Zoresan kaps. it is firm. 100 mg No. 30

Solid capsules Zoresan are appointed at the following indications:

• monotherapy at adult patients with partial epileptic seizures with secondary generalization or without, with for the first time the diagnosed epilepsy;
• additional therapy at adults and children is more senior than 6 years with partial epileptic seizures with secondary generalization or without.

Structure

Active ingredient: zonisamid;

Each solid capsule contains zonisamid 25 mg or 50 mg, 100 mg;

Excipients: microcrystalline cellulose, sodium lauryl sulfate, silicon dioxide colloidal, the castor oil hydrogenated;

capsule Cover:

• for the solid capsule on 25 mg or 50 mg gelatin, water purified, ferrous oxide yellow (E172), ferrous oxide black (E172), the titan dioxide (E 171), sodium lauryl sulfate;
• for the solid capsule on 100 mg gelatin, water purified, ferrous oxide red (E172), the titan dioxide (E 171), sodium lauryl sulfate.

Contraindication

Hypersensitivity to active ingredient, to any of excipients or streptocides.

Route of administration

to use the Drug Zoresan® inside irrespective of meal.

Feature of use

Pregnant

Zonisamid should not be applied during pregnancy unless the potential advantage, according to the doctor, exceeds possible risk for a fruit.

Children

children should use Drug aged from 6 years and with body weight more than 20 kg.

Drivers

Researches of influence of a zonisamid on ability to run motor transport and to work with mechanisms. However, considering that some patients can experience drowsiness or difficulties with concentration of attention, especially at the beginning of therapy or after increase in a dose, it is necessary to abstain from the activity demanding the increased concentration of attention, for example, control of motor transport or work with other mechanisms.

Overdose

Symptoms: drowsiness, nausea, gastritis, nystagmus, myoclonus, coma, bradycardia, renal failure, arterial hypotension and respiratory depression. As zonisamid has long elimination half-life, symptoms of overdose can have steady character. There is no specific antidote for overdose treatment zonisamidy. In case of an established fact of overdose or suspicion to perform gastric lavage or artificial calling of vomiting against the background of the ordinary actions directed to support of passability of airways to it.

Side effects

Infection and invasion: pneumonia, urogenital infections.

from blood and lymphatic system: ecchymomas, agranulocytosis, aplastic anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia.

from the immune system: hypersensitivity reactions, caused by cider of medicamentous hypersensitivity, DRESS syndrome (rash with an eosinophilia and system symptoms).

from metabolism: anorexia, loss of appetite, hypopotassemia, metabolic acidosis, renal tubular acidosis.

from mentality: excitement, irritability, confusion of consciousness, depression, emotional lability, differences of mood, acute psychosis, uneasiness, insomnia, psychotic disorders, anger, rage, suicide thoughts and attempts of suicide, hallucination.

from nervous system: ataxy, dizziness, memory disturbance, drowsiness, bradyphrenia (block of thinking), disturbances of attention, nystagmus, paresthesias, disturbances of the speech, tremor, spasms, amnesia, coma, big epileptic seizures, myasthenic syndrome, malignant antipsychotic syndrome, epileptic status.

from an organ of sight: diplopia, glaucoma, eye pain, shortsightedness, illegibility of sight, decrease in visual acuity.

from the respiratory system, bodies of a thorax and mediastinum: short wind, aspiration pneumonia, breath disturbance, a pneumonitis connected with hypersensitivity.

from digestive tract: abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, pancreatitis.

from a liver and biliary tract: cholecystitis, cholelithiasis, hepatocellular damages.

from skin and hypodermic cellulose: rash, itching, alopecia, anhidrosis, multiformny erythema, Stephens-Johnson's syndrome, toxic epidermal necrolysis. From a musculoskeletal system and connective tissue: rhabdomyolysis.

from an urinary system: nephrolithiasis, urolithiasis, hydronephrosis, renal failure, disturbances of composition of urine.

General disturbances and reactions in the injection site: increased fatigue, grippopodobny states, fervescence, peripheral hypostases.

Interaction

At patients with epilepsy the long reception zonisamid in therapeutic doses has no clinically significant influence on pharmacokinetics of carbamazepine, a lamotrigin, Phenytoinum and Valproatum of sodium.

to Store

in original packing at a temperature not above 25 °C. To store out of children's reach.

Expiration date - 2 years.