FORTEX FUNGITER 1% medicinal cream against fungi 15g
FUNGITER 1% cream
FUNGITER 1% cream
Terbinafine hydrochloride
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.
- 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 14 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What is FUNGITER 1% cream and what is it used for
2. What you should know before using 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 package and additional information
1. What is FUNGITER 1% cream and what is it 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;
• multi-colored lichen (pityriasis versicolor).
FUNGITER 1% cream is also used to treat skin infections caused by yeast.
How FUNGITER 1% cream works
How to tell if you have any of the following problems:
- Fungus on the feet: most often appear between the toes, but can also be on the arch of the foot, the bottom or other part of the feet. The most common type of athlete's foot causes the skin to crack or peel, but you may also have mild swelling, blisters, or wet sores.
- Fungi in the inguinal areas: appear where the skin can be folded and itchy, especially if it is moist - this is often the groin and inner thighs.
- Fungi on the body (ringworm): can appear anywhere on the body, but are 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.
- Cutaneous 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.
- Multicolored lichen (pityriasis versicolor): appears on the skin as scaly spots 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 should know before using 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 to 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 of 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
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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. 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 chest. The drug may pass into breast milk.
Driving and using machines
FUNGITER 1% cream does not affect the ability to drive and operate machinery.
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. If you are not sure, ask your doctor or pharmacist.
Instructions for use
• clean and dry the affected skin and adjacent areas and wash your hands;
• apply a sufficient amount of the cream 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 an 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 an 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 if use is stopped too early.
When using FUNGITER 1% cream, the condition of the skin improves after a few days. But complete recovery of the affected skin after the infection is removed is achieved for 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 healing
To aid healing, 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 forgot 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 missed 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 frequency as follows: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) ), rare (≥1/10,000 to <1/1,000), 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, application site pain, application site irritation.
Rare - skin dryness, eczema, contact dermatitis (a type of skin inflammation).
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 via
Medicines Executive Agency,
8 Damyan Gruev St., 1303 Sofia, Bulgaria,
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 FUNGITER 1% cream
Keep out of the reach of children.
Keep the tube closed in the original package.
Shelf life after first opening the tube: 14 days.
To be stored below 25°C.
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 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 aluminum tube of 15 g of cream together with a patient leaflet.
License holder
Fortex Nutraceuticals Ltd
10 Prohladen kat St., Sofia 1362
Bulgaria
Manufacturer
SC Hyperion SA
169A Nicolina Street, Iasi
Romania
Date of last revision of leaflet
May 2021
