Expiration date: 09/2024
Structure and Composition:
One tablet contains active substance:
Carbamazepine 200 mg
Excipients: MCC - gelatine 60 mg - 11 mg Sodium croscarmellose - Magnesium stearate 6 mg - 3 mg
in blister PVC / PVDC / aluminum foil 10 pcs. a stack of cardboard 3, 4 or 5 blisters.
Description pharmaceutical form:
White round tablets with bevelled, convex on one side and the notch in the form of a wedge-shaped recess - on the other.
Absorption - slow, but complete (food intake does not significantly affect the rate and extent of absorption). Cmax after a single dose tablet is achieved after 12 h. The average value of the unchanged active substance Cmax after a single dose of 400 mg of carbamazepine is about 4.5 mg / ml. Tmax is 4-5 hours Equilibrium plasma concentrations are reached within 1-2 weeks (the rate of achievement depends on the individual metabolism:. Auto-induction of the liver enzyme systems geteroinduktsiya other simultaneously applied drugs, as well as the condition of the patient, the dose and duration of treatment ). There are substantial interindividual differences equilibrium concentrations in the therapeutic range of values: the majority of patients, these values ??range from 4 to 12 micrograms / ml (17-50 mol / l). Concentrations of carbamazepine-10,11-epoxide (pharmacologically active metabolite) constitute about 30% of the concentration of carbamazepine. Connection with the plasma protein in children - 55-59% in adults - 70-80%. Vd - 0,8-1,9 liters / kg. In the cerebrospinal fluid and saliva concentrations are proportional to the amount of unbound protein active substances (20-30%). It penetrates through the placental barrier. Concentration in breast milk is 25-60% of that in plasma.
It is metabolized in the liver, principally by way of epoxy to form the main metabolites: active - carbamazepine-10,11-epoxide - and inactive conjugate with glucuronic acid. The basic isoenzyme providing Carbamazepine biotransformation carbamazepine-10,11-epoxide is cytochrome P450 (CYP3A4). As a result of metabolic reactions, a small and active metabolite 9-hydroxy-10-methyl-karbamoilakridan. It may induce its own metabolism. The concentration of carbamazepine-10,11-epoxide is 30% of the concentration of carbamazepine.
T1 / 2 after administration of a single oral dose is 25-65 hours (an average of about 36 hours), after repeated administration, depending on the duration of treatment - 12-24 hours (due to auto-induction of the monooxygenase system of the liver). Patients receiving other anticonvulsants in addition - monooxygenase system inductors (phenytoin, phenobarbital), T1 / 2 is an average of 9-10 hours after a single dose of carbamazepine into 72% of the dose is excreted in urine and 28% in feces.. About 2% of the dose is excreted in the urine as unchanged carbamazepine, about 1% - in the form of 10,11-epoxide metabolite. In children, due to the increased elimination, it may require the use of relatively high doses of the drug per 1 kg of body weight compared to adults. Data on changes in the pharmacokinetics of carbamazepine in elderly patients there.
Description of the pharmacological actions:
Antiepileptics (derivative dibenzazepine) provider as antidepressant, antipsychotic and antidiuretic effect, analgesic effect in patients with neuralgia. The mechanism of action related to the blockade of voltage-gated sodium channels, resulting in stabilization of Membrane overexcited neurons, inhibition of occurrence of serial bits neurons and reduction of synaptic impulses. It prevents re-formation of Na + -dependent action potentials in depolarized neurons. It reduces the release of excitatory amino acid neurotransmitter - glutamate - increases reduced convulsive threshold of the central nervous system and thus reduces the risk of an epileptic seizure. Increases the conductivity of K +, modulates the voltage-sensitive Ca2 + channels, which may also contribute to the anticonvulsant effect of the drug. Effective with focal (partial) epileptic seizures (simple and complex), accompanied or not by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as combinations of these types of seizures (usually not effective for small seizures - petit mal, absence seizures and myoclonic seizures ). In patients with epilepsy (especially in children and adolescents) noted a positive effect on symptoms of anxiety and depression, as well as reducing irritability and aggressiveness. Effects on cognitive function and psychomotor performance depends on the dose. Starting anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism). In essential and secondary trigeminal neuralgia carbamazepine in most cases prevents the appearance of pain attacks. Easing the pain of trigeminal neuralgia is celebrated through 8-72 hours. When alcohol withdrawal syndrome raises the seizure threshold, which in this state is usually reduced, and reduces the severity of the clinical manifestations of the syndrome (irritability, tremors, gait disturbance). Antipsychotic (antimanic) action develops in 7-10 days, may be due to inhibition of metabolism of dopamine and norepinephrine.
- epilepsy: partial seizures with elementary symptoms (focal seizures), partial seizures with complex symptomatology, psychomotor seizures, large seizures of focal origin mainly (large seizures during sleep, diffuse large seizures), mixed forms of epilepsy
- tic douloureux
- idiopathic glossopharyngeal neuralgia
- pain in patients with lesions of the peripheral nerves in diabetes, pain in diabetic neuropathy
- epileptiform seizures in multiple sclerosis, muscle spasms of the facial trigeminal neuralgia, tonic seizures, paroxysmal disorders of speech and movement (paroxysmal dysarthria and ataxia), paresthesia and paroxysmal pain attacks
- alcohol withdrawal syndrome (anxiety, convulsions, hyperexcitability, sleep disorders)
- psychotic disorders (affective and schizoaffective disorders, psychosis, disturbances of the limbic system).
- hypersensitivity to carbamazepine and other ingredients, as well as the tricyclic antidepressants
- disorders of bone marrow hematopoiesis (anemia, leukopenia)
- acute intermittent porphyria (including history)
- AV block
- co-administration of drugs lithium and MAO inhibitors.
Precautions: decompensated chronic heart failure, hyponatremia dilutions (hypersecretion of ADH syndrome, hypopituitarism, hypothyroidism, adrenal insufficiency), liver failure and kidney failure, advanced age, active alcoholism (enhanced CNS depression, increased carbamazepine metabolism), inhibition of bone marrow hematopoiesis in the background medication (history), prostatic hyperplasia, increased intraocular pressure in combination with a sedative-hypnotics.
Application of pregnancy and breastfeeding:
Women of reproductive age Finlepsin possible is administered as monotherapy, in the minimum effective dose, as frequency of congenital anomalies of newborns from mothers treated with combination anti-epileptic medication, higher than monotherapy.
When the pregnancy is necessary to compare the potential benefits of therapy and possible complications, especially in the first trimester of pregnancy. It is known that children of mothers with epilepsy are prone to violations of fetal development, including malformations. Finlepsin can increase the risk of these disorders. There are few reports of cases of congenital diseases and malformations, including spina bifida (spina bifida).
Antiepileptic drugs increase the folic acid deficiency is often observed during pregnancy, which can help to increase the frequency of birth defects in children, so before the planned pregnancy and during pregnancy, folic acid is recommended. In order to prevent hemorrhagic complications in newborns, the women in the last weeks of pregnancy and the newborn is recommended to prescribe vitamin K.
Carbamazepine passes into breast milk, so you should compare the benefits and possible adverse effects of breastfeeding in the face of continued therapy. If you continue breastfeeding while taking finlepsin to install child monitoring due to the possibility of adverse reactions (eg severe drowsiness, allergic skin reactions).
When evaluating the frequency of occurrence of various adverse reactions following grading used: very often - 10% and more often - 1-10%, sometimes - 0.1-1%, rarely - 0.01-0.1%, very rare - less 0.01%.
Development of adverse reactions from the central nervous system may be a consequence of the relative drug overdose or significant fluctuations in carbamazepine plasma levels.
CNS: often - dizziness, ataxia, drowsiness, weakness, headache, paresis of accommodation sometimes - abnormal involuntary movements (eg tremor, fluttering tremor - asterixis, dystonia, tics), nystagmus rarely - hallucinations (visual or auditory), depression , loss of appetite, restlessness, aggressive behavior, agitation, disorientation, activation of psychosis, orofacial dyskinesia, oculomotor disturbances, speech disorders (eg dysarthria or slurred speech), horeoatetoidnye disorders, peripheral neuritis, paresthesia, muscle weakness and symptoms of paresis. Role in the development of the drug neuroleptic malignant syndrome, especially in combination with neuroleptics, remains unclear.
Allergic reactions: often - urticaria, sometimes - erythroderma, multiorgan reaction of delayed-type hypersensitivity with fever, skin rashes, vasculitis (including erythema nodosum as a manifestation of cutaneous vasculitis), lymphadenopathy, symptoms resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function tests (these manifestations occur in various combinations). There may also be involved and other organs (eg lungs, kidneys, pancreas, myocardium, colon). Aseptic meningitis, with myoclonus and peripheral eosinophilia, anaphylactoid reactions, angioedema, allergic pneumonitis or eosinophilic pneumonia. application of the drug to be terminated at occurrence of allergic reactions mentioned above. Rarely - lupus-like syndrome, skin itching, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), photosensitivity.
Hematopoietic organs and blood: often - leukopenia, thrombocytopenia, eosinophilia, rarely - leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, pure red cell aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia, splenomegaly.
From the digestive system: often - nausea, vomiting, dry mouth, increased activity of gamma-glutamyl transferase (due to induction of this enzyme in the liver), which usually has no clinical significance, elevated alkaline phosphatase sometimes - increase in liver enzymes, diarrhea or constipation , abdominal pain, rarely - glossitis, gingivitis, stomatitis, pancreatitis, hepatitis, cholestatic, parenchymal (hepatocellular) types of jaundice, granulomatous hepatitis, hepatic failure.
From the CCC: rarely - a violation of intracardiac conduction decrease or increase in blood pressure, bradycardia, arrhythmias, AV block with fainting, collapse, worsening or development of congestive heart failure, coronary artery disease worsening (including the appearance or increased frequency of angina attacks), thrombophlebitis, thromboembolic syndrome.
On the part of the endocrine system and metabolism: often - edema, fluid retention, weight gain, hyponatremia (decrease in plasma osmolarity due to an effect similar to the action of ADH, which in rare cases leads to hyponatremia breeding, accompanied by lethargy, vomiting, headache, disorientation and neurological disorders), rarely - increased prolactin levels (may be accompanied by galactorrhea and gynecomastia) reduction in the concentration of L-thyroxine and increased TSH concentrations (usually not accompanied by clinical symptoms) disorders of calcium-phosphorus metabolism in bone tissue (reduction of the concentration of Ca2 + and 25-OH-cholecalciferol plasma) osteomalacia, hypercholesterolemia (including HDL cholesterol) and hypertriglyceridemia lymphadenopathy, hirsutism.
From the urogenital system: rarely - interstitial nephritis, renal failure, renal impairment (eg albuminuria, haematuria, oliguria, increase in urea / azotemia), urinary frequency, urinary retention, reduced potency.
From the musculoskeletal system: rarely - arthralgia, myalgia or cramps.
From the sensory organs: rarely - a violation of taste sensations, cataract, conjunctivitis hearing disorders, including tinnitus, hyperacusis, Gipoakuzija, change in pitch perception.
Other: violation of skin pigmentation, purpura, acne, sweating, alopecia.
Co-administration of carbamazepine with CYP3A4 inhibitors may lead to an increase in its concentration in blood plasma and the development of adverse reactions. The combined use of inducers of CYP3A4 may accelerate metabolism of carbamazepine, reducing its concentration in plasma and decrease the therapeutic effect on the contrary, their removal may reduce the rate of biotransformation of carbamazepine and lead to an increase in its concentration. Increasing the concentration of carbamazepine in verapamil plasma diltiazem, felodipine, dextropropoxyphene, viloksazin, fluoxetine, fluvoxamine, cimetidine, acetazolamide, danazol, desipramine, nicotinamide (in adults, only in high doses), macrolides (erythromycin, josamycin, clarithromycin, troleandomycin) azoles (itraconazole , ketoconazole, fluconazole), terfenadine, loratadine, isoniazid, propoxyphene, grapefruit juice, protease inhibitors of virus used in the treatment of HIV infection (eg ritonavir) - requires correction dosing regimen or monitoring of carbamazepine plasma concentration.
Felbamate reduces the concentration of carbamazepine in the plasma and increases the concentration of carbamazepine-10,11-epoxide, possibly with simultaneous reduction in serum concentration of felbamate.
The concentration of carbamazepine reduce phenobarbital, phenytoin, primidone, metsuksimid, fensuksimid, theophylline, rifampicin, cisplatin, doxorubicin, perhaps - clonazepam, valpromid, valproic acid, oxcarbazepine and vegetable, products containing St. John's wort (Hypericum perforatum). It is possible to displace valproic acid, primidone carbamazepine and from association with plasma proteins and enhance the concentration of a pharmacologically active metabolite (carbamazepine-10,11-epoxide). If concomitant use of valproic acid with finlepsin in exceptional cases can occur coma, and confusion. Isotretinoin modifies the bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxide (carbamazepine be monitored plasma concentration). Carbamazepine may lower the plasma concentration (reduce or even reverse the effects), and require dose adjustment following drugs: clobazam, clonazepam, digoxin, ethosuximide, primidone, valproic acid, alprazolam, corticosteroids (prednisone, dexamethasone), cyclosporine, teteratsikliny (doxycycline) haloperidol, methadone, oral drugs containing estrogen and / or progesterone (requires selection of alternative contraceptive methods), theophylline, oral anticoagulants (warfarin, phenprocoumon, dikumarol), lamotrigine, topiramate, tricyclic antidepressants (imipramine, amitriltilin, nortriptyline, clomipramine), clozapine , felbamate, tiagabine, oxcarbazepine, protease inhibitors used in the treatment of HIV infection (indinavir, ritonavir, saquinovir), BPC (group digidropiridonov eg felodipine), itraconazole, levothyroxine, midazolam, olazapin, praziquantel, risperidone, tramadol, ziprasidone. It is possible to increase or decrease phenytoin plasma levels of carbamazepine, and against the background of improving mefenitoina. With simultaneous use of carbamazepine and drugs lithium may increase neurotoxic effect of both active substances.
Tetracyclines may reduce the therapeutic effect of carbamazepine. In a joint application with paracetamol on the liver increases the risk of toxic effects and reduced therapeutic efficacy (acceleration of metabolism of paracetamol). Co-administration of carbamazepine with phenothiazines, pimozide, thioxanthenes, molindone, haloperidol, maprotiline, clozapine and tricyclic antidepressants leads to increased inhibitory action on the central nervous system and weaken the anticonvulsant effect of carbamazepine.
MAO inhibitors increase the risk of giperpireticheskih crises, hypertensive crises, convulsions, death (before the appointment of carbamazepine MAO inhibitors should be canceled at least 2 weeks, or if the clinical situation allows, even .For a longer period). Co-administration with a diuretic (hydrochlorothiazide, furosemide) may lead to hyponatremia, accompanied by clinical symptoms. It reduces the effects of non-depolarizing muscle relaxants (pancuronium). In the case of such a combination may need to increase the dose of muscle relaxants, with careful monitoring of the patient in connection with the possibility of more rapid termination of muscle relaxants. Carbamazepine reduces ethanol tolerance.
Myelotoxic drugs increase the expression gematoksichnosti drug.
It accelerates the metabolism of indirect anticoagulants, hormonal contraceptive drugs, folic acid, praziquantel, may enhance the elimination of thyroid hormones.
It accelerates the metabolism of anesthetic agents (enflurane, halothane, halothane), and increases the risk of hepatotoxic effects enhances the formation of nephrotoxic metabolites methoxyflurane. It enhances the hepatotoxic effects of isoniazid.
Dosage and administration:
Inside, during or after meals, drinking plenty of fluids.
In those cases where this may Finlepsin be administered as a monotherapy. Joining finlepsin to the already ongoing antiepileptic therapy should be gradual, with the dose of the drugs correcting if necessary. If the patient has forgotten to take timely the next dose, the missed dose should be taken as soon as the omission was noticed, while you can not take a double dose of the drug.
Adults. Starting dose - 200-400 mg (. Table 1-2) per day and then gradually increase the dose until the optimum effect. Maintenance dose - 800-1200 mg / day, which is distributed to 1-3 administration. The maximum daily dose - 1.6-2 g
Children. If the child is not able to swallow the tablet whole, it can be chewed, crushed or shake in a little water.
The initial dose for children from 1 year to 5 years - 100-200 mg / day, then gradually increase the dose to 100 mg per day to achieve the optimal effect.
The starting dose for children 6 to 10 years - 200 mg / day and then gradually increase the dose to 100 mg per day to achieve the optimal effect.
The starting dose for children 11 to 15 years - 100-300 mg / day, then gradually increase the dose to 100 mg per day to achieve the optimal effect.
Supporting dose: children 1-5 years - 200-400 mg / day (in divided doses), 6-10 years - 400-600 mg / day (2-3 hours) 11-15 years - 600-1000 mg / day (2-3 hours).
The recommended dosing regimen:
|Starting dose||Maintenance dose|
|Adults||1 tablet. 1 time per day||1-2 tablets. 3 times per day|
|Children from 1 year to 5 years||1/2 tablet. 1-2 times per day||1 tablet. 1-2 times per day|
|Children 6 to 10 years||1/2 tablet. 2 times per day||1 tablet. 3 times per day|
|Children from 11 to 15 years||1/2 tablet. 2-3 times per day|
1 tablet. 3-5 times per day
Duration of treatment depends on the indication and the patient's individual response to the drug. The decision to transfer the patient to Finlepsin, duration of application and the treatment of the cancellation is received by the doctor individually. The possibility of reducing the dose or discontinuation of treatment is considered after a 2-3-year period, the total absence of seizures.
Treatment was discontinued, gradually reducing the dose over 1-2 years, under the control of the EEG. In children, while reducing the daily dose should be taken into account body weight increase with age.
Trigeminal neuralgia, idiopathic glossopharyngeal neuralgia
The initial dose is 1-2 tablets. (Corresponding to 200-400 mg of carbamazepine), which is raised to Table 2-4. 1-2 reception (corresponding to 400-800 mg of carbamazepine) until complete disappearance of pain. At a certain part of the treatment of patients can continue using a lower maintenance dose is 1 tab. Two times a day (equivalent to 400 mg of carbamazepine).
Elderly patients and patients with hypersensitivity Finlepsin administered in an initial dose of 1/2 Table. Two times a day (equivalent to 200 mg of carbamazepine).
Treatment of alcohol withdrawal in a hospital
The average daily dose - 1 tab. 3 times per day (equivalent to 600 mg of carbamazepine). In severe cases, the dose during the first days can be increased to 2 tablets. 3 times per day (equivalent to 1200 mg of carbamazepine).
If necessary Finlepsin can be combined with other agents used to treat alcohol withdrawal.
Treatment of alcohol withdrawal syndrome finlepsin stop, gradually reducing the dose for 7-10 days.
During treatment should regularly monitor the content of carbamazepine in plasma.
In connection with the possible development of side effects of the central and autonomic nervous system of patients is set close observation in the hospital.
Pain in diabetic neuropathy
The average daily dose - 1 tab. 3 times per day (equivalent to 600 mg of carbamazepine). In exceptional cases Finlepsin can be administered in a dose of 2 tablets. 3 times per day (equivalent to 1200 mg of carbamazepine).
Epileptiform seizures in multiple sclerosis
The average daily dose - 1-2 tablets. Two times a day (equivalent to 400-800 mg of carbamazepine).
Treatment and prevention of psychoses
The initial and maintenance dose is usually the same: Table 1-2. per day (corresponding to 200-400 mg of carbamazepine). If necessary, the dose can be increased to 2 tablets. Two times a day (equivalent to 800 mg of carbamazepine).
Symptoms usually reflect a violation of the CNS, cardiovascular and respiratory systems.
Central nervous system and sensory organs - the oppression of the CNS, disorientation, drowsiness, agitation, hallucinations, coma, blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia (in the beginning), hyporeflexia (later), convulsions, psychomotor disturbances, myoclonus, hypothermia, mydriasis.
CCC - tachycardia, decreased blood pressure, increased blood pressure sometimes, violations of intraventricular conduction with the expansion of the QRS complex fainting, cardiac arrest.
Respiratory system - respiratory depression, pulmonary edema.
The digestive system - nausea and vomiting, delayed evacuation of food from the stomach, decreased motility of the colon.
The urinary system - urinary retention, oliguria or anuria, fluid retention, hyponatremia.
Laboratory tests - leukocytosis or leukopenia, hyponatremia, possible metabolic acidosis, hyperglycemia and possible glucosuria, increased muscle creatine phosphokinase fraction.
Treatment: there is no specific antidote. It should be symptomatic supportive care in the intensive care unit, monitoring of cardiac function, body temperature, corneal reflexes, kidney and bladder, correction of electrolyte disorders. It is necessary to define carbamazepine plasma concentrations for confirmation of poisoning with this agent and assess the extent of overdose, gastric lavage, the appointment of activated carbon. Late evacuation of gastric contents may result in delayed absorption in the 2nd and 3rd day and the re-emergence of symptoms of intoxication during the recovery period. Forced diuresis, hemodialysis and peritoneal dialysis are ineffective but dialysis is indicated for combination of severe poisoning and renal failure. Children may need blood transfusions.
Begins with monotherapy of epilepsy destination initial low dose and gradually increasing it until the desired therapeutic effect.
When selecting the optimal dose of carbamazepine is advisable to determine the concentration in the blood plasma, in particular in combination therapy. In some cases, the optimal dose may significantly deviate from the recommended initial and maintenance doses, for example in connection with the induction of hepatic microsomal enzymes, or due to interactions with combination therapy.
Finlepsin should not be combined with sedative-hypnotics. If necessary, it can be combined with other agents used to treat alcohol withdrawal. During treatment should regularly monitor the content of carbamazepine in plasma. In connection with the development of side effects of the central and autonomic nervous systems of patients establish close observation in the hospital. When transferring a patient on carbamazepine should gradually reduce the dose previously designated antiepileptic drug, until its complete abolition. Sudden discontinuation of carbamazepine may trigger epileptic seizures. If necessary abruptly interrupt treatment, the patient should be transferred to another antiepileptic drug undercover shown in such cases the drug (e.g. diazepam administered in / or rectally, or phenytoin administered in / in).
It described several cases of vomiting, diarrhea and / or low power, seizures and / or respiratory depression in newborns whose mothers took carbamazepine concomitantly with other anticonvulsants (probably these reactions are manifestations of neonatal withdrawal syndrome). Before the appointment of carbamazepine in the treatment process to be a study of liver function, especially in patients with a history of which there is evidence of liver disease and in elderly patients. In the case of strengthening the already existing liver dysfunction or when active liver disease drug should be discontinued immediately. Before treatment to conduct a study of the blood picture (including platelet count, reticulocyte count), the iron level in the blood serum of urinalysis, the urea level in the blood, EEG, determination of electrolytes in serum concentration (and periodically during the treatment, since may develop hyponatremia). Subsequently, these indicators should be monitored during the first month of treatment each week, and then - on a monthly basis.
In most cases, a transient or a persistent decline in the number of platelets and / or leukocytes is not a harbinger of the beginning of aplastic anemia or agranulocytosis. However, before treatment and periodically during the treatment process should be carried out clinical blood tests, including counting the number of platelets and possibly reticulocytes and determine the level of iron in the blood serum. Non-progressive asymptomatic leukopenia does not require withdrawal of the drug, but the treatment should be discontinued when a progressive leukopenia or leucopenia, accompanied by clinical symptoms of the infectious disease. Carbamazepine should be immediately canceled the appearance of hypersensitivity reactions or symptoms, presumably indicating the development of Stevens-Johnson syndrome or Lyell's syndrome. Weakly expressed skin reactions (isolated makuleznaya or maculopapular rash) usually disappear within a few days or weeks, even with continued treatment or after the dose of the drug (the patient at this time should be under close medical supervision).
It is necessary to take into account the possibility of activation of a latent psychosis occurring, and in elderly patients - the possibility of disorientation or agitation.
In some cases, treatment with antiepileptic drugs was accompanied by the emergence of suicidality / suicidal intentions. This was also confirmed in meta-analyzes of randomized clinical trials involving antiepileptics. Since the mechanism of occurrence of suicide attempts using antiepileptic drugs is unknown, we can not exclude them from occurring in the treatment of patients finlepsin. Patients (and staff) to warn of the need to monitor for the emergence of suicidal ideation / suicidal behavior in the event of symptoms seek immediate medical attention.
Possible violations of male fertility and / or disorders of spermatogenesis, but the relationship of these disorders with carbamazepine has not been established. Perhaps the emergence of intermenstrual bleeding while the use of oral contraceptives. Carbamazepine may adversely affect the reliability of oral contraceptive pills, so women of childbearing age during treatment should use alternative methods of contraception. Carbamazepine should be used only under medical supervision. It is necessary to inform patients about the early signs of toxicity, as well as the symptoms of the skin and liver .. The patient was informed of the need to consult a doctor immediately in case of adverse reactions such as fever, sore throat, rash, ulceration of the oral mucosa mouth, wanton bruising, hemorrhages in the form of petechiae or purpura.