Finlepsin

Package leaflet: information for the user

Finlepsin, 200 mg, tablets
Carbamazepinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your 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 pack and other information

1. What is Finlepsin and what is it used for

Finlepsin contains carbamazepine, a tricyclic compound with mainly anticonvulsant activity, as well as neurotropic and psychotropic effects. It also has analgesic properties, for example in trigeminal neuralgia and other paroxysmal pains. The anticonvulsant mechanism of action of carbamazepine is only partially understood. The drug probably blocks the spread of abnormal electrical discharges in the brain.

Indications for the use of Finlepsin are:

• Epilepsy: simple and complex partial seizures; generalized tonic-clonic seizures (especially secondarily generalized), occurring during sleep, and mixed seizure types;
• Idiopathic trigeminal neuralgia;
• Idiopathic glossopharyngeal neuralgia;
• Pain associated with diabetic neuropathy;
• Trigeminal neuralgia in multiple sclerosis;
• Prevention of convulsive seizures in alcohol withdrawal syndrome under hospital conditions.

2. Important Information Before Using Finlepsin

When not to use 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 dysfunction or a history of bone marrow suppression;
• if the patient has severe cardiac 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 (MAOIs), or within 14 days after discontinuation of such treatment;
• if the patient is taking voriconazole (an antifungal medicine), as it interferes with the action of carbamazepine.

If any of the above points apply to the patient, the doctor must be informed
before taking Finlepsin. If the patient suspects an allergy to the medicine, they should consult
their doctor.
Warnings and precautions
Before starting treatment with Finlepsin, discuss this with your doctor or pharmacist.

• if the patient has blood disorders (including those caused by other medicines);
• if the patient has ever experienced unusual hypersensitivity (rash or other allergic symptoms) to oxcarbazepine or other medicines. Patients allergic to carbamazepine may also experience hypersensitivity to oxcarbazepine in approximately 1 in 4 cases (25%);
• if the patient has or has had heart, liver, 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 disorientation or agitation;
• if the patient is using hormonal contraceptives. Finlepsin may reduce the effectiveness of hormonal contraceptives. Therefore, the patient should use alternative or additional non-hormonal contraceptive methods during treatment with Finlepsin. Inform the doctor if breakthrough bleeding or spotting occurs. In case of any doubts, contact your doctor.

If any of these points apply to the patient, the doctor must be informed:

• if hypersensitivity reactions such as fever with swollen lymph nodes, rash, or skin eruptions occur, the doctor must be contacted immediately or the nearest hospital visited (see section 4);
• if the patient develops severe skin reactions such as rash, or the following skin reactions: redness of the skin, blistering of the lips, eyes, and peeling of the skin accompanied by fever, contact the doctor immediately;
• if the frequency or severity of epileptic seizures increases, inform the doctor immediately.

Do not discontinue treatment with Finlepsin without first consulting your doctor. Abruptly stopping
the medicine may cause a sudden increase in epileptic seizures.
A small number of people taking antiepileptic medicines containing carbamazepine have had thoughts of harming
themselves or committing suicide. If such thoughts ever occur, contact your doctor immediately.
There is a risk of harmful effects on the unborn child when Finlepsin is used during pregnancy. If the patient is of childbearing age, she should use an effective method of contraception during treatment with Finlepsin 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 treatment with carbamazepine. Skin rashes may often be accompanied by ulcers in the mouth, throat, nose, genital organs, and conjunctivitis (red, swollen eyes). These severe rashes are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash may progress to blistering and peeling of the skin. The highest 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. The doctor should advise the patient whether blood tests are necessary before starting treatment with carbamazepine.
If a rash or other skin symptoms occur, discontinue carbamazepine immediately and contact the doctor without delay.
Taking Finlepsin with food and drink
Finlepsin should be taken during or after meals, with sufficient fluid (e.g., a glass of water).
Use of alcohol
Do not consume alcohol while taking Finlepsin, as alcohol may unpredictably alter the effects of carbamazepine.
Finlepsin and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Medicines that may increase carbamazepine plasma levels:
Increased plasma levels of carbamazepine may cause adverse effects (e.g., dizziness, drowsiness, ataxia, double vision). Therefore, the dose of Finlepsin should be adjusted appropriately and plasma levels monitored when co-administered with the following substances:

• Analgesics and anti-inflammatory drugs: dextropropoxyphene, ibuprofen.
• Androgenic agents: danazol.
• Antibiotics: macrolide antibiotics (e.g., erythromycin, troleandomycin, josamycin, clarithromycin).
• Antidepressants: e.g., desipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, vilazodone.
• Antiepileptic drugs: stiripentol, vigabatrin, brivaracetam.
• Antifungal drugs: azoles (e.g., itraconazole, ketoconazole, fluconazole, voriconazole).
• Antihistamines: loratadine, terfenadine.
• Antipsychotics: loxapine, olanzapine, quetiapine.
• Antituberculosis drugs: isoniazid.
• Antiviral drugs: protease inhibitors used in HIV treatment (e.g., ritonavir).
• Carbonic anhydrase inhibitors: acetazolamide.
• Cardiovascular drugs: diltiazem, verapamil.
• Drugs used 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 levels of the active metabolite 10,11-epoxide carbamazepine:
Increased plasma levels of carbamazepine may cause adverse effects (e.g., dizziness, fatigue, unsteady gait, double vision). 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 levels:
Dosage adjustment of Finlepsin may be necessary when used concomitantly with the following medicines:

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

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

• Analgesics and anti-inflammatory drugs: 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 with monoamine oxidase inhibitors (MAOIs) is not recommended. MAOI treatment should be discontinued at least two weeks before starting Finlepsin, if the clinical situation allows.
• Antiepileptic drugs: clobazam, clonazepam, eslicarbazepine, ethosuximide, felbamate, lamotrigine, oxcarbazepine, primidone, tiagabine, topiramate, valproic acid, zonisamide.
• Reports indicate that under the influence of carbamazepine, serum phenytoin levels may either increase or decrease. Rare reports exist of increased mephenytoin serum levels.
• Antifungal drugs: itraconazole.
• Antiparasitic drugs: praziquantel.
• Antineoplastic drugs: imatinib.
• Antipsychotics: clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, ziprasidone.
• Antiviral drugs: protease inhibitors used 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 drugs: calcium channel blockers (dihydropyridine derivatives, e.g., felodipine), digoxin.
• Corticosteroids (medicines used to reduce inflammation): prednisolone, dexamethasone.
• Immunosuppressants: cyclosporine, everolimus.
• Medicines used for thyroid disorders: levothyroxine.

Hormonal contraceptives, e.g., pills, patches, injections, or implants:
Finlepsin may affect the efficacy of hormonal contraceptives and reduce their effectiveness in preventing pregnancy. Discuss with your doctor the most appropriate type of contraception during treatment with Finlepsin.
Combination treatments requiring special attention:
Concomitant use of carbamazepine and levetiracetam has been reported to increase the hepatotoxic effects of carbamazepine.
Concomitant use of carbamazepine and isoniazid has been reported to increase its hepatotoxic effects.
Simultaneous administration of carbamazepine and lithium salts or metoclopramide, and 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 (decreased blood sodium concentration).
Carbamazepine may antagonize the action of non-depolarizing muscle relaxants (e.g., pancuronium). In such cases, higher doses may be required, and patients should be closely monitored due to the possibility of faster-than-expected resolution of neuromuscular blockade.
Like other psychotropic drugs, carbamazepine may reduce tolerance to alcohol. Therefore, patients should refrain from alcohol consumption during treatment.
Note that the above considerations also apply in cases where the discussed medicines have recently been discontinued.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Before using any medicine, consult your doctor or pharmacist.
Finlepsin may be used during pregnancy only after the doctor has weighed the benefits of treatment against the associated risks.
Finlepsin may cause serious congenital malformations. If the patient takes Finlepsin during pregnancy, the risk of congenital malformations in the child may be up to three times higher than in women who do not take antiepileptic drugs. Serious congenital malformations have been reported, including neural tube defects (spina bifida), facial malformations such as cleft lip and palate, cranial defects, heart defects, genital malformations such as hypospadias, and digital malformations. If the patient takes Finlepsin during pregnancy, the unborn child should be closely monitored.
Neurological developmental problems (brain development) have been reported in infants born to mothers who used Finlepsin during pregnancy. Some studies have shown that carbamazepine has a negative effect on the development of the nervous system in children exposed to carbamazepine in utero, while other studies have not demonstrated such an effect. An effect on neurological development cannot be ruled out.
If the patient is of childbearing age and does not plan pregnancy, she should use effective contraception during treatment with Finlepsin. Finlepsin may affect the efficacy of hormonal contraceptives, such as birth control pills, and reduce their effectiveness in preventing pregnancy. The patient should discuss the most appropriate type of contraception with her doctor during treatment with Finlepsin. If treatment with Finlepsin is discontinued, effective contraception should be continued for two weeks after stopping the medicine.
If the patient is of childbearing age and plans to become pregnant, she should consult her doctor before stopping contraception and before becoming pregnant to change the treatment to another method appropriate for protecting the unborn child from exposure to carbamazepine.
If the patient is or suspects she may be pregnant, she should inform her doctor immediately. Do not discontinue the medicine until discussing it with the doctor. Stopping the medicine without consultation may cause epileptic seizures, which may be dangerous for both the patient and her 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 immediately after delivery. The doctor may prescribe a medicine for both the patient and the baby to prevent this. During pregnancy, the 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. Combining carbamazepine with other antiepileptic drugs or other medicines should also be avoided, as this increases the risk of complications.
Since carbamazepine induces liver enzymes and may cause folic acid deficiency, folic acid supplementation is recommended before conception and during pregnancy.
Breastfeeding
Carbamazepine passes into human milk in small amounts. Breastfeeding may be continued if the doctor approves. If adverse effects occur, e.g., if the infant fails to gain weight or shows excessive drowsiness and increased need for sleep, breastfeeding should be discontinued and the doctor informed.
Driving and operating machinery
During the initial period of treatment with carbamazepine, adverse effects on the central nervous system may occur, such as dizziness, drowsiness, gait disturbances, or headaches. These symptoms may occur with high doses and during combination therapy with other medicines affecting the central nervous system. This may significantly impair the ability to drive or operate machinery.
Note that alcohol consumption further reduces alertness and prolongs reaction time.
Information on sodium content in Finlepsin
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Finlepsin

This medicine should always be used as directed by the physician or pharmacist. If in doubt, consult your
physician or pharmacist.
Dosage and method of administration
If the physician has not prescribed otherwise, follow the recommendations below.
Failure to follow these recommendations may result in improper 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 divided doses and ranges from 400 to 1200 mg of
carbamazepine. The maximum daily dose (in exceptional cases) should not exceed 1600 mg due to
increased occurrence of adverse effects at higher doses.
The dose should be determined based on plasma drug concentration, especially during combination
therapy. Therapeutic carbamazepine concentrations 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 drug metabolism caused by enzyme-inducing
or enzyme-inhibiting agents 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 dosage regimen is recommended:

* Note:
In children over 3 years of age and under 6 years of age, if they are able to swallow tablets.

Recommended dose

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

Trigeminal neuralgia / Glossopharyngeal neuralgia
The usual daily dose of carbamazepine is 200 to 400 mg. The dose should be increased until pain subsides, usually up to 400 or 800 mg per day in one or two divided doses.
In some cases, treatment may be continued with a reduced maintenance dose – 1 tablet of Finlepsin taken twice daily (equivalent to 400 mg of carbamazepine).
In elderly patients or particularly sensitive individuals, an initial dose of 0.5 tablet of Finlepsin (equivalent to 100 mg of carbamazepine) taken as a single morning or evening dose may be sufficient.

Pain in diabetic neuropathy
The usual daily dose is 600 mg (1 tablet of Finlepsin taken three times daily).
In exceptional cases, the dose may be increased to 2 tablets of Finlepsin taken three times daily (equivalent to 1200 mg per day).

Trigeminal neuralgia in multiple sclerosis
The average daily dose is 1 tablet of Finlepsin taken 2–4 times daily (equivalent to 400 to 800 mg of carbamazepine).

Prevention of seizures in alcohol withdrawal syndrome under hospital conditions
The usual daily dose is 1 tablet of Finlepsin taken three times daily (equivalent to 600 mg, 200 mg in the morning and 400 mg in the evening). In severe cases, the initial dose may be increased to 3 tablets of Finlepsin taken twice daily (equivalent to 1200 mg of carbamazepine per day).
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.

NOTE!
In patients with severe cardiovascular disease, liver disorders or renal insufficiency, as well as in elderly individuals, a reduced dose may be sufficient.

Administration method
Finlepsin tablets are divisible and should be taken with sufficient fluid (e.g. a glass of water) during or after meals.
In some cases, good efficacy has been demonstrated with a daily dose divided into 4 to 5 doses.
The timing of drug administration depends on the indication and individual patient response. Under no circumstances should the patient discontinue therapy on their own.
The duration of treatment is determined by the treating physician.
Antiepileptic treatment is usually long-term. The dose, duration of treatment, and discontinuation of therapy are determined individually by a specialist physician (neurologist). Usually, dose reduction and discontinuation of treatment may only be considered after a seizure-free period of 2 to 3 years. Treatment should be discontinued gradually over a period of 1 to 2 years. During this period, weight gain in children should be monitored. 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. The dose should be cautiously reduced to determine whether spontaneous resolution of symptoms occurs. If pain recurs, 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
Overdose of Finlepsin may lead to intensification of adverse effects. The first symptoms of poisoning appear 1 to 3 hours after drug intake and are primarily disturbances in nervous system function. Cardiovascular disturbances are mild. Severe disturbances occur only after very large doses.

Symptoms may include: depression of central nervous system function, disorientation, drowsiness, agitation, tremors, generalized tonic-clonic seizures, respiratory disturbances, cardiovascular disturbances – decreased arterial pressure (increased blood pressure may also occur), increased heart rate (tachycardia), cardiac conduction disturbances (atrioventricular block, ECG changes), 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 overdose depends on the complications present and is usually conducted in a hospital setting.
Carbamazepine overdose should be treated symptomatically; the 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-sustaining 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, appropriate anticonvulsant treatment should be initiated. According to published data, barbiturates are not recommended due to respiratory depression, especially in children.

Missed dose of Finlepsin
If a dose is missed, the drug should be continued according to the established regimen.
Under no circumstances should a double dose be taken.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Dose-dependent adverse effects usually disappear within a few days after starting treatment or after
reducing the dose. Nervous system reactions 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 effects is higher with combination therapy than with monotherapy.
Dizziness, drowsiness, sedation, fatigue, cerebellar ataxia (disorder, incoordination, impaired motor coordination), headache, diplopia, malaise, nausea,
vomiting or allergic reactions may commonly occur. In elderly patients, anxiety and disorientation may occur.
The following adverse effects may occur during treatment with carbamazepine.
Very common (may affect more than 1 in 10 patients): leukopenia, dizziness, ataxia, drowsiness,
malaise,
nausea, vomiting, increased liver enzyme activity: gamma-glutamyltransferase (usually
clinically insignificant), allergic skin inflammation, urticaria (including severe forms).
Common (may affect up to 1 in 10 patients): headache, diplopia, accommodation disorders (blurred vision), dryness of oral mucous membranes, loss of appetite, increased activity
of alkaline phosphatase (a group of enzymes present in the liver, bones, intestines and kidneys),
thrombocytopenia, eosinophilia, hyponatremia, which causes fluid retention, edema, weight gain and reduced plasma osmolality.
In rare cases, this has led to nausea, vomiting, headache and rarely – disorientation,
lethargy and other neurological abnormalities.
Uncommon (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 condition and redness of the entire skin, often accompanied by desquamation of the epidermis).
Rare (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),
folate deficiency, delayed-type hypersensitivity with fever, skin rash, vasculitis,
lymph node swelling, joint pain (arthralgia), changes in white blood cell count, eosinophilia
(increase in eosinophils in blood smear above 4%), enlargement of liver and spleen or
abnormal 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 disturbances, 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 rare (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 (proliferation of glandular breast tissue)
in males, thyroid dysfunction (decreased FT4, T3, T4 levels) 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 syndrome, taste disturbances, neuroleptic malignant syndrome (a serious, life-threatening complication occurring mainly in patients treated with neuroleptic drugs), cataract formation, conjunctivitis, increased intraocular pressure, hearing disturbances (tinnitus, increased or decreased auditory sensitivity, changes in tone perception), bradycardia, arrhythmia, atrioventricular block sometimes with loss of consciousness or syncope (cardiac rhythm and conduction disorders), collapse, congestive heart failure, exacerbation of coronary artery disease, thrombophlebitis, thromboembolic episodes, pulmonary hypersensitivity reactions with fever, dyspnea, as well as lung inflammation or fibrosis (in case of such reactions, 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 (reduced sperm count or (and) reduced motility), male infertility, libido disorders, impotence.
Single cases: decreased serum levels of folate, vitamin B and homocysteine.
Frequency not known (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 should consult their doctor or pharmacist if undergoing long-term antiepileptic therapy, have osteoporosis or are taking steroids.
Reporting of adverse effects
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store the medicine Finlepsin

Keep this medicine out of the sight and reach of children.
No special precautions for storage of the medicine are required.
Do not use the medicine Finlepsin after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Finlepsin contains

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

What Finlepsin looks like and contents of the pack
Finlepsin is white, round tablets, bevelled on both sides with a deep dividing line on one side,
convex on the other side, with smooth surface, intact edges and uniform appearance.
50 tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53, 00-113 Warsaw
tel.: (22) 345 93 00

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