Prigabilon - instructions for use, doses, side effects, contraindications

Excipients: lactose monohydrate 55.00 mg / 18.00 mg / 27.00 mg / 36.00 mg / 54.0 mg / 72.00 mg / 108.00 mg, corn starch - 10.00 mg / 16.00 mg / 24.00 mg / 32.00 mg / 48.0 mg / 64.00 mg / 96.00 mg, talc 10.00 mg / 16.00 mg / 24.00 mg / 32.00 mg (48.00 mg) 64.0 mg / 96.00 mg.

Capsule shell composition:

cap capsules - gelatin 14,8960 mg/ 18,8160 mg/ 18,7553 mg/ 29,6959 mg/ 29,7920 mg/ 37,5881 mg/ 37,5106 mg/, dye iron oxide red (E172) - / - / 0,2420 mg/ 0,3832 mg/ - / 0,0424 mg/ 0,4840 mg/, dye iron oxide yellow (E172) - / - / 0,1815 mg/ 0,2874 mg/ - / 0,1273 mg/ 0,3630 mg/, dye iron oxide black (E172) - / - / - / - / - / 0,0424 mg/ - /, titanium dioxide (E171) 0,3040 mg/ 0,3840 mg/ 0,0212 mg/ 0,0335 mg/ 0,6080 mg/ 0,5998 mg/ 0,0424 mg;

capsule body - gelatin 22,3440 mg/ 28,2240 mg/ 28,2240 mg/ 44,5438 mg/ 44,6880 mg/ 56,3821 mg/ 56,4480 mg/, dye iron oxide red (E172) - / - / - / 0,5748 mg/ - / 0,0636 mg/ - /, dye iron oxide yellow (E172) - / - / - / 0,4311 mg/ - / 0,1909 mg/ - /, dye iron oxide black (E172) - / - / - / - / - / 0,0636 mg/ - /, titanium dioxide (E171) 0,4560 mg/ 0,5760 mg/ 0,5760 mg/ 0,0503 mg/ 0,9120 mg/ 0,8998 mg/ 1,1520 mg.

The composition of the ink used to inscribe the capsules: shellac solution in ethanol 59.420%, iron dye oxide black 24.650%, butanol 9.750%, water purified 3.249%, propylene glycol 1.300%, ethanol 1.080%, isopropanol 0.550%, ammonia water 0.001%.

Description:

Hard gelatin capsules containing powder or slightly formed agglomerates of white or almost white color (for all dosages).

Dosage of 25 mg:

capsule number 4, white with the inscription "25" on the body.

Dosage 50 mg:

capsule number 3, white with the inscription "50" on the body.

Dosage of 75 mg:

capsule number 3, body white, cap - red-brown color, on the body of the inscription "75".

Dosage of 100 mg:

capsule number 1, red-brown color with the inscription "100" on the body.

Dosage of 150 mg:

capsule number 1, white with the inscription "150" on the body.

Dosage of 200 mg:

capsule number 0, light brown color with the inscription "200" on the body.

Dosage of 300 mg:

capsule number 0, body white, cap - red-brown color, on the body of the inscription "300".

Pharmacotherapeutic group:antiepileptic agent

ATX: & nbsp

N.03.A.X.16 Pregabalin

Pharmacodynamics:

Pregabalin is an analog of gamma-aminobutyric acid ((S) -3- (aminomethyl) -5-methylhexanoic acid) - has antiepileptic and anticonvulsant activity. Has no direct, nor indirect GAMK-ergicheskogo action. The mechanism of action is based on the binding of pregabalin with an additional subunit (α2-delta protein) potential-dependent calcium channels in the central nervous system, irreversibly replacing [3H] -gabapentin. It is suggested that such binding can contribute to the manifestation of its analgesic and anticonvulsant effects.

Neuropathic pain

The efficacy of pregabalin has been noted in patients with diabetic neuropathy and postherpetic neuralgia.

It has been established that when taking pregabalinum with courses up to 13 weeks twice a day and up to 8 weeks three times a day, in general, the risk of developing side effects and the effectiveness of the drug at doses of two or three times a day are the same.

When taking a course of up to 13 weeks, the pain decreased during the first week, and the effect persisted until the end of treatment.

The pain index was reduced by 50% in 35% of patients who received pregabalinum, and 18% taking placebo. Among patients who did not experience drowsiness, the effect of this pain reduction was observed in 33% of pregabalin and 18% of patients in the placebo group. In 48% of patients who took pregabalinum, and 16% of patients taking placebo had drowsiness.

Fibromyalgia

A marked decrease in pain symptoms associated with fibromyalgia is noted with the use of pregabalin in doses from 300 mg to 600 mg per day. The efficacy of doses of 450 mg and 600 mg per day is comparable, but tolerability of 600 mg per day is usually worse. Also, the use of pregabalin is associated with a marked improvement in the functional activity of patients and a decrease in the severity of sleep disorders. The use of pregabalin at a dose of 600 mg per day led to a more pronounced improvement in sleep, compared with a dose of 300-450 mg per day.

Epilepsy

When taking the drug for 12 weeks, two or three times a day, the noted risk of side effects and the effectiveness of the drug under these dosing regimens are the same.The reduction in the frequency of seizures began within the first week.

Generalized anxiety disorder

Reduction of symptoms of generalized anxiety disorder is noted in the first week of treatment. When using the drug for 8 weeks, 52% of patients who received pregabalinum, and 38% of patients receiving a placebo had a 50% reduction in symptoms on the Hamilton anxiety scale (NAM-A).

In clinical trials in patients who have been pregabalinum, adverse reactions on the part of the visual organ (such as blurred vision, decreased visual acuity, changes in the visual fields) were more frequent (with the exception of changes in the fundus) than in patients receiving a placebo.

Pharmacokinetics:

The pharmacokinetics of pregabalin in the range of recommended daily doses is linear. Interindividual variability is low (<20%). The pharmacokinetics of pregabalin with repeated application is consistent with data after single dose administration, so there is no need for regular monitoring of pregabalin concentrations.

Suction

After oral administration on an empty stomach pregabalinum quickly absorbed.The maximum concentration of pregabalin in plasma (FROMmOh) is achieved after 1 hour as with a single or repeated application. Bioavailability of pregabalin for oral administration is ≥90% and does not depend on the dose. At repeated reception the equilibrium concentration is reached in 24-48 hours. When using the drug after eating C_mOh decreases by about 25-30%, and the time to reach the maximum concentration (W) increases to approximately 2.5 hours. However, eating does not have a clinically significant effect on the overall absorption of pregabalin.

Distribution

The apparent volume of distribution of pregabalin after oral administration is approximately 0.56 l / kg. Pregabalin does not bind to plasma proteins. Pregabalin well penetrates through blood-brain and hematoplacental barriers, and also excreted in breast milk.

Metabolism

Pregabalinum is practically not exposed to a metabolism. Share of Nmethylated derivative of pregabalin, which is the main metabolite found in urine, is 0.9% of the dose. There were no signs of racemization Senantiomer of pregabalin in R-enantiomer.

Excretion

Pregabalin is excreted mainly by the kidneys in unchanged form.

The average half-life is 6.3 hours. The clearance of pregabalin from the plasma and the kidney clearance are directly proportional to the creatinine clearance. In patients with impaired renal function and patients on hemodialysis, dose adjustment is necessary.

Linearity / nonlinearity

The pharmacokinetics of pregabalin in the range of recommended daily doses is linear, interindividual variability is low (<20%). The pharmacokinetics of pregabalin with repeated application can be predicted on the basis of single dose data. Consequently, there is no need for regular monitoring of pregabalin concentrations.

Pharmacokinetics in special patient groups

Sexual differences

The sex of the patient does not have a clinically significant effect on the concentration of pregabalin in plasma.

Impaired renal function

The clearance of pregabalin is directly proportional to the creatinine clearance. Given that pregabalinum is mainly excreted by the kidneys, in patients with impaired renal function it is recommended to reduce the dose of pregabalin. Besides, pregabalinum is effectively removed from the plasma during hemodialysis (after a 4-hour hemodialysis session, pregabalin plasma concentration is reduced by approximately 50%), after hemodialysis it is necessary to prescribe an additional dose of the drug.

Impaired liver function

The pharmacokinetics of pregabalin in patients with impaired liver function has not been specifically studied. Pregabalin practically does not undergo metabolism and is excreted mainly unchanged in the urine, therefore, a violation of liver function should not significantly change the concentration of pregabalin in the plasma.

Elderly patients (over 65 years of age))

Clearance of pregabalin with age tends to decrease, which reflects the age-related decrease in creatinine clearance. Elderly people with impaired renal function may need to reduce the dose of the drug.

Breastfeeding mothers

The pharmacokinetics of pregabalin, 150 mg, when taken every 12 hours (daily dose of 300 mg) was evaluated in 10 women during lactation (at least 12 weeks postpartum period). Lactation had little or no effect on the pharmacokinetics of pregabalin. Pregabalin was excreted through breast milk at an equilibrium concentration of about 76% of the concentration in the blood plasma of the mother.When taking 300 mg / day or a maximum dose of 600 mg / day, the dose of pregabalin received by the baby during breastfeeding (with an average milk intake of 150 mg / kg / day) is approximately 0.31 or 0.62 mg / kg / day, respectively. The calculated doses are about 7% of the total daily dose for the mother when calculated in mg / kg.

Indications:

- Neuropathic pain in adults;

- epilepsy (as adjunctive therapy in adults with partial convulsive seizures accompanied or not accompanied by secondary generalization);

- generalized anxiety disorder in adults;

- fibromyalgia in adults.

Contraindications:

- Hypersensitivity to pregabalinum or other components of the drug.

- rare hereditary diseases, incl. intolerance to galactose, deficiency of lactase, glucose-galactose malabsorption.

- pregnancy, the period of breastfeeding.

- Children and adolescents under 17 years of age (safety and efficacy not established).

Carefully:

- Renal failure;

- heart failure;

- diabetes;

- An encephalopathy in the anamnesis;

- drug dependence in the anamnesis.

Pregnancy and lactation:

Pregnancy

Adequate data on the use of pregabalin in pregnant women do not.

When used in animals, the drug had a toxic effect on reproductive function. In this regard, Prigabilon® should not be used in pregnancy, except when the intended benefit to the mother exceeds the potential risk to the fetus.

When treated with Prigabilon®, women of reproductive age should use adequate methods of contraception.

Breastfeeding period

Pregabalin® is excreted in breast milk. Therefore, during treatment with Prigabilon®, breastfeeding should be discontinued.

Fertility

There are no clinical data on the effect of pregabalin on the fertility of women with a preserved genital function.

In a clinical study to assess the effect of pregabalin on sperm motility, healthy men took pregabalinum in a dose of 600 mg / day. After 3 months of treatment, no effect of the drug on sperm motility was recorded.

A study in female rats revealed negative effects on the reproductive system. A study in male rats revealed adverse side effects on reproductive function and subsequent ontogenetic development. The clinical significance of these results is unknown.

Dosing and Administration:

Inside, regardless of food intake.

The drug is used in a dose of 150 to 600 mg per day, in two or three divided doses. The duration of treatment and the dose of Prigabilon® is determined by the attending physician individually for each patient, depending on the nature of the disease and the individual characteristics of the patient.

Neuropathic pain

Treatment begins with a dose of 150 mg per day. Depending on the effect achieved and tolerance in 3-7 days, the dose can be increased to 300 mg per day, and, if necessary, after 7 days - up to a maximum dose of 600 mg per day.

Epilepsy

The initial dose is 150 mg per day. Taking into account the achieved effect and tolerability after 1 week, the dose can be increased to 300 mg per day, and in a week to a maximum dose of 600 mg per day.

Generalized anxiety disorder

Treatment with the drug begins with a dose of 150 mg per day.Depending on the effect achieved and the tolerability after 7 days, the dose can be increased to 300 mg per day. In the absence of a positive effect after 7 days, increase the dose to 450 mg per day, and if necessary, after 7 days - up to a maximum dose of 600 mg per day.

Fibromyalgia

Treatment with pregabalin begins with a dose of 75 mg twice a day (150 mg per day). Depending on the effect achieved and the tolerability after 7 days, the dose can be increased to 150 mg twice a day (300 mg per day). In the absence of a positive effect, a dose of 225 mg twice daily (450 mg per day) is increased, and if necessary, after 7 days - up to a maximum dose of 600 mg per day.

Abolition of the drug

If treatment with Prigabilon® should be stopped, it is recommended to do this gradually for at least 1 week.

Use in special patient groups

Patients with impaired renal function

In patients with impaired renal function, the dose is selected individually, taking into account the clearance of creatinine (CC) (Table 1), which is calculated by the following formula:

CK (ml / min) = [140 - age in years] x body weight (kg) (x 0.85 for women) / 72 x serum creatinine (mg / dL)

In patients receiving hemodialysis treatment, the daily dose of pregabalin is selected taking into account the kidney function.Immediately after each 4-hour hemodialysis session, an additional dose is given (see Table 1).

Table 1. Selection of a dose of Prigabilon® taking into account the function of the kidneys

Creatinine clearance (CK), ml / min	The daily dose of Prigabilon®		Multiplicity of reception per day
Creatinine clearance (CK), ml / min	Initial dose, mg / day	The maximum dose, mg / day	Multiplicity of reception per day
≥60	150	600	2-3
≥30 - <60	75	300	2-3
≥15- <30	25-50	150	1-2
<15	25	75	1
Additional dose after dialysis (mg)
	25	100	Once

Patients with impaired hepatic function

In patients with impaired liver function, dose adjustment is not required.

Patients of advanced age (over 65 years)

Older patients may need to reduce the dose of pregabalin due to a decrease in kidney function.

Skipping the drug

If you miss the dose of Prigabilon®, you should take the next dose as soon as possible, but do not take the missed dose if the next time is right.

Side effects:

Based on the experience of clinical use of pregabalin in more than 12000 patients, the most common adverse events were dizziness and drowsiness. The observed phenomena were usually mild and moderate.The frequency of cancellation of pregabalin and placebo due to adverse reactions was 14% and 7%, respectively.

Dizziness (4%) and drowsiness (3%), depending on their subjective tolerance, were the main undesirable effects that required discontinuation of treatment.

Other side effects that also lead to drug cancellation: ataxia, confusion, asthenia, impaired attention, blurred vision, impaired coordination, peripheral edema.

Against the background of therapy of central neuropathic pain associated with damage to the spinal cord, there is an increase in the incidence of adverse reactions in general, as well as adverse reactions from the central nervous system, in particular, drowsiness.

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often (≥ 10%), often (≥ 1%, <10%), infrequently (≥ 0.1%, <1%), rarely (≥ 0.01% , <0.1%), very rarely (<0.01%); frequency is unknown (according to available data, it is not possible to establish the frequency of occurrence).

Infectious diseases: often - nasopharyngitis.

Violations of the blood and lymphatic system: infrequently - neutropenia.

Immune system disorders: infrequently - hypersensitivity reactions *; rarely - angioedema, * allergic reactions *.

Disorders from the metabolism and nutrition: often - increased appetite; infrequently - anorexia, hypoglycemia.

Disorders of the psyche: often - a state of euphoria, confusion, irritability, disorientation, insomnia, decreased libido; infrequently - hallucinations, panic attack, anxiety, agitation, depression, depressed mood, high spirits, mood swings, aggression *, depersonalization, difficulty with the selection of words, anxious dreams, increased libido, anorgasmia, apathy; rarely - disinhibition.

Disturbances from the nervous system: very often - dizziness, drowsiness, headache; often - ataxia, impaired coordination, tremor, dysarthria, amnesia, memory impairment, attention impairment, paresthesia, hypesthesia, sedation, imbalance, lethargy; infrequent states, stupor, myoclonia, loss of consciousness *, psychomotor agitation, dyskinesia, orthostatic dizziness, intentional tremor, nystagmus, cognitive impairment,mental disorders *, speech impairment, weakening of reflexes, hyperesthesia, agevzia (loss of taste sensations), burning sensation on the mucous membranes and skin; rarely - convulsions *, parosmia, hypokinesia, dysgraphy.

Disturbances on the part of the organ of sight: often - blurred vision, diplopia; infrequent - loss of peripheral vision, visual impairment, eye swelling, visual field defect, visual acuity, eye pain, asthenopia, photopsy, dry eyes, increased lacrimation, irritation of the eye mucosa; rarely - oscilloscopy (subjective sensation of fluctuations in the subjects under consideration), change in the depth of visual perception, mydriasis, strabismus, increased brightness of visual perception, keratitis *, loss of vision *.

Hearing disorders and labyrinthine disorders: often - vertigo; infrequently - a hyperacusis.

Heart Disease: infrequently - tachycardia, atrioventricular block of the I degree, sinus bradycardia, chronic heart failure *; rarely - sinus tachycardia, sinus arrhythmia, prolongation of the QT interval *.

Vascular disorders: infrequently - hypotension, hypertension, skin hyperemia, "hot flashes", cold extremities.

Disturbances from the respiratory system, chest and mediastinal organs: infrequently - shortness of breath, nosebleed, cough, nasal congestion, rhinitis, snoring, dryness of the nasal mucosa; rarely - a feeling of tightness in the throat, pulmonary edema *.

Disorders from the gastrointestinal tract: often - nausea *, vomiting, constipation, diarrhea *, flatulence, bloating, dryness of the oral mucosa; infrequently - gastroesophageal reflux, hypersecretion of the salivary glands, decreased sensitivity of the oral mucosa; rarely - ascites, pancreatitis, edema of the tongue *, dysphagia.

Disturbances from the skin and subcutaneous tissues: infrequently - papular rash, urticaria, increased sweating, skin itch *; rarely - Stevens-Johnson syndrome *, cold sweat.

Disturbances from musculoskeletal system and connective tissue: often - muscle cramps, arthralgia, back pain, pain in the limbs, spasm of the muscles of the cervical spine; infrequently - swelling of the joint, myalgia, muscle cramps, pain in the neck, stiffness of the muscles; rarely rhabdomyolysis.

Disorders from the kidneys and urinary tract: infrequent - urinary incontinence, dysuria; rarely - renal failure, oliguria, urinary retention *.

Disorders from the reproductive system: often - erectile dysfunction; infrequently - sexual dysfunction, delay of ejaculation, dysmenorrhea, pain in the area of the mammary glands; rarely - amenorrhea, discharge from the mammary glands, enlargement of mammary glands, gynecomastia *.

General disorders and disorders at the site of administration: Often - peripheral edema, impaired gait, falling, feeling drunk, malaise, fatigue; rare - generalized edema, face edema *, chest tightness, pain, fever, thirst, fever, general weakness, malaise *.

Laboratory and instrumental dataFrequently - weight gain, infrequently - hypercreatininemia, increased activity of alanine aminotransferase, aspartate aminotransferase, creatine kinase, increase the concentration of glucose in the blood, decreased platelet count, hypokalemia, weight loss; rarely - a decrease in the content of leukocytes in the blood.

* - adverse reactions observed during the post-marketing use of the drug.

After discontinuation of short-term and prolonged treatment with pregabalin, some patients had withdrawal symptoms.

The following undesirable reactions were noted: insomnia, headache, nausea, anxiety, diarrhea, flu-like syndrome, convulsions, increased excitability, depression, pain, hyperhidrosis, dizziness.

Patients should be informed of possible withdrawal symptoms before starting therapy.

The available data indicate that in the case of cancellation of prolonged treatment with pregabalin, the incidence and severity of withdrawal symptoms may depend on the dose of the drug.

Overdose:

Overdose of the drug (up to 15 g) of other (not described above) adverse reactions was not recorded. In the course of post-marketing use, the most common adverse events that developed with an overdose of pregabalin were: affective disorders, drowsiness, confusion, depression, agitation and anxiety. In rare cases, cases of coma have been reported.

Treatment: carry out gastric lavage, maintenance treatment and, if necessary, hemodialysis.

Interaction:

Pregabalin is excreted by the kidneys mainly in unchanged form, undergoes minimal metabolism in humans (in the form of metabolites, less than 2% of the dose is excreted by the kidneys), does not inhibit the metabolism of other medicinal substances in vitro and does not bind to plasma proteins, so it is unlikely that pregabalinum may enter into a pharmacokinetic interaction.

Research in vivo and population pharmacokinetic analysis

There were no signs of clinically significant pharmacokinetic interaction of pregabalin with phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone and ethanol.

It has been established that oral hypoglycemic agents, diuretics, insulin, phenobarbital, tiagabine and topiramate have no clinically significant effect on the clearance of pregabalin.

Oral contraceptives, norethisterone and / or ethinyl estradiol

When using oral contraceptives containing norethisterone and / or ethinyl estradiol, simultaneously with pregabalin, the equilibrium pharmacokinetics of both drugs did not change.

Drugs affecting the central nervous system

There have been reports of violations of breathing and the onset of coma with the simultaneous use of pregabalin with other drugs that depress the central nervous system.

Repeated oral administration of pregabalin with oxycodone, lorazepam or ethanol did not have a clinically significant effect on respiration.

Pregabalin, apparently, enhances cognitive and motor function disorders caused by oxycodone.

Pregabalin can enhance the effects of ethanol and lorazepam.

Opioid analgesics

In the course of post-marketing use of the drug, there were cases of lowering the function of the lower parts of the gastrointestinal tract (including the development of intestinal obstruction, paralytic ileus, constipation) with simultaneous use with opioid analgesics.

Special instructions:

Patients with diabetes mellitus

In some patients with diabetes mellitus, in the case of weight gain on the background of treatment with Prigabilon®, dosage adjustment of hypoglycemic agents may be required.

Hypersensitivity reactions

In the course of the post-marketing application of pregabalin, there have been cases of development of hypersensitivity reactions, including angioedema.In case of symptoms of angioedema (such as facial edema, perioral edema or swelling of upper respiratory tract tissues), therapy with Prigabilon® should be discontinued.

Dizziness, drowsiness, loss of consciousness, confusion and mental disturbance

Treatment with pregabalin may be accompanied by dizziness and drowsiness, which increases the risk of accidental injuries (falls) in elderly patients.

In the course of post-marketing use of the drug, there were also cases of loss of consciousness, confusion and mental disorders. Therefore, as long as patients do not evaluate the possible effects of the drug, care should be taken.

Effect of pregabalin on vision

With the use of pregabalin, the appearance of such undesirable reactions as blurred vision, reduced visual acuity, or other disturbances on the part of the visual organ, which in most cases pass on their own. Despite the fact that the clinical significance of these disorders is not established, patients should inform the doctor about changes in vision against the background of pregabalin therapy. The withdrawal of the drug may lead to the disappearance of these symptoms.

Renal insufficiency

There were also cases of development of renal failure, in some cases after the abolition of pregabalin kidney function was restored.

Cancellation of concomitant therapy with anticonvulsants

Information on the possibility of canceling other anticonvulsants with suppression of seizures with pregabalin and the advisability of monotherapy with this drug are insufficient. There are reports of the development of seizures, including epileptic status and minor seizures with pregabalin or immediately after therapy.

Symptoms of cancellation of pregabalinum

As a result of cancellation of pregabalin after prolonged or short-term therapy, the following undesirable phenomena were observed: insomnia, headache, nausea, diarrhea, flu-like syndrome, depression, sweating, dizziness, convulsions, anxiety. The available data indicate that the incidence and severity of manifestations of the "withdrawal" syndrome may depend on the dose of pregabalin.

Congestive heart failure

In the course of post-marketing use of the drug, chronic heart failure was reported against the background of pregabalin therapy in some patients.These reactions were mainly observed in elderly patients with diseases of the cardiovascular system who received the drug for the treatment of neuropathy. therefore pregabalinum this category of patients should be used with caution. After the abolition of pregabalin, the disappearance of manifestations of such reactions is possible.

Therapy of central neuropathic pain associated with spinal cord injury

The incidence of adverse events on the part of the CNS, especially such as drowsiness, is increased in the treatment of central neuropathic pain caused by spinal cord injury, which, however, may be a consequence of the summation of the effects of pregabalin and other concurrent agents (eg, antispastic). This circumstance should be taken into account when presgabalin is prescribed for this indication.

Suicidal thoughts and behavior

Antiepileptic drugs, including pregabalinum, can increase the risk of suicidal thoughts and behavior. Therefore, patients receiving these drugs should be carefully monitored for the appearance or deterioration of depression, the appearance of suicidal thoughts or behavior.

Decreased gastrointestinal function

If simultaneous use of pregabalin and opioid analgesics is necessary, the need for preventive measures to prevent the development of constipation and intestinal obstruction (especially in elderly patients and women) should be considered.

Drug addiction

There are reports of cases of development of dependence when using pregabalin. Patients with drug dependence in a history need careful medical observation for symptoms of dependence on pregabalin.

Encephalopathy

There have been cases of encephalopathy, especially in patients with concomitant diseases, which can lead to the development of encephalopathy.

Effect on the ability to drive transp. cf. and fur:

During the period of treatment with Prigabilon®, you should not drive a car or engage in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions. possibly the development of such adverse reactions as dizziness, drowsiness, disturbances from the organ of vision.

Form release / dosage:

Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg and 300 mg.

Packaging:

Dosage of 25 mg, 50 mg and 75 mg

For 14 capsules in an aluminum foil blister / PVC / PVDC; 1 or 4 blisters together with instructions for use in a cardboard box.

Dosage of 100 mg and 200 mg

7 capsules per blister of aluminum foil / PVC / PVDC; 3 or 12 blisters together with instructions for use in a cardboard box.

Dosage of 150 mg and 300 mg

7 capsules per blister of aluminum foil / PVC / PVDC; 2 or 8 blisters together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003493

Date of registration:09.03.2016

Expiration Date:09.03.2021

The owner of the registration certificate:Pharmaceutical factory "POLFARMA" JSCPharmaceutical factory "POLFARMA" JSC Poland

Manufacturer: & nbsp

Pharmaceutical Works POLPHARMA, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp10.08.2016

Illustrated instructions

Instructions

Prigabilon (Pregabilon)