Brintellix® 20mg film-coated tablets – patient leaflet, side effects, dosage

1. What Brintellix is and what it is used for

Brintellix contains the active substance vortioxetine.

It belongs to a group of medicines called antidepressants.

Brintellix is used to treat major depressive episodes in adults.

Brintellix has been shown to reduce the broad range of depressive symptoms, including sadness, inner tension (feeling anxious), sleep disturbances (reduced sleep), reduced appetite, difficulty in concentrating, feelings of worthlessness, loss of interest in favourite activities, feeling of being slowed down.

2. What you need to know before you take Brintellix

Do not take Brintellix:

• if you are allergic to vortioxetine or any of the other ingredients of this

  medicine (listed in section 6).

• if you are taking other medicines for depression known as non-

  selective monoamine oxidase inhibitors or selective MAO-A inhibitors. Ask your doctor if you are uncertain.

Warnings and 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 with active substance names

    ending in ‘triptans’ (used to treat migraine).

Taking these medicines together with Brintellix may increase the risk of serotonin syndrome. This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea.

• have had fits (seizures).

  Your doctor will treat you cautiously if you have a history of fits or have unstable fit disorders/epilepsy. Fits are a potential risk with medicines used to treat depression. Treatment should be discontinued in any patient who develops fits or where there is an increase in the frequency of fits.

• have had mania

• have a tendency to bleed or bruise easily, or if you are pregnant

  (See ‘Pregnancy, breast-feeding and fertility’).

• have low sodium level in the blood.
• are 65 years of age or older.
• have a severe kidney disease.
• have a severe liver disease or 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.

When you are on antidepressant treatment, including vortioxetine, 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 antidepressants, since these medicines all take 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.

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 should not be used in paediatric patients (under 18 years of age) because efficacy has not been demonstrated. The safety of Brintellix in children and adolescents aged 7 to 17 years is described in section 4.

Other medicines and Brintellix

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:

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine

  (medicines to treat depression called non-selective 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.

• moclobemide (a medicine to treat depression).
• selegiline, rasagiline (medicines to treat Parkinson’s disease).
• 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 (see section warnings and precautions)
• lithium (a medicine to treat depression and mental disorders) or tryptophan.
• medicines known to cause low sodium level.
• rifampicin (a medicine to treat tuberculosis and other infections)
• carbamazepine, phenytoin (medicines to treat epilepsy or other illness)
• warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid and non-steroidal anti-inflammatory drugs (blood thinning medicines and medicines used for pain relief). These may increase bleeding-tendency.

Medicines that increase the risk of fits:

• sumatriptan and similar medicines with active substance names ending in ‘triptans’.
• tramadol (a strong painkiller).
• mefloquine (a medicine to prevent and treat malaria).
• bupropion (a medicine to treat depression also used to wean from smoking).

• fluoxetine, paroxetine and other medicines to treat depression called

  SSRI/SNRIs, tricyclics

• St John’s wort (hypericum perforatum) (a medicine to treat depression).
• quinidine (a medicine to treat heart rhythm disorders).
• chlorpromazine, chlorprothixene, haloperidol (medicines to treat mental disorders belonging to the groups called phenothiazines, thioxanthenes, butyrophenones).

Please tell your doctor if you are taking any of the medicines above, since your doctor needs to know if you already are at risk for seizures.

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 alcohol

Combining this medicine with alcohol is not advisable.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Brintellix should not be used during pregnancy unless the doctor says it is absolutely necessary.

If you take medicines to treat depression, including Brintellix, during the last 3 months of your pregnancy, you should be aware that 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. Contact your doctor immediately if your newborn baby has any of these symptoms.

Make sure your midwife and/or doctor know you are on Brintellix. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like 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. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take Brintellix 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 Brintellix so they can advise you.

Breast-feeding

A small amount of Brintellix will pass into breast milk, but no harmful, drug-associated effects have been observed in the infants. Brintellix is not to be used during breast-feeding. Your doctor will make a decision on whether you should stop breast-feeding, or stop using Brintellix taking into account the benefit of breast-feeding for your child, and the benefit of therapy for you.

Driving and using machines

Brintellix has no or negligible influence on the ability to drive and use machines. However, as adverse reactions such as diziness have been reported, caution is advised during such activities when beginning Brintellix treatment or changing the dose.

Brintellix contains Sodium

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to

  others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This

  includes any possible side effects not listed in this leaflet. See section 4.

3. How to take Brintellix

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose of Brintellix is 10mg vortioxetine taken as one daily dose in adults less than 65 years of age. The dose may be increased by your doctor to a maximum of 20mg vortioxetine per day or lowered to a minimum of 5mg vortioxetine per day depending on your response to treatment.

For elderly people 65 years of age or older, the starting dose is 5mg vortioxetine taken once daily.

Method of administration

Take one tablet with a glass of water.

The tablet can be taken with or without food.

Duration of treatment

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

If you take more than the prescribed dose of Brintellix, contact your doctor or nearest hospital emergency department immediately. Have the container and any remaining tablets available. Do this even if there are no signs of discomfort. Overdose signs could be 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.

Your doctor may decide to reduce your dose before you finally stop taking this medicine.

Some patients who stop taking Brintellix have experienced symptoms such as dizziness, headache, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), inability to sleep, feeling sick or vomiting, feeling anxious, irritable or agitated, feeling tired or shaking. These symptoms may occur within the first week after stopping Brintellix.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects were mild to moderate and occurred within the first two weeks of treatment. The reactions were usually temporary and did not lead to cessation of therapy.

Side effects listed below have been reported in the following frequencies.

Very common: may affect more than 1 in 10 people

• nausea

Common: may affect up to 1 in 10 people

• diarrhoea, constipation, vomiting
• dizziness
• itching of the whole body
• abnormal dreams
• increased sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

• flushing
• night sweats
• blurred vision
• involuntary shaking (tremor)
• hallucinations (seeing, hearing or feeling things that are not there)

Rare: may affect up to 1 in 1,000 people

• enlarged pupils (mydriasis), which can increase the risk of glaucoma

  (see section 2)

Not known: frequency cannot be estimated from available data

• low levels of sodium in the blood (the symptoms may include feeling

  dizzy, weak, confused, sleepy or very tired, or feeling or being sick; more serious symptoms are fainting, fits or falls)

• serotonin syndrome (see section 2)

• allergic reactions, that may be serious, causing swelling of the face,

  lips, tongue or throat, difficulties breathing or swallowing, and/or a sudden drop in blood pressure (making you feel dizzy or lightheaded)

• hives

• excessive or unexplained bleeding (including bruising, nose bleeding,

  gastrointestinal and vaginal bleeding)

• rash
• sleep disorders (insomnia)

• agitation and aggression. If you experience these side effects, contact

  your doctor (see section 2)

• headache
• increase in a hormone called prolactin in the blood
• a constant urge to move (akathisia)
• grinding one’s teeth (bruxism)
• inability to open your mouth (lockjaw/trismus)

• restless leg syndrome (urges to move the legs to stop painful or odd

  sensations, often occurring at night)

  • abnormal milky discharge from the breast (galactorrhoea)
  • sexual dysfunction

An increased risk of bone fractures has been observed in patients taking this type of medicines.

An increased risk of sexual dysfunction has been reported with the 20mg dose, and in some patients this side effect was observed at lower doses.

Additional side effects in children and adolescents

Side effects observed with vortioxetine in children and adolescents were similar to those seen for adults except for abdominal pain related events that were observed more often than in adults and suicidal thoughts that were observed more often in adolescents than in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brintellix

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions. Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.

If the tablet becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Brintellix contains

The active ingredient in the Brintellix is vortioxetine.

Each film-coated tablet contains 20mg vortioxetine (as hydrobromide).

The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171) and iron oxide red (E172).

What Brintellix looks like and contents of the pack

Brintellix is red, almond-shaped film-coated tablet marked with ‘TL’ on one side and ‘20’ on the other side.

It is available in blister pack size of 28 tablets.

Manufactured by: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.

Procured from within the EU & repackaged by the Product Licence holder: Gowrie Laxmico Limited, trading as B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Brintellix^® 20mg film-coated tablets; PL 18799/4377

Leaflet date: 02.10.2026

Brintellix is the registered trademark of H. Lundbeck A/S.

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