Erfin

PATIENT INFORMATION LEAFLET: USER INFORMATION

ERFIN, 250 mg, tablets

(Terbinafine)

Read the leaflet carefully before taking the medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Erfin and what is it used for
• 2. Important information before taking Erfin
• 3. How to take Erfin
• 4. Possible side effects
• 5. How to store Erfin
• 6. Other information

1. WHAT IS ERFIN AND WHAT IS IT USED FOR

Erfin is an antifungal medicine for systemic use, containing the active substance terbinafine, from the allylamine group.
Erfin is indicated for use in:

• fungal skin infections (groin, other body surfaces, feet, scalp) caused by dermatophytes of the genus Trichophyton, Microsporum canis, and Epidermophyton floccosum, when treatment is justified due to the location and extent of the infection,
• onychomycosis (fungal infection of the nails) caused by dermatophytes.

Note:
Erfin is not effective in the treatment of pityriasis versicolor.

2. IMPORTANT INFORMATION BEFORE TAKING ERFIN

When not to take Erfin

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Erfin.

When to be cautious when taking Erfin

If symptoms suggesting liver dysfunction occur, such as: itching, unexplained nausea, loss of appetite or feeling of fatigue, jaundice, vomiting, tiredness, abdominal pain, dark urine or pale stools, you should stop taking Erfin immediately and contact your doctor. The doctor will decide whether to stop treatment with Erfin.
You should inform your doctor about liver diseases, as it is not recommended to take Erfin in patients with liver diseases.
You should inform your doctor about kidney diseases. In patients with renal impairment (creatinine clearance below 50 ml/min or serum creatinine above 300 µmol/l), the doctor will recommend taking half of the usual dose.
Terbinafine should be used with caution in patients with psoriasis, as Erfin may exacerbate its course.
You should consult your doctor, even if the above warnings refer to past situations.

Taking other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, even those that are available without a prescription.
Medicines that stimulate cytochrome P450 (such as rifampicin) weaken and shorten the effect of terbinafine, while medicines that inhibit the activity of this enzyme (such as cimetidine) enhance and prolong the effect of terbinafine. If the doctor considers it necessary to take terbinafine with medicines that modify cytochrome P450 activity, they will adjust the terbinafine dose accordingly.
Terbinafine may inhibit the metabolism of such medicines as: tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors, and MAO-B inhibitors.
Terbinafine may slightly decrease or increase the clearance of medicines metabolized by the cytochrome P450 system (e.g., cyclosporine, tolbutamide, terfenadine, triazolam, and oral contraceptives).
In women taking terbinafine and oral contraceptives, menstrual disorders, such as intermenstrual bleeding and irregular menstrual cycles, may occur.

Erfin contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist.
Pregnancy
Erfin should not be taken during pregnancy, unless the potential benefits outweigh the risks.
If you become pregnant, you should stop taking Erfin and inform your doctor.
Breastfeeding
Terbinafine passes into breast milk, so women who are breastfeeding should not take Erfin.

Driving and using machines

Erfin has no effect on the ability to drive or operate machines.

3. HOW TO TAKE ERFIN

Erfin should always be taken as directed by your doctor. If you are unsure, consult your doctor.
Do not change the dose or stop treatment without consulting your doctor, as irregular use of Erfin or premature discontinuation of treatment may lead to a relapse of the infection.

Adults:

Orally, 250 mg once a day.
The duration of treatment depends on the indication and severity of the infection.
Treatment duration:
Fungal skin infections:
Interdigital foot mycosis, plantar/moccasin-type: usually 2 to 6 weeks.
Body ringworm, groin ringworm: usually 2 to 4 weeks.
Scalp ringworm: usually 4 weeks.
Nail fungal infections:
Usually 6 to 12 weeks.
Fungal infections of the toenails require longer treatment than fungal infections of the fingernails. Treatment of toenail onychomycosis for 3 months is usually sufficient, but in some patients, 6 months or longer may be necessary.
Patients with slow nail growth may require a longer treatment period.
To facilitate treatment and prevent relapses, it is essential to keep the treated areas dry, not overheated, and to change clothes that come into direct contact with them daily.
If you feel that the effect of Erfin is too strong or too weak, consult your doctor.

Children:

Terbinafine is not recommended for oral use in children due to limited data on its use in this age group.

Missing a dose of Erfin

Do not take a double dose to make up for a missed dose.

Taking more than the recommended dose of Erfin

Symptoms of overdose are: headache, nausea, abdominal pain, and dizziness.
In case of overdose, the doctor will prescribe activated charcoal to eliminate the medicine, and if necessary, will provide symptomatic and supportive treatment.
If you have taken more than the recommended dose of Erfin, seek medical attention immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Erfin can cause side effects, although not everybody gets them.
Side effects are usually mild to moderate.
Side effects are grouped by frequency of occurrence.
Side effects may occur:

• often (more than 1 in 100 patients, but less than 1 in 10 patients),
• uncommonly (more than 1 in 1000 patients, but less than 1 in 100 patients),
• rarely (more than 1 in 10,000 patients, but less than 1 in 1000 patients),
• very rarely (less than 1 in 10,000 patients, including single reports).

Often:
Transient gastrointestinal symptoms (feeling of fullness, loss of appetite, nausea, mild abdominal pain, diarrhea) may occur, as well as skin reactions (rash, urticaria) and headache.
Uncommonly:
Taste disturbances, including loss of taste, usually resolving within a few weeks after discontinuation of the medicine, may occur. In rare cases, permanent taste disturbances leading to decreased appetite and significant weight loss have been reported.
Rarely:
Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity, angioedema) may occur. If a rash worsens, treatment with Erfin should be discontinued, and medical attention should be sought immediately.
Paresthesia (sensory disturbances), decreased sensation, dizziness, malaise, fatigue, and muscle and joint pain, which may indicate allergic reactions, may occur.
If liver dysfunction occurs (jaundice, cholestasis, hepatitis), you should stop taking Erfin immediately and consult your doctor (see section 2. Important information before taking Erfin).
Very rarely:
Psychiatric disturbances, such as depression and anxiety, exacerbation of psoriasis, decreased blood cell count, such as neutropenia (decreased white blood cell count), agranulocytosis (decreased granulocyte count), thrombocytopenia (decreased platelet count), symptoms of systemic lupus erythematosus or exacerbation of its symptoms, and severe hypersensitivity reactions (anaphylactic reactions) may occur.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ERFIN

Keep out of the reach and sight of children.
Store in a temperature below 25°C, in the original packaging.
Do not use Erfin after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What Erfin contains

• The active substance of Erfin is terbinafine (in the form of hydrochloride). One tablet contains 250 mg of terbinafine.
• Erfin also contains: microcrystalline cellulose, sodium carboxymethyl starch, hypromellose, magnesium stearate, colloidal silicon dioxide.

What Erfin looks like and what the pack contains

Erfin is available as tablets.
The pack contains 14 or 28 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: (24) 357 44 44
Fax: (24) 357 45 45
Email: [email protected]

Date of leaflet approval: