GABANEVRAL caps. 100 mg. 100 caps

 

GABANEVRAL - 100 Capsules - 100 mg.

Drug per capsule Gabanevral 100 mg: Gabapentin 100 mg.

 

Excipients

 

Gabanevral 100 mg capsules: lactose monohydrate, maize starch, talc, titanium dioxide, gelatin, yellow iron dioxide, gelatin

 

WHAT GABANEVRALI WHAT IT IS USED

 

Gabanevral a structure analogous to gamaaminomaslenata acid, but the mechanism of action is different from that of many other drugs that interact with its synapses. Has anticonvulsant activity. Gabanevral is used to treat:

 

Epilepsy:

 

Monotherapy for adults and children over 12 years with partial onset seizures with or without secondary generalization;

 

Adjunctive therapy in adults and children over 3 years with partial onset seizures with or without secondary generalization.

Neuropathic pain:

 

Treatment of neuropathic pain in patients over 18 years.

 

WHAT YOU NEED TO KNOW BEFORE TREATMENT WITH GABANEVRAL

 

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:

 

Treatment with the product is not established phenomenon of increased symptoms after stopping treatment. However, treatment discontinuation should be gradual due to risk of unlock status epilepticus. The same goes for dose reduction, discontinuation or replacement with another anticonvulsant. This should be done gradually over a period of one week. This product is not effective in absence seizures.

 

Patients taking Gabanevral may show changes in mood and behavior.

 

The product is used with caution in patients with a history of mental illness because of the risk of psychotic episodes. They resolved with dose reduction or discontinuation.

 

Small number of people, epileptics, and Gabanevral have had thoughts of harming or killing yourself. If you have these, contact your doctor.

 

Application Gabanevral and intake of foods and beverages.

 

No evidence of a need for a special diet or restriction of certain foods and drinks during treatment with this product.

 

Pregnancy

 

Before taking any medicines, check with your doctor or pharmacist

 

There are no adequate studies in pregnant women. It is therefore recommended Gabanevral be used in those cases when the potential benefit to the mother is greater than the potential risk to the fetus.

 

Lactation

 

Before taking any medicines, check with your doctor.

 

Gabanevral passes into breast milk. Therefore, you should carefully consider whether the benefits of treatment clearly outweigh the risks of 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 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 fenotoin, phenobarbital, valproic acid and carbamazepine.

 

Combined use of the product with an oral contraceptive containing norethindrone and / or ethinyl estradiol, does not affect the pharmacokinetics.

 

The bioavailability of the product decreased by about 20% by concomitant antiatsedi containing aluminum and magnesium. It is desirable that the product should be administered at least 2 hours after taking antacids.

 

Probenecid does not affect renal excretion of Gabanevral.

 

In patients receiving concomitant morphine Gabanevral may increase the concentration of product in the plasma. These patients should be monitored for signs of CNS depression such languor and doses of morphine Gabanevral must be reduced.

 

HOW TO USE GABANEVRAL

 

Always Gabanevral as instructed by your doctor.

 

Epilepsy:

 

For adults and children over 12 years - starting dose 300 mg - three times daily on day 1. The daily dose divided into three equal intake can be increased to a maximum dose of 3600 mg. The maximum time between doses in the triple regimen should not exceed ca 12 hours to prevent seizures.

 

For children 3 to 12 years - the effective dose of the product is 25 to 35 mg / kg / day, taken in three equal doses. Originally titration to achieve therapeutically effective dose is made in the first three days by applying a 10 mg / kg / day on day 1, 20 mg / kg / day on day 2 and 30 mg / kg / day for 3 days. The daily dose in three divided doses may be increased to a maximum dose of 35 mg / kg / day.

 

If required discontinuation of the product and / or the addition of another anticonvulsant to therapy, this should be done gradually over a minimum of one week.

 

Neuropathic pain in adults:

 

The initial dose of 900 mg / day, taken in three equal doses. This dozda can be increased as necessary until the clinical response to a maximum dose of 3600 mg / day.

 

POSSIBLE SIDE EFFECTS

 

Like all medicines, Gabanevral can cause side effects

 

Epilepsy in adults

 

Since Gabanevral was used more frequently in combination with other antiepileptic drugs, it is not possible to determine which product caused the corresponding reaction.

  The most common adverse reactions (> 1/10) - languor and confusion;

  Common possible side effects (between 1/10 and 1/100) - ataxia, fatigue, visual problems (nystagmus), tremor, double vision. myopia, impaired speech, forgetfulness, weight loss, numbness, joint pain, purpura, heartburn, anxiety, weight gain, urinary infections and pharyngitis

  Uncommon possible side effects (between 1/100 and 1/1000), low white blood cells, nervousness, fever, impotence.

 

Rarely loss of urine, inflammation of the pancreas, liver enzymes, severe skin reactions (erythema multiforme syndrome Stevens Johnson), depression, emotional lability, hostility, changes in thinking and psychoses / hallucinations. Been reported instability of glucose in patients with diabetes. More rarely reported muscle pain, 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, adverse reactions with an incidence of 2% or more compared with placebo: languor, fatigue, weight gain, hostility, emotional lability, confusion, movement disorders (hyperkinesia), nausea / vomiting, viral infection, fever, bronchitis, respiratory infections. Some of these effects can be attributed to the banal viral disease in children.

 

Neuropathic pain

 

The most common adverse reactions (> 1/10) relating to the treatment of neuropathic pain are the product confusion and languor.

  Common side effects (between 1/10 and 1/100) - diarrhea, dry mouth, peripheral edema, weight gain, abnormal gait, forgetfulness, impaired movements (ataxia), abnormal thinking, rash and short-sightedness.

  Uncommon side effects (between 1/100 and 1/1000) - injuries, weight loss, back pain, constipation, flatulence, nausea, disorientation, hyperesthesia, dizziness, dyspnea, pharyngitis.

 

Adverse reakiii from postmarketing surveillance

 

Other adverse reactions observed in the treatment of epilepsy and neuropathic pain is acute renal failure, allergic reactions, incl. urticaria, alopecia, chest pain, hepatitis, jaundice, hallucinations, movement disorders (choreoathetosis, dyskinesia and dystonia), palpitations, low platelets, noise ushite.Ot adverse events following discontinuation of treatment most frequently reported anxiety, insomnia, nausea, pain and izpotyavane.Ako notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.