Amofun 5 % Solution

AMOFUN 5 % Solution (Nail lacquer) Each Solution contains a morolfine hydrochloride equivalent to amorolfine 5 % w/v (50 mg /mL amorolfine base). AMOFUN 5 % is used to treat fungal infections of the nails. AMOFUN 5 % 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. Onychomycoses caused by dermatophytes, yeasts and moulds. Only little experience is available in cases where the nail matrix was involved.

Do not use AMOFUN 5 % • if you are hypersensitive to amorolfine or any of the other ingredients of AMOFUN 5 % (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 product with a nail varnish remover or the cleaning swabs provided with the package and seek medical advice. The product must not be reapplied. You must get urgent medical help if you have any of the following symptoms: • You have difficulty breathing • Your face, lips, tongue or throat swell • Your skin develops a severe rash Talk to your health care provider before using AMOFUN 5 % . • The lacquer should not be applied on the skin around the nail.

• Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils). • After applying AMOFUN 5 %, an interval of at least 10 minutes should be allowed before application of any cosmetic nail lacquer. Before repeat application of AMOFUN 5 %, the cosmetic nail lacquer should be removed carefully. • Do not inhale. • Wear impermeable gloves when using organic solvents to stop the nail lacquer from being removed. • Do not use nail varnish or artificial nails during treatment with AMOFUN 5 %. • The nail lacquer is not affected by soap and water, so you may wash your hands and feet in the normal way. • If you need to use chemicals such as white spirit or paint thinners, you must wear rubber gloves; otherwise the nail lacquer will dissolve. • Due to the very low systemic absorption of amorolfine after using the nail lacquer a risk to the foetus appears to be negligible. (if applicable).

Children

Do not use AMOFUN 5 % in children.

Other medicines and AMOFUN 5 %

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) There are no known interactions with other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your health care provider for advice before taking this medicine. You should not use AMOFUN 5 % and tell your health care provider if you are pregnant, planning to become pregnant or are breast-feeding. Your health care provider will then decide whether you should use AMOFUN 5 %. Ask your health care provider for advice before taking any medicine.

Driving and using machines

It is not always possible to predict to what extent AMOFUN 5 % may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which AMOFUN 5 % affects them.

Do not share medicines prescribed for you with any other person. Always use AMOFUN 5 % exactly as described in this leaflet or as your health care provider have told you. Check with your health care provider if you are not sure.

Duration of administration

Your health care provider will tell you how long your treatment with AMOFUN 5 % will last. Do not stop treatment early. If you have the impression that the effect of AMOFUN 5 % is too strong or too weak, tell your health care provider.

For Nail Lacquer Solutions

1. File the nail
   File the affected nails, especially the diseased parts of the nail surface using the nail file provided.
2. Clean the nail
   Using one of the swabs provided wipe the entire surface of the affected nail(s) and remove any previous coat of the nail lacquer.
3. Take some lacquer from the bottle
   Dip the applicator into the bottle of nail lacquer. The lacquer must not be wiped off the applicator on the edge of the bottle before it is applied.
4. Apply the lacquer
   Apply the lacquer evenly over the entire surface of the nail. Repeat steps 3 and 4 each affected nail.
5. Allow to dry
   Let the treated nail(s) dry for approximately three to five minutes.
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.
7. Close the nail lacquer bottle tightly and throw away the used swab
   The nail lacquer must be applied to the affected finger or toenails once or twice weekly.

• Every step of the treatment procedure is important. For a successful cure you must repeat each of the steps every time you treat your nails. • These measures and precautions may appear fussy; however, they are indispensable because they speed up healing and prevent healthy nails from becoming infected. • Cosmetic nail lacquer may be applied at least 10 minutes after AMOFUN 5 % application. • Remember: Successful treatment depends on your patience and perseverance. • It is important to carry on using AMOFUN 5 % until the infection has cleared, and healthy nails have grown back. This usually takes 6 months for fingernails and 9 to 12 months for toenails.

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

Less frequent side effects:

• Nail damages, nail discoloration, fragile or brittle nails.
• Skin burning sensation.

Side effects with frequency unknown:

• Systemic allergic reaction (a serious allergic reaction that can be associated with swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash)
• Redness, itching, hives, blister, allergic skin reaction

If you notice any side effects not mentioned in this leaflet, please inform your health care provider.

Reporting of side effects

If you get side effects, talk to your health care provider. 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. By reporting side effects, you can help provide more information on the safety of AMOFUN 5 %.

Store all medicines out of reach of children. • Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. • Keep the pack away from heat (store below 30°C) and keep the bottle tightly closed after use. • 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. • Return all unused medicine to your pharmacist.