Amorolfine Lacquer Chanelle

Amorolfine hydrochloride.

Amorolfine Lacquer contains 50 mg/ml of the active substance amorolfine (equivalent to 55.74 mg/ml amorolfine hydrochloride).
Excipients/Inactive Ingredients: The other ingredients are Eudragit RL 100 (ammonio methacrylate copolymer A), triacetin, butyl acetate, ethyl acetate and ethanol (anhydrous).

Amorolfine Lacquer is used to treat fungal infections of the nails.
Amorolfine 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.

How to use Amorolfine Lacquer: Always use Amorolfine Lacquer exactly as the doctor has told. Check with the doctor or pharmacist if not sure.
Amorolfine Lacquer should be applied to the affected finger or toe nails once or twice weekly.

Do not use Amorolfine Lacquer if: Allergic (hypersensitive) to amorolfine or any of the other ingredients of Amorolfine Lacquer. Check by reading the list of ingredients in Description. If the answer is yes, the patient must inform the doctor before starting treatment. Seek immediate medical attention if the patient experiences symptoms of an allergic reaction. Signs or symptoms of a severe allergic reaction may include a rash, with or without itching, swelling of the face, eyelids or lips and difficulty in breathing.
Pregnant, planning to become pregnant, or are breast-feeding.
Do not use in children under 12 years of age. The safety and effectiveness of amorolfine in children have not been established.

Tell the doctor or pharmacist if: 1. The patient is allergic to any medicines, foods, dyes or preservatives.
2.The patient has any other health problems.
3. The patient is taking any other medicines.
4. The patient has diabetes.
5. The patient is being treated because of a weak immune system.
6. The patient has poor circulation in the hands and feet.
7. The nail is severely damaged or infected.
Take special care with Amorolfine Lacquer: Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (e.g. mouth and nostrils).
Do not inhale.
Do not apply to the nail bed as it may cause localised effects such as contact dermatitis.
Things that must not do: Do not use nail files for infected nails on healthy nails.
Do not use artificial nails during treatment with Amorolfine.
Do not apply cosmetic nail varnish or other medication(s) on the nail(s) being treated.
Do not give Amorolfine to anyone else to use, even if they have the same condition.
Do not use Amorolfine to treat other complaints unless the doctor says to.
Things to be careful of: Take care that Amorolfine does not come into contact with the skin.

Pregnancy and breast-feeding: The patient should not use Amorolfine Lacquer 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 Lacquer. Ask the doctor or pharmacist for advice before taking any medicine.

Like all medicines, Amorolfine Lacquer can cause side effects, although not everybody gets them.
In addition to the beneficial effects of Amorolfine Lacquer, it is possible that unwanted effects will occur during treatment, even when it is used as directed.
Rare side effects: The nail may become discoloured, broken or brittle during treatment with amorolfine nail lacquer. However these reactions may also be linked to the nail infection itself.
Very rare side effects: A burning sensation may occur in the area around the nail.
Unknown frequency of occurrence: Allergic skin reaction (contact dermatitis).
Itching or redness of the skin.
If any of the side effects gets serious, or if the patient notices any side effects not listed in this monograph, tell the doctor or pharmacist.

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 Lacquer.

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 it may spread the infection. To prevent the spread of infection take care that no one else uses the files from the 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. Let the treated nail(s) dry for approximately 3 minutes.
Step 5: 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 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 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 patient may wash the hands and feet 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 Amorolfine 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.
The doctor will probably check how the treatment is progressing every 3 months or so. If there is no improvement, or only small improvement after 6 to 12 months of treatment, see a healthcare professional.
If Amorolfine Lacquer get in the eyes or ears: If Amorolfine Lacquer get in the eyes or ears wash out with water immediately and contact the doctor, pharmacist or nearest hospital straight away.
If Amorolfine Lacquer is accidentally swallowed: If the lacquer is accidentally swallowed, contact the doctor or nearest hospital straight away even if there are no signs of discomfort or poisoning. The patient may need urgent medical attention.
If the patient forgot to use Amorolfine Lacquer: Do not worry if the patient forgot to use the lacquer at the right time. When the patient remembers, start using the product again, in the same way as before.
If Amorolfine Lacquer is stopped: Do not stop using Amorolfine Lacquer before the doctor tells to or the infection could come back. If there are any further questions on the use of this product, ask the doctor or pharmacist.

Keep the pack away from heat (store below 30°C) and keep the bottle tightly closed after use.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Topical Antifungals & Antiparasites

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

GSL