Brintellix Side Effects

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

What is Brintellix?

Brintellix contains the active ingredient Vortioxetine hydrobromide.

• Active ingredient — Vortioxetine hydrobromide
• Registration number — 48/1.2/0429; 48/1.2/0430; 48/1.2/0431; 48/1.2/0432
• Registration holder — H. Lundbeck (Pty) Ltd

It is approved for:

• BRINTELLIX belongs to a group of medicines called antidepressants
• BRINTELLIX is used to treat major depressive episodes in adults

Common side effects of Brintellix

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.

Less frequent side effects

• flushing
• night sweats
• low levels of sodium in the blood (the symptoms may include feeling dizzy, weak, confused, sleepy or even very tired, or feeling of being sick; more serious symptoms are fainting, fits or falls)
• serotonin syndrome
• hives
• excessive or unexplained bleeding (including bruising, nose bleeding, gastrointestinal and vaginal bleeding)
• headache
• increase in a hormone called prolactin in the blood
• enlarged pupils (mydriasis), which can increase the risk of glaucoma
• sleep disorders (insomnia)
• agitation and aggression. If you experience these side effects, contact your doctor. You may experience less satisfaction with orgasm or sexual arousal, especially at the 20 mg BRINTELLIX dose. An increased risk of bone fractures has been observed in patients taking this type of medicine

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 allergic to vortioxetine or any of the other ingredients of this medicine
• if you are taking other medicines for depression such as monoamine oxidase inhibitors. Ask your doctor if you are uncertain

Use with care, and tell your doctor, if

• are taking medicines with a so-called serotonergic effect, such as:
• tramadol and similar medicines ( strong painkillers)
• sumatriptan and similar medicines to BRINTELLIX with active substance names ending in “triptans” (used to treat migraine). Taking these medicines together with BRINTELLIX may cause serotonin syndrome. This syndrome may be associated with hallucinations (distorted perception), involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea
• have had fits Your doctor will treat you cautiously if you have a history of fits or have unstable fit disorders/epilepsy. You should stop taking BRINTELLIX if you develop fits or if there is an increase in the frequency of fits
• have had mania (elevated mood)
• have a tendency to easily develop bleedings or bruises, or if you are pregnant
• are elderly
• have a liver disease called cirrhosis
• have or previously have had increased pressure in the eye or glaucoma. If your eyes become painful and you develop blurred vision during treatment, contact your doctor
• have low sodium level in the blood
• are treated with other medicines known to cause low sodium level. When you are on antidepressant treatment, including BRINTELLIX, you may also experience feelings of aggression, agitation, anger and irritability. If this occurs, you should talk to your doctor. Thoughts of suicide and worsening of your depression 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 to take BRINTELLIX, since it takes time to work, usually about two weeks but sometimes longer. You may be more likely to think like this if you:
• have previously had thoughts about killing or harming yourself
• are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant such as BRINTELLIX. If you have thoughts of harming or killing yourself at any time, contact your doctor 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. Children and adolescents BRINTELLIX is not recommended in children and adolescents under 18 years

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 BRINTELLIX
• Pregnancy BRINTELLIX should not be used during pregnancy as it may harm your baby
• If you are of childbearing age you should use effective contraception while taking BRINTELLIX
• The following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties
• BRINTELLIX may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish
• These symptoms usually begin during the first 24 hours after the baby is born

Interactions and medicines to check

The approved leaflet names these interactions.

• moclobemide (a medicine to treat depression)
• selegiline, rasagiline (a medicine to treat Parkinson’s disease) phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called monoamine oxidase inhibitors) You must not take any of these medicines together with Brintellix. If you have taken any of these medicines you will need to wait 14 days before you start taking BRINTELLIX. After stopping BRINTELLIX you must allow 14 days before taking any of these medicines
• linezolid (a medicine to treat bacterial infections)
• medicinal products with serotonergic effect e.g. tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). Taking these medicines together with Brintellix may increase the risk of serotonin syndrome
• lithium (a medicine to treat depression and mental disorders) or tryptophan
• medicines that increase the risk of fits; sumatriptan and similar medicines to BRINTELLIX with active substance names ending in “triptans”
• tramadol (a strong painkiller)
• mefloquin (a medicine to prevent and treat malaria)
• bupropion (a medicine to treat depression and also used to wean from smoking)
• fluoxetine, paroxetine and other medicines to treat depression called SSRI/SNRIs, tricyclics
• St John’s Wort (a medicine to treat depression)
• quinidine (a medicine to treat heart rhythm disorders)
• medicines to treat mental disorders and belongs to the groups called phenothiazines, thioxanthenes, butyrophenones
• rifampicin (a medicine to treat tuberculosis)
• carbamazepine, phenytoin (medicines to treat epilepsy or other illness)
• Warfarin and low-dose aspirin (blood thinning medicines) If you are having a urine drug screen, taking BRINTELLIX may cause positive results for methadone when some test methods are used, even though you may not be taking methadone. If this happens, a more specific test can be performed. BRINTELLIX with food, drink and alcohol BRINTELLIX can be taken with or without food. Combining BRINTELLIX with alcohol is not advisable

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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