Daktarin oral

Active Ingredients

Active ingredient and its concentration:

Miconazole 20 mg/g.

Indications

Therapeutic group:

Antifungal, of the imidazole derivatives.

Daktarin Oral Gel intended for the treatment and prevention of oral mycosis and fungal infections of the upper gastrointestinal tract (throat, esophagus, stomach, intestines).

Instructions

Daktarin Oral Gel is for oral use only.

Open the tube, unscrew the cap and pierce the sealed part of the tube, using the pin on the top of the cap.

Do not swallow the gel straight away, rather, keep it in your mouth for as long as possible, thereby enabling the medicine to remain in contact with the mouth for a while, then swallow.

If the infection is only in the mouth, apply the gel to the affected area with a clean finger.

If you have dentures, take them out at night, and brush them with Daktarin Oral Gel. This will prevent them from also becoming infected.

If you are giving the gel to a child or an infant over 6 months of age, be sure there is no risk of choking, by dividing the required dose into small portions - never place the entire dose in the child's mouth at once. Place the gel at the front of the mouth. Never place the gel in the back part of the throat.

The dosage of the medicine depends on the type of fungus and its location.

Recommended dosage for treatment of oral mycosis and fungal infection of the throat:

Children above 2 years of age and adults:

1/2 measuring spoon (2.5 ml) of gel, 4 times a day, after meals.

Children from 6 months to 2 years of age:

1/4 measuring spoon (1.25 ml) of gel, 4 times a day, after meals. Divide the required dose into small portions and apply to the affected area with a clean finger.

The dosage for the treatment of fungal infection of the stomach and intestines will be determined by the doctor only.

Do not exceed the recommended dose.

Continue the treatment for at least one week after all the clinical symptoms have gone away. This will prevent the symptoms from coming back. If the symptoms persist, refer to the doctor.

Take care to measure the dose using a measuring spoon, or special measuring cup, dropper, etc.

If you forget to take the medicine at the scheduled time, do not take a double dose. Take the next dose at the usual time and consult a doctor.

Refer to the doctor if the signs of the disease (symptoms) worsen or do not improve.

Avoid contact with the eyes.

Do not use the preparation beyond 3 months after first opening.

Warnings

Do not use Daktarin Oral Gel if you are sensitive (allergic) to miconazole, to similar antifungals or to any of the additional ingredients contained in the medicine.

This medicine is not intended for infants below the age of 6 months or for infants whose swallowing reflex is not sufficiently developed, due to the risk of choking.

Do not use this medicine if you are suffering from any liver disease.

Do not use Daktarin Oral Gel if you are taking any of the following medicines:

• terfenadine, astemizole and mizolastine
• (medicines for hay fever or allergy).
•  cisapride (a medicine used to treat certain digestive problems).
•  cholesterol-lowering medicines, such as simvastatin and lovastatin.
•  midazolam (taken by mouth) and triazolam (medicines used to treat anxiety and sleep
• disorders).
•  pimozide and sertindole (medicines used to treat psychotic disorders).
•  quinidine and dofetilide (medicines used to treat heart rhythm problems).
• certain medicines used to treat migraine such as ergot alkaloids.

If you are taking blood thinners (anticoagulants) or phenytoin (a medicine for epilepsy), the doctor may want to check the levels of the medicines in your blood via blood test.

Combination with some medicines may require monitoring or a dosage change of either Daktarin Oral Gel or of the other medicine. Tell your doctor before taking, or if you are already taking, one of the following medicines:

• anticoagulants such as warfarin.
• medicines for the treatment of the AIDS virus, such as HIV protease inhibitors, e.g., saquinavir.
• certain medicines for the treatment of cancer, such as busulfan, docetaxel and a group of
• medicines known as 'vinca alkaloids'.
• medicines that act on the heart and blood vessels called calcium channel blockers, such
• as dihydropyridines and verapamil.
• cyclosporine, tacrolimus and sirolimus, which are usually given after an organ transplant.
• phenytoin and carbamazepine, for treatment of epilepsy.
• alfentanil for pain.
• certain tranquilizers for the treatment of anxiety or sleeping difficulties, such as buspirone, alprazolam, brotizolam or intravenous midazolam.
• rifabutin for tuberculosis.
• methylprednisolone, a medicine given by mouth or injection for the treatment of inflammations.
• ebastine, a medicine used to treat allergy.
• reboxetine, a medicine used to treat depression.
• oral medicines used to treat diabetes, such as sulphonylureas, such as chlorpropamide and glibenclamide.
• sildenafil, a medicine used to treat male impotence.
• trimetrexate, a medicine used to treat a certain type of pneumonia.
• cilostazol or disopyramide, medicines that act on the heart and blood vessels.
•  

Tell your doctor before taking, or if you are already taking, any of the medicines listed above. This can alter the treatment.

Do not start treatment with a new medicine without first consulting the doctor or pharmacist.

Daktarin Oral Gel is a sticky substance, which enables it to stay in the mouth for as long as possible. If the gel blocks the throat passageway, infants and children may choke.Make sure that the gel does not close off the child's throat, as this could cause the child to choke. For this purpose, take the following precautions:

• Place the gel in the front of the mouth and never put it in the back of the throat.
• Divide the required dose into small portions. Never put the entire dose in the child's mouth at once.
• Apply the gel to the affected areas of the mouth (white patches) with a clean finger and according to the doctor's instructions.
• If you are breastfeeding, never apply the gel to your nipple in order to treat your baby.

If you are pregnant or if you think you might be pregnant inform the doctor who will decide if you can use the medicine.

If you are breastfeeding, inform the doctor who will decide if you can use the medicine.

If you are breastfeeding, never apply the gel to your nipple in order to treat your baby.

Daktarin Oral Gel contains small amounts of ethanol (alcohol), less than 100 mg per dose.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.