Lexamil Side Effects

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Answer the side-effect intent for lexamil 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 Lexamil?

Lexamil contains the active ingredient Escitalopram.

• Active ingredient — Escitalopram
• Registration number — 41/1.2/0394; 41/1.2/0395; 41/1.2/0396
• Registration holder — CIPLA MEDPRO (PTY) LTD

It is approved for:

• Major depressive episodes
• Panic disorder with or without agoraphobia (fear of open/public spaces)
• Social anxiety disorder (social phobia)
• Generalised anxiety disorder
• Obsessive-compulsive disorder

Common side effects of Lexamil

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.

Those that occur frequently side effects

• Decreased or increased appetite, weight gain
• Anxiety, restlessness, abnormal dreams, decreased libido or inability to reach orgasm.
• Headache
• Inability to sleep or excessive sleepiness, dizziness, or tremor
• Pain over the sinuses with blocked or runny nose
• Nausea, runny stomach, constipation, vomiting or dry mouth
• Muscle or joint pain
• Ejaculation disorder or impotence
• Yawning
• Increased sweating
• Fatigue

Those that occur less frequently side effects

• Heavy menstruation or more frequent menstruation
• Weight loss
• Grinding of the teeth or clenching of the jaw, agitation, nervousness
• Taste disturbances
• Dilation of the pupil
• Ringing in the ears
• Hair loss

Those for which the frequency is not known side effects

• Loss of appetite

Serious side effects and warning signs

The leaflet lists these as serious side effects needing immediate attention.

Those that occur less frequently

• Severe allergic reactions presenting with shortness of breath, hives or itching, swelling of the face, tongue, or whole body, tightness of the chest, nausea, vomiting or fever.
• Any combination of the following: rapidly developing changes in consciousness or alertness with confusion, elevated mood, agitation, hyperactive behaviour, shivering, fever, tremor, abnormal eye movements, severe muscle spasms, and inability to co-ordinate movements. These symptoms may be due to serotonin syndrome (see “Take special care with LEXAMIL”).
• Vomiting of blood or a substance that resembles coffee-grounds, or passing blood per rectum or passing black, tarry, foul-smelling stools.
• Confusion, aggression, personality changes or hallucinations (seeing or hearing things that are not real).
• Slow heart rate or palpitations

Those for which the frequency is not known

• Convulsions (seizures)
• Yellow discolouration of the skin or whites of the eyes accompanied by loss of appetite, nausea and/or vomiting with or without pain over the liver area.
• Pinpoint red spots on the skin, easy bruising, bleeding from the gums or blood in the urine, since any combination of these symptoms may be due to low platelet counts.
• Extremely elevated mood with inappropriate behaviour
• Inability to pass urine
• Persistent painful erection

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 allergic (hypersensitive) to escitalopram oxalate or to any of the inactive ingredients of LEXAMIL. Please discuss this with your doctor or pharmacist if you are unsure
• If you are younger than 18 years of age, as safety and efficacy in children have not been proven
• If you are also taking monoamine oxidase inhibitors (MAOIs) for the treatment of depression or other mood disorders. Please speak to your doctor or pharmacist if you are unsure
• If you are taking linezolid, an antibiotic
• If you have been diagnosed with an abnormal heart rhythm or heart block or if you have previously been told that the medicines you are using may slow your heart rate

Use with care, and tell your doctor, if

• Previously been diagnosed with mania or manic episodes
• Seizures (convulsions) or epilepsy
• Diabetes mellitus
• You think about suicide
• Previously been diagnosed with a bleeding disorder. Please inform your doctor immediately if you develop bruising, blood in the urine, bleeding from the gums, or pinpoint red spots on the skin while taking LEXAMIL
• You are scheduled to undergo electroconvulsive therapy (ECT)
• Your heart rate is very slow, you recently suffered a heart attack or if you are in heart failure. Please speak to your doctor if you are unsure. Since treatment with LEXAMIL may slow your heart rate, your doctor may perform an electrocardiogram (ECG) before you start treatment with LEXAMIL
• Previously been diagnosed with heart disease. Please inform your doctor if you experience increased anxiety while taking LEXAMIL for panic disorder. Safety and efficacy of LEXAMIL in children under 18 years of age have not been established. There have been increased reports of hostility and suicide-related adverse events, such as suicidal thoughts and self-harm. Please report any such thoughts or behaviour to your doctor as soon as possible. If you take other medicines known as monoamine oxidase inhibitors or other medicines that increase serotonin levels, you may develop a condition known as the serotonin syndrome. Symptoms of this syndrome include confusion, agitation, hyperactivity, shivering, fever, tremors, eye movements, severe muscle spasms, incoordination of movements, and abnormal behaviour. Please report any of these symptoms to your doctor as a matter of urgency. Treatment with LEXAMIL may also cause a condition known as akathisia (an unpleasant or distressing restlessness and a need to move often, or an inability to sit or stand still)
• This is most likely to occur during the first few weeks of treatment. If you develop any of these symptoms, please inform your doctor as soon as possible. LEXAMIL may lower your blood levels of sodium. The likelihood of this is greater in elderly patients, patients with liver cirrhosis, or if you use other medicines that may lower your blood sodium levels, such as diuretics (water pills). Please inform your doctor if you develop nausea and vomiting, headache, confusion, loss of energy, fatigue, muscle weakness, muscle spasms or muscle cramps. You should not use LEXAMIL in combination with herbal remedies for depression, such as St. John’s Wort. If you are 50 years of age or older, there may be an increased risk of bone fractures if you are taking LEXAMIL. Escitalopram, as in LEXAMIL, may cause increased pressure in the eye (also known as glaucoma), especially if you are prone to this condition. Inform your doctor if you currently have, or have previously had increased pressure in the eye (glaucoma). Taking LEXAMIL with food and drink LEXAMIL can be taken with or without food

Pregnancy and breastfeeding

• The use of LEXAMIL while you are pregnant or breastfeeding your baby is not recommended
• The safe and effective use of LEXAMIL in pregnancy and while you are breastfeeding has not been established
• If you are pregnant and have been taking LEXAMIL while you are pregnant, please inform your doctor/gynaecologist, as your newborn baby may require special observation/treatment
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking LEXAMIL
• Driving or using machinery It is unlikely that LEXAMIL will impair your ability to drive or use machines
• However, if your alertness is impaired, or if you should experience side-effects such as dizziness, you should avoid driving a car or operating machinery

Interactions and medicines to check

The approved leaflet names these interactions.

• Monoamine oxidase inhibitors for the treatment of depression. You should wait 14 days after stopping a monoamine oxidase inhibitor before you start LEXAMIL and at least 7 days should elapse after you stop LEXAMIL before you can start treatment with a monoamine oxidase inhibitor. Please discuss this with your doctor or pharmacist if you are unsure
• Any medicines for the treatment of abnormal heart rhythms
• Other medicines that may slow your heart rate, such as:
• Certain antidepressants
• Certain medicines for the treatment of psychosis, such as haloperidol and pimozide. Please speak to your doctor or pharmacist if you are unsure
• Antibiotics, such as sparfloxacin, moxifloxacin, erythromycin (intravenous) or pentamidine
• Malaria treatment, especially halofantrine
• Certain antihistamines, e.g. mizolastine, to treat or prevent allergies
• Medicines which may increase your risk of developing seizures (convulsions), such as:
• Certain antidepressants (please speak to your doctor or pharmacist if you are unsure)
• Phenothiazines (chlorpromazine, fluphenazine, trifluoperazine and prochlorperazine) for the treatment of schizophrenia, mania, psychological disorders or behaviour disturbances
• Thioxanthenes (flupenthixol and zuclopenthixol) for the treatment of depression
• Haloperidol for the treatment of psychotic disorders, schizophrenia and mania
• Mefloquine for the prevention of malaria
• Bupropion for the treatment of depression and to assist with stopping smoking
• Cimetidine, omeprazole, esomeprazole or lansoprazole for the treatment of stomach ulcers, heartburn or reflux
• Sumatriptan for the treatment of migraine (severe headaches)
• Tramadol for the treatment of moderate to severe pain
• Linezolid, an antibiotic
• Lithium for the treatment of psychosis or manic depression (bipolar disorder)
• Tryptophan, a component of many alternative medicines to help treat sleeping disorders, anxiety, depression, bipolar disorder, premenstrual syndrome, attention deficit disorder, to stop smoking and for other conditions
• St. John’s Wort, a herbal remedy used for mild depression
• Tricyclic antidepressants, e.g. imipramine for the treatment of depression, panic and anxiety
• Metoprolol for the treatment of heart failure
• Selegiline for the treatment of Parkinson’s disease
• Warfarin, a blood thinner, used for the treatment of blood clotting disorders
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac or ibuprofen
• Alcohol

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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