Depakine 200 mg. 40 tablets

DETERMINATION OF THE MEDICINAL PRODUCT
a) the name of the medicine
DEPAKINE 200 mg, gastro-resistant tablets Valproate 200 mg, gastro-resistant tablets

b) qualitative and quantitative COMPOSITION
The active ingredient of the tablet is DEPAKINE: Sodium valproate 200 mg Excipients: Povidone K 90, a calcium salicylate, talc, magnesium stearate, polyethylene glycol, corn starch, povidion R 30, titanium dioxide, cellulose acetate phthalate, ethyl phthalate.

c) PHARMACEUTICAL FORM
gastro-resistant tabletkiDEPAKIN 200 mg are placed in a polypropylene container. One pack contains 40 tablets.
d) Pharmaco-therapeutic group
Antiepileptics

2. WHEN TO USE THIS DRUG? (Therapeutic indications)
This drug has been shown to treat various types of epileptic seizures.

3. WARNING
a) WHEN NOT TO USE THIS DRUG?
This medicinal product MUST NOT BE USED in the following cases:
- Liver disease, such as hepatitis,
- Personal or family history of serious liver disease, especially associated with the use of a medicinal product
- Known allergy to valproate divalproat, valpromide or to one of the ingredients of the medicinal product.
- Hepatic porphyria (an inherited disease associated with abnormal production of pigments known as porphyrins)
- Mefloquine combination with (a medicinal product for the treatment of malaria),
- In combination with St. John's wort
This medicine should not be used in combination with lamotrigine unless prescribed by your doctor.
IF YOU HAVE ANY QUESTIONS VERY IMPORTANT TO ASK FOR ADVICE TO YOUR DOCTOR OR PHARMACIST.
b) SPECIAL WARNING
In the beginning of treatment, the incidence of seizures may be increased or that new types of seizures. In this case, consult your lekar.Pri exceptional circumstances this product may cause damage to the liver or pancreas and this is zhivotozastrashavashto.Tova can happen mostly during the first 6 months of treatment.
- Sudden fatigue, loss of appetite, fatigue, sleepiness,
Tell your doctor if any of the following signs:
- Frequent vomiting, abdominal pain,
- Resumption of seizures, irrespective of the proper conduct of the treatment.

Your doctor will then decide whether to order blood tests to stop or change treatment.
It is essential that:
- Never stop your treatment without medical advice
- To follow the prescribed doses
- Regularly visit your doctor. He may decide to order blood tests to monitor your liver function, especially in the first 6 months of treatment
- Inform your doctor about all other medicines you are taking, even those that are available without a prescription.

c) PRECAUTIONS FOR USE
During treatment, children should avoid taking medicines containing aspirin.
Tell your doctor if you have kidney zabolyavane.Pri surgery, tell the surgeon or anesthetist that you are taking this medicine produkt.Tay this drug can lead to obesity, recommended measures for diet and weight control.

d) DRUG AND OTHER INTERACTIONS
Adoption of mefloquine (medicine used for malaria) is contraindicated during treatment sDepakin. Contraindicated is the use of yellow kantarion.ZA TO AVOID INTERACTIONS BETWEEN different medicines, you should inform your doctor or pharmacist for any other treatment that place.

e) PREGNANCY - BREASTFEEDING
Tell your doctor if you want to get pregnant, because you will need special nablyudenie.Ako pregnant and, if necessary, your treatment will be optimized. It is important not to interrupt the treatment because there is a risk of recurrence of seizures, which could impact both on you and on bebeto.Sled birth will be closely monitored novorodenoto.Informirayte your doctor if you are taking this medicine and intend to breast-feed her child.

f) DRIVE AND USE MACHINES
If your condition is not under control, that you continue to have seizures, driving and use of potentially hazardous machinery is riskovano.Osven, there is a risk of drowsiness associated with the use of this product, especially in combination with other medicinal products act on the central nervous system.
g) ATHLETES AND SPORTSMEN
No data

h) the list of excipients which must be accurately shown safe use of this drug in some patients
No data

4. HOW TO USE THIS DRUG?
a) DOSAGE
This formulation is not suitable for children under 6 years (risk of choking). The use of a syrup, oral solution (by mouth) or granular form.
The dose that should be taken is determined by your doctor. It is strictly individualna.Priemayte medication regularly; Do not change or stop your treatment suddenly without telling your doctor.

b) AND METHOD OF ADMINISTRATION
Oral use.
c) the frequency and time of ingestion
The drug should be administered in 2 or 3 servings daily, preferably during meals.

d) Duration of treatment
You must follow the prescribed dosage and duration of treatment and do not interrupt treatment without consulting first with your doctor.
JUST FOLLOW THE PRESCRIPTION OF YOUR DOCTOR.

e) WHAT TO MAKE OF OVERDOSE?
Contact your doctor immediately or compartment for emergency medical help.

e) WHAT SHOULD BE DONE IN CASE OF RELEASE OF ONE OR MORE DOSES?
If you find that you miss a dose shortly after the usual time, take your dose as obiknoveno.Ako know you miss a dose shortly before the time for your next dose, do not take double doza.Ako have forgotten to take several doses, immediately inform your doctor.

g) risk of withdrawal syndrome
Treatment should be discontinued gradually; abrupt discontinuation of treatment (or significant reduction of the dose) may lead to recurrence of seizures.

5. SIDE EFFECTS enemies?
Like all active substances, this medicine can cause side effects causing varying degrees discomfort in some patients:
- In exceptional circumstances, a potentially serious damage to the liver and pancreas (see Warnings)
- Nausea, vomiting, stomach pain, diarrhea (early treatment), temporary hair loss, slight trembling of the hands, drowsiness, these effects are transient, however, you may need your doctor to adjust the dose
- Disorders of the menstrual cycle, weight gain,
- Confused consciousness, isolated or associated with new onset seizures, headache,
- Occurrence of mild bleeding (nose, gums ...). Must immediately report this to your doctor, who can then appoint laboratory tests due notice of bleeding
- Abnormal blood counts, reduction of platelets, white blood cells and fibrinogen. Reduction of the number or change in size of the red blood cells. Prolonged bleeding time increased amonemiya,
- In rare cases: tremors, rigid muscles, cramps, difficulty moving or unnatural movements
- In very rare cases, gradually occurring disorders in cognitive functions (memory impairment, difficulty concentrating, confusion of consciousness, disorientation) that require medical supervision
- Described cases of renal impairment and hearing loss in exceptional circumstances,
- Rash all over the body. In exceptional circumstances, it may be accompanied by blistering of the skin secretion, fever, sores in the mouth or genitals, requiring immediate medical attention
- Very rare cases of edema (swelling in the feet and legs).
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

6. STORAGE
a) DO NOT USE AFTER EXPIRY DATE SPECIFIED ON THE OUTER PACKAGE
b) SPECIAL PRECAUTIONS FOR STORAGE
Keep at temperatures below 30 ° C, dry place. Keep out of reach of children.

c) warning of VISIBLE SYMPTOMS OF DETERIORATION
Do not apply to visible signs of deterioration