Instructions Pregadol capsules 150 mg blister No. 30
Composition
active ingredient: pregabalin;
1 capsule contains pregabalin 150 mg;
excipients: corn starch, talc.
Composition of the 150 mg capsule shell: gelatin, titanium dioxide (E171).
Dosage form
Capsules.
Main physicochemical properties: hard opaque gelatin capsules with a white cap and body. The contents of the capsules are white or almost white powder.
Pharmacotherapeutic group
Antiepileptic drugs. ATX code N03A X16.
Pharmacological properties
Pharmacodynamics
The active substance pregabalin is an analogue of gamma-aminobutyric acid [(S)-3-(aminomethyl)-
5-methylhexanoic acid)].
The mechanism of action of pregabalin is to bind to the auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system (CNS).
Clinical efficacy and safety.
– Neuropathic pain.
Studies have shown that the drug is effective in treating diabetic neuropathy, postherpetic neuralgia, and spinal cord injury. The drug's effectiveness in other types of neuropathic pain has not been studied.
Pregabalin has been studied in 10 controlled clinical trials of up to 13 weeks duration with a twice-daily dosing regimen and in 8-week trials with a three-times-daily dosing regimen. Overall, the safety profile and efficacy of both regimens were similar.
In clinical studies of up to 12 weeks duration, when pregabalin was used to treat neuropathic pain in peripheral and central nervous system lesions, pain reduction was observed after the first week and was maintained throughout the treatment period.
In controlled clinical trials of peripheral neuropathic pain, 35% of patients treated with pregabalin and 18% of patients in the placebo group had a 50% improvement in pain scores. Among patients who did not experience somnolence, this improvement was observed in 33% of patients in the pregabalin group and 18% of patients in the placebo group. Among patients who experienced somnolence, the number of patients who responded to treatment was 48% in the pregabalin group and 16% in the placebo group.
In controlled clinical trials in central neuropathic pain, 22% of patients treated with pregabalin and 7% of patients in the placebo group had a 50% improvement in pain scores.
– Epilepsy.
Additional treatment.
Pregabalin has been studied in 3 controlled clinical trials of 12 weeks duration with twice- or three-times-daily dosing. Overall, the safety profile and efficacy were similar for the twice- and three-times-daily dosing regimens.
A reduction in seizure frequency was observed in the first week.
Monotherapy (for patients with newly diagnosed disease).
Pregabalin was studied in 1 controlled clinical trial of 56 weeks duration with a twice-daily regimen. Pregabalin did not achieve greater efficacy compared to lamotrigine as assessed at 6 months for the seizure-free endpoint. Pregabalin and lamotrigine were equally safe and well tolerated.
– Generalized anxiety disorder.
Pregabalin has been studied in 6 controlled trials of 4-6 weeks duration, one 8-week study in elderly patients, and one long-term relapse prevention study with a 6-month double-blind phase.
Relief of symptoms of generalized anxiety disorder according to the Hamilton Anxiety Rating Scale (HAM-A) was observed in the first week.
In controlled clinical trials (4-8 weeks duration), 52% of patients treated with pregabalin and 38% of patients in the placebo group had at least a 50% improvement in the total HAM-A score from baseline to endpoint.
In controlled trials, blurred vision was reported more frequently in patients treated with pregabalin than in patients treated with placebo. In most cases, this phenomenon resolved with continued use of the drug. Ophthalmological examinations (including visual acuity testing, formal visual field testing, and dilated fundus examination) were performed in over 3600 patients in controlled clinical trials. Among these patients, visual acuity deteriorated
in 6.5% of patients treated with pregabalin and 4.8% of patients in the placebo group. Visual field changes were observed in 12.4% of patients treated with pregabalin and 11.7% of patients in the placebo group. Fundus changes were observed in 1.7% of patients treated with pregabalin and 2.1% of patients in the placebo group.
Pregabalin monotherapy has been studied in 5 placebo-controlled studies: 3 fixed-dose studies of 12 weeks duration, 1 fixed-dose study of 7 weeks duration, and 1 6-month long-term efficacy study. In all fixed-dose studies, pregabalin (300-600 mg/day twice daily) provided significant reductions in fibromyalgia-related pain. In the three 12-week fixed-dose studies, 40% of patients in the pregabalin group had a 30% improvement in pain score compared with 28% of patients in the placebo group; 23% of patients in the pregabalin group had a 50% improvement in pain score compared with 15% in the placebo group.
Pregabalin provided significantly better scores on the Patient Global Impression of Change (PGIC) scale in three 12-week fixed-dose studies compared with placebo (41% of patients in the pregabalin group felt much better or much improved compared with 29% in the placebo group). According to the Fibromyalgia Impact Questionnaire (FIQ), pregabalin provided statistically significant improvements in function compared with placebo in two of the three fixed-dose studies in which this measure was assessed. Pregabalin provided significant improvements in sleep in four fixed-dose studies, as measured by the MOS-SS (Medical Sleep Survey Scale) sleep disturbance subscale, the MOS-SS total sleep problems index, and the sleep quality diary.
During the 6-month pain reduction study, improvements in global assessment (PGIC), functioning (FIQ total score), and sleep (MOS-SS sleep disturbance subscale) were noted, which were maintained for much longer in patients in the pregabalin group than in patients in the placebo group.
Patients taking 600 mg of pregabalin per day experienced additional improvements in sleep compared with those taking 300 and 450 mg/day; mean effects on pain, global score, and FIQ were similar to those with 450 and 600 mg of pregabalin per day, although the 600 mg/day dose was slightly less well tolerated.
Pharmacokinetics
The steady-state pharmacokinetics of pregabalin were similar in healthy volunteers, patients with epilepsy taking antiepileptic drugs, and patients with chronic pain.
Absorption.
Pregabalin is rapidly absorbed in the fasting state and reaches peak plasma concentrations within 1 hour after single and multiple dosing. The estimated oral bioavailability of pregabalin is greater than 90% and is independent of dose. After multiple dosing, steady state is reached within 24–48 hours. The rate of absorption of pregabalin is reduced when taken with food, resulting in a decrease in maximum concentration (Cmax) by approximately 25–30% and a delay in tmax by approximately 2.5 hours. However, taking pregabalin with food had no clinically significant effect on the extent of its absorption.
Distribution.
Preclinical studies have shown that pregabalin crosses the blood-brain barrier in animals. Pregabalin also crosses the placenta in animals and is excreted in the milk of lactating animals. In humans, the apparent volume of distribution of pregabalin after oral administration is approximately 0.56 L/kg. Pregabalin is not bound to plasma proteins.
Metabolism.
Pregabalin undergoes minimal metabolism in humans. After administration of a dose of radiolabeled pregabalin, approximately 98% of the radioactivity is excreted in the urine as unchanged pregabalin. The N-methylated derivative of pregabalin, the major metabolite of the drug, was detected in the urine and accounted for 0.9% of the administered dose. In preclinical studies, there was no racemization of the S-enantiomer of pregabalin to the R-enantiomer.
Breeding.
Pregabalin is eliminated from the systemic circulation unchanged primarily by renal excretion. The mean elimination half-life of pregabalin is 6.3 hours. The plasma and renal clearance of pregabalin are directly proportional to creatinine clearance (see section "Pharmacokinetics. Renal impairment").
For patients with impaired renal function and patients on hemodialysis, the dose of the drug must be adjusted (see section "Method of administration and dosage", table 1).
Linearity/non-linearity.
The pharmacokinetics of pregabalin are linear over the recommended dose range. The inter-patient variability in the pharmacokinetics of pregabalin is low (less than 20%). The pharmacokinetics of multiple doses are predictable based on single-dose data. Therefore, routine monitoring of pregabalin plasma concentrations is not required.
Sex.
The results of clinical studies indicate that there is no clinically significant effect of gender on the concentration of pregabalin in blood plasma.
Kidney failure.
Pregabalin clearance is directly proportional to creatinine clearance. In addition, pregabalin is effectively removed from plasma by hemodialysis (after 4 hours of hemodialysis, the concentration of pregabalin in the blood plasma decreases by approximately 50%). Since renal excretion is the main route of drug elimination, patients with renal insufficiency should reduce the dose of the drug, and after hemodialysis - take an additional dose (see section "Method of administration and dosage", Table 1).
Specific pharmacokinetic studies in patients with hepatic impairment have not been conducted. Since pregabalin does not undergo significant metabolism and is excreted primarily unchanged in the urine, it is unlikely that hepatic impairment will significantly affect pregabalin plasma concentrations.
Indication
Neuropathic pain.
The drug Pregadol is prescribed for the treatment of neuropathic pain in adults with damage to the peripheral and central nervous system.
Epilepsy.
Pregadol is prescribed as an adjunctive therapy for partial seizures with or without secondary generalization in adults.
Generalized anxiety disorder.
The drug Pregadol is prescribed for the treatment of generalized anxiety disorder in adults.
Fibromyalgia.
Contraindication
Hypersensitivity to the active substance or any of the excipients. Children's age.
Interaction with other medicinal products and other types of interactions
Pregabalin is mainly excreted unchanged in the urine, undergoes little metabolism in humans (less than 2% of the dose is excreted in the urine as metabolites), does not inhibit the metabolism of other drugs in vitro, and does not bind to plasma proteins, so it is unlikely that pregabalin can cause or be the subject of pharmacokinetic interactions.
In vivo studies and population pharmacokinetic analysis.
In vivo studies have not shown any clinically significant pharmacokinetic interactions between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone and ethanol. Population pharmacokinetic analysis has shown that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate have no clinically significant effect on the clearance of pregabalin.
Oral contraceptives, norethisterone and/or ethinyl estradiol.
Co-administration of pregabalin with oral contraceptives, norethisterone and/or ethinyl estradiol did not affect the steady-state pharmacokinetics of either drug.
Drugs that affect the CNS.
Pregabalin may potentiate the effects of ethanol and lorazepam. In controlled clinical trials, co-administration of multiple oral doses of pregabalin with oxycodone, lorazepam, or ethanol did not cause clinically significant effects on respiratory function. Respiratory failure and coma have been reported in post-marketing experience in patients taking pregabalin with other CNS depressants. Pregabalin is likely to potentiate the cognitive and gross motor impairments associated with oxycodone.
Elderly patients.
Specific pharmacodynamic interaction studies have not been conducted in elderly volunteers. Interaction studies have only been conducted in adults.
Application features
Patients with diabetes.
Some patients with diabetes who gain weight while taking pregabalin may require dose adjustment of hypoglycemic drugs.
Hypersensitivity reactions.
Hypersensitivity reactions, including angioedema, have been reported in post-marketing experience. If symptoms of angioedema such as facial edema, perioral edema, or upper airway edema occur, pregabalin should be discontinued immediately.
Dizziness, drowsiness, loss of consciousness, confusion and mental disorders.
Pregabalin has been associated with dizziness and drowsiness, which may increase the risk of falls in elderly patients. Rare cases of loss of consciousness or confusion, and mental disorders have been reported. Therefore, patients should exercise caution until they are aware of the potential effects of the drug.
Vision disorders.
In controlled studies, blurred vision was more frequently observed in patients treated with pregabalin compared to patients treated with placebo. In most cases, this phenomenon resolved with continued use of the drug. In clinical studies in which ophthalmological examinations were performed, the incidence of visual acuity deterioration and visual field changes was higher in patients treated with pregabalin compared to patients in the placebo group; the incidence of fundus changes was higher in patients in the placebo group (see section "Pharmacological properties. Pharmacodynamics").
Post-marketing reports of visual adverse reactions, including vision loss, blurred vision, or other changes in visual acuity, many of which were transient, have also been reported. Discontinuation of pregabalin may resolve or reduce these symptoms.
Kidney failure.
Cases of renal failure have been reported. This effect was sometimes reversible after discontinuation of pregabalin.
Withdrawal of concomitant antiepileptic medications.
Data on the withdrawal of concomitant antiepileptic drugs after seizure control is achieved with the addition of pregabalin are insufficient to switch to pregabalin monotherapy.
Some patients have experienced withdrawal symptoms after discontinuation of short- or long-term pregabalin treatment. Insomnia, headache, nausea, anxiety, diarrhea, flu-like syndrome, nervousness, depression, pain, seizures, hyperhidrosis, and dizziness have been reported, indicating the development of physical dependence. This information should be communicated to the patient before starting treatment.
Convulsions, including status epilepticus and grand mal seizures, may occur during treatment with pregabalin or shortly after discontinuation of its use.
Regarding discontinuation of long-term pregabalin treatment—there are no data on the incidence and severity of withdrawal symptoms related to the duration of pregabalin use and its dose.
Congestive heart failure.
Congestive heart failure has been reported in some patients taking pregabalin in the post-marketing setting. This reaction has been observed primarily in the treatment of neuropathic pain in elderly patients with cardiovascular disease. Pregabalin should be used with caution in such patients. This phenomenon may resolve after discontinuation of pregabalin.
Treatment of neuropathic pain of central origin due to spinal cord injury.
In the treatment of central neuropathic pain due to spinal cord injury, the incidence of adverse reactions in general, adverse reactions from the central nervous system and especially drowsiness was increased. This may be due to the additive effect of concomitant medicinal products (e.g. antispasticity agents) required for the treatment of this condition. These data should be taken into account when prescribing pregabalin to such patients.
Suicidal thinking and behavior.
Suicidal ideation and behavior have been reported in patients treated with antiepileptic drugs for certain indications. A meta-analysis of randomized, placebo-controlled trials of antiepileptic drugs showed a small increased risk of suicidal ideation and behavior. The mechanism of this risk is unknown, and the available data do not exclude its existence with pregabalin.
Therefore, patients should be closely monitored for signs of suicidal thinking and behavior and treated appropriately if they develop. Patients (and caregivers of patients) should be advised to seek medical advice if signs of suicidal thinking or behavior appear.
Deterioration of the function of the lower gastrointestinal tract.
Post-marketing reports of lower gastrointestinal events (intestinal obstruction, paralytic ileus, constipation) have been reported following co-administration of pregabalin with medicinal products that may cause constipation, such as opioid analgesics. Precautions should be taken to prevent constipation when pregabalin is co-administered with opioids (especially in women and the elderly).
Addictive potential.
Cases of misuse, abuse and dependence have been reported. Caution should be exercised when prescribing the drug to patients with a history of drug dependence. Patients should be monitored for signs of misuse, abuse or dependence (development of tolerance, dose escalation, drug seeking).
Encephalopathy.
Encephalopathy occurred predominantly in patients with comorbidities that could cause encephalopathy.
Elderly patients (over 65 years of age).
Pregabalin clearance tends to decrease with age. This decrease in oral pregabalin clearance is consistent with the age-related decrease in creatinine clearance. Patients with age-related renal impairment may require a reduced dose of pregabalin (see Dosage and Administration, Table 1). Elderly patients may be more likely to experience adverse reactions such as dizziness, confusion, tremor, incoordination, and lethargy.
Ability to influence reaction speed when driving vehicles or other mechanisms
Pregadol may have minor or moderate influence on the ability to drive and use machines. The drug may cause dizziness and drowsiness and may affect the ability to drive and use machines. Therefore, patients should be advised to refrain from driving, operating complex machinery, or other potentially hazardous activities until it is known whether this drug affects their ability to perform such work.
Use during pregnancy or breastfeeding
Women of reproductive age/contraceptives for women and men.
Since the potential risk to humans is unknown, women of childbearing potential should use effective contraception.
Pregnancy.
There are no reliable data on the use of pregabalin in pregnant women.
Pregadol should not be used during pregnancy, except in exceptional cases when the expected therapeutic benefit to the pregnant woman clearly outweighs the potential risk to the fetus.
Breast-feeding.
It is not known whether pregabalin is excreted in human milk. However, pregabalin has been detected in animal milk. Therefore, breast-feeding is not recommended during treatment with pregabalin.
Reproductive function.
There are no clinical data on the effects of pregabalin on female reproductive function.
In a clinical study of the effects of pregabalin on sperm motility, healthy male volunteers received a dose of pregabalin 600 mg per day. After 3 months of treatment, no effect on sperm motility was observed.
Fertility studies have shown adverse effects on female reproductive function and adverse effects on male reproductive function and development. The clinical relevance of these findings is unknown.
Method of administration and doses
Pregabalin is prescribed in a dose of 150-600 mg/day, divided into 2 or 3 doses. The drug can be taken regardless of meals. Pregadol is intended for oral use only.
Neuropathic pain.
Pregabalin treatment should be initiated at a dose of 150 mg per day, divided into 2 or 3 doses. Depending on the efficacy and individual tolerability of the drug, the dose can be increased to 300 mg per day after 3-7 days, and if necessary, to the maximum daily dose of 600 mg per day after another 7 days.
Epilepsy.
Pregabalin treatment can be started at a dose of 150 mg per day, divided into 2 or 3 doses. Depending on the effectiveness and individual tolerability of the drug, the dose can be increased to 300 mg per day after the first week of treatment. After another week, the dose can be increased to a maximum of 600 mg per day.
Generalized anxiety disorder.
The dose, divided into 2 or 3 doses, may vary between 150 and 600 mg per day. The need for continued treatment should be reassessed periodically.
Pregabalin treatment can be started at a dose of 150 mg per day. Depending on the effectiveness and individual tolerability of the drug, the dose can be increased to 300 mg per day after the first week of treatment. After another week of taking pregabalin, the dose can be increased to 450 mg per day. After another week, the dose can be increased to a maximum of 600 mg per day.
Discontinuation of pregabalin treatment.
In accordance with current clinical practice, it is recommended to discontinue pregabalin treatment gradually, over a period of at least one week, regardless of the indication (see sections “Special precautions” and “Adverse reactions”).
Patients with renal failure.
Pregabalin is eliminated from the systemic circulation unchanged primarily by renal excretion. Since pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction for patients with renal impairment should be individualized according to creatinine clearance (CLcr).
Pregabalin is effectively removed from plasma by haemodialysis (50% of the drug within 4 hours). For patients on haemodialysis, the daily dose of pregabalin should be adjusted according to renal function. In addition to the daily dose, an additional dose of the drug should be administered immediately after each 4-hour haemodialysis session (see Table 1).
Table 1. Pregabalin dose adjustment according to renal function
| Creatinine clearance (CLcr) (mL/min) | Total daily dose of pregabalin * | Application mode | |
| Starting dose (mg/day) | Maximum dose (mg/day) | | |
| ≥ 60 | 150 | 600 | Twice or three times a day |
| ≥ 30—< 60 | 75 | 300 | |
| ≥ 15—< 30 | 25-50** | 150 | Once or twice a day |
| < 15 | 25** | 75 | Once a day |
| Additional dose after hemodialysis (mg) | | | |
| 25** | 100** | One-time |
* The total daily dose (mg/day) should be divided by the number of doses according to the regimen to obtain the required dose (mg).
** Pregabalin should be used in the appropriate dosage form.
Fibromyalgia.
Usually, a dose of 300-450 mg per day should be used, divided into 2 or 3 doses. For some patients, an increase in the dose to 600 mg per day may be necessary. The drug should be started with a dose of 75 mg 2 times a day (150 mg/day), which can be increased depending on the effectiveness and individual tolerability of the drug to 150 mg 2 times a day (300 mg/day) within one week. For patients for whom the dosage of 300 mg/day is not effective enough, the dose can be increased to 225 mg 2 times a day (450 mg/day). If necessary, the dose can be increased after another 7 days to the maximum - 600 mg per day.
Patients with liver failure.
No dose adjustment is necessary for patients with hepatic insufficiency (see section "Pharmacokinetics").
Use in elderly patients (over 65 years of age).
Elderly patients may require a reduction in the dose of pregabalin due to decreased renal function (see section 4.4).
Children
The safety and efficacy of pregabalin in children (under 18 years of age) have not been established. Use in children is not recommended.
Overdose
The most common adverse reactions in case of pregabalin overdose were drowsiness, confusion, agitation and restlessness. Coma has been reported rarely.
Treatment of pregabalin overdose consists of general supportive measures and may include haemodialysis if necessary (see section 4.2, Table 1).
Adverse reactions
The most common adverse reactions were dizziness and drowsiness. Adverse reactions were usually mild or moderate.
In all controlled trials, the rate of discontinuation due to adverse reactions was 12% in patients treated with pregabalin and 5% in patients treated with placebo. The most common adverse reactions leading to withdrawal from the pregabalin group were dizziness and somnolence.
Table 2 lists all adverse reactions that occurred more frequently than placebo and in more than one patient; these adverse reactions are presented by class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (< 1/10,000), frequency unknown (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
These adverse reactions may also be related to the course of the underlying disease and/or concomitant use of other medications.
During the treatment of central neuropathic pain due to spinal cord injury, the incidence of adverse reactions in general, CNS adverse reactions and especially drowsiness was increased (see section "Special warnings and precautions for use").
Additional adverse reactions reported since pregabalin was marketed are indicated in italics in the “Frequency unknown” column.
Infections and infestations
Uncommon: Nasopharyngitis
Blood and lymphatic system disorders
Uncommon: Neutropenia
On the part of the immune system
Frequency unknown: hypersensitivity reactions, angioedema, allergic reaction
Metabolic disorders
Common: Increased appetite
Uncommon: Loss of appetite, hypoglycaemia
From the psyche
Common: Euphoric mood, confusion, irritability, decreased libido, disorientation, insomnia
Uncommon: Hallucinations, panic attacks, agitation, restlessness, depression, depressed mood, mood swings, depersonalization, difficulty in word selection, abnormal dreams, increased libido, anorgasmia, apathy
Single: Disinhibition, elation
Frequency unknown: Aggression
From the nervous system
Very common: Dizziness, drowsiness
Common: Ataxia, coordination abnormal, tremor, dysarthria, memory impairment, disturbance in attention, paraesthesia, sedation, balance disorder, lethargy, headache
Uncommon: Loss of consciousness, stupor, myoclonus, psychomotor hyperactivity, ageusia, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive impairment, speech disorder, hyporeflexia, hypoaesthesia, amnesia, hyperaesthesia, burning sensation, paraoral paraesthesia, myoclonus, hypalgesia
From the organs of vision
Common: Blurred vision, diplopia, conjunctivitis
Uncommon: Visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, dry eye, lacrimation increased, accommodation disorder, blepharitis, intraocular hemorrhage, photosensitivity, retinal edema
Rare: Peripheral vision loss, oscillopsia, altered visual depth perception, photopsia, eye irritation, mydriasis, strabismus, visual acuity reduced, anisocoria, corneal ulcer, exophthalmos, ocular muscle paralysis, iritis, keratoconjunctivitis, miosis, night blindness, ophthalmoplegia, optic nerve atrophy, optic disc edema, ptosis, uveitis
Frequency unknown: Vision loss, keratitis
From the side of the organs of hearing and vestibular apparatus
Frequent Vertigo
Uncommon Hyperacusis
Cardiovascular system
Uncommon Tachycardia, atrioventricular block first degree, hot flushes, hypotension, hypertension
Sinus tachycardia, sinus bradycardia, sinus arrhythmia, feeling cold in the extremities
Frequency unknown Congestive heart failure, QT prolongation
Respiratory, thoracic and mediastinal disorders
Uncommon Dyspnoea, nasal dryness
Uncommon Epistaxis, throat tightness, cough, nasal congestion, rhinitis, snoring, laryngospasm, pharyngolaryngeal pain, apnea, atelectasis, bronchiolitis, hiccups, pulmonary fibrosis, yawning
Frequency unknown Pulmonary edema
Gastrointestinal tract
Common Vomiting, dry mouth, constipation, flatulence, gastroenteritis
Uncommon Abdominal distension, gastroesophageal reflux disease, salivation hypersecretion, oral hypoaesthesia, cholecystitis, cholelithiasis, colitis, gastrointestinal haemorrhage, melena, tongue oedema, rectal haemorrhage
Uncommon Ascites, pancreatitis, dysphagia, aphthous stomatitis, esophageal ulcer, periodontal abscesses
Frequency unknown Swollen tongue, diarrhea, nausea
Skin and subcutaneous tissue disorders
Rare Urticaria, cold sweat, exfoliative dermatitis, lichenoid dermatitis, melanosis, nail disorder, petechial rash, purpura, pustular rash, skin atrophy, skin necrosis, cutaneous and subcutaneous nodules
Frequency unknown Stevens-Johnson syndrome, pruritus
Musculoskeletal and connective tissue disorders
Uncommon Muscle twitching, joint swelling, muscle cramps, myalgia, arthralgia, back pain, pain in extremity, muscle rigidity
Uncommon Rhabdomyolysis, cervical spasm, neck pain
From the urinary system
Uncommon Urinary incontinence, dysuria, albuminuria, haematuria, renal calculi, nephritis
Rare Renal failure, oliguria, acute renal failure, glomerulonephritis, pyelonephritis
Frequency not known Urinary retention
Reproductive system and breast disorders
Common Erectile dysfunction, impotence
Uncommon Ejaculation delay, sexual dysfunction, leukorrhea, menorrhagia, metrorrhagia
Uncommon Amenorrhea, breast discharge, breast pain, dysmenorrhea, breast enlargement, cervicitis, balanitis, epididymitis
Frequency unknown Gynecomastia
General disorders and administration site conditions
Common Gait disturbance, feeling drunk, fatigue, peripheral oedema, oedema
Uncommon Fall, chest tightness, general weakness, thirst, pain, malaise, chills, abscess, cellulitis, photosensitivity reaction
Uncommon Generalised oedema, fever, anaphylactoid reactions, granuloma, intentional harm, retroperitoneal fibrosis, shock
Frequency not known Facial swelling
Research
Common Weight gain
Uncommon Blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased.
Rare: Increased blood glucose levels, decreased blood potassium levels, decreased blood leukocyte levels, increased blood creatinine levels, decreased body weight.
Some patients have experienced withdrawal symptoms after discontinuation of short- or long-term pregabalin treatment. Insomnia, headache, nausea, anxiety, diarrhea, flu-like syndrome, nervousness, depression, pain, seizures, hyperhidrosis, and dizziness have been reported, indicating the development of physical dependence. This information should be communicated to the patient before starting treatment.
Regarding discontinuation of long-term pregabalin treatment, there are no data on the incidence and severity of withdrawal symptoms related to the duration of pregabalin use and its dose.
Expiration date
2 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 capsules in a blister, 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Location of the manufacturer and its business address
Ukraine, 03134, Kyiv, Myru St., 17.
