Prescribing Information for the Patient

Brintellix 5 mg Film-Coated Tablets

vortioxetine

Read this entire prescribing information carefully before starting to take this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prescribing information. See section 4.

Brintellix contains the active ingredient vortioxetine. This belongs to a group of medicines called antidepressants.

Brintellix is used to treat episodes of major depression in adults.

It has been shown that Brintellix reduces a wide range of depressive symptoms, including sadness, internal tension (feeling of anxiety), sleep disturbances (reduced sleep), decreased appetite, difficulty concentrating, feelings of uselessness, loss of interest in enjoyable activities, feeling of slowness.

Do not take Brintellix

• if you are allergic to vortioxetine or any of the other ingredients in this medication (listed in section 6).

• if you are taking other medications for depression known as monoamine oxidase inhibitors or selective MAO-A inhibitors. If you have any doubts, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Brintellix if:

• you are taking medications with the called serotoninergic effect, such as:

tramadol and similar medications (strong analgesics).

The use of these medications together with Brintellix may increase the risk of serotonin syndrome. This syndrome may be associated with hallucinations, involuntary muscle contractions, rapid heart rate, high blood pressure, fever, nausea, and diarrhea.

• you have had seizures.

Your doctor will treat you with caution if you have a history of seizures or have unstable/epileptic convulsive disorders. Seizures are a potential risk of medications used to treat depression. Treatment should be interrupted in any patient who experiences seizures or an increase in their frequency.

• you have had mania.

• you are prone to bleeding or bruising easily or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).
• you have low sodium levels in your blood.
• you are 65 years or older.
• you have severe kidney disease.
• you have severe liver disease, or a liver disease called cirrhosis.

• you have or have had increased intraocular pressure or glaucoma. If you feel eye pain and have blurred vision during treatment, contact your doctor.

If you are receiving antidepressant treatment, including vortioxetine, you may also experience feelings of aggression, agitation, irritable reaction, and irritability. If this happens, you should consult your doctor.

Thoughts of suicide and worsening of your depression

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming or killing yourself. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer.

You would be more prone to having these thoughts:

• if you previously had thoughts of harming or killing yourself.
• if you are a young adult.

Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders treated with an antidepressant.

If you ever have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital. It may be helpful for you to tell a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

Children and adolescents

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

Taking Brintellix with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Inform your doctor if you are taking any of the following medications:fenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (depression medications called non-selective monoamine oxidase inhibitors); do not take any of these medications with Brintellix. If you have taken any of these medications, wait 14 days before starting Brintellix. After stopping Brintellix, wait 14 days before taking any of these medications.

• moclobemide (depression medication).
• selegiline, rasagiline (Parkinson's disease medications).
• linezolid (bacterial infection medication).
• medications with a serotoninergic effect, such as tramadol or similar medications (strong analgesics) and sumatriptán and similar medications with active ingredient names ending in “-triptán” (administered to treat migraines). Taking these medications with Brintellix may increase the risk ofserotonin syndrome(see the warnings and precautions section).
• lithium (depression and mental disorder medication) or tryptophan.
• medications known to cause decreased sodium levels.
• rifampicin (tuberculosis and other infection medication).
• carbamazepine, phenytoin (epilepsy and other disease medication).
• warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose aspirin, and nonsteroidal anti-inflammatory drugs (anticoagulants and pain relief medications). These may increase the risk of bleeding.

Medications that increase the risk of seizures:

-sumatriptán and similar medications with active ingredient names ending in “-triptán”.

• tramadol (strong analgesic).
• mefloquine (malaria prevention and treatment medication).
• bupropion (depression medication also used to quit smoking).

• fluoxetine, paroxetine, and other depression medications called SSRIs/SNRIs, tricyclics.
• St. John's Wort (Hypericum perforatum) (depression medication).
• quinidine (heart rhythm disorder medication).

• chlorpromazine, chlorprothixene, haloperidol (mental disorder medications belonging to the groups called phenothiazines, thioxanthenes, or butyrophenones).

Please talk to your doctor if you are taking any of the mentioned medications, as your doctor needs to know if you are at risk of having seizures.

If you are given a urine toxicology test, taking Brintellix may cause positive results for methadone when using some testing methods, although you are not taking methadone. If this happens, a more specific test can be performed.

Taking Brintellix with alcohol

It is not recommended to combine this medication with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

Brintellix should not be used during pregnancy unless your doctor considers it absolutely necessary.

If you take medications to treat depression, including Brintellix, during the last 3 months of pregnancy, you should know that the following effects may be observed in the newborn: respiratory problems, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, intense reflexes, tremors, nervousness, irritability, drowsiness, persistent crying, sleep difficulties, and a tendency to sleep and difficulty sleeping. If your baby shows any of these symptoms, contact your doctor immediately.

Make sure your midwife and/or doctor know that you are taking Brintellix. When taken during pregnancy, especially in the last 3 months, medications likeBrintellix may increase the risk of a serious disease in the baby, called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Brintellix in the final stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Brintellix to be able to advise you.

Breastfeeding

It is expected that the ingredients of Brintellix will pass into breast milk. Brintellix should not be used during breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop taking Brintellix, taking into account the benefit of breastfeeding for the child and the benefit of treatment for you.

Driving and operating machinery

Brintellix has little or no influence on the ability to drive or operate machinery. However, since side effects such as dizziness have been reported, caution is recommended during these activities at the beginning of treatment with Brintellix or when changing doses.

Brintellix contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Brintellix is 10 mg of vortioxetine once a day in adults under 65 years of age. Your doctor may increase the dose up to a maximum of 20 mg of vortioxetine per day or reduce it to a minimum of 5 mg of vortioxetine per day, depending on your response to treatment.

For elderly patients 65 years of age or older, the initial dose is 5 mg of vortioxetine once a day.

Administration Form

Take a tablet with a glass of water.

The tablet can be taken with or without food.

Treatment Duration

Take Brintellix for the time your doctor tells you to.

Continue taking Brintellix even if it takes some time to notice an improvement in your condition.

You should continue treatment for at least 6 months after feeling well again.

If you take more Brintellix than you should

If you take more Brintellix than indicated, consult your doctor immediately or go to the nearest hospital emergency department. Bring the packaging and remaining tablets with you. Do this even if you do not experience any discomfort. Symptoms in case of overdose are: dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, tendency to sleep, and redness (redness of the skin).

After ingesting several times the prescribed dose, seizures and a rare condition called serotonin syndrome have been reported.

If you forgot to take Brintellix

Take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Brintellix

Do not stop taking Brintellix without consulting your doctor.

Your doctor may decide to reduce your dose before stopping treatment with this medication completely.

Some patients who have stopped taking Brintellix have experienced symptoms such as dizziness, headache, tingling sensation or sensations similar to electric shocks (especially in the head), inability to sleep, nausea or vomiting, feeling of anxiety, irritability or agitation, feeling of fatigue or tremors. These symptoms may appear in the first week after stopping Brintellix.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The observed side effects were mostly mild or moderate and occurred in the first two weeks of treatment. These side effects were generally transient and did not require suspension of treatment.

The following side effects have been observed with the frequencies indicated:

Very common: may affect more than 1 in 10 people

• nausea.

Common: may affect up to 1 in 10 people

• diarrhea, constipation, vomiting.
• dizziness.
• itching all over the body.
• abnormal dreams.
• increased sweating.
• indigestion.

Uncommon: may affect up to 1 in 100 people

• rubor (redness of the skin).
• nocturnal sweating.
• blurred vision.
• involuntary tremors.

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

• dilated pupils (mydriasis), which may increase the risk of glaucoma (see section 2).

Frequency not known: cannot be estimated from available data

• low sodium levels in the blood (some symptoms may be dizziness, weakness, confusion, drowsiness or extreme fatigue, or nausea or vomiting; other more serious symptoms are fainting, seizures or falls).
• serotonin syndrome (see section 2).

• allergic reactions, which can be severe, and cause swelling of the face, lips, tongue or throat; difficulty breathing or swallowing, and/or sudden drop in blood pressure (which may cause dizziness or lightheadedness).

• bruxism.

• excessive or unexplained bleeding (including petechiae, nosebleeds, gastrointestinal bleeding and vaginal bleeding).
• eruption.
• 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.
• constant need to move (akathisia).
• teeth grinding (bruxism).
• inability to open the mouth (trismus).
• restless legs syndrome (impulses to move the legs to stop

painful or strange sensations, which often occur at night).

• abnormal secretion of milk from the breast (galactorrhea).

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

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

Other side effects in children and adolescents

The side effects observed with vortioxetine in children and adolescents were similar to those observed in adults, except for the events related to abdominal pain, which were observed more frequently than in adults, and suicidal ideation, which was observed more frequently in adolescents than in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Brintellix

• The active ingredient is vortioxetine. Each film-coated tablet contains 5 mg vortioxetine (as hydrobromide).

• The other components are mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide red (E172).

Appearance of the product and contents of the packaging

Film-coated tablet (compressed tablet), pink in color and almond-shaped (5 x 8.4 mm), engraved with “TL” on one face and with “5” on the other.

Brintellix 5 mg film-coated tablets are available in blisters of 14, 28, 98, 56x1, 98x1, 126 (9x14), 490 (5x(98x1)) tablets and in containers of 100 and 200 tablets.

The sizes of the 56x1, 98x1, and 490 film-coated tablets are presented in single-dose blisters.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: 10/2023

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.