FUNGOFIN cream 15 g.

WHAT FUNGOFIN 1% CREAM AND WHAT IT IS USED
FUNGOFIN 1% cream is a synthetic antifungal for the treatment of skin infections caused by fungi.
FUNGOFIN 1% Cream is indicated for the treatment of:
Superficial fungal infections caused by strains of Trichophyton (T. rubrum and T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis u Tinea pedis (athlete's foot), Tinea cruris (groin fungal infection) or Tinea corporis (in body - ringworm) caused by Epidermophyton floccosum;
Skin infections (intertrigo) caused by yeasts of Candida (Candida albicans);
Pityriasis versicolor (tinea versicolor) caused by Pytirosporum orbiculare (Malassezia furfur).
2. BEFORE YOU USE FUNGOFIN 1% CREAM
Do not use FUNGOFIN 1% cream
if you are allergic (hypersensitive) to terbinafine hydrochloride or any of the other ingredients of FUNGOFIN 1% cream. An allergic reaction may be recognized as a: rash, itching, redness of the skin or difficulty breathing.
Take special care with FUNGOFIN 1% cream
FUNGOFIN cream is intended for use on the skin and should not be administered orally, nasally, or vaginally in the eye. If irritation occurs or hypersensitivity application of FUNGOFIN 1% cream should be discontinued and appropriate therapy initiated.
Infected areas should be covered with tight clothes. Patients with infections of the foot must be shod comfortable and airy shoes. Shoes and socks are changed at least once a day. To avoid contamination of the infected area, hands should be washed after each use.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
No evidence of drug interactions with the topical use of FUNGOFIN 1% cream.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
The drug should not be used during pregnancy unless prescribed by a doctor.
FUNGOFIN 1% cream should not be used during breastfeeding, because the active substance passes into breast milk.
It should not allow the baby to have contact with treated areas of the skin, including the breast.

Driving and using machines
No data FUNGOFIN 1% cream can affect your ability to drive and use machines.

Important information about some of the ingredients of FUNGOFIN 1% cream.
Cetyl alcohol and stearyl alcohol may cause local skin reactions (eg. Contact dermatitis).

3. HOW TO USE FUNGOFIN 1% CREAM
It is important to use FUNGOFIN 1% cream properly. Carefully follow the instructions. If you're not sure, ask your doctor or pharmacist.
Pierce the bursting disk (if the tube is sealed) by the tapered portion of the tip of the cap;
Clean and dry the infected and the skin around it, and then wash your hands;
Unscrew the cap and squeeze a small amount of cream on your finger, then screw cap tube;
Apply an amount of cream sufficient to deposit a thin layer to the affected area and the surrounding skin; gently rub;
Wash your hands after you have touched infected skin to not spread the infection on yourself or on others.
If you are treating infections in the area of two contiguous skin surfaces (under the breast, fingers, between glutes, in the inguinal area) affected skin may be covered with gauze compress, especially at night. In that case, use a new, clean lint every time you apply the cream.
FUNGOFIN® 1% cream is applied once or twice daily. The duration of the treatment varies according to the indication and the severity of the infection.

Recommended duration of treatment:
Athlete's foot, superficial skin mycoses: 1-2 weeks (1-2 times daily);
Tinea of the foot: one week (two times daily), 2 weeks (one a day);
Cutaneous candidiasis: 1-2 weeks (1-2 times daily);
Tinea versicolor: 2 weeks (1-2 times daily).
When using the 1% cream FUNGOFIN skin condition improves within a few days. Irregular use or early discontinuation of treatment may increase the risk of recurrence of the infection. If there is no improvement after two weeks of treatment, consult your doctor or pharmacist.

How to support the treatment?
It is necessary to keep clean the affected area as wash it regularly. Dry gently without rubbing, as asked gently. Try not to scratch the affected area, although that may be itchy, it does not cause further complication and delay the healing process or spread the infection.
Because these infections can be transmitted to others, use individual cloth and clothes, wash them often to prevent reinfection.

Use in children
Clinical experience in children is limited.

Use in elderly patients
No adjustment of the dose in the elderly.

If you use more than the amount FUNGOFIN 1% cream
No evidence of an overdose of the product.
If accepted orally, please immediately contact your doctor.

If you forget to use FUNGOFIN 1% cream
If you forget to apply the cream, use it as soon as you remember and then continue as usual. If you remember during the next application, apply the proper amount and proceed as usual.
Try to use the cream as directed. It is important not to miss applications to reduce the risk of a return of the infection.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, FUNGOFIN 1% cream can cause side effects, although not everybody gets them.
FUNGOFIN 1% cream was well tolerated.
Adverse reactions are evaluated depending on the frequency at which they meet. For this purpose, the following categories of frequency of adverse reactions:
Common: Side effects that may occur in less than 1 person in every 10.
Uncommon: Side effects that may occur in less than 1 person in 100 patients.
Rare: Side effects that may occur in less than 1 person per 1000 patients.
Very rare: Side effects that may occur in less than 1 person in 10,000 patients.
Isolated cases: Side effects that may occur in even smaller number of patients.

Rare: Burning, itching, redness, and / or mild edema, which are related to topical application of the cream.
These side effects are usually well tolerated.
They should be distinguished from hypersensitivity reactions that lead to swelling and pain, rashes and itching. If you notice any of these symptoms, stop using the cream and immediately consult your doctor or pharmacist.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE FUNGOFIN 1% CREAM
Keep out of reach of children.
Store in the original container.
Do not store above 25 ° C.
Protect from light and moisture.

Do not use FUNGOFIN 1% cream after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Shelf life after first opening: 1 month.

6. ADDITIONAL INFORMATION
What FUNGOFIN 1% cream
The active substance is terbinafine hydrochloride.
1 g of cream contains 10 mg terbinafine hydrochloride.
The other ingredients are: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.