TERBINAFINA 250 mg Tabletka Powlekana

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1. TERBINAFINA DOC Generici 250 mg tablets
   1. What is TERBINAFINA DOC Generici and what is it used for
   2. What you need to know before taking TERBINAFINA DOC Generici
   3. How to take TERBINAFINA DOC Generici
   4. Possible side effects
   5. How to store TERBINAFINA DOC Generici
   6. Contents of the pack and other information

TERBINAFINA DOC Generici 250 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effect gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What TERBINAFINA DOC Generici is and what it is used for
• 2. What you need to know before you take TERBINAFINA DOC Generici
• 3. How to take TERBINAFINA DOC Generici
• 4. Possible side effects
• 5. How to store TERBINAFINA DOC Generici
• 6. Contents of the pack and other information

1. What is TERBINAFINA DOC Generici and what is it used for

TERBINAFINA DOC Generici 250 mg tablets is an systemic antimycotic drug and
is used for the treatment of:
Fungal skin infections of the scalp and nails caused by dermatophytes, namely
Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum),
Microsporum canis and Epidermophyton floccosum. The administration of the tablets is indicated
in the treatment of dermatophyte skin mycoses (Tinea corporis, Tinea cruris, Tinea pedis and
Tinea capitis) and skin infections caused by yeasts, supported for example by the genus Candida (e.g.:
Candida albicans) for which oral therapy is considered appropriate due to their
location, severity or extent of the infection.
Onychomycosis (fungal nail infections) caused by dermatophyte fungi.
Note: Unlike topical formulations, terbinafine administered orally is inactive
in Pityriasis versicolor.

2. What you need to know before taking TERBINAFINA DOC Generici

Do not take TERBINAFINA DOC Generici

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine.
• if you suffer from active or chronic liver disease.

Do not administer TERBINAFINA DOC Generici to children under 2 years of age.
TERBINAFINA DOC Generici is generally contraindicated in pregnancy and during
breastfeeding (see Fertility, pregnancy and breastfeeding).

Warnings and precautions
Take special care with TERBINAFINA DOC Generici in the following cases:
Liver function
Terbinafina tablets are not recommended in patients with active or chronic liver disease. Before
prescribing terbinafina tablets, a liver function test must be performed. Liver toxicity may
occur in patients with or without pre-existing liver disease, therefore periodic monitoring (after 4-6
weeks of treatment) with a liver function test is recommended. Very rare cases of severe liver
failure (some with fatal outcome or requiring liver transplantation) have been reported in patients
treated with terbinafina tablets. In most cases of liver failure, patients had pre-existing
severe systemic diseases and the causal relationship with the intake of terbinafina tablets was not
certain ( see Possible Side Effects).
It is advisable that patients undergoing treatment with terbinafina tablets are informed to promptly
report to their doctor any sign or symptom of persistent nausea without apparent cause,
loss of appetite, fatigue, vomiting, pain in the upper right abdominal area, jaundice, dark urine or
pale stools. Patients who present these symptoms should stop therapy with oral terbinafina and
their liver function should be immediately evaluated.
Dermatological effects
Very rare cases of severe dermatological reactions (e.g. Stevens-Johnson syndrome, toxic epidermal
necrosis) have been reported in patients treated with terbinafina tablets. If a worsening rash
appears, treatment with terbinafina tablets must be discontinued.
Hematological effects
Very rare cases of blood dyscrasias (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia)
have been reported in patients treated with terbinafina tablets. The etiology of any blood disorder
that may occur in patients undergoing treatment with terbinafina tablets must be evaluated and
possible changes in the therapeutic regimen, including discontinuation of terbinafina tablets, must
be considered.
Renal function
The use of terbinafina tablets in patients with reduced renal function (creatinine clearance
less than 50 ml/min or serum creatinine greater than 300 micromoles/l) has not been adequately
studied, and is therefore not recommended .
Terbinafina should be administered with caution to patients with a history of psoriasis or lupus
erythematosus, as very rare cases of lupus erythematosus have been reported.
Interactions with other medicines
In vitro and in vivo studies have shown that terbinafina inhibits the metabolism mediated
by the CYP2D6 enzyme. Therefore, patients must be monitored in case of concomitant treatment
with drugs metabolized primarily by CYP2D6 (e.g. some drugs
belonging to the following classes: tricyclic antidepressants, beta-blockers, selective serotonin
reuptake inhibitors, antiarrhythmics (including those of class IA, IB and IC), monoamine oxidase
inhibitors type B), especially if the drug administered simultaneously
has a narrow therapeutic window (see Taking TERBINAFINA DOC Generici with other

medicines).

Other medicines and TERBINAFINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those without a prescription.

Effects of other medicines on terbinafina
The plasma clearance of terbinafina can be accelerated by drugs that induce metabolism and
can be inhibited by drugs that inhibit cytochrome P450. In cases where concomitant administration
of these drugs is necessary, an adjustment of the dosage of terbinafina tablets may be necessary.

• The following medicines may increase the effect or plasma concentration ofterbinafinaCimetidine has decreased the clearance of terbinafina by 33%. Fluconazole has increased the Cmax and AUC of terbinafina by 52% and 69% respectively following the inhibition of both CYP2C9 and CYP3A4 enzymes. A similar increase in exposure may occur when other drugs that inhibit both CYP2C9 and CYP3A4, such as ketoconazole and amiodarone, are administered concurrently with terbinafina.
• The following medicines may decrease the effect or plasma concentration ofterbinafinaRifampicin has increased the clearance of terbinafina by 100%.

Effects of terbinafina on other medicines
Based on the results of studies conducted in vitro and in healthy volunteers, terbinafina alters in
a negligible way the plasma clearance of most drugs that are metabolized
through the cytochrome P450 enzyme system (e.g. terfenadine, triazolam, tolbutamide or
oral contraceptives), with the exception of those metabolized through CYP2D6 (see below).
Terbinafina does not interfere with the clearance of antipyrine or digoxin.
In patients who have taken terbinafina tablets concurrently with oral contraceptives, some cases of
irregular menstruation have been found, although the incidence of these disorders falls
within that of patients who take oral contraceptives alone.

• Terbinafina may increase the effect or plasma concentration of the following drugsCaffeineTerbinafina has decreased the clearance of caffeine administered intravenously by 19%. Drugs predominantly metabolized by CYP2D6In vitro and in vivo studies have shown that terbinafina inhibits the metabolism mediated by the CYP2D6 enzyme. This may be clinically significant for drugs primarily metabolized by CYP2D6, such as some drugs belonging to the following classes: tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors, antiarrhythmics (including those of class IA, IB and IC), monoamine oxidase inhibitors type B), especially if these drugs also have a narrow therapeutic window (see Take special care withTERBINAFINA DOC Generici).Terbinafina has decreased the clearance of desipramine by 82%.
• Terbinafina may decrease the effect or plasma concentration of the following drugsTerbinafina has increased the clearance of cyclosporine by 15%.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine
Pregnancy
Studies of fetal toxicity and fertility in animals have not shown any adverse effects.
Since clinical experience in pregnant women is very limited, terbinafina tablets
should not be used during pregnancy unless the clinical condition of the woman requires
oral treatment with terbinafina and the potential benefits for the mother outweigh the potential
risks to the fetus.
Breastfeeding
Terbinafina is excreted in breast milk; therefore, patients treated with oral terbinafina
should not breastfeed.
Fertility
Studies of toxicity and fertility in animals have not shown any adverse effects.

Driving and using machines
Studies have not been conducted on the effects of terbinafina tablets on the ability to drive
vehicles and operate machinery. Patients who experience dizziness as a side effect should avoid
driving vehicles or operating machinery.

TERBINAFINA DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take TERBINAFINA DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor.
The duration of oral treatment varies depending on the type and severity of the infection and may
possibly be increased at the doctor's discretion.

Adults
Fungal skin infections (Tinea pedisinterdigitale, plantar and/or moccasin type, Tinea corporis,

Tinea crurisand Cutaneous Candidiasis):
1 tablet of 250 mg once a day, for 2 weeks.
Complete resolution of signs and symptoms of the infection may occur several weeks after
mycological cure.
Onychomycosis: 1 tablet of 250 mg once a day. For most patients, the duration
of treatment is between 6 and 12 weeks: 6 weeks of therapy are generally sufficient in
cases of onychomycosis of the fingers, 12 weeks for the treatment of onychomycosis of the
toes.
Some patients with reduced nail growth may require an extension of therapy.
Complete resolution of signs and symptoms of the infection requires several months after
discontinuation of treatment (i.e. until the growth of the nail plate has determined the
complete renewal of the plate itself).

Children over 2 years of age with a weight greater than 12 kg
Recommended treatment duration:

Tinea pedis(interdigitale, plantar and/or moccasin type): 2 - 6 weeks

Tinea corporis, cruris:2 - 4 weeks

Cutaneous Candidiasis: 2 - 4 weeks

Tinea capitis:2 - 4 weeks

Onychomycosis:6 - 12 weeks

Onychomycosis of the fingers: 6 weeks

Onychomycosis of the toes: 12 weeks
Note: in children, Tinea capitisis mainly found.

Additional information on particular populations of patients
Patients with hepatic impairment
Terbinafine tablets are not recommended for patients with chronic or active liver disease
(see Do not take TERBINAFINADOC Genericiand Pay particular attention with

TERBINAFINADOC Generici).
Patients with renal impairment
The use of terbinafine tablets has not been adequately studied in patients with renal impairment
and is therefore not recommended in this population of patients (see Pay particular

attention with TERBINAFINADOC Generici).
Elderly patients
There is no evidence to suggest that elderly patients require a different dosage or that
they are subject to different adverse effects than those observed in younger patients. When
prescribing terbinafine tablets to patients in this age group, the possibility of pre-existing hepatic or renal impairment should be considered (see paragraph

Pay particular attention with TERBINAFINA DOC Generici).
Use in children
In children over 2 years of age, terbinafine tablets have been shown to be well tolerated.

If you take more TERBINAFINA DOC Generici than you should
Some cases of overdose (up to 5 g) have been reported, with the appearance of headache, nausea,
pain in the upper abdomen and dizziness.
In case of overdose, it is recommended to remove the drug by administering
activated charcoal accompanied, if necessary, by symptomatic supportive treatment.
If you have any doubts about the use of TERBINAFINA DOC Generici, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effect not listed here, please tell your doctor or pharmacist.
The following adverse reactions have been observed during clinical studies or in post-marketing experience.

Adverse reactions (Table 1) are classified according to frequency, listing the most frequent first and using the following convention: very common (≥ 1/10); common (≥ 1/100 and <

1/10); uncommon (≥ 1/1,000 and <1/100); rare (≥1/10,000 and < 1/1,000); very rare (< 1/10,000) and

not known (frequency cannot be estimated from the available data).
Table 1

Blood and lymphatic system disorders
Very rare Neutropenia, agranulocytosis, thrombocytopenia,
pancytopenia.
Not known Anemia.

Immune system disorders
Very rare Anaphylactoid reactions, angioedema, Cutaneous and systemic Lupus erythematosus.
Not known Anaphylactic reactions, serum sickness-like reactions.

Metabolism and nutrition disorders
Very common Decreased appetite.

Psychiatric disorders
Not known Anxiety, depression.

Nervous system disorders
Common Headache.
Uncommon Hypogeusia, ageusia.
Very rare Dizziness, paraesthesia and hypoesthesia.
Not known Anosmia.

Ear and labyrinth disorders
Not known Hearing impairment, altered hearing, tinnitus.

Vascular disorders
Not known Vasculitis.

Gastrointestinal disorders
Very common Abdominal bloating, dyspepsia, nausea, abdominal pain, diarrhea.
Not known Pancreatitis.

Hepatobiliary disorders
Rare Hepatic failure, increased liver enzyme levels.
Not known Hepatitis, jaundice, cholestasis.

Skin and subcutaneous tissue disorders
Very common Rash, urticaria.
Very rare Multiforme erythema, Stevens-Johnson syndrome,
toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP).
Psoriasiform eruptions or exacerbations of psoriasis.
Alopecia.
Not known Photosensitivity reaction, photodermitis, allergic photosensitivity reactions and polymorphic light eruption.

Musculoskeletal and connective tissue disorders
Very common Arthralgia, myalgia.
Not known Rhabdomyolysis.

Systemic disorders and administration site conditions
Very rare Fatigue.
Not known Influenza-like syndrome, fever.

Laboratory tests
Not known Increased blood creatine phosphokinase values,
body weight decrease***.
* Anxiety and depressive symptoms secondary to dysgeusia.
** Hypogeusia including ageusia, which generally resolves within a few weeks after
discontinuation of the medicine. Isolated cases of hypogeusia have been reported.
*** Weight loss secondary to hypogeusia.

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 through the national reporting system at www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store TERBINAFINA DOC Generici

Do not store at a temperature above 25 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TERBINAFINA DOC Generici contains
The active ingredient is: terbinafine.
Each tablet contains: terbinafine 250 mg (as terbinafine hydrochloride)
The excipients are: methylcellulose, croscarmellose sodium, magnesium stearate, colloidal anhydrous
silica.

Description of the appearance of TERBINAFINA DOC Generici and contents of the pack
The tablets of TERBINAFINA DOC Generici are white or off-white, round, with
TER and 250 engraved separated by the fracture line on one side, flat on the other side.
The fracture line is only for dividing the tablet to facilitate swallowing and does not
subdivide it into two equal doses
TERBINAFINA DOC Generici is available in packs of 8 tablets of 250 mg in blisters.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan

Manufacturers
Lamp San Prospero S.p.A. Via della Pace 25/A – 41030 S. Prospero S/S (MO) - Italy
INDUSTRIA FARMACEUTICA NOVA ARGENTIA S.R.L.
Via G. Pascoli, 1- 20064 Gorgonzola (MI) - Italy