Amorolfine 5% w/v medicated nail lacquer

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Amorolfine
Available from:
Chanelle Medical
ATC code:
D01AE16
INN (International Name):
Amorolfine
Dosage:
5 percent weight/volume
Pharmaceutical form:
Medicated nail lacquer
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
amorolfine
Authorization status:
Not marketed
Authorization number:
PA0688/031/001
Authorization date:
2013-06-21

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Package Leaflet: Information for the User

Amorolfine 5% w/v Medicated Nail Lacquer

amorolfine (as hydrochloride)

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even

if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Amorolfine Lacquer is and what it is used for

What you need to know before you use Amorolfine Lacquer

How to use Amorolfine Lacquer

Possible side effects

How to store Amorolfine Lacquer

Contents of the pack and other information

1.

What Amorolfine Lacquer is and what it is used for

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 anti fungals. It kills a wide variety of fungi that can

cause nail infections.

2.

What you need to know before you use Amorolfine Lacquer

Do not use Amorolfine Lacquer if you are:

Allergic (hypersensitive) to amorolfine or any of the other ingredients of Amorolfine Lacquer.

Please check by reading the list of ingredients in section 6. If you answer yes, you must inform

your doctor before starting treatment.

Please seek immediate medical attention if you experience 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.

Warnings and precautions:

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.

You must get urgent medical help if you have any of the following symptoms:

You have difficulty breathing

Your face, lips, tongue or throat swell

Your skin develops a severe rash

Talk to your doctor or pharmacist before using 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.

Wear impermeable gloves when using organic solvents to stop the nail lacquer from being

removed.

Other medicines and Amorolfine Lacquer

There are no known interactions with other medicines.

Using other nail products

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Nail varnish or artificial nails should not be used while using Amorolfine Lacquer.

Pregnancy and breast-feeding

You should not use Amorolfine 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

Lacquer. Ask your doctor or pharmacist for advice before taking any medicine.

3.

How to use Amorolfine Lacquer

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

Amorolfine Lacquer should be applied to the affected finger or toe nails once weekly.

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 spatulas 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 spatula

The spatulas 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 the 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 above.

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.

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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 fingernails and 9 to 12 months for

toenails.

Your doctor will probably check how your treatment is progressing every 3 months or so.

If you get Amorolfine Lacquer in your eyes or ears

If you get Amorolfine 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 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 Lacquer

Do not worry if you forget to use the lacquer at the right time. When you remember, start using the

product again, in the same way as before.

If you stop using Amorolfine Lacquer

Do not stop using Amorolfine Lacquer before your doctor tells you to or your infection could come

back. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

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: may affect up to 1 in 1,000 people

Nail damages, nail discoloration, fragile or brittle nails.

Very rare: may affect up to 1 in 10,000 people

Skin burning sensation

Not known: frequency cannot be estimated from the available data

Systemic allergic reaction (a serious allergic reaction that can be associated with swelling of the

face, lips, tongue or throat, difficulty breathing and/or a severe skin rash)

Redness, itching, hives, blister, allergic skin reaction

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. You can also report side effects directly via HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517

Website: www.hpra.ie, e-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Amorolfine 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 carton and bottle. The

expiry date refers to the last day of that month.

Keep the pack away from heat (store below 30°C) and keep the bottle tightly closed after use.

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 to protect the environment.

6.

Contents of the pack and other information

What Amorolfine Lacquer contains

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Each 1 ml of Amorolfine Lacquer contains 50 mg of the active substance amorolfine (as

hydrochloride). The other ingredients are Eudragit RL 100 (ammonio methacrylate copolymer A),

triacetin, butyl acetate, ethyl acetate and ethanol (anhydrous).

What Amorolfine Lacquer looks like and contents of the pack

Amorolfine Lacquer is a clear, colourless to pale yellow solution.

It is available in 2.5 ml, 3 ml and 5 ml packs; 1 bottle packed with or without cleansing swabs, spatulas

and / or nail files. Amorolfine Lacquer is also available in 7.5 ml and 10 ml packs; 2 bottles packed with

or without cleansing swabs, spatulas and / or nail files.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is Chanelle Medical, Loughrea, Co. Galway, Ireland.

The manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.

This leaflet was last revised in: 11/2018

Health Products Regulatory Authority

01 April 2019

CRN008P19

Page 1 of 4

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Amorolfine 5% w/v medicated nail lacquer

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1ml contains 50mg amorolfine (as hydrochloride).

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Medicated nail lacquer.

A clear, colourless to almost colourless liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Onychomycoses caused by dermatophytes, yeasts and moulds.

4.2 Posology and method of administration

The nail lacquer should be applied to the affected finger or toe nails once weekly.

The patient should apply the nail lacquer as follows:

1. Before the first application of Amorolfine 5% w/v Medicated 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 an alcohol cleaning pad. Before repeat application of Amorolfine 5% w/v

Medicated 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.

2. With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nails. Allow the nail

lacquer to dry for 3-5 minutes. After use, clean the spatula with the same cleaning pad used before for nail cleaning. Keep the

bottle tightly closed.

For each nail to be treated, dip the spatula into the nail lacquer without wiping off any of the lacquer on the bottle neck.

The required 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).

Elderly

There are no specific dosage recommendations for use in elderly patients.

Children

There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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01 April 2019

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4.4 Special warnings and precautions for use

Avoid contact of the lacquer with eyes, ears and mucous membranes.

Caution: Amorolfine 5% w/v Medicated Nail Lacquer should not be applied to the nail bed as it may cause localised effects

such as contact dermatitis.

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.

A systemic or local allergic reaction could possibly occur after use of this product. If this happens, the product should be

stopped immediately and medical advice should be sought.

Remove the product carefully by using a nail remover solution.

The product should not be reapplied.

4.5 Interaction with other medicinal products and other forms of interactions

No interaction studies have been performed.

Use of nail varnish or artificial nails should be avoided during treatment.

4.6 Fertility, pregnancy and lactation

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.

Reproductive toxicology studies showed no evidence of teratogenicity in laboratory animals, but embryotoxicity was observed

at high oral doses. The systemic absorption of amorolfine during and after topical administration is very low and therefore the

risk to the human foetus appears to be negligible. It is unknown whether amorolfine is excreted in human milk.

Amorolfine 5% w/v Medicated Nail Lacquer should not be used during pregnancy and/or lactation unless clearly necessary.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

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.

System Organ Class

Frequency

Adverse drug reaction

Immune system disorders

Unknown frequency*

Hypersensitivity (systemic allergic reaction)*

Skin and subcutaneous tissue disorders

Rare (≥1/10,000 to <1/1,000)

Nail disorder, nail discoloration, onychoclasis (broken

nails), onychorrhexis (brittle nails)

Very rare (<1/10,000)

Skin burning sensation

Unknown frequency*

Erythema*, pruritus*, contact dermatitis*, urticaria,

blister*

* post marketing experience

Reporting of suspected adverse reactions

Health Products Regulatory Authority

01 April 2019

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Reporting suspected adverse reactions 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 via HPRA Pharmacovigilance,Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517;

Website: www.hpra.ie; e-mail: medsafety@hpra.ie

4.9 Overdose

Accidental oral ingestion

Amorolfine 5% w/v Medicated Nail Lacquer is for topical use. In the event of accidental oral ingestion, appropriate

symptomatic measures should be taken if needed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Other antifungals for topical use ATC code: D01AE16

Amorolfine 5% w/v Medicated 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.

Amorolfine is a broad spectrum antimycotic. It is highly active (MIC < 2mcg/ml) in vitro against

yeasts: Candida, Cryptococcus, Malassezia

dermatophytes: Trichophyton, Microsporum, Epidermophyton

moulds: Hendersonula, Alternaria, 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.

5.2 Pharmacokinetic properties

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 5% w/v Medicated Nail Lacquer, there is no indication of drug accumulation in the

body.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of

the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ammonio methacrylate copolymer type A (Eudragit RL 100)

Triacetin

n-Butyl acetate

Ethyl acetate

Ethanol, anhydrous

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Health Products Regulatory Authority

01 April 2019

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3 years

6.4 Special precautions for storage

Amorolfine 5% w/v medicated nail lacquer should be stored below 30°C. Protect from heat. Keep the bottle upright and tightly

closed after use.

6.5 Nature and contents of container

Amber glass bottle (Type I or Type III) and a HDPE cap with a PTFE liner and tamper evident ring.

The pack is available in sizes of 2.5 ml, 3 ml, 5 ml, 7.5 ml and 10 ml.

Each 2.5 ml, 3 ml and 5 ml pack consists of 1 bottle filled with Amorolfine 5% w/v Medicated Nail Lacquer. Each pack may also

contain cleansing swabs, spatulas and nail files.

Each 7.5 ml and 10 ml pack consists of 2 bottles filled with Amorolfine 5% w/v Medicated Nail Lacquer. Each pack may also

contain cleansing swabs, spatulas and nail files.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Chanelle Medical

Loughrea

Co. Galway

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0688/031/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21

June 2013

Date of last renewal: 20

June 2018

10 DATE OF REVISION OF THE TEXT

April 2019

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