INFECTOSOOR Mundgel

Important notes (mandatory information)

InfectoSoor Oral Gel. Active ingredient: Miconazole. Areas of application: used to treat yeast infections of the oral mucosa (oral thrush).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

InfectoSoor Oral Gel, 20 mg/g gel for use in the oral cavity
Active ingredient: Miconazole

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 5 days, contact your doctor or pharmacist.

What is in this leaflet

1. WHAT IS INFECTOSOOR ORAL GEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING INFECTOSOOR ORAL GEL?
3. HOW IS INFECTOSOOR ORAL GEL USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD INFECTOSOOR ORAL GEL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS INFECTOSOOR ORAL GEL AND WHAT IS IT USED FOR?

InfectoSoor Oral Gel is an antifungal agent against fungal infections (antimycotic). InfectoSoor Oral Gel is used to treat yeast infections of the oral mucosa (oral thrush).

2. WHAT SHOULD YOU CONSIDER BEFORE USING INFECTOSOOR ORAL GEL?

InfectoSoor Oral Gel must not be used:

• if you are allergic to miconazole, related antifungal medications, or any of the other ingredients of this medicine listed in section 6.
• in infants under 4 months of age and children whose gag reflex is not yet fully developed.
• if you have liver disease.
• if you are taking any of the following medicines at the same time:
• oral anticoagulants (e.g., warfarin or phenprocoumon)
• certain anti-allergy medicines (terfenadine and mizolastine)
• cisapride (medicine to treat movement disorders in the gastrointestinal tract)
• certain sleeping or sedatives (triazolam, midazolam for oral use)
• certain medicines to treat heart rhythm disorders (quinidine and dofetilide)
• pimozide (medicine for psychotic disorders) or
• certain medicines to lower cholesterol such as simvastatin and lovastatin. (See also "Using InfectoSoor Oral Gel with other medicines".)

Warnings and precautions

Please talk to your doctor or pharmacist before using InfectoSoor Oral Gel. Special precautions are necessary in infants and toddlers (4-24 months) to prevent the gel from blocking the throat. Therefore, do not apply the gel to the back of the throat. Divide each dose into small portions and spread them in the mouth with a clean finger. Please observe your child for signs of possible inhalation of the gel. Signs of this may include coughing or shortness of breath. In premature infants or children with delayed development, InfectoSoor Oral Gel should only be used from the age of 5 to 6 months.

In the following cases, InfectoSoor Oral Gel may only be used under medical supervision:

• if this is the first time the condition has occurred.
• if you or your child have had several such fungal infections in the past 12 months.
• if the condition worsens or does not improve after 5 days.
• in infants aged 4 to 6 months.

Using InfectoSoor Oral Gel with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or plan to take/use any other medicines. The effect of the following drugs or groups of preparations may be affected when used concomitantly with InfectoSoor Oral Gel. Medicines that are broken down by a certain enzyme system in the liver (cytochrome P450) may be increased in their effect and side effects. This applies to all medicines listed in the section "InfectoSoor Oral Gel must not be used" and additionally to the following medicines, whose dosage should be reduced if used concomitantly with miconazole:

• certain medicines for AIDS (HIV protease inhibitors) such as saquinavir
• medicines for the treatment of "cancer" (cytostatics) such as vinca alkaloids, busulfan and docetaxel
• certain medicines for high blood pressure such as dihydropyridines and possibly verapamil
• medicines to reduce the immune system (immunosuppressants): ciclosporin, tacrolimus, sirolimus (= rapamycin)
• tablets for elevated blood sugar levels (oral antidiabetics)
• certain medicines for the treatment of seizures: carbamazepine, phenytoin
• alfentanil, a strong pain reliever
• sildenafil, a medicine for the treatment of male impotence
• certain sleeping or sedatives such as alprazolam, midazolam i.v., buspirone, brotizolam
• certain medicines for the treatment of tuberculosis, such as rifabutin
• methylprednisolone, a medicine for inflammation
• trimetrexate, a medicine for a certain type of pneumonia
• ebastine, an anti-allergy medicine
• reboxetine, a medicine for the treatment of depression
• tobramycin, an antibiotic.

Combinations with systemically used medicines for fungal diseases (polyene antimycotics, e.g., amphotericin B) should be avoided.

Using InfectoSoor Oral Gel with food and drink

Use InfectoSoor Oral Gel after meals.

Pregnancy and

breastfeeding

Pregnancy

InfectoSoor Oral Gel should not be used in the first 3 months of pregnancy. From the 4th month of pregnancy, InfectoSoor Oral Gel should only be used on the express instructions of a doctor.

Breastfeeding

It is not known whether the active ingredient passes into breast milk. InfectoSoor Oral Gel should only be used during breastfeeding on the express instructions of a doctor.

Driving and operating machinery

No special precautions are required.

InfectoSoor Oral Gel contains ethanol and propylene glycol

InfectoSoor Oral Gel contains a small amount of alcohol (less than 100 mg per dose). The cocoa flavoring contained in InfectoSoor Oral Gel contains, among other things, propylene glycol. Propylene glycol can cause skin irritation.

3. HOW IS INFECTOSOOR ORAL GEL USED?

Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Infants and children 4-24 months: 1 small measuring spoon (1 ml gel) 4 times a day, adults and children 2 years and older: 1 large measuring spoon (2 ml gel) 4 times a day.

Method of administration

Gel for use in the oral cavity. Use InfectoSoor Oral Gel 4 times a day after meals. Use the enclosed double measuring spoon to measure the dose. Fill the appropriate measuring spoon to the brim with oral gel. The small measuring spoon contains 1 ml of gel (= 1.25 g), corresponding to 25 mg of miconazole, the large measuring spoon contains 2 ml of gel (= 2.5 g), corresponding to 50 mg of miconazole.

If you are using InfectoSoor Oral Gel in infants and children (4-24 months):

• apply the oral gel to the affected areas in small portions with a clean finger.
• apply the gel to the front of the mouth and never to the back of the mouth.

These precautions are important to avoid inhalation of the oral gel into the respiratory tract (see also section 2 under "Warnings and precautions"). The gel should not be swallowed immediately, but should be kept in the mouth for as long as possible.

Note

The dosage information is only a guideline. Depending on the size of the oral cavity, a smaller amount may be required for small infants, for example, or a larger amount for some adults, in order to apply a thin layer to the mucous membrane. To treat yeast infections of the oral mucosa, dentures should be removed at night and also brushed with the gel.

Duration of use

Usually, the signs of oral thrush recede significantly within the first 5 days after the start of treatment. However, continue treatment for at least one week beyond the disappearance of symptoms.

If you have used more InfectoSoor Oral Gel than you should

If you have applied too much oral gel, vomiting and diarrhea may occur. If you notice any unusual signs of illness, please contact your doctor.

If you forget to use InfectoSoor Oral Gel

Make up for a missed application and continue treatment as usual. Do not use double the amount if you have forgotten the previous application.

If you stop using InfectoSoor Oral Gel

Treatment should be carried out as described under "Duration of use", even if the signs of illness (symptoms) have already disappeared. The infection may still be present and may possibly break out again if the medication is discontinued too early.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following side effects, stop using InfectoSoor Oral Gel and contact your doctor immediately: swelling of the face, tongue or throat; difficulty swallowing;

hives and difficulty breathing (angioedema, anaphylactic reactions, very rare side effects, see below). Contact your doctor or pharmacist if you notice any of the following side effects

Common (may affect up to 1 in 10 people)

Dry mouth, nausea, unpleasant feeling in the mouth, vomiting, regurgitation of food, altered product taste.

Uncommon (may affect up to 1 in 100 people)

Taste disturbances.

Very rare (may affect up to 1 in 10,000 people)

Hypersensitivity reactions with itching and swelling and redness of the skin; also severe cases with shortness of breath and drop in blood pressure, burn-like skin and mucous membrane reactions (Lyell's syndrome = toxic epidermal necrolysis), hives, rash, severe general malaise with high fever, accompanied by acute blotchy rash with later blistering (Stevens-Johnson syndrome), drug rash with eosinophilia and systemic manifestations, swallowing of the gel into the respiratory tract, diarrhea, inflammation of the oral mucosa, discoloration of the tongue, liver inflammation (hepatitis).

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

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD INFECTOSOOR ORAL GEL BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "Use by" and on the tube fold. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Shelf life after first opening: The shelf life after first opening is 8 weeks.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What InfectoSoor Oral Gel contains

The active ingredient is: Miconazole. 1 g of gel contains 20 mg of miconazole. The other ingredients are: Polysorbate 20, saccharin sodium, pregelatinized starch (from potatoes), orange flavor, cocoa flavor (contains, among other things, propylene glycol), ethanol 96%, glycerol, purified water.

What InfectoSoor Oral Gel looks like and contents of the pack

InfectoSoor Oral Gel is a whitish gel for use in the oral cavity and is available in packs of 20 g and 40 g.

Pharmaceutical entrepreneur and manufacturer

Infectopharm Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
www.infectopharm.com

This leaflet was last revised in November 2015.

Source: Information from the package leaflet
Status: 11/2016
Active ingredient: Miconazole. Areas of application: used to treat yeast infections of the oral mucosa (oral thrush).