GABANEURAL 400 mg. 100 capsules

WHAT GABANEURAL AND WHAT IT IS USED
Gabaneural in structure is an analogue of gamaaminomaslenata acid, but the mechanism of action is different from that of many other drugs that interact with its synapses. It possesses anticonvulsant effect.
Gabanevral is applied for the treatment of:
Epilepsy
• Monotherapy in adults and children over 12 years with partial seizures with and without secondary generalization;
• adjunctive therapy in adults and children over 3 years with partial seizures with and without secondary generalization.

Neuropathic pain
• Treatment of neuropathic pain in patients over 18 years.
2. WHAT YOU NEED TO KNOW BEFORE TREATMENT WITH GABANEURAL
Gabanevral not be used in patients with hypersensitivity to the active substance or to any of the excipients.
In this medicinal product, please note the following:
In the treatment with the product is not a proven phenomenon of increased symptoms after stopping treatment. However, discontinuation of treatment should be gradual due to the risk of unlocking status epilepticus. The same applies for dose reduction, discontinuation or replacement with a different anticonvulsant. This should be done gradually over a period of one week. The product is not effective in absences.
Patients taking Gabanevral can exhibit changes in mood and behavior.
The product is used with caution in patients with a mental illness because of the risk of psychotic episodes. They resolved with dose reduction or discontinuation of therapy.
A small number of people being treated with antiepileptics such as gabanevral have had thoughts of harming or killing themselves. If these occur, immediately contact your doctor.
Application Gabaneural and intake of foods and beverages
No evidence of the need for special diets or restrictions on certain types of foods and beverages during treatment with this product.
Pregnancy
Before taking any medicine, consult your doctor or pharmacist
There are no adequate studies in pregnant women. It is therefore recommended Gabanevral be used in such cases only if the potential benefit to the mother is greater than the potential risk to the fetus.
Breastfeeding
Before taking any medicine, consult your doctor or pharmacist
Gabanevral passes into breast milk. Therefore, it should carefully evaluate whether the benefits of treatment outweigh the risks categorically it.
Driving and using machines
Patients should be advised not to drive or engage in activities requiring a high degree of concentration until you are sure that the product does not change their reactivity.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they have not been prescribed by your doctor
No evidence of interactions between Gabanevral and phenytoin, phenobarbital, valproic acid and karabamazepin.
Combined use of the product with oral contraceptives containing norethindrone and / or ethinyl estradiol, does not influence the pharmacokinetics.
The bioavailability of the product reduced by 20% when administered with antacids containing aluminum and magnesium. It is desirable that the product be taken at least 2 hours after taking antacids.
Probenecid did not alter renal excretion of Gabanevral.
Upon determination of protein in urine tests Ames N-Multitrix SG can be observed false positive results. Preferably in this case is to use a more specific assay with sulfosalicylic acid.
In patients receiving concomitant morphine and Gabanevral can increase product concentration in plasma. These patients should be monitored for symptoms of CNS depression such as drowsiness and doses of morphine and Gabanevral should be reduced.
3. HOW TO USE GABANEURAL
Always take Gabaneural according to the instructions of the doctor!
Epilepsy
• For adults and children over 12 years - starting dose of 300 mg three times daily on day 1, as described in the table. The daily dose, divided into three equal intake can be increased to a maximum dose of 3600 mg. The maximum time between doses in triple dose regimen should not exceed 12 hours to prevent the occurrence of seizures.

• In children aged 3 to 12 years - the effective dose of the product is 25-35 mg / kg / day, taken in three equal adopt, as shown in Table 2. Initial titration to achieve a therapeutically effective dose is made in the first three days applying the 10 mg / kg / day on day 1, 20 mg / kg / day at day 2 and 30 mg / kg / day at day 3, as shown in Table 3. Then, a daily dose, in three divided doses may be increased up to a maximum dose of 35 mg / kg / day.

If the discontinuation of treatment with the product and / or adding to other anticonvulsant therapy, this should be done gradually over a minimum of one week.
Neuropathic pain in adults
The starting dose is 900 mg / day, taken in three equal doses. This dose can be increased as necessary to achieve the clinical response to a maximal dose of 3600 mg / day.
Patients with renal insufficiency

The total daily dose is administered in three doses.
* Adopt as 300 mg every other day.
In hemodialysis patients recommended loading dose of 300 to 400 mg after every 4 hours of hemodialysis adopted by 200 to 300 mg Gabanevral.
If you have the impression that the effect of the application of Gabanevral is strong or weak, talk to your doctor or pharmacist!
If you take a large amount of the drug:
When administered at the recommended dose immediately contact a doctor!
Acute life-threatening toxicity in overdose Gabanevral at doses up to 49 g have not been established. Symptoms of overdose include dizziness, double vision, slurred speech, drowsiness, lethargy, diarrhea. As the product is absorbed to a lesser extent, at high doses, this limits the absorption and overdose.
The product can be removed from the body by hemodialysis, but this is not recommended. In patients with severe renal impairment, it is the tool of choice.
If you forget to Gabanevral:
If you forget to take another dose, take it missed as soon as possible, but do not double the next one.
4. POSSIBLE SIDE EFFECTS
Like any other medicine, Gabanevral can cause adverse reactions
Epilepsy in adults
Since Gabanevral is applied more often in combination with other antiepileptic drugs, it is not possible to determine which product caused the respective undesirable effect.
• The most common adverse reactions (> 1/10) - drowsiness and confusion;
• Common possible side effects (between 1/10 and 1/100) - ataxia, fatigue, visual disturbances (nystagmus), shaking, double 6
vision, myopia, impaired speech, forgetfulness, weight loss, tingling, joint pain, purpura, heartburn, anxiety, weight gain, urinary infections and pharyngitis;
• Uncommon possible side effects (between 1/100 and 1/1000) - reduced number of white blood cells, nervousness, fever, impotence.
Rarely micturition disorders, inflammation of the pancreas, elevated liver enzymes, severe skin reactions (erythema multiforme syndrome Stevens Johnson), depression, emotional lability, hostility, changes in thinking and psychoses / hallucinations.
Have been reported instability of the glucose level in patients with diabetes. Rarely reported more muscle aches, headache, nausea and / or vomiting.
Epilepsy in children
In children aged 3-12 years the most common (> 10%) adverse reactions were emotional lability, nervousness, changes in thinking (abnormal thoughts). All these events were rated as mild to moderate and do not require frequent discontinuation.
In children aged 3-12 years in clinical trials experienced adverse reactions with an incidence of 2% or more compared with placebo: somnolence, fatigue, weight gain, hostility, emotional lability, confusion, movement disorders (hyperkinesia), nausea / vomiting, viral infections, fever, bronchitis, respiratory infections. Some of these reactions can be attributed to banal viral disease in children.
Neuropathic pain
The most common adverse reactions (> 1/10) related to the treatment of neuropathic pain with the product are confusion and drowsiness.
• Common side effects (between 1/10 and 1/100) - diarrhea, dry mouth, peripheral edema, weight gain, abnormal gait, forgetfulness, movement disorder (ataksiya), abnormal thinking, rash and shortsighted.
• Uncommon side effects (between 1/100 and 1/1000) - injuries, weight loss, back pain, constipation, flatulence, nausea, disorientation, hyperaesthesia, dizziness, dyspnea, pharyngitis.
Adverse reactions in post marketing surveillance.
Other side effects observed in the treatment of epilepsy and neuropathic pain are acute renal failure, allergic reactions, incl. urticaria, alopecia, chest pain, hepatitis, jaundice, hallucinations, movement disorders (choreoathetosis, dyskinesia and dystonia), palpitations, low platelet counts, or tinnitus.
Side effects after discontinuation of treatment most commonly reported anxiety, insomnia, nausea, pain and sweating.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. Storage
At temperatures below 25 ° C.
Keep out of reach of children!
Do not use after the expiry date stated on the package!