CONVULEX Chrono 500 mg. 30 capsules

WHAT CONVULEX Chrono AND WHAT IT IS USED
The active substance in acting CONVULEX chrono - sodium valproate has an anticonvulsant effect in different types of seizures. Furthermore CONVULEX shows good efficacy and fast action in the treatment of acute manic phases in patients with bipolar disorder, and when used to prevent, decrease the number and severity of manic phases. Active active ingredient is released slowly into the body, and the effect manifests itself in many hours.

Used for:
Epilepsy:
For the treatment of various forms of epilepsy (fits).

Bipolar disorder:
For the treatment of acute manic episodes.

2. BEFORE YOU TAKE CONVULEX Chrono
Do not take CONVULEX chrono:
if you are allergic to sodium valproate or any of the other ingredients of the tablets;
if you have liver problems;
if members of your family (lineal relatives) have severe liver problems;
if you suffer from porphyria (a rare metabolic disease);
If you are taking mefloquine.
Take special care with CONVULEX chrono:
Patients with symptoms of systemic lupus erythematosus (a rare disease of the immune system, collagen) can carry out treatment Konvuleks chrono only after consultation with your doctor, because in rare cases during treatment with sodium valproate may be symptoms of disorder the immune system.

Tell your doctor or pharmacist if:
suffering from other diseases or have allergies;
taking other medicines, including those not prescribed by a doctor;
planning to become pregnant, are pregnant or wish to breast-feed your baby.
Before starting treatment and at regular intervals in the course, your doctor may require carrying out various laboratory tests: enumeration of blood elements, examination of blood clotting, liver function, pancreas, kidneys, the concentration of valproate in blood. This is especially the case when you have a high risk of developing liver disease or increased risk of bleeding.
Tell your doctor that you take Konvuleks chrono before any surgical intervention.
If in the course of treatment, you get severe abdominal pain, nausea and / or vomiting - consult your doctor immediately. These symptoms may be an expression of pancreatitis, which in severe cases can be life-threatening. In these cases is an absolute must immediately and thoroughly to determine the origin of these symptoms. The risk of a deterioration in these cases is particularly high in young children, in patients who are undergoing combination therapy and those suffering from severe liver disorders. The use of sodium valproate can cause an increase in body weight. Consult your doctor what precautions you can take to influence this unwanted effect. If you take other medicines to treat epilepsy or anxiety and insomnia (benzodiazepines) simultaneously Konvuleks chrono can sometimes feel dizzy. In this case it can be affected your ability to drive.
Testing urine for ketone bodies carried in diabetes, can give false positive results when taking sodium valproate. You are necessary to tell your doctor before performing such tests.
A small number of people being treated with antiepileptics such as sodium valproate have had thoughts of harming or killing themselves. If these occur, immediately contact your doctor.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The medicines may affect each other's effects.

Observed following interactions:
increasing the effect of certain antidepressant drugs, some drugs for the treatment of anxiety and insomnia (neuroleptics, benzodiazepines), other drugs for treating a seizure (phenobarbital, primidone, phenytoin, carbamazepine, lamotrigine), certain anticoagulants (used to thin the blood, such as warfarin; ) and zidovudine (used to treat HIV infections);
increase the effect of sodium valproate can be caused by other drugs such as certain anti-epileptics (felbamate), acetylsalicylic acid, certain antibiotics (erythromycin), cimetidine (used to treat stomach ulcers);
lowering effect of sodium valproate may be caused by other medicines, such as some anti-epileptics (phenytoin, phenobarbital, carbamazepine), medicines to treat malaria (mefloquine, chloroquine), antibiotics of the carbapenem type and cholestyramine (used to treat high level of lipids in the blood).
Sodium valproate did not affect the effects of oral contraceptives.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Your doctor will decide whether you can take CONVULEX chrono during pregnancy or while breast-feeding your baby.

Driving and using machines
If you take other medicines to treat epilepsy or anxiety and insomnia (benzodiazepines) simultaneously CONVULEX chrono can sometimes feel dizzy. In this case it can be affected your ability to drive.

3. HOW TO TAKE CONVULEX Chrono
Always take Konvuleks chrono just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
As a rule, treatment is initiated with low doses, which subsequently slowly increased from your doctor, until reaching the optimal dose for you.

Epilepsy
Monotherapy:
Adults: The initial dosage is usually 500-600 mg daily, followed by a gradual rise, as prescribed by your doctor. The usual dosage of Konvuleks chrono is between 1,000 and 2,000 mg per day. If necessary, your doctor may prescribe to 2500 mg daily. This amount can be taken in one dose or be divided into two doses.

Children over 20 kg: dose starts from 250-300 mg daily, followed by a gradual rise, as prescribed by your doctor. The further dosing Konvuleks chrono is performed on the basis of kilograms of body weight. The usual dose is 20 to 30 mg per kilogram weight (eg. At 30 kg child and an average daily dose of 25 mg / kg body weight: 2 1/2 tablets Konvuleks chrono 300 mg tablet or 1 1/2 Konvuleks chrono 500 mg day), but as prescribed by the treating physician the dose may be increased to a maximum of 40-50 mg per kg body weight. This amount can be taken in one dose or be divided into two doses.

Children under 20 kg: Treatment generally begins at a dose 10-15 mg / kg body weight, followed by a gradual increase, to the control of seizures, or up to a maximum dosage of 50 mg / kg / day.
Patients with renal failure should the physician to prescribe a lower dose.

Combination therapy:
If you take another antiepileptic medicine, your doctor may gradually reduce their dose slowly rising dose CONVULEX chrono.

Bipolar disorder (only for adults over 18):
Recommended initial dose 500-1000 mg daily, in divided doses. Depending on the severity of the clinical picture, the doctor may prescribe up to 1500 mg daily.
Your doctor may recommend slowly increase the dosage, depending on the measured concentration of the active substance of blood. Prophylactic treatment is individual and carried out with the lowest effective dose.

Route of administration:
Take the tablets during or after meals with sufficient water.
The tablets can be broken in halves, but should not be chewed or mashed.

If you take more dose CONVULEX chrono
Acute overdose could lead to severe side effects in the central nervous system and breathing difficulties. Seek medical help immediately.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, CONVULEX chrono may cause side effects, although not everybody gets them.
This section lists all adverse reactions during treatment with this drug have been notified, even if they are manifested in extremely rare cases.
During the first six months of treatment, you should be especially careful about the appearance of any of the following symptoms: sudden illness, nausea, vomiting, abdominal pain, severe tiredness, loss of appetite, jaundice, swelling in the legs or worsening of epileptic events. The occurrence of any of these symptoms or the like, immediately consult your doctor or the nearest hospital as they can be a sign of rare but severe liver damage. Patients with partial higher risk are children under three years and patients suffering from other concomitant diseases.
Very often these and similar symptoms can also be an expression of an inflammation of the pancreas, which in severe cases can be life-threatening.
In isolated cases reported occurrence of the syndrome of Fanconi (rare kidney disease).
Vomiting, impaired coordination of movements, impairment of consciousness, and in isolated cases, other neurological symptoms may be a signal of increasing nitrogen levels in the blood. In these cases, you should stop treatment and consult your doctor immediately.
There are also reports of an increase in appetite during treatment. In these cases, the application of sodium valproate was associated with weight gain.
Often at the beginning of treatment may occur mild gastrointestinal complaints and less nausea. These effects usually resolve if they are taken during or after meals.
Upon acceptance of doses higher than recommended, treatment with sodium valproate may lead to reversible disorders in the number of blood cells and / or bleeding (come with increased bleeding or tendency for easy bruising of the injured parts of the body) .
Sometimes sodium valproate may cause incoordination of movements or muscle twitching. More rarely can occur weakness, lethargy, confusion (sometimes associated with occurrence of hallucinations or seizures) and very rare cases of transient loss of consciousness. Very rarely, severe movement disorders, including "Parkinsonism". Possible development of transitional dementia (memory impairment). These side effects usually resolve after discontinuation of Konvuleks chrono. The occurrence of these symptoms or the like, immediately consult your doctor as you may need to stop treatment.
It may appear an increase of attention. This effect is usually beneficial, but sometimes it is possible aggression, hyperactivity or behavioral confusion.
In some patients noted transient hair loss. Hair growth is restored normally within 6 months but grown hair can be more wavy than before. In very rare cases, the occurrence of acne or facial and / or body.
Rarely can occur skin reactions such as rash or in extremely rare cases - severe skin reactions or vasculitis (inflammation of blood vessels, characterized by pain, redness or itching).
Very rarely reported hearing impairment (sometimes transient, sometimes permanently).
In extremely rare cases may appear swollen mammary glands in men and menstrual irregularities in women.
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 Chrono
No special storage conditions. Keep out of reach of children.
Do not use CONVULEX chrono after the expiry date stated on the packaging. Carefully and tightly close the bottle every time you remove the tablets from him.
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. ADDITIONAL INFORMATION
What CONVULEX chrono
The active substance is sodium valproate
Other ingredients are:
Core: citric acid monohydrate, ethylcellulose, ammonio methacrylate copolymer (type B) (containing sorbic acid), purified talc, colloidal silicic dioxide, magnesium stearate.
Film-coating: ammonio methacrylate copolymer (type A and B) (containing sorbic acid), purified talc, croscarmellose sodium, titanium dioxide (E171), triethyl citrate, vanillin.

CONVULEX chrono looks like and contents of the pack
a) Glass bottle of amber (hydrolytic resistant type III, PhEur) with HDPE white screw cap, protected against accidental opening and HDPE white tear tape, placed in a cardboard box.
or
b) HDPE cylindrical bottle for tablets with LDPE screw cap, closing with a click and protected against accidental opening, LDPE tear tape and sealing ring placed in a cardboard box.
or
c) PE cylindrical HDPE bottle with a white cap protected against accidental opening and LDPE white tear tape with / without absorbent placed in a cardboard box.