Finlepsin 400 retard

Patient Information Leaflet

Finlepsin 200 retard, 200 mg, prolonged-release tablets
Finlepsin 400 retard, 400 mg, prolonged-release tablets
Carbamazepinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

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

Finlepsin retard contains carbamazepine, a tricyclic compound with primarily anticonvulsant, as well as neurotropic and psychotropic, effects. It also has analgesic properties, for example in trigeminal neuralgia and other paroxysmal pain conditions. The anticonvulsant mechanism of action of carbamazepine is only partially understood. The drug probably blocks the spread of abnormal bioelectrical discharges in the brain.
Indications for Finlepsin retard include:

• Epilepsy: simple and complex partial seizures; generalized tonic-clonic seizures (particularly secondarily generalized), occurring during sleep, and mixed seizure types;
• Idiopathic trigeminal neuralgia;
• Idiopathic glossopharyngeal neuralgia;
• Pain in diabetic neuropathy;
• Trigeminal neuralgia in multiple sclerosis;
• Prophylaxis of bipolar affective disorders in patients unresponsive to lithium treatment;
• Prevention of seizures in alcohol withdrawal syndrome under hospital conditions.

2. What you need to know before taking Finlepsin retard
When not to take Finlepsin retard:

• If you are allergic to carbamazepine, tricyclic antidepressants, or any of the other ingredients of this medicine (listed in section 6).
• If you have bone marrow dysfunction or a history of bone marrow suppression;
• If you have severe cardiac conduction disorders (atrioventricular block);
• If you have acute intermittent porphyria (a genetically determined porphyrin metabolism defect);
• If you are taking monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuation of such treatment;
• If you are taking voriconazole (an antifungal agent), as it interferes with carbamazepine's action.

If any of the above apply to you, please inform your doctor before taking Finlepsin retard. If you suspect you may be allergic to the medicine, consult your doctor.
Warnings and precautions
Before starting Finlepsin retard, discuss this with your doctor or pharmacist.

• If you have blood disorders (including those caused by other medicines);
• If you have ever experienced unusual hypersensitivity (rash or other allergic symptoms) to oxcarbazepine or other medicines. Patients allergic to carbamazepine may, on average in 1 out of 4 cases (25%), also be hypersensitive to oxcarbazepine;
• If you have or have had heart, liver, or kidney diseases;
• If you have increased intraocular pressure (glaucoma);
• If you have been diagnosed with psychiatric disorders called psychoses and may experience disorientation or agitation;
• If you are using hormonal contraceptives. Finlepsin retard may render contraceptive medicines ineffective. Therefore, you should use other or additional non-hormonal contraceptive methods while taking Finlepsin retard. Inform your doctor if you experience intermenstrual bleeding or spotting. If in doubt, contact your doctor.

If any of these points apply to you, inform your doctor:

• If you experience hypersensitivity reactions such as fever with swollen lymph nodes, rash, or skin eruptions, contact your doctor immediately or go to the nearest hospital (see section 4);
• If you develop severe skin reactions, such as rash or the following skin reactions, skin redness, blistering of the lips, eyes, and peeling of the epidermis accompanied by fever, contact your doctor immediately;
• If the number of epileptic seizures increases, inform your doctor immediately.

Do not stop treatment with Finlepsin retard without first consulting your doctor. Abrupt discontinuation of the medicine may lead to a sudden worsening of epileptic seizures.
A small number of people taking antiepileptic medicines containing carbamazepine have had thoughts of harming or killing themselves. If you ever experience such thoughts, contact your doctor immediately.
Taking Finlepsin retard during pregnancy may harm the unborn child. If you are of childbearing age, you should use an effective method of contraception during treatment with Finlepsin retard and for two weeks after the last dose (see "Pregnancy and breastfeeding").
Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported during carbamazepine treatment. Skin rashes may often be accompanied by oral, pharyngeal, nasal, or genital ulcers, 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 may progress to blistering and peeling. The greatest risk of severe skin reactions occurs during the first months of treatment.
Severe skin reactions are more common in patients of Asian origin. The risk of such reactions in patients of Chinese or Thai descent can be predicted by blood testing. Your doctor should advise whether blood testing is necessary before starting carbamazepine treatment.
If a rash or other skin symptoms appear, discontinue carbamazepine and contact your doctor immediately.
Taking Finlepsin retard with food and drink
Finlepsin retard should be taken during or after meals, with sufficient fluid (e.g. a glass of water). The tablet may also be dispersed in water and taken as a suspension.
Alcohol use
Do not consume alcohol while taking Finlepsin retard, as it may unpredictably alter the action of carbamazepine.
Finlepsin retard and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Medicines that may increase carbamazepine plasma concentration:
Increased carbamazepine plasma concentration may cause adverse effects (e.g. dizziness, drowsiness, ataxia, diplopia), therefore the dose of Finlepsin retard should be appropriately adjusted and plasma levels monitored when co-administered with the following substances:

• Analgesics, anti-inflammatory agents: dextropropoxyphene, ibuprofen.
• Androgenic agents: danazol.
• Antibiotics: macrolide antibiotics (e.g. erythromycin, troleandomycin, josamycin, clarithromycin).
• Antidepressants: e.g. desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, vilazodone.
• Antiepileptics: stiripentol, vigabatrin, brivaracetam.
• Antifungal agents: azoles (e.g. itraconazole, ketoconazole, fluconazole, voriconazole).
• Antihistamines: loratadine, terfenadine.
• Antipsychotics: loxapine, olanzapine, quetiapine.
• Antituberculosis agents: isoniazid.
• Antiviral agents: protease inhibitors in HIV treatment (e.g. ritonavir).
• Carbonic anhydrase inhibitors: acetazolamide.
• Cardiovascular agents: diltiazem, verapamil.
• Medicines for peptic ulcer disease: cimetidine, omeprazole.
• Muscle relaxants: oxybutynin, dantrolene.
• Platelet aggregation inhibitors: ticlopidine.
• Other interactions: grapefruit juice, nicotinamide (in adults, only at high doses).

Medicines that may increase plasma concentration of the active metabolite 10,11-epoxide carbamazepine:
Increased carbamazepine plasma concentration may cause adverse effects (e.g. dizziness, fatigue, unsteady gait, diplopia). If such symptoms occur, plasma levels 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 plasma concentration:
Dosage adjustment of Finlepsin retard may be necessary when used concomitantly with the following medicines:

• Antiepileptics: felbamate, methsuximide, oxcarbazepine, phenobarbital, fensuximide, phenytoin, fosphenytoin, primidone, progabide, and, although data are partially conflicting, clonazepam, valproic acid, and valpromide.
• Antineoplastic agents: cisplatin, doxorubicin.
• Antituberculosis agents: rifampicin.
• Bronchodilators: theophylline, aminophylline.
• Dermatological agents: isotretinoin.
• Others: preparations containing St. John's wort (Hypericum perforatum).

Effect of carbamazepine on plasma concentrations of concomitantly administered medicines:
Carbamazepine may reduce plasma concentrations, reduce, or even abolish the effects of certain medicines. Dose adjustment of the following medicines may be necessary depending on clinical requirements:

• Analgesics and anti-inflammatory agents: methadone, paracetamol, tramadol, phenazone (antipyrine).
• Antibiotics: doxycycline.
• Anticoagulants: oral anticoagulants (e.g. warfarin, phenprocoumon, dicoumarol, acenocoumarol).
• Antidepressants: bupropion, citalopram, trazodone, tricyclic antidepressants (e.g. imipramine, amitriptyline, nortriptyline, clomipramine). Concomitant use of Finlepsin retard with monoamine oxidase inhibitors (MAOIs) is not recommended. MAOI treatment should be discontinued at least two weeks before starting Finlepsin retard, if clinically feasible.
• Antiepileptics: clobazam, clonazepam, eslicarbazepine, ethosuximide, felbamate, lamotrigine, oxcarbazepine, primidone, tiagabine, topiramate, valproic acid, zonisamide.
• Under the influence of carbamazepine, phenytoin plasma concentrations have been reported to both increase and decrease; rare reports exist of increased mephenytoin plasma concentration.
• Antifungal agents: itraconazole.
• Antiparasitic agents: praziquantel.
• Antineoplastic agents: imatinib.
• Antipsychotics: clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, ziprasidone.
• Antiviral agents: protease inhibitors in HIV treatment (e.g. indinavir, ritonavir, saquinavir).
• Anxiolytics: alprazolam, midazolam.
• Bronchodilators or antiasthmatics: theophylline.
• Contraceptives: hormonal contraceptives containing estrogens and/or progestogens (alternative contraceptive methods should be considered).
• Cardiovascular agents: calcium channel blockers (dihydropyridine derivatives, e.g. felodipine), digoxin.
• Corticosteroids (medicines used to alleviate inflammatory conditions): prednisolone, dexamethasone.
• Immunosuppressants: cyclosporine, everolimus.
• Medicines used in thyroid disorders: levothyroxine.

Hormonal contraceptives, e.g. pills, patches, injections, or implants:
Finlepsin retard may affect the action of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. Discuss with your doctor the most appropriate type of contraception during treatment with Finlepsin retard.
Combination therapy requiring special attention:
Concomitant use of carbamazepine and levetiracetam has been reported to increase the hepatotoxic effect of carbamazepine.
Concomitant use of carbamazepine and isoniazid has been reported to increase its hepatotoxic effect.
Simultaneous administration of carbamazepine and lithium salts or metoclopramide, as well as carbamazepine and neuroleptics (e.g. haloperidol, thioridazine), may lead to increased neurological adverse effects (even at therapeutic plasma concentrations in the case of neuroleptics).
Concomitant use of carbamazepine and certain diuretics (hydrochlorothiazide, furosemide) may cause symptomatic hyponatremia (reduced blood sodium concentration).
Carbamazepine may antagonize the action of non-depolarizing muscle relaxants (e.g. pancuronium). If necessary, higher doses should be used, with careful monitoring of patients due to the possibility of faster-than-expected resolution of neuromuscular blockade.
Like other psychotropic drugs, carbamazepine may reduce alcohol tolerance. Therefore, it is advisable for patients to abstain from alcohol during treatment.
Note that the above considerations also apply when the medicines discussed have only recently been discontinued.
Pregnancy, breastfeeding, and effects on fertility
Pregnancy
Before taking any medicine, consult your doctor or pharmacist.
Finlepsin retard may be used during pregnancy only after the doctor has weighed the benefits of treatment against the associated risks.
Finlepsin retard may cause serious congenital malformations. If you take Finlepsin retard during pregnancy, the risk of congenital malformation in the child may be up to three times higher than in women who do not take antiepileptic medicines. Serious congenital malformations have been reported, including neural tube defects (spina bifida), facial malformations such as cleft lip and palate, cranial malformations, heart defects, genital malformations such as hypospadias, and digital malformations. If you take Finlepsin retard during pregnancy, the unborn child should be closely monitored.
Neurological development problems (brain development) have been reported in infants born to mothers who used Finlepsin retard during pregnancy. Some studies have shown that carbamazepine has a negative effect on the nervous system development of children exposed to carbamazepine in utero, while other studies have not demonstrated such an effect. A neurological developmental impact cannot be excluded.
If you are of childbearing age and do not plan pregnancy, you should use effective contraception during treatment with Finlepsin retard. Finlepsin retard may affect the action of hormonal contraceptives, such as oral contraceptives, and reduce their effectiveness in preventing pregnancy. You should discuss with your doctor the most appropriate type of contraception during treatment with Finlepsin retard. If you discontinue treatment with Finlepsin retard, effective contraception should be continued for two weeks after stopping the medicine.
If you are of childbearing age and plan to become pregnant, you should consult your doctor before stopping contraception and before becoming pregnant, to change your treatment to another method appropriate for protecting the unborn child from exposure to carbamazepine.
If you are or suspect you may be pregnant, inform your doctor immediately. Do not stop taking the medicine until you have discussed this with your doctor. Stopping the medicine without consulting your doctor may cause epileptic seizures, which may be dangerous for you and your unborn child. Your doctor may decide to change your treatment.
If you take Finlepsin retard during pregnancy, there is also a risk of bleeding problems immediately after delivery. Your doctor may prescribe a medicine for you and your child to prevent this. In pregnancy, your doctor should reduce the dose of the medicine to the minimum necessary to prevent seizures. This is particularly important between the 20th and 40th day of pregnancy. It is also advisable to avoid combining carbamazepine with other antiepileptic medicines and other substances in general, as this increases the risk of complications.
Since carbamazepine induces liver enzymes and may cause folic acid deficiency, it is recommended to take folic acid supplements before conception and during pregnancy.
Breastfeeding
Carbamazepine passes into human milk in small amounts. If your doctor approves, breastfeeding may be continued. If adverse effects occur, for example if the infant fails to gain weight or shows excessive sedation and increased need for sleep, breastfeeding should be discontinued and your doctor informed.
Driving and using machines
During the initial period of carbamazepine treatment, adverse effects on the central nervous system may occur, such as dizziness, drowsiness, gait disturbances, or headache. These symptoms may occur after taking high doses and also during combination therapy with other medicines affecting the central nervous system. This may significantly impair the ability to drive vehicles and operate machinery.
Note that alcohol consumption further reduces alertness and prolongs reaction time.

3. How to use Finlepsin retard

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dosage and method of administration
If your doctor has not prescribed otherwise, follow the recommendations below.
Failure to follow these recommendations may result in inadequate effectiveness of the medicine.
Carbamazepine treatment should be initiated at low doses individually adjusted according to the
patient's clinical condition. The dose should then be gradually increased until the optimal maintenance dose is achieved.
The daily dose is usually administered 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 adverse effects at higher doses.
The dose should be determined based on plasma concentration of the drug, especially during combination therapy. Therapeutic concentrations of carbamazepine range from 4 to 12 μg/mL.
In individual cases, the required dose may significantly differ from the recommended initial and maintenance doses (e.g. due to increased or decreased drug metabolism caused by enzyme-inducing or enzyme-inhibiting drugs in combination therapy).
Whenever possible, monotherapy with a single antiepileptic drug should be used.
Treatment should be supervised by a specialist.
When switching from other antiepileptic drugs to carbamazepine preparations, the dose of the drug being discontinued should be gradually reduced.
For the treatment of epileptic seizures, the following general dosing regimen is recommended:

* Note:
Pharmaceutical forms other than extended-release tablets (e.g. suspensions, syrups, or tablets) are available for children under 6 years of age for initial and maintenance dosing. Administration of extended-release tablets is not recommended in children under 6 years of age due to lack of experience.

Recommended dose
Epilepsy
For treatment of epilepsy in adults, the initial dose should be 0.5 to 1 extended-release tablet of Finlepsin 200 retard or 0.5 tablet of Finlepsin 400 retard (equivalent to 100 to 200 mg of carbamazepine per day), gradually 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 carbamazepine/kg body weight/day.
Recommended dosing regimen: see above.

Trigeminal neuralgia / Glossopharyngeal neuralgia
The daily dose of carbamazepine is usually 200 to 400 mg. The dose should be increased until pain relief is achieved, usually up to 400 or 800 mg daily, divided into 1 or 2 doses. In some cases, treatment may be continued with a reduced maintenance dose – 1 tablet of Finlepsin 200 retard or 0.5 tablet of Finlepsin 400 retard (equivalent to 200 mg carbamazepine), taken twice daily (equivalent to 400 mg carbamazepine).
After pain subsides, the dose may be gradually reduced and the drug discontinued after several weeks of treatment if no recurrence of pain occurs. In case of pain recurrence, treatment should be continued with the maintenance dose. In elderly patients or particularly sensitive individuals, the recommended initial dose is half a tablet of Finlepsin 200 retard (equivalent to 100 mg carbamazepine) taken twice daily.

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, dosing may be increased to 3 tablets of Finlepsin 200 retard (600 mg) twice daily (1200 mg daily) or 1.5 tablets of Finlepsin 400 retard (600 mg) twice daily (1200 mg daily).

Trigeminal neuralgia in multiple sclerosis
The average daily dose is:
1 to 2 tablets of Finlepsin 200 retard taken twice daily (equivalent to 400 to 800 mg carbamazepine) or 0.5 to 1 tablet of Finlepsin 400 retard taken twice daily (equivalent to 400 to 800 mg carbamazepine).

Prevention of seizures in alcohol withdrawal syndrome under hospital conditions
The usual daily dose is 600 mg (200 mg in the morning, 400 mg in the evening). In severe cases, the initial dose may be increased to 3 tablets of Finlepsin 200 retard or 1.5 tablets of Finlepsin 400 retard taken twice daily (equivalent to 1200 mg carbamazepine daily).
Concomitant use of carbamazepine with sedatives and hypnotics is not recommended.
Carbamazepine may be used together with other agents commonly used in the treatment of alcohol withdrawal syndrome. Serum carbamazepine concentrations should be monitored regularly.
Special medical attention is required, as adverse effects on the central and peripheral nervous system may occur.

Prophylaxis 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) daily. The maintenance dose usually corresponds to the initial dose. The maintenance dose may be increased if necessary up to 800 mg daily. Prophylactic treatment of affective disorders is long-term therapy.

WARNING!
In patients with severe cardiovascular disease, liver disorders or renal insufficiency, and in elderly individuals, a reduced dose of the drug may be sufficient.

Method of administration
Extended-release tablets of Finlepsin retard may be divided into equal doses.
They should be taken with sufficient fluid (e.g. a glass of water) during or after meals.
The tablet may be dispersed in water, as the extended-release properties are preserved in suspension after dissolving the extended-release tablet in water.
In some cases, good efficacy has been demonstrated with a daily dose divided into 4 to 5 doses. However, for this purpose, pharmaceutical forms other than extended-release formulations are suitable.
The timing of drug administration depends on the indication and individual patient response. Under no circumstances should the patient discontinue therapy on their own.

Antiepileptic treatment is usually long-term. The dose, duration of treatment, and discontinuation are determined individually by a specialist physician (neurologist). Dose reduction and discontinuation of treatment may be considered only after a seizure-free period of 2 to 3 years. Treatment should be discontinued gradually over a period of 1 to 2 years. In children, body weight gain should be monitored during this period.
Pathological changes in EEG recordings should not worsen.

In the treatment of neuralgia, a maintenance dose should be used that ensures complete pain relief for several weeks. Through careful dose reduction, it should be verified whether symptoms resolve spontaneously. In case of pain recurrence, treatment should be continued with the maintenance dose.

The same principles apply in the treatment of pain in diabetic neuropathy and non-epileptic seizures in multiple sclerosis as in the treatment of neuralgia.

Carbamazepine treatment of alcohol withdrawal syndrome should be completed within 7 to 10 days by gradually reducing the dose.

Use of higher than recommended dose of Finlepsin retard
Overdose of Finlepsin retard may lead to intensification of adverse effects. The first symptoms of intoxication appear 1 to 3 hours after ingestion and are primarily disturbances of nervous system function. Cardiovascular disturbances are mild. Severe disturbances may occur only after very high doses.

Symptoms may include: depression of central nervous system function, states of disorientation, drowsiness, agitation, tremors, cerebral seizures (tonic-clonic seizures), respiratory disturbances, cardiovascular disturbances – decreased arterial blood pressure (increased blood pressure may also occur), increased heart rate (tachycardia), cardiac conduction disturbances (atrioventricular block, changes in ECG), disturbances of consciousness, and even circulatory arrest.

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

There is no specific antidote for carbamazepine.

Therapeutic management in cases of Finlepsin retard overdose depends on the complications present and is usually conducted under hospital conditions.

Carbamazepine overdose should be treated symptomatically; harmful substance should be removed as quickly as possible by inducing vomiting and/or gastric lavage, and absorption should be reduced by administering activated charcoal or laxatives.

Life functions should be maintained in an intensive care unit, cardiac function should be monitored, serum drug concentrations should be measured, and electrolyte imbalances should be corrected if required by the patient's condition.

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

Missed dose of Finlepsin retard
If a dose is missed, continue taking the medication according to the established schedule.
Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Dose-dependent adverse reactions usually resolve within a few days after starting treatment or after
reducing the dose. Reactions affecting the nervous system may indicate
drug overdose or significant fluctuations in serum drug concentration. In such cases,
monitoring of drug levels is recommended, along with splitting the total daily dose.
The occurrence of adverse reactions is more common during combination therapy than during monotherapy.
Dizziness, drowsiness, sedation, fatigue, cerebellar ataxia (lack of coordination, unsteadiness, impaired motor coordination), headache, diplopia, malaise, vomiting,
or allergic reactions may commonly occur. In elderly patients, anxiety and disorientation may occur.
The following adverse reactions may occur during treatment with carbamazepine.
Adverse reactions may occur:
Very commonly (may affect more than 1 in 10 patients):
leukopenia, dizziness, ataxia, somnolence, malaise, vomiting, increased activity of the liver enzyme: gamma-glutamyltransferase (usually clinically insignificant), allergic skin reactions, urticaria (including severe forms).
Commonly (may affect up to 1 in 10 patients):
headache, diplopia, accommodation disorders (blurred vision), dryness of oral mucous membranes, loss of appetite, increased alkaline phosphatase activity (a group of enzymes present in the liver, bones, intestines, and kidneys), thrombocytopenia, eosinophilia, hyponatremia leading to fluid retention, edema, weight gain, and decreased plasma osmolality. In rare cases, this has led to vomiting, headache, and rarely – disorientation, lethargy, and other neurological abnormalities.
Uncommonly (may affect 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 redness of the entire skin, often with desquamation).
Rarely (may affect up to 1 in 1000 patients):
leukocytosis (increased number of white blood cells – leukocytes), lymphadenopathy (enlargement of lymph nodes due to antigenic stimulation), folic acid deficiency, delayed-type hypersensitivity with fever, skin rash, vasculitis, lymph node swelling, joint pain (arthralgia), changes in leukocyte count, eosinophilia (increased eosinophils in blood smear above 4%), hepatosplenomegaly or changes in liver function tests, as well as effects on other organs such as lungs, kidneys, pancreas, myocardium, and colon; acoustic and visual hallucinations, depression, phobia, aggressive behavior, agitation, disorientation, thought disorders, speech disorders, involuntary facial movements resembling grimaces (orofacial dyskinesia), uncontrolled body movements with lively gesticulation (choreoathetosis), peripheral neuropathy, paresthesia (abnormal sensation due to changes in nerves or sensory pathways), limb paresis, eye movement disorders, conduction disturbances, hypertension or hypotension, abdominal pain, various forms of hepatitis (cholestatic, hepatocellular, mixed type), jaundice, systemic lupus erythematosus, pruritus, muscle weakness.
Very rarely (may affect up to 1 in 10,000 patients):
agranulocytosis, aplastic anemia, pancytopenia, bone marrow aplasia, anemia, megaloblastic anemia, porphyria, reticulocytosis, hemolytic anemia (bone marrow dysfunction), aseptic meningitis with clonic seizures and eosinophilia, anaphylactic reactions and angioedema, increased prolactin secretion with symptoms (or asymptomatic) galactorrhea, gynecomastia (enlargement of glandular breast tissue) in men, thyroid dysfunction (decreased FT4, T3, T4 activity) and increased TSH activity; bone metabolism disorders (decreased serum calcium and 25-hydroxycholecalciferol levels), which in rare cases may lead to bone damage (osteoporosis/osteomalacia); increased cholesterol, HDL, and triglyceride levels, activation of latent psychotic disorders, taste disturbances, neuroleptic malignant syndrome (a serious, life-threatening complication occurring mainly in patients treated with neuroleptics), loss of lens transparency, conjunctivitis, increased intraocular pressure, hearing disturbances (tinnitus, increased or decreased auditory sensitivity, changes in tone perception), bradycardia, arrhythmia, atrioventricular block sometimes leading to loss of consciousness or syncope (disturbances in heart rhythm and conduction), collapse, congestive heart failure, worsening of coronary artery disease, venous thrombophlebitis, thromboembolic episodes, pulmonary hypersensitivity reactions with fever and dyspnea, including lung inflammation or fibrosis (if these reactions occur, carbamazepine treatment should be discontinued), stomatitis, gingivitis, glossitis; pancreatitis, granulomatous hepatitis, liver failure, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), photosensitivity, erythema multiforme and nodosum, skin pigmentation changes, purpura, alopecia, excessive sweating, acne, hirsutism, joint pain, muscle pain, muscle cramps, spermatogenesis disorders (decreased sperm count or/and motility), male infertility, libido disorders, impotence.
Single cases: decreased serum levels of folic acid, vitamin B, and homocysteine.
Frequency unknown (frequency cannot be estimated from available data):
elevated blood ammonia levels (hyperammonemia). Symptoms of hyperammonemia may include irritability, disorientation, vomiting, loss of appetite, and somnolence.
There have been reports that carbamazepine may exacerbate symptoms of multiple sclerosis.
As with other antiepileptic drugs, carbamazepine may increase the frequency of epileptic seizures. Seizures of the “absence” type (a specific form of seizure originating in both cerebral hemispheres) may be intensified or triggered.
There have been reports of bone disorders, including osteopenia, osteoporosis ("thinning" of bones), and fractures. Patients on long-term antiepileptic therapy, those with osteoporosis, or those taking steroids should consult their doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions may also be reported to the Marketing Authorization Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Finlepsin retard
Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use Finlepsin retard after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Finlepsin retard contains

• The active substance 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.
• Other ingredients are: Eudragit RS 30 D (ammonium methacrylate copolymer type B), triacetin, talc, Eudragit L 30 D-55 (copolymer of methacrylic acid and ethyl acrylate (1:1)), microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate.

What Finlepsin retard looks like and contents of the pack
White to yellowish, round, flat, cloverleaf-shaped tablets with bevelled edges and crossed dividing lines on both sides, smooth surface, intact edges, and uniform appearance.
The tablet may 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 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