DAKTARIN GEL 2% ORAL

Daktarin gel is indicated for the treatment of fungal infections of the mouth and throat in adults and children 12 years of age and older. Oral use. Composition: 1 g of oral gel contains 20 mg of miconazole. The other ingredients are: potato starch, saccharin sodium, polysorbate 20, orange and cocoa flavor, ethanol, glycerol, purified water. Dosage: Recommended dose for adults and children 12 years of age and older: ½ measuring spoon (2.5 ml) of the gel, applied four times a day after meals. Warnings: Store below 30°C Shelf life after opening the primary packaging: 28 days Keep out of the reach of children. Read the leaflet before use. Leaflet: information for the user Daktarin 20 mg/g oral gelDaktarin 20 mg/g oral gelMiconazole (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 any further information or advice, ask your pharmacist. - If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - If you do not feel better after 7 days or if your condition gets worse, you should seek medical advice. What this leaflet contains

What Daktarin is and what it is used for
What you need to know before you take Daktarin
How to take Daktarin
Possible side effects
How to store Daktarin
Package contents 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 aged 12 years and over. 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 any of the other ingredients of this medicine (listed in section 6); - if you are taking any of the following medicines: The effects and/or side effects of many medicines can be increased or decreased when taken at the same time as Daktarin. Examples of medicines that should never be taken while you are taking Daktarin oral gel: - some anti-allergic medicines called terfenadine, astemizole and mizolastine; - cisapride, a medicine used for some digestive problems; - some cholesterol-lowering medicines, such as simvastatin and lovastatin; - midazolam (by mouth) and triazolam, medicines used for anxiety or to help you sleep (tranquilizers); - pimozide and sertindole, medicines used for some psychotic disorders; - halofantrine, a medicine for malaria; - some medicines used to treat migraines, such as Cafergot; - some 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. Particular care is needed 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 adjustment (for example in the dosage). See section „Do not take Daktarin” Combining with some other medicines may require additional monitoring or a change in the dosage of both Daktarin and the other medicines. Examples include: - some medicines taken by mouth to treat diabetes (sulphonylureas); - some medicines for AIDS such as HIV protease inhibitors; - some medicines used to treat cancer; - some medicines that affect the heart and blood vessels (calcium channel blockers); - ciclosporin A, tacrolimus and sirolimus, which are usually given after an organ transplant; - phenytoin, a medicine to treat epilepsy; - some anaesthetics used in hospitals such as alfentanil; - sildenafil, used for male impotence; - some medicines used for anxiety and sleep (tranquilisers); - some medicines to treat tuberculosis; - methylprednisolone, taken by mouth 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 medicine prescribed to you, please discuss this with your doctor or pharmacist. While taking Daktarin oral gel, do not start any other treatment without informing your doctor or pharmacist. Daktarin with food, drink and alcohol Daktarin oral gel should be taken after a meal. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 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 7.73 mg of alcohol (ethanol) per 1000 mg, which is equal to 0.00773 mg/mg (0.773 % w/w). The amount in 1000 mg is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. Daktarin contains sodium This medicine contains less than 1 mmol (23 mg) of 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 to be taken by mouth. The gel should be taken after a meal. How much Daktarin you should take and for how long depends on the type of fungus and the location of the infection. Continue treatment for at least one week after symptoms have disappeared. The gel should not be swallowed immediately, but kept in the mouth for as long as possible. If you wear dentures, remove them before going to bed and apply the gel to them. This can prevent the spread of a fungal infection to your dentures. The recommended dose for treating mouth and throat infections:• For adults and children 12 years and older: 1/2 measuring spoon (2.5 ml) of the gel, applied four times a day 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 Daktarin than you shouldIn 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 drugs (e.g. warfarin, oral hypoglycemic agents and phenytoin), their effects and/or side effects may be increased. If you forget to take Daktarin Do not take a double dose to make up for a forgotten dose of Daktarin oral gel. If you stop taking Daktarin If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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 when using Daktarin oral gel. Common (affects less than 1 in 10 people):

unusual sense of taste;
dry mouth, oral discomfort;
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;
tongue discoloration, mouth inflammation;
diarrhea.

Unknown frequency

Rash with pus-filled pimples/blisters (acute generalized exanthematous pustulosis).

 Nausea and vomiting are very common side effects (may affect more than 1 in 10 people) in children, and the return of stomach contents to the mouth (regurgitation) is a common reaction. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Bulgarian Medicines Agency, Damyan Gruev Street, 81303 Sofia, Tel.: +359 2 8903417, website: www.bda.bg. By reporting side effects, you can help to provide more information on the safety of this medicine. 5. How to store Daktarin Store below 30°C. Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of that month. Shelf life after opening the immediate packaging: 28 days. Do not use this medicine if you notice any visible signs of deterioration in the quality of the product. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. 6. Contents of the pack and additional information What Daktarin containsThe 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 packDaktarin is available in the form of an oral gel:

40 g tubes with a 5 ml measuring spoon;
one full measuring spoon contains 124 mg of miconazole;
One gram of the gel contains 20 mg of miconazole.

 Marketing Authorisation Holder McNeil Healthcare (Ireland) Ltd. Airton Road, Tallaght Dublin 24 Ireland Manufacturer JANSSEN PHARMACEUTICA NV Tumhoutseweg 30B-2340 Beerse Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Johnson & Johnson Bulgaria EOOD zh.k. Mladost 4, Business Park Sofia, building 4 Sofia 1766 Tel.: 02/489 94 00