Epitec Side Effects

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Answer the side-effect intent for epitec 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 Epitec?

Epitec contains the active ingredient Lamotrigine.

• Active ingredient — Lamotrigine
• Registration number — A38/2.5/0571; A38/2.5/0572; A38/2.5/0573; A38/2.5/0574
• Registration holder — CIPLA MEDPRO (PTY) LTD

It is approved for:

• EPITEC contains the active substance lamotrigine, and belongs to a group of medicines called anticonvulsants or antiepileptics
• They are also sometimes called antiseizure medicines
• Epilepsy EPITEC is used to treat various types of epilepsy (seizures) in adults and children, including seizures associated with Lennox-Gastaut syndrome
• EPITEC may be used on its own to treat adults and children over 12 years

Common side effects of Epitec

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.

Reported side effects

• Potentially serious skin reaction: A small number of people taking EPITEC get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. These symptoms are more likely to happen during the first few months of treatment with EPITEC, especially if the dose is too high or if the dose is increased too quickly, or if EPITEC is taken together with a medicine called valproate. Serious skin reactions are more common in children. Isolated cases have occurred after prolonged treatment (e.g. 6 months). Symptoms of these allergic reactions include: o skin rashes or redness, which may develop into severe skin reactions including widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome and toxic epidermal necrolysis) or extended rashes with liver, blood and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS hypersensitivity syndrome) o a sore mouth or eyes o a high temperature (fever), flu-like symptoms or drowsiness o swelling around your face, or swollen glands in your neck, armpit or groin In many cases, these symptoms will be signs of less serious side effects. But you must be aware that they are potentially serious and can develop into more serious problems, such as organ failure (kidney and liver failure) and a serious blood clotting disorder which can cause unexpected bruising or bleeding (disseminated intravascular coagulation)
• These are all potentially very serious side effects. If you have them, you may have had a serious reaction to EPITEC. Rarely, deaths have been reported. You may need urgent medical attention or hospitalisation. It is not possible to predict whether a mild rash will develop into a more serious reaction. A doctor should therefore be consulted immediately
• Serious immune system condition (haemophagocytic lymphohistiocytosis or HLH): A serious immune system condition, in which the part of the body system that fights disease is overactive, has been reported while taking EPITEC. Although, it has been reported very rarely, it can be life-threatening, so it is important that you know the symptoms to look out for. Symptoms include: o a high temperature (fever) o skin rashes o trouble walking or seeing, and fits (seizures) for the first time or happening more often o enlarged liver and/or spleen with pain and/or tenderness in the region towards the top of the stomach o yellowing of the skin and/or eyes o swollen glands in the neck, armpit and/or groin o bleeding and/or bruising more easily; looking pale, feeling tired. In most cases these symptoms may be signs of less serious side effects, but you must be aware that they can be signs of a condition which can be serious if not recognised early. Contact a doctor immediately if you have any of these symptoms
• Liver and blood problems: These have been reported less frequently while taking EPITEC. The following symptoms may be accompanied by a general feeling of being sick or unwell: o yellowing of the skin o itching o abdominal pain and/or tenderness o feeling very tired o unexpected bleeding or bruising, or the fingers turning blue o a sore throat, or more infections (such as colds) than usual. Contact a doctor immediately if you notice any of these symptoms. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking EPITEC
• Seizures in Epilepsy worsening: In people who already have epilepsy: seizures happening more often. Tell your doctor as soon as possible if this happens
• Thoughts of harming yourself or suicide: Occasionally, the symptoms of depression or bipolar disorder may include thoughts of harming yourself or committing suicide. If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you are taking EPITEC, contact a doctor immediately or go to the nearest hospital for help. Frequent side effects include:
• headache
• skin rash
• feeling sleepy, clumsiness and lack of co-ordination (ataxia), feeling dizzy
• aggression, agitation or irritability
• feeling drowsy, difficulty sleeping (insomnia), tremors, rapid, uncontrollable eye movements (nystagmus)
• feeling sick (nausea) or being sick (vomiting), diarrhoea
• feeling tired
• pain in your back, joints or elsewhere Less frequent side effects include:
• blurred or double vision
• a severe skin reaction (Stevens-Johnson syndrome)
• itchy eyes with discharge and crusty eyelids (conjunctivitis)
• a group of side effects together including: headache, fever, nausea, vomiting, stiff neck, rash, unusual sensitivity to light, muscle pains, chills, confusion and drowsiness. This may be caused by an inflammation of the membranes that cover the brain and spinal cord (meningitis)
• unusual hair loss or thinning (alopecia)
• a severe skin reaction including extensive peeling of the skin (toxic epidermal necrolysis) multi-organ failure or a serious blood clotting disorder which can cause unexpected bruising or bleeding (disseminated intravascular coagulation)
• a serious immune system condition (haemophagocytic lymphohistiocytosis or HLH), see also the information at the beginning of section 4
• swelling of the face (oedema) or swollen glands in the neck, armpits or groin (lymphadenopathy)
• a high temperature (fever)
• in people who already have epilepsy, seizures happening more often
• inflammation of the kidney (tubulointerstitial nephritis), which may occur in association with inflammation of the eye (uveitis)
• uncontrollable bodily movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual body movements such as jerking, shaking or stiffness
• feeling wobbly or unsteady when you move around
• confusion or agitation
• seeing or hearing things that aren’t really there (hallucinations)
• nightmares
• in people who already have Parkinson’s disease, a worsening of the symptoms lupus (symptoms may include: back or joint pain which sometimes may be accompanied by fever and/or general ill health)
• changes in liver function
• reduced numbers of red blood cells (anaemia)
• reduced numbers of white blood cells (neutropenia, leucopenia, agranulocytosis)
• reduced numbers of blood platelets, the cells that help blood to clot (thrombocytopenia)
• a reduced number of all these types of cells (pancytopenia)
• a disorder of the bone marrow called aplastic anaemia
• a decrease in antibodies (immunoglobulins)

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 lamotrigine or any of the other ingredients of EPITEC (listed in section 6). EPITEC should not be administered to children younger than 2 years of age, since safety and efficacy in this age group have not been demonstrated

Use with care, and tell your doctor, if

• if you have ever developed a rash after taking EPITEC or other medicines for bipolar disorder or epilepsy
• if you have ever developed meningitis after taking EPITEC (read the description of these symptoms in section 4 of this leaflet: Less frequent side effects)
• if you are already taking medicine that contains lamotrigine
• if you have a history of heart problems or irregular heart beats or any of your family members have any heart problem, including a condition called Brugada syndrome which is a genetic disease that affects the heart
• if you suffer from kidney or liver problems, because you will require adjustments of your EPITEC dosage. Please inform your doctor if you have kidney or liver function impairment
• if you are pregnant or want to become pregnant. If any of these apply to you, tell your doctor, who may decide to lower the dose, or decide that EPITEC is not suitable for you. Conditions you need to look out for:
• Important information about potentially serious skin reactions: Some people taking EPITEC get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems such as organ failure if they are not treated. These can include Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms to look out for while you are taking EPITEC. This risk may be associated with a variant in genes in people from Asian origin (mainly Han Chinese and Thai). If you are of such origin and have been tested previously carrying this genetic variant (HLA-B* 1502), discuss this with your doctor before taking EPITEC
• Read the descriptions on these symptoms in section 4 of this leaflet under ‘Potentially serious skin reaction’
• Serious immune system condition (haemophagocytic lymphosistiocytosis or HLH): A serious immune system condition, in which the part of the body that fights disease is overactive. Although it has been reported very rarely in people taking EPITEC, it can be life-threatening. If you have any of the associated symptoms, immediately report them to your doctor
• Read the descriptions on these symptoms in section 4 of this leaflet under ‘Serious immune system condition
• Thoughts of harming yourself or suicide: There have been reports of suicidal behaviour (including suicidal thoughts and suicide attempts) in patients being treated with anti-epileptic medicines such as EPITEC. If at any time you have these thoughts, contact your doctor immediately. If you are taking EPITEC to prevent extreme mood swings, you may not experience the full effect for several weeks. Occasionally, the symptoms of depression or bipolar disorder may include thoughts of harming yourself or committing suicide. This risk may be higher:
• when starting treatment or changing dose
• for patients who currently have (or have previously had) thoughts of harming themselves or committing suicide
• for young adults. If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you’re taking EPITEC: Contact a doctor immediately or go to the nearest hospital for help. You may find it helpful to tell a family member, caregiver or close friend that you can become depressed or have significant changes in mood and ask them to read this leaflet. You might ask them to tell you if they are worried about your depression or other changes in your behaviour. EPITEC should not be given to people aged under 18 years to treat bipolar disorder. Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years
• If you are taking EPITEC for epilepsy: The seizures in some types of epilepsy may occasionally become worse or happen more often while you are taking EPITEC. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often or if you experience a severe seizure while you are taking EPITEC:Contact a doctor as soon as possible

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking EPITEC
• • There may be an increased risk of babies developing a cleft lip or cleft palate if EPITEC is taken during the first few months of pregnancy
• • Talk to your doctor if you are breastfeeding or planning to breastfeed
• The active ingredient in EPITEC passes into breast milk and may affect your baby
• • Driving and using machinesEPITEC can cause drowsiness, dizziness and double vision
• • Don’t drive or operate machines unless you are sure you are not affected

Interactions and medicines to check

The approved leaflet names these interactions.

• other medicines for treating epilepsy (fits) such as sodium valproate, phenytoin, carbamazepine, phenobarbitone and primidone
• oral contraceptives such as ethinyloestradiol/levonorgestrel
• rifampicin, used for treating tuberculosis (TB)
• medicines for treating HIV infection: lopinavir/ritonavir and atazanavir/ritonavir
• aripriprazole, used for treating mood disorders
• risperidone, used in the treatment of psychosis, a mental health problem. Tell your doctor or pharmacist if you are taking any of these, or if you start or stop taking any. Your doctor may decide to adjust your dose. Hormonal contraceptive pills can affect the way EPITEC works: Your doctor may recommend that you take a particular type of hormonal contraceptive pill, or use another method of contraception, such as condoms, a cap or coil. If you are taking a hormonal contraceptive pill, or if you plan to start or stop taking one: Talk to your doctor, who will discuss suitable methods of contraception with you. EPITEC may also affect the way hormonal contraceptives work: If you are taking a hormonal contraceptive pill, EPITEC may affect how well this works. If you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods: Tell your doctor. These may be signs that EPITEC is affecting how well your contraceptive pill is working. Laboratory tests EPITEC may interfere with some laboratory tests to detect medicines. If you require a laboratory test, tell your doctor or hospital that you are taking EPITEC

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.

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