Fenspirid-LF

General characteristics. Structure:

Active ingredient: 80 mg of a fenspirid of a hydrochloride.

Excipients: gidroksipropilmetiltsellyuloza, magnesium stearate, hydrophosphate calcium dihydrate, опадрай II 85F18422 (white) (polyvinyl alcohol, titanium dioxide, polyethyleneglycol, talc).

The medicine belonging to group of the anti-inflammatory drugs operating effectively mainly for a mucous membrane of respiratory tracts.

Pharmacological properties:

Pharmacodynamics. Antiinflammatory action is result of interaction of various interconnected mechanisms:

- antagonistic activity at the level of histamine H1 receptors and papaverinopodobny (myotropic) spasmolytic action;

- antiinflammatory action is result of decrease in products of various pro-inflammatory factors (cytokines, ФНО-α, derivative arachidonic acid and free radicals) some of which also have bronkhokonstriktorny effect. However these effects were observed only at very high doses or concentration.

Pharmacokinetics. Absorption. After intake of the tablets Cmax it is reached in 6 h, after syrup reception - in 2.3±2.5 h (from 0.5 to 8 h).

Removal. T1/2 makes 12 h. It is removed preferential with urine.

Indications to use:

Symptomatic treatment of respiratory diseases (cough, otkhozhdeny phlegms and other symptoms).

Treatment fenspiridy does not replace antibacterial therapy and cannot serve as the reason for postponement of adequate purpose of antibacterial medicines.

Route of administration and doses:

Tablets appoint the adult 80 mg (1 tablets) 2 times a day, in the morning and in the evening. For stronger effect and/or at an acute form of a disease – on 3 tablets (in the morning, in the afternoon, in the evening). Syrup is appointed the adult on 3-6 tablespoons (45-90 ml) 1 tablespoon contains 30 mg of a fenspirid of a hydrochloride.

At children only syrup is used. To children and teenagers drug is appointed at the rate of 4 mg/kg of body weight. To children with body weight to 10 kg – 2-4 teaspoons of syrup (10-20 ml), it is possible to add to a small bottle with food. To children with body weight more than 10 kg – 2-4 tablespoons of syrup (30-60 ml)

Features of use:

Reception Fenspirid-LF does not replace antibacterial therapy and cannot serve as the reason of a delay of adekvtny purpose of antibacterial medicines.

If during medicine reception symptoms remain or there is an aggravation of symptoms, it is necessary to see a doctor.

Reception of this drug at pregnancy is not recommended. During pilot studies at two animal species (rats and rabbits) sky crevices at a fruit were noted. At the moment there are no clinical data testimonial of ability of a fenspirid to cause toxicity or maldevelopment of a fruit at administration of drug during pregnancy. Therefore reception of a fenspirid during pregnancy is not recommended though confirmation of pregnancy at reception of a fenspirid does not demand abortion.

At the moment there are no authentic data on allocation of a fenspirid with breast milk. Therefore purpose of a fenspirid is not recommended to the women nursing.

Special researches on impact assessment of administration of drug on ability to driving and for work with potentially dangerous mechanisms were not conducted.

Side effects:

Frequency of undesirable reactions which were observed or during conduct of clinical trials or were received from spontaneous messages on development of undesirable reactions is defined as follows: often (> 1/100 - <1/10); infrequently (> 1/1000 - <1/100); seldom (> 1/10 000 - <1/1000); very seldom (<1/10 000), it is unknown (frequency cannot be determined by the data which are available for today).

parties of CCC: seldom – the moderate sinusoidny tachycardia decreasing after a dose decline.

From a GIT: often – digestive disturbances, nausea, a stomach ache; frequency is not known – diarrhea, vomiting.

From TsNS: seldom – drowsiness.

From skin and hypodermic cellulose: seldom – an erythema, the fixed pigmental erythema, rash, a small tortoiseshell, a Quincke's edema; frequency is unknown – an itch.

General disturbances: adynamy (weakness), fatigue.

In case of the side reactions including which are not specified in this application instruction it is necessary to stop use of medicine and to see a doctor.

Interaction with other medicines:

Combined use with sedatives in a consequence of potentiation of sedation is not recommended.

Strengthens sedation of the medicines blocking H1-histamine receptors (antihistamines).

Contraindications:

- children's age up to 14 years (for tablets);
- pregnancy;
- lactation period;
- hypersensitivity to any of drug components.

Overdose:

At reception of a large amount of drug the following symptoms can be observed: drowsiness or excitement, nausea, vomiting, sinus tachycardia.

Treatment: Symptomatic therapy. To carry out by Neobjkhodimo a gastric lavage, monitoring of an ECG.

Storage conditions:

In the place protected from moisture and light at a temperature not above 25 °C. To store in the places protected from children. Period of storage 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in blister strip packagings. On the 3rd blister strip packagings in a cardboard pack together with the application instruction.