Fungiter

• Short description
• How to use

• • FUNGITER 5% medicated nail lacquer Amorolfine
  • Treat fungal infections in nails
  • All packs contain 1 glass bottle, 30 cleaning swabs, 30 nail files, 10 spatulas

• CONTENT
  Pack sizes: 2.5ml. All packs contain 1 glass bottle, 30 cleaning swabs, 30 nail files, 10 spatulas

  Method of use

  Instructions for use: 1. Before the first application of FUNGITER 5% medicated nail lacquer Amorolfine, carefully clean your nails: file down the affected area of the nail (particularly its surface) as completely as possible using the nail file provided. Take care not to file the skin around the nail. 2. Clean the surface of the nail and remove any grease using the swabs provided. 3. Apply the varnish using one of the reusable spatulas (provided in the carton) to the entire affected nail. Clean the reusable spatula between use on different nails, to avoid contaminating the varnish. Do not wipe the spatula on the edge of the bottle 4. Repeat the operations 1 to 3 for each affected nail. 5. Clean the spatula using the swabs provided 6. Seal the bottle completely. Let the treated nail(s) dry for approximately 3 - 5 minutes.

• General information
• Ingredients

• Package leaflet: Information for the user

  Package leaflet: Information for the user

   

  FUNGITER 5% medicated nail lacquer

  Amorolfine

   

  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 3 months.

   

  What is in this leaflet

   1. What FUNGITER 5% medicated nail lacquer is and what it is used for  

  2. What you need to know before you use FUNGITER 5% medicated nail lacquer  

  3. How to use FUNGITER 5% medicated nail lacquer  

  4. Possible side effects  

  5. How to store FUNGITER 5% medicated nail lacquer  

  6. Contents of the pack and other information

   

    1. What FUNGITER 5% medicated nail lacquer is and what it is used for

   FUNGITER 5% medicated nail lacquer is used to treat fungal infections of the nails. It contains the active ingredient amorolfine which belongs to a group of medicines known as antifungals. Amorolfine kills a wide variety of fungi that can cause nail infections.

  2. What you need to know before you use FUNGITER 5% medicated nail lacquer

   Do not use FUNGITER 5% medicated nail lacquer

  - if you are allergic to the active substance (amorolfine) or any of the other ingredients of FUNGITER 5% medicated nail lacquer (listed in section 6).  

   Warnings and precautions  

  This medicine can cause allergic reactions, some can be serious. If this happens, stop applying the product immediately, remove the medicated nail lacquer with the cleaning swabs provided with the package and seek medical advice. The product must not be reapplied.

  Seek urgent medical help if you have any of the following symptoms:

  - difficulty breathing;

  - swelling of the face, lips, tongue or throat;

  - severe skin rash.

  Talk to your doctor or pharmacist before using FUNGITER 5% medicated nail lacquer:

  - if you suffer from diabetes;

  - if you are being treated due to a weak immune system;

  - if you have poor blood circulation in your hands and feet;

  - if your nail is severely damaged or infected.

  If FUNGITER 5% medicated nail lacquer accidentally gets in your eyes or ears rinse immediately with water and contact your doctor or pharmacist. Avoid the lacquer coming into contact with mucous membranes. Do not breathe it in. The medicated nail lacquer should not be applied on the skin around the nail. When working with organic solvents (thinners, white spirit, etc.), wear waterproof gloves to keep the medicated nail lacquer on the nails.

   Children and adolescents

  FUNGITER 5% medicated nail lacquer is not recommended for children and adolescents.

   Other medicines and FUNGITER 5% medicated nail lacquer

  You can use the nail lacquer whilst you are taking other medicines. The cosmetic nail polish can be applied at least 10 minutes after the application of FUNGITER 5% healing nail polish.

   Using other nail products

  During treatment with amorolfine, it is recommended not to wear artificial nails. Avoid applying cosmetic nail polish.

   Tell your doctor or pharmacist if you are using, have recently used or might use any other nail 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.

  As a precautionary measure, it is preferable to avoid the use of FUNGITER 5% medicated nail lacquer during pregnancy, unless absolutely necessary.

  Experience with the use of amorolfine during breastfeeding is limited. It is not known whether amorolfine is excreted in human milk.

  FUNGITER 5% medicated nail lacquer can be used during breastfeeding only when absolutely necessary.

   Driving and using machines

  FUNGITER 5% medicated nail lacquer does not affect the ability to drive and operate machines.

   

   3. How to use FUNGITER 5% medicated nail lacquer

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

   FUNGITER 5% medicated nail lacquer should be applied to the affected nails once a week exactly according to the instructions for use:

   Instructions for use:

  Step 1: File the nail

  Before the first application, file as thoroughly as possible the infected areas of the nail, including the nail surface, using the nail file provided.

  CAUTION: Nail files used for infected nails should not be used on healthy nails. Otherwise, the infection may spread. To prevent the spread of infection, ensure that the nail files provided are not used by others.

    Step 2: Clean the nail

  Use one of the swabs provided (or nail polish remover) to clean the nail surface.

  Repeat steps 1 and 2 for each affected nail.  

   Step 3: Take some lacquer from the bottle

  Dip one of the provided reusable spatulas into the bottle of medicated nail lacquer. The lacquer must not be wiped off the edge of the bottle before it is applied.  

   Step 4: Apply the medicated nail lacquer

  Apply the medicated nail lacquer evenly over the entire surface of the nail. Repeat this step for each affected nail.

  Let the treated nail(s) dry for approximately 3-5 minutes.

    Step 5: Cleaning the spatulas

  The spatulas provided are reusable. It is important to clean them thoroughly after each treatment procedure using the same swab used for nail cleansing. Avoid touching freshly treated nails with the swab. Close the nail lacquer bottle tightly.

  Carefully dispose of the swab as it is inflammable.  

   • Before using the nail lacquer again, first remove the old layer of lacquer from your nails using a swab, then file the nails if necessary.

  • Reapply the medicated nail lacquer as described above in the instructions for use.

  • When dry, the nail lacquer is unaffected by soap and water, so you may wash your hands and feet as usual.

  • It is important to continue using FUNGITER 5% medicated nail lacquer until the infection clears and healthy nails grow. This usually takes 6 months for fingernails and 9 to 12 months for toenails. You will notice the growth of a healthy nail at the place of the damaged one.

   If you accidentally swallow FUNGITER 5% medicated nail lacquer

  If you, or anyone else, accidentally swallows the medicated nail lacquer contact your doctor or pharmacist or visit the nearest hospital immediately.

   If you forget to use FUNGITER 5% medicated nail lacquer

  Do not worry if you forget to use the medicated nail lacquer at the time specified. When you remember, start the application of the product again according to the instructions for use.

   If you stop using FUNGITER 5% medicated nail lacquer

  Do not stop using FUNGITER 5% medicated nail lacquer until your doctor tells you to do so. Otherwise, the infection could come back.

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

    4. Possible side effects

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

   Stop using FUNGITER 5% medicated nail lacquer and seek immediate medical advice if you experience any of the following reactions:

   Rare side effects (may affect up to 1 in 1000 people)

  Your nail may change color, break, or become brittle.

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

  Burning sensation in the area around the nail.

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

  Redness, itching, hives, skin blisters and allergic skin reaction (contact dermatitis).

   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 Drug Agency,

  8, Damyan Gruev str.,

  1303 Sofia,

  tel. +359 2 890 34 17

  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 5% medicated nail lacquer

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

  Store below 30°C.

  Keep the bottle tightly closed and upright.

  Protect from heat.

   

  This product is flammable! Keep the solution away from fire and flames!

   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 5% medicated nail lacquer contains  

  - Active substance: 1 ml contains 55,74 mg amorolfine hydrochloride, equivalent to 50 mg amorolfine (5% w/v amorolfine).  

  - Excipients: ammonio methacrylate copolymer A (Eudragit RL 100), triacetin, butyl acetate, ethyl acetate and anhydrous ethanol.  

   

  What FUNGITER 5% medicated nail lacquer looks like and contents of the pack

  Brown glass bottle (type I or type III) with a high-density polyethylene (HDPE) cap, a polytetrafluoroethylene (PTFE) liner and a protective ring.

   Each 2,5 ml pack consists of 1 glass bottle filled with medicated nail lacquer, 30 cleansing swabs, 30 nail files, 10 spatulas and leaflet: information for the user.

   

  Marketing Authorisation Holder

  Fortex Nutraceuticals LTD.

  10, Prohladen kat str.,

  1362 Sofia, Bulgaria

   

  Manufacturer

  Chanelle Medical Unlimited Company

  Dublin Road, Loughrea,

  Co. Galway, H62FH90,

  Ireland

   

  This leaflet was last revised in may 2023.

   

   

   

• 1 ml contains 55,74 mg amorolfine hydrochloride (equivalent to 50 mg amorolfine). 

  Excipients: ammonio methacrylate copolymertype A (Eudragit RL 100), triacetin, butylacetate, ethylacetate, anhydrous ethanol    

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