Tersilat 10 mg/g, aerosol

Product description

Tersilat
10 mg/g, cutaneous spray solution

Terbinafini hydrochloridum


pdf Package leaflet dla pacjenta Tersilat 


Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if after 7 days you do not feel better or if you feel worse.

In this leaflet:
1. What Tersilat is and what it is used for
2. What you need to know before you use Tersilat
3. How to use Tersilat
4. Possible side effects
5. How to store Tersilat
6. Contents of the pack and other information

1. What Tersilat is and what it is used for

Tersilat is an antifungal medication for use on the skin, containing terbinafine hydrochloride as the active substance. Tersilat acts on various fungi species causing skin diseases.
Terbinafine contained in the medication has an anti-fungal action on dermatophytes and yeasts (kills fungi cells). Depending on the species, it has a fungicidal or fungistatic (inhibiting fungal growth) action on yeasts.

Tersilat is used for local treatment of:

athlete’s foot;
fungal infections of the folds (intertriginous areas);
fungus on the body (ringworm);
pityriasis versicolor.

Athlete’s foot – appears on the feet, mainly between the toes. It can spread to the soles, edges or the instep of the feet. It may affect one or both feet. Fungal changes between the toes are characterised by maceration and flaking; they can also appear as vesicles. A sudden flare-up of athlete’s foot, with the appearance of numerous vesicles and blisters, is usually caused by hot weather. Itching, pain, inflammation, and vesicles may be mild or intense in nature. Persistent athlete’s foot may lead to nail infection (fungal infection of the surface or the underside of the nail plate). Nails become thickened and matt, and keretotic masses accumulate under their distal edge. As the nail plate peels, the nail may become damaged. If you notice any of the above changes within nails, ask your doctor for advice as Tersilat is not effective in the treatment of fungal nail infections and treatment will require prescription medicines.

Fungal infections of the folds (intertriginous areas) – may appear in areas of the body where the skin can be folded (especially if wet), that is:

in the groin;
on inner thighs (changes on both sides, but often one side is more affected than the other; can subsequently spread between the legs and to the buttocks or up towards the stomach);
under the breasts;
in the area of the armpits.
Fungal changes appearing on the skin in such places cause skin redness, itching and flaking.

Fungus on the body (ringworm) – can occur anywhere on the body, but is most often found on the neck, face, arms, and hairless scalp. Usually appear as ring-like pink to red spots. They are covered with lumps and scales, spread circularly and tend to disappear in the central region.

Pityriasis versicolor – appears on the skin as scaly skin patches. These changes may be pronounced only in the summer, as focal areas of fungal infections do not turn brown under the influence of tanning; they appear as sun spots of different sizes. Pityriasis versicolor occurs mainly in the torso, neck and arms, especially in hot weather and sweating.

2. What you need to know before you use Tersilat

Do not use Tersilat:
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Tell your doctor or pharmacist if you are hypersensitive to these substances, as Tersilat must not be used in such case.

Warnings and precautions

This medicine is intended for use on skin only.
Do not allow the medicine to come in contact with your face and eyes, and with damaged skin, as alcohol contained in the product may cause irritation. Should the medicine accidentally come into contact with your eyes, rinse with plenty of running water.
Do not inhale the medicine. If after accidental inhalation you experience any worrying symptoms, contact your doctor.

Other medicines and Tersilat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

Do not apply any other medicines or treatment methods on the affected areas (including medicines dispensed without a doctor’s prescription) during treatment with Tersilat.

Children and adolescents
This medicine must not be used in children.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not be used during pregnancy, unless you are advised to do so by your doctor.
Terbinafine passes into breast milk; therefore Tersilat should not be used during breastfeeding. Infants must not be allowed to come into contact with any treated skin, including the breast.

Driving and using machines
This medicine does not affect the ability to drive and use machines.

Tersilat contains propylene glycol.
Propylene glycol may cause skin irritation.

3. How to use Tersilat

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Unless your doctor tells you otherwise, Tersilat should be used on affected areas as directed below.

Adults
athlete’s foot – once daily for 1 week;
fungal infections of the folds (intertriginous areas) – once daily for 1 week;
fungus on the body (ringworm) – once daily for 1 week;
pityriasis versicolor – twice daily for 1 week.

This medicine should be used at the recommended doses for the recommended period, even if infection symptoms begin to disappear already after a few days from the use of the medicine. This will prevent the disease from recurring, which may happen if the medicine is not used regularly or is used for a period shorter than recommended.

Use in children
This medicine should not be used in children.

If there are no signs of improvement after one week of treatment, consult your doctor.

If you feel that the effect of Tersilat is too strong or too weak, talk to your doctor or pharmacist.

How to use
This medicine is for use on the skin only.

Strictly follow the following direction for use:
- Cleanse and dry the affected areas thoroughly and wash your hands.
- Spray just enough medicine to form a thin layer on the affected skin and surrounding areas.
- After each use, wipe the remaining medicine on the outlet of the bottle with a clean dry cloth.
- Wash your hands each after using the spray.

What to do during treatment with Tersilat in order to improve treatment effectiveness
During treatment, the affected areas of skin should:
- be kept clean by regular washing;
- wiped gently (no rubbing);
- avoid scratching the affected areas, as it may slow down the treatment or cause the infection to spread.

It is essential for the prevention of fungal skin infections that you use your own towel and personal clothes, and that you wash frequently.

If you use more Tersilat than you should

If you use more Tersilat than you should or if you accidentally swallow Tersilat, contact your doctor.

If you forget to use Tersilat

If you forget to use Tersilat, apply the product as soon as possible, and then continue the rest of your treatment as usual. If you only remember that you forgot to use the medicine during next application, apply the usual amount of the medicine and then continue the rest of your treatment as usual.
This medicine should be used regularly as its use according to the doctor’s advice is essential to a successful treatment and reduces the risk of infection recurrence.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Skin redness, itching, burning, and symptoms of skin irritation may occur at the site of application. Treatment rarely has to be stopd for this reason. Such symptoms must not however be confused with allergic reactions, such as: itching, rash, bullous eruptions and hives, which are rare but require discontinuation of the medicine and contacting a doctor.

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 to the Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB)
Al. Jerozolimskie 181C
02-222 Warszawa
Telephone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
E-mail: ndl@urpl.gov.pl

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

5. How to store Tersilat

Keep this medicine out of the reach and sight of children.

Store in the outer packaging to protect from light.

Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month.

Discard the bottle after 6 months after first opening the bottle.

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 protect the environment.

6. Contents of the pack and other information

What Tersilat contains

- The active substance is terbinafine hydrochloride.
1 gram of medicine contains 10 mg of terbinafine hydrochloride.

- The other ingredients are:
ethanol, propylene glycol, macrogol cetostearyl ether, purified water.

What Tersilat looks like and content of the pack

Tersilat, cutaneous spray is a colourless clear solution.

Packs

Brown-glass bottle, closed with a POM spray pump and a polypropylene cap, containing 15 ml or 30 ml of the medicine, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna
Germany

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

This leaflet was last revised in: 12.2015

“Read the package leaflet before use because it contains important information on indications, contraindications, side effects, dosing and use of this medicine or talk to your doctor or pharmacist as misuse of medicines may be dangerous to your life or health.”