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Ekzifin 250 mg (16 tablets)




The instruction for medical use

of Ekzifin® medicine

the Trade name
of Ekzifin®

the International unlicensed

name Terbinafin Lekarstvennaya a form
of a tablet of 250 mg

One tablet contains Structure:
active agent: a terbinafina a hydrochloride of 281.310 mg, it is equivalent to a terbinafin – 250 mg
excipients: cellulose microcrystalline (a grade 102), sodium of starch glikolit (type A), starch prezhelatinizirovanny, magnesium stearate, silicon dioxide colloidal anhydrous.
The description
of the Tablet from white till yellowish color, round shape with a smooth biconvex surface, 4.7 high + 0.20 mm, a dimeter 11.1 + 0.20 mm.

Pharmacotherapeutic group
Antifungal drugs for treatment of diseases of skin.
Antifungal drugs for system use. Terbinafin
the ATX D01BA02 Code

the Pharmacological

Pharmacokinetics At properties purpose of a terbinafin inside in skin, hair and nails are created the concentration of drug providing fungicide action. After single dose of a terbinafin inside in a dose of 250 mg, the maximum concentration in plasma is reached in 2 hours and makes 0.97 mkg/ml. The period of semi-absorption is 0.8 hours, and the semi-distribution period – 4.6 hours.
Terbinafin substantially contacts proteins of blood plasma (99%). He quickly gets through a thermal layer of skin and concentrates in a lipophilic corneal layer. Terbinafin also gets into secretion of sebaceous glands that leads to creation of high concentrations in hair follicles, hair and in the skin rich with sebaceous glands. Also terbinafin gets into nail plates in the first several weeks after the beginning of therapy.
Terbinafin is metabolized quickly, with the participation of P450 cytochrome isoenzymes, the main role is played by isoenzymes of CYP2C9, CYP1A2, CYP3A4, CYP2C8 and CYP2C19. The metabolites which do not have antifungal activity and removed mainly with urine are as a result formed. Final elimination half-life makes 17 hours. Any proofs of cumulation of drug in an organism are not available. Changes of equilibrium concentration of a terbinafin in plasma depending on age are not revealed, but at patients with a renal failure or a liver drug clearance rate can be slowed down that results in higher concentrations of a terbinafin in blood.

A pharmacodynamics
Ekzifin – antifungal drug, derivative allylamine. In low concentration has fungicide effect concerning dermatophytes, mold mushrooms and some dimorphous mushrooms. Action on barmy mushrooms can be fungistatic or fungicidal, depending on a species of a mushroom.
Drug specifically suppresses an early stage of biosynthesis of sterols in a mushroom cell. Ekzifin inhibits a skvalenepoksidaza in a cellular membrane of a mushroom, it results in deficiency of ergosterol and to intracellular accumulation of squalene that causes death of a cell of a mushroom. Enzyme of a skvalenepoksidaz does not belong to a system P450 cytochrome therefore Ekzifin does not influence metabolism of hormones or other medicines.
At intake and external use Ekzifin is active concerning causative agents of dermatomycoses: Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis, Epidermophyton floccosum, yeast-like mushrooms of the sort Candida (in the main Candida albicans). At external use Ekzifin is active also concerning Pityrosporum orbiculare (Malassezia furfur) – multi-colored (scaly) depriving of the activator.
– an onychomycosis,
– mycosis of a hairy part of the head,
– dermatomycoses (an epidermophitia of skin and nail plates, rubromikoza, trichophytias, microsporias),
– candidiases of skin, mucous membranes,
– scaly (multi-colored) deprive.

The route of administration and doses
of the Dose of drug are established individually, taking into account indications and disease severity.
Adults. Appoint inside 250 mg of 1 times a day or on 125 mg 2 times a day.
In candidiases Ekzifin appoint inside only at crushing widespread defeats.
Treatment duration in dermatomycoses of feet (localization interdigital, in the field of a sole, the foot arch) – 2-6 weeks, in dermatomycoses of large folds, skins of a breast, a stomach – 2-4 weeks, in mycoses of a hairy part of the head (mainly at children) – 4-6 weeks.
In dermatomycoses of nail plates (onychomycoses) duration of treatment depends on localization of defeat and growth rate of nails and is from 6 weeks to 3 months. At patients of young age with the normal growth rate of nails at damages of fingers of hands or legs (except thumbs) the term of treatment can be less than 3 months. Patients with damage of a nail of a thumb have legs, especially at the slow growth rate of nails, duration of treatment can be more than 6 months. In mycoses of nails the optimum clinical effect is observed in several months after mycologic treatment and the termination of treatment. It is connected with the period which is required for growth of healthy tissue of nail.
To patients of advanced age Ekzifin appoint in the same doses, as the adult.

Side effects
– a headache
– overflow of a stomach, loss of appetite, dyspepsia, nausea, a mild abdominal pain, diarrhea, a meteorism
– rash, an itching, urticaria
– an arthralgia, myalgia
– disturbances of flavoring feelings, including their loss (restoration happens within several weeks after the treatment termination).
Extremely seldom:
– Stephens-Johnson’s syndrome, a toxic epidermal necrolysis, an acute anaphylaxis
– a neutropenia, an agranulocytosis or thrombocytopenia
– psoriazopodobny rashes, exacerbation of psoriasis
– aggravation of a system lupus erythematosus

of the Contraindication
– hypersensitivity to a terbinafin or to other components of drug
– pregnancy and the period of a lactation
– children’s age till 6th years, with body weight less than 40 mg

Medicinal interactions
of Ekzifin®, at intake has extremely small ability of interaction with drugs which are metabolized through the system of P450 cytochrome (for example, cyclosporine, tolbutamide, oral contraceptives).
Drugs which cause induction of microsomal enzymes of a liver can accelerate removal of a terbinafin (for example, rifampicin). On the contrary, the drugs inhibiting P450 cytochrome (for example, Cimetidinum), slow down removal of a terbinafin. In need of combined use of these drugs the dose adjustment of Ekzifina® can be required. Экзифин® reduces clearance of the caffeine applied intravenously by 19% and clearance of desipramine for 82%. Экзифин® increases clearance of cyclosparinum by 15%.

Special instructions
Use for patients from the liver broken by function and kidneys
Patients with the profound abnormal liver functions and/or kidneys (clearance of creatinine less than 50 ml/min. or concentration of creatinine in serum more than 300 µmol/l) should appoint a half of a usual dose of Ekzifin. Before an initiation of treatment it is necessary to estimate initial indicators of function of a liver and to provide their monitoring in the course of treatment. If at the patient the phenomena indicating presence of an abnormal liver function, such as inexplicable persistent nausea, lack of appetite, fatigue, jaundice, dark urine or decoloured by kcal are noted, it is necessary to cancel treatment terbinafiny.
Due to the treatment terbinafiny it was reported about the gepatobiliarny disturbances (which are initially connected with a cholestasia) including about cases of a liver failure.
At treatment by Ekzifin it is necessary to follow the general rules of hygiene for prevention of a possibility of repeated infection (through linen, socks, footwear).
Influence on ability to driving of motor transport and to control of mechanisms
Data on influence of a terbinafin on ability to drive the car and to work with mechanisms are absent.

Symptoms: nausea or vomiting, dizziness.
Treatment: gastric lavage with the subsequent prescribing of activated carbon. If necessary carry out symptomatic therapy.

The form of release and packing
On 16 tablets pack into blister strip packaging from a film of PVC and aluminum foil.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a cardboard pack.

To Store storage conditions in the dry place protected from light at a temperature not over 250C.
To store out of children’s reach!
Period of storage
3 years.
After an expiration date not to apply
Prescription status. According to the prescription

Producer “Dr. of Reddi’s Laboratoris Ltd”
Site No. 137, 138 and 146, S.V.S.I.E.,
Bollaram – 502,325, the Region of Medak,
Andhra Pradesh, India

the Owner of the registration certificate
“Dr. of Reddi’s Laboratoris Limited”, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality a produktsiipredstavitelstvo of the “Dr. of Reddi’s Laboratoris Limited” company in the Republic of Kazakhstan: 050057 Almaty, 22nd Line St., 45, ph. 8 (727) 3941688, fax: 8 (727) 3941294
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