DAKTARIN oral gel 2%-40g
DAKTARIN oral gel 2% 40 g. JANSSEN - CILAG
Leaflet: user information
Daktarin 20 mg/g oral gel
Daktarin 20 mg/g oral gel
miconazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Daktarin is and what it is used for
2. What you need to know before you take Daktarin
3. How to take Daktarin
4. Possible side effects
5. How to store Daktarin
6. Contents of the package and additional information
1. What Daktarin is and what it is used for
Daktarin oral gel is used to treat fungal infections of the mouth and throat in adults and children 12 years of age and older.
2. What you need to know before you take Daktarin
Do not take Daktarin if:
you suffer from any liver disease;
if you are allergic to the active substance, other similar antifungal medicines or to any of the other ingredients of this medicine (listed in point 6);
if you are taking any of the following medicines:
The effects and/or side effects of many drugs can be increased or decreased when taken simultaneously with Daktarin.
Examples of drugs that should never be taken while taking Daktarin Oral Gel:
certain anti-allergy medicines called terfenadine, astemizole and mizolastine;
cisapride, a medicine used to treat certain digestive problems;
certain cholesterol-lowering drugs, such as simvastatin and lovastatin;
midazolam (by mouth) and triazolam, medicines used for anxiety or to help sleep (tranquilizers);
pimozide and sertindole, medicines used in some psychotic disorders;
halofantrine, an anti-malaria drug;
certain medicines used to treat migraines, such as ergoalkaloids (Cafergot);
certain medicines used to treat heart rhythm disorders, such as bepridil, quinidine and dofetilide
warfarin, a medicine used to treat and prevent blood clots (anticoagulant)
Warnings and precautions
Daktarin oral gel is sticky, which ensures that it stays in the mouth for as long as possible. Special care should be taken when using it in children to prevent the possibility of choking.
Daktarin oral gel can cause severe allergic reactions. You should be aware of the signs of an allergic reaction while taking Daktarin Oral Gel. See section "Possible side effects".
Other medicines and Daktarin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines should not be taken at the same time as Daktarin, and others where this is possible, may require some change (for example in the dosage). See section "Do not take Daktarin"
Combining with certain other drugs may require additional monitoring or a change in the dosage of both Daktarin and the other drugs. Examples of this are:
certain medicines taken by mouth to treat diabetes (sulfanylureas);
certain AIDS drugs, such as HIV protease inhibitors; certain medicines used to treat cancer;
some medicines acting on the heart and blood vessels (calcium channel blockers);
cyclosporine A, tacrolimus and sirolimus, which are commonly used after organ transplantation;
phenytoin, a medicine used to treat epilepsy;
some anesthetics used in hospitals, such as alfentanil;
sildenafil, used for male impotence;
certain medicines used for anxiety and to help sleep (tranquilizers);
certain medicines to treat tuberculosis;
methylprednisolone, taken orally or by injection, in cases of inflammation;
trimetrexate, used to treat some forms of pneumonia;
ebastine, a medicine used for allergies;
reboxetine, a medicine used to treat depression;
warfarin, a medicine used to treat and prevent blood clots (anticoagulant).
If you are taking any of these medicines, as well as any other prescribed medicine, please discuss this with your doctor or pharmacist.
While you are taking Daktarin oral gel, do not start any other treatment without telling your doctor or pharmacist.
Daktarin with food, drink and alcohol
Daktarin oral gel should be taken after a meal.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
There are no restrictions, as Daktarin oral gel does not affect your attention and ability to drive.
Daktarin contains ethanol.
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Daktarin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per gram (g), i.e. it is essentially “sodium free”.
3. How to take Daktarin
Read the instructions below carefully. If you are not sure, ask your doctor or pharmacist.
Daktarin is available as an oral gel that is taken by mouth. The wire should be taken after a meal. How much Daktarin you should take and for what period of time depends on the type of fungus and the location of the infection.
Continue treatment for at least one week after symptoms disappear.
The gel should not be swallowed immediately, but kept in the mouth as long as possible. If you wear dentures, remove them before going to bed and apply the gel. This can prevent the spread of a fungal infection on your dentures.
The recommended dose for treating mouth and throat infections:
For adults and children 12 years and older: 1/2 scoop (2.5 ml) of the gel applied four times daily after meals.
To open the tube, unscrew the cap and then pierce the opening of the tube using the pointed tip of the cap.
If you have taken more than the required dose of Daktarin
In case you have taken too much Daktarin, inform your doctor. Possible symptoms of overdose include vomiting and diarrhea.
Information for the doctor in case of overdose
Treatment is symptomatic and supportive.
There is no specific antidote.
If the patient is also taking other medications (eg, warfarin, oral hypoglycemic agents, and phenytoin), their effects and/or side effects may be enhanced.
If you forget to take Daktarin
Do not take a double dose to make up for a missed dose of Daktarin Oral Gel.
If you have stopped taking Daktarin
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause unwanted effects.
4. Possible side effects
Like all medicines, this medicine can cause unwanted effects.
If you experience any of the following side effects, stop taking Daktarin and contact your doctor immediately:
Swelling of the face, tongue or throat; difficulty swallowing; rash and difficulty breathing (angioedema, anaphylactic reactions).
The following side effects may occur with the use of Daktarin oral gel.
Common (affects less than 1 in 10 people):
unusual sense of taste;
dry mouth, discomfort in the mouth;
nausea, vomiting;
unusual taste of products.
Very rare (affects less than 1 in 10,000 people):
allergic reaction, sometimes severe;
severe skin reaction, rash, hives;
choking;
liver damage;
discoloration of the tongue, inflammation of the mouth;
diarrhea.
With an unknown frequency
Rash with pustules/bubbles (acute generalized exanthematous pustulosis).
Nausea and vomiting are very common side effects (may affect more than 1 in 10 people) in children, and regurgitation is a common reaction.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Phone: +359 2 8903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Daktarin
To be stored below 30°C.
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiration date corresponds to the last day of the specified month.
Shelf life after opening the primary packaging: 28 days.
Do not use this medicine if you notice visible signs of product deterioration.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Daktarin contains
The active substance is: miconazole.
The other ingredients are: potato starch saccharin sodium polysorbate 20 orange and cocoa flavor ethanol glycerol purified water
What Daktarin looks like and contents of the pack
Daktarin is available as an oral gel:
40 g tubes with a 5 ml measuring spoon;
one full scoop contains 124 mg of miconazole;
one gram of the gel contains 20 mg of miconazole.
License holder
McNeil Healthcare (Ireland) Ltd., Ireland.
Manufacturer
JANSSEN PHARMACEUTICA NV, Belgium.
Date of last revision of leaflet: 07/2019
