Terbinafine Zentiva Cream 1% Tb 15g

Terbinafine Zentiva Cream is a medicine for the treatment of fungal infections of the skin caused by filamentous fungi, such as athlete's foot, superficial skin fungi, pityriasis versicolor.

The cream is also effective against fungal infections caused by yeasts (skin candidiasis).

Under treatment with Terbinafine Zentiva, general symptoms such as itching, scaling and redness subside.

Most patients with athlete's foot have not relapsed 2 months after a week's treatment with Terbinafine Zentiva.

Swissmedic-approved patient information

What is Terbinafine Zentiva Cream and when is it used?

Terbinafine Zentiva cream is a medicine for the treatment of fungal infections of the skin caused by filamentous fungi, such as athlete's foot, superficial skin fungi, pityriasis versicolor.

The cream is also effective against fungal infections caused by yeasts (skin candidiasis).

Under treatment with Terbinafine Zentiva, general symptoms such as itching, scaling and redness subside.

Most patients with athlete's foot have not relapsed 2 months after a week's treatment with Terbinafine Zentiva.

What should be considered?

To prevent fungal infections, you should follow a few rules:

• Change clothing that comes into contact with the diseased skin every day.
• Avoid tight-fitting clothing that is not very permeable to air.
• Dry the skin carefully after washing.
• Change towels every day.
• If you have athlete's foot, do not go barefoot, sprinkle stockings and shoes with a powder that is effective against fungal infections or spray them with a spray every day.
• Hands wash well after use and after contact with the affected skin. This can prevent the fungal infection from spreading.

When should Terbinafine Zentiva cream not be used?

Terbinafine Zentiva must not be used at Hypersensitivity to the active substance terbinafine or any of the excipients contained.

Terbinafine Zentiva Cream has not been tested for use in children under 12 years of age. The use of Terbinafine Zentiva cream in children under 12 years of age is not recommended due to a lack of clinical experience.

When should caution be taken when using Terbinafine Zentiva Cream?

Terbinafine Zentiva Cream is for external use only; the cream must not get into the eyes. If the preparation comes into contact with the eyes, the eyes must be rinsed out immediately with running water. Consult your doctor if the symptoms do not go away.

Terbinafine Zentiva Cream contains cetyl and stearyl alcohol which may cause local skin reactions.

Your doctor should be consulted in the event of extensive fungal infestation or joint infestation of the nails.

Do not apply other medicines to the treated skin.

Tell your doctor, pharmacist or druggist if you:

• suffer from other diseases,
• have allergies or
• take (or use externally) other medicines (including those you bought yourself!).

Can Terbinafine Zentiva Cream be used during pregnancy or breastfeeding?

Pregnancy

During pregnancy Terbinafine Zentiva Cream should not be used unless specifically prescribed by a doctor. If you are planning a pregnancy, you should only use Terbinafine Zentiva Cream after consulting a doctor.

Breastfeeding

Terbinafine Zentiva Cream should not be used while breastfeeding. Small children must not come into contact with the treated skin areas.

How do you use Terbinafine Zentiva Cream?

Before applying Terbinafine Zentiva, the affected skin areas should be thoroughly cleaned with a cotton ball and warm water and dried.

Adults and children over 12 years of age:

Terbinafine Zentiva Cream can be applied once or twice a day - in the morning and/or in the evening. Terbinafine Zentiva Cream must be applied thinly to the diseased and adjacent areas of skin and rubbed in gently.

Usual treatment regimens:

Athlete's foot, superficial skin fungal diseases: 1 time per day for 1 week.

Athlete's foot of the "moccasin" type (athlete's foot on the soles and edges of the feet): 2 weeks, twice a day.

Fungal infections caused by yeast: 1 to 2 times a day for 1 week.

Pityriasis versicolor: 2 weeks 1 to 2 times a day.

In order to avoid recurrence, stick to the stated duration of use. If there are no signs of improvement after 1 week, a doctor should be consulted.

Follow 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 Terbinafine Zentiva cream have?

The following side effects can occur when using Terbinafine Zentiva:

Common side effects include flaking and itching. Occasionally skin irritation, pigmentation disorders, redness, burning sensation on the skin, pain or irritation at the application site can occur. Dry skin and eczema are rare.

If Terbinafine Zentiva Cream accidentally comes into contact with the eyes, eye irritation may occur (see «When should care be taken when using Terbinafine Zentiva Cream?»)

Stop using Terbinafine Zentiva Cream and tell your doctor straight away if you get any of the following symptoms, which may be signs of an allergic reaction:

• Trouble breathing or swallowing
• Swelling of the face, lips, tongue or throat
• Intense itching of the skin with a red rash or blisters.

If you notice side effects, contact your doctor, pharmacist or druggist.

This also applies in particular to side effects that are not listed in this leaflet.

What else do you need to know?

Keep at room temperature (15-25°C) in the original packaging and out of the reach of children.

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

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

What does Terbinafine Zentiva cream contain?

Per 1 g cream are 10 mg terbinafine hydrochloride (active ingredient), cetyl alcohol, stearyl alcohol, benzyl alcohol and contain other excipients.

Approval number

57513 (Swissmedic).

Where can you obtain Terbinafine Zentiva Cream? What packs are available?

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

Tube of 15 g.

Authorization holder

Helvepharm AG, Frauenfeld.

This leaflet was last checked by the drug authority (Swissmedic) in June 2014.