Finlepsin - instructions for use, dose, side effects, contraindications

Antiepileptic agent (derivative of dibenzazepine), which also has antidepressant, antipsychotic and antidiuretic effect, has analgesic effect in patients with neuralgia. The mechanism of action is associated with the blockade of potential-dependent sodium channels, which leads to the stabilization of the membrane of overexcited neurons, inhibition of the occurrence of serial discharges of neurons, and a decrease in synaptic impulses. Prevents repeated Na formation⁺-dependent action potentials in depolarized neurons. Reduces the release of the excitatory neurotransmitter amino acid glutamate, increases the lowered convulsive threshold of the central nervous system and, thus, reduces the risk of developing an epileptic attack. Increases the conductivity K⁺, modulates the potential-dependent Ca²⁺channels, which can also contribute to the anticonvulsant effect of the drug.

Effective in focal (partial) epileptic attacks (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, and also with a combination of these types of seizures (usually ineffective in small attacks - petit mal, absences and myoclonic seizures ).

Patients with epilepsy (especially in children and adolescents) have a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness.

Influence on cognitive function and psychomotor parameters depends on the dose. The onset of an anticonvulsant effect varies from a few hours to several days (sometimes up to 1 month due to autoinduction of metabolism).

With essential and secondary neuralgia of the trigeminal nerve carbamazepine in most cases, prevents the occurrence of pain attacks.

Relaxation of pain in trigeminal neuralgia is noted after 8-72 hours.

With the alcohol withdrawal syndrome increases the threshold of convulsive readiness, which in this state is usually reduced, and reduces the severity of clinical manifestations of the syndrome (increased excitability, tremor, gait disturbance).

Antipsychotic (antimanic) action develops after 7-10 days, may be due to oppression of the metabolism of dopamine and norepinephrine.

Pharmacokinetics:

Absorption - slow, but complete (eating does not significantly affect the speed and degree of absorption). After a single tablet intake, the maximum concentration is reached after 12 hours. The average value of the maximum concentration of unchanged active substance after a single dose of 400 mg of carbamazepine is about 4.5 μg / ml. The time to reach the maximum concentration is 4-5 hours. Equilibrium plasma concentrations in the plasma are achieved after 1-2 weeks (the rate of achievement depends on the individual characteristics of the metabolism: autoinduction of the liver enzyme systems, heteroinduction by other, simultaneously applied,drugs), as well as on the patient's condition, the dose of the drug and the duration of treatment. There are significant interindividual differences in the values of equilibrium concentrations in the therapeutic range: in most patients these values range from 4 to 12 μg / ml (17-50 μmol / l). The concentrations of carbamazepine-10,11-epoxide (pharmacologically active metabolite) are about 30% of the concentration of carbamazepine. The connection with plasma proteins in children is 55-59%, in adults 70-80%. The apparent volume of distribution is 0.8-1.9 l / kg. In spinal cord fluid and saliva, concentrations are created in proportion to the amount of active substance unbound with proteins (20-30%). Penetrates through the placental barrier. Concentration in breast milk is 25% -60% of that in plasma. Metabolised in the liver, mainly along the epoxide route with the formation of the main metabolites: active - carbamazepine-10,11-epoxide and inactive conjugate with glucuronic acid. The main isoenzyme providing the biotransformation of carbamazepine in carbamazepine-10,11-epoxide is cytochrome P450 (CYP ZA4). As a result of metabolic reactions, a little active metabolite of 9-hydroxy-methyl-10-carbamoylacridan is formed. Can induce own metabolism.The concentration of carbamazepine-10,11-epoxide is 30% of the concentration of carbamazepine. Half-life after taking a single oral dose of 25-65 hours (an average of about 36 hours), after repeated administration, depending on the duration of treatment - 12-24 hours (due to autoinduction of the monooxygenase system of the liver). In patients receiving additionally other anticonvulsant drugs-inducers of the monooxygenase system (phenytoin, phenobarbital) half-life is an average of 9-10 hours. After a single intake of carbamazepine, 72% of the dose is excreted in the urine and 28% with feces. About 2% of the dose is excreted in the urine in the form of unchanged carbamazepine, about 1% - in the form of 10,11-epoxide metabolite. Children, due to accelerated elimination, may need to use relatively higher doses of the drug per kg of body weight compared to adults. There is no evidence of a change in the pharmacokinetics of carbamazepine in elderly patients.

Indications:

- Epilepsy: partial seizures with elementary symptoms (focal seizures), partial seizures with complex symptoms, psychomotor seizures,large convulsive seizures in mainly focal genesis (large convulsive attacks during sleep, diffuse large seizures), mixed forms of epilepsy;

- trigeminal neuralgia;

- idiopathic glossopharyngeal neuralgia;

- Pain in the defeat of peripheral nerves in diabetes mellitus, pain in diabetic neuropathy;

- epileptiform cramps in multiple sclerosis, spasms of facial muscles with trigeminal neuralgia, tonic convulsions, paroxysmal speech and movement disorders (paroxysmal dysarthria and ataxia), paroxysmal paresthesia and pain attacks;

- alcohol withdrawal syndrome (anxiety, convulsions, hyperexcitability, sleep disturbance);

- psychotic disorders (affective and schizoaffective disorder, psychosis, disturbance of the limbic system).

Contraindications:

- Hypersensitivity to carbamazepine and other components of the drug, as well as to tricyclic antidepressants;

- disorders of bone marrow hematopoiesis (anemia, leukopenia);

- acute intermittent porphyria (including in history);

- atrioventricular block;

- simultaneous administration of lithium preparations and MAO inhibitors.

Carefully:

Decompensated chronic heart failure;

- hyponatremia of dilution (ADH hypersecretion syndrome, hypopituitarism, hypothyroidism, insufficiency of the adrenal cortex);

- Insufficiency of liver and kidney function;

- elderly age;

- active alcoholism (CNS depression is exacerbated, carbamazepine metabolism is increased);

- oppression of bone marrow hemopoiesis against the background of medication (in history);

- hyperplasia of the prostate;

- increased intraocular pressure;

- in combination with sedative-hypnotics.

Pregnancy and lactation:

Women of reproductive age Finlepsin® is possibly administered as a monotherapy in a minimally effective dose, since the incidence of congenital anomalies in newborns from mothers taking combined antiepileptic treatment is higher than in monotherapy.

At the onset of pregnancy, the expected benefit of therapy and possible complications should be compared, especially in the first trimester of pregnancy. It is known that children of mothers with epilepsy,predisposed to violations of intrauterine development, including malformations. Finlepsin® can increase the risk of these disorders. There are isolated reports of cases of congenital diseases and malformations, including the spina bifida.

Antiepileptic drugs increase the deficiency of folic acid, often observed during pregnancy, which can contribute to an increase in the frequency of birth defects in children, so folic acid intake is recommended before the planned pregnancy and during pregnancy. In order to prevent hemorrhagic complications in newborns, women in the last weeks of pregnancy, as well as newborns are recommended to prescribe vitamin K1.

Carbamazepine penetrates into breast milk, so the benefits and possible undesirable effects of breastfeeding should be compared in the context of ongoing therapy. With the continuation of breastfeeding with the reception of Finlepsin® should be monitored for the child due to the possibility of developing adverse reactions (eg, severe drowsiness, allergic skin reactions).

Dosing and Administration:

Inside, during or after a meal, with plenty of liquid.

Epilepsy

Whenever possible, Finlepsin® should be given as a monotherapy. The addition of Finlexin ® to already conducted antiepileptic therapy should be carried out gradually, with the doses of the drugs used, if necessary, corrected.

If the patient forgot to take the next dose of the drug in a timely manner, you should take the missed dose as soon as this omission became noticed, while you can not take a double dose of the drug.

Adults

The initial dose is 200-400 mg (1-2 tablets) per day, then the dose is gradually increased to achieve the optimal effect. The maintenance dose is 800-1200 mg per day, which is divided into 1-3 doses per day.

The maximum daily dose is 1.6-2 g.

Children

If the child is not able to swallow the whole tablet, it can be chewed, crushed or shaken in a small amount of water. The initial dose for children from 1 year to 5 years is 100-200 mg per day, then the dose is gradually increased by 100 mg per day until the optimal effect is achieved.

The initial dose for children from 6 to 10 years is 200 mg per day, then the dose is gradually increased by 100 mg per day until the optimal effect is achieved.

The initial dose for children from 11 to 15 years is 100-300 mg per day, then the dose is gradually increased by 100 mg per day until the optimal effect is achieved.

Supporting doses: for children 1-5 years - 200-400 mg per day (in several receptions), 6-10 years - 400-600 mg per day (in 2-3 sessions); 11-15 years - 600-1000 mg per day (in 2-3 sessions).

The following dosing schedule is recommended:

	Initial dose	Maintenance dose
Adults	1 tablet once a day	1-2 tablets 3 times a day
Children
from 1 year to 5 years	½ tablets 1-2 times a day	1 tablet 1-2 times a day
from 6 to 10 years	½ tablets 2 times a day	1 tablet 3 times a day
from 11'to 15 years	½ tablets 2-3 times a day	1 tablet 3-5 times a day

The duration of application depends on the indication and the individual reaction of the patient to the drug. The decision to transfer the patient to Finlepsin®, the duration of its application and the withdrawal of treatment is made by the doctor individually. The possibility of reducing the dose of the drug or discontinuing treatment is considered after a 2-3-year period of complete absence of seizures.

Treatment is stopped, gradually reducing the dose of the drug for 1-2 years, under the control of the EEG. Children with a decrease in the daily dose of the drug should take into account the increase in body weight with age.

Neuralgia of the trigeminal nerve, idiopathic glossopharyngeal neuralgia

The initial dose is 1-2 tablets (corresponding to 200-400 mg of carbamazepine), which is increased to 2-4 tablets in 1-2 doses (corresponding to 400-800 mg of carbamazepine), until the pain completely disappears. In a certain part of patients, treatment can be continued with a lower maintenance dose of 1 tablet 2 times a day (corresponding to 400 mg of carbamazepine).

Elderly patients and patients with increased sensitivity Finplexin® are prescribed in an initial dose of 1/2 tablet twice a day (corresponding to 200 mg of carbamazepine).

Treatment of alcohol abstinence in a hospital

The average daily dose is -1 tablet 3 times a day (corresponding to 600 mg of carbamazepine).

In severe cases, in the first days the dose can be increased to 2 tablets 3 times a day (corresponding to 1200 mg of carbamazepine).

If necessary, Finlexin® can be combined with other substances used for the treatment of alcohol abstinence.

Treatment for alcohol withdrawal syndrome Finlepsin® is stopped, gradually reducing the dose for 7-10 days.

During the treatment, the content of carbamazepine in the blood plasma must be regularly monitored.

In connection with the possible development of side effects from the central and autonomic nervous system, patients are carefully monitored in a hospital.

Pain in diabetic neuropathy

The average daily dose is -1 tablet 3 times a day (corresponding to 600 mg of carbamazepine). In exceptional cases, Finlepsin® can be given in a dose of 2 tablets 3 times a day (corresponding to 1200 mg of carbamazepine).

Epileptiform cramps in multiple sclerosis

The average daily dose is 1-2 tablets 2 times a day (corresponding to 400-800 mg of carbamazepine).

Treatment and prevention of psychosis

The initial dose and maintenance dose, as a rule, are the same: 1-2 tablets per day (corresponding to 200-400 mg of carbamazepine). If necessary, the dose can be increased to 2 tablets 2 times a day (corresponding to 800 mg of carbamazepine).

Side effects:

In assessing the incidence of various adverse reactions, the following grades were used: very often 10% or more, often 1-10%, sometimes 0.1-1%, rarely 0.01-0.1%, very rarely less 0.01%.

The development of adverse reactions from the central nervous system may be due to a relative overdose of the drug or significant fluctuations in the concentration of carbamazepine in the blood plasma.

From the side of the central nervous system: often - dizziness, ataxia, drowsiness, general 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, anxiety, aggressive behavior, psychomotor agitation, disorientation, psychosis activation, orofacial dyskinesia, oculomotor disorders, speech disorders (eg, dysarthria or slurred speech), choreoathetoid disorders, peripheral neuritis, paresthesia, muscle weakness and paresis symptoms. The role of the drug in the development of malignant neuroleptic syndrome, especially in combination with neuroleptics, remains unclear.

Allergic reactions: often - hives; sometimes erythroderma, multiorgan hypersensitivity reactions of delayed type with fever, skin rashes, vasculitis (including erythema nodosum, manifestation of cutaneous vasculitis), lymphadenopathy, signs resembling lymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function (these manifestations occur in various combinations).Other organs (for example, lungs, kidneys, pancreas, myocardium, large intestine), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, allergic pneumonitis, or eosinophilic pneumonia may also be involved. If the above-mentioned allergic reactions occur, the drug should be discontinued, rare - lupus-like syndrome, skin itching, multiform exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), photosensitivity.

On the part of the organs of hematopoiesis: often - leukopenia, thrombocytopenia, eosinophilia; rarely - leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, true erythrocyte aplasia, metal regional anemia, acute "intermittent" porphyria, reticulocytosis, hemolytic anemia, splenomegaly.

From the digestive system: often - nausea, vomiting, dry mouth increase in the activity of gamma-glutamyltransferase (due to the induction of this enzyme in the liver), which usually has no clinical significance,increased activity of alkaline phosphatase; sometimes - increased activity of "liver" transaminases, diarrhea or constipation, abdominal pain; rarely glossitis, gingivitis, stomatitis, pancreatitis, hepatitis, cholestatic, parenchymal (hepatocellular) type, jaundice, granulomatous hepatitis, hepatic insufficiency.

From the side of the cardiovascular system: rarely - violations of intracardiac conduction; decrease or increase in blood pressure, bradycardia, arrhythmia, atrioventricular blockade with syncope, collapse, aggravation or development of chronic heart failure, exacerbation of coronary heart disease (including the appearance or increase in angina attacks), thrombophlebitis, thromboembolic syndrome.

From the endocrine system and metabolism: often - swelling, fluid retention, weight gain, hyponatremia (decreased plasma osmolarity due to an effect similar to that of antidiuretic hormone, which in rare cases leads to hyponatremia of the breeding, accompanied by lethargy, vomiting, headache, disorientation and neurologic disorders); rarely - increased concentrationprolactin (may be accompanied by galactorrhea and gynecomastia); a decrease in the concentration of L-thyroxin and an increase in thyroid-stimulating hormone (usually not accompanied by clinical manifestations); disturbance of calcium phosphate metabolism in bone tissue (decrease in Ca concentration²⁺ and 25-OH-cholecalciferol in blood plasma): osteomalacia, hypercholesterolemia (including high-density lipoprotein cholesterol), hypertriglyceridemia and enlarged lymph nodes, hirsutism.

From the genitourinary system: rarely - interstitial nephritis, renal failure, impaired renal function (eg, albuminuria, hematuria, oliguria, urea / azotemia increase), frequent urination, urinary retention, decreased potency.

From the side of the musculoskeletal system: rarely - arthralgia, myalgia or cramps.

From the sense organs: rarely - violations of taste sensations, increased intraocular pressure; lens opacity, conjunctivitis; Hearing impairment, incl. noise in the ears, hyperacusia, hypoacusia, changes in perception of the height of sound.

Other: disorders of skin pigmentation, purpura, acne, sweating, alopecia.

Overdose:

Symptoms

Symptoms usually reflect violations from the central nervous system, cardiovascular and respiratory system.

Central nervous system and sense organs: oppression of central nervous system functions, disorientation, drowsiness, agitation, hallucinations, coma; blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia (at the beginning), hyporeflexia (later), convulsions, psychomotor disorders, myoclonus, hypothermia, mydriasis);

The cardiovascular system: tachycardia, lowering blood pressure, sometimes raising blood pressure, violation of intraventricular conduction with expansion of the QRS complex; fainting, cardiac arrest;

Respiratory system: respiratory depression, pulmonary edema;

Digestive system: nausea and vomiting, delayed evacuation of food from the stomach, decreased motility of the colon;

urinary system: urinary retention, oliguria or anuria; fluid retention; hyponatremia;

Laboratory indicators: leukocytosis or leukopenia, hyponatremia, metabolic acidosis is possible, hyperglycemia and glucosuria are possible, muscle fraction of creatine phosphokinase is increased.

Treatment

There is no specific antidote.It requires symptomatic supportive treatment in the intensive care unit, monitoring of heart function, body temperature, corneal reflexes, kidney and bladder function, correction of electrolyte disorders. It is necessary to determine the concentration of carbamazepine in the plasma to confirm poisoning with this drug and assess the degree of overdose, gastric lavage, the appointment of activated charcoal. Late evacuation of gastric contents can lead to delayed absorption on days 2 and 3 and the re-emergence of symptoms of intoxication during recovery). Forced diuresis, hemodialysis and peritoneal dialysis are ineffective; however, dialysis is indicated by a combination of severe poisoning and renal failure. Children may have a need for blood transfusion.

Interaction:

Simultaneous administration of carbamazepine with inhibitors of CYP3A4 may lead to an increase in its concentration in the blood plasma and the development of adverse reactions. The combined use of inducers CYP3A4 can lead to an acceleration of the metabolism of carbamazepine, a decrease in its concentration in the blood plasma and a decrease in the therapeutic effect;on the contrary, their cancellation can reduce the rate of biotransformation of carbamazepine and lead to an increase in its concentration.

Increase the concentration of carbamazepine in plasma verapamil, diltiazem, felodipine, dextropropoxyphene, viloxazine, 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, viral protease inhibitors used in HIV therapy (for example, ritonavir) - correction of the dosing regimen or monitoring of carbamazepine concentration in plasma is required.

Felbamate reduces the concentration of carbamazepine in plasma and increases the concentration of carbamazepine-10,11-epoxide, while a simultaneous decrease in serum felbamate concentration is possible.

The concentration of carbamazepine is reduced phenobarbital, phenytoin, primidon, metsuksimide, fensuksimid, theophylline, rifampicin, cisplatin, doxorubicin, perhaps: clonazepam, valpromid, valproic acid, oxcarbazepine and herbal preparations containing St. John's wort (Hypericum perforatum). There is the possibility of displacing valproic acid and primidone carbamazepine from the connection with plasma proteins and increasing the concentration of the pharmacologically active metabolite (carbamazepine-10,11-epoxide). With the combined use of the drug Finplesin ® with valproic acid in exceptional cases, coma and confusion may occur. Isotretinoin changes the bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxide (carbamazepine concentration in the plasma is monitored).

Carbamazepine can reduce the concentration in the plasma (reduce or even completely neutralize effects) and require correction of the doses of the following drugs: clobazam, clonazepam, digoxin, ethosuximide, primidon, valproic acid, alprazolam, glucocorticosteroids (prednisolone, dexamethasone), cyclosporine, tetracyclines (doxycycline), haloperidol, methadone, oral preparations containing estrogens and / or progesterone (it is necessary to select alternative methods of contraception), theophylline,oral anticoagulants (warfarin, fenprocumone, dicumarol), lamotrigine, topiramate, tricyclic antidepressants (imipramine, amitriltiline, nortriptyline, clomipramine), clozapine, felbamate, tiagabine, oxcarbazepine, protease inhibitors used in HIV therapy (indinavir, ritonavir, saquinovir) , calcium channel blockers (a group of dihydropyridones, for example, felodipine), itraconazole, levothyroxine, midazolam, olazapine, praziquantel, risperidone, tramadol, and ziprasidone. There is the possibility of increasing or reducing the level of phenytoin in the blood plasma against the background of carbamazepine and increasing the level of mephenytoin.

With the simultaneous use of carbamazepine and lithium preparations, the neurotoxic effects of both active substances can be enhanced.

Tetracyclines can weaken the therapeutic effect of carbamazepine.

When combined with paracetamol, the risk of its toxic effect on the liver increases and therapeutic effectiveness decreases (acceleration of the metabolism of paracetamol).

Simultaneous administration of carbamazepine with phenothiazine, pimozide, thioxanthenes, molindone, haloperidol, maprotiline,clozapine and tricyclic antidepressants leads to an intensifying inhibitory effect on the central nervous system and a weakening of the anticonvulsant effect of carbamazepine.

Monoamine oxidase inhibitors increase the risk of developing hyperpyretic crises, hypertensive crises, seizures, and death (prior to prescribing carbamazepine, monoamine oxidase inhibitors should be discontinued at least 2 weeks or, if the clinical situation permits, even over a longer period).

Simultaneous administration with diuretics (hydrochlorothiazide, furosemide) can lead to hyponatremia, accompanied by clinical manifestations.

Weakens the effects of nondepolarizing muscle relaxants (pancuronium). If such a combination is used, it may be necessary to increase the dose of muscle relaxants, and careful monitoring of the patient's condition is necessary in connection with the possibility of a faster cessation of the muscle relaxants.

Carbamazepine reduces the tolerance of ethanol.

Myelotoxic drugs increase manifestations of hematotoxicity of the drug.

Accelerates the metabolism of indirect anticoagulants, hormonal contraceptives, folic acid; prazikvantela, can enhance the elimination of thyroid hormones.

Accelerates the metabolism of drugs for anesthesia (enflurane, halothane, ftorotana) and increases the risk of hepatotoxic effects; enhances the formation of nephrotoxic metabolites of methoxyflurane.

Enhances the hepatotoxic effect of isoniazid.

Special instructions:

Monotherapy for epilepsy begins with the appointment of a low initial dose, gradually increasing it to achieve the desired therapeutic effect.

When choosing the optimal dose, it is advisable to determine the concentration of carbamazepine in the blood plasma, especially when combined therapy. In some cases, the optimal dose may deviate significantly from the recommended initial and maintenance dose, for example, due to the induction of microsomal liver enzymes or due to interactions in combination therapy.

Finlepsin® should not be combined with sedative-hypnotic means. If necessary, it can be combined with other substances used to treat alcohol withdrawal.During the treatment, the content of carbamazepine in the blood plasma must be regularly monitored. In connection with the development of side effects from the central and autonomic nervous system, patients are carefully monitored in a hospital. When transferring a patient to carbamazepine should gradually reduce the dose of the previously prescribed antiepileptic agent until its complete cancellation. A sudden discontinuation of carbamazepine may provoke epileptic seizures. If it is necessary to abruptly terminate treatment, the patient should be transferred to another antiepileptic agent under the cover of the drug shown in such cases (for example, diazepam administered intravenously or rectally, or phenytoin administered intravenously).

Several cases of vomiting, diarrhea and / or reduced nutrition, seizures and / or respiratory depression in newborns whose mothers have been taken carbamazepine concomitantly with other anticonvulsants (perhaps these reactions are manifestations in newborn withdrawal syndrome). Before the appointment of carbamazepine and during the treatment it is necessary to study the function of the liver,especially in patients with a history of which there is evidence of liver disease, as well as in elderly patients. In case of strengthening of already existing violations of the liver function or when there is an active liver disease, the drug should be immediately canceled. Before starting treatment, it is necessary to conduct a blood test (including platelet count, reticulocyte count), serum iron level, total urine test, blood urea level, electroencephalogram, determination of serum electrolyte concentration (and periodically during treatment, t. possibly the development of hyponatremia). Subsequently, these indicators should be monitored during the first month of treatment on a weekly basis, and then on a monthly basis.

In most cases, a transient or persistent decrease in the number of platelets and / or leukocytes is not a harbinger of the onset of aplastic anemia or agranulocytosis. Nevertheless, before the start of treatment, and also periodically during the treatment, clinical blood tests should be performed, including counting the number of platelets and, possibly, reticulocytes, as well as determining the level of iron in the blood serum.Non-progressive asymptomatic leukopenia does not require withdrawal, however, treatment should be discontinued if progressive leukopenia or leukopenia occurs, accompanied by clinical symptoms of an infectious disease. Carbamazepine should be immediately withdrawn when hypersensitivity reactions or symptoms, presumably indicative of the development of Stevens-Johnson syndrome or Lyell syndrome, appear. Slightly expressed skin reactions (isolated macular or maculopapular exanthema) usually pass for several days or weeks, even with continued treatment or after a decrease in the dose of the drug (the patient at this time should be under close medical supervision).

It should take into account the possibility of activation of latent psychoses, and in elderly patients - the possibility of development of disorientation or psychomotor agitation.

In some cases, treatment with antiepileptic drugs was accompanied by the appearance of suicidal attempts / suicidal intentions. This was also confirmed by a meta-analysis of randomized clinical trials using antiepileptic drugs.As the mechanism of occurrence of suicidal attempts at use of antiepileptic preparations is not known, it is impossible to exclude their occurrence and at treatment of patients with preparation Finlepsin®. Patients and attendants should be warned about the need to monitor the occurrence of suicidal thoughts / suicidal behavior and in the event of symptoms, seek medical help immediately.

There are male fertility disorders and / or disorders of spermatogenesis, but the relationship between these disorders with carbamazepine has not been established.

Mezhmentsrualnyh may cause bleeding, while the use of oral contraceptives. Carbamazepine can adversely affect the reliability of oral contraceptives, so women of reproductive age should be treated with alternative methods of protection during pregnancy.

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 is informed of the need to immediately consult a doctor if there are undesirable reactions such as fever, sore throat, rash, ulceration of the oral mucosa, unjustified bruising, hemorrhage in the form of petechiae or purpura.

Before the beginning of treatment it is recommended to conduct an ophthalmological examination, including examination of the fundus and measurement of intraocular pressure. In the case of prescribing patients with increasing intraocular pressure, a constant monitoring of this indicator is required.

Patients with severe cardiovascular diseases, liver and kidney damage, as well as elderly people are prescribed lower doses of the drug. Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very low, nevertheless, regular determination of the level of carbamazepine can be useful in the following situations: with a sharp increase in the frequency of seizures; to check whether the patient is taking the drug properly; during pregnancy; when treating children or adolescents; with suspected drug absorption abnormalities; if suspected to develop toxicreactions in case the patient takes several medicines.

During treatment with Finplesin® it is recommended to refrain from drinking alcohol.

Effect on the ability to drive transp. cf. and fur:During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets 200 mg.

Packaging:For 10 tablets in a blister of PVC / PVDC / aluminum foil.

For 3.4 or 5 blisters with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015012 / 01

Date of registration:10.10.2008

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Operations Poland, Sp. z o.o. Poland

Representation: & nbspTeva Teva Israel

Information update date: & nbsp11.09.2012

Illustrated instructions

Instructions

Finlepsin® (Finlepsin® )