FUNGITER 1% cream

• Short description
• How to use

• • antifungal medicinal product that works by killing the fungi that cause skin infections
  • fungus between the toes and fungus on the foot (tinea pedis);
  • fungus in the inguinal areas (tinea cruris);
  • fungus on the body – ringworm (tinea corporis);
  • skin candidiasis – intertrigo; pityriasis versicolor.

• CONTENT
  Each pack contains one aluminum tube of 15 g of cream together with a patient leaflet.

  Method of use

  FUNGITER 1% cream is used 1-2 times a day for 1-2 weeks. Instructions for use • clean and dry the affected skin and adjacent areas and wash your hands; • apply a sufficient amount of the cream in order to apply a thin layer on the affected skin and adjacent areas; • rub gently; • put the cap on the tube; • wash your hands after touching infected skin to avoid spreading the infection to yourself or others; • if you are treating and infection in areas where the skin folds, you can cover the treated areas with a gauze bandage, especially at night. In this case, use a new, clean gauze each time you apply the cream

• General information
• Ingredients

• Package leaflet: Information for the patient

  FUNGITER 1% cream

  Terbinafine hydrochloride

  Read all of this leaflet carefully before you start using 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.  

  - Ask your pharmacist if you need more information or advice.

  - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  - You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

  What is in this leaflet

   1. What FUNGITER 1% cream is and what it is used for  

  2. What you need to know before you use FUNGITER 1% cream  

  3. How to use FUNGITER 1% cream

  4. Possible side effects  

  5. How to store FUNGITER 1% cream  

  6. Contents of the pack and other information

   1. What FUNGITER 1% cream is and what it is used for

  FUNGITER 1% cream is an antifungal medicinal product that works by killing the fungi that cause skin infections.

  FUNGITER 1% cream is available without a prescription for the treatment of the following skin infections:

  • fungus between the toes and fungus on the foot (tinea pedis);

  • fungus in the inguinal areas (tinea cruris);

  • fungus on the body – ringworm (tinea corporis);

  • skin candidiasis – intertrigo;

  • pityriasis versicolor.

  FUNGITER 1% cream is also used to treat skin infections caused by yeasts.

  How FUNGITER 1% cream works

  How to tell if you have any of the following problems:

  - Fungus on the feet: most often occurs between the toes, but can also be on the arch of the foot, the fottom of the foot, or other parts of the foot. The most common type of fungus on the feet causes the skin to crack or peel, but you may also have mild swelling, blisters, or wet sores.

  - Fungus in the inguinal areas: occurs where the skin can be folded and itchy, especially if it is moist – this is often the groin and inner thighs.

  - Fungus on the body (ringworm): can appear anywhere on the body, but is most often found on the head, neck, face, or hands. They usually look like round patches of red rash, but they can appear as scaly patches and itch.

  - Skin candidiasis (intertrigo): in folded areas of the body where the skin is moist from perspiration (for example, under the breasts or armpits). They usually occur in elderly or obese patients, or those suffering from other diseases such as diabetes. They cause redness, itching, peeling.

  - Pytiriasis versicolor: appears on the skin as scaly peeling patches that turn white due to the loss of skin pigmentation. The spots are most noticeable in the summer, as the skin around them darkens normally. They appear mainly on the torso (below the neck to the waist), neck, and arms and can recur for months, especially in warm weather and sweating.

  If you are not sure of the cause of your infection, consult your doctor or pharmacist before using FUNGITER 1% cream.

  2. What you need to know before you use FUNGITER 1% cream  

   Do not use FUNGITER 1% cream

  - if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6).

  Warnings and precautions  

  Talk to your doctor or pharmacist before using FUNGITER 1% cream.

  • FUNGITER 1% cream is applied on the skin;

  • FUNGITER 1% cream is for external use only;

  • not to be used in the mouth and not to be swallowed;

  • FUNGITER 1% cream can cause eye irritation. In cases of accidental contact with FUNGITER 1% cream in the eyes, rinse them thoroughly with running water.

   Children and adolescents

  It is not recommended to use FUNGITER 1% cream in children under 12 years of age.

   Other medicines and FUNGITER 1% cream

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

   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 taking this medicine.

  FUNGITER 1% cream should not be used during pregnancy, unless absolutely necessary. Do not use FUNGITER 1% cream while breastfeeding. Do not allow babies to come into contact with treated skin, including the breasts. The medicine may pass into breast milk.

   Driving and using machines

  FUNGITER 1% cream does not affect the ability to drive and operate machines.

  FUNGITER 1% cream contains cetostearyl alcohol, which may cause local reactions (e.g. contact dermatitis).

  FUNGITER 1% cream contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which can cause allergic reactions (probably of the delayed type).

    3. How to use FUNGITER 1% cream

   Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

   Instructions for use

  • clean and dry the affected skin and adjacent areas and wash your hands;

  • apply a sufficient amount of the cream in order to apply a thin layer on the affected skin and adjacent areas;

  • rub gently;

  • put the cap on the tube;

  • wash your hands after touching infected skin to avoid spreading the infection to yourself or others;

  • if you are treating and infection in areas where the skin folds, you can cover the treated areas with a gauze bandage, especially at night. In this case, use a new, clean gauze each time you apply the cream.

  How often and how long should you use FUNGITER 1% cream

  FUNGITER 1% cream is used 1-2 times a day for 1-2 weeks.

   Use FUNGITER 1% cream within the recommended treatment period, even if you notice improvement earlier. Alleviation of clinical symptoms usually occurs after a few days, but the infection may recur if FUNGITER 1% cream is not applied regularly or use is stopped too early.

   When using FUNGITER 1% cream, the condition of the skin improves after a few days. But the complete recovery of the affected skin after the infection is removed is achieved in a longer period – up to 4 weeks. FUNGITER 1% cream will continue to work even after you have finished the full course of treatment. Although you will not use FUNGITER 1% cream after this, the improvement should continue.

   If you have no signs of improvement after two weeks, you should consult a doctor.

  How to support treatment

  To support the treatment, keep the affected area clean by washing it regularly. Dry it gently without rubbing by gently blotting. Try not to touch the affected area, even though it may be itchy, as this can further complicate and delay the healing process or spread the infection.

  Because these infections can be passed on to other people, use an individual towel and clothes and do not share them with others.Wash your clothes and towels regularly to prevent re-infection.

   If you forget to use FUNGITER 1% cream

  If you forget to apply FUNGITER 1% cream, apply it as soon as you remember and then continue as usual. Do not use a double dose to make up for a forgotten dose.

    4. Possible side effects

   Like all medicines, this medicine can cause side effects, although not everybody gets them.

   Adverse reactions are classified by system organ class and by frequency as follows: very common (≥1/10), common (≥ 1/100 до < 1/10), uncommon (≥ 1/1 000 до < 1/100), rare (≥1/10 000 до <1/1000), very rare (≤ 1/10 000), not known (frequency cannot be estimated from the available data).

  Common – peeling of the skin, itching.

  Uncommon – skin lesions, scabs, skin disorder, pigmentation changes, redness, skin burning sensation, pain on the place of application, irritation on the place of application.

  Rare – skin dryness, eczema, contact dermatitis (a type of skin inflammation).

  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:

  Bulgarian Drug Agency

  8, Damyan Gruev str., 1303 Sofia, Bulgaria,

  tel. +359 2 8903417

  website: www.bda.bg.

  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store FUNGITER 1% cream

   Keep this medicine out of the sight and reach of children.

  Keep the tube closed in the original packaging.

  Shelf life after first opening of the tube: 14 days.

  To be stored below 25°C.

  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

   6. Contents of the pack and other information

   What FUNGITER 1% cream contains  

  - The active substance is terbinafine hydrochloride.  

  - The other ingredients are purified water, cetostearyl alcohol, glycerol, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), octyldodecanol, liquid paraffin.  

  Each pack contains one aluminium tube of 15 g of cream together with a patient leaflet.

   

  Marketing Authorisation Holder

  Fortex Nutraceuticals LTD.

  8, Prohladen kat str.,

  1362 Sofia

  Bulgaria

  Manufacturer

  S.C. Hyperion S.A.

  169A Nicolina Street, Iasi

  Romania

   

  This leaflet was last revised in May 2021.

   

• What FUNGITER 1% cream contains  

  - The active substance is terbinafine hydrochloride.  

  - The other ingredients are purified water, cetostearyl alcohol, glycerol, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), octyldodecanol, liquid paraffin.  

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