Amorolfine 5 %

AMOROLFINE 5 % GLENMARK is a nail lacquer used for a nail fungus infection of the toenails or fingernails. AMOROLFINE 5 % GLENMARK contains the active ingredient amorolfine (as the hydrochloride), which belongs to a group of medicines known as antifungals. It kills a wide variety of fungi that can cause nail infections.

Do not use AMOROLFINE 5 % GLENMARK:

• If you are hypersensitive (allergic) to amorolfine or any of the other ingredients of AMOROLFINE 5 % GLENMARK (see section 6)
• If you are pregnant or breastfeeding your baby
• If you are a child (especially young children and babies).

Warnings and precautions

Special care should be taken with AMOROLFINE 5 % GLENMARK:

• If you experience any allergic reaction you need to stop applying AMOROLFINE 5 % GLENMARK, immediately remove it with a nail varnish remover or the cleaning swabs provided with the package and seek medical advice. The product must not be applied again.
• Do not apply AMOROLFINE 5 % GLENMARK on the skin around the nail
• Do not apply on the nails of young children and babies
• If you want to apply cosmetic (nail polish) nail lacquer, wait at least ten (10) minutes after applying AMOROLFINE 5 % GLENMARK
• If you are using organic solvents, you need to wear protective gloves

Children

Do not use AMOROLFINE 5 % GLENMARK in children.

Other medicines and AMOROLFINE 5 % GLENMARK

Always tell your healthcare provider if you are using, have recently used or might use any other medicines. (This includes all complementary or traditional medicines.) There are no known interactions with other medicines.

Do not share medicines prescribed for you with any other person. Always use AMOROLFINE 5 % GLENMARK exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist if you are not sure.

AMOROLFINE 5 % GLENMARK should be applied to the affected nail/ nails once or twice per week.

Instructions for use

1. Step 1. File the nail
   Before the first application, file down the infected areas of nail, including the nail surface, as much as possible using the nail file provided. CAUTION: Do not use nail files used for infected nails on healthy nails, otherwise you may spread the infection. To prevent the spread of infection, take care that no one else uses the files from your kit.
2. Step 2. Clean the nail
   Use one of the swabs provided to clean the nail surface. Repeat steps 1 and 2 for each affected nail.
3. Step 3. Take some lacquer from the bottle
   Dip the applicator into the bottle of nail lacquer. The lacquer must not be wiped off on the edge of the bottle before it is applied.
4. Step 4. Apply the lacquer
   Apply the nail lacquer evenly over the entire surface of the nail. Repeat steps 3 and 4 for each affected nail.
5. Step 5. Allow to dry
   Let the treated nail(s) dry for approximately 3 minutes. Wait at least 10 minutes before applying cosmetic nail varnish.
6. Step 6. Clean the applicator
   The applicator provided is re-usable. However, it is important to clean it thoroughly after completing each treatment procedure, using the same swab you used for nail cleansing. Avoid touching newly treated nails with the swab.

If you use more AMOROLFINE 5 % GLENMARK than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, consult the nearest hospital or poison centre.

If you forget to use AMOROLFINE 5 % GLENMARK
Do not use a double application to make up for forgotten individual doses.

AMOROLFINE 5 % GLENMARK can have side effects. Not all side effects reported for AMOROLFINE 5 % GLENMARK are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using AMOROLFINE 5 % GLENMARK, please consult your health care provider for advice.

If any of the following happens, stop taking AMOROLFINE 5 % GLENMARK and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Hypersensitivity (allergic reaction) which can present as swelling of the face and throat area, skin rash, nausea, vomiting, difficulty breathing and shock

These are all very serious side effects. If you have them, you may have had a serious reaction to AMOROLFINE 5 % GLENMARK. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Nail disorder (abnormal appearance of the nail)
• Nail discolouration (abnormal colour of the nail)
• Onychoclasis (broken nails)
• Onychorrhexis (brittle nails)

Less frequent side effects:

• Skin burning sensation

Side effects with unknown frequency:

• Erythema (redness of the skin, either in a limited area or all over)
• Pruritis (an uncomfortable, irritating sensation that creates an urge to scratch)
• Contact dermatitis (a skin rash caused by contact with a certain substance)
• Urticaria (a skin rash triggered by a reaction to food, medicine or other irritants presenting as red, itchy welts that result from a skin infection)
• Blisters (an area of skin covered by a raised, fluid-filled bubble)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects
If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Store all medicines out of reach of children. Keep the bottle away from heat. Keep the bottle tightly closed after use. Store at or below 25 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).