Название документа

Pregalon – antiepileptic means. Drug is shown for treatment of neuropatichesky pain of peripheral or central origin at adults.

Drug Pregalon is shown by

to adults as additional treatment at partial convulsive attacks with secondary generalization or without it.

Drug is shown to

for treatment of a generalized anxiety disorder at adults and fibromyalgia.

Structure

  • active ingredient: pregabalin;
  • 1 capsule contains 75 mg of a pregabalin;
  • other components: lactoses monohydrate, starch corn, talc;
  • a capsule cover for 75 mg: gelatin, titan dioxide (E 171), ferrous oxide red (E 172), ferrous oxide yellow (E 172), ferrous oxide black (E 172).

Contraindication

Hypersensitivity to active ingredient or any of excipients.

Side reactions

Most frequent side reactions which led to phase-out of medicament in group of a pregabalin were dizziness and drowsiness.

Infection and an invasion – it is frequent: nasopharyngitis.

from blood and lymphatic system – infrequently: neutropenia.

from the immune system – infrequently: hypersensitivity. Seldom Quincke's disease, allergic reactions, anaphylactoid reactions.

Disbolism, metabolism – is frequent: increase in appetite. Infrequently: loss of appetite, hypoglycemia.

from mentality – it is frequent: euphoric mood, confusion of consciousness, irritability, disorientation, insomnia, decrease in a libido. Infrequently: hallucinations, the panic attacks, concern, excitement, a depression, oppressed mood, high spirits, aggression, changes of mood, depersonalization, the complicated selection of words, pathological dreams, strengthening of a libido, an anorgazmiya, apathy. Seldom: disinhibition.

from nervous system – it is very frequent: dizziness, drowsiness, headache. Often: ataxy, lack of coordination, tremor, dysarthtia, amnesia, memory impairment, disturbance of attention, paresthesia, hypesthesia, sedation, balance disturbance, lethargy. Infrequently: to a syncope, stupor, myoclonia, loss of consciousness, psychomotor hyperactivity, dyskinesia, postural dizziness, intentsionny tremor, nystagmus, disturbance of cognitive functions, disturbance of mentality, speech disorder, hyporeflexia, hyperesthesia, burning sensation, myoclonus. Seldom: spasms, parosmiya, hypokinesia, dysphagy, hypalgesia, dependence, cerebellar syndrome, syndrome of a cogwheel, lump, delirium, encephalopathy, extrapyramidal syndrome, syndrome Hyena Barra, intracranial hypertensia, maniacal reactions, paranoid reactions.

Route of administration

Drug is taken irrespective of food.

This medicine is intended to

only for oral administration.

Range of doses of medicament can change within 150–600 mg/days. The daily dose is distributed on 2-3 receptions.

Neuropatichesky pain

Therapy pregabaliny can be begun with

with the dose 150 mg/days distributed on 2-3 receptions. Depending on the individual answer and tolerance of medicament the patient the dose can be increased up to 300 mg/days in 3-7 days, and if necessary – to the maximum dose of 600 mg/days after 7 days.

Epilepsy

Therapy pregabaliny can be begun with

with the dose 150 mg/days distributed on 2-3 receptions. Depending on the individual answer and tolerance of medicament the patient it is possible to increase a dose to 300 mg/days after the first week of treatment. In one week the dose can be increased to maximum – 600 mg/days

Generalized anxiety disorder

Dose distributed on 2–3 receptions can change within 150–600 mg/days. Periodically it is necessary to reconsider need of continuation of therapy.

Therapy pregabaliny can begin with

with a dose 150 mg/days. Depending on the individual answer and tolerance of medicament the patient it is possible to increase a dose to 300 mg/days after the first week of treatment. After one more week of reception it is possible to increase a dose to 450 mg/days. In one week the dose can be increased to maximum – 600 mg/days

Feature of use

Use during pregnancy or feeding by a breast

Drug Pregalon should not be used during pregnancy needlessly (when the advantage for mother obviously exceeds possible risk for a fruit).

feeding Period a breast

a Small amount of a pregabalin was revealed

in milk nursing. It is necessary to tell women who nurse that feeding by a breast is not recommended at use of a pregabalin.

Children

Safety and efficiency of a pregabalin at its use to children are younger than 18 years are not established.

Ability to influence speed of response at control of motor transport or other mechanisms

Pregabalin can have insignificant or moderate impact on ability to run vehicles and to work with mechanisms. Pregabalin can cause dizziness and drowsiness and, thus, to affect ability to run vehicles and to work with mechanisms. In this regard patients should recommend to abstain from control of vehicles.

to

from work with a difficult technique or from other potentially dangerous activity, it will not become known yet whether this medicine affects their ability to such activity.

to

Overdose

by

After medicament entry into the market it was reported that the most frequent side reactions at overdose of a pregabalin were drowsiness, confusion of consciousness, excitement and concern. Also messages about spasms arrived.

to

it was Seldom reported about coma cases.

Treatment of overdose of a pregabalin consists in the general supporting measures and if necessary can include a hemodialysis.

Storage conditions

to Store

at a temperature not over 25C. To store out of children's reach.

Characteristics
Active ingredients Pregabalin
Amount of active ingredient 75 mg
Applicant Technologist
Code of automatic telephone exchange N03AX16 Pregabalin
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status Generic-generic
Origin Chemical
Prescription status According to the prescription
Primary packing blister
Producer PRAT TECHNOLOGIST
Quantity in packing 14 capsules (2 blisters on 7 pieces)
Release form capsules for internal use
Route of administration Oral
Sign Domestic
Storage temperature from 5 °C to 25 °C
Trade name Pregalon

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Pregalon kaps. 75 mg No. 14

  • Product Code: 184170
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