DEPAKINE CHRONO Tablet

This medicine is used to treat various types of seizures in adults and children over 6 years of age and weighing more than 17kg.

Dosage

The daily dose to be administered is determined and controlled individually by your doctor.

It is generally divided into 1-2 doses per day, preferably during meals.

Children from 6 years of age and weighing more than 17kg

Not recommended, as they can have trouble swallowing the tablet and choke. There are other more suitable medicines available.

Method of administration

Always take the tablets whole with a large glass of water. Do not crush or chew the tablets. The tablets are scored, i.e., you can break them into 2 equal halves if necessary.

- if you are allergic to the active substance of this medicine (sodium valproate) or to any of the other ingredients in Depakine Chrono.

- if you are allergic to a medicine in the same family as valproate (divalproate, valpromide),

- if you are liver disease (acute or chronic hepatitis),

- if you or a member of your family have ever had serious liver disease, particularly related to use of a medicine,

- if you have a hepatic porphyria (hereditary liver disease),

- if you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome),

- if you are currently taking the following medicines:

- mefloquine

- St John’s Wort

Consult your doctor or pharmacist immediately if you experience any of the following effects:

- Liver damage (hepatitis) or pancreas damage (pancreatitis), which may be serious and life-threatening, and that can start suddenly with fatigue, loss of appetite, exhaustion, drowsiness, nausea, vomiting and bowel pain.

- Allergic reaction:

- sudden swelling of the face and/or neck that can cause difficulty breathing and be life-threatening (angioedema),

- serious allergic reaction (drug hypersensitivity syndrome) including several symptoms such as fever, skin rash, increased size of lymph nodes, liver damage, kidney damage and abnormal blood test results such as increase in the number of certain white blood cells (eosinophils).

- Raised skin rash, sometimes with blisters that can also affect the mouth (erythema multiforme), blisters with detachment of the skin that can rapidly spread to the entire body and be life-threatening (toxic epidermal necrolysis, Stevens-Johnson syndrome).

Other possible side effects:

- Congenital birth defects and mental and physical development disorders.

Very common

- nausea

- tremor

Common

- at the beginning of treatment: vomiting, stomach pain, diarrhoea,

- weight gain,

- headache,

- drowsiness,

- seizures,

- memory disorders,

- confusion, aggression, agitation, attention deficit disorders, hallucinations (seeing, hearing of feeling things that are not there),

- extrapyramidal disorders (a group of symptoms such as tremor, stiffness of the limbs and difficulty walking) that are sometimes irreversible. In some cases the Parkinsonian syndrome may be reversible,

- rapid and uncontrollable eye movements,

- hearing loss,

- gum disorders (gingival disorders), in particular an increase in gum size (gingival hypertrophy),

- painful, swollen mouth, sores and burning sensation in the mouth (stomatitis),

- hair loss,

- menstrual disorders (menstrual irregularity),

- bleeding,

- decrease in the number of platelets (thrombocytopenia), decrease in the number of red blood cells (anemia),

- decrease in the amount of sodium in the blood (hyponatremia, syndrome of inappropriate antidiuretic hormone secretion).

Uncommon

- impaired alertness that may go as far as transient coma, regressing after the dose is decreased or the treatment stopped,

- difficulty coordinating movements,

- sensation of numbness or prickling in the hands and feet,

- abnormal fair texture, change in hair color, abnormal hair growth,

- rash or hives on the skin,

- excessive hair growth, particularly in women, virilism, acne (hyperandrogenism),

- decreased body heart (hypothermia),

- swelling of the extremities (edema),

- amenorrhoea (lack of menstrual period),

- breathing difficulty and pain, due to inflammation of the protective membranes of the lungs (pleural effusion),

- decrease in the numbers of all blood cells

- cases of bone disorders have been reported, such as the bones becoming more fragile (osteopenia), a decrease in bone mass (osteoporosis) and fractures. Consult your doctor or pharmacist if you are receiving long-term treatment with an antiepileptic drug, if you have a history of osteoporosis or if you are taking corticosteroids.

Rare

- memory and mental capacity disorders that appear gradually (cognitive disorders, dementia) and regress a few weeks to a few months after stopping treatment,

- difficulty or inability to retain urine (enuresis, urinary incontinence),

- reduced sperm motility,

- abnormal functioning of the ovaries (polycystic ovary syndrome),

- behavioral disturbances, increased psychomotor activity, leaning disabilities,

- auto-immune reaction with painful joints, skin rash and fever (systemic lupus erythematosus),

- decreased thyroid gland activity (hypothyroidism),

- muscle pain, muscle weakness that may be serious (rhabdomyolysis),

- kidney damage (kidney failure, tubulointerstitial nephritis),

- increase in the size of red blood cells (macrocytosis), major decrease in the number of white blood cells (agranulocytosis),

- reduced production of blood cells (bone marrow aplasia), blood cell production abnormality myelodysplasia),

- decrease i coagulation factors, abnormal blood coagulation test results (increase in INR, increase in activated partial thromboplastin time),

- decrease in the amount of vitaminB8 (biotin)/biotinidase,

- increase in the amount of ammonium in the blood.

You must never take this medicine if you are taking any of the following medicines:

- mefloquine

- St. John’s Wort

You must tell your doctor if you are taking lamotrigine or penems.

Especially in children under 3 years of age, you must avoid giving medicines that contain aspirin during treatment.

See the package insert about the details below.

Pregnancy

Valproate can be harmful to unborn children when taken by a woman during pregnancy.

- Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the risks but all doses carry a risk.

- Children exposed to valproate in utero have a high risk of serious birth defects and developmental disorders (mental and physical) and behavioral disturbances.

- Autistic spectrum disorders are more often diagnosed in children exposed to valproate.

- Limited data indicate that children may be more likely to develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).

Lactation

You must not breast-feed during treatment with this medicine unless otherwise indicated by your doctor. Ask your doctor or pharmacist for advice before taking any medicine.

This medicine can, in very rare cases, cause liver damage (hepatitis) or pancreas damage (pancreatitis), which can be serious and life-threatening.

Your doctor will prescribe blood tests to regularly monitor your liver function, particularly during the first 6 months of treatment.

Inform your doctor immediately if any of the following signs appear:

- sudden fatigue, loss of appetite, exhaustion, drowsiness, swelling of the legs, general malaise,

- repeated vomiting, nausea, stomach or bowel pain, yellow color of the skin or eyes (jaundice),

- recurrence of epileptic seizures even though you are taking your treatment correctly.

- Before taking this medicine, tell your doctor if you have kidney disease (renal insufficiency), systemic lupus erythematosus or hereditary enzyme deficiencies, particularly an enzyme deficiency of the urea cycle that can cause increased amounts of ammonium in the blood or if you know that there is a genetic problem causing a mitochondrial disorder in your family.

- If you are scheduled to have surgery, you must inform the medical personnel that you are taking this medicine.

- At the start of treatment, your doctor will check that you are not pregnant that you have a method of contraception.

- Consult your doctor immediately if the frequency of seizures increases or if you experience a different type of seizure.

- This medicine can cause weight gain. Your doctor will recommended that you are certain dietary measures and will monitor your weight.

- Self-destructive or suicidal thoughts have also been observed in a small number of people treated with antiepileptics such as Depakine Chrono. If you have these kinds of thoughts, contact your doctor immediately.

- If you have carnitine palmitoyltransferase typeⅡdeficiency, the risk of developing serious muscle problems (rhabdomyolysis) is higher with this medicine.

Inform your doctor if your child is taking another antiepileptic treatment or has another neurological or metabolic disease or severe forms of epilepsy.

Depakine Chrono belongs to a family of medicines called antiepileptics.