Tersilat, 10 mg/g, cream

Product description

Tersilat, 10 mg/g, cream

Terbinafini hydrochloridum


  Package leaflet 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 14 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 a white cream containing 10 mg/g of terbinafine hydrochloride as the active substance.

Tersilat is used externally to treat patients with fungal or yeast infections of the skin, such as athlete’s foot.

2. What you need to know before you use Tersilat

Do not use Tersilat:

if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section). Hypersensitivity may be manifested for example by red spots or skin swelling and/or itching.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tersilat.

Tersilat is for external use only.
Tersilat may cause eye irritation. Avoid contact of the cream with your eyes. If it gets into the eyes accidentally, the eyes should be rinsed thoroughly with running water.

Children
Tersilat is not recommended for children under 12 years of age. Data on the use of this medicine in children is limited.

Other medicines and Tersilat
There is no data available indicating that Tersilat cream negatively affects other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

Pregnancy and Breastfeeding

Pregnancy
Tersilat cream should not be used during pregnancy, unless absolutely necessary.

Breastfeeding
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.

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.

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

Tersilat contains cetostearyl alcohol.
Cetostearyl alcohol can cause local skin reactions (e.g. contact dermatitis).

3. How to use Tersilat

How to use
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The tube is tightly sealed by means of an aluminium seal. Use the tip of the cap to break the seal and open the tube.
This medicine is for external use only.
Make sure that you have cleaned and dried the affected skin and surrounding areas thoroughly before applying the cream in a thin layer. The cream should be rubbed in gently. If the cream is not intended for treatment of hands, wash your hands thoroughly after applying the cream.

Duration of treatment and frequency of use

Adults and children above 12 years of age:

Athlete’s foot:
Once a day for one week
Fungal infection caused by dermatophytes (fungal infections of the folds, fungus on the body):
Once a day for one week
Fungal skin infections (cutaneous candidiasis):
Once a day for 1 to 2 weeks
Pityriasis versicolor:
Once to twice daily for 2 weeks
Infections usually appear to improve within a few days of starting to use the cream.
Irregular use or early termination of treatment increases the likelihood of symptoms reappearing. If you see no improvement in your skin condition after 2 weeks, talk to your doctor or pharmacist.
Elderly patients
There is no data indicating that dosing must be modified in elderly patients or that other side effects may occur than those observed in younger patients.
Use in children
Due to a limited amount of available information on the use of Tersilat cream in children under 12 years of age, this medicine is not recommended for use in this age group.

If you use more Tersilat than you should
No cases of Tersilat overdose are known during its external use.
If you have any doubts about the use of this medicine, contact your doctor or pharmacist.

If you or someone else (for example a child) accidentally swallows Tersilat cream, the expected side effects will be similar to those occurring after overdosing terbinafine in tablets (such symptoms may include headache, feeling sick, nausea and stomach ache).
In such case contact your doctor or go to the nearest hospital emergency department.

Should the cream accidentally come into contact with your eyes, rinse with plenty of running water.

If you forget to use Tersilat
Continue your treatment as usual. Do not use additional applications of the cream or larger amounts of cream than usual.

If you stop using Tersilat
If you stop using Tersilat before completion of full treatment, the initial symptoms may reappear.

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.

Stop using the cream and seek medical help immediately if you have any of the following allergic reactions:

persistent itching of the skin with red rash or raised lumps, hives or blisters, difficulty breathing or swelling of the mouth, face, lips, tongue or throat.
Frequency of such allergic reactions is not known (cannot be estimated from the available data).
The following side effects have also been reported:

Common (may affect up to 1 in 10 people): peeling skin, itching of the skin.

Uncommon (may affect up to 1 in 100 people): skin changes skin, scab, skin disorders, pigmentation disorders, redness of the skin (erythema), skin burning sensation, pain, application site pain, application site irritation.

Rare (may affect up to 1 in 1000 people): dry skin, contact dermatitis, eczema, worsening of the skin condition.

Not known (frequency cannot be estimated from the available data):
hypersensitivity, rash.
If Tersilat cream gets into your eyes, eye irritation may occur.

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.

Do not use this medicine after the expiry date shown on the tube and carton after 'EXP'.

The expiry date refers to the last day of that month.

There are no special precautions for the storage of this medicine.

Expiry date after first opening
Discard the tube after 6 months after first opening the tube.

6. Contents of the pack and other information

What Tersilat contains

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

The other ingredients are:
purified water, cetostearyl alcohol, isopropyl myristate, cetyl palmitale, sorbitan stearate, benzyl alcohol, polysorbate 60, sodium hydroxide.

What Tersilat looks like and content of the pack

Tersilat is a white cream.
Tersilat is available in tubes of 15 g and 30 g.

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 medicinal product is authorised for marketing in the member states of the European Economic Area under the following names:

Austria: Terbiderm 10 mg/g Creme
Germany: Terbiderm Creme
Poland: Tersilat
Sweden: Terbinafine Dermapharm 10 mg/g Kräm

This leaflet was last revised in: 05.2015

“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.”