Label: Information for the Patient

Brintellix 20 mg/ml Oral Solution

vortioxetine

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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 side effects, consult your doctor or pharmacist, even if they are not listed in this label. 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 the wide range of depressive symptoms, including sadness, internal tension (feeling of anxiety), sleep alterations (reduced sleep), decreased appetite, difficulty concentrating, feelings of uselessness, loss of interest in pleasant activities, feeling of slowness.

Do not take Brintellix:

Warnings and precautions

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

• Taking these medicines with Brintellix may increase the risk of serotonin syndrome. This syndrome can be associated with hallucinations, involuntary muscle spasms, rapid heartbeat, 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 medicines used to treat depression. Treatment should be discontinued 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 (seePregnancy, breastfeeding, and fertility).
• you have low sodium levels in your blood.
• you are 65 years of age or older.
• you have severe kidney disease.
• you have severe liver disease, or a liver disease called cirrhosis.
• you have or have had increased eye pressure or glaucoma. If you experience eye pain and blurred vision during treatment, contact your doctor.

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

Thoughts of suicide and worsening of your depression

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

You would be more likely to have these thoughts:

• if you have previously had thoughts of harming yourself or taking your own life.
• if you are a young adult.

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

If you ever have thoughts of harming yourself or taking your own life, 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 usedinpatients under 18 years of agebecause its efficacy has not been demonstrated. The safety of Brintellix in children and adolescents aged 7 to 17 years is described in section 4.

Taking Brintellix with other medicines

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

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

• fenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (depression medicines called non-selective monoamine oxidase inhibitors); do not take any of these medicines with Brintellix. If you have taken any of these medicines, wait 14 days before starting to take Brintellix. After stopping Brintellix, wait 14 days before taking any of these medicines.
• moclobemide (depression medicine).
• selegiline, rasagiline (Parkinson's disease medicines).
• linezolid (bacterial infection medicine).
• medicines with a serotonin effect, for example, tramadol or similar medicines (strong analgesics) and sumatriptan and similar medicines with active ingredient names ending in “-triptan” (administered to treat migraines). Taking these medicines with Brintellix may increase the risk of serotonin syndrome (see the warnings and precautions section).
• lithium (depression and mental disorder medicine) or tryptophan.
• medicines known to cause a decrease in sodium levels.
• rifampicin (tuberculosis and other infection medicine).
• carbamazepine, phenytoin (epilepsy and other disease medicine).
• warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose aspirin, and non-steroidal anti-inflammatory drugs (anticoagulants and pain-relieving medicines). These may increase the risk of bleeding.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines with active ingredient names ending in “-triptan”.
• tramadol (strong analgesic).
• mefloquine (malaria prevention and treatment medicine).
• bupropion (depression medicine also used to quit smoking).
• fluoxetine, paroxetine, and other depression medicines called SSRIs/SNRIs, tricyclics.
• St. John's Wort (Hypericum perforatum) (depression medicine).
• quinidine (heart rhythm disorder medicine).
• chlorpromazine, chlorprothixene, haloperidol (mental disorder medicines belonging to the groups called phenothiazines, thioxanthenes, or butyrophenones).

Please talk to your doctor if you are taking any of the medicines mentioned, 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 done.

Taking Brintellix with alcohol

It is not recommended to combine this medicine with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor before using this medicine.

Pregnancy

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

If you take medicines 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: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, intense reflexes, tremors, nervousness, irritability, drowsiness, 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 of pregnancy, medicines like Brintellix may increase the risk of a serious disease in the baby, called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe more quickly 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 stages 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

The ingredients in Brintellix are expected to 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 baby and the benefit of treatment for you.

Driving and operating machines

Brintellix has little or no influence on the ability to drive or operate machines. However, since dizziness has been reported, you should exercise caution when driving or operating machines at the start of treatment with Brintellix or when changing doses.

Brintellix contains ethanol

This medicine contains 85mg of alcohol (ethanol at 96%) in each ml, which is equivalent to 10.1% v/v. The amount in 1ml of this medicine is less than 3ml of beer or 1ml of wine.

The reduced amount of alcohol in this medicine has no perceptible effects.

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.

5 mg corresponds to 5 drops.

10 mg corresponds to 10 drops.

15 mg corresponds to 15 drops.

20 mg corresponds to 20 drops.

Administration Form

Brintellix can be taken with or without food.

The drops can be mixed with water, juice, or other non-alcoholic beverages. Brintellix oral drops should not be mixed with other medications.

Turn the bottle completely upside down. If no drops come out, gently tap the base of the bottle to make the drops fall.

Treatment Duration

Take Brintellix for the time your doctor tells you to.

Continue taking Brintellix even if it takes some time to start noticing 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 bottle and remaining solution 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 flushing (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 (skin redness).
• 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 section2).

Unknown frequency: 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 section2).
• headache.

• increased levels of 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 milk secretion from the breast (galactorrhea).

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

There has been an observed increase in the risk of bone fractures 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 prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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.

Once opened, the drops should be used within 8 weeks.

Medicines 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. By doing so, you will help protect the environment.

Composition of Brintellix

• The active ingredient is vortioxetine. Each drop of solution contains 1 mg of vortioxetine (as (D,L)-lactate).
• The other components are hydroxypropylbetadex, ethanol (96%) and purified water.

Appearance of the product and contents of the packaging

Oral drops in solution

Transparent solution, almost colorless to slightly yellowish.

Brintellix oral drops in solution are available in amber-colored glass bottles of 20 ml with a screw cap with a dropper (child-resistant safety closure).

Each bottle contains 15 ml of Brintellix oral drops in solution.

Holder of the marketing authorization and responsible for manufacturing

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: 10/2023

Other sources of information

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