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

Excipients: lactose monohydrate (35 mg / 70 mg / 8.25 mg / 11 mg / 16.5 mg / 22 mg /33 mg), corn starch (20 mg / 40 mg / 8.375 mg / 11.17 mg / 16.75 mg / 22.33 mg / 33.5 mg), talc (20 mg / 40 mg / 8.375 mg / 11, 17 mg / 16.75 mg / 22.33 mg / 33.5 mg).

Capsule body composition: iron dye oxide red (for the dosage of 100 mg - 1.7361%, for the dosage of 200 mg - 0.4398%), titanium dioxide (2.4423% / 2.4423% / 2.4423% / 0.409% / 2.4423 % / 0.4144% / 2.4423%), gelatin (for all dosages up to 100%).

Composition of cap capsule: iron dye oxide red (only for dosages of 75 mg, 100 mg for 1.7361%, for a dosage of 200 mg for 0.4398%, for a dosage of 300 mg to 0.7361%),titanium dioxide (2.4423% / 2.4423% / 0.409% / 0.409% / 2.4423% / 0.4144% / 0.409%), gelatin (for all dosages up to 100%).

Composition of ink: shellac (24-27%), ethanol (23-26%), isopropanol (0.5-3%), butanol (0.5-3%), propylene glycol (3-7%), ammonia solution concentrated (1- 2%), potassium hydroxide (0.05-0.1%), purified water (15-18%), ferric oxide black oxide (24-28%).

Description:

Dosage of 25 mg: hard gelatin capsules No. 4 with a white lid and a white body. Black ink on the capsule body indicates the dosage and product code - PGN 25, on the lid - Pfizer.

For a dosage of 50 mg: hard gelatin capsules No. 3 with a white lid and a white body with a black stripe. Black ink on the capsule body indicates the dosage and product code - PGN 50, on the lid - Pfizer.

Dosage of 75 mg: hard gelatin capsules No. 4 with a lid of red-brown to dark red-brown color * and a white body. Black ink on the capsule body indicates the dosage and product code - PGN 75, on the lid - Pfizer.

Dosage of 100 mg: hard gelatin capsules No. 3 with lid from red-brown to dark-red-brown * and body from red-brown to dark-red-brown color *. Black ink on the capsule body indicates the dosage and product code - PGN 100, on the lid - Pfizer.

Dosage of 150 mg: Hard gelatin capsules No. 2 with a white lid and a white body. Black ink on the capsule body indicates the dosage and product code - PGN 150, on the lid - Pfizer.

Dosage 200 mg: hard gelatin capsules No. 1 with a lid from light reddish brown to reddish-brown * and a body from light reddish brown to reddish-brown *. Black ink on the capsule body indicates the dosage and product code - PGN 200, on the lid - Pfizer.

Dosage of 300 mg: hard gelatin capsules No. 0 with lid from red-brown to dark-red-brown * and white body. Black ink on the capsule body indicates the dosage and product code - PGN 300, on the lid - Pfizer. The contents of capsules are white or almost white powder.

Note: * In the original manufacturer's certificates, these colors are described as: "from red-brown to dark-red-brown" - "orange";" from light red-brown to red-brown "-"light orange", which corresponds to the color of the comparison pontoons used in the European Union in carrying out this type of analysis.

Pharmacotherapeutic group:Antiepileptic remedy

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

It was found that pregabalinum binds to an additional subunit (α2-delta- protein) potential-dependent calcium channels in the central nervous system (CNS), 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 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 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 placebo had a 50% reduction in the Hamilton anxiety symptom score (NAM-A).

In clinical trials in patients who have been pregabalinum, adverse reactions on the part of the visual organ (such as blurred vision, reduced 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").

Pharmacokinetics:

Parameters of pharmacokinetics of pregabalin in equilibrium in healthy volunteers, in patients with epilepsy, who received antiepileptic therapy, and in patients who received 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 pregabalin when ingested is ≥ 90% and does not depend on the dose. At repeated application 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 (t_mOh) 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 unchanged form.

The average half-life is 6.3 hours. The clearance of pregabalin from the plasma and the renal clearance are directly proportional to the creatinine clearance (see Fig."Renal function disorder"). 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.

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 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.section "Method of administration and dose" tab. 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 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:

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. Concerning pregabalinum can be used during pregnancy only in that 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.

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. You should stop breastfeeding or cancel pregabalin therapy, taking into account the need for therapy for the mother and breastfeeding for the newborn.

Fertility

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

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 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 daily (450 mg / day) 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

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 after 7 days, increase the dose to 450 mg / day, and if necessary, after 7 days - to a maximum dose of 600 mg / day.

The need to continue therapy should be regularly assessed.

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:

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

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

Clearance creatinine, 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 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 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 because of adverse reactions was 14 and 7%, respectively. The main undesirable effects that required cessation of treatment were dizziness (4%) and drowsiness (3%), depending on their subjective tolerance. 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.

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 the system-standard classes (SOK). The frequency of occurrence of these undesirable reactions was determined by the number of adverse events in the array of clinical trials regardless of the cause-effect relationship assessment: very frequent (≥ 1/10), frequent (≥ 1/100, <1/10), infrequent (≥ 1 / 1,000, <1/100) and rare (<1 / 1,000). The reactions observed during the post-marketing use of the preparation are indicated in italics.

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

System-Organ Class	Undesirable reactions
Infections and invasions
Frequent	Nasopharyngitis
Blood and lymphatic system
Infrequent	Neutropenia
Metabolic and nutritional disorders
Frequent	Increased appetite
Infrequent	Anorexia, hypoglycemia
Mental disorders
Frequent	Euphoria, confusion, insomnia, irritability, depression, disorientation, decreased libido, panic attack, apathy
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 coordination, tremor, dysarthria, amnesia, memory impairment, attention impairment, paresthesia, hypesthesia, sedation, imbalance, lethargy, agevia
Infrequent	Fainting conditions, myoclonia, psychomotor agitation, dyskinesia, orthostatic dizziness, intentional tremor, nystagmus, speech impairment, decreased reflexes, burning sensation on the skin and mucous membranes, hyperesthesia, loss of consciousness, cognitive impairment
Rare	Pathological stupor, parosmia, hypokinesia, 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 lacrimation, irritation of the eye mucosa
Rare	Oscilloscopy (vibration of visible objects), 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 block 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	A feeling of restraint in the throat, pulmonary edema
From the digestive system
Frequent	Vomiting, constipation, flatulence, bloating, dry mouth, nausea, diarrhea
Infrequent	Gastroesophageal reflux, hypersecretion of the salivary glands,decreased sensitivity of the oral mucosa
Rare	Ascites, pancreatitis, dysphagia, swelling of the tongue
From the skin and subcutaneous tissues
Infrequent	Papular rash, hives. increased sweating, face swelling, itchy skin
Rare	Syndrome Stevens-Johnson. cold sweat
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	Urinary incontinence, dysuria
Rare	Renal failure, oliguria, retention of urine
From the side of the reproductive system
Frequent	Pain in the mammary gland, erectile dysfunction
Infrequent	Sexual dysfunction, delayed ejaculation, dysmenorrhea
Rare	Amenorrhea, discharge from the mammary glands, enlargement of mammary glands, gynecomastia
General disorders and disorders at the site of administration
Frequent	Peripheral edema, gait disturbance, falling, feeling of intoxication, poor state of health, fatigue
Infrequent	Generalized edema, chest tightness, pain, fever, thirst, chills, general weakness, malaise
Laboratory and instrumental data
Frequent	An increase in body weight, an increase in the concentration of creatinine in the blood
Infrequent	Increase in activity of creatine phosphokinase, alanine aminotransferase, aspartate aminotransferase, increase in blood glucose concentration, decrease in platelet count, decrease in potassium in the blood, decrease in body weight
Rare	Reducing the number of leukocytes in the blood
Immune system disorders
Infrequent	Hypersensitivity reactions
Rare	Angioedema, allergic reactions

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 were reported. There were also cramps.

Treatment: 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 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 to 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 ethinylestradiol

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 were 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 when used in elderly patients

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

Special instructions:

Patients with diabetes mellitus

A 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 angioneurotic edema (such as, facial edema, perioral edema or swelling of the tissues of the upper respiratory tract).

Suicidal thoughts and behavior

Antiepileptic 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 elderly patients and 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.In the course of post-marketing use of the drug, 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 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 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 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 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 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 responsible for the development of drug abuse in patients. During post-registration studies, cases of a violation of the recommended dosing regimen or abuse of pregabalin were noted. As with any drug that affects the central nervous system, it is necessary to carefully assess the patient's medical history for existing cases of abuse of drugs, as well as to observe the patient in connection with violations of the recommended dosing regimen, or the abuse of pregabalin (such as the development of resistance to therapy pregabalin, unjustified increase in the dose of the drug, addictive behavior of the patient).

Congestive heart failure

Despite the fact that the apparent correlation with the concentration of pregabalin in plasma and development of heart failure were observed during post-marketing use of drugs has been reported about the development of congestive heart failure during therapy with pregabalin, some patients.In patients without clinically significant signs of heart or vascular disease, 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 with cardiac impairment and who received the 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 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.

Encephalopathy

There were cases of encephalopathy, especially in patients with concomitant diseases,which can lead to the development of this state.

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 complex 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, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg or 300 mg.

Packaging:

For 10, 14 or 21 capsules in a blister of polyvinyl chloride and aluminum foil.

1 or 4 blisters for 14 capsules, 4 blisters for 21 capsules or 10 blisters for 10 capsules in a cardboard box with the first opening control along with instructions for 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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001752

Date of registration:20.07.2011

Expiration Date:Unlimited

The owner of the registration certificate: Pfizer Inc. Pfizer Inc. USA

Manufacturer: & nbsp

PFIZER MANUFACTURING DEUTSCHLAND, GmbH Germany

Representation: & nbspPfizer LtdPfizer LtdUSA

Information update date: & nbsp11.04.2018

Illustrated instructions

Instructions

Lyrics® (Lyrica®)