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

Excipients: ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate copolymer [1: 2: 0.1] (Eudragit® Rs30D), triacetin, talc, methacrylic acid and ethyl acrylate copolymer (Eudragit® L30D-55), cellulose microcrystalline, rospovidone, silicon dioxide colloid, magnesium stearate.

Description:

Tablets of prolonged action 200 mg: from white to white with a yellowish hue of color, rounded flat pills with bevelled edges, with crosswise fault lines on both sides and 4 notches on the side surface.

Long-acting tablets 400 mg: from white to white with a yellowish hue of color, rounded flat pills with bevelled edges, with crosswise fault lines on both sides and 4 notches on the side surface.

Pharmacotherapeutic group:antiepileptic agent

ATX: & nbsp

N.03.A.F.01 Carbamazepine

Pharmacodynamics: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 re-education Na⁺-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 the focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic attacks, as well as with a combination of these types of seizures (usually ineffective in small seizures - 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.

The prolonged dosage form ensures the maintenance of a more stable concentration of carbamazepine in the blood when taken 1-2 times a day.

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 32 hours. The average value of the maximum concentration of unchanged active substance after a single dose of 400 mg of carbamazepine is about 2.5 μg / ml. Equilibrium concentrations of the drug in the plasma are achieved after 1-2 weeks (the rate of achievement depends on the individual features of the metabolism: autoinduction of enzyme systems of the liver, heteroinduction by other, simultaneously used, drugs), as well as the patient's condition, dose of the drug and the duration of treatment. There are significant individual 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 the cerebrospinal fluid and saliva, concentrations proportional to the amount of the active substance unbound with proteins (20-30%) are created. 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 an inactive conjugate with glucuronic acid. The main isoenzyme providing the biotransformation of carbamazepine in carbamazepine-10,11-epoxide is cytochrome P450 (CYP3A4). As a result of these metabolic reactions, a 9-hydroxy-methyl-10-carbamoylacridan metabolite is also formed, which has a weak pharmacological activity. Carbamazepine can induce its own metabolism.

Half-life after oral administration of a single dose is 60-100 hours (an average of about 70 hours), with prolonged admission, the elimination half-life decreases due to autoinduction of the liver enzyme systems. After a single admission of carbamazepine, 72% of the dose taken is excreted in urine and 28% with feces; while about 2% of the dose taken is excreted in the urine in the form of unchanged carbamazepine, about 1% - in the form of a 10,11-epoxide metabolite.

Data showing that the pharmacokinetics of carbamazepine varies in elderly patients is not.

Indications:

- Epilepsy: primary-generalized seizures (with the exception of absences), partial forms of epilepsy (simple and complex seizures), secondary generalized seizures;

- 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:

For women of childbearing age, Finlepsin® retard is administered as a monotherapy if possible 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 are predisposed to violations of intrauterine development, including developmental defects. Finlepsin® retard is capable of increasing the risk of these disorders. There are isolated reports of cases of congenital diseases and malformations, including non-vertebral arches (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 on the background of taking the drug should be established observation of the child due to the possibility of developing adverse reactions (eg, pronounced drowsiness, allergic skin reactions).

Dosing and Administration:

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

For ease of use, the tablet (as well as its half or quarter) can be pre-dissolved in water or in juice, since the prolonged release of the active ingredient after dissolution of the tablet in the liquid is maintained. The range of doses used is 400-1200 mg per day, which is divided into 1-2 doses per day.

The maximum daily dose should not exceed 1600 mg.

Epilepsy

Whenever possible, Finlepsin® retard should be given as a monotherapy. Treatment begins with the application of a small daily dose, which is then slowly increased until an optimal effect is achieved. Attachment Finlepsin® retard to already conducted antiepileptic therapy should be carried out gradually, while the doses of the drugs used do not change or, if necessary, correct. 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 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 1-2 doses per day.

Children

The initial dose for children from 6 to 15 years is 200 mg per day, then the dose is gradually increased by 100 mg per day until the optimal effect is achieved.

Supportive doses for children 6-10 years - 400-600 mg per day (in 2 divided doses); for children 11-15 years - 600-1000 mg per day (in 2 divided doses).

The following dosing schedule is recommended:

	Initial dose	Maintenance dose
Adults	200-300 mg in the evening	200-600 mg in the morning 400-600 mg in the evening
Children from 6 to 10 years	200 mg in the evening	200 mg in the morning 200-400 mg in the evening
from 11 to 15 years	200 mg in the evening	200-400 mg in the morning 400-600 mg in the evening

The duration of application depends on the indication and individual response of the patient to treatment. The decision to transfer a patient to the drug Finlepsin® retard, the duration of its application and the withdrawal of treatment is taken 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 200-400 mg per day, which is divided into 2 doses. The initial dose is increased until the pain disappears completely, on average, to 400-800 mg per day. After this, in a certain part of patients, treatment can be continued with a lower maintenance dose of 400 mg.

Patients with advanced age and patients susceptible to carbamazepine Finlepsin® retard is prescribed in an initial dose of 200 mg once a day.

Pain in diabetic neuropathy

The average daily dose of 200 mg in the morning and 400 mg in the evening. In exceptional cases, Finlexin® retard can be given in a dose of 600 mg twice a day.

Treatment of alcohol abstinence in a hospital

The average daily dose is 600 mg (200 mg in the morning and 400 mg in the evening).

In severe cases, in the early days, the dose can be increased to 1200 mg per day, which is divided into 2 divided doses.

If necessary, Finlexin® retard can be combined with other substances used to treat alcohol withdrawal, except for sedatives and hypnotics.

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.

Epileptiform cramps in multiple sclerosis

The average daily dose is 200-400 mg 2 times a day.

Treatment and prevention of psychosis

The initial dose and the maintenance dose, as a rule, are the same: 200-400 mg per day. If necessary, the dose can be increased to 400 mg twice a day.

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, decreased appetite,anxiety, aggressive behavior, psychomotor agitation, disorientation, activation of psychosis, 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 - an increase in the concentration of prolactin (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 CYP3A4 can lead to an increase in its concentration in the blood plasma and the development of adverse reactions. Joint application of inducersCYP3A4 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 Finlexin® retard 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 (the choice of alternative methods of contraception), theophylline, oral anticoagulants (warfarin, fenprocumone, dicumarol), lamotrigine, topiramate, tricyclic antidepressants (imipramine, amitriltiline, nortriptyline, clomipramine), clozapine, felbamate, tiagabine, oxcarbazepine, protease inhibitors HIV infection (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® retard should not be combined with sedative hypnotics. 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 in the process of treatment, it is necessary to study the liver function, especially in patients whose history includes information on liver diseases, 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 the beginning of treatment it is necessary to conduct a study of the blood picture (including platelet count, reticulocyte count), serum iron level, general urine analysis, urea level in the blood, electroencephalogram,determination of the concentration of electrolytes in the blood serum (and periodically during treatment, since it is possible to develop 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. Since the mechanism of occurrence of suicidal attempts with the use of antiepileptic drugs is not known, one can not exclude their occurrence in the treatment of patients with the drug Finplesin® retard. 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 may be violations of male fertility and / or impaired spermatogenesis, but the relationship between these disorders and carbamazepine is not yet established.

There may be inter-menstrual bleeding with the simultaneous 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 there is a suspicion of the development of toxic reactions in the event that the patient takes several medicines.

During treatment Finlepsin® retard it is recommended to refrain from using adrinking.

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 of prolonged action 200 mg, 400 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 ⁰ FROM.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N 015417/01

Date of registration:17.10.2008

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® retard (Finlepsin® retard)