Sanail-Mepha Once a Week Nail Varnish 50 mg/ml 2.5 ml Fl

What is Sanail-Mepha once a week and when is it used?

Sanail-Mepha once a week active ingredient nail polish is a medicine against fungal infections (mycoses) of the nails that is used externally. Without a doctor's prescription, Sanail-Mepha once a week nail polish containing active ingredients is used to treat nail mycoses on the front and side edges of the nails if no more than two nails are affected. If the infection affects more than just the front and side edges of the nail, then you must consult a doctor.

Nail mycosis is usually associated with a white, yellow or brown discoloration and thickening of the nail, whereby the appearance of the infestation can vary greatly.

The active ingredient amorolfine contained in Sanail-Mepha once a week nail polish containing active ingredients inhibits the growth of the fungi and kills them. Sanail-Mepha once a week nail polish containing active ingredients works against a wide variety of fungi, such as yeasts, the actual skin fungi (dermatophytes) and moulds. However, bacteria are not sensitive to amorolfine.

What should be considered?

Fungal infections are often very stubborn. The success of a treatment with Sanail-Mepha once a week nail polish containing active ingredients depends on its uninterrupted use, which may require several months depending on the type of fungus, site of infection and severity.

When must Sanail-Mepha once a week not be used?

Sanail-Mepha once a week nail polish containing active ingredients must not be used again in patients who have reacted hypersensitively to the treatment or to treatment with amorolfine.

If you are pregnant, suspect or plan to be pregnant, or are breastfeeding, do not use Sanail-Mepha once a week nail polish containing active ingredients.

Sanail-Mepha once a week nail polish containing active ingredients may only be used on children under the age of 12 in exceptional cases and on medical prescription.

When is caution required when using Sanail-Mepha once a week?

In the case of inflammation and/or injuries to the neighboring skin the doctor and a specialist experienced in nail care (e.g. podiatrist).

Ask your doctor, pharmacist or druggist for advice if you suffer from diabetes or are being treated for an immune disease, if you have been diagnosed with circulatory disorders in your hands and feet, or if your nail is very damaged or badly affected.

When using the nail polish containing active ingredients, local or general allergic reactions can occur. In this case you should stop using the medicated nail polish, rub off the medicated nail polish with nail polish remover and seek advice from your doctor or pharmacist. The product should not be reapplied.

You need urgent medical attention if you experience any of the following symptoms:

• Breathlessness
• Swelling of the face, lips, tongue or throat
• Severe skin rash

Tell your doctor or pharmacist if you

• have any other diseases
• Allergic or take
• other medicines (including those you bought yourself!) or use them externally!

This product contains ethanol (alcohol). Excessive application frequency or incorrect application can cause irritation and drying of the skin in the vicinity of the nail.

Can Sanail-Mepha Once a Week be used during pregnancy or while breastfeeding?

During pregnancy, Sanail-Mepha Once a Week nail polish containing active ingredients may only be used with the express permission of your doctor.

During breastfeeding, the use of Sanail-Mepha Once a Week is prohibited avoid using nail polish that contains active ingredients.

How do you use Sanail-Mepha once a week?

Apply the nail surface affected by the infection in the sketch of the leaflet: This will allow you to remember the original appearance of your nail, which will help you to evaluate the effectiveness during the course of the treatment. The area affected by the infection should then be recorded every 3 months until the treated nail has fully grown back. If two nails are affected, then the most affected nail must be selected. Take this leaflet with you if you ask your doctor, pharmacist or druggist for advice.

Before the treatment	3 months	6 months	12 months

Unless otherwise prescribed by the doctor, the affected fingernails or toenails are treated once a week with nail polish containing the active ingredient Sanail-Mepha.

For the success of the therapy, good accompanying nail care is of crucial importance. It may be advisable to consult a specialist experienced in nail care (e.g. podiatrist).

The nail polish containing active ingredients should be used as follows:

1. File off diseased parts of the nails (especially nail surfaces) as well as possible with a nail file included in the pack. File as necessary during the course of the treatment.
   Caution: A nail file used for the treatment must no longer be used to care for healthy nails, otherwise the infection could be spread.
2. Before each application, degrease the diseased nails and remove any varnish residues. Use the enclosed swabs to degrease and clean the nail surface.
3. Dip one of the supplied, reusable spatulas into the bottle with the medicinal varnish. The medicated nail polish should not be wiped off the neck of the bottle.
4. Apply the medicated nail polish to the entire surface of the diseased nail and allow to dry. Dip the spatula again for each nail to be treated.
5. Close the bottle tightly immediately after use.
6. To reuse, clean the spatula after use with the swab already used for the nails. Make sure not to touch freshly treated nails with the swab.

During the treatment, you should not wear artificial nails.

Important notes:

• Nail polish containing active ingredients that has been spilled into your eyes or ears must be rinsed out with water immediately contact.
• Avoid contact of the nail polish containing the active ingredient with mucous membranes (e.g. mouth and nose). Do not inhale!
• If you accidentally swallow the nail polish containing active ingredients, you should contact a doctor, pharmacist or druggist or the nearest hospital immediately.

Duration of treatment

The treatment should be continued uninterrupted until the affected areas have healed completely and the nail has grown back. It usually takes about six months for affected fingernails to heal, and nine to twelve months for toenails.

Observe the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Sanail-Mepha once a week have?

The following side effects can occur when using Sanail-Mepha once a week medicated nail polish:

Uncommon (affects 1 to 10 users in 1000)

Uncommonly, a slight, temporary burning sensation in the nail area has been observed after application of the nail polish containing the medicated substance.

Rare (affects 1 to 10 users in 10,000)

In rare cases, nail changes such as discoloration, brittle or broken nails have been reported. Such changes can also be caused by the fungal disease of the nail itself.

Very rare (affects less than 1 user in 10,000)

Very rarely, burning skin sensations have been observed near the nail.

Severe allergic reactions, which could be associated with swelling of the face, lips, tongue or throat, shortness of breath and/or a severe skin rash, have been observed with an unknown frequency , and contact dermatitis, redness, itching, and hives

You need urgent medical attention if you get any of the following symptoms:

• Breathlessness
• Swelling of your face, lips, tongue, or throat
• Severe skin rash

If you get any side effects, talk to your doctor, pharmacist, or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be taken into account?

The medicine may only be used up to the date marked «EXP» on the container.

Storage instructions

Store in the original packaging and not above 25°C. Do not freeze and do not store in the refrigerator. Close the bottle tightly immediately after use. Keep out of the reach of children.

Further information

Since the varnish applied to the nail can be dissolved or removed when handling organic solvents (nitro thinner, turpentine substitute, etc.), it is advisable to wear impermeable gloves during such work to protect the Sanail-Mepha once a week varnish layer.

Your doctor, pharmacist or druggist can provide you with further information, pharmacist or druggist. These people have the detailed technical information.

What does Sanail-Mepha once a week contain?

Active ingredients

1 ml nail polish containing active ingredients contains 50 mg amorolfine (as hydrochloride)-

Excipients

Anhydrous ethanol, ammonium methacrylate copolymer (type A), triacetin, n-butyl acetate, ethyl acetate.

Authorization number

65130 (Swissmedic).

Where can you get Sanail-Mepha once a week? Which packs are available?

In pharmacies and drugstores, without a doctor's prescription.

Pack with 1 bottle of 2.5 ml.

The pack also contains 30 swabs soaked in isopropyl alcohol for cleaning, 10 spatulas and 30 files.

Marketing authorization holder

Mepha Pharma AG, Basel.

This leaflet was last checked by the drug authority (Swissmedic) in April 2017.

Internal version number: 4.3