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

Capsule shell: Capsule body composition: titanium dioxide 1.2% / 2% / 1.2%, gelatin up to 100% (for all dosages); composition of the cap capsule: iron dye red dioxide E172 (for a dosage of 75 mg - 1.7%, for a dosage of 300 mg - 1.7%), titanium dioxide (for a dosage of 150 mg - 2%), gelatin to 100% (for all dosages).

Description:

Dosage 75 mg. Hard gelatin capsules No. 4 with a white body and a cap from red-brown to dark-red-brown color.

Dosage of 150 mg. Hard gelatin capsules No. 2 with a white body and a white lid.

Dosage 300 mg. Hard gelatin capsules № 0 with a white body and a lid from red-brown to dark-red-brown color.

The contents of the capsules are a homogeneous powder or a compacted mass of white or white with a yellowish tint of color, disintegrating when pressed with a glass rod.

Pharmacotherapeutic group:antiepileptic agent

ATX: & nbsp

N.03.A.X.16 Pregabalin

Pharmacodynamics:

The active substance is pregabalinum - analogue of gamma-aminobutyric acid ((S) -3- (aminomethyl) -5-methylhexanoic acid).

Mechanism of action

Pregabalin binds to the additional subunit (α2-delta protein) of 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% of patients taking placebo. Among patients who did not experience drowsiness, the effect of this pain reduction was observed in 33% of the pregabalin group and 18% of the placebo group. In 48% of patients who took pregabalinum, and 16% of patients taking placebo, develop 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 pedules in 52% of patients who received pregabalinum, and 38% of patients taking placebo had a 50% reduction in the Hamilton anxiety symptom score (NAM-A).

Pharmacokinetics:

Parameters of pharmacokinetics of pregabalin in equilibrium in healthy volunteers, in patients with epilepsy receiving antiepileptic therapy, and in patients receiving it for chronic pain syndromes were similar.

Suction

Pregabalin is rapidly absorbed on an empty stomach. The maximum concentration of nregabasine in plasma (C_mOh) is achieved after 1 h as with a single or repeated application. Bioavailability of pregabalin when ingested is ≥ 90% and does not depend on the dose. At repeated application the equilibrium concentration is reached through 24-48 hours. At application of a preparation after reception of food With_mOh decreases by about 25-30%, and the time to reach the maximum concentration (t_max) increases to about 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.

In studies of pregabalin on animals, it was noted that it penetrates the blood-brain barrier in mice, rats and monkeys. It was also shown that pregabalinum can penetrate into the placenta and is found in milk in rats during lactation.

Metabolism

Pregabalinum is practically not exposed to a metabolism. After taking labeled pregabalin, approximately 98% of the radioactive label was detected in the urine unchanged. Share of Nmethylated derivative of pregabalin, which is the main metabolite found in urine, was 0.9% of the dose.Pre-clinical studies showed no signs of racemization Senantiomer of pregabalin in R-enantiomer.

Excretion

Pregabalin is excreted mainly by the kidneys in an 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 (see the paragraph "Dysfunction of the kidneys"). In patients with impaired renal function and patients on hemodialysis, dose adjustment is necessary (see the "Method of administration and dose" section of Table 1).

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 from the data of single dose reception. Consequently, there is no need for regular monitoring of pregabalin concentrations.

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 mainly excreted by the kidneys, in patients with impaired renal function it is recommended to reduce the dose of pregabalin. Besides, pregabalinum it is effectively removed from the plasma during hemodialysis (after a 4-hour hemodialysis session, pregabalin plasma concentrations are reduced by approximately 50%), after hemodialysis, an additional dose of the drug should be prescribed (see the "Method of administration and dose" table. 1).

Impaired liver function

The pharmacokinetics of pregabalia in patients with impaired liver function has not been specifically studied. Pregabalin practically does not undergo metabolism and is excreted mostly 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 (see the "Method of administration and dose" table. 1).

Breastfeeding mothers

The pharmacokinetics of pregabalin, 150 mg, when taken every 12 hours (daily dose - 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 amount contained in the mother's blood plasma. 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 ml / kg / day) is approximately 0.31 and 0.62 mg / kg / day, respectively. The calculated doses are about 7% of the total daily dose received by the lactating woman in mg / kg.

Indications:

Neuropathic pain

Treatment of neuropathic pain in adults.

Epilepsy

As an additional therapy in adults with partial seizures, accompanied or not accompanied by secondary generalization.

Generalized anxiety disorder

Treatment of generalized anxiety disorder in adults.

Fibromyalgia

Treatment of fibromyalgia in adults.

Contraindications:

Hypersensitivity to the active substance or any other component of the drug.

Rare hereditary diseases, including intolerance to galactose, lactase deficiency and impaired absorption of glucose / galactose.

Children and adolescents up to the age of 17 inclusive due to the lack of application data.

Carefully:

Renal failure (see section "Method of administration and dose"); heart failure (see section "Side effect").

In connection with the registered single cases of uncontrolled use of pregabalin, it must be administered with caution to patients with drug dependence in the history. Such patients need close medical supervision during drug treatment.

Pregnancy and lactation:

Pregnancy

There is no reliable data on the efficacy and safety of pregabalin in pregnancy. When used in animals, the drug had a toxic effect on reproductive function. Concerning pregabalinum can be used in pregnancy only if the benefit to the mother clearly exceeds the possible risk to the fetus. In the treatment of pregabalin, women of reproductive age should use effective methods of contraception.

Lactation

Pregabalin is excreted in breast milk. Since the safety of the use of pregabalin in newborns is unknown, during treatment with pregabalin it is not recommended to breast-feed.Stop breastfeeding or cancel pregabalin therapy, taking into account the need for mother therapy and breastfeeding for the newborn.

Fertility

There are no clinical data on the effect of pregabalin on female fertility. 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.

Undesirable effects on the fertility of males and female rats were observed only when the drug was used in doses far exceeding the therapeutic dose. Undesirable effects on the genital organs and sperm parameters of male rats were reversible and were observed only when the drug was used at doses far exceeding therapeutic,or associated with spontaneous degenerative processes in the genital organs of rats.

Dosing and Administration:

Inside, regardless of food intake. The drug is used in a dose of 150 to 600 mg / day in two or three doses.

Neuropathic pain

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

Epilepsy

Treatment with pregabalin begins with a dose of 150 mg / day, taken in two divided doses. Taking into account the achieved effect and tolerability after 1 week, the dose can be increased to 300 mg / day, and if necessary in a week - up to a maximum dose of 600 mg / day.

Fibromyalgia

Treatment with pregabalin begins with a dose of 150 mg / day, taken in two divided doses. Depending on the effect achieved and the tolerability after 7 days, the dose can be increased to 300 mg / day. In the absence of a positive effect, the dose is increased to 450 mg / day, and if necessary, after 7 days - up to a maximum dose of 600 mg / day.

Generalized anxiety disorder

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

Canceling pregabalinum

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

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:

For men:

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

For women:

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

In patients receiving hemodialysis treatment, the daily dose of pregabalin is selected taking into account the kidney function. After a 4-hour hemodialysis session, pregabalin concentrations in the blood plasma are reduced by approximately 50%. Immediately after each 4-hour hemodialysis session, an additional dose is prescribed (see Table 1).

Table 1. Selection of a dose of pregabalin with account of kidney function

Creatinine clearance, ml / min	Daily dose of pregabalinum		Multiplicity of reception per day
	Starting dose, mg / day	The maximum dose, mg / 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

Use in patients with impaired liver function

In patients with impaired liver function, dose adjustment is not required (see section "Pharmacokinetics").

Use in children under 12 years and adolescents (12-17 years, inclusive)

Safety and efficacy of pregabalin in children under 12 years of age and in adolescents under 17 years of age have not been established. The use of the drug in children and adolescents is not recommended.

Application the older people (over 65)

Older people may need to reduce the dose of pregabalin due to a decrease in kidney function (see section "Pharmacokinetics", use in patients with impaired renal function).

In the case of missing a dose of pregabalin, the next dose should be taken as soon as possible, however, do not take the missed dose if the next time is appropriate.

Side effects:

According to 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 or moderate.The frequency of cancellation of pregabalin and placebo due to adverse reactions was 14% and 7%, respectively.

The main undesirable effects requiring cessation of treatment were dizziness (4%) and snotty (3%), depending on their subjective tolerability. Other side effects that also lead to drug cancellation: ataxia, confusion, asthenia, impaired attention, blurred vision, impaired coordination, peripheral edema.

There were also undesirable reactions arising after the cancellation of pregabalin: insomnia, headache, nausea, anxiety, flu-like syndrome, convulsions, increased excitability, depression, pain, hyperhidrosis and diarrhea.

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

After discontinuation of short-term and prolonged treatment with pregabalin, some patients had withdrawal symptoms. The following reactions were recorded: insomnia, headache, nausea, anxiety, diarrhea, flu-like syndrome, seizures,increased excitability, depression, pain, increased sweating and dizziness, indicating a physical dependence. The patient should be informed about this before starting therapy.

Observations show 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.

The table lists all the undesirable events, the frequency of which exceeded that in the placebo group (observed in more than 1 person). They are distributed according to system-organ classes and frequency (very frequent (≥1 / 10), frequent (≥1 / 100, <1/10), infrequent (≥1 / 1000, <1/100) and rare (<1 / 1000)).

The reactions observed during the post-marketing use of the drug were isolated in italics.

The listed undesirable phenomena could be associated with the underlying disease and / or concomitant therapy.

System	Undesirable reactions
Infections and invasions
Infrequent	Nasopharyngitis
Blood and lymphatic system
Infrequent	Neutropenia
Disorders of metabolism and nutrition
Frequent	Increased appetite
Infrequent	Anorexia, hypoglycemia
Mental disorders
Frequent	Euphoria, confusion, decreased libido, insomnia, irritability, disorientation, panic attack, apathy, depression
Infrequent	Hallucinations, anxiety, anxious arousal, depressed mood, high spirits, mood swings, aggressiveness, depersonalization, anxious dreams, difficulties with the selection of words, increased libido, anorgasmia, increased insomnia
Rare	Disinhibition
Neurological disorders
Very Frequent	Dizziness, drowsiness, headache
Frequent	Ataxia, impaired attention, impaired coordination, memory impairment, tremor, dysarthria, paresthesia, imbalance, amnesia, lethargy, kinesisia, sedation, agevia
Infrequent	Fainting conditions, myoclonia, psychomotor agitation, dyskinesia, orthostatic dizziness, intentional tremor, nystagmus, speech impairment, decreased reflexes, a burning sensation on the skin and mucous membranes, hyperesthesia, loss of consciousness, cognitive impairment
Rare	Pathological stupor, hypokinesia, parosmia, dysgraphia, convulsions
Changes from the organ of vision
Frequent	Blurred vision, diplopia
Infrequent	Loss of peripheral vision, visual impairment, eye swelling, visual field defect, visual acuity, eye pain, asthenopia, photopsy, dry eye syndrome, increased tear, irritation of the eye mucosa
Rare	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
Changes in the organ of the hearing and vestibular apparatus
Frequent	Vertigo
Infrequent	Hyperacusis
From the side of the cardiovascular system
Infrequent	Tachycardia, atrioventricular blockade of the 1st degree, sinus bradycardia, chronic heart failure
Rare	Sinus tachycardia, sinus arrhythmia, interval lengthening QT
Vascular disorders
Infrequent	Hypotension, hypertension, skin hyperemia, hot flushes, cold limbs
From the respiratory system
Frequent	Dryness of the nasal mucosa
Infrequent	Shortness of breath, nosebleeds, cough, nasal congestion, rhinitis, snoring
Rare	The feeling of "embarrassment" in the throat, pulmonary edema
From the digestive system
Frequent	Dry mouth, constipation, vomiting, flatulence, bloating, nausea, diarrhea
Infrequent	Increased salivation, gastroesophageal reflux, hypoesthesia of the oral mucosa
Rare	Ascites, dysphagia, pancreatitis, swelling of the tongue
From the skin and subcutaneous tissues
Infrequent	Increased sweating, papular rash, hives, swelling of the face, itchy skin
Rare	Cold sweat, Stevens-Johnson syndrome
From the side of the musculoskeletal system
Frequent	Muscle cramps, arthralgia, back pain, pain in the limbs, spasm of the muscles of the cervical spine
Infrequent	Swelling of the joint, myalgia, muscle cramp, neck pain, stiffness of the muscles
Rare	Rhabdomyolysis
From the urinary system
Infrequent	Dysuria, incontinence
Rare	Oliguria, kidney failure, retention of urine
From the side of the reproductive system
Frequent	Erectile dysfunction, pain in the mammary gland
Infrequent	Delayed ejaculation, sexual dysfunction, dysmenorrhea
Rare	Amenorrhea, discharge from the mammary glands, enlargement of mammary glands, gynecomastia
General disorders and disorders at the site of administration
Frequent	Fatigue, peripheral edema, a feeling of intoxication, gait disturbance, poor health, falling
Infrequent	Feeling of chest tightness, thirst, chills, pain, fever, general weakness, generalized edema, malaise
Immune system disorders
Infrequent	Hypersensitivity reactions
Rare	Angioedema
Laboratory and instrumental data
Frequent	An increase in body weight, an increase in the concentration of creatinine in the blood
Infrequent	An increase in the activity of alanine aminotransferase, creatine phosphokinase, aspartate aminotransferase, a decrease in the number of platelets, an increase in blood glucose concentration, a decrease in potassium in the blood, a decrease in body weight
Rare	Reducing the number of leukocytes in the blood

If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose:

Overdose of the drug (up to 15 g) of other (not described above) adverse reactions was not recorded.In the course of postmarketing 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 (see section "Method of administration and dose" of Table 1).

Interaction:

Pregabalin is excreted by the kidneys mostly unchanged, 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 drugs in vitro and does not bind to plasma proteins, so it is unlikely to enter into a pharmacokinetic interaction.

Study 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 do not exert a 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 the violations of cognitive and motor functions caused by oxycodone. Pregabalin can enhance the effects of ethanol and lorazepam.

Effect on the gastrointestinal tract

Also reported was the negative effect of pregabalin on the activity of the gastrointestinal tract (including the development of intestinal obstruction, paralytic ileus, constipation) with concomitant use with drugs that cause constipation (such as opioids) (see section "Special instructions").

Interaction of drugs in the application the elderly patients

Special studies of pharmacodynamic interaction with other drugs in elderly patients have not been conducted.

Special instructions:

Patients with diabetes mellitus

Part of patients with diabetes mellitus in case of weight gain on the background of treatment with pregabalin may require correction of doses of hypoglycemic agents.

Hypersensitivity reactions

Pregabalinum should be canceled in case of development of symptoms of angioedema (such as facial edema, perioral edema or swelling of the tissues of the upper respiratory tract).

Suicidal thoughts and behavior

Anti-epileptic drugs, including pregabalinum, may increase the risk of suicidal thoughts or 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

With the simultaneous use of pregabalin and opioids, consideration should be given to the need for preventive measures to prevent the development of constipation (especially in older women)

Dizziness, drowsiness, loss of consciousness, confusion and cognitive impairment

Treatment with pregabalin was accompanied by dizziness and drowsiness, which increases the risk of accidental injuries (falls) in the elderly. During the postmarketing use of the drug, there were also cases of loss of consciousness, confusion, and cognitive impairment. Therefore, until patients do not evaluate the possible effects of the drug, they must be careful.

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.

Effect of pregabalin on vision

In clinical trials in patients who have been pregabalinum, a side effect such as blurred vision was noted more often than in patients receiving placebo. At the same time, this side effect ceased as the treatment continued.

In clinical studies, during which an ophthalmological examination of patients was performed, visual acuity and vision changes were more often observed in patients receiving pregabalinumthan in those receiving placebo. The frequency of changes in the fundus was higher in patients receiving a placebo.

Despite the fact that the clinical significance of these disorders is not established, patients should inform the doctor about changes in vision at the foyer of pregabalin therapy. If symptoms persist, visual impairment should be continued. More frequent eye examinations should be performed in patients who are already regularly observed with an ophthalmologist. When such undesirable reactions appear in response to the use of pregabalin such as loss of vision, blurred vision or other abnormalities on the part of the visual organ, 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.

Symptoms of cancellation of pregabalinum

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

Abuse of pregabalin

There is no evidence that pregabalinum is active against receptors associated with the development of drug abuse by patients. During post-marketing studies, cases of abuse of pregabalin have been reported. As with any drug that affects the central nervous system, one should carefully evaluate the patient's medical history for existing drug abuse cases, and observe the patient due to the possibility of dysregulation or abuse of pregabalin (for example, the development of resistance to pregabalin therapy, unreasonable increase in the dose of the drug, additive behavior of the patient).

Congestive heart failure

Despite the fact that there was no apparent relationship between the use of pregabalin and the development of heart failure,in the course of postmarketing use of the drug, chronic heart failure was reported against the background of pregabalin therapy in some patients. In patients without clinically significant signs of heart disease or blood vessels, there was no association between peripheral edema and cardiovascular complications, such as increased blood pressure or chronic heart failure. These reactions were predominantly observed in elderly patients suffering from cardiac dysfunction and receiving a drug for 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 injuries

The incidence of adverse events from the central nervous system, especially such as drowsiness, is increased in the treatment of central neuropathic pain due to spinal cord injury, which, however, may result from 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.

Encephalopathy

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

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

Pregabalin may cause dizziness and drowsiness and, accordingly, affect the ability to drive and use sophisticated techniques. Patients should not drive a car, use complicated equipment or carry out other potentially hazardous activities until it becomes clear whether this drug affects their performance of such tasks.

Form release / dosage:

Capsules, 75 mg, 150 mg and 300 mg.

Packaging:

14 capsules in a planar cell packaging made of a polyvinylchloride film and aluminum foil; 1, 2 or 4 contour squares in a cardboard pack together with instructions for medical use.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003308

Date of registration:11.11.2015

Expiration Date:11.11.2020

The owner of the registration certificate:GEROPHARM, LLC GEROPHARM, LLC Russia

Manufacturer: & nbsp

GEROPHARM, LLC Russia

Information update date: & nbsp16.12.2016

Illustrated instructions

Instructions

Pregabalin (Pregabalin)