Телфаст

General characteristics. Structure:

For a dosage of 120 mg. Active agent: a feksofenadina a hydrochloride - 120,0 mg.

Excipients: croscarmellose sodium - 24,0 mg, starch prezhelatinizirovanny - 120,0 mg, cellulose of microcrystallic-133,0 mg, magnesium stearate - 3,0 mg.

Structure of a cover: a gipromelloza of E-15 - 2,84 mg, a gipromelloza of E-5 - 1,89 mg, povidone - 0,51 mg, titanium dioxide (Е 171) - 2,025 mg, silicon dioxide of colloid-0,73 mg, a macrogoal of 400 - 3,94 mg, dye ferrous oxide (pink mix) - 0,025 mg, dye ferrous oxide (yellow mix) - 0,040 mg.

For a dosage of 180 mg. Active agent: a feksofenadina a hydrochloride - 180,0 mg.

Excipients: croscarmellose sodium - 36,0 mg, starch prezhelatinizirovanny - 180,0 mg, cellulose microcrystallic - 199,5 mg, magnesium stearate - 4,5 mg.

Structure of a cover: a gipromelloza of E-15 - 4,26 mg, a gipromelloza of E-5 - 2,835 mg, povidone - 0,765 mg, titanium dioxide (Е 171) - 3,038 mg, silicon dioxide colloid - 1,095 mg, a macrogoal of 400 - 5,91 mg, dye ferrous oxide (pink mix) - 0,038 mg, dye ferrous oxide (yellow mix) - 0,060 mg.

Pharmacological properties:

Pharmacodynamics. Телфаст - a blocker histamine H1 receptors, have practically no sedative effect. Active agent of drug - фексофенадин - is pharmacological an active metabolite of a terfenadin.

The antihistaminic effect of drug is shown in 1 h, reaching a maximum in 6 h, and proceeds during 24 h. After 28 days of reception tolerance development is not observed.

At intake in the range of doses from 10 mg to 130 mg there is a linear dependence "dose effect". The dose of 120 mg is sufficient for maintenance of clinical effect of drug (at allergic rhinitis) during 24 h Telfast in a dose to 240 mg did not cause changes of an interval of QT.

Pharmacokinetics.  Absorption. After intake of a feksofenadin the hydrochloride is quickly absorbed from a GIT, reaching Cmax approximately in 1-3 h.

Average Cmax value at intake in a dose of 120 g 1 times/days makes about 289 ng/ml, and after reception in a dose of 180 mg of 1 time/days - about 494 ng/ml.

The pharmacokinetics at single and repeated use of a feksofenadin (to 120 mg of 2 times/days inside) has linear character.

Distribution. Linkng with proteins of plasma makes 60-70%.

Metabolism. Feksofenadin is exposed to insignificant metabolism (hepatic and extrahepatic).

Removal. Removal is two-phase. T1/2 is from 11 to 15 h after reception of repeated doses.

It is removed, apparently, preferential with bile whereas to 10% of the accepted dose it is allocated in not changed look with kidneys.

Indications to use:

Tablets of Telfast, coated, 120 mg and 180 mg:

— seasonal allergic rhinitis (including sneezing, an itch, cold, reddening of a conjunctiva) at adults and children is more senior than 12 years;

— a chronic small tortoiseshell (including reddening, a skin itch) at adults and children is more senior than 12 years.

Tablets of Telfast, coated, 30 mg:

— elimination of the symptoms connected with seasonal allergic rhinitis at children aged from 6 up to 11 years inclusive;

— treatment of uncomplicated skin displays of chronic idiopathic urticaria at children aged from 6 up to 11 years inclusive.

Route of administration and doses:

To adults and children 12 years at seasonal allergic rhinitis are more senior the recommended Telfast's dose makes 120 mg (1 tablets) 1 time/days, at a chronic small tortoiseshell - 180 mg (1 tablets) of 1 times/days.

To children aged from 6 up to 11 years inclusive for elimination of the symptoms connected with seasonal allergic rhinitis and uncomplicated skin displays of chronic idiopathic urticaria the recommended Telfast's dose makes 30 mg (1 tablets) of 2 times/days.

Inclusive at renal failures in the form of an initial dose Telfast in a dose of 30 mg (1 tablets) of 1 times/days is recommended to children aged from 6 up to 11 years.

Features of use:

Patients of advanced age and patients with a liver failure фексофенадин should appoint with care due to the lack of data on its use for these categories of patients.

It is recommended that a period between reception of a feksofenadin of a hydrochloride and antacids, the containing aluminum or magnesium hydroxide, made 2 h.

Use in pediatrics. For use for children aged from 6 up to 11 years tablets of 30 mg inclusive are issued.

Efficiency and safety of a feksofenadin of a hydrochloride at children under 6 years are not studied.

Influence on ability to driving of motor transport and to control of mechanisms. On the basis of a pharmakodinamichesky profile and the known side effects it is possible to believe that influence of reception of a feksofenadin of a hydrochloride on ability to drive the car and it is improbable to perform the works demanding concentration of attention. At conduct of clinical trials it was shown that Telfast does not make essential impact on the TsNS functions. Nevertheless to reveal the sensitive patients possessing non-standard reaction to medicines it is recommended to check individual reaction before starting performance of work, demanding concentration of attention.

Side effects:

Tablets of Telfast, coated, 120 mg and 180 mg. From TsNS: headache, drowsiness, dizziness, fatigue; seldom - sleeplessness, nervousness, a sleep disorder.

From the alimentary system: nausea.

Allergic reactions: in some cases - skin rash, a small tortoiseshell, a skin itch, a Quincke's disease, an asthma.

Tablets of Telfast, coated, 30 mg. From TsNS: headache (7.2%), drowsiness (2.2%), dizziness (2.2%). Frequency of emergence of such side effects at reception of a feksofenadin was similar or is slightly higher, than their frequency at placebo reception.

Interaction with other medicines:

At combined use of a feksofenadin of a hydrochloride with erythromycin or ketokonazoly concentration of a feksofenadin in plasma increases by 2-3 times. There is no significant effect on increase in an interval of QT.

Interaction between feksofenadiny and omeprazoly was not observed.

At reception containing aluminum or magnesium of antacids in 15 min. prior to reception of a feksofenadin of a hydrochloride reduction of its bioavailability, most possibly, due to binding in a GIT was observed. The recommended time interval between reception of a feksofenadin of a hydrochloride and antacids, the containing aluminum or magnesium hydroxide, makes 2 h.

Contraindications:

 — children's age up to 6 years;

— children's age up to 12 years (for tablets of 120 mg and 180 mg);

— pregnancy;

— period of a lactation (breastfeeding);

— hypersensitivity to components of drug of Telfast.

With care use drug at a chronic renal failure.

Overdose:

Messages on overdose of drug of Telfast were rare and contained limited information.

Symptoms: dizziness, drowsiness and dryness in a mouth.

Treatment: holding standard actions for removal of not absorbed drug from a GIT is recommended. The symptomatic and maintenance therapy is in case of need carried out. Use of a hemodialysis for removal of a feksofenadin of a hydrochloride from blood is inefficient.

Storage conditions:

In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated 120 mg and 180 mg.

On 10 tablets in the blister from PVC / aluminum foil. On 1 blister together with the application instruction place in a cardboard pack.