COMMON

• Nausea, vomiting, stomachache or diarrhoea


• Swelling of gums or sore mouth


• Fainting


• Hearing loss, double vision


• Nail and nail bed disorders


• Skin problems such as rashes


• Increased levels of some hormones (androgen), which may lead to increased hair growth on the face, breasts or chest, acne, or thinning hair


• Change in women’s periods and increased hair growth in women


• Breast enlargement in men


• Swelling of the feet and legs (oedema)


• Weight gain


• Kidney disease, kidney problem, blood in the urine, bedwetting or increased need to pass urine, urinary incontinence (unintentional passing of urine)


• Headache, hallucinations


• Aggression, agitation, disturbances in attention, abnormal behaviour, restlessness/hyperactivity, and learning disorder


• Tingling or numbness in the hands and feet


• Lowering of normal body temperature


• Abnormal blood clotting factors


• Muscle pain and weakness (rhabdomyolysis)


• Bone disorders such as osteopenia and osteoporosis


• Change levels of liver enzymes


• Male infertility

RARE

• Allergic reaction (including rash, joint pain, fever, swallowing or breathing problems, swelling of your lips, face, throat, or tongue)


• Jaundice (yellowing of the skin or whites of the eyes)


• Loss of appetite


• Worsening of your fits or general feeling of being unwell


• Blistering or bleeding of the skin around the lip, eye, mouth, nose, and genital, flu-like symptoms, and fever (Stevens-Johnson syndrome)


• Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body, feeling of being generally unwell, fever, chills, and aching muscles (Toxic epidermal necrolysis)


• Bruising more easily and getting more infections than usual(thrombocytopenia). Fall in the number of white blood cell, bone marrow depression or another condition that affects red blood cell, white blood cell and platelet (pancytopenia)


• Blood clotting problems


• Change in mood, loss of memory, lack of concentration and deep loss of consciousness (coma)


• Underactive thyroid gland


• Breathing difficulty and pain due to inflammation of the lung (pleural effusion)


• Change in the amount of ammonia in the blood


• Tremor


• Rapid, uncontrollable movement of the eyes


• Increase in the number and severity of convulsion

PREGNANCY

EPILEX is not recommended for use in pregnant women unless necessary. Discuss the risks and benefits with your doctor.

BREASTFEEDING

EPILEX should be used with caution in breast feeding women. Consult your doctor before taking this medicine.

DRIVING AND USING MACHINES

Do not drive or operate any machine while taking this medicine since it may cause sleepiness.

ALCOHOL

Consumption of alcohol is not recommended during treatment with EPILEX.

KIDNEY

EPILEX should be used with caution in patients suffering from active kidney diseases. Before taking, discuss the risks and benefits with your doctor.

LIVER

EPILEX is not recommended in patients with active liver diseases. Before taking, discuss the risks and benefits with your doctor.

ALLERGY

Do not take EPILEX if you are allergic (hypersensitive) to sodium valproate or any other ingredients in this medicine.

OTHERS

Tell your doctor if you have or had a condition such as,

• Rare illness called porphyria


• Metabolic disorder (urea cycle disorder)


• Genetic problem caused by a mitochondrial disorder (Alpers-Huttenlocher syndrome)


• Diabetes


• Carnitine palmitoyltransferase type II deficiency


• Brain disease or a metabolic condition affecting your brain


• Illness called systemic lupus erythematosus (SLE)