FINLEPSIN retard 200 mg. 50 tablets

Qualitative and quantitative composition
Active substance: 1 prolonged-release tablet contains as active substance 200mg carbamazepine.
Excipients: Copolymer methacrylate, glycerol triacetate, talc, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate.


Pharmaceutical form and quantity in one package
Prolonged osvobozhdavane.Finlepsin 200 retard in packages of 50 prolonged-release tablets.


Pharmacotherapeutic group
Antiepileptic medicine. Carboxamide derivative.

Indications
♦ epilepsies: simple partial seizures; complex partial seizures; primary generalized tonic-clonic seizures; partial seizures with secondary generalization; mixed forms of epilepsy;
♦ paroxysmal occurring pain of the face (trigeminal neuralgia);
♦ breakthrough pain of unknown cause in the throat (genuinna glossopharyngeal neuralgia);
♦ painful conditions due to nerve damage in diabetes (diabetic neuropathy);
♦ non-epileptic seizures in multiple sclerosis such as trigeminal neuralgia, tonic attacks, disturbances of speech (dysarthria) and movement (paroxysmal ataxia), paroxysmal numbness or tingling (paraesthesia paroxysmal) and pain attacks;
♦ prevent seizures in alcohol withdrawal;

Note:
In the indication "prevention of seizures in alcohol withdrawal" Finlepsin® 200 retard should be administered only in hospital.
♦ acute mania and maintenance treatment of bipolar affective disorders prevention or reduction of relapses.

Contraindications
In what cases should not take Finlepsin 200 retard?
Finlepsin 200 retard should not be used in: bone marrow damage, heart conduction disorders (atrioventricular block), presence of hypersensitivity to the active substance, tricyclic antidepressants or any of the excipients of the medicinal product (see "Qualitative and quantitative composition '), and acute intermittent porphyria (a serious disorder of metabolism) .Finlepsin 200 retard should not be administered concomitantly with lithium (see "Drug interactions and other forms of interaction"). As Finlepsin 200 may retard causing a certain kind of attacks (so-called. absences), respectively. can be quickened appearance of existing ones, it should not be used in patients who complain of these relapsing forms.
In what cases only after consulting your doctor may take Finlepsin 200 retard?
The following describes the cases in which only under certain conditions and with particular attention may use Finlepsin 200 retard. Consult, please on these issues with your doctor. This also applies in case these data are valid for you and rano.Finlepsin 200 retard should not be administered concurrently or before they expire at least 14 days after discontinuation of MAO inhibitors. Finlepsin 200 retard should be used only in strict observance of the benefit / risk and appropriate precautions for diseases of the blood forming organs (haematological diseases), serious violations of the function of the heart, liver and kidneys (see "Undesirable effects" and "Dosage, method and duration of administration"), abnormal sodium metabolism.


Special precautions for use
What specific measures should be considered?
Based named as adverse reactions possible adverse actions and reactions of hypersensitivity recommended (especially during prolonged treatment) periodic monitoring of blood counts, the functions of the liver and kidneys, initially before treatment, during the first month of treatment - at the beginning of each week, and then - every month. After the first 6 months of treatment is recommended 2-4 checkup godishno.Plazmenite concentrations Finlepsin 200 retard and other anticonvulsant drugs in combination therapy also regularly to identify and therefore reduces doza.Ako daily in patients with epilepsy treated Finlepsin 200 retard, have a change of treatment, you should not be stopped abruptly but gradually move to other antiepileptic medicine. In patients with glaucoma should be periodically monitored intraocular pressure. Care must be taken, because the side effects are similar to abstinence phenomena abstinence from alcohol and can be confused with tyah.Finlepsin 200 retard taken with lithium only in exceptional cases, for the prevention of manic depression or their insufficient response to lithium. In this case, to avoid adverse interactions (see "Drug interactions and other forms of interaction") should be taken not to exceed a certain plasma concentration of carbamazepine (8 | ig / ml), and the plasma level of lithium to maintain within the lower therapeutic area (0.3-0.8 mvaf / L). It is desirable that the intake of neuroleptics to break no later than eight weeks before the start of treatment with Finlepsin® 200 retard and not conducted jointly treatment.

Drug interactions and other forms of interaction
What other drugs affect the action of Finlepsin 200 retard or are affected by it?
Due to the occurrence of undesirable effects on the central nervous system to avoid concomitant use of MAO inhibitors (medicines to treat depression). To observe the 14-day free treatment interval.Povliyavane plasma concentrations of other medicinal products Finlepsin® 200 retard: Finlepsin 200 retard may increase the activity of certain liver enzymes and thereby reduce plasma levels of other drugs. Therefore, the effect of certain other co-administered drugs that are degraded in the same manner as carbamazepine, may weaken or even increased.
When concomitant administration of Finlepsin 200 retard should be adjusted accordingly and resp. clinical requirements for the following drugs:
- Clonazepam, ethosuximide, primidone, valproic acid, lamotrigine - other drugs for the treatment of diseases occurring episodes;
- Alprazolam, clobazam - for the treatment of anxiety states;
- Corticosteroids (eg. Prednisone, dexamethasone);
- Cyclosporine - suppresses the immune system in organ transplantation;
- Digoxin - to treat heart disease;
- Tetracyclines such as. doxycycline (an antibiotic);
- Felodipine - medicine, lowering blood pressure;
- Haloperidol- to treat psychiatric disorders;
- Imipramine - antidepressant;
- Methadone - a pain killer;
- Theophylline - in the treatment of severe forms of diseases of the respiratory tract;
- Medicines that prevent blood clotting such. warfarin, phenprocoumon, dicoumarol.
Finlepsin 200 retard, like other anticonvulsants, may weaken the effect of hormonal contraceptives (medicines to prevent unwanted pregnancy). If a bleeding outside menstrual, hormonal protection is not sufficient. In such cases it is recommended to apply other non-hormonal contraceptive methods. Finlepsin retard 200 can both increase and decrease the plasma concentration of phenytoin, which in isolated cases can cause states of disorientation, even koma.Namalyavane the plasma concentration of carbamazepine by other agents: The plasma level of carbamazepine can reduced from phenobarbital, primidone, valproic acid, teofilin.Ot other hand, serum levels of the pharmacologically active metabolite (a breakdown product of Finlepsin 200 retard the process of metabolism) carbamazepine-10,11 -epoxide, can be increased by valproic acid and primidon.Poradi likelihood of mutual influence, particularly with concomitant several antiepileptic medicinal products are advised to monitor plasma levels Finlepsin 200 retard and to modify dosage.
Raise carbamazepine plasma concentrations of other medicinal products:
These drugs may increase the plasma concentrations of carbamazepine:
- Macrolide antibiotics, such as. erythromycin, josamycin (for the treatment of bacterial infections);
- Isoniazid - for the treatment of tuberculosis;
- Calcium antagonists, such as eg. verapamil, diltiazem - to treat angina pectoris;
- Acetazolamide - for the treatment of glaucoma;
- Dextropropoxyphene / propoxyphene - painkillers medicines;
- Viloxazine - antidepressant;
- Danazollekarstvo to block sex hormone gonadotropin;
- Nicotinamide in high dosages in adults (B vitamins);
- Cimetidine - used to treat peptic ulcer disease ;;
- Desipramine (antidepressant).
Increased plasma levels of carbamazepine can cause described as adverse reactions symptoms (eg. Dizziness, fatigue, uncertainty in gait, double vision). Therefore, in the manifestation of such symptoms need to measure plasma concentrations of carbamazepine and need to be reduced.

Other drug interactions:
Concomitant Finlepsin 200 retard and neuroleptics (medicines to treat mental illness) or metoclopramide (a medicine for the treatment of gastrointestinal disorders) may favor the occurrence of neurological adverse reaktsii.Pri patients treated with neuroleptics Finlepsin 200 retard may reduce their plasma level and thereby may cause a worsening of the clinical picture. Therefore, the physician, if necessary, may increase the relevant nevroleptik.Tryabva to note that coadministration of lithium (a medicine for the treatment and prevention of certain mental illnesses) and Finlepsin® 200 retard may increase neurotoxic and action of both drugs. This requires strict control of their level in the blood. The intake of neuroleptics should be terminated not later than eight weeks before the start of treatment with Finlepsin 200 retard and also not applied simultaneously. Care must be taken for the following symptoms of neurotoxic side effects: instability gait (ataxia), involuntary rhythmic eye movement (horizontal nystagmus), lively and tendon reflexes, muscle twitching (muscle fasciculation) Finlepsin 200 retard may increase toxicity of isoniazid against black drob.Kombiniraniyat intake Finlepsin® 200 retard with some diuretics (hydrochlorothiazide, furosemide) may reduce the level of sodium in seruma.Finlepsin 200 retard may reduce the effectiveness of drugs acting muscle relaxant (muscle relaxants eg. pancuronium), which contributes to faster overcoming of neuromuscular block. Patients who are treated with muscle relaxants, should be placed under strict medical supervision and, if necessary, increase the dosage accordingly im.Pri concomitant administration of isotretinoin (a medicine for the treatment of acne) and Finlepsin 200 retard should be monitored plasma levels karbamazepina.Finlepsin 200 enhances the radiation appears to retard (elimination) of thyroid hormones, which increases the need for them to patients with impaired function of the gland. Therefore these patients should be performed replacement therapy, and at the beginning and end of treatment Finlepsin® 200 retard to determine the parameters of the thyroid gland and thus to take a dose adjustment of the relevant hormonal drug produkti.Ednovremenniyat antidepressants type inhibitors metabolism of serotonin (an antidepressant such. fluoxetine) can lead to toxic serotonin sindrom.Molya note that these data may also apply to previously used drugs.

What food and drinks should avoid?
During treatment with Finlepsin 200 retard avoid alcohol as it unpredictable can change and enhance the effect of Finlepsin 200 retard.Kakvo you should consider during pregnancy? Finlepsin® 200 retard may be prescribed during pregnancy by a physician only after rigorous evaluation of the benefit / risk.Pri existing pregnancy or at its start, especially between the 20th and 40th day of pregnancy Finlepsin 200 retard should be given in as much as possible smaller doses controlling seizures. The daily dose, especially during the sensitive phase should allocate more single doses throughout the day. It is recommended that regular monitoring of plasma kontsentratsiya.Vav relation to the active substance, carbamazepine, in rare cases, congenital malformations and cleft spine. Combination with other antiepileptic drugs, and other drugs during pregnancy, if possible, should be avoided, as the risk of malformations in combination therapy uvelichava.Poradi enzimindutsirashtite properties of carbamazepine, a shortage of folic acid may be additional factor for fetal harm. It is therefore recommended folic acid before and during pregnancy. To avoid the risk of bleeding in newborns is recommended prophylactic administration of vitamin K of the mother in the final weeks of pregnancy, respectively. after the birth of deteto.Pri desire for pregnancy necessarily consult your doctor.
What must be considered during lactation?
Finlepsin 200 retard passes into breast milk in small quantities so that therapeutic doses it does not endanger the child. If it is found abnormal weight gain or increased need for sleep (sedation) in the infant, it should stop breastfeeding.

What should be considered in children and adults?
Finlepsin 200 retard due to the high content of the active substance and the lack of experience in children with prolonged release tablets is not suitable for patients under 6 years vazrast.Pri adults recommended lower dosage.

What you should consider when participating in traffic and operating machinery and working without secure support?
By the occurrence of undesirable effects on the central nervous system (eg. Dizziness, drowsiness, uncertainty in gait and headache) at the beginning of treatment, at high doses and / or in combination with other drugs affecting the central nervous system, Finlepsin 200 retard can, even if consistent with prescriptions use so much change reactivity, regardless of the response of the underlying disease that impair the ability -to participate actively in traffic or service mashini.Na unexpected and sudden situations you will not already fast enough to react purposefully.
Do not drive a car or other vehicles!
Do not operate power tools or machines!
Do not operate without secure support!
Pay particular attention to the fact that alcohol worsens your ability to participate in traffic.

Dosage, method and duration of administration
These data are valid in the event that your doctor has prescribed something for Finlepsin 200 retard. Please stick to the recommendations relevant because otherwise Finlepsin 200 retard may not act properly.
In how much and how often you should take Finlepsin 200 retard?
Treatment with carbamazepine gradually with lower starting dose, depending on the type and severity of the disease is applied individually, then the dose is slowly increased to therapeutic maintenance dose. Optimal dosing, especially in combination therapy is performed after determining the plasma level. In practice it has been found that the therapeutic plasma level of 200 Finlepsin retard is within 4-12 mg / ml.Pri a switch to 200 Finlepsin retard dosage of the anticonvulsant which reception is terminated must be gradually reduced. Anticonvulsant therapy should be performed whenever possible as monotherapy and should be monitored by a doctor-prescribed spetsialist.Obiknoveno 400-1200 mg daily Finlepsin 200 retard divided 1-2 single doses. Generally exceeding a total dose of 1200 mg is inappropriate. Should not exceed the maximum daily dose of 1600 mg, since at high doses increases the likelihood of experiencing adverse reaktsii.V individual cases dose may significantly deviate from that starting and maintenance dose (eg. Due to metabolism by speeding