CONVULEX 150 mg. 100 capsules

WHAT Convulex CAPSULES AND WHAT IT IS USED
Active substance existing in Convulex capsules has an anticonvulsant effect on various types of seizures. Moreover Convulex shows good efficacy and fast action in the treatment of acute manic phases in patients with bipolar disorder. When used as a prophylactic medicament reduces the number and severity of the depressive and manic phases.

Convulex apply to:
treatment of various forms of epilepsy (seizures);
treatment of acute manic episodes in patients with bipolar disorder.

2. BEFORE YOU TAKE Convulex CAPSULES
Do not take Convulex capsules
in case of hypersensitivity (allergy) to the active substance or other components of Convulex
at current liver disease;
if one family member currently has or had severe hepatic dysfunction;
hepatic porphyria (a rare metabolic disease).
Take special care with:
patients with a history of liver disease or pancreas, bone marrow disorders, patients with a tendency to increased bleeding, renal dysfunction, congenital enzyme defects, as well as suffering from severe relapsing forms;
children with mental retardation or brain damage;
children under 2 years of age (as they are especially prone to liver damage).
In these cases, the doctor will decide if it is appropriate use of Konvuleks.

Tell your doctor or pharmacist if:
suffering from other diseases or have allergies;
taking other medicines unless Konvuleks;
planning to become pregnant, are pregnant or wish to breast-feed your baby.
Convulex therapy should not be started or stopped without medical advice.
Non-specific symptoms of severe liver damage are: increasing the frequency of epileptic seizures, restlessness, weakness, loss of appetite, pain in the upper abdomen, fluid retention, lethargy, drowsiness, jaundice.
Similar symptoms may occur with inflammation of the pancreas.
If you notice any of these symptoms, immediately consult your doctor may be necessary to make laboratory tests.
If you suffer from systemic lupus eritematozes (rare immune disorder) Konvuleks should be taken only after consulting your doctor.
There is evidence of weight gain during treatment with Konvuleks. Your doctor will give you recommendations on how to avoid this risk.
Hepatic, pancreatic and renal function and blood clotting and serum levels of valproic acid should be checked periodically during treatment. It is important that these tests be carried out as prescribed by your doctor.
Symptoms such as vague abdominal pain, vomiting, loss of appetite, fever, tiredness, weakness, difficulty driving, convulsions, loss of consciousness, transient rash, enlarged liver, jaundice, edema, heavy breathing, affecting the central nervous system or impaired coagulation may be signs of a rare but severe liver or pancreas (See. What side effects also can cause Konvuleks capsules). If you notice any of these symptoms, immediately consult your doctor.
Tell your doctor before any surgical or dental interventions that take Konvuleks capsules.
A small number of people being treated with antiepileptics such as valproic acid have had thoughts of harming or suicide. If occur, immediately contact your doctor.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you are taking any other anticonvulsants (phenytoin, primidone, phenobarbital, diazepam, clonazepam, ethosuximide, carbamazepine, felbamate, lamotrigine) simultaneously with Convulex capsules strictly follow your doctor's instructions on laboratory tests.
The sedative effects of centrally acting drugs (neuroleptics and antidepressants) and alcohol are reinforced by valproic acid.
The effect of drugs that inhibit blood clotting (aspirin, anticoagulants, heparin) is potentiated.
Upon acceptance of medicines that lower temperature (salicylates) simultaneously with Convulex capsules side effects of valproic acid may be increased. Drugs affecting the liver may potentiate the possible side effects of valproic acid on the liver.
Interactions with oral contraceptives are not known.
Interaction with laboratory tests: test for ketones in the urine of diabetics can give false positive results.

Pregnancy and lactation
Ask your doctor before taking any medicine. Your doctor will decide whether you can take Konvuleks during pregnancy and lactation.

Driving and using machines
Attention! Taking this medicine may interfere with the reactivity when working with machines or the ability to drive!
This is especially true in combination therapy with other anticonvulsants or some tranquilizers and drugs. Alcohol consumption should be avoided.

3. HOW TO TAKE Convulex CAPSULES
Always take Konvuleks just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
In cases where your doctor has otherwise prescribed, follow these instructions:

epilepsy:
The required dosage is determined by your doctor.
As a rule, treatment is initiated with a dose of 15 mg / kg weight per day. Your doctor will recommend a gradual increase in dosage (with 5-10 mg / kg of weight weekly intervals) while achieving seizure control (mean daily dose 30 mg / kg weight per day) or until the maximum dose of 50 mg / kg / day.

Average daily dose in children, adolescents and adults:
Recommended doses (indicative table):
Age: 3-6 months: Body weight: 5.5-7.5 kg; Medium dose: 150 mg / day;
Age: 6-12 months: Body weight: 7.5-10 kg; Average dose: 150-300 mg / day;
Age: 1-3 years: Body weight: 10-15 kg; Medium dose: 300-450 mg / day;
Age: 3-6 years: Body weight: 15-20 kg; Average dose: 450-600 mg / day;
Age: 7-11 years: Body weight: 20-40 kg; Medium dose: 600-1200 mg / day;
Age: 12-17 years: Body weight: 40-60 kg; Medium dose: 1000-1500 mg / day;
Adults (including the elderly): Body weight> = 60 kg; Average dose: 1200-2100 mg / day.

As a rule, the daily dose should be divided doses. If you take only Konvuleks capsules to treat epilepsy, your doctor may recommend that you take the entire dose at once in the evening.
If you have taken a long time other antiepileptic drugs, your doctor may gradually reduce their dose.
Konvuleks 500 mg capsules are intended for patients, treatment of which requires high doses and which are already stabilized on therapy with valproic acid as well as those in which aims to maintain therapeutic levels in the morning after the evening dose.

Bipolar disorder (only for adults):
Recommended starting dose 500 - 1000 mg daily, in divided doses. Depending on the severity of the clinical picture, the doctor may prescribe up to 1,500 mg daily.
For a good adjustment of the dose can be carried out blood tests.

Route of administration:
Swallow the capsules whole during or after a meal with enough water.

overdose:
An overdose of this medicine can be dangerous. If you took an overdose, tell your doctor or seek emergency medical help immediately.

Advice for doctors:
Acute overdose could lead to falling into an unconscious state or respiratory depression. It is under symptomatic treatment. Reported success of the application of Naloxone as an antidote.

If you have further questions on the use of Convulex capsules, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Convulex capsules can cause side effects, although not everybody gets them.
The following list lists all the side effects associated with this medicine - even those that appear very rarely.

Blood: In cases of excessive doses of treatment with valproic acid may lead to transient abnormalities in blood count or bleeding disorders. When bruising or increased tendency to bleed, please inform your doctor immediately.
Immune system: It is possible to vasculitis (inflammation of blood vessels), which can be manifested as pain, redness or itching. There are known cases of allergic reactions (rash to hypersensitivity reactions) and rarely systemic lupus eritematozes (a rare immune disorder).
Endocrine disorders: Rarely observed menstrual disorders in women and breast enlargement in men.
Metabolism: vomiting, impaired coordination, prolonged clouding of consciousness may be a signal for elevated blood ammonia. If these symptoms immediately consult your doctor.
Nervous system: There are rare cases of impaired motor coordination, dizziness, trembling. Drowsiness is rarely seen primarily in concomitant treatment with other antiepileptic drugs or the initial stage alone. Have been reported rare cases of lethargy, confusional state sometimes followed by impaired consciousness or accompanied by hallucinations and convulsions. Very rarely transient loss of consciousness, depression, Parkinson's or dementia.
If you notice any of the above symptoms or the like, contact your doctor as quickly as possible.
Those side effects were generally transient and reversible upon discontinuation of treatment.
It can be observed increased ability to concentrate, which is generally seen as a positive effect, but in some cases can lead to hyperactivity, aggression or worsening behavior.
In rare cases, partially reversible tinnitus and hearing impairment, as there is no evidence to link them with ongoing treatment with sodium valproate. Rarely have headaches and twitching of the eyes.
Gastrointestinal disorders: Early treatment may occur nausea, vomiting, diarrhea, loss of appetite or constipation. There are cases of increase in body weight due to increased appetite during treatment.
At the beginning of treatment may be a transient increase in liver enzymes. In many cases rivers may develop severe liver dysfunction, sometimes fatal (see. "Take special care").
There are reports of rare cases of porphyria (a rare metabolic disease).
In very rare cases of pancreatitis, which can have life-threatening effects (see "Take special care").
Skin and subcutaneous tissue has been reported rare cases of edema (fluid in the tissues). Some patients showed transient hair loss. In very rare cases have been reported very strong acne and facial hair and body.
In extremely rare cases may occur skin changes (eg. Hives) or more serious skin reactions.
Renal and urinary disorders: Isolated cases of reversible renal function.

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

5. HOW TO STORE Convulex CAPSULES
Do not use after the expiry date stated on the packaging
Do not freeze.
Store at temperatures below 25 ° C.
Protect from light.
Keep out of reach of children.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Convulex capsules
The active substance is valproic acid 150, 300 or 500 mg per capsule.
Other ingredients are: Carrion, glycerol, gelatin, titanium dioxide (E 171), iron oxide red (E172), hydrochloric acid, shellac, iron oxide black (E172), a copolymer of methacrylic acid-ethacrylate (1: 1) 30% -dispersiya , triethyl citrate, macrogol 6000 glycerol monostearate 44-55 type II.