Zytomil Side Effects

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

What is Zytomil?

Zytomil contains the active ingredient Escitalopram.

• Active ingredient — Escitalopram
• Registration number — A42/1.2/0911; A42/1.2/0912; A42/1.2/0913; A42/1.2/0914
• Registration holder — Pharma Dynamics (Pty) Ltd

It is approved for:

• Major depression
• Panic disorder with or without agoraphobia (e.g. fear of leaving the house, entering shops, being in crowds and in public places)
• Social anxiety disorder (social phobia)
• Generalised anxiety disorder
• Obsessive-compulsive disorder

Common side effects of Zytomil

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

• Increased or decreased appetite, weight gain
• Feeling anxious, restlessness or need to keep moving, abnormal dreams, decrease in libido
• Sleep disturbance, sleepiness, dizziness, drowsiness, inability to sleep, sensations of tingling, burning, pricking (pins and needles), or numbness
• Sinusitis, yawning
• Nausea, constipation, diarrhoea, dry mouth, vomiting, indigestion
• Increased sweating
• Muscle or joint pain
• Sexual disturbances (delayed ejaculation, problem with erection, decreased sexual drive and women may experience difficulties achieving orgasm)
• Extreme tiredness, raised body temperature (fever)

Less frequent side effects

• Weight loss
• Involuntary habitual grinding of the teeth (typically during sleeping), feeling agitated, nervousness, panic attacks, feeling confused, aggressiveness, disorientation, feeling in a state in which one’s thoughts and feelings seem unreal or not to belong to oneself
• Taste disturbances, sleep disorder, fainting
• Dilation of the pupil of the eye
• Ringing or buzzing in the ears
• Heartbeat that is faster or slower than normal
• Nasal congestion (stuffy nose), hay fever, flu like symptoms, bleeding from the nose
• Abdominal pain
• Loss of hair, discolouration of the skin resulting from bleeding underneath, typically caused by bruising, rash or red welts on the hands, feet, face or genitals, hives, itching of the skin
• Bleeding from the uterus (womb) that is not associated with menstruation, abnormally heavy or extended menstrual flow
• Fluid retention. The following side effects have been reported but the frequency for them to occur is not known:
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage)
• Low levels of sodium in the blood (which may result in confusion, seizures, fatigue and low levels of consciousness), loss of appetite
• Headaches, difficulty concentrating, feeling of discomfort, illness or unease, difficulty controlling movement, twitching or abnormal uncontrolled movements
• Blurred or abnormal vision
• Low blood pressure (feeling lightheaded or dizzy when standing up)
• Salivation
• Inflammation of the liver
• Abnormal physical weakness or lack of energy
• Excessive or inappropriate production of milk, persistent and painful erection of the penis

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 escitalopram, or to any of the ingredients of ZYTOMIL
• If you are under the age of 18 years
• If you are taking any other medicines for depression such as monoamine oxidase inhibitors (MAOI). At least 14 days should pass between stopping such medication and starting with ZYTOMIL
• If you are taking other MAO inhibitors such as selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic)
• If you are taking the antibiotic linezolid, as your dosage may need to be adjusted
• If you are taking pimozide (an antipsychotic medicine), as it may lead to heart problems
• If you were born with or have had an episode of abnormal heart rhythm (as determined by an ECG: a test performed to check for problems with your heart)
• If you take medicines for heart rhythm problems or that may affect the heart’s rhythm
• If you are pregnant or breastfeeding your baby
• If you have a condition called porphyria (a rare blood disorder with symptoms such as severe abdominal pain, pain in your chest, back or legs, vomiting or a rapid heartbeat)

Use with care, and tell your doctor, if

• ZYTOMIL should not be used by children and adolescents under 18 years. Patients under 18 are more likely to experience side effects such as suicide attempt, suicidal thoughts and hostility (mainly aggression, oppositional behaviour and anger) when they take ZYTOMIL. The long-term safety effects concerning growth and development of ZYTOMIL in this age group have not yet been studied
• If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines take time to work (usually about two weeks but sometimes longer)
• If you have previously had thoughts about killing or harming yourself
• Your doctor will monitor your treatment and your progress carefully for the first few weeks. If you have any thoughts of harming or killing yourself at any time, contact your doctor immediately or go to a hospital straight away
• You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour
• If you suffer or have suffered from heart problems or have recently had a heart attack
• If your treatment is to be discontinued. Do not stop taking ZYTOMIL without talking to your doctor. If you stop taking your ZYTOMIL tablets suddenly, you may experience withdrawal effects
• If you are an elderly person (older than 65 years)
• If you have liver or kidney impairment
• If you get seizures (epilepsy) during treatment with ZYTOMIL, or have a history of epilepsy and there is an increase in seizure frequency your treatment will need to be gradually discontinued
• If you are receiving electroconvulsive treatment for your depression
• If you have episodes of mania (overactive behaviour or thoughts)
• If you have pre-existing slow heart rate
• If you are a diabetic (high blood sugar) as your dose of diabetic medicine may need to be adjusted
• If your anxiety increases during treatment. Some patients with panic disorder may experience increased anxiety symptoms at the start of treatment with ZYTOMIL. This reaction usually disappears within two weeks of continued treatment. Your doctor will start you on a lower dose in order to reduce the likelihood of increased anxiety attacks
• If you experience a feeling of restlessness, usually within the first few weeks of treatment
• If you have a decreased level of sodium in the blood as a result of severe diarrhoea and vomiting or use of diuretics
• If you are taking other similar medicines for a mental condition, anti- inflammatory drugs (NSAIDs) or aspirin and have a history of bleeding disorders as ZYTOMIL may increase the risk of bleeding
• if you are pregnant and your doctor has prescribed ZYTOMIL for you in the month before your baby is due, there is a risk of excessive bleeding after childbirth
• If you are taking medicine to prevent the clotting of blood (e.g. warfarin) or are prone to bleed easily as ZYTOMIL may increase the risk of bleeding
• If you take medicines to treat pain (e.g. tramadol), or migraine (e.g. sumatriptan) as you may be at risk of serotonin syndrome (a condition with symptoms such as agitation or restlessness, dilated pupils and heavy sweating)
• If you take medicines containing lithium or tryptophan as the effects of ZYTOMIL may be increased
• If you suffer from glaucoma (an eye condition that can result in the damage of the optic nerve)
• ZYTOMIL should not be used with monoamine oxidase inhibitors, imipramine, other medicines that increase serotonin levels, moclobemide, alcohol, warfarin or cimetidine
• If you are taking St. John’s Wort (a herbal medicine) as this may result in unwanted side effects
• If you are 50 years or older. An increased risk of bone fractures has been observed in patients aged 50 years or older taking ZYTOMIL

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before using ZYTOMIL
• If you take ZYTOMIL near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders
• Your doctor or midwife should be aware that you are taking ZYTOMIL so they can advise you
• You should not use ZYTOMIL if you are pregnant or breastfeeding

Interactions and medicines to check

The approved leaflet names these interactions.

• Do not take any other medicines to treat depression (for example monoamine oxidase inhibitors, imipramine, other serotonergic medicines (a medicine that affects the release of serotonin, a type of hormone), linezolid and moclobemide) without consulting your doctor as they may interact with ZYTOMIL
• Do not take ZYTOMIL if you take medicines that may affect the heart’s rhythm such as pimozide. Tell your doctor if you are taking any of the following medicines:
• Selegiline (used to treat Parkinson’s disease) increases the risk of side effects
• Medicines that prolong or affect the heart rhythm (phenothiazide derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial medicines (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment particularly halofantrine), certain medicines to treat allergies (mizolastine), as they may affect the way ZYTOMIL works
• Medicines used to treat heart burn or stomach ulcer such as cimetidine interact with the breakdown of escitalopram, and the dose of ZYTOMIL may need to be changed
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These medicines may increase the risk of side effects
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan (used by the body to generate serotonin which helps control your mood and sleep)
• Neuroleptics (medicines used to treat schizophrenia and other severe mental problems e.g. phenothiazines, thioxanthenes and butyrophenones), mefloquine (an antimalarial medicine), bupropion (an antidepressant medicine) and tramadol (medicine used to treat moderate to severe pain) and antidepressants (tricyclics, SSRIs) due to a possible risk of a lowered threshold for seizures
• Flecainide, propafenone, and metoprolol (used in cardiovascular disease); desipramine, clomipramine, and nortriptyline (antidepressants); and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of ZYTOMIL may need to be adjusted
• St. John’s Wort (Hypericum perforatum) – a herbal remedy used for depression
• Do not use alcohol while taking ZYTOMIL
• Medicines which lower potassium or magnesium levels in the blood as they may result in unwanted side effects
• Pimozide, an antipsychotic medicine, as it may affect the heart’s rhythm
• Aspirin and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood) may increase the risk of bleeding
• Warfarin (medicine used to thin the blood). Your doctor may check the coagulation time of your blood when starting and discontinuing ZYTOMIL in order to verify that your dose of anti-coagulant is still adequate. ZYTOMIL with food and drink ZYTOMIL can be taken with or without food. Avoid consuming alcohol whilst taking ZYTOMIL

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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