You watched
Dear buyers! Unfortunately, we are currently unable to accept the application to Canada and are revoking the license. Keep an eye on the site to see if there are any updates from Canada.
Catalog
Client
Currency:
Contacts
Our location:
Ternopil city
Contacts
E-mail
We are on social networks
Go to contacts
0 0
Catalog
Main page
Viewed
20
Wishlist
0
Compare
0
Contacts

Meditan capsules 300 mg blister No. 30

Brand: АТ «Фармак» SKU: an-45761
0
All about product
Description
Specification
Reviews 0
Questions0
new
Meditan capsules 300 mg blister No. 30
Meditan capsules 300 mg blister No. 30
Meditan capsules 300 mg blister No. 30
Meditan capsules 300 mg blister No. 30
Meditan capsules 300 mg blister No. 30
Meditan capsules 300 mg blister No. 30
In Stock
454.90 грн.
Active ingredient:Gabapentin
Adults:Can
ATC code:N AGENTS ACTING ON THE NERVOUS SYSTEM; N03 ANTIEPILEPTIC AGENTS; N03A ANTIEPILEPTIC AGENTS; N03A X Other antiepileptic drugs; N03A X12 Gabapentin
Country of manufacture:Ukraine
Diabetics:With caution
Delivery
USPS across the USA USPS across the USA
Canada Post across Canada Canada Post across Canada
Payment
Meditan capsules 300 mg blister No. 30
454.90 грн.
Description

Instructions Meditan capsules 300 mg blister No. 30

Composition

active ingredient: gabapentin;

1 capsule contains gabapentin calculated as 100% anhydrous substance 300 mg;

excipients: anhydrous lactose, corn starch, talc.

Dosage form

Capsules.

Main physicochemical properties:

300 mg capsules: hard gelatin capsules No. 1 or No. 0; capsule body and cap are dull yellow; capsule contents are a white or almost white powdery mixture.

Pharmacotherapeutic group

Other antiepileptic drugs. ATX code N03A X12.

Pharmacological properties

Pharmacodynamics.

The exact mechanism of action of gabapentin is unknown.

Gabapentin is structurally similar to the neurotransmitter GABA (gamma-aminobutyric acid), but its mechanism of action differs from that of other agents that interact with GABA receptors, such as valproate, barbiturates, benzodiazepines, GABA transferase inhibitors, GABA reuptake inhibitors, GABA agonists, and GABA precursors. In vitro studies with radioactive gabapentin in rat brain tissue, including the neocortex and hippocampus, have identified a novel peptide-binding fragment that may be responsible for the anticonvulsant and analgesic activity of gabapentin and its structural derivatives. The binding site of gabapentin is the alpha-2-delta subunit of voltage-gated calcium channels.

Gabapentin at therapeutic concentrations does not bind to receptors for other common drugs or brain neurotransmitter receptors, including GABAA, GABAB, benzodiazepine, glutamate, glycine, or N-methyl-D-aspartate receptors.

Gabapentin did not interact with sodium channels in vitro, in contrast to phenytoin and carbamazepine. In some in vitro test systems, gabapentin partially reduced the effects of the glutamate agonist N-methyl-D-aspartate (NMDA). This was achieved only at drug concentrations greater than 100 μM, which is not possible in vivo. Gabapentin slightly reduces the release of monoamine neurotransmitters in vitro. Gabapentin increases GABA turnover in some areas of the rat brain; a similar effect has been described for sodium valproate, but for other brain regions. The significance of these effects of gabapentin in relation to anticonvulsant activity has not yet been established. In animals, gabapentin crossed the blood-brain barrier and prevented maximally tolerated seizures induced by electric shock, as well as seizures induced by chemical convulsants, including GABA synthesis inhibitors, and seizures caused by genetic factors.

Clinical trials of adjunctive therapy for partial onset seizures in children aged 3 to 12 years showed a numerically greater but not statistically significant difference in the 50% response rate in favor of gabapentin compared with placebo. Additional post-hoc analyses of responder rates by age showed no significant effect of age using either continuous or binary variables (age groups 3–5 years and 6–12 years). The results of this analysis are presented in Table 1.

Table 1

Response rates (≥50% improvement) by treatment category and age group. MITT* population.
Age group Placebo Gabapentin P-value
< 6 years 4/21 (19.0%) 4/17 (23.5%) 0.7362
6–12 years 17/99 (17.2%) 20/96 (20.8%) 0.5144

* The MITT (modified population of patients who took at least one dose of a drug) includes all patients randomized to the study who were able to complete seizure diaries to a sufficient degree for assessment for 28 days during the baseline and double-blind phases.

Pharmacokinetics.

Absorption.

After oral administration of gabapentin, peak plasma concentrations are reached within 2–3 hours. There is a tendency for the bioavailability of gabapentin (the absorbed portion of the drug) to decrease with increasing dose. The absolute bioavailability of gabapentin when administered as a 300 mg capsule is approximately 60%. Food, including fatty foods, has no clinically significant effect on the pharmacokinetics of gabapentin.

Multiple administration does not affect the pharmacokinetics of gabapentin. Although plasma concentrations of the drug in clinical studies ranged from 2 μg/mL to 20 μg/mL, this value did not determine the efficacy and safety of the drug. Pharmacokinetic parameters are listed in Table 2.

Table 2

Summary of mean (%CV) steady-state pharmacokinetic parameters after every 8-hour dosing

Pharmacokinetic parameter

300 mg

(N = 7)

400 mg

(N = 14)

800 mg

(N=14)

Average %CV Average %CV Average %CV
Cmax (μg/mL) 4.02 (24) 5.74 (38) 8.71 (29)
tmax (hours) 2.7 (18) 2.1 (54) 1.6 (76)
T1/2 (hours) 5.2 (12) 10.8 (89) 10.6 (41)
AUC (0-8) μg·h/ml) 24.8 (24) 34.5 (34) 51.4 (27)
Ae% (%) Sun Sun 47.2 (25) 34.4 (37)

Cmax – maximum steady-state plasma concentration

T1/2 – elimination half-life

AUC (0-8) – the equilibrium area under the pharmacokinetic “concentration-time” curve from time 0 to 8 hours after drug administration

Ae% – percentage of the dose excreted in urine unchanged from time 0 to 8 hours after drug administration

Sun – unavailable

Distribution.

Gabapentin does not bind to plasma proteins. The volume of distribution of the drug is 57.7 l. The concentration of gabapentin in the cerebrospinal fluid of patients with epilepsy is approximately 20% of the equilibrium minimum plasma concentration. Gabapentin penetrates into breast milk.

Metabolism.

There are no data on the metabolism of gabapentin in humans. The drug does not induce hepatic oxidative enzymes involved in drug metabolism.

Breeding.

Gabapentin is excreted exclusively by the kidneys in unchanged form. The half-life of gabapentin is independent of dose and averages 5–7 hours.

In adults and patients with renal impairment, the plasma clearance of gabapentin is reduced. The elimination rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance.

Gabapentin is removed from plasma by hemodialysis. In patients with impaired renal function or those undergoing hemodialysis, dose adjustment is recommended (see section 4.2).

The pharmacokinetics of gabapentin in children were evaluated in 50 healthy subjects aged 1 month to 12 years. Overall, when calculated on a dose per kg body weight (mg/kg), plasma concentrations of gabapentin in children aged 5 years and older did not differ from those in adults.

Linearity/nonlinearity.

The bioavailability of gabapentin (the absorbed portion of the drug) decreases with increasing dose, which indicates the nonlinearity of the pharmacokinetics of the drug, namely the bioavailability parameters (F): Ae%, CL/F, Vd/F. Elimination pharmacokinetics (pharmacokinetic parameters that do not include F, such as CLr and T1/2) have a linear pattern. The equilibrium plasma concentration of gabapentin is predictable based on data from a single dose of the drug.

Indication

Epilepsy.

Gabapentin is used as an adjunctive drug in the treatment of partial seizures with or without secondary generalization in adults and children aged 6 years and older (see section "Pharmacodynamics").

Gabapentin is used as monotherapy in the treatment of partial seizures with or without secondary generalization in adults and children aged 12 years and older.

Neuropathic pain.

Gabapentin is indicated for the treatment of peripheral neuropathic pain, such as painful diabetic neuropathy and postherpetic neuralgia in adults.

Contraindication

Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other types of interactions

Antiepileptic drugs: After administration of gabapentin, no significant changes in the plasma concentrations of phenytoin, carbamazepine, valproic acid, phenobarbital, which were used as background therapy, were observed in pharmacokinetic studies. In the same studies, no changes in the pharmacokinetics of gabapentin were also observed.

Oral contraceptives: Co-administration of gabapentin and oral contraceptives containing norethisterone and/or ethinyl estradiol does not affect the steady-state concentrations of these drugs.

Antacids: Concomitant administration of gabapentin and antacids containing aluminum or magnesium reduces the bioavailability of gabapentin by a maximum of 24%. It is recommended that gabapentin be taken no earlier than 2 hours after taking antacids.

Cimetidine: Concomitant use with cimetidine has been shown to slightly decrease the renal excretion of gabapentin; this effect is not expected to be clinically significant.

Morphine: In a study of healthy volunteers (N = 12) who took a controlled-release capsule containing 60 mg of morphine 2 hours before gabapentin (600 mg capsule), there was a 44% increase in mean gabapentin AUC compared to when morphine was not administered. Therefore, patients should be closely monitored for signs of CNS depression, such as drowsiness, and the dose of gabapentin or morphine should be reduced accordingly when morphine is coadministered with gabapentin.

The use of probenecid does not impair the renal excretion of gabapentin.

Alcohol and inappropriate use of other drugs that affect the central nervous system. Possible increase in the CNS side effects of gabapentin (such as drowsiness, ataxia, etc.).

Myelotoxic drugs. Increased hematotoxicity (leukopenia).

Application features

If acute pancreatitis occurs during the use of gabapentin, discontinuation of gabapentin is indicated (see section "Adverse reactions").

Despite the lack of evidence of reactive seizures with gabapentin, abrupt withdrawal of anticonvulsant drugs in patients with epilepsy may contribute to the development of status epilepticus (see section "Method of administration and dosage").

As with other antiepileptic drugs, some patients may experience an increase in seizure frequency or the development of new seizure types when taking gabapentin.

Suicidal ideation and behavior have been observed in patients treated with antiepileptic drugs in some indications. A meta-analysis of randomized placebo-controlled trials of antiepileptic drugs also showed a small increased risk of suicidal ideation and behavior, the mechanism of which is unknown. The available data do not exclude an increased risk for gabapentin.

Therefore, it is important to monitor for signs of suicidal ideation and behavior and consider appropriate treatment. Patients (and caregivers) should be advised to seek medical advice if signs of suicidal ideation and behavior emerge.

As with other antiepileptic drugs, attempts to discontinue concomitant antiepileptic drugs in refractory patients receiving more than one antiepileptic drug to achieve monotherapy with Meditan have a low rate of success.

Gabapentin is not considered effective in the treatment of primary generalized seizures such as absences and may exacerbate these seizures in some patients. Therefore, gabapentin should be used with caution in patients with mixed seizures, including absences.

The effects of long-term (more than 36 weeks) use of gabapentin on learning ability, intelligence, and development in children and adolescents have not been adequately studied. Therefore, the potential risks should be considered when deciding whether long-term therapy is necessary. Misuse, Abuse, and Dependence

Gabapentin may cause drug dependence, which may occur at therapeutic doses. Cases of abuse have been reported. Patients with a history of substance abuse may be at increased risk of gabapentin misuse, abuse, and dependence, and gabapentin should be used with caution in such patients. The patient's risk of misuse, abuse, or dependence should be carefully evaluated before prescribing gabapentin.

Patients receiving gabapentin treatment should be monitored for symptoms of gabapentin misuse, abuse, or dependence, such as development of tolerance, dose escalation, and drug-seeking behavior.

Withdrawal symptoms

Withdrawal symptoms have been observed after discontinuation of both short-term and long-term treatment with gabapentin. Withdrawal symptoms may occur shortly after discontinuation of treatment, usually within 48 hours. The most commonly reported symptoms include anxiety, insomnia, nausea, pain, sweating, tremor, headache, depression, feeling abnormal, dizziness and malaise. The occurrence of withdrawal symptoms after discontinuation of gabapentin may indicate drug dependence (see section 4.8). The patient should be informed of this at the start of treatment. If gabapentin needs to be discontinued, it is recommended that this be done gradually over at least 1 week, regardless of the indication (see section 4.8).

Use in the Elderly: There have been no systematic studies of gabapentin in patients aged 65 years and older. In one double-blind study in patients with neuropathic pain, patients aged 65 years and older experienced a higher incidence of somnolence, peripheral edema, and weakness than younger patients. Other than these findings, clinical trials in this age group have not provided evidence of a different adverse event profile from that in the younger patient population.

Gabapentin treatment has been associated with dizziness and somnolence, which could potentially increase the risk of accidental injury in elderly patients.

There have also been postmarketing reports of loss of consciousness, confusion, and the development of psychiatric disorders with the use of gabapentin.

Therefore, patients should be advised to exercise caution until their individual response to gabapentin is known.

Patients receiving opiates and gabapentin concomitantly should be closely monitored for symptoms of CNS depression, such as drowsiness and respiratory depression.

When morphine and gabapentin are used simultaneously, an increase in gabapentin concentration is possible. The dose of gabapentin or opiates should be reduced.

Severe skin adverse reactions

If a patient has developed a serious reaction, such as SJS, TEN, or DRESS syndrome, while taking gabapentin, gabapentin treatment should never be restarted.

Gabapentin can cause anaphylactic shock or angioedema, occurring immediately after the first dose or at any time during treatment. Symptoms of reported cases included difficulty breathing, swelling of the lips, throat and tongue, hypotension requiring emergency treatment. Patients should immediately discontinue gabapentin and seek medical attention if they develop any signs of anaphylaxis or angioedema.

Laboratory tests.

Semi-quantitative determination of total urinary protein using rapid tests may result in false positive results. Therefore, it is recommended to verify such rapid test results using methods based on another analytical principle, such as the biuret test, turbidimetric method, or dye binding method, or to use these methods first.

Caution is recommended when treating patients with a history of psychotic illness.

This drug contains lactose, so it is not recommended for use in patients with lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Use during pregnancy or breastfeeding

General risks of epilepsy and antiepileptic therapy.

The risk of congenital pathology in children whose mothers took antiepileptic drugs increased by 2–3 times. The most frequently reported cases were cleft lip, cardiovascular anomalies, and neural tube defects. Combination antiepileptic therapy may be associated with a higher risk of developmental defects compared to monotherapy, so it is recommended to use monotherapy whenever possible. All pregnant women and women of reproductive age who need antiepileptic therapy should consult a specialist before starting it. When planning pregnancy, the need for antiepileptic therapy should be reconsidered. Abrupt discontinuation of antiepileptic drugs is unacceptable, as this can lead to seizures and significantly worsen the condition of the mother and child. Developmental delay in children is rarely observed in mothers with epilepsy. It is impossible to differentiate whether developmental delay is a consequence of genetic disorders, social factors, epilepsy in the mother, or her use of antiepileptic drugs.

Risk associated with gabapentin therapy.

There are no adequate data from the use of gabapentin in pregnant women. Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the fetus.

No conclusion has been made about the ability of gabapentin used during pregnancy to increase the risk of congenital pathology in children due to the presence of epilepsy in mothers per se and the use of gabapentin in this regard, or due to the combined use of other antiepileptic drugs.

Neonatal withdrawal syndrome has been reported in newborns exposed to gabapentin in utero.

Concomitant use of gabapentin and opioids during pregnancy may increase the risk of neonatal withdrawal syndrome in the newborn. The condition of the newborn should be closely monitored.

Gabapentin passes into breast milk. Since the effects of the drug on infants have not been studied, the appointment of gabapentin during breastfeeding should be carried out with caution. The use of gabapentin during breastfeeding is justified only when the benefit to the mother outweighs the potential risk to the infant.

Fertility.

In animal studies, gabapentin did not affect fertility.

Ability to influence reaction speed when driving vehicles or other mechanisms

Gabapentin affects the central nervous system and may cause drowsiness, dizziness, or other similar symptoms. These side effects, even mild or moderate, can be potentially dangerous when driving or operating other machinery, especially at the beginning of therapy and after increasing the dose.

Method of administration and doses

Intended for oral administration.

Gabapentin can be taken regardless of meals. The drug should be washed down with a sufficient amount of liquid (for example, a glass of water).

Table 3

Dosage regimen for initial dose selection for adults and children aged 12 years and over
Day 1 Day 2 Day 3
300 mg once daily 300 mg 2 times a day 300 mg 3 times a day

Gabapentin withdrawal.

According to current clinical guidelines, it is recommended to discontinue gabapentin gradually, over a minimum of 1 week, regardless of the indication.

Epilepsy.

Adults and children over 12 years of age: Effective doses for epilepsy range from 900 to 3600 mg/day. Treatment begins with titration of the drug as described in Table 3, or with a dose of 300 mg 3 times a day on day 1. Then, depending on individual tolerability and effectiveness, the dose can be increased by 300 mg/day every 2-3 days to a maximum dose of 3600 mg/day. Some patients may require slower titration of gabapentin. The shortest time to reach a dose of 1800 mg/day is 1 week, 2400 mg/day is 2 weeks, and 3600 mg/day is 3 weeks.

In long-term open clinical studies, a dose of 4800 mg/day was well tolerated by patients. The daily dose should be divided into 3 doses. The maximum interval between doses should not exceed 12 hours to avoid a break in anticonvulsant therapy and to prevent the occurrence of seizures.

Children aged 6 to 12 years.

The initial dose of the drug should be 10–15 mg/kg body weight/day. The effective dose should be achieved by titration over approximately 3 days. The effective dose of gabapentin for children aged 6 years and older is 25–35 mg/kg body weight/day. A dose of 50 mg/kg body weight/day has been shown to be well tolerated by patients in long-term clinical studies. The total daily dose should be divided into equal doses (3 times a day); the maximum interval between doses should not exceed 12 hours.

There is no need to monitor gabapentin serum levels. In addition, gabapentin can be used in combination with other antiepileptic drugs, as this does not change the plasma concentration of gabapentin or the serum concentration of other antiepileptic drugs.

Peripheral neuropathic pain.

Adults.

Treatment begins with titration of the drug dose as described in Table 3, or an initial dose of 900 mg/day should be divided into 3 doses. Then, depending on individual tolerability and effectiveness, the dose can be increased by 300 mg/day every 2–3 days to a maximum of 3600 mg/day. Some patients may require a slower titration of gabapentin. The shortest time to reach a dose of 1800 mg/day is 1 week, 2400 mg/day is 2 weeks, and 3600 mg/day is 3 weeks.

The efficacy and safety of gabapentin in the treatment of peripheral neuropathic pain (e.g. painful diabetic neuropathy or postherpetic neuralgia) have not been studied in long-term clinical trials lasting more than 5 months. If a patient requires longer-term (more than 5 months) treatment with gabapentin for neuropathic pain, the physician should assess the patient's clinical status and determine the need for additional therapy before continuing therapy.

In patients with severe general condition or certain aggravating factors, such as low body weight, post-transplant condition, titration should be carried out more slowly either by reducing the step dose or by prolonging the intervals between dose increases.

Elderly patients (over 65 years of age).

Elderly patients may require individual dose adjustment due to possible decreased renal function (see Table 4). Elderly patients are more likely to develop drowsiness, peripheral edema, and weakness.

Patients with renal failure.

Patients with severe renal impairment and/or patients on hemodialysis require individualized dose adjustment (see Table 4). Gabapentin 100 mg capsules are recommended for these patients.

Table 4

Gabapentin doses in renal impairment.

Creatinine clearance (ml/min)

Total daily dose of gabapentin*

(mg/day)

>80 (creatinine clearance norms) 900–3600
50–79 600–1800
30–49 300–900
15–29 150**–600
<15*** 150**–300

* The total daily dose should be divided into 3 doses. Reduced doses should be used in patients with renal insufficiency (creatinine clearance < 79 ml/min).

** Administer 100 mg 3 times a day every other day.

*** For patients with creatinine clearance < 15 ml/min, the daily dose should be reduced according to creatinine clearance (e.g., patients with creatinine clearance 7.5 ml/min should receive half the daily dose of patients with creatinine clearance 15 ml/min).

Dosage for patients receiving hemodialysis.

For anuric patients on hemodialysis who have never received gabapentin before, the recommended loading dose is 300–400 mg, followed by 200–300 mg of gabapentin after every 4 hours of hemodialysis. Gabapentin should not be taken on days off hemodialysis.

The maintenance dose of gabapentin for patients on hemodialysis is determined based on the recommendations in Table 4. In addition to the maintenance dose, patients on hemodialysis are recommended to take 200–300 mg of the drug after every 4 hours of hemodialysis.

Children.

Gabapentin is indicated for the treatment of children with epilepsy: as adjunctive therapy for children aged 6 years and older, and as monotherapy for children aged 12 years and older.

Overdose

Symptoms of overdose included dizziness, diplopia, slurred speech, drowsiness, loss of consciousness, lethargy, and mild diarrhea. All patients recovered fully after supportive treatment. The reduced absorption of gabapentin at high doses may limit the absorption of drugs and reduce the toxic effects of overdose.

During supportive therapy, the patients' condition fully recovered.

Although gabapentin can be removed by hemodialysis, based on previous experience this is usually not necessary. However, hemodialysis may be indicated in patients with severe renal insufficiency.

In studies in mice and rats, it was not possible to determine the lethal dose of gabapentin, despite the use of doses up to 8000 mg/kg. Symptoms of acute toxicity in animals included ataxia, difficulty breathing, ptosis, decreased activity or, conversely, increased excitability.

Overdose of gabapentin, especially in combination with other CNS depressant drugs, can lead to coma.

Adverse reactions

During studies of the use of drugs with the active substance gabapentin in epilepsy (adjunctive therapy or monotherapy) and neuropathic pain, the following undesirable effects were noted, listed taking into account their frequency: very common (> 1/10), common (> 1/100 - < 1/10), uncommon (> 1/1000 - <1/100) and rare (> 1/10000 - <1/1000). If the frequency of side effects differed in different studies, the report included data on the highest frequency. Additional side effects registered in post-marketing studies are listed in the category "not known" (cannot be estimated from the available data). Within each frequency grouping, side effects are listed in order of decreasing seriousness. Infectious and parasitic diseases.

Very common: viral infection.

Common: pneumonia, respiratory infection, urinary tract infection, otitis media, infection.

From the side of the hematopoietic system and lymphatic system.

Common: leukopenia.

Rare: thrombocytopenia.

From the immune system.

Rare: allergic reactions (e.g. urticaria).

Not known: hypersensitivity syndrome (DRESS syndrome), systemic reactions with various manifestations including fever, rash, hepatitis, lymphadenopathy, eosinophilia and other signs and symptoms.

From the side of metabolism and nutrition.

Common: increased appetite, anorexia.

Uncommon: hyperglycaemia (most common in patients with diabetes).

Rare: hypoglycemia (most common in patients with diabetes).

Not known: hyponatremia

Mental disorders.

Common: hostility, confusion and emotional lability, depression, anxiety, nervousness, abnormal thinking.

Rare: hallucinations.

Not known: drug dependence.

From the nervous system.

Very common: dizziness, drowsiness, ataxia.

Common: convulsions, hyperkinesia, dysarthria, tremor, insomnia, headache, sensory disturbances (paresthesia, hypoesthesia), coordination disorders, nystagmus, increased, decreased or absent reflexes, amnesia, memory impairment.

Rare: movement disorders (including choreoathetosis, dyskinesia, dystonia), loss of consciousness.

Uncommon: hypokinesia, mental impairment.

From the organs of vision.

Common: visual disturbances (e.g. amblyopia, diplopia).

On the part of the organs of hearing and balance.

Common: vertigo

Rare: ringing in the ears.

From the heart.

Rare: feeling of increased heartbeat.

From the side of the vessels.

Common: hypertension, vasodilation

Respiratory, thoracic and mediastinal disorders

Common: dyspnea, bronchitis, pharyngitis, cough, rhinitis.

From the gastrointestinal tract.

Common: vomiting, nausea, dental pathology, gingivitis, diarrhea, abdominal pain, dyspepsia, constipation, dry mouth or throat, abdominal bloating.

Uncommon: dysphagia.

Rare: pancreatitis.

From the liver and biliary tract.

Rare: hepatitis, jaundice.

On the part of the skin and subcutaneous tissues.

Common: facial swelling, purpura (most often described as bruising after injury), rash, pruritus, acne.

Not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms (see section 4.4), erythema multiforme, angioedema, alopecia

On the part of skeletal muscles and connective tissue.

Common: arthralgia, myalgia, back pain, muscle twitching.

Not known: rhabdomyolysis, myoclonic seizures.

On the part of the kidneys and urinary tract.

Common: urinary incontinence.

Rare: acute renal failure.

From the genitals and mammary glands.

Common: impotence.

Not known: breast hypertrophy, gynaecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia).

General disorders and administration site conditions.

Very common: fatigue, fever.

Common: peripheral edema, gait disturbance, asthenia, pain, malaise, flu-like syndrome.

Uncommon: Generalised oedema.

Not known: withdrawal reactions.

Investigations: Common: decreased white blood cell count, weight gain.

Uncommon: increased liver function tests (AST, ALT) and bilirubin.

Not known: increased creatine phosphokinase levels, fluctuations in blood glucose levels in patients with diabetes.

Injuries and poisoning.

Cases of acute pancreatitis have been described in association with gabapentin treatment. No association with gabapentin has been established (see section 4.4). Myopathy with elevated CPK levels has been reported in patients with end-stage renal disease undergoing haemodialysis. Cases of respiratory tract infections, otitis media, convulsions and bronchitis have only been reported in clinical studies in children. In addition, aggressive behaviour and hyperkinesia were quite common in studies in children.

Withdrawal symptoms have been observed after discontinuation of both short-term and long-term treatment with gabapentin. Withdrawal symptoms may occur shortly after discontinuation of treatment, usually within 48 hours. The most commonly reported symptoms include anxiety, insomnia, nausea, pain, sweating, tremor, headache, depression, feeling abnormal, dizziness and malaise (see section 4.4). The occurrence of withdrawal symptoms after discontinuation of gabapentin may indicate drug dependence (see section 4.8). The patient should be informed of this at the start of treatment. If gabapentin needs to be discontinued, it is recommended that this be done gradually over at least 1 week, regardless of the indication (see section 4.8).

Expiration date

2 years.

Do not use the drug after the expiration date indicated on the package.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging

10 capsules in a blister. 3 or 6 blisters in a pack.

Vacation category

According to the recipe.

Producer

JSC "Farmak".

Location of the manufacturer and its business address.

Ukraine, 04080, Kyiv, Kyrylivska St., 74.

Address

Ukraine, 04080, Kyiv, Kyrylivska St., 74.

Specifications
Characteristics
Active ingredient
Gabapentin
Adults
Can
ATC code
N AGENTS ACTING ON THE NERVOUS SYSTEM; N03 ANTIEPILEPTIC AGENTS; N03A ANTIEPILEPTIC AGENTS; N03A X Other antiepileptic drugs; N03A X12 Gabapentin
Country of manufacture
Ukraine
Diabetics
With caution
Dosage
300 мг
Drivers
With caution, dizziness and drowsiness are possible.
For allergies
With caution
For children
From 6 years old on doctor's prescription
Form
Capsules
Method of application
Inside, solid
Nursing
It is necessary to cancel feeding.
Pregnant
It is impossible.
Primary packaging
blister
Producer
Farmak JSC
Quantity per package
30 pcs
Trade name
Meditan
Vacation conditions
By prescription
Reviews

There are no reviews for this product.

There are no reviews for this product, be the first to leave your review.

Answers & questions
Add your question and we will answer as soon as possible.

No questions about this product, be the first and ask your question.

You are watched
new
Reboden capsules 820 mg blister No. 60
In stock
0
887.85 грн.
new
Minirin tablets 0.1 mg bottle No. 30
In stock
0
1 108.88 грн.
new
new
Nurofen film-coated tablets 200 mg blister No. 8
In stock
0
215.50 грн.
new
Ribavirin-Astrapharm capsules 200 mg blister No. 60
In stock
0
975.57 грн.
new
Sold out
Scarifier steel granum l №200
Распродано
0
192.40 грн.
new
Best-seller
Memantine tablets 20 mg No. 28
In stock
0
1 141.44 грн.
new
Zeptol tablets 200 mg strip No. 100
In stock
0
450.20 грн.
new
Nurofen film-coated tablets 200 mg blister No. 6
In stock
0
162.14 грн.