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Carbamazepine

Brand Teva

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Available since: 2019-09-19

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Clinical Pharmacology

Antiepileptic drug (dibenzazepine derivative). It also has an antidepressant, antipsychotic and antidiuretic effect, has an analgesic effect in patients with neuralgia. The mechanism of action is associated with the blockade of potential-dependent sodium channels, which leads to stabilization of the membrane of overexcited neurons, inhibition of the occurrence of serial discharges of neurons and a decrease in synaptic conduction of impulses. Prevents re-formation of Na⁺-dependent action potentials in depolarized neurons. It reduces the release of glutamate (amino acids with stimulating neurotransmitter properties), increases the reduced threshold of convulsive readiness and, thus, reduces the risk of an epileptic seizure. Increases the transport of potassium ions, modulates voltage gated calcium channels, which can also contribute to the anticonvulsant effect of the drug. Effective with focal (partial) epileptic seizures (simple and complex), accompanied or not accompanied by secondary generalization, with generalized tonic-clonic epileptic seizures, as well as with a combination of these types of seizures (usually ineffective with small attacks - petit mal, absans and myoclonic seizures ).

In patients with epilepsy (especially in children and adolescents), a positive effect on the symptoms of anxiety and depression, as well as a decrease in irritability and aggressiveness, was noted. The effect on cognitive function and psychomotor performance depends on the dose.

The onset of the anticonvulsant effect varies from several hours to several days (sometimes up to 1 month due to autoinduction of metabolism).

With essential and secondary trigeminal neuralgia in most cases prevents the occurrence of pain attacks. The weakening of pain in trigeminal neuralgia occurs after 8-72 hours.

In the case of alcohol withdrawal syndrome, the threshold of convulsive readiness (which is usually lowered in this condition) and reduces the severity of the clinical manifestations of the syndrome (irritability, tremor, gait disturbances).

Antipsychotic (anti-manic) action develops in 7-10 days, which may be due to inhibition of dopamine and noradrenaline metabolism.

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

Pharmacokinetics

Indications

epilepsy: primary generalized seizures (except for absences), partial forms of epilepsy (simple and complex seizures), secondary generalized seizures;
trigeminal neuralgia;
idiopathic neuralgia of the glossopharyngeal nerve;
diabetic polyneuropathy pain;
epileptiform convulsions in multiple sclerosis, facial muscle spasms in trigeminal neuralgia, tonic convulsions, paroxysmal dysarthria and ataxia, paroxysmal paresthesias and bouts of pain;
alcohol withdrawal syndrome (anxiety, convulsions, hyperexcitability, sleep disorders);
psychotic disorders (affective and schizoaffective disorders, psychosis, limbic function disorders

Composition

Excipients: copolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate (1: 2: 0.1) (Eudragit^® RS30D) - 11 mg, triacetin - 2.2 mg, talc - 15.6 mg, copolymer of methacrylic acid and ethyl acrylate (Eudragit^®L30D-55) - 35 mg, microcrystalline cellulose - 21.8 mg, crospovidone - 12.4 mg, colloidal silicon dioxide - 1.33 mg, magnesium stearate - 0.67 mg.

Carbamazepine is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Finlepsin retard	Teva	Israel	pills
Finlepsin	Teva	Israel	pills
Tegretol	Novartis	Switzerland	pills
Tegretol CR	Novartis	Switzerland	pills

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Dosage and Administration

The drug is taken orally during or after a meal, drinking plenty of fluids.

For ease of use, the tablet (as well as its half or quarter) can be pre-dissolved in water or in juice, since the property of prolonged release of the active substance after the tablet is dissolved in the liquid is retained. The range of doses used is 400-1200 mg / day. The daily dose is divided into 1-2 doses.

The maximum daily dose is 1600 mg.

Epilepsy

When possible, Finlepsin^® retard should be prescribed as monotherapy. Treatment begins with the use of a small daily dose, which is then slowly increased to achieve the optimal effect.

The accession of the drug Finlepsin^® The retard to already ongoing antiepileptic therapy should be carried out gradually, while the doses of the drugs used do not change or, if necessary, be adjusted.

When you skip taking the next dose of the drug, you should take the missed dose as soon as it is noticed, and you should not take a double dose of the drug.

Adults

The initial dose is 200-400 mg / day, then the dose is slowly increased to achieve the optimal therapeutic effect. Maintenance dose is 800-1200 mg / day in 1-2 doses.

Children

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

Maintenance doses for children aged 6-10 years - 400-600 mg / day (in 2 doses), for children aged 11-15 years - 600-1000 mg / day (in 2 doses).

The recommended dosing regimen is presented in the table.

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

The duration of application depends on the indications and the individual response of the patient to the drug.

The decision to transfer the patient to the use of the drug Finlepsin^® retard, the duration of its use or cancellation of treatment is taken by the doctor individually. The dose of the drug can be reduced or completely abolished not earlier than after a 2-3-year complete absence of seizures.

Treatment is stopped, gradually reducing the dose within 1-2 years, under the control of EEG. At the same time in children with a decrease in the daily dose should be considered an increase in body weight with age.

Trigeminal neuralgia, idiopathic glossopharyngeal nerve neuralgia

The initial dose is 200-400 mg / day in 2 doses. The initial dose is increased up to the complete disappearance of pain, on average, up to 400-800 mg / day. After that, in a certain part of patients, therapy can be continued with a lower maintenance dose of 400 mg / day.

Elderly patients and patients with individual sensitivity to the action of carbamazepine drug Finlepsin^® retard prescribed in the initial dose of 200 mg 1 time / day.

Diabetic Neuropathy Pain

The drug is prescribed 200 mg in the morning and 400 mg in the evening. In exceptional cases, the drug Finlepsin^® retard can be administered in a dose of 600 mg 2 times / day.

Treatment of alcohol withdrawal in the hospital

The average daily dose is 600 mg (200 mg in the morning and 400 mg in the evening). In severe cases, in the first days, the dose can be increased to 1200 mg / day in 2 divided doses.

If necessary, the drug Finlepsin^® Retard can be combined with other drugs used to treat alcohol withdrawal, in addition to sedatives and hypnotics.

During treatment, it is necessary to regularly monitor the content of carbamazepine in the blood plasma.

In connection with the development of adverse reactions from the central nervous system and the autonomic nervous system, patients are carefully monitored in the hospital.

Epileptiform convulsions in multiple sclerosis

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

Treatment and prevention of psychosis

The initial dose and maintenance dose, as a rule, are the same: 200-400 mg / day. If necessary, the dose can be increased to 400 mg 2 times / day.

Adverse reactions

When assessing the frequency of occurrence of various adverse reactions, the following criteria were used: very often (≥10%), often (≥1%, but

On the part of the central nervous system and peripheral nervous system: often - dizziness, ataxia, drowsiness, general weakness, headache, accommodation paresis; sometimes - abnormal involuntary movements (eg, tremor, "fluttering" tremor, dystonia, tics), nystagmus; rarely - hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggressive behavior, psychomotor agitation, disorientation, activation of psychosis, orofacial dyskinesia, oculomotor disturbances, speech disorders (for example, dysarthria or slurred speech), choreoathetoid disorders, peripheral neuritis, paresthesias, muscle weakness and paresis. The role of carbamazepine in the development of NNS, especially in combination with neuroleptics, remains unexplained.

The development of side effects from the central nervous system may be a consequence of the relative overdose of the drug or significant fluctuations in the concentration of carbamazepine in the blood plasma.

Allergic reactions: often - urticaria; sometimes - erythroderma, multiorgan hypersensitivity reactions of a delayed type with fever, skin rashes, vasculitis (including nodular erythema, as a manifestation of cutaneous vasculitis), lymphadenopathy, lymphoma-like signs, arthralgia, leukopenia, eosinophilia, a hepatic spleen, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver, a maver and a maver. (These manifestations are found in various combinations). Other organs (eg, lungs, kidneys, pancreas, myocardium, colon), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactoid reaction, angioedema, allergic pneumonitis, or eosinophilic pneumonia may also be involved. If you experience the above allergic reactions, the drug should be discontinued. Rarely - lupus-like syndrome, itchy skin, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), photosensitivity.

From the hemopoietic system: often - leukopenia, thrombocytopenia, eosinophilia; rarely - leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, true erythrocytic aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia, splenomegaly.

On the part of the digestive system: often - nausea, vomiting, dry mouth, increased GGT activity (due to the induction of this enzyme in the liver), which usually has no clinical significance, increased activity of alkaline phosphatase; sometimes - diarrhea or constipation, abdominal pain, increased activity of hepatic transaminases; rarely - glossitis, gingivitis, stomatitis, pancreatitis, hepatitis (cholestatic, parenchymatous), jaundice, granulomatous hepatitis, hepatic failure.

Since the cardiovascular system: rarely - violations of intracardiac conduction; decrease or increase in blood pressure, bradycardia, arrhythmias, AV blockade with fainting, collapse, worsening or development of chronic heart failure, exacerbation of coronary artery disease (including the occurrence or increase in 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 dilution hyponatremia, accompanied by lethargy, vomiting, headache, disorientation and neurological disorders); rarely, an increase in prolactin concentration (may be accompanied by galactorrhea and gynecomastia); a decrease in the concentration of L-thyroxine and an increase in the concentration of TSH (usually not accompanied by clinical manifestations); disorders of calcium-phosphorus metabolism in bone tissue (decrease in the concentration of Ca²⁺ and 25-OH-colecalciferol in plasma): osteomalacia, hypercholesterolemia (including cholesterol-HDL), hypertriglyceridemia and swollen lymph nodes, hirsutism.

On the part of the urogenital system: rarely - interstitial nephritis, renal failure, impaired renal function (for example, albuminuria, hematuria, oliguria, increased urea concentration / azotemia), frequent urination, urinary retention, reduced potency.

On the part of the musculoskeletal system: rarely - arthralgia, myalgia or convulsions.

From the senses: rarely - a violation of taste, increased intraocular pressure, clouding of the lens, conjunctivitis; hearing impairment, incl. tinnitus, hyperacusia, hypoacusia, changes in perception of pitch.

Dermatological reactions: skin pigmentation disorders, purpura, acne, sweating, alopecia.

The drug should be used with caution in decompensated chronic heart failure, in abnormal liver and / or kidney function, in elderly patients, in patients with chronic alcoholism (CNS depression increases, carbamazepine metabolism increases), in dilution hyponatremia (ADH hypersecretion syndrome, hypopituarism, hypothyroidism, adrenal cortex insufficiency), with inhibition of bone marrow hematopoiesis on the background of medication (in history), with prostatic hyperplasia, intraocular pressure; with simultaneous use with sedatives and hypnotic drugs.

Application for violations of the liver

With caution, the drug should be used in violation of the liver.

Drug interactions

With simultaneous use with CYP3A4 isoenzyme inhibitors, it is possible to increase the concentration of carbamazepine in the blood plasma and the development of adverse reactions.

Combined use with CYP3A4 isoenzyme inducers can lead to an acceleration of metabolism and a decrease in plasma plasma carbamazepine concentration and a decrease in the therapeutic effect. On the contrary, their cancellation may decrease the rate of biotransformation of carbamazepine and lead to an increase in its concentration.

When combined, the concentration of carbamazepine in plasma increases 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, protease inhibitors used in the treatment of HIV infection (for example, ritonavir) .

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

When used together, the concentration of carbamazepine is reduced by phenobarbital, phenytoin, primidone, metsuximid, phensuximide, theophylline, rifampicin, cisplatin, doxorubicin. A similar effect may cause clonazepam, valpromid, valproic acid, oxcarbazepine, and herbal preparations containing St. John's wort (Hypericum perforatum).

When used together, valproic acid and primidone can displace carbamazepine from binding to plasma proteins and increase the concentration of the pharmacologically active metabolite (carbamazepine-10,11-epoxide). With the combined use of the drug Finlepsin^® retardum with valproic acid in exceptional cases may occur coma and confusion.

When used together, isotretinoin alters the bioavailability and / or clearance of carbamazepine and carbamazepine-10,11-epoxide (monitoring plasma carbamazepine concentration is necessary).

With simultaneous application of carbamazepine can reduce the concentration of plasma and therefore minimize or even completely neutralize the effects and require a correction dose following drugs: klobazama, clonazepam, digoxin, ethosuximide, primidone, valproic acid, alprazolam, corticosteroids (prednisone, dexamethasone), cyclosporin tetracyclines (doxycycline), haloperidol, methadone, oral medications containing estrogen and / or progesterone (selection of alternative methods of contraception is necessary), theophylline, oral anti oagulans (warts); calcium channel blockers (a group of dihydropyridine, for example, felodipine), itraconazole, levothyroxine, midazolam, olanzapine, praziquantel, risperidone, tramadol, ziprasidone.

There is a possibility of increasing or decreasing phenytoin in the blood plasma against the background of carbamazepine and increasing the level of mephenytoin (in rare cases).

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

Tetracyclines may weaken the therapeutic effect of carbamazepine.

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

The simultaneous administration of carbamazepine with phenothiazine, pimozide, thioxanthenes (chlorprotixen), molindone, haloperidol, maprotilin, clozapine and tricyclic antidepressants leads to an increase in the inhibitory effect on the central nervous system and weaken the anticonvulsant effect of carbamazepine.

MAO inhibitors increase the risk of hyperthermic crises, hypertensive crises, convulsions, death (before prescribing carbamazepine, MAO inhibitors should be canceled at least 2 weeks later, or if the clinical situation allows, even for a longer period).

The simultaneous appointment with diuretics (hydrochlorothiazide, furosemide) can lead to hyponatremia, accompanied by clinical manifestations.

When combined, carbamazepine reduces the effects of non-depolarizing muscle relaxants (pancuronium). In the case of the use of such a combination, it may be necessary to increase the dose of muscle relaxants, and it is necessary to carefully monitor the patients, since their action can be terminated more quickly.

Reduces ethanol tolerance.

Myelotoxic drugs increase the hematotoxicity of carbamazepine.

Accelerates the metabolism of indirect anticoagulants, hormonal contraceptive drugs, folic acid; Praziquantel.

May enhance the elimination of thyroid hormones.

Accelerates the metabolism of anesthetic agents (enflurane, halothane, fluorothane) with an increased risk of hepatotoxic effects.

Enhances the formation of nephrotoxic metabolites of methoxyfluran.

Enhances the hepatotoxic effect of isoniazid.

Pregnancy and Lactation

The drug should be used only under the condition of regular medical supervision.

Epilepsy monotherapy begins with the appointment of the drug in low doses, gradually increasing them to achieve the desired therapeutic effect.

In some cases, treatment with antiepileptic drugs has been accompanied by the occurrence of suicidal attempts / suicidal intentions. This has also been confirmed in a meta-analysis of randomized clinical trials using antiepileptic drugs.Since the mechanism of the occurrence of suicidal attempts with the use of antiepileptic drugs is not known, their occurrence cannot be ruled out during the treatment with Finlepsin^® retard. Patients and service personnel 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.

It is advisable to determine the concentration of carbamazepine in plasma in order to select the optimal dose, especially in combination therapy. In some cases, the required dose for treatment may significantly deviate from the recommended initial and maintenance dose, for example, due to accelerated metabolism due to the induction of microsomal liver enzymes or as a result of drug interactions during combination therapy.

Drug Finlepsin^® retard should not be combined with sedative-hypnotics. If necessary, it can be combined with other substances used to treat alcohol withdrawal.

When transferring a patient to carbamazepine, the dose of a previously prescribed antiepileptic agent should be gradually reduced to its complete abolition. A sudden discontinuation of carbamazepine can trigger epileptic seizures. If it is necessary to abruptly interrupt the treatment, the patient should be transferred to another antiepileptic drug under the guise of the drug indicated in such cases (for example, diazepam IV or rectal, or phenytoin IV).

Several cases of vomiting, diarrhea and / or reduced nutrition, seizures and / or respiratory depression in newborns whose mothers took carbamazepine along with other anticonvulsants have been described (perhaps these reactions are manifestations of withdrawal syndrome in newborns).

It should be borne in mind that carbamazepine may adversely affect the reliability of oral contraceptive drugs, therefore, women of reproductive age during treatment should use alternative methods of contraception from pregnancy (intermenstrual bleeding is likely in women while using oral contraceptives).

Before the appointment of carbamazepine and in the process of treatment, monitoring of liver function indicators is necessary, especially in patients with a history of liver disease, as well as in elderly patients. In the case of an increase in the already existing liver dysfunction or in case of the appearance of an active liver disease, the drug should be immediately canceled. Before treatment, it is necessary to conduct a study of the blood picture (including platelet count, reticulocyte count), serum iron level, urinalysis, blood urea level, EEG, determination of electrolyte concentration in serum; blood (and periodically during treatment, as may develop hyponatremia). Subsequently, these indicators should be monitored during the first month of treatment weekly, and then monthly.

In most cases, a transient or persistent decrease in the number of platelets and / or leukocytes is not a precursor of the onset of aplastic anemia or agranulocytosis. However, before starting treatment, as well as periodically in the course of treatment, clinical blood tests should be carried out, including counting the number of platelets and possibly reticulocytes, as well as determine the level of serum iron. Non-progressive asymptomatic leukopenia does not require discontinuation, but treatment should be stopped when a progressive leukopenia or leukopenia appears, which is accompanied by clinical symptoms of an infectious disease.

Carbamazepine should be immediately discontinued when hypersensitivity reactions or symptoms appear, suggesting the development of Stevens-Johnson syndrome or Lyell's syndrome. Mild skin reactions (isolated macular or maculo-papular rash) usually go away within a few days or weeks even with continued treatment or after lowering the dose of the drug (the patient must be under medical supervision at this time).

When using the drug should take into account the possibility of activation of latent proceeding psychosis, and in elderly patients - the possibility of developing disorientation or psychomotor agitation.

Possible violations of male fertility and / or impaired spermatogenesis (the relationship of these disorders with the intake of carbamazepine has not yet been established).

The patient should be informed about possible early signs of toxic reactions from the hematopoietic system, liver and dermatological reactions and the need to immediately consult a doctor if undesirable reactions such as fever, sore throat, rash, ulceration of the oral mucosa, cause of hematomas occur. , hemorrhages in the form of petechiae or purpura.

Before treatment, it is recommended to perform an ophthalmologic examination, including examination of the fundus of the eye with a slit lamp and measurement of intraocular pressure if necessary. In appointing the drug to patients with elevated intraocular pressure, its constant monitoring is necessary.

Patients with severe diseases of the cardiovascular system, liver and kidney damage, as well as elderly people are prescribed the drug in lower doses.

Although the relationship between the dose of carbamazepine, its concentration and clinical efficacy or tolerability is very insignificant, regular determination of the concentration of carbamazepine in plasma is also useful with a sharp increase in the frequency of attacks; to check the regularity of taking the drug by the patient; during pregnancy; in the treatment of children or adolescents; if suspected violations of the absorption of the drug; if you suspect the development of toxic reactions in case the patient takes several drugs.

Against the background of the drug is recommended to abandon the use of alcohol.

Special instructions

The drug should be used only under the condition of regular medical supervision.

Epilepsy monotherapy begins with the appointment of the drug in low doses, gradually increasing them to achieve the desired therapeutic effect.

In some cases, treatment with antiepileptic drugs has been accompanied by the occurrence of suicidal attempts / suicidal intentions. This has also been confirmed in a meta-analysis of randomized clinical trials using antiepileptic drugs. Since the mechanism of the occurrence of suicidal attempts with the use of antiepileptic drugs is not known, their occurrence cannot be ruled out during the treatment with Finlepsin^® retard. Patients and service personnel 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.

Drug Finlepsin^® retard should not be combined with sedative-hypnotics.If necessary, it can be combined with other substances used to treat alcohol withdrawal.

Possible violations of male fertility and / or impaired spermatogenesis (the relationship of these disorders with the intake of carbamazepine has not yet been established).

Before treatment, it is recommended to perform an ophthalmologic examination, including examination of the fundus of the eye with a slit lamp and measurement of intraocular pressure if necessary.In appointing the drug to patients with elevated intraocular pressure, its constant monitoring is necessary.

Patients with severe diseases of the cardiovascular system, liver and kidney damage, as well as elderly people are prescribed the drug in lower doses.

Against the background of the drug is recommended to abandon the use of alcohol.

Overdosage

Overdose symptoms and complaints usually reflect violations of the central nervous system, cardiovascular and respiratory systems.

On the part of the central nervous system and sensory organs: depression of the central nervous system function, disorientation, drowsiness, agitation, hallucinations, coma, blurred vision, slurred speech, dysarthria, nystagmus, ataxia, dyskinesia, hyperreflexia, turning into hyporeflexia, seizures, psychomotor disorders, myoclonus, hypothermia mydriasis.

Since the cardiovascular system: tachycardia, lowering blood pressure, sometimes increasing blood pressure, disturbances of intraventricular conduction with the expansion of the QRS complex, syncope, cardiac arrest.

On the part of the respiratory system: respiratory depression, pulmonary edema.

On the part of the digestive system: nausea, vomiting, delayed evacuation of food from the stomach, decreased colon motility.

On the part of the urinary system: urinary retention, oliguria or anuria; fluid retention.

From the laboratory parameters: leukocytosis or leukopenia, hyponatremia, possible metabolic acidosis, possible hyperglycemia and glycosuria, increased muscle fraction of CPK.

Treatment: no specific antidote. Symptomatic supportive treatment in ICU, monitoring of heart function, body temperature, corneal reflexes, kidney and bladder function, correction of electrolyte disorders are needed. It is necessary to determine the concentration of carbamazepine in the plasma to confirm the poisoning of this tool and assess the degree of overdose, gastric lavage, the appointment of activated carbon. Late evacuation of gastric contents may lead to delayed absorption for 2 and 3 days and recurrence of symptoms of intoxication during the recovery period). Forced diuresis, hemodialysis, and peritoneal dialysis are ineffective; However, dialysis is indicated for a combination of severe poisoning and renal failure. Children may need blood transfusions.

Brand name: Finlepsin retard
Active ingredient: Carbamazepine
Dosage form: pills of prolonged action from white to white with a yellowish tinge, rounded, flat, with beveled edges, with cross-shaped fracture lines on both sides and 4 notches on the lateral surface.
Manufacturer: Teva
Country of Origin: Israel