Oflomil Patient Counseling Information

What Amorolfine Nail Lacquer is and what it is used for: Amorolfine Nail Lacquer is used to treat fungal infections of the nails.
Amorolfine Nail Lacquer 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.
What you need to know before you use Amorolfine Nail Lacquer: Do not use Amorolfine Nail Lacquer if you are: Allergic (hypersensitive) to amorolfine or any of the other ingredients of Amorolfine Nail Lacquer (see Contents of the pack and other information as follows for other ingredients).
Warnings and precautions: Talk to your doctor or pharmacist before using of Amorolfine Nail Lacquer.
Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils).
Do not inhale.
Wear impermeable gloves when using organic solvents to stop the nail lacquer from being removed.
Using other medicines: There are no known interactions with other medicines.
Using other nail products: Nail varnish or artificial nails should not be used while using Amorolfine Nail Lacquer.
Pregnancy and breast-feeding: You should not use Amorolfine Nail Lacquer and tell your doctor if you are pregnant, planning to become pregnant or are breast-feeding. Your doctor will then decide whether you should use Amorolfine Nail Lacquer.
Ask your doctor or pharmacist for advice before taking any medicine.
How to use Amorolfine Nail Lacquer: Always use this medicine exactly as your doctor had told you. Check with your doctor or pharmacist if you are not sure.
Amorolfine Nail Lacquer should be applied to the affected finger or toe nails once or twice a week exactly as directed by your doctor.
Instructions for use: 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.
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.
Step 3. Take some lacquer from the bottle: Dip one of the re-usable applicators into the bottle of nail lacquer.
The lacquer must not be wiped off on the edge of the bottle before it is applied.
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.
Step 5. Allow to dry: Let the treated nail(s) dry for approximately 3 minutes.
Step 6. Clean the applicator: The applicators provided are re-usable. However, it is important to clean them thoroughly after completing each treatment procedure, using the same swab you used for nail cleansing. Avoid touching newly treated nails with the swab. Close the nail lacquer bottle tightly. Dispose of the swab carefully as it is inflammable.
Before using Amorolfine Nail Lacquer again, first remove the old lacquer from your nails using a swab, then file down the nails again if necessary.
Re-apply the lacquer as described previously.
When dry the nail lacquer is unaffected by soap and water, so you may wash your hands and feet as normal. If you need to use chemicals such as paint thinners or white spirit, rubber or other impermeable (waterproof) gloves should be worn to protect the lacquer on your fingernails.
It is important to carry on using Amorolfine Nail Lacquer until the infection has cleared and healthy nails have grown back. This usually takes 6 months for finger nails and 9 to 12 months for toe nails.
Your doctor will probably check how your treatment is progressing every 3 months or so.
If you get Amorolfine Nail Lacquer in your eyes or ears: If you get Amorolfine Nail Lacquer in your eyes or ears wash out with water immediately and contact your doctor, pharmacist or nearest hospital straight away.
If you accidentally swallow Amorolfine Nail Lacquer: If you, or anyone else, accidentally swallows the lacquer contact your doctor, pharmacist or nearest hospital straight away.
If you forget to use Amorolfine Nail Lacquer: Don't worry if you forget to use Amorolfine Nail Lacquer at the right time. When you remember, start using the product again, in the same way as before.
If you stop using Amorolfine Nail Lacquer: Do not stop using Amorolfine Nail Lacquer before your doctor tells you to or your infection could come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects: Like all medicines, this medicine can cause side effects, although not everybody gets them. In addition to the beneficial effects of Amorolfine Nail Lacquer, it is possible that unwanted effects will occur during treatment, even when it is used as directed.
Rare side effects (occurring in less than 1 in 1000 people): Your nail may become discoloured, broken or brittle.
Very rare side effects (occurring in less than 1 in 10, 000 people): A burning sensation may occur in the area around the nail.
Unknown frequency of occurrence: Redness, itching, hives, 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. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Amorolfine Nail Lacquer: Keep this medicine out of the sight and 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.
Store at temperatures not exceeding 30°C. Do not Freeze. Protect from light. Keep the bottle tightly close after use.
Flammable. Keep away from heat & flame.
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.
Contents of the pack and other information: What Amorolfine Nail Lacquer contains: Amorolfine Hydrochloride, Absolute Alcohol (Ethanol 99% v/v), N-butyl Acetate Extra Pure, Ethyl Acetate, Ammonio Methacrylate Copolymer (Type A), Triacetin.
What Amorolfine Nail Lacquer looks like and contents of the pack: Each pack consists of 1 bottle filled with 2.5 mL of Amorolfine (Oflomil) 5% nail lacquer with tamper-evident HDPE closure together with cleaning pads, applicators and nail files.
FOR EXTERNAL USE ONLY.