Replica - instructions for use, dose, side effects, contraindications

Capsule shell: body: gelatin - 85.500% / 83.3125% / 82.875%, methyl parahydroxybenzoate - 0.180% / 0.180% / 0.180%, propyl parahydroxybenzoate 0.020% 0.020% 0.020%, sodium lauryl sulfate 0.100% 0.100% 0.100% water 14.200% 14.200% 14.200%, a dye Ponso 4R - - / 0.1458% / -, dye sunset sunset yellow - - / 0.2917% / -, dye azorubin - - / 0.5833% / -, titanium dioxide - - / 1.1667% / 2.625%; lid: gelatin - 85.413% (83.3125%), 84.147%, methyl parahydroxybenzoate - 0.180% / 0.180% / 0.180%, propyl parahydroxybenzoate 0.020% 0.020% 0.020%, sodium lauryl sulfate 0.100% 0.100% 0.100% water 14.200% 14.200% 14.200%, a dye Ponso 4R - - / 0.1458% / 0.3937%, dye sunset yellow - - / 0.2917% / 0.0700%, dye azorubin - 0.0875% / 0.5833% / 0.3062%, titanium dioxide - - / 1.1667% / 0.5833%.

Description:

Dosage of 75 mg:

Hard gelatin capsules No. 3 with a transparent, colorless body and a pink lid.

The contents of the capsules are white or almost white powder or a mixture of white or almost white powder and colorless crystals.

Dosage of 150 mg:

Hard gelatin capsules No. 1 with a brownish-red body and cap.

The contents of the capsules are white or almost white powder or a mixture of white or almost white powder and colorless crystals.

Dosage of 300 mg:

Hard gelatin capsules № 0 with a white body and a lid of dark red color.

The contents of the capsules are white or almost white powder or a mixture of white or almost white powder and colorless crystals.

Pharmacotherapeutic group:antiepileptic agent

ATX: & nbsp

N.03.A.X.16 Pregabalin

Pharmacodynamics:

The active substance is pregabalinum - analogue of gamma-aminobutyric acid ((8) -3- (aminomethyl) -5-methylhexanoic acid).

Mechanism of action

It was found that pregabalinum binds to an additional subunit (α₂delta 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 was 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 patients in the pregabalin group and 18% in the placebo group. Do 48% 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 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.

Monotherapy (in newly diagnosed patients)

In a controlled clinical trial of 56 weeks with 2 times a day pregabalinum achieved comparable efficacy with lamotrigine on the basis of the final 6-month absence of seizures. Pregabalin and lamotrigine had similar safety and good tolerability.

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 placebo had a 50% reduction in the Hamilton anxiety symptom score (NAM-A).

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

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 pregabalin in plasma (C_mOh) is achieved after 1 hour as with a single or repeated application. Bioavailability of pregabalinum at intake makes> 90% and does not depend on a dose.At repeated application the equilibrium concentration is reached in 24-48 hours. When using the drug after eating C_max decreases by about 25-30%, and the time to reach the maximum concentration (T_max) 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. In studies in animals, it was noted that pregabalinum penetrates the blood-brain barrier in mice, rats and monkeys. It was also shown that pregabalinum can penetrate into the placenta and be 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. 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 (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 on the basis of single dose data. Consequently, there is no need for regular monitoring of pregabalin concentrations.

Pharmacokinetics in special groups

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 is effectively removed from the plasma during hemodialysis (after a 4-hour hemodialysis session, pregabalin plasma concentrations are reduced by approximately 50%), after hemodialysis it is necessary to prescribe an additional dose of the drug (see the section "Method of administration and dose" of Table 1).

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 the 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 section "Method of administration and dose" of Table 1).

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 under 17 years of age (no application data).

Carefully:

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

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

Pregnancy and lactation:

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

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 outweighs the possible risk to the fetus. In the treatment of pregabalin, women of reproductive age should use adequate methods of contraception.

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

Reproductive function

There are no clinical data on the effect of pregabalin on the reproductive function of women.

In a clinical study of the effect of pregabalin on motility of spermatozoa, healthy male volunteers received a dose of pregabalin 600 mg per day. After a 3-month treatment, no effect on sperm motility was detected.

The fertility study demonstrated the negative impact on the reproductive function of female rats and the negative impact on reproductive function and development of male rats.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 / day in two or three doses.

Neuropathic pain

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

Fibromyalgia

Treatment with pregabalin begins with a dose of 75 mg twice daily (150 mg / day). Depending on the effect achieved and the tolerance in 3-7 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 - 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 - 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: CC (ml / min) = 0.85 x [140 - age in years] x body weight (kg) / 72 x serum creatinine (mg / dl)

In patients receiving hemodialysis treatment, the daily dose of pregabalin is selected taking into account the function of the kidneys. 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 the section "Pharmacokinetics").

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

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

Application in the elderly (over 65 years)

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 case of missed dose Pregabalin should be taken the next dose as soon as possible, however, do not take the missed dose if the time of the next intake is already appropriate.

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. Adverse reactions were usually mild or moderate. In all controlled trials, the discontinuation rate due to adverse reactions was 14% among patients who received pregabalinum, and 7% among patients receiving placebo. The most frequent adverse reactions requiring discontinuation of treatment were dizziness (45) and drowsiness (3%), depending on 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 events occurring 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.

The table below shows all adverse reactions that occurred more frequently than with placebo and more than one patient: (very frequent (> 1/10), frequent (> 1/100, <1/10), infrequent ( > 1/1000, <1/100) and rare (<1/1000), is unknown (it is impossible to estimate from the available data) and is distributed according to system-organ classes.In each group, the incidence of adverse reactions is listed in order of decreasing severity.

The listed adverse reactions may also be associated with the course of the underlying disease and / or the concomitant use of other drugs. Additional adverse reactions reported after the release of the drug on the market are included in the list below and are indicated in italics.

Systems of organs	Adverse reactions to the drug
Infections and invasions
Infrequent	Nasopharyngitis
On the part of the blood and lymphatic system
Rare	Neutropenia
From the immune system
Infrequently	Hypersensitivity
Frequency unknown	Angioedema, allergic reaction
Metabolic disorders
Frequent	Increased appetite
Infrequent	Loss of appetite, hypoglycemia
From the side of the psyche
Frequent	Euphoria, confusion, irritability, decreased libido, disorientation, insomnia, panic attacks, depression, apathy
Infrequent	Hallucinations, agitation, anxiety, depressed mood, aggressiveness, elevated mood, mood changes, depersonalization, difficulty in finding words, pathological dreams, increased libido, anorgasmia, increased insomnia.
Rare	Disinhibition
From the nervous system
Very Frequent	Dizziness, drowsiness, headache
Frequent	Ataxia, impaired coordination, tremor, amnesia, dysarthria, memory impairment, attention impairment, paresthesia, hypesthesia, sedation, imbalance, lethargy, agevia
Infrequent	Fainting, myoclonia, psychomotor hyperactivity, dyskinesia, postural dizziness, intentional tremor, nystagmus, speech disorders, hyporeflexia, hyperesthesia, burning sensation, perioral paresthesia, myoclonus, loss of consciousness, cognitive impairment.
Rare	Pathological stupor, hypokinesia, parosmia, dysgraphia, convulsions
From the side of the organs of sight
Frequent	Blurred vision, diplopia
Infrequent	Visual impairment, eye swelling, loss of peripheral vision, visual field defect, visual acuity, eye pain, asthenopia, dry eyes, increased lacrimation, irritation of the eye mucosa
Rare	Oscilloscopy, changes in visual perception of depth, mydriasis, strabismus, increased brightness of visual perception, keratitis, loss of vision
From the organs of hearing and vestibular apparatus
Frequent	Vertigo
Infrequent	Hyperacusis
From the heart
Infrequent	Tachycardia, first degree block, sinus bradycardia, chronic heart failure
Rare	Sinus tachycardia, interval lengthening QT, sinus arrhythmia
Vascular disorders
Infrequent	Tides, skin hyperemia, arterial hypotension, arterial hypertension, cold extremities
From the respiration of the respiratory system, the organs of the thorax and the mediastinum
Often	Dryness of the nasal mucosa
Infrequent	Shortness of breath, nosebleed, nasal congestion, rhinitis, cough, snoring
Rare	The feeling of "embarrassment" in the throat, pulmonary edema
From the gastrointestinal tract
Frequent	Vomiting, dry mouth, constipation, flatulence, bloating, nausea, diarrhea
Infrequent	Gastroesophageal reflux disease, excessive salivation, hypoesthesia of the oral mucosa,
Rare	Ascites, pancreatitis, dysphagia, swelling of the tongue
From the skin and subcutaneous tissue
Infrequent	Papular rash, hyperhidrosis, urticaria, swelling of the face, itchy skin
Rare	Stevens-Johnson syndrome, cold sweat
From the side of the locomotor system and connective tissue
Often	Muscle twitching, arthralgia, pain in the extremities, back pain, cervical spasm
Infrequent	Swelling of the joints, muscle cramps, myalgia, neck pain, stiffness of the muscles
Rare	Rhabdomyolysis
From the urinary system
Infrequent	Urinary incontinence, dysuria,
Rare	Renal failure, oliguria, retention of urine
From the side of the reproductive system and mammary glands
Frequent	Pain in the mammary gland, erectile dysfunction
Infrequent	Ejaculation delay, sexual dysfunction, dysmenorrhea
Rare	Amenorrhea, discharge from the mammary glands, enlargement of mammary glands, gynecomastia
General disorders and reactions at the site of administration
Frequent	Violation of gait, a sense of intoxication, increased fatigue, peripheral edema, swelling, poor health
Infrequent	Generalized edema, a feeling of "tightness" in the chest, asthenia, thirst, pain, hyperthermia, chills, malaise
Rare
Study
Frequent	Increase in body weight, increase in creatinine concentration in plasma
Infrequent	Elevated levels of CK in the blood, increased levels of alanine aminotransferase,an increase in the level of aspartate aminotransferase, a decrease in the number of platelets, an increase in glucose concentration, a decrease in potassium in the blood, a decrease in body weight
Rare	Reduction of the level of leukocytes in the blood

Some patients experienced withdrawal symptoms after discontinuation of short- or long-term treatment with pregabalin. There have been reports of insomnia, headache, nausea, anxiety, diarrhea, flu-like syndrome, convulsions, increased excitability, depression, pain, hyperhidrosis and dizziness, indicating physical dependence. This information should be reported to the patient before starting treatment.

Observations show that in the case of cancellation of prolonged treatment with pregabalin, the frequency 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 postmarketing use, the most common adverse events that developed with an overdose of pregabalin were: affective disorders, drowsiness, confusion, depression, agitation and anxiety,there are reports of cases of coma.

Treatment: gastric lavage, maintenance treatment, and the need for hemodialysis (see section "Method of administration and dose" of Table 1).

Interaction:

Because the pregabalinum mainly excreted unchanged in the urine undergoes slight metabolism in the human body (less than 2% dose is excreted in the urine in the form of metabolites) does not inhibit in vitro metabolism of other drugs and does not bind to blood plasma proteins, it is unlikely that pregabalinum may cause pharmacokinetic interaction or be the object of such interaction.

Study in vivo and population pharmacokinetic analysis

In studies in vivo no significant clinical pharmacokinetic interaction between pregabalin, phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol. Population pharmacokinetic analysis showed that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate have no clinically significant effect on clearance of pregabalin.

Oral contraceptives, norethisterone and / or ethinyl estradiol

The simultaneous use of pregabalin with oral contraceptives, norethisterone and / or ethinylestradiol does not affect the pharmacokinetics of the equilibrium state of one of the drugs.

Drugs affecting CHC

Pregabalin can enhance the action of ethanol and lorazepam. In controlled clinical trials, simultaneous administration of multiple oral doses of pregabalin with oxycodone, lorazepam or ethanol did not lead to clinically significant effects on respiration. After the release of the drug, the market reported the occurrence of respiratory insufficiency and coma in patients who took pregabalinum together with other drugs that depress the function of the central nervous system. Pregabalin, probably, strengthens violations of cognitive and basic motor functions caused by the use of oxycodone.

Interaction the elderly patients

Special studies of pharmacodynamic interaction involving elderly volunteers were not conducted. The study of interaction was conducted only with respect to adults.

Special instructions:

Patients with diabetes mellitus

In some patients with diabetes mellitus, if weight gain is added to the background of pregabalin therapy, dosage adjustment of hypoglycemic agents may be required.

Hypersensitivity reactions

Pregabalin should be discontinued if symptoms of angioedema develop (such as facial swelling, perioral edema, or swelling of the upper respiratory tract).

Suicidal thoughts and behavior

Antiepileptic drugs, including pregabalinum, may increase the risk of suicidal thoughts or behavior. When suicidal thoughts and behavior appear, as well as the worsening of depression, patients or caregivers should immediately seek medical help.

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

Treatment with pregabalin was accompanied by dizziness and drowsiness, which increases the risk of accidental trauma (falls) in elderly patients. In the course of the post-marketing application of pregabalin, there were also cases of loss of consciousness, confusion, and violation of cognitive functions.Therefore, as long as patients do not evaluate the possible effects of the drug, they should be careful.

Cancellation of concomitant anticonvulsant therapy

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 more common than in patients receiving placebo. At the same time, this side effect ceased as the treatment continued. In clinical studies, during which an ophthalmologic examination of patients was performed, visual acuity and visual field changes were more often observed in patients receiving pregabalinum, than those who received 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 be informed of the changes in vision with 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 withdrawal

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

Abuse of the drug

There is no evidence that pregabalinum is active against receptors associated with the development of drug abuse by patients.During post-registration studies, cases of abuse of pregabalin were observed. As with any drug that affects the central nervous system, the patient's medical history should be carefully assessed for the incidence of LS abuse, and the patient should be monitored for the possibility of abuse of pregabalin (eg, development of resistance to pregabalin therapy, an unreasonable increase in the dose of the drug, addictive behavior patient). 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.

Chronic heart failure

During the post-marketing application of pregabalin, chronic heart failure (CHF) was reported on the background of pregabalin therapy in some patients. These reactions were predominantly observed in elderly patients with cardiac dysfunction who received pregabalinum in occasion of a neuropathy. therefore pregabalinum this category of patients should be used with caution.After the abolition of pregabalin, the disappearance of the manifestation of similar reactions is possible.

Treatment of neuropathic pain of the central genesis due to spinal cord injury

In the treatment of central neuropathic pain caused by spinal cord injury, the frequency of AEs from the CNS, especially such as drowsiness, increased. This may be a consequence of the summation of the effects of pregabalin and other medications taken (eg, antispastic). This circumstance should be taken into account when using pregabalin for this indication.

Encephalopathy

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

Disorders from the digestive tract

In case of simultaneous use with opioid analgesics, measures should be taken to prevent constipation and intestinal obstruction, in particular in elderly patients and women (see section "Interaction with other drugs").

Treatment of elderly patients

In elderly patients, more frequent occurrence of such adverse reactions as dizziness, confusion, tremor,impaired coordination, lethargy.

The remedy contains lactose. Patients with such hereditary diseases as galactose intolerance, lactase deficiency or impaired absorption of glucose-galactose should not take this medication.

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

Pregabalin may cause dizziness and drowsiness and, accordingly, affect the ability to drive and work with machinery. Patients should not drive or carry out other potentially dangerous species activities that require an increased concentration of attention and speed of psychomotor reactions, until it becomes clear whether pregabalinum to carry out such tasks.

Form release / dosage:Capsules, 75 mg, 150 mg, 300 mg.

Packaging:

10 capsules in Al / PVC blisters.

For 10 blisters per pack of cardboard along with instructions for use.

Storage conditions:

Store in a dark place at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003601

Date of registration:04.05.2016

Expiration Date:04.05.2021

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

Manufacturer: & nbsp

SCAN BIOTECH, Ltd. India

Representation: & nbspARS, LLCARS, LLC

Information update date: & nbsp10.07.2016

Illustrated instructions

Instructions

Replica (Replica)