FUNGOFIN 250 mg. 14 tablets
FUNGOFIN belongs to the class of antifungal agents, and is used in the treatment of fungal infections of the skin, nails and scalp. It is active against strains of the following organisms: Trichophyton (T. rubrum and T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum and Candida albicans. After taking terbinafine tablets reaches a concentration sufficient to kill the fungus or stop their development.
FUNGOFIN tablets is indicated for the treatment of:
Onychomycosis (nail fungal infection) in the toes or fingers caused by dermatophytes (tinea unguium);
Tinea capitis (fungal infection on the scalp);
Fungal infections of the skin, for the treatment of tinea corporis (ringworm), tinea cruris (fungal infection in the groin) and tinea pedis (athlete's foot);
Skin infections caused by yeasts of Candida (eg. Candida albicans).
2. What you need to know before taking FUNGOFIN
Do not take FUNGOFIN:
if you are allergic (hypersensitive) to terbinafine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognized as a: rash, itching, redness of the skin and difficulty breathing;
if you suffer from chronic or active liver disease.
Warnings and Precautions
Talk to your doctor pharmacist before taking FUNGOFIN:
Before treatment with FUNGOFIN tell your doctor if you have impaired liver function or renal impairment;
Tell your doctor if during the intake FUNGOFIN are experiencing any of the following symptoms: nausea, anorexia (loss of appetite, psychological problems characterized by aversion to eating and fear of weight gain), fatigue, vomiting, right sided abdominal or jaundice, dark urine or light stools. If you have these symptoms, you should stop taking oral terbinafine and immediately assess liver function.
Other medicines and FUNGOFIN
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
It is interaction with concomitant administration of terbinafine and the following medicinal products:
Cimetidine (for treating ulcers) - can increase the level of terbinafine in the blood;
Rifampicin (for tuberculosis) - may reduce the effect of terbinafine;
Some antidepressants, beta-blockers (used to treat high blood pressure), caffeine - can increase the level of these drugs in the blood;
Cyclosporin (used in transplant patients) - can reduce the level of this medicine in the blood.
Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
FUNGOFIN should not be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking FUNGOFIN during pregnancy.
During treatment with FUNGOFIN should not breastfeed, as terbinafine is excreted into breast milk and may harm your baby.
Driving and using machines
No data FUNGOFIN influence on the ability to drive and use machines.
3. How to take FUNGOFIN
Always take this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
The length of treatment varies depending on the indication and the severity of the infection.
The recommended dose is 250 mg once daily (1 tablet FUNGOFIN day) orally.
Recommended duration of treatment:
Onychomycosis: 6-12 weeks (one a day);
Onychomycosis porn: 6 weeks (one a day);
Onychomycosis legs 12 weeks (one a day);
Tinea capitis: 4-6 weeks (one a day);
Tinea corporis, tinea cruris: 2-4 weeks (one a day);
Tinea pedis: 2-6 weeks (one a day);
Candidiasis / skin candidiasis /: 2-4 weeks (one a day).
Onychomycosis: In most patients, therapeutic success is achieved when treatment duration between 6 and 12 weeks. Duration less than three months may be considered in patients with infection involving the nails of fingers, nails on your toes without the nail of the big toe or in younger patients. In the treatment of infections of the toenails 3 months is usually sufficient, but a small number of patients may need treatment for 6 months or more.
Poor nail-growth during the first weeks of treatment may indicate which patients need more prolonged therapy. Your doctor will discuss this issue. Complete disappearance of the signs and symptoms of infection may not occur even several weeks after the fungal therapy.
FUNGOFIN use in children:
In children aged 3 to 16 years be taken into account in the diagram below according to the weight:
Children weighing 12-20 kg: 62,5 mg per day;
Children weighing 20-40 kg: 125 mg daily;
Children weighing> 40 kg: 250 mg daily.
FUNGOFIN use in elderly patients:
No dose adjustment is required in elderly patients.
If you take more dose FUNGOFIN
If you take more dose FUNGOFIN immediately visit the nearest hospital and take your medicine or its container with you or contact your doctor.
Signs of overdose include headache, nausea, abdominal pain and dizziness.
It is recommended that the elimination of the product with activated charcoal and symptomatic treatment.
Do not exceed the recommended dose and duration of treatment.
If you forget to take FUNGOFIN
If you miss a tablet, take it as soon as you remember. Do not take it, if your next dose is less than 4 hours. In this case take your next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking FUNGOFIN
Do not stop the treatment before you have completed the full course of treatment. It is important to take the tablets every day and continue treatment until your doctor terminate it. This will ensure full cure the infection and reduce the chances of its recurrence after you stop taking the tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, FUNGOFIN can cause side effects, although not everybody gets them.
FUNGOFIN generally well tolerated. Side effects are mild to moderate and transient expressed.
In this leaflet, when side effects are described as "common" this means that they have been reported in more than 1 in every 100 patients, but less than 1 in every 10 patients.
When side effects are described as "uncommon", this means that they were reported in more than 1 in 1000 patients but less than 1 out of 100 patients.
When side effects are described as "rare", this means that they were reported in more than 1 in 10 000 patients, but less than 1 in 1000 patients.
When side effects are described as "very rare", this means that they have been reported in less than 1 in 10,000 patients, including isolated cases not known.
In some cases, any of the following side effects:
Blood and lymphatic system:
Very rare: blood dyscrasias: reducing the number of white blood cells, which increases the likelihood of infection; reduction of platelet count, which increases the risk of bleeding or bruising.
Immune system disorders:
Very rare: allergic reaction which causes difficulty in breathing or dizziness (including swelling of the face or throat), cutaneous and systemic lupus erythematosus (a disorder of the immune system that causes joint pain, skin rashes and fever).
Nervous system disorders:
Uncommon: taste disturbances, including taste loss, which is most often recovered several weeks after discontinuation of the drug.
Very common: indigestion, feeling of fullness, loss of appetite, nausea, mild abdominal pain, diarrhea.
Rare: biliary and liver problems.
Skin and subcutaneous tissue disorders:
Very common: allergic skin reactions (skin rash with redness and itching);
Very rare: serious skin reactions (including Syndrome Stevens-Johnson), hair loss.
Musculo-skeletal and connective tissue disorders:
Very common: pain in muscles and joints.
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
Keep out of reach of children.
Do not store above 25 ° C.
Store in the original container.
Do not use FUNGOFIN after the expiry date stated on the carton. The expiry date refers to the last day of that month.
6. Contents of the pack and further information
The active substance is terbinafine. Each tablet contains terbinafine hydrochloride equivalent to 250 mg terbinafine.
Other ingredients are: hypromellose, croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
FUNGOFIN looks like and contents of the pack
Round, white tablets, scored on one side.
One blister contains 4 or 14 the number of tablets.
Pack sizes: 4, 14 or 28 the number of tablets.