PETINIMID 250 mg. 100 capsules

WHAT PETINIMID AND WHAT IT IS USED
Ethosuximide, the active substance of Petinimid capsule is effective in the treatment of certain forms of epileptic seizures.
Petinimid capsules are used for the treatment of absence seizures associated with epilepsy (small seizures).

Do not take Petinimid capsules:
if you are allergic (hypersensitive) to ethosuximide or other substances of the same pharmaceutical group (succinimide), or any of the other ingredients of Petinimid capsules;
if the child is under three years.
Take special care with Petinimid capsules
Caution should be exercised if, when you found damage to the liver or kidneys (must conduct regular control!).
During treatment, your doctor will ask your regular blood tests, urine and liver function tests. All clinical and laboratory studies should be carried out exactly as prescribed by your doctor!
If you notice signs of infection (such as sore throat, fever) should immediately consult your doctor. These symptoms may be signs of a serious, sometimes life-threatening violation of hematopoiesis and must immediately blood counts.
If severe allergic skin reactions and changes in the blood picture (for early symptoms, see "Possible side effects"), Petinimid treatment should be withdrawn immediately. In this case, you should immediately consult your doctor. Following the doctor's instructions, you should continue treatment with different antiepileptic medicinal product that is not the group of succinimide.
As with any therapeutic regimen for the treatment of epilepsy, Petinimid must be taken regularly. Changes in dosage, addition or discontinuation of concomitant medicinal products should be gradual and never suddenly.
Do not change the dose or duration of treatment without medical advice. Do not interrupt treatment with Petinimid without first consulting your doctor, even if you may not have seizures.
Treatment alone Petinimid patients with mixed synthetic seizures in some patients it is possible to frequent generalized tonic-clonic (Grand mal) seizures.
The effect of hormonal contraceptives (pills, transdermal patches, etc.) Can be reduced by Petinimid. For this reason, you should use other methods of birth control.

Taking other medicines
Drugs and other substances may have a mutually influence their effects. Therefore, before starting treatment, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This applies, for example, other antiepileptic drugs used together with Petinimid. Your doctor may order regular lab tests in some therapeutic combinations.
Valproic acid may result in an increase or decrease in the effect of Petinimid.
Carbamazepine can rain effect Petinimid. Use of Petinimid can enhance the effect of phenytoin.
During treatment with Petinimid should avoid the use of hypnotics and alcohol as they can lead to an increase in the sedative effect.
Drugs that can cause cramps should not be used in conjunction with Petinimid. The effect of hormonal contraceptives (tablets, transdermal patches, etc.) Can be reduced by Petinimid.

Taking Petinimid with food and drink
During treatment should be avoided alcohol.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
If you become pregnant, contact your doctor immediately. Your doctor will decide whether to take Petinimid during pregnancy or lactation.

Driving and using machines
Warning: The use of this medication may affect your ability to drive. Since Petinimid may impair reactivity requires special care when driving or operating machinery.

3. HOW TO TAKE PETINIMID CAPSULES
Always take Petinimid capsules exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Treatment schedule below is a general guideline. The exact dosage and duration of treatment is determined individually by your doctor.
The initial dose is 10 mg / kg daily.

 Daily number of capsules
 First week, second week, third week, fourth week
Children under 3 years 1 2 3 3
School-age children 1 2 4 4 (-6)
Adults 2 4 6 6 (-8)
Your doctor will decide the right dose for long term treatment. Usually your doctor prescribed daily dose be taken in two doses.
If you have a mixed type seizures, Petinimid can be combined with other anti-epileptic drugs. In most cases the additional intake of drugs to avoid large (Grand mal) seizures.
If you have severe renal impairment, your doctor will prescribe a lower dose.
For children is available Petinimid syrup.

Application:
The capsules are swallowed whole with sufficient liquid during meals.

If you take more dose capsules Petinimid
Acute overdosage can lead to nausea, vomiting and central nervous system, including coma and breathing difficulties. Requires immediate medical attention.

Information for doctors:
No association was found between the toxicity of ethosuximide and plasma concentrations. The therapeutic range is between 40 mg / l and 100 mg / l, although the indicated levels to 150 mg / l without toxicities.
In cases of intoxication, given the long half-life of ethosuximide (60 hours in adults, approximately 30 hours in children).
There is no known specific antidote. Treatment is symptomatic.
Forced diuresis and exchange transfusions are not effective. Since ethosuximide not bound to plasma proteins, can be held hemodialysis or peritoneal lavage.

If you forget to take Petinimid
Do not take a double dose to make up the missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Petinimid can cause side effects, although not everybody gets them.
Please note that the following are all side effects of this drug, which has been reported - even those that occur only sporadically.
Using higher daily doses or in patients with sensitive stomachs can sometimes occur gastrointestinal complaints such as decreased appetite, dyspepsia, nausea, vomiting, hiccups, cramps, stomach or abdominal pain, weight loss and diarrhea. There have been reports of swelling of the tongue and palate. Usually these effects are transient, rarely severe and generally do not require discontinuation of treatment.
Sometimes observed symptoms of the nervous system such as drowsiness, headache, dizziness, hyperactivity, elevated mood, irritability, abnormal gait and drowsiness.
Reported primarily in patients with data in the past for psychiatric disorders, changes in behavior (psychotic episodes) with symptoms such as irritability, agitation, moreover states of anxiety or anxiety, and aggression, inability to concentrate and other psychological changes. There have been isolated cases of increased sexual desire, paranoid psychosis and severe depression and suicidal thoughts. Cases with parkinsonian symptoms and hypersensitivity to light. Possible occurrence of allergic reactions, hives and other skin reactions, including rash accompanied by itching, syndrome Stevens-Johnson and Systemic lupus erythematosus. As possible side effects are described and blood disorders, which in some cases may lead to serious consequences. Changes in the blood can be accompanied by the following preceding events: increase in body temperature, flu-like symptoms, pathological changes in the skin and mucous membranes. It is also reported for myopia and vaginal bleeding.

If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PETINIMID CAPSULES
Keep out of reach of children.
Do not store above 25 ° C.
Do not refrigerate or freeze.
Store in the original package in order to protect from light.
Petinimid not use after the expiry date stated on the carton.