Epilim Side Effects

Home › Medicine Side Effects › Epilim

Answer the side-effect intent for epilim without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

Part of mental health medication side effects side effects.

What is Epilim?

Epilim contains the active ingredient Sodium valproate.

• Active ingredient — Sodium valproate
• Registration number — 53/2.5/0670; 53/2.5/0671; 53/2.5/0672
• Registration holder — Abex Pharmaceutica (Pty) Ltd

It is approved for:

• NAVALZYD IV contains sodium valproate, which belongs to a group of medicines called antiepileptics
• These are used to control epileptic seizures
• NAVALZYD IV solution for injection is used to treat various types of epileptic seizures (fits) when it is not possible to take sodium valproate tablets
• NAVALZYD IV is also used in mania: where you may feel excited, elated, agitated, enthusiastic or hyperactive

Common side effects of Epilim

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Anaemia (the number of red blood cells in your body is too low), causing weakness, fatigue, pale skin
• Too low blood sodium concentration (signs may be mental changes, headache, nausea, vomiting, tiredness, muscle spasms)
• Weight gain
• State of confusion, hallucinations (seeing and hearing things that do not exist)
• Aggression, agitation
• Attention disturbances
• Sleepiness
• Convulsions
• Trembling of hands and arms, clumsiness or unsteadiness
• Headache
• Involuntary eye movements (nystagmus)
• Dizziness
• Hearing loss (which may be irreversible)
• Diarrhoea
• Nausea, vomiting
• Indigestion
• Gum disease (swollen gums)
• Stomach or abdominal pain
• Sore mouth
• Hair loss or thinning of hair
• Nail and nail bed disorders
• Losing bladder control (incontinence)
• Painful menstrual periods

Less frequent side effects

• Hyperandrogenism (excessive presence of male hormones in females including symptoms like excessive hair growth, acne, male pattern hair loss)
• Double vision (diplopia)
• Encephalopathy (an altered mental state – declining ability to reason and concentrate, memory loss, personality change, seizures and twitching may be experienced)
• Lethargy (a lack of energy)
• Parkinsonism (which is reversible), lack of muscle control, affected movement, speech (ataxia)
• Pins and needles sensation in arms, hands, legs and feet (paraesthesia)
• Dementia (which is reversible)
• Trouble understanding things (cognitive disorder)
• Sedation
• Vasculitis (inflammation of the blood vessels – you may experience fever, fatigue, weight loss and muscle and joint pain)
• Build-up of fluid in the area between the layers of tissue that line the lungs causing chest pain, cough, difficulty breathing
• Skin rash
• Change in hair texture, colour, growth
• Decreased bone mineral density (brittle bones and fractures)
• Osteoporosis (brittle bones), osteopenia (reduced bone mass)
• Frequent urination at night
• Inflammation of the kidneys (back pain, fever)
• Fanconi syndrome: a rare disorder of kidney tubule function that causes increased urination, increased thirst, pain and weakness in muscle and bones
• Absent menstrual periods or abnormal bleeding from uterus
• Male infertility
• Polycystic ovaries (symptoms may be weight gain, irregular periods, heavy bleeding)
• Swollen breasts in males
• Feeling very cold, shivering (hypothermia)
• Swelling of the hands, ankles and feet
• Myelodysplastic syndrome (symptoms may include fatigue, shortness of breath and unusual paleness)
• This is a condition where immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells

Frequency unknown side effects

• Malformation of the foetus and developmental disorders

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to sodium valproate or any of the ingredients of NAVALZYD IV (listed in Section 6)
• if you have liver problems, or have a family history of liver problems
• if you suffer from porphyria (a rare condition that affects the breakdown of components of red blood cells)
• if you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
• if you suffer from urea cycle disorder (a certain metabolic disorder)
• if you are pregnant or breastfeeding your baby. See “Warnings and precautions” and “Pregnancy, breastfeeding and fertility”

Use with care, and tell your doctor, if

• have diabetes. NAVALZYD IV may affect the results of urine tests
• have a carnitine palmitoyltransferase type II deficiency, which prevents the body from using certain fats for energy, as you may be more prone to serious side effects
• have kidney problems. Your doctor may give you a lower dose
• have a brain disease or a metabolic condition affecting your brain
• have a ‘urea cycle disorder’ where too much ammonia builds up in the body
• have an illness called ‘systemic lupus erythematosus (SLE)’ – a disease of the immune system which affects skin, bones, joints and internal organs
• know that there is a genetic problem caused by a mitochondrial disorder in your family. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking NAVALZYD IV
• are having surgery, including dental surgery, tell the doctor or dentist that you are receiving NAVALZYD IV. You will need to take extra care in cleaning your teeth to prevent infection, as side effects of NAVALZYD IV include bleeding and swelling of the gums. Liver damage NAVALZYD IV may cause severe and life-threatening damage to your liver. Signs that you may notice include seizures that are becoming more severe or happen more often, or excessive tiredness, lack of energy, weakness, stomach pain, loss of appetite, nausea, vomiting, yellow skin and eye whites or swelling of the face
• Tell your doctor immediately if you notice these symptoms. If your child is under 3 years of age, NAVALZYD IV should not be administered together with aspirin. Pancreas damage NAVALZYD IV may cause serious or life-threatening damage to the pancreas. This may occur at any time during your treatment. If you experience any of the following symptoms, tell your doctor immediately: stomach pain, nausea, vomiting, or loss of appetite. Suicidal thoughts and behaviour A small number of people being treated with antiepileptics such as sodium valproate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. There may also be a risk that you will experience changes in your mental health if your condition is not treated. Convulsions Convulsions may become worse or happen more frequently while taking this medicine. If this happens contact your doctor immediately. Weight gain Having NAVALZYD IV may make you put on weight. Talk to your doctor about how this will affect you. Blood tests Your doctor may wish to do blood tests before you are given NAVALZYD IV and during your treatment. Children and adolescents While treated with NAVALZYD IV, do not give salicylates (aspirin) to children under 3 years due to the risk of liver toxicity. Additionally, do not use salicylates in children under 16 years as it can increase the risk of Reye’s syndrome (an acute condition that causes swelling in the brain and liver). Children (male and female) less than 18 years of age: NAVALZYD IV should be used with caution in male and female children under the age of 18 years, for the treatment of epilepsy. For female children, ensure that the conditions of the pregnancy prevention programme are met. Some psychiatric disorders, including aggression, agitation, disturbance in attention, abnormal behaviour, psychomotor hyperactivity and learning disorder, may be observed in paediatric patients receiving NAVALZYD IV. Current evidence is inconclusive as to the possibility of harm to reproductive organs, skeletal system growth or developing brain of patients less than 18 years of age

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult with your doctor, pharmacist or other healthcare provider for advice before this medicine is administered to you
• Pregnancy If you are pregnant, you should not be given NAVALZYD IV, unless other treatments are not effective or well tolerated
• Do not stop receiving NAVALZYD IV without consulting your doctor as doing so could cause harm to you or an unborn child
• If you are a woman able to have a baby, you must not receive NAVALZYD IV unless you use an effective method of birth control (contraception) during your entire treatment with NAVALZYD IV
• Speak to your doctor if you have any questions about which contraceptive method is appropriate for you
• NAVALZYD IV can cause malformation and problems with early development of children if they are exposed to valproates in the womb

Interactions and medicines to check

The approved leaflet names these interactions.

• some medicines used for pain and inflammation (salicylates) such as aspirin
• some other medicines used to treat fits – This includes medicines such as phenobarbital, primidone, phenytoin, carbamazepine, rufinamide, topiramate, lamotrigine and felbamate
• acetazolamide used to treat glaucoma, oedema or fits. NAVALZYD IV Injection may increase the effect of the following medicines:
• medicines for depression, for example, monoamine oxidase inhibitors (MAOI) such as moclobemide, selegiline
• medicines used to calm emotional and mental health problems (including schizophrenia, bipolar disorder and depression) such as quetiapine, diazepam, olanzapine and lithium
• propofol – used for anaesthesia
• zidovudine used to treat HIV infection
• nimodipine (used to decrease problems due to a certain type of bleeding in the brain)
• temozolomide used to treat cancer
• medicines used for thinning the blood (such as warfarin). The following medicines can affect the way NAVALZYD IV works:
• some medicines used for the prevention and treatment of malaria such as mefloquine and chloroquine
• cimetidine used for stomach ulcers
• antibiotics e.g. erythromycin, carbapenems (antibiotics used to treat bacterial infections). The combination of valproic acid and carbapenems should be avoided because it may decrease the effect of sodium valproate
• rifampicin used to treat tuberculosis and other infections
• protease inhibitors such as lopinavir and ritonavir – used for HIV infection and AIDS
• cholestyramine used to lower blood fat (cholesterol) levels. It may still be possible for you to be given NAVALZYD IV; your doctor will advise you on what is suitable for you
• oestrogen-containing products (including some birth control pills)
• metamizole, a pain killer, may reduce the effect of NAVALZYD IV. Using NAVALZYD IV with food and drink Alcohol intake is not recommended during treatment. You should not drink alcoholic drinks while you are treated with NAVALZYD IV

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

Related pages

• Lexamil side effects

← Back to more medicine side effects.