Brintellix 5 mg/10 mg/15 mg/20 mg Film-Coated Tablets

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

Do not take BRINTELLIX

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

Warnings and special precautions

Talk to your doctor or pharmacist before taking BRINTELLIX if you:

• 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 (see ‘Pregnancy, breastfeeding and fertility’).
• 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.

Other medicines and BRINTELLIX

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Also tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• 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)

Do not share medicines prescribed for you with any other person. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The normally recommended dose of BRINTELLIX is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day or lowered to a minimum of 5 mg per day depending on your response to treatment. For elderly people 65 years of age or older, the starting dose is of BRINTELLIX 5 mg taken once daily. Do not change the dose of your medicine without talking to your doctor first. Take one tablet with a glass of water. The tablet can be taken with or without food. If you have the impression that the effect of BRINTELLIX is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents

BRINTELLIX is not for use in children and adolescents under 18 years.

Duration of treatment

Your doctor will tell you how long your treatment with BRINTELLIX will last. Take BRINTELLIX for as long as your doctor recommends. Continue to take BRINTELLIX even if it takes some time before you feel any improvement in your condition. Treatment should be continued for at least 6 months after you feel well again.

If you take more BRINTELLIX than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Have the container and any remaining tablets available. Do this even if there are no signs of discomfort. Overdose signs are dizziness, nausea, diarrhoea, stomach discomfort, itching of the whole body, sleepiness and flushing. Following intake of dosages several times higher than the prescribed dose, fits(seizures) and a rare condition called serotonin syndrome have been reported. If you forget to take BRINTELLIX Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking BRINTELLIX Do not stop taking BRINTELLIX without talking with your doctor. If you have any further questions on the use of BRINTELLIX, ask your doctor or pharmacist.

BRINTELLIX can cause side effects. Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BRINTELLIX, please consult your health care professional for advice. If any of the following happens, stop taking BRINTELLIX and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the face, lips, tongue or throat
• difficulties in breathing or swallowing
• rash or itching
• a sudden drop in blood pressure (making you feel dizzy or lightheaded).

These are all very serious side effects. If you have them, you may have had a serious reaction to BRINTELLIX. You may need urgent medical attention or hospitalisation.

Side effects listed below have been reported by patients taking BRINTELLIX in the following frequencies:

Frequently:

• nausea
• diarrhoea, constipation, vomiting
• dizziness
• itching of the whole body
• abnormal dreams
• increased sweating
• drowsiness, feeling tired

Less frequent:

• 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 (see Warnings and special precautions)
• 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 (see section 2)
• sleep disorders (insomnia)
• agitation and aggression. If you experience these side effects, contact your doctor (see section 2).

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. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to the South African Health Products Regulatory Authority (SAHPRA) via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BRINTELLIX.

Store all medicines out of the reach of children. Store at or below 30 °C. Do not use BRINTELLIX after the expiry date which is stated on the packaging after ‘EXP’. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).