Full Prescribing Info
Amorolfine hydrochloride.
Each mL of Amorolfine (Locetar) contains 50 mg Amorolfine in hydrochloride form.
Each pack consists of 1 bottle filled with 2.5 mL of Amorolfine (Locetar) 5% nail lacquer together with cleansing swabs, reusable applicators and nail files.
The active substance in Locetar is amorolfine (as the hydrochloride) which belongs to a group of medicines known as antifungals.
Amorolfine (Locetar) is used to treat fungal infections affecting up to 2 nails and affecting the upper half or sides of the nail.
Amorolfine (Locetar) kills a wide variety of fungi that can cause nail infections. A fungal nail infection is likely to result in discoloured (white, yellow or brown), thick or brittle nails, although their appearance can vary considerably.
Dosage/Direction for Use
Always use Amorolfine (Locetar) exactly as the doctor or pharmacist has told the patient.
The patient should check with the doctor or pharmacist if not sure.
Adults and the Elderly: Before Commencing Treatment: In the diagram in the Patient Information Leaflet of Locetar, shade the area affected by the fungal nail infection. This will help the patient in remembering how the nail looked originally when the treatment is reviewed. Every three months, shade the area now affected until the infected nail has completely grown out. If more than one nail is affected, select the worst affected nail for this exercise. Take the leaflet to the pharmacist or podiatrist when treatment is being reviewed to inform them of treatment progress to date.
Instructions for Use: Treat the infected nails as described as follows. Nails should be treated once or twice weekly.
Once weekly application should continue for 6 months for finger nails and 9 to 12 months for toe nails.
Nails grow slowly so it may take 2 or 3 months before the patient starts to see an improvement. It is important to carry on using the nail lacquer until the infection has cleared and healthy nails have grown back. The following steps should be followed carefully for each affected nail: Step 1: Prepare the Nail: Using a new file, gently file down the infected areas of nail, including the nail surface. Protect any healthy nails while doing this so that the patient doesn't spread the infection.
CAUTION: Do not use the same nail file for infected nails and healthy nails, as this could spread the infection as well.
To prevent the spread of infection take care that no one else uses the files from the patient's kit.
Step 2: Clean the nail: Use one of the swabs provided, to clean the nail surface. Do not throw the swab away as it will be needed for later to clean the applicator.
Step 3: Treat the nail: 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. Apply the lacquer. Apply the nail lacquer evenly over the entire surface of the nail.
Allow to dry. Let the treated nail(s) dry for approximately 3 minutes.
Step 4: Clean the applicator: The applicators provided can be used more than once. However, it is important to clean them thoroughly each time so that the patient doesn't spread the infection. Use the same swab used for cleaning the nails. Don't touch the newly treated nails with the swab.
Close the nail lacquer bottle tightly. Dispose of the swab carefully as it is inflammable.
Before using the nail lacquer again, first remove the old lacquer from the 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 the hands and feet can be washed as normal. If the patient needs to use chemicals such as paint thinners or white spirit, rubber or other impermeable (waterproof) gloves should be worn to protect the lacquer on the fingernails.
It is important to carry on using the nail lacquer 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. The patient will see a healthy nail growing as the diseased nail grows out.
If Amorolfine (Locetar) is accidentally swallowed: If the patient, or anyone else, accidentally swallows the lacquer contact the doctor, pharmacist or nearest hospital straight away.
If the use of Amorolfine (Locetar) was forgotten: Do not worry if the patient forgets to use the lacquer at the right time. When remembered, start using the product again, in the same way as before.
If using Amorolfine (Locetar) has been stopped: Do not stop using Amorolfine (Locetar) before the doctor tells the patient to or the infection could come back. If there are any further questions on the use of this product, ask the doctor or pharmacist.
Do not use Amorolfine (Locetar) if: Allergic (hypersensitive) to amorolfine or any of the other ingredients.
Pregnant, planning to become pregnant or are breast feeding.
Under the age of 18.
Special Precautions
Take special care with Amorolfine (Locetar): if the patient suffers from diabetes.
If the patient is being treated because of a weak immune system.
If the patient has poor circulation in the hands and feet.
If the nail is severely damaged or infected.
If the patient gets Amorolfine (Locetar) in the eyes or ears wash it out with water immediately and contact the doctor, pharmacist or nearest hospital straight away.
Avoid the lacquer coming into contact with mucous membranes (e.g. mouth and nostrils). Do not inhale.
Use In Pregnancy & Lactation
The patient should not use Amorolfine (Locetar) and tell the doctor if the patient is pregnant, planning to become pregnant or is breast-feeding. The doctor will then decide whether the patient should use Amorolfine (Locetar).
Ask the doctor or pharmacist for advice before taking any medicine.
Side Effects
Like all medicines, Amorolfine can cause side effects, although not everybody gets them.
Rare side effects (occurring in less than 1 in 1000 people): The 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: Allergic skin reaction (contact dermatitis).
If any of the side effects gets serious, or if the patient notices any side effects not mentioned in this monograph, please tell the doctor or pharmacist.
Drug Interactions
Using other medicines: The patient can use the nail lacquer whilst taking other medicines.
Using other nail products: Nail varnish or artificial nails should not be used while using Amorolfine (Locetar). Please tell the doctor or pharmacist if using or have recently used any other medicines, including medicines obtained without a prescription.
Do not store at temperatures exceeding above 30°C. Keep the pack away from heat. Keep the bottle tightly closed after use.
MIMS Class
Topical Antifungals & Antiparasites
ATC Classification
D01AE16 - amorolfine ; Belongs to the class of other antifungals for topical use.
Locetar nail lacquer 5%
2.5 mL x 1's (P2,866/container)
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