Serdep Side Effects

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Answer the side-effect intent for serdep 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 Serdep?

Serdep contains the active ingredient Sertraline.

• Active ingredient — Sertraline
• Registration number — 36/1.2/0272; 36/1.2/0273
• Registration holder — Ranbaxy Pharmaceuticals {Pty) Ltd

It is approved for:

• Depression and recurrence of depression in adults
• Panic disorder with or without agoraphobia (fear of open places) in adults
• Obsessive-compulsive disorder (OCD) in adults and children aged 13 – 17 years

Common side effects of Serdep

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

• If you develop a severe skin rash that causes blistering (erythema multiforme), (this can affect the mouth and tongue). These may be signs of a condition known as Stevens – Johnson syndrome, or Toxic Epidermal Necrolysis (TEN). Your doctor will stop your treatment in these cases. Allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing problems, wheezing, swollen eyelids, face or lips
• If you experience agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat
• These are symptoms of Serotonin Syndrome. In rare cases this syndrome may occur when you are taking certain medicines at the same time as SERLIFE Your doctor may wish to stop your treatment
• If you develop yellow skin and eyes which may mean liver damage
• If you experience depressive symptoms with ideas of harming or killing yourself (suicidal thoughts)
• If you have a fit (seizure)
• If you have a manic episode. The most frequent side effects experienced include the following:
• sore throat Loss of appetite, decreased appetite, increased appetite
• difficulty sleeping, depression, feeling strange, nightmare, agitation, anxiety, nervousness, decrease of sex drive (libido), grinding of the teeth, suicidal thoughts or behaviour, suicide attempt
• dizziness, sleepiness, headache, loss of sensation, uncontrolled muscle movements, skin tingling*, shaking, muscle tension, abnormal taste, lack of attention
• abnormal vision, visual disturbance
• ringing of the ears
• palpitations
• hot flushes
• yawning
• diarrhoea, dry mouth, nausea, stomach pain, constipation, upset stomach/indigestion, vomiting, excess amount of air/gas in the stomach
• excessive sweat, rash
• joint pain, muscle pain
• ejaculation disorder, problems with sexual function, menstrual irregularities
• tiredness, feeling unwell, chest pain Less frequent side effects may include the following:
• chest cold, runny nose
• intestinal problems, ear infection
• a new and abnormal growth of tissue in some parts of the body (neoplasm)
• swollen glands, decrease in white blood cells, decrease in blood clotting cells
• severe allergic reaction
• underactive thyroid, increased secretion of a hormone which causes imbalance of salt and fluid levels (antidiuretic hormone), elevated prolactin levels in the blood
• diabetes mellitus, low blood sodium, changes in blood sugar levels, increased blood cholesterol
• hallucinations (seeing or hearing things that are not there), aggression, feeling excited, depressive symptoms, lack of caring, thinking abnormal, terrifying abnormal Dreams, psychosis, psychotic disorder*, paranoia, sleep walking, premature ejaculation
• confusion, coma, convulsions (fits), fainting, uncontrolled muscle movements*, migraine, abnormal coordination, moving a lot, amnesia, speech disorder, dizziness while standing up, abnormal movements, difficulty moving, increased sensation, sensory disturbance, sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome)
• dilation of pupils, glaucoma, tear problem, spots in front of eyes, double vision, light hurts eye, blood in the eye, unequal sized pupils
• ear pain
• Increased rate of heartbeat, heart attack, slow heartbeat, heart contractions
• high blood pressure, flushing, poor circulation of arms and legs, abnormal bleeding such as intestinal bleeding
• constriction of air passages, difficulty breathing, nose bleeds, closing up of throat, breathing fast, breathing slow, a harsh vibrating noise when breathing caused by an obstruction in the windpipe, difficulty talking, hiccups, progressive scarring of lung tissue (interstitial lung disease)
• inflammation of the oesophagus, difficulty swallowing, haemorrhoids, increased saliva, tongue disorder, burping, blood in stool, inflammation of the mouth or tongue, mouth or tongue ulceration, tooth disorder, inflammation of the pancreas
• problems with liver function, yellow skin and eyes (jaundice allergic skin reaction (dermatitis or hives), itching, purpura (small, purple-coloured spots caused by bleeding into the skin), hair loss, severe skin rash that causes blistering, swelling under the skin, dead skin cells, rash, skin sensitivity to sunlight, swelling of the face or around the eye, cold sweat, dry skin, rash around hair follicles, abnormal hair texture, abnormal skin odour
• muscle cramps, joint pain, muscular weakness, back pain, muscle twitching, bone disorder
• urinary incontinence and changes in frequency of urination including bed wetting
• vaginal bleeding, sexual dysfunction, female sexual dysfunction, abnormally heavy bleeding at menstruation, dry vaginal area, genital discharge, prolonged erection*, secretion of breastmilk in men or in women who are not breastfeeding*, breast enlargement in males, heavy vaginal bleeding shortly after birth (postpartum haemorrhage)
• swelling of legs, chills, fever, thirst, hernia, decreased medicine tolerance, changes in walking movement
• Increase in liver enzyme levels, abnormal laboratory readings, changes in weight, abnormal semen, abnormal platelet function test
• injury, relaxation of blood vessels procedure
• symptoms that can occur when sertraline containing medicine such as SERLIFE is stopped include agitation, anxiety, dizziness, headache, nausea, and pins and needles

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 sertraline or any of the other ingredients of this medicines. (An allergic reaction may include rash, itching, swelling of the face, lips, or hands/feet, or breathing difficulties)
• If you are taking or have recently taken (within the last two weeks) another antidepressant drug known as a monoamine oxidase inhibitor (MAOI) including the antibiotic linezolid. You should not take SERLIFE tablets at the same time as or within two weeks of stopping irreversible MAO inhibitors. Also do not take MAO inhibitors for at least one week after stopping SERLIFE tablets
• If you are taking any medicine called pimozide used to treat certain kinds of mental illness
• If you are under the age of 18 years and suffering from both a condition called obsessive-compulsive disorder along with depression
• If you suffer from liver or kidney impairment
• If you are pregnant or breastfeeding

Use with care, and tell your doctor, if

• If you have suffered from serotonin syndrome (life- threatening medicine reaction) or neuroleptic malignant syndrome (neurological disorder) after taking certain medicines including triptans, fentanyl, tramadol, dextromethorphan, tapentadol, meperidine, methadone and pentazocine, MAOIs, antipsychotics and other dopamine antagonists
• If you are taking, or have taken in the last two weeks, any medicines called monoamine oxidase inhibitors (MAOIs), like selegiline (to treat Parkinson’s disease), moclobemide (to treat depression), linezolid (an antibiotic) and methylene blue
• If you have suffered from symptoms including fast heart beat or loss of consciousness
• If you are switching from another antidepressant medicine
• If you have suffered from a manic depressive illness or schizophrenia
• If you have epileptic fits or a history of seizures
• If you have or have had thoughts of harming or killing yourself
• If you have a history of bleeding disorders or have been taking medicines which thin the blood
• If you have low sodium levels in your blood, since this can occur as a result of taking sertraline containing medicines such as SERLIFE
• If you have problems with your liver or kidneys
• If you suffer from diabetes mellitus as your blood sugar levels may alter and your dose of diabetic medicines may need to be adjusted
• If you have a laboratory reading for benzodiazepines (e.g. diazepam, alprazolam), as a false reading can result if taking sertraline containing medicines such as SERLIFE
• If you have angle-closure glaucoma or history of glaucoma (build-up of pressure behind the eye)
• If you have any diseases or conditions that affect your metabolism or your blood responses
• If you have a history of heart disease
• If you drink alcohol
• If you are being treated with electroconvulsive therapy (ECT)

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking SERLIFE
• You should not take SERLIFE while you are pregnant
• Women of childbearing potential should use adequate methods of contraception if taking sertraline containing medicines such as SERLIFE
• If you take SERLIFE 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 SERLIFE so they can advise you You should not take sertraline containing medicines such as SERLIFE while you are breastfeeding your baby
• Driving and using machinery: Special care should be taken when driving, operating machinery or performing any hazardous tasks

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemide (to treat depression) and selegiline (to treat Parkinson’s disease), the antibiotic linezolid and methylene blue (to treat high levels of methaemoglobin in the blood). Do not use sertraline containing medicines such as SERLIFE together with these medicines
• Medicines to treat mental disorders such as psychosis (pimozide). Do not use sertraline containing medicines such as SERLIFE together with pimozide. Fenfluramine (used to treat weight loss) or the herbal medicine St. John’s Wort
• Aspirin or other pain killers known as NSAIDs (non-steroidal anti-inflammatory drugs)
• Diuretics (known as water tablets) as they may alter the sodium levels in your blood Medicines that are known to affect your platelet function (e.g. atypical antipsychotics and phenothiazines, tricyclic antidepressants)
• Antipsychotics or antibiotics which could increase risk of underactive thyroid and/or heart contractions
• Lithium or another antidepressant or anti-obsessional medicine to treat mania and depression
• Phenytoin to treat epilepsy
• Sumatriptan to treat migraine headaches
• Warfarin (blood thinning medicine)
• Sedatives e.g. diazepam
• Medicines to treat diabetes e.g. tolbutamide
• Any medicines to regulate the rate and rhythm of your heart (e.g. flecainide, propenone)
• Cimetidine to treat excessive stomach acid and ulcers SERLIFE with food, drink and alcohol: Sertraline containing medicines such as SERLIFE can be taken with or without food. Alcohol should be avoided whilst taking sertraline containing medicines such as SERLIFE

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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