DAKTARIN 20 mg /G Oral Gel

Зміст інструкції

1. Daktarin 20 mg/g oral gel
   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

Daktarin 20 mg/g oral gel

Miconazole

Read this leaflet carefully before using this medicine as 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 want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

• 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

Daktarincontains miconazole which belongs to a group of medicines called “antimicrobial and
antiseptic” used to treat fungal and yeast infections.

Daktarinis a medicine for local oral treatment. This medicine can be used for the treatment and
prevention of the following infections:

• Candidiasis (yeast infection) of the oropharyngeal cavity (mouth and throat) and the gastrointestinal tract.
• Other mycoses (fungal infections) of the digestive tract, or systemic mycoses (infections that spread throughout the body), such as candidiasis, South American blastomycosis and coccidioidomycosis. See a doctor if you do not feel better or if you feel worse.

2. What you need to know before using Daktarin

DO NOT use Daktarin

• if you are allergic to miconazole, or 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 whom swallowing is not yet sufficiently developed (see section “Warnings and precautions”).
• in case of liver dysfunction.
• if you are taking the following medicines (see section “Other medicines and Daktarin”):
• some medicines for the treatment of allergies (terfenadine, astemizole and mizolastine);
• medicines for the treatment of some digestive disorders (cisapride);
• some medicines that lower cholesterol levels in the blood (simvastatin and lovastatin);
• medicines for the treatment of anxiety and insomnia (triazolam and oral midazolam);
• medicines for the treatment of psychotic mental disorders (pimozide and sertindole);
• medicines against malaria (halofantrine);
• some medicines for the treatment of migraine (ergot alkaloids);
• medicines in case of cardiac arrhythmias (quinidine, bepridil and dofetilide);
• medicines that slow down blood clotting or make it more fluid (warfarin).

Warnings and precautions
Consult your doctor or pharmacist before using Daktarin.
The effectiveness and side effects of the following medicines may be increased or decreased, if used
simultaneously with Daktarin:

• oral hypoglycemic agents (medicines used in the treatment of diabetes) and phenytoin (an antiepileptic medicine): effectiveness and side effects may be increased if administered simultaneously with miconazole. Inform your doctor or pharmacist if you are taking other medicines (see section “Other medicines and Daktarin”). This medicine can cause skin and mucous membrane diseases, even fatal ones such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which can manifest with lesions of the skin and mucous membranes (see section Side effects). If you notice the appearance of a skin rash, consult your doctor as soon as possible, as it may be necessary to stop therapy with Daktarin. ChildrenIt is important to consider that the development of swallowing varies in infants, especially when miconazole oral gel is administered to infants between 4-6 months of age. In premature infants or in whom swallowing is not yet sufficiently developed, Daktarin should not be used before 5-6 months of age.

Choking in infants and children
Daktarin has adhesive properties that allow it to remain in the mouth for longer. Take particular care
when administering Daktarin to infants and children (ages 4 months to 2 years) to avoid the gel
obstructing the throat. Therefore, it is advisable to adopt the following precautions:

• do not administer the entire dose at once, but divide it into small portions;
• apply the gel, with a clean finger, to the affected areas of the mouth (white patches) as recommended by your doctor or pharmacist;
• do not apply the gel to the back of the oral cavity (throat), but to the front;
• do not apply the gel to the nipple of a breastfeeding woman for administration to the infant.

Other medicines and Daktarin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take the following medicines in conjunction with Daktarin:

• some medicines for the treatment of allergies (terfenadine, astemizole and mizolastine);
• medicines for the treatment of some digestive disorders (cisapride);
• some medicines that lower cholesterol levels in the blood (simvastatin and lovastatin);
• medicines for the treatment of anxiety and insomnia (triazolam and oral midazolam);
• medicines used for the treatment of mental illnesses (pimozide and sertindole);
• medicines used for the treatment of malaria (halofantrine);
• some medicines used for the treatment of migraine (ergot alkaloids);
• medicines used in case of cardiac arrhythmias (quinidine, bepridil and dofetilide);
• medicines that slow down blood clotting or make it more fluid (warfarin).

The association of Daktarin with the following medicines may require an adjustment of the doses,
of one or the other:

• some oral medicines for the treatment of diabetes (sulfonylureas);
• phenytoin, a medicine used for the treatment of epilepsy (see section “Warnings andprecautions”);
• some medicines for the cure of AIDS (HIV-protease inhibitors, for example saquinavir);
• some medicines used in the treatment of cancer (vinca alkaloids, busulfan and docetaxel);
• some medicines that act on the heart and blood vessels (dihydropyridines, verapamil, disopyramide cilostazol);
• medicines routinely used after organ transplants (cyclosporine, tacrolimus, sirolimus (rapamycin);
• medicines for the treatment of epilepsy (phenytoin and carbamazepine);
• some anesthetics for hospital use (alfentanil);
• sildenafil, for the treatment of impotence;
• some medicines for the treatment of anxiety and insomnia (tranquilizers) (alprazolam, brotizolam, buspirone, midazolam IV (sedative-hypnotic));
• drugs for tuberculosis;
• methylprednisolone by mouth or by injection, used for the treatment of inflammation;
• trimetrexate, used for the treatment of some types of pneumonia;
• ebastine, a medicine for the treatment of allergies;
• reboxetine, a medicine for the treatment of depression;
• rifabutin, a medicine for the treatment of tuberculosis.

During treatment with Daktarin oral gel, do not start new treatments without first consulting
your doctor or pharmacist.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before using this medicine.
It is preferable to avoid the use of Daktarin during pregnancy unless your doctor considers that the
benefits of therapy are considered greater than the risks to the fetus.

Breastfeeding
It is not known whether miconazole or its metabolites are excreted in breast milk, so use Daktarin with
caution during breastfeeding.

Driving and operating machinery
Daktarin does not impair the ability to drive vehicles or operate machinery.

Daktarincontains ethanol, orange aroma, cocoa aroma and sodium
Ethanol
This medicine contains 7.85 mg of alcohol (ethanol) per 1000 mg, which is equivalent to 0.00785 mg/mg
(0.785 % mg/mg). The amount in 1000 mg of this medicine is equivalent to less than 1 mL of beer or 1 mL
of wine.
The small amount of alcohol in this medicine will not produce significant effects.

Orange aroma
This medicine contains orange aroma (containing: citral, citronellol, d-limonene, geraniol, linalool).

Cocoa aroma
This medicine contains cocoa aroma (containing: benzyl benzoate and benzyl alcohol which can
cause allergic reactions). This medicine contains 0.000000017 mg of benzyl benzoate in each
maximum single maximum dose for an adult (10 ml of oral gel). Benzyl benzoate may cause a
mild local irritation.

Benzyl alcohol
This medicine contains 0.0000000285 mg of benzyl alcohol in each maximum single maximum dose for
an adult (10 ml of oral gel). Benzyl alcohol may cause allergic reactions.
The administration of benzyl alcohol is associated with the risk of serious side effects including breathing problems
("respiratory distress syndrome") in young children.
Do not administer to newborns up to 4 weeks of age unless otherwise recommended by the doctor.
Ask your doctor or pharmacist if you are pregnant or if you are breastfeeding. This is because
large amounts of benzyl alcohol can accumulate in your body and can cause side effects
(called "metabolic acidosis").
Ask your doctor or pharmacist if you suffer from kidney disease. This is because large amounts of
benzyl alcohol can accumulate in your body and cause side effects (called "acidosis
metabolic").
Benzyl alcohol can cause mild local irritation.

Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per g, i.e. it is essentially “sodium-free”.

3. How to use Daktarin

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The measuring spoon (scoop) provided is equivalent to 124 mg per 5 ml
The recommended dose is:

• Oral-pharyngeal candidiasis
• Infants (4-24 months): 1.25 ml of gel (1/4 of scoop) to be applied four times a day after meals. Divide each dose into smaller portions and apply the gel to the affected area of the infection 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, but should be held in the mouth for as long as possible.
• Adults and children over 2 years of age: 2.5 ml of gel (1/2 scoop) to be applied four times a day after meals. The gel should not be swallowed immediately, but should be held in the mouth for as long as possible. Continue treatment for at least one week after the disappearance of symptoms. In the case of oral candidiasis, remove dentures at night and brush them with the gel.
• Gastrointestinal candidiasisThe gel can be used for infants (from 4 months of age), children and adults. The dose is 20 mg/kg of body weight per day, administered in four divided doses. The daily dose should not exceed 250 mg (10 ml of oral gel) four times a day. Continue treatment for at least one week after the disappearance of symptoms.

If you use more Daktarinthan you should
In case of accidental overdose, vomiting and diarrhea may occur.
The effectiveness and side effects of other medicines (e.g. oral hypoglycemic agents and phenytoin) when taken
together with Daktarin may be increased.
If you accidentally take an excessive dose of Daktarin, inform your doctor immediately or
go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Choking may occur in children and infants if the gel obstructs the throat.
The following side effects have been reported with Daktarin.

Common (may affect up to 1 in 10 people):

• Dry mouth
• Nausea
• Oral discomfort
• Vomiting
• Taste alteration Uncommon (may affect up to 1 in 100 people):
• Dysgeusia (distortion or reduction of the sense of taste) Not known (frequency cannot be estimated from available data):
• Anaphylactic reaction
• Difficulty swallowing
• Difficulty breathing
• Angioedema (swelling of the face, tongue or throat)
• Hypersensitivity
• Diarrhoea
• Stomatitis (inflammation of the oral mucosa)
• Discoloration of the tongue
• Hepatitis
• Rash
• Urticaria
• Severe skin and/or mucous membrane reaction induced by the drug (toxic epidermal necrolysis; Stevens-Johnson syndrome)
• Rash with pus-filled blisters (Acute Generalized Pustulosis Exanthematous); drug reaction with eosinophilia and systemic symptoms (DRESS))

Additional side effects in children
The following side effects may occur with Daktarin in children

Very common (may affect more than 1 in 10 people):

• Nausea
• Vomiting Common (may affect up to 1 in 10 people):
• Regurgitation

Not known (frequency cannot be estimated from available data):

• Choking

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine

5. How to store Daktarin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
Do not store at a temperature above 25°C .

6. Contents of the pack and other information

What Daktarin contains
The active ingredient is miconazole. One gram of oral gel contains 20 mg of miconazole.
The other ingredients are:

• polysorbate monolaurate,
• sodium saccharin,
• purified water,
• pregelatinized potato starch,
• orange flavour,
• cocoa flavour,
• ethanol,
• glycerol.

Description of the appearance of Daktarinand contents of the pack
Oral gel 20 mg/g - 1 tube of 80 g with dosing spoon (measuring spoon).
The measuring spoon provided is equivalent to 124 mg of miconazole per 5 ml of gel.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
Johnson & Johnson S.p.A., Via Ardeatina, km 23,500 - 00071 Santa Palomba – Pomezia - Roma

MANUFACTURER
Janssen Pharmaceutica NV
Turnhoutseweg, 30
B-2340 Beerse (Belgium)