This medication is indicated for the treatment of different types of seizures in adults and children over 17 kg.
This medicine SHOULD NOT BE USED in the following cases.
- Liver disease, for example hepatitis.
- Previous personal or family history of serious liver disease , in particular drug-related,
- Known allergy to valproate, divalproate , valpromide or to one of the ingredients in the medicinal product,
- Hepatic porphyria (an abnormality of production of pigments known as porphyrines).
- In combination with mefloquine (a medication for the treatment of malaria), St. – John’s wort.
- Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives experience has indicated that children under the age of two years are at a considerably risk of developing fatal toxicity , especially those on multiple anticonvulsants , those with congenital metabolic disorders , those with severe seizure disorders accompanied by mental retardation , and those with organic brain disease .
- When vedge is used in this patient group , it should be used with extreme caution and as a sole agent . the benefits of the therapy should be weighed against the risks , above this age group , experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient group .
- These incidents usually have occurred during the first six months of the treatment .serious of fatal hepatotoxicity may be preceded by non specific symptoms such as malaise , weakness , lethargy , facial edema , anorexia , and vomiting . in patients with epilepsy , a loss of seizure control may also occur
- Liver function tests should be performed prior to therapy and at frequent intervals thereafter , especially during the first six months
- Valproate can produce teratogenic effects such as neural tube defects (e.g : spina bifida ).
According , the use of valproate products in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to fetus . this is especially important when the treatment of spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g : migraine ) is contemplated .
- Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate . some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death .
- This medication should not used in combination with lamotrigine, unless otherwise indicated by your doctor.
IN CASE OF DOUBR, IT IS IMPORTANT TO ASK YOUR DOCTOR OF PHARMACIST FOR ADVICE.
• Special warnings: ?
At the start of treatment, the frequency of seizures may increase or different types of seizures may occur: In such a case, immediately consult your doctor.
In rare instances, this medication can cause a disorder of the liver or pancreas which can be life-threatening for the patient.
This event can occur especially during the first six months of treatment.
Actions to be taken when one or more doses have missed:
• If you notice a little after the planned time of administration, take the usual dose.
• If you notice this a little before the following dose, do not double the dose.
• If you have forgotten to take several doses, contact your doctor immediately.
• Risk of withdrawal effects: Discontinuation of treatment must be gradually; sudden discontinuation of treatment or major decrease in doses can result in recurrence of seizures.
LIKE ANY MEDICINAL PRODUCT, THIS PRODUCT MAY. IN CERTAIN, GIVE RISE TO VARYING DEGREES OF BOTHRSOME EFFECTS.
-In exceptional circumstances, potentially serious liver or pancreatic impairment (see Special warnings).
-Nausea , vomiting , stomach pain , diarrhea ( at the start of treatment ) , temporary hair loss , slight tremor in the hands , drowsiness: these effects are transient , but may nevertheless require your doctor to adjust to adjust the dosage, hands , drowsiness : these effects are transient , but may nevertheless require your doctor to adjust the dosage.
- Menstrual disorders, weight gain.
- Consciousness disorders, isolated or with a seizures, headache.
- Onset of mild bleeding (nose, gums …). This must be reported to your doctor who may then prescribe laboratory tests, since bleeding disorders have been reported.
- Blood abnormalities: reduction in platelets, white blood cells and fibrinogen. Reduction in the number or change in the size of red blood cells, prolonged blooding time, increased ammonaemia.
- In rare circumstances : tremor , rigid muscles , cramps difficulty moving, or abnormal movements,
- In very rare circumstances, cognitive disorders of gradual onset (memory disorders, attention disorders, confusion, disorientation) requiring medical assessment.
- In exceptional circumstances , cases of kidney impairment and hearing loss have been described,
- Onset of a disseminated rash over the body. In exceptional circumstances, this may be accompanied by blisters with the skin becoming detached, fever, erosions in the mouth or on genital organs requiring urgent medical at tension.
- Very rare cases of edema (swelling of the feet and legs).
Tell your Doctor or pharmacist of any unwanted or bothersome effect not mentioned in this leaflet.
- Do not exceed the expiry date indicated on the outer packaging.
- Store below 30 °C and protect from humidity.
Epilepsy is a neurologic disease. It is the expression of an abnormal acute and transient functioning of electrical activity in the brain, and manifested by epileptic seizures. Seizures can be repeated during a certain time in a subject’s life.
There are many forms for expression of seizures and their progression: there is not one form but several forms of epilepsy.
Similarly, there is not one treatment but treatments: your doctor will prescribe the one which is best suited for your case.
In order that the medication prescribed for you is effective, you must necessarily follow your doctor’s recommendations and comply with the following:
- The prescribed daily dose.
- The timing of doses.
- The duration of treatment, this is generally extended.
- Advice for your lifestyle, avoid overwork. Lack of sleep, as well as alcohol.
- Changes are dosage and especially a sudden discontinuation of treatment can result in recurrence of disturbances.
- Do not forget to take your medication if you travel.
• Tell your doctor immediately if the following signs occur:
- Sudden fatigue, loss of appetite, prostration, drowsiness, repeated vomiting and abdominal pain.
- Recurrence of epileptic seizures even though the treatment is correctly followed.
Your doctor will decide on the need to prescribe blood tests or to discontinue or modify treatment.
• It is essential to do the following:
- Never discontinue treatment without asking your doctor's advice.
- Follow the prescribed dosage.
- Have regular consultation with your doctor. He or she may decide to order blood test to measure the function of the liver, in particular during the first six months of treatment,
- To tell your doctor of all medications you are taking, even episodic, without forgetting those obtained without a prescription.
Children should avoid taking medication that contains aspirin during treatment with this product.
Tell your doctor if you have a kidney disease.
In case you are to undergo surgery, tell the surgeon and the anesthetist that you are taking this medication.
This product may lead to weight gain; diet control and weight monitoring are recommended.
Sucrose : if you have been told by your doctor that you have an intolerance to some sugars , contact your doctor before taking this medicinal product
Treatment with mefloquine (a medication for malaria) and with
St- John's wort is contraindicated during the treatment with this product.
TO PREVENT POSSIBLE INTERACTION BETWEEN SEVERAL MEDICATIONS, YOU SHOULD SYSTEMATICALLY TELL YOUR DOCTOR OR PHARMACIST OF ANY OTHER MEDICATION YOU ARE TAKING.
Inform your doctor if you are hoping to become pregnant, since specific monitoring will be necessary.
If you are pregnant, your treatment will be adjusted if necessary. It is important not stop taking your treatment since a risk of recurrence of seizure, which could have effect on both yourself and your baby.
At the time of the birth of your baby, careful monitoring of the new – born is necessary.
Tell your doctor that you are taking this medication if you wish to breast-feed your baby.
• Effect on ability to drive or use machines:
If your disease is not controlled, that is if you continue to experience seizures, it is dangerous to drive or use potentially hazardous machines. In addition, risk drowsiness is associated with ingestion this medication, in particular in case of combination use with other medications which act on the central nervous system.
- Reserved for adults and children over 17Kg.
- This form is not suability for children under 6 years of ago (risk of choking).
- The dose to be used is determined by your doctor. It is strictly individual.
- Take your medication regularly; do not change or stop abruptly without telling your doctor.
- Oral route:
Swallow the tablet without crushing or chewing.
The medication is administration in 1 or 2 daily doses, preferably during meals.
If your disease is well-controlled by treatment, your doctor may prescribe it as 1 dose a day.
You should absolutely comply with dosage and the duration of treatment prescribed, in particular you should not discontinue treatment without asking your doctor's advice.
FOLLOW YOUR DOCTOR'S PRESCRIPTION EXACTLY
• Symptoms in case of overdose and actions to be taken.
Immediately tell your doctor or contact a hospital emergency department.