Pregabalin Zentiva - instructions for use, dose, side effects, contraindications

capsule shell: body: ferrous oxide black oxide 0.025%, titanium dioxide 2%, gelatin up to 100%; lid: ferric oxide black oxide 0.025%, titanium dioxide 2%, gelatin up to 100%.

1 capsule 75 mg contains:

active substance: pregabalin 75 mg;

Excipients: lactose monohydrate 7.50 mg, corn pregelatinized starch 6.00 mg, talc 11.50 mg;

shell capsule: body: ferrous oxide black oxide 0.025%, titanium dioxide 2%, gelatin up to 100%; lid: dye iron oxide red 0.47%, iron oxide dye yellow 0.45%, titanium dioxide 1%, gelatin up to 100%.

1 capsule 150 mg contains:

active substance: pregabalin 150 mg;

Excipients: lactose monohydrate 15.00 mg, corn pregelatinized corn starch 12.00 mg, talc 23.00 mg;

shell capsule: body: iron oxide dye oxide 0.025%, titanium dioxide 2%, gelatin up to 100%; lid: dye iron oxide black 0.025%, titanium dioxide 2%, gelatin up to 100%.

1 capsule 300 mg contains:

active substance: pregabalin 300 mg;

Excipients: lactose monohydrate 30.00 mg, corn starch pregelatinized starch 24.00 mg, talc 46.00 mg;

shell capsules: body: ferrous oxide black oxide 0.025%, titanium dioxide 2%, gelatin up to 100%; lid: ferric iron oxide 0.47% red, iron oxide oxide yellow 0.45%, titanium dioxide 1%, gelatin up to 100%.

Composition of ink: shellac glazed (22% esterified) in IMS 74 OP 47.5%, [ferric oxide black oxide, propylene glycol, ethanol denatured (methylated alcohol) 74 OP] 52.5%.

Description:

Capsules 50 mg: Hard gelatin capsules №4 with engraving "50" applied to the capsule body. Housing: from white to light gray, lid: from white to light gray.

Capsules 75 mg: Hard gelatin capsules №4 with engraving "75", applied to the capsule body. Housing: from white to light gray, the lid: a reddish brown.

Capsules 150 mg: Hard gelatin capsules number 2 with engraving "150" applied to the capsule body. Housing: from white to light gray, the lid: from white to light gray.

Capsules 300 mg: Hard gelatin capsules №0 with engraving "300", applied to the capsule body. Housing: from white to light gray, the lid: a red-brown color.

Contents of capsules: Powder from white to almost white.

Pharmacotherapeutic group:antiepileptic agent

ATX: & nbsp

N.03.A.X.16 Pregabalin

Pharmacodynamics:

Active substance, pregabalinum, is an analogue of gamma-aminobutyric acid (GABA) ((S) -3- (aminomethyl) -5-methylhexapic acid).

Mechanism of action

Pregabalin binds to an additional subunit (α2-δ protein) of potential-dependent calcium channels in the central nervous system.

Neuropathic pain

The efficacy of pregabalin was noted in patients with diabetic neuropathy, postherpetic neuralgia and pain caused by spinal cord injury.

It was established that when taking pregabalin courses up to 13 weeks two times a day and up to 8 weeks three times a day, the safety and efficacy profiles were the same.

When taking pregabalin up to 12 weeks, peripheral and central neuropathic pain decreased during the first week, and the effect persisted until the end of treatment.

A 50% reduction in pain index was noted in 35% of patients who received pregabalinum, and in 18% of patients taking placebo. Among patients who did not experience drowsiness, the effect of this decrease was noted in 33% of the pregabalin group and in 18% of the placebo group. Among patients who experienced drowsiness, 48% of the pregabalin group and 16% of the placebo group had an effect of this pain reduction.

With central neuropathic pain, the pain index was reduced by 50% in 22% of patients who received pregabalinum, and in 7% of patients receiving placebo.

Generalized anxiety disorder

Reduction of symptoms of generalized anxiety disorder on the Hamilton anxiety scale (MAM-A) was 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 symptom scores on the Hamilton anxiety scale.

In clinical trials in patients who have been pregabalinum, adverse reactions from 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 placebo (see section "Special instructions").

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, it was noted that the 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.

Pharmacokinetics:

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

Suction

Pregabalin is rapidly absorbed after ingestion on an empty stomach. The maximum concentration of pregabalin (C_max) in the blood plasma is achieved after 1 hour as a single or repeated application. Bioavailability of pregabalin when ingested is ≥ 90% and does not depend on the dose. At repeated application the equilibrium state 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 plasma concentration (T_1/2) increases to about two and a half hours. However, eating does not have a clinically significant effect on the overall absorption of pregabalin.

Distribution

In preclinical studies it was shown that pregabalinum penetrates the blood-brain barrier in mice, rats and monkeys, it also passes through the placental barrier and penetrates into the milk of female rats. In humans, the apparent volume of pregabalin distribution after ingestion is approximately 0.56 l / kg. The drug does not bind to plasma proteins.

Metabolism

Pregabalin practically does not undergo metabolism in the human body. After taking labeled pregabalin, approximately 98% of the radioactive substance 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

Basically pregabalinum is excreted from the systemic blood stream by the kidneys in unchanged form. The mean half-life (T_1/2) of pregabalin is 6.3 hours. The clearance of pregabalin from the plasma and the kidney clearance are directly proportional to the clearance of creatinine (see the paragraph "Violation of the function of the kidneys"). Patients with reduced renal function or patients on hemodialysis need an individual dose selection (see p.section "Method of administration and dose")

Linearity / Nonlinearity

Pharmacokinetics of pregabalin in the range of recommended daily doses is linear, individual variability is low (<20%). The pharmacokinetics of the drug in repeated application can be predicted on the basis of single dose data. Therefore, 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 the blood plasma.

Renal insufficiency

The clearance of pregabalin is directly proportional to the creatinine clearance. Due to the fact that the drug is mainly excreted by the kidneys, it is recommended to reduce the dose of pregabalin in case of kidney damage. Besides, pregabalinum is effectively removed from the blood plasma during hemodialysis (after a 4-hour hemodialysis session, pregabalin concentrations in the plasma 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").

Liver failure

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

Elderly people (over 65)

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")

Indications:

Neuropathic pain

Treatment of central and peripheral 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 of the excipients of the drug.

Rare hereditary disorders of galactose tolerance, lactase deficiency of lobes (Saami), glucose-galactose malabsorption.

Children and adolescents under 17 years of age (no application data).

Carefully:

Preparation Pregabalin Zentiva should be used with caution in patients with renal (see section "Method of administration and dose") and 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

Animal studies have proven presence of toxic action Pregabalin on the reproductive system. In humans, the possible risk is unknown. There are no clinical data on the use of pregabalin during pregnancy.

Preparation Pregabalin Zentiva is not recommended for use during pregnancy, except in cases of pronounced need, when the benefit to the mother greatly exceeds the risk for the fetus.

Breastfeeding period

There is no evidence of the ability of pregabalin to penetrate breast milk in humans, however, pregabalinum penetrates into the milk of female rats. In this regard, during treatment with Pregabalin Zentiva is not recommended to breast-feed.

Women of childbearing age / contraception

During the administration of Pregabalin Zentiva, women of childbearing age should use appropriate methods of contraception, since a possible risk to a person is unknown.

Dosing and Administration:

The drug is used in a dose of 150 to 600 mg per day. The daily dose of Pregabalin Zentiva can be divided into 2 or 3 doses (50 mg 3 times a day at the beginning of treatment, 150 mg twice a day and 300 mg twice a day with the drug at the maximum daily dose). If you need to use the drug at a dose of 25 mg, you should use other preparations of pregabalin having such a dosage.

Neuropathic pain

The recommended initial therapeutic dose of Pregabalin Zentiva is 75 mg twice daily (150 mg / day). Depending on the effectiveness of the drug and individual tolerance in 3-7 days, the dose of the drug can be increased to 150 mg twice a day (300 mg / day), if necessary, after 7 days the dose can be increased to a maximum of 300 mg twice a day 600 mg / day). Between each dose increase, an interval of three to seven days should be observed.

Epilepsy

The recommended initial therapeutic dose of Pregabalin Zentiva is 75 mg twice daily (150 mg / day). Depending on the effectiveness of the drug and individual tolerability after 1 week, the dose can be increased to 150 mg twice a day (300 mg / day), if necessary, after a week, the dose can be increased to a maximum of 300 mg twice a day (600 mg / day ). Between each dose increase, an interval of seven days must be observed.

Fibromyalgia

Treatment begins with a dose of 75 mg twice a day (150 mg / day). Depending on the achieved effect and tolerability after 7 days, the dose can be increased to 150 mg twice a day (300 mg / day). In the absence of a positive effect, a dose of 225 mg twice a day (450 mg / day) is increased, and if necessary, after 7 days - up to a maximum dose of 600 mg / day. It should be borne in mind that a dose of 600 mg / day does not provide additional benefits, but is worse tolerated.

Generalized anxiety disorder

The recommended initial therapeutic dose of Pregabalin Zentiva is 75 mg twice daily (150 mg / day). Depending on the effectiveness of the drug and individual tolerability after 1 week, the dose can be increased to 150 mg twice a day (300 mg / day).In the future, in the absence of the desired effect, after a week, the dose is increased to 450 mg per day, and if necessary, 7 days later to the maximum, 600 mg per day. Between each dose increase, an interval of seven days must be observed.

The need to continue treatment should be reviewed regularly.

Abolition of the drug

If treatment with Pregabalin Zentiva should be stopped, it is recommended to reduce the dose gradually for at least one week until the drug is completely discontinued regardless of the indication for use.

Special Populations

Patients with renal insufficiency

Basically pregabalinum is excreted from the systemic blood stream by the kidneys in unchanged form. Due to the fact that the clearance of pregabalin is directly proportional to the creatinine clearance, the dose of the drug for patients with renal insufficiency is calculated individually depending on the creatinine clearance (CL_CT) (see section "Pharmacokinetics"), as indicated in Table 1 by the formula below:

CL_from_r(ml / min) = (1.23 x [140 - age, years] x body weight, kg) x 0.85 for women/ serum creatinine, μmol / l

Pregabalin is effectively excreted from the blood by hemodialysis (in four hours 50% of the drug substance is excreted).In patients on hemodialysis, the daily dose of pregabalin is selected according to the function of the kidneys. In addition to the daily dose, after each 4-hour hemodialysis session, an additional dose of the drug should be taken without delay (see Table 1).

Table 1. Selection of a dose of pregabalin depending on renal function

Clearance creatinine (CL_cr) (ml / min)	Total daily dose of pregabalipa *		Multiplicity of reception per day
	Initial dose (mg / day)	The maximum dose (mg / day)
≥60	150	600	2 or 3
≥ 30-< 60	75	300	2 or 3
≥ 15-< 30	25-50	150	1 or 2
< 15	25	75	1
Additional dose after hemodialysis (mg)
	25	100	Single-shot +

* Depending on the dosage regimen, the total daily dose (.mg / day) should be divided into several doses in milligrams.

⁺Single dose - the dose of the drug for one additional reception.

Patients with impaired hepatic function

In patients with hepatic insufficiency, there is no need to select a special dose (see the section "Pharmacokinetics").

Children under 12 years and adolescents (12-17 years old)

Due to the lack of data on the efficacy and safety of the drug, it is not recommended for use in children under twelve years of age and adolescents (aged 12-17 years).

Patients of advanced age (over 65 years)

Elderly people due to impaired renal function may need to reduce the dose of Pregabalin Zentiva (see section "Pharmacokinetics").

If a dose is missed, the drug should be taken as soon as possible, however, if the time for the next dose is appropriate, the missed dose is not taken.

Side effects:

Based on the experience of clinical use of pregabalin in more than 12000 patients, the most common adverse events were drowsiness and dizziness. By severity, adverse events were mostly mild and moderate. The frequency of discontinuation due to adverse events was 14% in the pregabalin group and 5% in the placebo group. The main side effects that required cessation of treatment with pregabalin were dizziness and drowsiness.

The frequency of adverse reactions was determined according to the following gradation (classification of the World Health Organization): very often more than 1/10, often from more than 1/100 to less than 1/10, infrequently from more than 1/1000 to less than 1/100, from more than 1/10000 to less than 1/1000, very rarely - from less than 1/10000, including individual messages.

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

Infectious and parasitic diseases:

Often: nasopharyngitis.

Violations from the blood and lymphatic system:

Infrequent: neutropenia.

Disorders from the metabolism and nutrition:

Often: increased appetite.

Infrequently: anorexia, hypoglycaemia.

Disorders of the psyche:

Often: confusion, disorientation, irritability, euphoria, decreased libido, insomnia.

Infrequently: depersonalization, anorgasmia, anxiety, depression, agitation, mood changes, depressed mood, difficulty in finding words, hallucinations, unusual dreams, increased libido, panic attacks, apathy.

Rarely: disinhibition.

Impaired nervous system:

Very often: dizziness, drowsiness, headache.

Often: ataxia, impaired coordination of movements, balance disorder, amnesia, attention impairment, memory impairment, tremor, dysarthria, paresthesia, sedation, lethargy.

Infrequently: cognitive disorders, hypoesthesia, nystagmus, speech disorders, myoclonic cramps, weakened reflexes, dyskinesia,psychomotor agitation, postural dizziness, hyperesthesia, loss of taste, burning sensation on the mucous membranes and skin, intentional tremor, stupor, loss of consciousness, mental disorders, malaise.

Rarely: convulsions, hypokinesia, parosmia, dysgraphia.

Disorders from the side of the organ of vision:

Often: blurred vision, diplopia.

Infrequent: blurred vision, loss of peripheral vision, visual field defects, dry eyes, eye swelling, decreased visual acuity, eye pain, asthenopia, lacrimation, eye irritation, photopsy.

Rarely: mydriasis, loss of vision, keratitis, oscilloscopy (subjective sensation of fluctuations in the subjects under consideration), changes in visual perception of depth, strabismus, increased brightness of visual perception.

Hearing disorders and labyrinthine disturbances:

Often: vertigo.

Infrequently: hyperacusis.

Heart Disease:

Infrequent: atrioventricular block of the I degree, tachycardia, sinus bradycardia, congestive heart failure.

Rarely: interval lengthening QT, sinus tachycardia, sinus arrhythmia.

Vascular disorders:

Infrequent: lowering blood pressure (BP), increasing blood pressure, skin hyperemia, a feeling of heat, cold extremities.

Disturbances from the respiratory system, chest and mediastinal organs:

Infrequent: shortness of breath, dry nasal mucosa, cough, nasal congestion, epistaxis, rhinitis, snoring.

Rarely: pulmonary edema, a feeling of "restraint" in the throat.

Disorders from the gastrointestinal tract:

Often: vomiting, nausea, constipation, dry mouth, flatulence, bloating.

Infrequently: hypersalivation, gastroesophageal reflux, oral cavity hypoesthesia.

Rarely: dysphagia, pancreatitis, ascites, edema of the tongue.

Disturbances from the skin and subcutaneous tissues:

Infrequently: sweating, papular rashes, hives, itching of the skin.

Rarely: cold sweat, Stevens-Johnson syndrome.

Disturbances from the musculoskeletal and connective tissue:

Often: muscle twitching, muscle cramps, arthralgia, back pain, pain in the extremities, spasm of the neck muscles.

Infrequently: myalgia, swelling of the joints, neck pain, rigidity of the muscles.

Rarely: rhabdomyolysis.

Disorders from the kidneys and urinary tract:

Uncommon: dysuria, urinary incontinence.

Rarely: oliguria, renal failure, urinary retention.

Violations of the genitals and breast:

Often: erectile dysfunction.

Infrequent: delay in ejaculation, sexual dysfunction, dysmenorrhea, pain in the mammary gland.

Rare: amenorrhea, discharge from the breast, dysmenorrhea, breast enlargement, gynecomastia.

General disorders and disorders at the site of administration:

Common: peripheral edema, edema, gait disturbance, feeling "drunk", fatigue, falls, abnormal sensations.

Uncommon: chest tightness, swelling of the face, pain, chills, thirst, generalized edema, pyrexia, asthenia.

Impact on laboratory and instrumental research results:

Often: weight gain.

Infrequently: increased activity of alanine aminotransferase, creatine kinase, aspartate aminotransferase, decreased platelet count, increased glucose concentration in the blood plasma, increased creatinine concentration in blood plasma, reduction of potassium concentration in blood plasma, reduction of body weight.

Rarely: a decrease in the number of leukocytes in the blood.

Overdose:

In the course of application the most frequent undesirable phenomena,developed with an overdose of pregabalin, were: drowsiness, confusion, depression, agitation and anxiety. In rare cases, a coma was recorded.

Treatment: Gastric lavage is carried out, which supports symptomatic treatment and, if necessary, hemodialysis (see the "Method of administration and dosage" section of Table I).

Interaction:

Pregabalin is mainly excreted by the kidneys in an unchanged form (only a small amount of it, less than 2% undergoes metabolism and is metabolized in the form of metabolites with urine), does not inhibit the metabolism of drugs in vitro and does not bind to plasma proteins, so it is unlikely to enter into pharmacokinetic interactions.

There were no signs of clinically significant pharmacokinetic interactions of pregabalin with phenytoin, carbamazepine, valproic acid, lamotrigine, gabapeptin, lorazepam, oxycodone and ethanol. In addition, it has been established that oral hypoglycemic agents, diuretics, insulin, phenobarbital, tiagabine and topiramate do not have a clinically significant effect on the clearance of pregabalin.

When combined use of pregabalin and oral contraceptives containing norethisterone and / or ethinyl estradiol, the equilibrium pharmacokinetics of the drugs did not change.

The preparation Pregabalin Zentiva can enhance the action of ethanol and lorazepam. Reported cases of coma and respiratory failure in the background of simultaneous administration of pregabalin with other drugs that depress the central nervous system. Pregabalin can enhance cognitive and motor function disorders caused by oxycodone.

During postmarketing use, negative effects on intestinal peristalsis (including constipation, intestinal obstruction, paralytic ileus) were observed with the simultaneous use of pregabalin with constipation-inducing drugs, such as opioid analgesics.

Special instructions:

It was noted that treatment with pregabalin may lead to an increase in body weight. In this regard, patients with diabetes mellitus in case of weight gain need to review the treatment with hypoglycemic drugs and, if necessary, change their dose.

The combined use of Pregabalin Zentiva and hypoglycemic agents from the group of thiazolidinediones may increase the likelihood of peripheral edema and weight gain.

Treatment with Pregabalin Zentiva should be stopped immediately if an angioedema occurs (facial edema, perioral edema, or swelling of the upper respiratory tract).

Antiepileptic drugs, including Pregabalin Zentiva, may increase the risk of suicidal thoughts and behavior. Therefore, in order to avoid suicide, patients should be monitored. When suicidal thoughts and behavior appear, as well as the worsening of depression, patients or caregivers should immediately seek medical help.

Treatment with Pregabalin Zentiva may be accompanied by drowsiness and dizziness, which increases the risk of accidental injuries (due to falling) in the elderly. When pregabalin was used, cases of loss of consciousness, confusion, and violation of cognitive functions were noted.Therefore, patients should be careful until they evaluate the possible effects of the drug.

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 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 be informed to the doctor about the changes in vision at the foyer of therapy with Pregabalin Zentiva. 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 there appear in response to the use of Pregabalin Zentiva preparation of such undesirable reactions as loss of vision,blurred vision or other abnormalities on the part of the visual organ, cancellation of the drug may lead to the disappearance of these symptoms.

Information on the possibility of canceling other anticonvulsants with the cramping of seizures with Pregabalin Zentiva and the advisability of monotherapy with this drug are not enough. There are reports of the development of seizures, including epileptic status and minor seizures with pregabalin or immediately after therapy.

The discontinuation of taking pregabalin after a short or prolonged treatment was accompanied by withdrawal symptoms in some patients. The following symptoms were noted: insomnia, headache, nausea, anxiety, diarrhea, flu-like symptoms, nervousness, depression, discomfort, pain, cramps, excessive sweating and dizziness. Before starting treatment, all patients should be aware of the possibility of the appearance of the above symptoms.

No information was received on the incidence and severity of withdrawal symptoms, depending on the duration of treatment and the dose of pregabalin. However, as with all antiepileptic drugs, the symptoms of "cancellation" disappear not earlier than one week later.

During the use of pregabalin, the development of congestive heart failure was reported in some patients. These reactions were predominantly observed in elderly patients with impaired heart function who received the drug for neuropathy. Therefore, patients like Pregabalin Zentiva should be taken with caution. After the drug is discontinued, it is possible that such reactions disappear. Data on the use of pregabalin in patients with severe congestive heart failure have been insufficiently collected, and therefore Pregabalin Zentiva should be used with caution in these patients (see the side effect section).

During the treatment of central neuropathic pain caused by spinal cord injury, Pregabalin Zentiva increases the incidence of adverse events on the part of the central nervous system, especially drowsiness. This may be due to the intensification of the effect of other drugs (such as antispastic agents) that are used in parallel. This should be taken into account when prescribing Pregabalin Zentiva in connection with this indication.

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

There were reports of drug abuse. Patients with drug dependence in a history should be under close medical supervision for the timely detection of signs of abuse of pregabalin.

The preparation Pregabalin Zentiva contains lactose. Patients with such hereditary diseases as galactose intolerance, lactase deficiency of lobes (Saami) or impaired absorption of glucose-galactose, should not take this medication.

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

Pregabalin Zentiva may cause dizziness and drowsiness. Therefore, patients should not drive vehicles, work with complex mechanisms or engage in other potentially hazardous activities during treatment with Pregabalin Zentiva, until it becomes clear whether the drug affects the performance of similar tasks or not.

Form release / dosage:

Capsules, 50 mg, 75 mg, 150 mg, 300 mg.

Packaging:

7 capsules in a PVC / A blisterl or OPA / PVC / Al.

For 2 or 8 blisters are placed in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Shelf life:2 years.

Terms of leave from pharmacies:On prescription

Registration number:LP-002942

Date of registration:02.04.2015

Date of cancellation:2017-11-14

The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic

Manufacturer: & nbsp

ZENTIVA SAGLIK URUNLERI SANAYI VE TICARET, A.S. Turkey

Representation: & nbspZENTIVA PHARMA, LLCZENTIVA PHARMA, LLC

Information update date: & nbsp14.11.2017

Illustrated instructions

Instructions

Pregabalin Zentiva (Pregabalin Zentiva)