Oflomil

Amorolfine.

Amorolfine Hydrochloride Ph.Eur. equivalent to Amorolfine 50 mg, Absolute Alcohol 63.5% v/v, Base q.s.
Excipients/Inactive Ingredients: Absolute Alcohol (Ethanol 99% v/v), N-butyl Acetate Extra Pure, Ethyl Acetate, Ammonio Methacrylate Copolymer (Type A), Triacetin.

Pharmacotherapeutic group: Other antifungals for topical use. ATC code: D01AE16.
Pharmacology: Pharmacodynamics: Mechanism of action: Amorolfine nail lacquer is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.
Pharmacokinetics: Amorolfine from nail lacquer penetrates into and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed. Systemic absorption of the active ingredient is very low with this type of application.
Following prolonged use of Amorolfine Nail Lacquer, there is no indication of drug accumulation in the body.
Toxicology: Preclinical safety data: None stated.
Microbiology: Amorolfine is a broad spectrum antimycotic. It is highly active (MIC <2 mcg/mL) in vitro against yeasts: Candida, Cryptococcus, Malassezia; dermatophytes: Trichophyton, Microsporum, Epidermophyton; moulds: Hendersonula, Altemaria, Scopulariopsis; dematiacea: Cladosporium, Fonsecaea, Wangiella; dimorphic fungi: Coccidioides, Histoplasma, Sporothrix.
With the exception of Actinomyces, bacteria are not sensitive to amorolfine. Propionibacterium acnes is only slightly sensitive.

Onychomycoses caused by dermatophytes, yeasts and moulds.

The nail lacquer should be applied to the affected finger or toe nails once weekly. Twice weekly application may prove beneficial in some cases.
The patient should apply the nail lacquer as follows: Before the first application of Amorolfine Nail Lacquer, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using the nail file supplied. The surface of the nail should then be cleansed and degreased using a cleaning pad (as supplied). Before repeat application of Amorolfine Nail Lacquer, the affected nails should be filed down again as required, following cleansing with a cleaning pad to remove any remaining lacquer.
Caution: Nail files used for affected nails must not be used for healthy nails.
With one of the reusable applicators supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the applicator with the same cleaning pad used before for nail cleaning. Keep the bottle tightly closed.
For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck.
Caution: When working with organic solvents (thinners, white spirit, etc.) wear impermeable gloves in order to protect the Amorolfine Nail Lacquer on the nails.
Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required frequency and duration of treatment depends essentially on intensity and localisation of the infection. In general, it is six months (finger nails) and nine to twelve months (toe nails). A review of the treatment is recommended at intervals of approximately three months.
Co-existent tinea pedis should be treated with an appropriate antimycotic cream.
Elderly: There are no specific dosage recommendations for use in elderly patients.
Paediatric population: There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

No systemic signs of overdose are expected following topical application of amorolfine 5% nail lacquer.
In case of accidental oral ingestion, appropriate symptomatic measures should be taken if needed.

Hypersensitivity to the active substance or to any of the excipients listed in Description.

Avoid contact of the lacquer with eyes, ears and mucous membranes.
Owing to the lack of clinical experience available to date, children should not be treated with amorolfine 5% nail lacquer.
During the application of amorolfine no cosmetic nail lacquer or artificial nails shall be used.
When organic solvents are used impermeable gloves shall be used otherwise amorolfine nail lacquer will be removed.
Effects on ability to drive and use machines: Not relevant.

Experience with amorolfine use during pregnancy and/or lactation is limited. Only a few cases of exposure to topical amorolfine use in pregnant women have been reported in the post-authorisation setting, therefore the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses; it is unknown whether amorolfine is excreted in human milk. Amorolfine should not be used during pregnancy and/or lactation unless clearly necessary.

Adverse drug reactions are rare. Nail disorders (e.g. nail discoloration, broken nails, brittle nails) may occur. These reactions can also be linked to the onychomycosis itself. (See table.)

Click on icon to see table/diagram/image

Reporting of suspected adverse reactions: Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

No interaction studies have been performed.
Use of nail varnish or artificial nails should be avoided during treatment.

Incompatibilities: Not Applicable.
Special precautions for disposal and other handling: Should be disposed off in accordance with local requirement.

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.
Shelf life: 24 months.

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.

Topical Antifungals & Antiparasites

D01AE16 - amorolfine ; Belongs to the class of other antifungals for topical use.

Non-Rx