver).

Additional side effects in children

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

Asphyxia in infants and children

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Daktarin Composition

• The active ingredient is miconazole. Each gram of gel contains 20 mg of miconazole.
• The other components (excipients) are: sodium saccharin, pregelatinized potato starch, polisorbate 20, orange flavor (containslimonene, linalol, citral, citronellol, and geraniol), cocoa flavor (contains ethanol), glycerol, ethanol, and purified water.

Product appearance and packaging contents

Daktarin is a homogeneous white gel, presented in an aluminum tube with a white high-density polyethylene cap containing 40 g of gel, along with a double-plastic spoon of polystyrene with the volume of each spoon engraved, the small one with a volume of 1.25 ml and the large one with a volume of 2.5 ml.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

EstevePharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona (Spain)

Manufacturer responsible

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa- Barcelona

Spain

Last review date of this leaflet:

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)