Locetar

Each mL of Amorolfine (Locetar) contains 50 mg Amorolfine in hydrochloride form.
Each pack consists of 1 bottle filled with 1.25 or 2.5mL of Amorolfine (Locetar) 5% nail lacquer together with cleansing swabs, nail files and spatula integrated in the cap or separate spatulas.
Locetar contains 50 mg/mL of amorolfine (equivalent to 6.4% amorolfine hydrochloride).
Excipients/Inactive Ingredients: Ammonio methacrylate copolymer A, triacetin, butyl acetate, ethyl acetate and ethano.

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 nail mycoses (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.

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.
Amorolfine (Locetar) 5% nail lacquer should be applied to affected finger or toenails once or twice weekly.
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.
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.
Close the nail lacquer bottle tightly. Dispose of the swab carefully as it is inflammable.
Step 5: Allow to dry: Let the treated nail(s) dry for approximately 3 minutes.
Step 6: Clean the applicator: The patient can use the applicators provided 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.
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 the patient gets Locetar in the eyes or ears: If the patient gets Locetar in the eyes or ears, wash out with water immediately and contact the doctor, pharmacist or nearest hospital straight away.
If the patient accidently swallowed Amorolfine (Locetar): If the patient, or anyone else, accidentally swallows the lacquer contact the doctor, pharmacist or nearest hospital straight away.
If the patient forgot to use Amorolfine (Locetar): 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 the patient stops using Amorolfine (Locetar): 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 the patient is: Allergic (hypersensitive) to amorolfine or any of the other ingredients.
Pregnant, planning to become pregnant or are breast feeding.
Under the age of 18.

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.
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. Get urgent medical help if the patient has the following symptoms: Difficulty of breathing; face, lips, tongue or throat swell, skin develops a severe rash.
Talk to the doctor or pharmacist before using Locetar.
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.

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.

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.
Not known: frequency cannot be estimated from the available data: Systemic allergic reaction (a serious allergic reaction that can be associated with the swelling of the face, lips, tongue or throat, difficulty breathing and/or a severe skin rash).
Redness, itching, hives, blister, allergic skin reaction.
If any of the side effects gets serious, or if the patient notices any side effects not listed in this monograph, please tell the doctor or pharmacist.

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.
Shelf life after first opening: 6 months.

Topical Antifungals & Antiparasites

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

Non-Rx