Finlepsin

Leaflet accompanying the packaging: information for the user

Finlepsin, 200 mg, tablets

Carbamazepine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Finlepsin and what is it used for
• 2. Important information before taking Finlepsin
• 3. How to take Finlepsin
• 4. Possible side effects
• 5. How to store Finlepsin
• 6. Contents of the packaging and other information

1. What is Finlepsin and what is it used for

Finlepsin contains carbamazepine, a tricyclic compound with mainly anticonvulsant, neurotropic, and psychotropic effects. It also has analgesic effects, e.g., in cases of trigeminal neuralgia and other paroxysmal pains. The mechanism of anticonvulsant action of carbamazepine is only partially understood. The drug probably blocks the spread of abnormal bioelectric discharges in the brain.

Indications for the use of Finlepsin are:

• epilepsy: simple and complex partial seizures; generalized tonic-clonic seizures (especially secondary generalized), occurring during sleep and mixed-type seizures;
• idiopathic trigeminal neuralgia;
• idiopathic glossopharyngeal neuralgia;
• pain in diabetic neuropathy;
• trigeminal neuralgia in multiple sclerosis;
• prevention of seizures in alcoholic withdrawal syndrome in hospital conditions.

2. Important information before taking Finlepsin

When not to take Finlepsin:

• if the patient is allergic to carbamazepine, tricyclic antidepressants, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has bone marrow disorders or bone marrow suppression in their medical history;
• if the patient has severe heart conduction disorders (atrioventricular block);
• if the patient has acute intermittent porphyria (a genetically determined defect in porphyrin metabolism);
• if the patient is taking monoamine oxidase inhibitors and for 14 days after their withdrawal;
• if the patient is taking voriconazole (an antifungal medicine), as it disrupts the action of carbamazepine.

If any of the above points apply to the patient, they should inform their doctor before taking Finlepsin.If the patient suspects that they may be allergic to the medicine, they should consult a doctor.

Warnings and precautions

Before starting treatment with Finlepsin, the patient should discuss it with their doctor or pharmacist.

• if the patient has blood diseases (including those caused by other medicines);
• if the patient has ever had an atypical hypersensitivity reaction (rash or other allergic symptoms) to oxcarbazepine or other medicines. In patients allergic to carbamazepine, there may be cross-sensitivity to oxcarbazepine in about 1 in 4 (25%) of cases;
• if the patient has or has had liver, heart, or kidney disease in the past;
• if the patient has increased intraocular pressure (glaucoma);
• if the patient has been diagnosed with psychiatric disorders called psychoses and may experience a state of disorientation or agitation;
• if the patient is taking hormonal contraceptives. Finlepsin may reduce the effectiveness of hormonal contraceptives. Therefore, the patient should use other or additional non-hormonal contraceptive methods during treatment with Finlepsin. The patient should tell their doctor about any bleeding or spotting between periods. In case of any doubts, the patient should contact their doctor.

If any of these points apply to the patient, they should inform their doctor:

• if such hypersensitivity reactions occur, such as fever with lymph node swelling, rash, or skin lesions, the patient should immediately inform their doctor or go to the nearest hospital (see section 4);
• if the patient experiences severe skin reactions, such as rash or the following skin reactions, redness of the skin, blistering on the lips, eyes, and shedding of the skin with accompanying fever, they should immediately contact their doctor;
• if the patient experiences an increase in the number of seizures, they should immediately inform their doctor.

Do not stop taking Finlepsin without consulting a doctor first. Sudden withdrawal of the medicine may cause a sudden increase in seizures.

A small number of people taking antiepileptic medicines, including those containing carbamazepine, have thought about harming or killing themselves. If such thoughts occur, the patient should immediately contact their doctor.

During treatment with Finlepsin during pregnancy, there is a risk of harmful effects on the unborn child. If the patient is of childbearing age, they should use effective contraception during treatment with Finlepsin and for two weeks after taking the last dose (see "Pregnancy and breastfeeding").

There have been reports of severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) during carbamazepine treatment. The rash is often accompanied by ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe rashes are often preceded by flu-like symptoms such as fever, headache, and bone pain. The rash can develop into blistering. The greatest risk of severe skin reactions is in the first few months of treatment.

Severe skin reactions are more common in patients of Asian descent. The risk of reaction in people of Chinese or Thai descent can be predicted by testing their blood. The doctor should advise the patient whether blood tests are needed before starting treatment with carbamazepine.

If a rash or other skin symptoms occur, the patient should stop taking carbamazepine and contact their doctor immediately.

Using Finlepsin with food and drink

Finlepsin should be taken during or after meals, with a sufficient amount of liquid (e.g., a glass of water).

Using substances that may interact with Finlepsin

During treatment with Finlepsin, the patient should not consume alcohol, as it may unpredictably change the effect of carbamazepine.

Finlepsin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Medicines that may increase carbamazepine levels in the blood:

Increased carbamazepine levels in the blood may cause side effects (e.g., dizziness, drowsiness, ataxia, double vision). Therefore, the dose of Finlepsin should be adjusted and the carbamazepine level in the blood should be monitored when given with the following substances:

• Pain and anti-inflammatory medicines: dextropropoxyphene, ibuprofen.
• Androgenic medicines: danazol.
• Antibiotics: macrolide antibiotics (e.g., erythromycin, troleandomycin, josamycin, clarithromycin).
• Antidepressant medicines: e.g., desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine.
• Antiepileptic medicines: stiripentol, vigabatrin, brivaracetam.
• Antifungal medicines: azoles (e.g., itraconazole, ketoconazole, fluconazole, voriconazole).
• Antihistamine medicines: loratadine, terfenadine.
• Antipsychotic medicines: loxapine, olanzapine, quetiapine, risperidone, ziprasidone.
• Antituberculosis medicines: isoniazid.
• Antiviral medicines: protease inhibitors in HIV treatment (e.g., ritonavir).
• Carbonic anhydrase inhibitors: acetazolamide.
• Cardiovascular medicines: diltiazem, verapamil.
• Medicines for stomach ulcers: cimetidine, omeprazole.
• Muscle relaxants: oxybutynin, dantrolene.
• Platelet aggregation inhibitors: ticlopidine.
• Other interactions: grapefruit juice, nicotinamide (in adults, only in high doses).

Medicines that may increase the level of the active metabolite 10,11-epoxide of carbamazepine in the blood:

Increased carbamazepine levels in the blood may cause side effects (e.g., dizziness, fatigue, unsteady gait, double vision). In case of such symptoms, the level should be measured and the carbamazepine dose adjusted if necessary. This applies to the following medicines: loxapine, quetiapine, primidone, valproic acid, valnoctamide, and valpromide.

Medicines that may decrease carbamazepine levels in the blood:

The dose of Finlepsin may need to be adjusted when given with the following medicines:

• Antiepileptic medicines: felbamate, methsuximide, oxcarbazepine, phenobarbital, phensuximide, phenytoin, fosphenytoin, primidone, progabide, and, although the data are partially conflicting, clonazepam, valproic acid, and valpromide.
• Anticancer medicines: cisplatin, doxorubicin.
• Antituberculosis medicines: rifampicin.
• Bronchodilators: theophylline, aminophylline.
• Dermatological medicines: isotretinoin.
• Others: products containing St. John's Wort (Hypericum perforatum).

Effect of carbamazepine on the blood levels of other medicines:

Carbamazepine may decrease the blood levels of certain medicines, reduce, or even abolish their effects. The dose of the following medicines may need to be adjusted based on clinical requirements:

• Pain and anti-inflammatory medicines: methadone, paracetamol, tramadol, phenazone (antipyrine).
• Antibiotics: doxycycline.
• Anticoagulants: oral anticoagulants (e.g., warfarin, phenprocoumon, dicumarol, acenocoumarol).
• Antidepressant medicines: bupropion, citalopram, trazodone, tricyclic antidepressants (e.g., imipramine, amitriptyline, nortriptyline, clomipramine). It is not recommended to use Finlepsin in combination with monoamine oxidase inhibitors (MAOIs), which should be discontinued at least 2 weeks before administering Finlepsin, if the clinical situation allows.
• Antiepileptic medicines: clobazam, clonazepam, eslicarbazepine, ethosuximide, felbamate, lamotrigine, oxcarbazepine, primidone, tiagabine, topiramate, valproic acid, zonisamide.
• It has been reported that under the influence of carbamazepine, phenytoin blood levels have both increased and decreased. There are rare reports of increased mephenytoin blood levels.
• Antifungal medicines: itraconazole.
• Antiparasitic medicines: praziquantel.
• Anticancer medicines: imatinib.
• Antipsychotic medicines: clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, ziprasidone.
• Antiviral medicines: protease inhibitors in HIV treatment (e.g., indinavir, ritonavir, saquinavir).
• Anxiolytic medicines: alprazolam, midazolam.
• Bronchodilators or anti-asthmatic medicines: theophylline.
• Contraceptives: hormonal contraceptives containing estrogens and/or progestogens (alternative contraceptive methods should be considered).
• Cardiovascular medicines: calcium channel blockers (dihydropyridine derivatives, e.g., felodipine), digoxin.
• Corticosteroids (medicines used to alleviate inflammation): prednisolone, dexamethasone.
• Immunosuppressive medicines: cyclosporine, everolimus.
• Medicines used in thyroid diseases: levothyroxine.

Hormonal contraceptives, e.g., pills, patches, injections, or implants:

Finlepsin may affect the effectiveness of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. The patient should discuss with their doctor the most suitable type of contraception during treatment with Finlepsin.

Combination therapy requiring special attention:

It has been reported that concomitant use of carbamazepine and levetiracetam increases the toxic effect of carbamazepine on the liver.

It has been reported that concomitant use of carbamazepine and isoniazid increases its toxic effect on the liver.

Concomitant administration of carbamazepine and lithium salts or metoclopramide, as well as carbamazepine and neuroleptics (e.g., haloperidol, thioridazine), may lead to increased neurological side effects (in the case of neuroleptics, even at therapeutic blood levels).

Concomitant use of carbamazepine and certain diuretics (hydrochlorothiazide, furosemide) may cause symptomatic hyponatremia (decreased sodium levels in the blood).

Carbamazepine may antagonize the effect of muscle relaxants that do not cause depolarization (e.g., pancuronium). If necessary, they should be used in higher doses, while closely monitoring the patient due to the possibility of faster-than-usual reversal of neuromuscular blockade.

Similar to other psychotropic medicines, carbamazepine may reduce alcohol tolerance. It is therefore recommended that patients abstain from drinking alcohol during treatment.

It should be remembered that the above comments also apply to cases where the mentioned medicines have been recently discontinued.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

Before taking any medicine, the patient should consult a doctor or pharmacist.

Finlepsin may be used during pregnancy only after the doctor has weighed the benefits of therapy against the associated risks.

Finlepsin may cause serious birth defects. If the patient takes Finlepsin during pregnancy, the risk of birth defects in the child is up to three times higher than in women who do not take antiepileptic medicines. Serious birth defects have been reported, including neural tube defects (spina bifida), facial defects such as cleft lip and palate, head defects, heart defects, and genital defects.

If the patient takes Finlepsin during pregnancy, the unborn child should be closely monitored.

In infants born to mothers who took Finlepsin during pregnancy, developmental problems (brain development) have been reported.

In some studies, it has been shown that carbamazepine has a negative effect on the development of the nervous system in children exposed to carbamazepine in the womb, while in other studies, no such effect has been found. The effect on neurological development cannot be ruled out.

If the patient is of childbearing age and does not plan to become pregnant, they should use effective contraception during treatment with Finlepsin. Finlepsin may affect the effectiveness of hormonal contraceptives, such as birth control pills, and reduce their effectiveness in preventing pregnancy. The patient should discuss with their doctor the most suitable type of contraception during treatment with Finlepsin. If treatment with Finlepsin is discontinued, the patient should continue to use effective contraception for two weeks after stopping the medicine.

If the patient is of childbearing age and plans to become pregnant, they should consult their doctor before stopping contraception and before becoming pregnant, to change their treatment to one that is safe for the unborn child.

If the patient is or thinks they may be pregnant, they should immediately tell their doctor. The patient should not stop taking Finlepsin until they have discussed it with their doctor. Stopping the medicine without consulting a doctor may cause seizures, which can be dangerous for the patient and their unborn child. The doctor may decide to change the treatment.

If the patient takes Finlepsin during pregnancy, there is also a risk of bleeding problems in the patient after childbirth. The doctor may prescribe a medicine to the patient and the child to prevent this.

In the case of pregnancy, the doctor should reduce the dose of Finlepsin to the minimum necessary to prevent seizures. This is especially important between the 20th and 40th days of pregnancy. The doctor should also avoid combining carbamazepine with other antiepileptic medicines and other agents in general, as this increases the risk of complications.

Since carbamazepine induces liver enzymes and may cause folate deficiency, it is recommended to take folic acid supplements before becoming pregnant and during pregnancy.

Breastfeeding

Carbamazepine passes into breast milk in small amounts. If the doctor agrees, breastfeeding can be continued. If side effects occur, such as the infant not gaining weight or showing excessive sedation and increased need for sleep, breastfeeding should be stopped and the doctor informed.

Driving and using machines

In the initial period of treatment with carbamazepine, side effects from the central nervous system may occur, such as dizziness, drowsiness, walking disturbances, or headaches. These symptoms occur with high doses and during combination therapy with other medicines affecting the central nervous system. This may significantly impair the ability to drive and operate machinery.

It should be remembered that alcohol consumption further impairs alertness and prolongs reaction time.

Information on sodium content in Finlepsin

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Finlepsin

This medicine should always be taken as directed by a doctor or pharmacist. If the patient has any doubts, they should consult a doctor or pharmacist.

Dosage and administration

If the doctor has not prescribed a different dosage, the patient should follow the recommendations below.

Not following these recommendations may cause the medicine to not work properly.

Treatment with carbamazepine should be started with small doses, individually adjusted according to the patient's clinical condition. The dose is then gradually increased to achieve the optimal maintenance dose.

The daily dose is usually given in 1 or 2 single doses and ranges from 400 to 1200 mg of carbamazepine. The maximum daily dose (in exceptional cases) should not exceed 1600 mg due to the increased occurrence of side effects at higher doses.

The dose should be determined based on the blood level of the medicine, especially in combination therapy. Therapeutic levels of carbamazepine range from 4 to 12 μg/mL.

In individual cases, the required dose may significantly differ from the initial and maintenance doses (e.g., due to increased or decreased metabolism of the medicine under the influence of inducing or inhibiting enzymes in combination therapy).

If possible, monotherapy with one antiepileptic medicine should be used.

Treatment should be supervised by a specialist.

When switching from other antiepileptic medicines to carbamazepine, the dose of the discontinued medicine should be gradually reduced.

In the treatment of seizures, the following general dosage regimen is recommended:

* Note:

For children over 3 years and under 6 years, if they are able to swallow the tablet.

Recommended dose for:

Epilepsy

In the treatment of epilepsy in adults, the initial dose of 0.5 or 2 Finlepsin tablets (equivalent to 100 or 400 mg of carbamazepine per day) should be gradually increased to a maintenance dose of 3 to 6 Finlepsin tablets (equivalent to 600 to 1200 mg of carbamazepine). The maintenance dose in children is 10-20 mg of carbamazepine/kg body weight/day.

Recommended dosage regimen: see above.

Trigeminal neuralgia/Glossopharyngeal neuralgia

The daily dose of carbamazepine is usually 200 to 400 mg. The dose is increased until the pain disappears, usually to 400 or 800 mg per day in 1 or 2 divided doses.

In some cases, maintenance treatment can be continued with a reduced dose - 1 Finlepsin tablet taken twice a day (equivalent to 400 mg of carbamazepine).

In elderly or particularly sensitive patients, an initial dose of 0.5 Finlepsin tablets (equivalent to 100 mg of carbamazepine) taken in a single dose in the morning or evening may be sufficient.

Pain in diabetic neuropathy

The usual daily dose is 600 mg (1 Finlepsin tablet taken three times a day).

In exceptional cases, the dose can be increased to 2 Finlepsin tablets taken three times a day (equivalent to 1200 mg per day).

Trigeminal neuralgia in multiple sclerosis

The average daily dose is 1 Finlepsin tablet taken 2-4 times a day (equivalent to 400-800 mg of carbamazepine).

Prevention of seizures in alcoholic withdrawal syndrome in hospital conditions

The usual daily dose is 1 Finlepsin tablet taken three times a day (equivalent to 600 mg, 200 mg in the morning and 400 mg in the evening). In severe cases, the initial dose can be increased to 3 Finlepsin tablets taken twice a day (equivalent to 1200 mg of carbamazepine per day).

It is not recommended to use carbamazepine in combination with sedative and hypnotic medicines.

Carbamazepine can be used with other substances commonly used in the treatment of alcoholic withdrawal syndrome. The carbamazepine level in the blood should be regularly monitored.

Special attention from the doctor is required, as side effects from the central and peripheral nervous system may occur.

WARNING!

In patients with severe cardiovascular disease, liver disease, or kidney failure, as well as in the elderly, a reduced dose may be sufficient.

Method of administration

Finlepsin tablets are divisible and should be taken with a sufficient amount of liquid (e.g., a glass of water) during or after meals.

In some cases, it has been shown that dividing the daily dose into 4-5 doses is effective.

The duration of treatment depends on the indications and the individual patient's response. In no circumstances should the patient stop treatment on their own.

The duration of treatment is determined by the attending doctor.

Antiepileptic treatment is usually long-term. The dose, duration of treatment, and discontinuation of treatment are determined for individual patients by a specialist doctor (neurologist). Typically, the dose can be reduced and treatment discontinued only after a seizure-free period of 2-3 years. Treatment is discontinued by gradually reducing the dose over a period of 1-2 years. In children, weight gain should be monitored during this period. Pathological changes in the EEG recording should not worsen.

In the treatment of neuralgia, the maintenance dose should be such that it ensures complete relief from pain for several weeks. By carefully reducing the dose, it should be checked whether the symptoms disappear on their own. In case of recurrence of pain, treatment should be continued with the maintenance dose.

The same principles apply to the treatment of pain in diabetic neuropathy and seizures in multiple sclerosis.

Treatment of alcoholic withdrawal syndrome with carbamazepine should be discontinued within 7-10 days by gradually reducing the dose.

Taking a higher dose of Finlepsin than recommended

Overdose of Finlepsin may cause an increase in side effects. The first symptoms of poisoning occur 1-3 hours after taking the medicine and are primarily disorders of the nervous system. Cardiovascular disorders are mild. Severe disorders may occur only with very high doses.

The following may occur: central nervous system depression, disorientation, drowsiness, agitation, tremors, seizures (tonic-clonic seizures), respiratory disorders, cardiovascular disorders - decreased blood pressure (increased blood pressure may also occur), tachycardia, conduction disorders (atrioventricular block, changes in the ECG), impaired consciousness, and even cardiac arrest.

In laboratory tests, individual cases of leukocytosis (increased white blood cell count), leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), ketonuria (presence of ketone bodies in the urine), and glycosuria (presence of glucose in the urine) have been reported.

There is no specific antidote for carbamazepine.

Treatment of overdose with Finlepsin depends on the complications that occur and is usually carried out in hospital conditions.

Overdose of carbamazepine should be treated symptomatically; the harmful substance should be removed as soon as possible by inducing vomiting and/or gastric lavage, and absorption should be reduced by administering activated charcoal or laxatives.

Vital functions should be supported in the intensive care unit, cardiac function should be monitored, blood levels of the medicine should be measured, and electrolyte disturbances should be corrected if the patient's condition requires it.

In case of seizures, treatment with an appropriate anticonvulsant medicine should be initiated. According to literature data, barbiturates are not recommended due to the risk of respiratory depression, especially in children.

Missing a dose of Finlepsin

If a dose is missed, the medicine should be continued according to the established schedule.

Under no circumstances should a double dose be taken.

4. Possible side effects

Like all medicines, Finlepsin can cause side effects, although not everybody gets them.

Dose-dependent side effects usually disappear within a few days of starting treatment or after reducing the dose. Neurological reactions may indicate overdose or significant fluctuations in the blood level of the medicine. In such cases, it is recommended to monitor the blood level of the medicine and divide the total dose.

The occurrence of side effects is greater in combination therapy than in monotherapy.

Common side effects may include dizziness, drowsiness, sedation, fatigue, ataxia (lack of coordination, clumsiness, disturbance of balance), headaches, double vision, malaise, vomiting, or allergic reactions. In elderly patients, restlessness and disorientation may occur.

During treatment with carbamazepine, the following side effects may occur.

Very common (may occur in more than 1 in 10 patients): leukopenia, dizziness, ataxia, drowsiness, malaise, vomiting, increased activity of the liver enzyme gamma-glutamyltranspeptidase (usually clinically insignificant), allergic skin inflammation, hives (including severe forms).

Common (may occur in up to 1 in 10 patients): headaches, double vision, accommodation disorders (blurred vision), dryness of the mucous membranes of the mouth, loss of appetite, increased activity of alkaline phosphatase (a group of enzymes found in the liver, bones, intestines, and kidneys), thrombocytopenia, eosinophilia, hyponatremia, which causes fluid retention, edema, weight gain, and decreased osmolality of the blood.

In rare cases, this has led to vomiting, headaches, and rarely - disorientation, lethargy, and other neurological abnormalities.

Uncommon (may occur in up to 1 in 100 patients): involuntary movements (tremors, dystonia, tics), oculogyric crisis, diarrhea or constipation, increased activity of liver enzymes - aminotransferases, exfoliative dermatitis, erythroderma (inflammation and redness of the entire skin, often with shedding of the skin), toxic epidermal necrolysis, Stevens-Johnson syndrome.

Rare (may occur in up to 1 in 1000 patients): leukocytosis (increased white blood cell count), lymphadenopathy (enlargement of lymph nodes due to antigenic stimulation), folate deficiency, late-type hypersensitivity with fever, rash, vasculitis, lymphadenopathy, arthralgia (joint pain), changes in white blood cell count, eosinophilia (increased eosinophil count in the blood smear), hepatosplenomegaly (enlargement of the liver and spleen) or changes in liver function tests, as well as effects on other organs such as lungs, kidneys, pancreas, heart, and colon, auditory and visual hallucinations, depression, phobia, aggressive behavior, agitation, disorientation, thinking disorders, speech disorders, involuntary facial movements resembling grimaces (dyskinesia), uncontrolled body movements with lively gesticulation (choreoathetosis), peripheral neuropathy, paresthesia (numbness due to changes in nerves or sensory pathways), paresis, eye movement disorders, conduction disorders, hypertension or hypotension, abdominal pain, various forms of hepatitis (cholestatic, hepatocellular, mixed), jaundice, systemic lupus erythematosus, itching, muscle weakness.

Very rare (may occur in up to 1 in 10,000 patients): agranulocytosis, aplastic anemia, pancytopenia, bone marrow aplasia, anemia, megaloblastic anemia, porphyria, reticulocytosis, hemolytic anemia (bone marrow disorders), aseptic meningitis with seizures and eosinophilia, anaphylactic reactions and angioedema, increased prolactin secretion with symptoms (or asymptomatic) galactorrhea, gynecomastia (breast tissue growth in men), changes in thyroid function (decreased FT4, T3, T4 activity) and increased TSH activity; changes in bone metabolism (decreased calcium and 25-hydroxycholecalciferol levels in the blood), which in rare cases can lead to bone damage (osteoporosis/osteomalacia); increased cholesterol, HDL, and triglyceride levels, exacerbation of a latent psychotic syndrome, changes in taste, malignant neuroleptic syndrome (a life-threatening side effect that occurs mainly in people taking neuroleptic medicines), loss of lens transparency, conjunctivitis, increased intraocular pressure, hearing disorders (tinnitus, increased or decreased hearing sensitivity, changes in tone perception), bradycardia, arrhythmia, atrioventricular block sometimes with loss of consciousness or syncope (heart rhythm and conduction disorders), collapse, congestive heart failure, exacerbation of coronary artery disease, thrombophlebitis, embolic episodes, hypersensitivity reactions with fever, dyspnea, also pneumonitis or pulmonary fibrosis (in case of these reactions, carbamazepine treatment should be discontinued), oral, gum, and tongue inflammation; pancreatitis, hepatic granulomatous inflammation, liver failure, potentially life-threatening severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), hypersensitivity to light, erythema multiforme and nodular, changes in skin pigmentation, purpura, alopecia, excessive sweating, acne, hirsutism, joint pain, muscle pain, muscle spasms, disorders of spermatogenesis (reduced sperm count or (and) reduced sperm motility), disorders of male fertility, changes in libido, impotence.

Isolated cases: decreased folate, vitamin B, and homocysteine levels in the blood.

Frequency not known (frequency cannot be estimated from the available data):

High blood ammonia levels (hyperammonemia). Symptoms of hyperammonemia may include irritability, disorientation, vomiting, loss of appetite, and drowsiness.

There are reports that carbamazepine exacerbates the symptoms of multiple sclerosis.

Like other antiepileptic medicines, carbamazepine may increase the frequency of seizures. Seizures of the "absence" type (a special type of seizure with onset in both hemispheres of the brain) may be intensified or triggered.

There are reports of bone disorders, including osteopenia, osteoporosis (bone "thinning"), and fractures. The patient should consult their doctor or pharmacist if they are taking long-term antiepileptic therapy, have osteoporosis, or are taking steroids.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Finlepsin

The medicine should be stored out of sight and reach of children.

There are no special precautions for storing the medicine.

Finlepsin should not be used after the expiry date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Finlepsin contains

• The active substance of Finlepsin is carbamazepine. One Finlepsin tablet contains 200 mg of carbamazepine.
• The other ingredients of the medicine are: microcrystalline cellulose, gelatin, sodium croscarmellose, magnesium stearate.

What Finlepsin looks like and contents of the pack

Finlepsin is a white, round tablet, with a beveled edge on one side and a deep score line, convex on the other side, with a smooth surface, intact edges, and a uniform appearance. 50 tablets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

Date of last revision of the leaflet