Finlepsin 200 retard

Leaflet accompanying the packaging: information for the user

Finlepsin 200 retard, 200 mg, prolonged-release tablets

Finlepsin 400 retard, 400 mg, prolonged-release tablets

Carbamazepine

You should carefully read the contents of the leaflet before using 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Finlepsin retard and what is it used for

Finlepsin retard 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.

The indications for the use of Finlepsin retard are:

• epilepsy: simple and complex partial seizures; generalized tonic-clonic seizures (especially secondary generalized), occurring during sleep and mixed seizure types;
• idiopathic trigeminal neuralgia;
• idiopathic glossopharyngeal neuralgia;
• pain in diabetic neuropathy;
• trigeminal neuralgia in multiple sclerosis;
• prevention of bipolar affective disorders in patients who do not respond to lithium treatment;
• prevention of seizures in alcohol withdrawal syndrome in hospital settings.

2. Important information before taking Finlepsin retard

When not to take Finlepsin retard:

• 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 blood 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 discontinuation;
• if the patient is taking voriconazole (an antifungal drug), 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 retard.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 retard, 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%) cases;
• if the patient has or has had heart, liver, or kidney diseases in the past;
• if the patient has increased intraocular pressure (glaucoma);
• if the patient has been diagnosed with psychotic disorders and may experience a state of disorientation or agitation;
• if the patient is taking hormonal contraceptives. Finlepsin retard may reduce the effectiveness of hormonal contraceptives. Therefore, the patient should use other or additional non-hormonal contraceptive methods during treatment with Finlepsin retard. The patient should tell their doctor about any intermenstrual bleeding or spotting. 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 skin reactions listed below, redness of the skin, blistering on the lips, eyes, and shedding of the epidermis 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 retard without consulting a doctor first. Abrupt discontinuation of the medicine may cause a sudden increase in seizures.

A small number of people taking antiepileptic drugs, including carbamazepine, have thought about harming themselves or committing suicide. If the patient ever has such thoughts, they should immediately contact their doctor.

During treatment with Finlepsin retard 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 retard 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 oral, pharyngeal, and genital ulcers, as well as conjunctivitis (red and swollen eyes). These severe skin reactions are often preceded by flu-like symptoms such as fever, headache, and bone pain. The rash can progress to 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 necessary before starting treatment with carbamazepine.

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

Taking Finlepsin retard with food and drink

Finlepsin retard should be taken during or after meals, with a sufficient amount of liquid (e.g., a glass of water). The tablet can also be dissolved in water, and the medicine can be taken in the form of a suspension.

Using substances that may interact with Finlepsin retard

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

Finlepsin retard 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:

• 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.
• Antituberculosis medicines: isoniazid.
• Antiviral medicines: HIV protease inhibitors (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 levels of the active metabolite 10,11-epoxide of carbamazepine in the blood:

• Loxapine, quetiapine, primidone, valproic acid, valnoctamide, and valpromide.

Medicines that may decrease carbamazepine levels in the blood:

• Antiepileptic medicines: felbamate, mesuximide, oxcarbazepine, phenobarbital, phensuximide, phenytoin, fosphenytoin, primidone, and progabide, as well as, 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: St. John's Wort (Hypericum perforatum) preparations.

Effect of carbamazepine on the levels of other medicines in the blood:

• Pain and anti-inflammatory medicines: methadone, paracetamol, tramadol, phenazone (antipyrine).
• Antibiotics: doxycycline.
• Anticoagulant medicines: 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 take Finlepsin retard in combination with monoamine oxidase inhibitors (MAOIs), which should be discontinued at least 2 weeks before taking Finlepsin retard, 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 carbamazepine can increase or decrease phenytoin levels in the blood; there are rare reports of increased mephenytoin levels in the blood.
• Antifungal medicines: itraconazole.
• Antiparasitic medicines: praziquantel.
• Anticancer medicines: imatinib.
• Antipsychotic medicines: clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, ziprasidone.
• Antiviral medicines: HIV protease inhibitors (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 for thyroid diseases: levothyroxine.

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

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

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 an increase in unwanted neurological symptoms (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, carefully monitoring the patient due to the possibility of faster-than-usual resolution of neuromuscular blockade.

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

Please note that the above comments also apply to cases where the mentioned medicines have been discontinued recently.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

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

Finlepsin retard may cause serious birth defects. If the patient takes Finlepsin retard 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, including neural tube defects (spina bifida), facial defects such as cleft lip and palate, head defects, heart defects, and genital defects, have been reported.

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

In infants born to mothers who took Finlepsin retard during pregnancy, developmental problems (brain development) have been reported. Some studies have shown that carbamazepine has a negative effect on the development of the nervous system in children exposed to carbamazepine in the womb, while other studies have not found such an effect. 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 retard. Finlepsin retard may affect the effectiveness of hormonal contraceptives, such as birth control pills, and reduce their effectiveness in preventing pregnancy. The patient should discuss this with their doctor, who will discuss the most suitable type of contraception during treatment with Finlepsin retard. If the patient stops taking Finlepsin retard, they 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 becoming pregnant, so that their treatment can be changed 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 retard 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 retard during pregnancy, there is also a risk of bleeding problems in the patient and their newborn. The doctor may prescribe a medicine to prevent this.

During pregnancy, the doctor should reduce the dose of Finlepsin retard 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 medicines in general, as this increases the risk of complications.

Since carbamazepine induces liver enzymes and may cause folate deficiency, it is recommended to take folate 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 should be informed.

Driving and using machines

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

Please note that alcohol consumption further impairs alertness and prolongs reaction time.

3. How to take Finlepsin retard

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage and administration

If the doctor has not prescribed otherwise, the patient should follow the instructions below.

Not following these instructions 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 incidence of side effects at higher doses.

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

In individual cases, the required dose may differ significantly from the recommended 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).

Whenever possible, monotherapy with a single 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:

Pharmaceutical forms other than prolonged-release tablets (suspensions, syrups, or tablets) are available for children under 6 years of age for initial and maintenance dosing. It is not recommended to give prolonged-release tablets to children under 6 years of age due to the lack of experience.

Recommended dose

Epilepsy

In the treatment of epilepsy in adults, the initial dose is 0.5 to 1 prolonged-release tablet of Finlepsin 200 retard or 0.5 tablet of Finlepsin 400 retard (equivalent to 100 to 200 mg of carbamazepine per day) and is slowly increased to a maintenance dose of 1.5 to 3 tablets of Finlepsin 400 retard (equivalent to 600 to 1200 mg of carbamazepine). The maintenance dose in children is 10-20 mg of carbamazepine per kilogram of body weight per 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 tablet of Finlepsin 200 retard or 0.5 tablet of Finlepsin 400 retard (equivalent to 200 mg of carbamazepine) taken twice a day (equivalent to 400 mg of carbamazepine).

After the pain disappears, the dose can be gradually reduced and the medicine stopped after a few weeks of treatment, if there is no recurrence of pain. In case of recurrence of pain, maintenance treatment should be continued.

In elderly or particularly sensitive patients, the recommended initial dose is half a tablet of Finlepsin 200 retard (equivalent to 100 mg of carbamazepine) taken twice a day.

Pain in diabetic neuropathy

The usual daily dose is 600 mg (1 tablet of Finlepsin 200 retard in the morning and 2 tablets of Finlepsin 200 retard in the evening or 1 tablet of Finlepsin 400 retard in the evening). In exceptional cases, the dose can be increased to 3 tablets of Finlepsin 200 retard (600 mg) twice a day (1200 mg per day) or 1.5 tablets of Finlepsin 400 retard (600 mg) twice a day (1200 mg per day).

Trigeminal neuralgia in multiple sclerosis

The average daily dose is:

1 to 2 tablets of Finlepsin 200 retard taken twice a day (equivalent to 400 to 800 mg of carbamazepine) or 0.5 to 1 tablet of Finlepsin 400 retard taken twice a day (equivalent to 400 to 800 mg of carbamazepine).

Prevention of seizures in alcohol withdrawal syndrome in hospital settings

The usual daily dose is 600 mg (200 mg in the morning, 400 mg in the evening). In severe cases, the initial dose can be increased to 3 tablets of Finlepsin 200 retard or 1.5 tablets of Finlepsin 400 retard taken twice a day (equivalent to 1200 mg of carbamazepine per day).

It is not recommended to combine carbamazepine with sedative and hypnotic medicines.

It is possible to use carbamazepine with other substances commonly used in the treatment of alcohol withdrawal syndrome. The patient's carbamazepine levels should be regularly monitored.

The doctor should exercise special caution, as side effects from the central and peripheral nervous system may occur.

Prevention of bipolar affective disorders

The initial dose is 200 to 400 mg (1 to 2 tablets of Finlepsin 200 retard or 0.5 to 1 tablet of Finlepsin 400 retard) per day. The maintenance dose is usually the same as the initial dose. If necessary, the maintenance dose can be increased to 800 mg per day. Preventive treatment of affective disorders is long-term.

NOTE!

In patients with severe cardiovascular disease, liver disease, or renal impairment, as well as in elderly patients, a reduced dose of the medicine may be sufficient.

Method of administration

Prolonged-release tablets of Finlepsin retard can be divided into equal doses.

They should be taken with a sufficient amount of liquid (e.g., a glass of water) during or after meals. The tablet can also be dissolved in water, as the prolonged-release properties are preserved in the resulting suspension.

In some cases, it has been shown that dividing the daily dose into 4 to 5 doses is effective. However, this is only possible with pharmaceutical forms other than prolonged-release tablets.

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

Antiepileptic treatment is usually long-term. The dose, duration of treatment, and discontinuation of treatment are determined individually for each patient by a specialist doctor (neurologist). Reduction of the dose and discontinuation of treatment can usually be considered only after a seizure-free period of 2 to 3 years. Treatment is discontinued by gradually reducing the dose over a period of 1 to 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 patient should take a maintenance dose that ensures complete relief from pain for several weeks. By carefully reducing the dose, the patient should check if the symptoms resolve on their own. In case of recurrence of pain, maintenance treatment should be continued.

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

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

Taking a higher dose of Finlepsin retard than recommended

Overdose of Finlepsin retard may cause an increase in side effects. The first symptoms of poisoning occur 1 to 3 hours after taking the medicine and are mainly related to disturbances in the functioning of the central nervous system. Cardiovascular disturbances are mild. Severe disturbances may occur only after very high doses.

The following may occur: central nervous system depression, disorientation, sedation, agitation, tremors, seizures (tonic-clonic seizures), respiratory disturbances, cardiovascular disturbances - decreased blood pressure (which may also increase), tachycardia, conduction disturbances, changes in 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 retard depends on the complications that occur and is usually carried out in a hospital setting.

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.

Life-supporting functions should be maintained 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 started. According to the literature, barbiturates should not be administered due to the risk of respiratory depression, especially in children.

Missing a dose of Finlepsin retard

If a dose is missed, the patient should continue taking the medicine according to the established schedule.

The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Finlepsin retard 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 blood levels of the medicine. In such cases, it is recommended to monitor blood levels and divide the total dose.

The incidence of side effects is higher in combination therapy than in monotherapy.

The following side effects may occur frequently: dizziness, drowsiness, sedation, fatigue, ataxia (lack of coordination, clumsiness, disturbance of balance), headaches, double vision, poor well-being, vomiting, or allergic reactions. In elderly patients, restlessness and disorientation may occur.

The following side effects may occur during treatment with carbamazepine:

Very common (may occur in more than 1 in 10 patients):

leukopenia, dizziness, ataxia, drowsiness, poor well-being, 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 disturbances (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), nystagmus, diarrhea or constipation, increased activity of liver enzymes - aminotransferases, exfoliative dermatitis, erythroderma (inflammatory and redness of the entire skin, often with shedding of the epidermis).

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, and lymphadenopathy, arthralgia (joint pain), changes in liver and kidney function, as well as effects on other organs such as lungs, kidneys, pancreas, heart muscle, and colon.

Very rare (may occur in up to 1 in 10,000 patients):

agranulocytosis, aplastic anemia, pancytopenia, aplastic anemia, anemia, megaloblastic anemia, porphyria, reticulocytosis, hemolytic anemia (blood disorders), aseptic meningitis with clonic seizures and eosinophilia, anaphylactic reactions and angioedema, increased prolactin levels with symptoms (or asymptomatic) galactorrhea, gynecomastia (breast tissue growth) in men, thyroid function disorders (decreased FT4, T3, T4 activity) and increased TSH activity; bone metabolism disorders (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 underlying psychotic symptoms, taste disturbances, 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 disturbances (tinnitus, increased or decreased hearing sensitivity, changes in tone perception), bradycardia, arrhythmia, atrioventricular block sometimes with loss of consciousness or fainting (heart rhythm and conduction disorders), collapse, congestive heart failure, exacerbation of coronary artery disease, thrombophlebitis, embolic episodes, hypersensitivity reactions from the lungs with fever, dyspnea, as well as pneumonitis or pulmonary fibrosis (in case of these reactions, carbamazepine treatment should be discontinued), oral, gingival, and tongue inflammation; pancreatitis, granulomatous hepatitis, liver failure, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), photosensitivity, erythema multiforme, and nodular, pigmentation changes, purpura, alopecia, excessive sweating, acne, hirsutism, joint pain, muscle pain, muscle spasms, sperm disturbances (reduced sperm count and/or motility), fertility disorders in men, libido disorders, 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. Absence seizures (a special type of seizure with onset in both cerebral hemispheres) 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 side effects occur, including any side effects not mentioned in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 retard

The medicine should be stored in a place invisible and inaccessible to children.

The medicine should be stored at a temperature below 30°C.

Finlepsin retard 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 retard contains

• The active substance of the medicine is carbamazepine. One prolonged-release tablet of Finlepsin 200 retard contains 200 mg of carbamazepine. One prolonged-release tablet of Finlepsin 400 retard contains 400 mg of carbamazepine.
• The other ingredients of the medicine are: Eudragit RS 30 D (ammonium methacrylate copolymer type B), triacetin, talc, Eudragit L 30 D-55 (methacrylic acid and ethyl acrylate copolymer (1:1)), microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.

What Finlepsin retard looks like and what the pack contains

White to yellowish, round, flat, cloverleaf-shaped tablets with beveled edges and intersecting dividing lines on both sides, with a smooth surface, intact edges, and a uniform appearance.

The tablet can be divided into equal doses.

Finlepsin 200 retard: 50 tablets in a cardboard box.

Finlepsin 400 retard: 30 or 50 tablets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

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

Manufacturer

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

Date of last leaflet update: