Epilim Chrono

What Epilim Chrono is and what it is used for

What Epilim Chrono is The name of your medicine is Epilim Chrono 200, 300 and 500mg Controlled Release Tablets (called Epilim Chrono in this leaflet). “Controlled release” means that the active ingredient sodium valproate is slowly released from the tablets over a period of time. What Epilim Chrono contains Epilim Chrono contains sodium valproate. It belongs to a group of medicines called anti-convulsants or anti-epileptic agents. It works by helping to calm the brain down. What Epilim Chrono is used for Epilim Chrono is used to treat epilepsy (fits) in adults and children.

How to take Epilim Chrono

Always take Epilim Chrono exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Epilim Chrono treatment must be started and supervised by a doctor specialised in the treatment of epilepsy. Taking this medicine
• Your doctor will decide how much Epilim Chrono to give you or your child depending on your or your child’s body weight.
• Take this medicine by mouth.
• Take Epilim Chrono with or after food. This will help to stop the feelings of sickness that may happen after taking Epilim Chrono.
• Do not crush or chew the tablets.
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself but ask your doctor. How to take this medicine
• This medicine can be taken once or twice daily. How much to take Adults (including the elderly)
• The starting dose is 600mg daily. Your doctor will gradually increase this dose by 200mg every 3 days depending on your condition.
• The usual dose is generally between 1000mg and 2000mg (20-30mg per kilogram of body weight) each day.
• This may be increased to 2500mg each day depending on your illness. Children over 20 kilograms
• The starting dose should be 400mg daily. Your doctor should increase this dose depending on your child’s illness.
• The usual dose is then between 20mg and 30mg for each kilogram of body weight each day.
• This may be further increased to 35mg for each kilogram of body weight each day depending on your child’s illness. Children under 20 kilograms Epilim Chrono is not recommended in children that weigh less than 20 kilograms. Epilim Liquid (sugar free) or Epilim Syrup is recommended instead. Patients with kidney problems
• Your doctor may decide to adjust your or your child’s dose. Patients taking other medicines for fits (epilepsy)
• You or your child may be taking other medicines for epilepsy at the same time as Epilim Chrono. If so, your doctor should gradually initiate treatment depending on your or your child’s condition.
• Your doctor may increase the dose of Epilim Chrono by 5-10mg for each kilogram of body weight each day depending on which other medicines you are taking. If you take more Epilim Chrono than you should If you take more Epilim Chrono than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling sick or being sick, pupils of the eye become smaller, dizziness, loss of consciousness, weak muscles and poor reflexes, breathing problems, headaches, fits (seizures), confusion, memory loss and unusual or inappropriate behaviour. If you forget to take Epilim Chrono If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Epilim Chrono Keep taking until your doctor tells you to stop. Do not stop taking Epilim Chrono just because you feel better. If you stop your fits may come back. Tests Make sure you or your child keep your regular appointments for a check-up. They are very important as your or your child’s dose may need to be changed. Epilim Chrono can change the levels of liver enzymes shown up in blood tests. This can mean that your or your child’s liver is not working properly. If you or your child go into hospital or visit another doctor or a dentist, tell them you are taking Epilim Chrono. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Epilim Chrono can cause side effects, although not everybody gets them. Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
• You have an allergic reaction. The signs include: a rash, joint pain, fever (systemic lupus erythematosus), swallowing or breathing problems, swelling of your lips, face, throat or tongue. Hands, feet or genitals may also be affected. More severe allergic reactions can lead to lymph node enlargement and possible impairment of other organs.
• Liver problems and problems of the pancreas may show as a sudden illness which may happen in the first six months of treatment. This happens in a very small number of people taking Epilim Chrono. It includes feeling and being sick many times; being very tired, sleepy and weak; stomach pain including very bad upper stomach pain; jaundice (yellowing of the skin or whites of the eyes); loss of appetite; swelling (especially of the legs and feet but may include other parts of the body); worsening of your fits or a general feeling of being unwell. Your doctor may tell you to stop taking Epilim Chrono immediately if you have these symptoms.
• You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme’.
• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘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. Also a feeling of being generally unwell, fever, chills, and aching muscles. This may be something called ‘Toxic epidermal necrolysis’.
• Bruising more easily and getting more infections than usual. This could be a blood problem called ‘thrombocytopenia’. It can also be due to a fall in the number of white blood cells, bone marrow depression or another condition that affects red blood cells, white blood cells and platelets (pancytopenia) or how the blood clots.
• Blood clotting problems (bleeding for longer than normal), bruising or bleeding for no reason.
• Changes in mood, loss of memory, lack of concentration and deep loss of consciousness (coma).
• Underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism).
• Breathing difficulty and pain due to inflammation of the lungs (pleural effusion). Tell your doctor as soon as possible if you have any of the following side effects:
• Changes in behaviour including being very alert, and sometimes also aggressive, hyperactive and unusual or inappropriate behaviour. This is more likely if other medicine to treat fits such as phenobarbital and topiramate are taken at the same time or if the Epilim Chrono starting dose is high or has been suddenly increased.
• Changes in the amount of ammonia in the blood. Symptoms of this condition are being sick, problems with balance and co-ordination, feeling lethargic or less alert.
• Feeling shaky (tremor), sleepy or unsteady when walking or jerky muscle movements.
• Feeling tired or confused with loss of consciousness sometimes accompanied by hallucinations or fits.
• Blisters with the skin flaking away.
• Rapid, uncontrollable movement of the eyes.
• An increase in the number and severity of convulsions. Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet:
• Feeling sick (nausea), being sick (vomiting), stomach ache or diarrhoea, especially when starting treatment. This may be helped by taking the tablets with food.
• Swelling of gums or sore mouth
• Fainting
• Hearing loss
• Nail and nail bed disorders
• Skin problems such as rashes. These happen rarely, but more often in people also taking lamotrigine.
• Hair disorders (changes in texture, colour or growth), hair loss which is usually temporary. When it grows back it may be more curly than before.
• Increased levels of some hormones (androgens), which may lead to increased hair growth on the face, breasts or chest, acne or thinning hair.
• Skin rash caused by narrow or blocked blood vessels (vasculitis)
• Changes in women’s periods and increased hair growth in women
• Breast enlargement in men
• Swelling of the feet and legs (oedema)
• Obesity, weight gain – as your appetite may be increased
• Kidney disease, kidney problems, blood in the urine, bedwetting or increased need to pass urine, urinary incontinence (unintentional passing of urine)
• Headache
• Seeing or hearing things that are not there (hallucinations)
• Aggression, agitation, disturbance 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 There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term anti-epileptic medication, have a history of osteoporosis, or take steroids. Tests Epilim Chrono can change levels of liver enzymes, salts or sugars shown up on blood and urine tests. Male fertility Taking Epilim Chrono can be a contributing factor in male infertility.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. United Kingdom You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Malta You can also report side effects directly via ADR Reporting: www.medicinesauthority.gov.mt/adrportal. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Epilim Chrono

Keep out of the sight and reach of children. Do not take this medicine after the expiry date shown on the blister and carton after EXP. The expiry date refers to the last day of that month. Do not remove the tablets from the foil until just before you take them. Do not cut the blister strips. Store in a dry place below 30°C. Medicines should not be disposed of via household wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment