TERBINAFINA 250 mg Coated Tablet

Зміст інструкції

1. TERBINAFINA TECNIGEN 250 mg tablets
2. terbinafine in combination with oral contraceptives have been reported to cause some cases of

TERBINAFINA TECNIGEN 250 mg tablets

Terbinafina

Generic medicine

PHARMACOTHERAPEUTIC CATEGORY
Systemic antifungal.

THERAPEUTIC INDICATIONS

• Onychomycosis (fungal infections of the nails) caused by dermatophyte fungi.
• Tinea capitis.
• Dermatophyte skin infections (Tinea corporis, Tinea cruris, Tinea pedis), and skin infections due to yeasts, sustained 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. Note: Unlike topical formulations of terbinafine, terbinafine tablets administered orally are not effective against Pityriasis versicolor.

CONTRAINDICATIONS

• Known hypersensitivity to the active substance or to any of the excipients of Terbinafina TecniGen.
• Do not administer to children under 2 years of age.
• Generally contraindicated in pregnancy and during breastfeeding (see "Special Warnings").

PRECAUTIONS FOR USE
Liver function
Terbinafina TecniGen is not recommended in patients with active or
chronic liver disease. A liver function test must be performed before taking Terbinafina TecniGen. Hepatic 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. Terbinafine must
be immediately discontinued in case of an increase in liver function parameters. Very rare cases of severe hepatic failure (some with fatal outcome or requiring
liver transplantation) have been reported in patients treated with terbinafine. In most cases of hepatic failure, patients
had pre-existing severe systemic diseases and a causal relationship with
the assumption of terbinafine was uncertain (see “Undesirable Effects”). It is appropriate
that patients treated with Terbinafina TecniGen promptly inform
their attending physician of any sign and symptom of persistent nausea without apparent cause,
loss of appetite, fatigue, vomiting, pain in the upper right abdominal quadrant, jaundice, dark urine or pale stools. Patients who present
these symptoms should discontinue terbinafine oral therapy and their liver function must
be immediately evaluated.

Dermatological Effects
Very rare cases of severe dermatological reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms) have been reported in patients treated with terbinafine. If a progressively worsening skin rash occurs, treatment with Terbinafina TecniGen
must be discontinued.
Terbinafine must be administered with caution to patients with pre-existing psoriasis or lupus
erythematosus, as cases of drastic worsening and exacerbation of psoriasis and cutaneous and systemic lupus erythematosus have been reported
in post-marketing experience.

Hematological Effects
Very rare cases of hematological dyscrasias (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported in patients treated with terbinafine. The etiology of any hematological disorder that should occur in patients
treated with Terbinafina TecniGen must be evaluated and possible changes
in the therapeutic regimen, including discontinuation of treatment with Terbinafina
TecniGen, must be considered.

Renal Function
The use of terbinafine in patients with impaired renal function (creatinine clearance below 50 ml/min or serum creatinine greater than 300 micromoles/l) has not
been adequately studied, and is therefore not recommended.

Interactions with other medicines
Patients receiving concomitant treatments with some drugs belonging to the following classes must be medically monitored: tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors, antiarrhythmics
(including those of class IA, IB and IC), monoamine oxidase inhibitors type B
(see "Interactions").

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other
medicines, including those without a prescription.
Use caution when Terbinafina TecniGen is taken with drugs such as:

• cimetidine;
• fluconazole, ketoconazole, amiodarone;
• rifampicin;
• tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors, antiarrhythmics (including those of class IA, IB and IC), monoamine oxidase inhibitors type B (see “Precautions for use”);
• desipramine;
• dextromethorphan;
• caffeine (when administered intravenously);
• cyclosporine as interference with the action of individual drugs may occur.

Terbinafine interferes insignificantly with drugs based on terfenadine,
triazolam, tolbutamide or oral contraceptives; in patients who have taken

terbinafine in combination with oral contraceptives have been reported to cause some cases of

irregular menstruation, although the incidence of these disorders is within the range of those of
patients taking oral contraceptives alone.
Interactions with food/beverages: Terbinafina TecniGen can be taken on an
empty stomach or after meals.

SPECIAL WARNINGS
Ask your doctor or pharmacist for advice before taking any medicine.

Women of childbearing potential
In patients who have taken terbinafine in combination with oral contraceptives, some
cases of irregular menstruation have been reported, although the incidence of these
disorders is within the range of those of patients taking oral contraceptives alone.
There are no data to support special recommendations for women of childbearing potential.

Pregnancy
Because clinical experience in pregnant women is very limited, terbinafine should not be used
during pregnancy unless the woman's clinical condition requires treatment with oral terbinafine and the
potential benefits to the mother outweigh the potential risks to the fetus.

Breastfeeding
Terbinafine is excreted in breast milk; therefore, patients treated with
Terbinafina TecniGen should not breastfeed.

Fertility
Studies of toxicity and fertility in animals have not shown any adverse effects.

Effects on ability to drive and operate machinery
Patients who experience dizziness, impaired vision and reduced visual acuity as an adverse
effect should avoid driving vehicles or operating machinery.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Posology
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
1 tablet of 250 mg once a day.

Children over 2 years of age weighing more than 20 kg
There are no data available on use in children under 2 years of age
(generally weighing < 12 kg).

Daily dosage
250 mg tablets do not allow treatment of children weighing <20 kg.

Skin infections
Recommended treatment duration

• Tinea pedis (interdigital, plantar and/or moccasin type): 2 - 6 weeks
• Tinea corporis, cruris: 2 - 4 weeks
• Cutaneous candidiasis: 2 - 4 weeks Complete resolution of signs and symptoms of the infection may occur several weeks after healing from the fungal infection.

Scalp infections
Recommended treatment duration:

• Tinea capitis: 2 - 4 weeks Note: Tinea capitis is mainly found in children.

Onychomycosis
For most patients, the duration of treatment is between 6 and 12
weeks:

• Onychomycosis of the fingers: 6 weeks
• Onychomycosis of the toes: 12 weeks

Some patients with slow 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
nail plate growth has resulted in complete renewal of the
plate itself).

Additional information on special patient populations

Patients with hepatic impairment
Terbinafina TecniGen is not recommended in patients with chronic or
active liver disease (see “Precautions for use”).

Patients with renal impairment
The use of terbinafine has not been adequately studied in patients with renal
insufficiency and is therefore not recommended in this population of patients (see
“Precautions for use”).

Elderly patients
There is no evidence to suggest that elderly patients require a different
dosage or are subject to different adverse effects compared to those observed
in younger patients. When prescribing Terbinafina TecniGen to patients in this
age group, consideration should be given to the possibility of pre-existing
hepatic or renal impairment (see "Precautions for use").

Method of administration

The divisible tablets should be taken orally with water. They should be
taken preferably every day at the same time, on an empty stomach or after meals.
The tablets are divisible to allow dosage in children according to their
body weight.
If you have any doubts about the use of the medicine, consult your doctor or pharmacist.

OVERDOSE
In case of accidental ingestion/intake of an excessive dose of Terbinafina
TecniGen, immediately notify your doctor or go to the nearest hospital.
Some cases of overdose (up to 5 g) have been reported, with headache,
nausea, upper abdominal pain and dizziness. In case of overdose
it is recommended to eliminate the drug by administering activated charcoal
accompanied, if necessary, by symptomatic treatment.

UNDESIRABLE EFFECTS
Like all medicines, Terbinafina TecniGen can cause side effects
although not everyone will experience them.
The adverse reactions to the medicinal product observed during clinical studies or from
pharmacovigilance are listed according to the MedDRA system organ and class classification. Within each frequency group, adverse reactions are listed in
decreasing order of severity. In addition, the frequency category corresponding to
each adverse reaction is defined according to 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 (the frequency cannot be defined
based on available data).

Blood and lymphatic system disorders
Uncommon Anemia.
Very rare Neutropenia, agranulocytosis, thrombocytopenia,
pancytopenia.

Immune system disorders
Very rare Anaphylactoid reactions (including angioedema),
cutaneous and systemic lupus erythematosus.
Not known Anaphylactic reactions, serum sickness-like reactions.

Metabolism and nutrition disorders
Very common Decreased appetite.

Psychiatric disorders
Common Depression.
Uncommon Anxiety.

Nervous system disorders
Very common Headache.
Common Dysgeusia*, including ageusia*, dizziness.
Uncommon Paresthesia and hypoesthesia.
Not known Anosmia, including permanent anosmia, hyposmia.

Eye disorders
Common Impaired vision, reduced
visual acuity.

Ear and labyrinth disorders
Uncommon Tinnitus.
Not known Hearing loss, hearing impairment.

Vascular disorders
Not known Vasculitis.

Gastrointestinal disorders
Very common Gastrointestinal symptoms (abdominal fullness,
dyspepsia, nausea, abdominal
pain, diarrhea).
Not known Pancreatitis.

Hepatobiliary disorders
Rare Hepatic insufficiency, hepatitis, jaundice, cholestasis,
increased liver enzyme levels (see
“Precautions for use”).

Skin and subcutaneous tissue disorders
Very common Rash, urticaria.
Uncommon Photosensitivity reactions.
Very rare Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized
pustulosis (AGEP), erythema multiforme,
toxic skin eruption, exfoliative dermatitis,
bullous dermatitis.
Psoriasiform eruptions or exacerbations of
psoriasis.
Alopecia.
Not known Drug rash with eosinophilia and systemic
symptoms, photodermatitis, allergic and polymorphous
light eruption.

Musculoskeletal and connective tissue disorders
Very common Musculoskeletal reactions (arthralgia,
myalgia).
Not known Rhabdomyolysis.

Systemic and administration site disorders
Uncommon Pyrexia.
Common Fatigue.
Not known Flu-like syndrome.

Laboratory tests
Uncommon Weight loss**.
Not known Increased blood creatine phosphokinase.

undesirable effects.
If any of the side effects become severe or if you notice any
pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, please tell your doctor or pharmacist. You can also report side effects
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information
on the safety of this medicine.

SHELF LIFE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging,
correctly stored.
Caution: do not use the medicine after the expiry date indicated on the
packaging.
Do not store above 30°C.
Keep the blister in the outer packaging to protect it from light.
Keep the medicine out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This
will help protect the environment.

COMPOSITION
Each tablet contains:
Active ingredient:
terbinafine hydrochloride ................................................................................... 281.250 mg
equivalent to 250 mg of terbinafine base
Excipients:
Microcrystalline cellulose PH101, Hypromellose, Sodium croscarmellose, Colloidal anhydrous
silica, Magnesium stearate.

PHARMACEUTICAL FORM AND CONTENT
Terbinafina TecniGen tablets are round, flat, white in color, with
an engraving on one side.
The tablets are available in a pack containing a PVC/Aluminum blister
of 8 tablets.

MARKETING AUTHORISATION HOLDER AND
MANUFACTURERS

MAH
TECNIGEN S.R.L. – Via Galileo Galilei 40- 20092 Cinisello Balsamo (MI)

Manufacturers
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n. 11,
Venda Nova, 2
700-486 Amadora,
Portugal
Atlantic Pharma - Produções de Especialidades Farmacêuticas, S.A.
Rua da Tapada Grande, n. 2
Abrunheira,
2710-089 Sintra
Portugal.

OF THE MEDICINAL PRODUCT