Brand name Brintellix

Form tablets, film-coated

Active substance / Dosage

VORTIOXETINE HYDROBROMIDE

Prescription type Prescription only

ATC code

N06AX26

Registration number 043187

Manufacturer H. LUNDBECK A/S

Table of Contents

Package leaflet: Information for the patient
Brintellix 5 mg film-coated tablets
1. What Brintellix is and what it is used for
2. What you should know before taking Brintellix
3. How to take Brintellix
4. Possible side effects
5. How to store Brintellix
6. Package contents and other information
Patient information leaflet: information for the patient
Brintellix 10 mg film-coated tablets
1. What Brintellix is and what it is used for
2. What you should know before taking Brintellix
3. How to take Brintellix
4. Possible side effects
5. How to store Brintellix
6. Contents of the pack and other information
Patient Information Leaflet
Brintellix 15 mg film-coated tablets
1. What Brintellix is and what it is used for
2. What you should know before taking Brintellix
3. How to take Brintellix
4. Possible side effects
5. How to store Brintellix
6. Package contents and other information
Patient information leaflet
Brintellix 20 mg film-coated tablets
1. What Brintellix is and what it is used for
2. What you need to know before taking Brintellix
3. How to take Brintellix
4. Possible side effects
5. How to store Brintellix
6. Package contents and other information
Package leaflet: information for the patient
Brintellix 20 mg/mL oral drops, solution
1. What Brintellix is and what it is used for
2. What you should know before taking Brintellix
3. How to take Brintellix
4. Possible side effects
5. How to store Brintellix
6. Package contents and other information

Package leaflet: Information for the patient

Brintellix 5 mg film-coated tablets

Vortioxetine (Vortioxetine)
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

What Brintellix is and what it is used for
What you need to know before taking Brintellix
How to take Brintellix
Possible side effects
How to store Brintellix
Contents of the pack and other information

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 various symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced sleep), decreased appetite,
difficulty concentrating, feeling worthless, loss of interest in favourite activities, and feeling slowed down.

2. What you should know before taking Brintellix

Do not take Brintellix:

if you are allergic to vortioxetine or to 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 (MAO inhibitors) or selective MAO-A inhibitors. Ask your doctor if you are unsure.

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 “triptan”, 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 muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhoea.

you have had seizures. Your doctor will treat you cautiously if you have a history of seizures or if you have unstable seizure disorders/epilepsy. Seizures are a potential risk associated with medicines used in the treatment of depression. Treatment must be discontinued in patients who develop seizures or experience an increase in seizure frequency.
you have had manic episodes.
you tend to bleed easily or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
you have low sodium levels in your blood.
you are aged 65 years or older.
you have severe kidney disease.
you have severe liver disease or liver disease called cirrhosis.
you have or have had increased intraocular pressure or glaucoma. If you experience eye pain or blurred vision during treatment, contact your doctor.

When being treated with antidepressants, including vortioxetine, you may also experience feelings of
aggression, agitation, anger, and irritability. If this occurs, discuss it with your doctor.
Suicidal thoughts and worsening of your depression
If you are depressed and/or suffer from anxiety disorders, you may sometimes think about harming yourself or committing suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines require time to take effect, usually 2 weeks but sometimes longer.
You are more likely to have these thoughts if:

you have previously thought about killing yourself or harming yourself
you are a young adult.

Data from clinical trials have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with antidepressants.
If at any time you experience thoughts of self-harm or suicide, contact your doctor or go to hospital immediately. You may find it helpful to tell a relative or close friend that you are depressed or suffer from an anxiety disorder and ask them to read this leaflet.
You may ask them whether they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.
Children and adolescents
Brintellix must not be used in paediatric patients (under 18 years of age) as 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.
Inform your doctor if you are taking any of the following medicines:

phenelzine, iproniazide, isocarboxazide, nialamide, tranylcypromine (medicines for depression known as non-selective monoamine oxidase inhibitors, MAO inhibitors); you must not take any of these medicines together with Brintellix. If you have used

these medicines, you must wait 14 days before starting Brintellix. After stopping Brintellix, you must wait 14 days before taking these medicines.

moclobemide (a medicine for depression)
selegiline and rasagiline (medicines for Parkinson’s disease)
linezolid (an antibiotic)
medicines with serotonergic effect, e.g. tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines with active substance names ending in “triptan”, 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 for depression and mental illnesses) or tryptophan
medicines that cause low sodium levels in the blood
rifampicin (a medicine used to treat tuberculosis and other infections)
carbamazepine, phenytoin (medicines for epilepsy and other conditions)
warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to thin the blood and medicines used to relieve pain). These may increase the tendency to bleed.

Medicines that increase the risk of seizures:

sumatriptan and similar medicines with active substance names ending in “triptan”
tramadol (a strong painkiller)
mefloquine (a medicine to prevent and treat malaria)
bupropion (a medicine for depression and smoking cessation)
fluoxetine, paroxetine and other medicines for depression called SSRIs/SNRIs, tricyclics
St. John’s wort (Hypericum perforatum) (a herbal medicine for depression)
quinidine (a medicine for heart rhythm disorders)
chlorpromazine, chlorprothixene, haloperidol (medicines for mental disorders belonging to the group of so-called phenothiazines, thioxanthenes, butyrophenones)

Inform your doctor if you are taking any of the medicines listed above, as you need to know whether you are already at risk of seizures.
If you undergo urine testing for drug screening, taking Brintellix may cause false positive results for methadone when certain analytical methods are used, even if you are not taking methadone. If this occurs, a more specific test can be performed.
Brintellix and alcohol
It is not recommended to take Brintellix with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Brintellix must not be used during pregnancy unless your doctor has specifically indicated it is absolutely necessary.
If you take medicines to treat depression, including Brintellix, during the last 3 months of pregnancy, you should be aware that the following effects may occur in your newborn baby: breathing problems, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, stiff or floppy muscles, overactive reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. Contact your doctor immediately if your newborn shows any of these symptoms.
Ensure that your midwife and/or doctor know that you are taking Brintellix. Medicines such as Brintellix, when taken during pregnancy, particularly during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Brintellix near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Brintellix so they can advise you on what to do.
Breastfeeding
It is expected that components of Brintellix will pass into breast milk. Brintellix must not be taken during breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop treatment with Brintellix, based on an assessment of the benefits of breastfeeding for the child and the benefits of therapy for you.
Driving and using machines
Brintellix has no or negligible influence on the ability to drive or use machines. However, since side effects such as dizziness have been reported, caution is advised when performing such activities, especially when starting treatment with Brintellix or when changing the dose.
Brintellix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Brintellix

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Brintellix for adults under 65 years of age is 10 mg of vortioxetine taken once daily. Your doctor may increase your dose up to a maximum of 20 mg of vortioxetine per day or reduce it down to a minimum of 5 mg of vortioxetine per day, depending on your response to treatment.
For elderly patients aged 65 years and over, the initial dose is 5 mg of vortioxetine taken once daily.

Method of administration
Take one tablet with a glass of water.
The tablet may be taken with or without food.

Duration of treatment
Keep taking Brintellix for as long as your doctor recommends.
Continue taking Brintellix even if it takes some time before you notice an improvement in your condition.
Treatment should be continued for at least 6 months after you start feeling well again.

If you take more Brintellix than you should
If you take more Brintellix than prescribed, contact your doctor or the nearest hospital emergency department immediately. Bring the container and any remaining tablets with you. Do this even if you do not feel unwell. Signs of overdose may include dizziness, nausea, diarrhoea, stomach discomfort, itching all over the body, drowsiness, and flushing.
After taking doses many times higher than prescribed, seizures and a rare condition called serotonin syndrome have been reported.

If you forget to take Brintellix
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Brintellix
Do not stop taking Brintellix without talking to your doctor first.
Your doctor may decide to gradually reduce your dose before stopping treatment completely.
Some patients who have stopped treatment with Brintellix have reported symptoms such as dizziness, headache, sensations like pins and needles or electric shocks (especially in the head), inability to sleep, feeling unwell or nausea, anxiety, irritability or agitation, tiredness, or tremor. These symptoms may occur within the first week after stopping Brintellix.

If you have any questions about how to use 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 side effects observed have been mild to moderate and occurred within the first two
weeks of treatment. Reactions were usually temporary and did not lead to discontinuation of therapy.
The side effects listed below have been reported with 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 all over the body
abnormal dreams
increased sweating
indigestion

Uncommon: may affect up to 1 in 100 people

flushing
night sweats
blurred vision
involuntary shaking (tremor)

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

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

Not known: frequency cannot be estimated from the available data

low levels of sodium in the blood (symptoms may include dizziness, weakness, confusion, drowsiness or increased fatigue, or feeling sick or vomiting; more severe symptoms include fainting, seizures or falls)
serotonin syndrome (see section 2)
allergic reactions, even severe ones, causing swelling of the face, lips, tongue and throat, breathing or swallowing difficulties and/or sudden drop in blood pressure (dizziness or feeling faint)
hives
excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal or vaginal bleeding)
skin redness
sleep disorders (insomnia)
agitation and aggression. If you experience these side effects, contact your doctor (see section 2)
headache
increased levels of a hormone called prolactin in the blood
constant restlessness causing an urge to move (akathisia)
teeth grinding (bruxism)
inability to open the mouth (trismus)
restless legs syndrome (urge to move the legs to relieve painful or strange sensations, often occurring at night)
abnormal milk secretion from the breast (galactorrhoea)

An increased risk of bone fractures has been observed in patients taking this type of medicine.
An increased risk of sexual dysfunction has been observed with the 20 mg dose, and in some patients this side effect has also been observed with lower doses.

Additional side effects in children and adolescents
Side effects observed with vortioxetine in children and adolescents were similar to those seen in adults, except for abdominal pain-related events, which were observed more frequently than in adults, and suicidal thoughts, which were observed more frequently in adolescents than in adults.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brintellix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP or Exp.) stated on the
packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Brintellix contains

The active substance is vortioxetine. Each film-coated tablet contains 5 mg of vortioxetine (as hydrobromide).
The other components are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), and red iron oxide (E172).

Description of the appearance of Brintellix and package contents
Film-coated tablets, almond-shaped, 5 x 8.4 mm, pink (tablets), marked with “TL” on one side and “5” on the other side.
Brintellix 5 mg film-coated tablets are available in blisters of 14, 28, 56 x 1, 98, 98 x 1, 126 (9x14), 490 (5 x (98 x 1)) tablets and in bottles containing 100 and 200 tablets.
The pack sizes of 56 x 1, 98 x 1 and 490 film-coated tablets are supplied in blisters divided into unit doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Lundbeck S.A./N.V. H. Lundbeck A/S
Tél/Tel: +32 2 535 7979 Tel: +45 36301311 (Denmark)
[email protected]

България Luxembourg/Luxemburg
Lundbeck Export A/S Representative Office Lundbeck S.A.
Tel: +359 2 962 4696 Tél: +32 2 535 7979

Česká republika Magyarország
Lundbeck Česká republika s.r.o. Lundbeck Hungaria Kft.
Tel: +420 225 275 600 Tel: +36 1 4369980

Danmark Malta
Lundbeck Pharma A/S H. Lundbeck A/S
Tlf: +45 4371 4270 Tel: +45 36301311

Deutschland Nederland
Lundbeck GmbH Lundbeck B.V.
Tel: +49 40 23649 0 Tel: +31 20 697 1901

Eesti Norge
Lundbeck Eesti AS H. Lundbeck AS
Tel: +372 605 9350 Tlf: +47 91 300 800

Ελλάδα Österreich
Lundbeck Hellas S.A. Lundbeck Austria GmbH
Τηλ: +30 210 610 5036 Tel: +43 1 253 621 6033

España Polska
Lundbeck España S.A. Lundbeck Poland Sp. z o.o.
Tel: +34 93 494 9620 Tel.: +48 22 626 93 00

France Portugal
Lundbeck SAS Lundbeck Portugal Lda
Tél: +33 1 79 41 29 00 Tel: +351 21 00 45 900

Hrvatska România
Lundbeck Croatia d.o.o. Lundbeck Romania SRL
Tel.: +385 1 6448263 Tel: +40 21319 88 26

Ireland Slovenija
Lundbeck (Ireland) Limited Lundbeck Pharma d.o.o.
Tel: +353 1 468 9800 Tel.: +386 2 229 4500

Ísland Slovenská republika
Vistor hf. Lundbeck Slovensko s.r.o.
Tel: +354 535 7000 Tel: +421 2 5341 42 18

Italia Suomi/Finland
Lundbeck Italia S.p.A. Oy H. Lundbeck Ab
Tel: +39 02 677 4171 Puh/Tel: +358 2 276 5000

Κύπρος Sverige
Lundbeck Hellas A.E. H. Lundbeck AB
Τηλ.: +357 22490305 Tel: +46 4069 98200

Latvija United Kingdom (Northern Ireland)
H. Lundbeck A/S Lundbeck (Ireland) Limited
Tel: +45 36301311 (Denmark) Tel: +353 1 468 9800
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Patient information leaflet: information for the patient

Brintellix 10 mg film-coated tablets

vortioxetine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms appear identical to yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist (see section 4).

Contents of this leaflet:

What Brintellix is and what it is used for
What you need to know before taking Brintellix
How to take Brintellix
Possible side effects
How to store Brintellix
Contents of the pack and other information

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 for the treatment of major depressive episodes in adults.
Brintellix has been shown to reduce the various symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced sleep), decreased appetite, difficulty concentrating, feeling worthless, loss of interest in usual activities, and feeling slowed down.

2. What you should know before taking Brintellix

Do not take Brintellix:
if you are allergic to vortioxetine or to 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 (MAOIs) or selective MAO-A inhibitors. Ask your doctor if you are unsure.

Warnings and precautions
Talk to your doctor or pharmacist before taking Brintellix if:

you are taking medicines with a so-called serotoninergic effect such as:
tramadol and similar medicines (strong painkillers)
sumatriptan and similar medicines with active substance names ending in “triptan”, 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 muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhoea.

you have had seizures. Your doctor will treat you cautiously if you have a history of seizures or if you have unstable seizure disorders/epilepsy. Seizures are a potential risk associated with medicines used in the treatment of depression. Treatment must be discontinued in patients who develop seizures or experience an increase in seizure frequency.
you have had manic episodes.
you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
you have low levels of sodium in your blood.
you are aged 65 years or older.
you have severe kidney disease.
you have severe liver disease or a liver condition called cirrhosis.
you have or have had increased intraocular pressure or glaucoma. If you experience eye pain or blurred vision during treatment, contact your doctor.

If you are being treated with antidepressants, including vortioxetine, you may experience feelings of aggression,
agitation, anger, and irritability. If this occurs, discuss it with your doctor.

Suicidal thoughts and worsening of your depression
If you are depressed and/or suffer from anxiety disorders, you may sometimes think about harming yourself or committing suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines require time to take effect—usually 2 weeks, but sometimes longer.
You are more likely to have these thoughts if:
you have previously considered suicide or self-harm
you are a young adult.
Data from clinical trials have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with antidepressants.
If at any time you experience thoughts of self-harm or suicide, contact your doctor or go to hospital immediately.
You may find it helpful to inform a family member or close friend that you are depressed or suffer from an anxiety disorder and ask them to read this leaflet.
You may ask them whether they notice your depression or anxiety worsening, or if they are concerned about changes in your behaviour.

Children and adolescents
Brintellix must not be used in paediatric patients (under 18 years of age) as 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.
Inform your doctor if you are taking any of the following medicines:

phenelzine, iproniazide, isocarboxazide, nialamide, tranylcypromine (medicines for depression called non-selective monoamine oxidase inhibitors, MAOIs); you must not
take any of these medicines together with Brintellix. If you have used any of these medicines, you must
wait 14 days before starting Brintellix. After stopping Brintellix, you must wait 14
days before taking any of these medicines.
moclobemide (a medicine for depression)
selegiline and rasagiline (medicines for Parkinson’s disease)
linezolid (an antibiotic)
medicines with a serotoninergic effect, e.g. tramadol and similar medicines (strong painkillers), and sumatriptan and similar medicines with active substance names ending in “triptan”, 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 for depression and mental illnesses) or tryptophan
medicines that cause low sodium levels in the blood
rifampicin (a medicine used to treat tuberculosis and other infections)
carbamazepine, phenytoin (medicines for epilepsy and other conditions)
warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (medicines used to thin the blood and medicines used to relieve pain). These may increase the tendency to bleed.

Medicines that increase the risk of seizures:

sumatriptan and similar medicines with active substance names ending in “triptan”
tramadol (a strong painkiller)
mefloquine (a medicine to prevent and treat malaria)
bupropion (a medicine for depression and smoking cessation)
fluoxetine, paroxetine, and other medicines for depression called SSRIs/SNRIs, tricyclics
St John’s wort (Hypericum perforatum) (a herbal medicine for depression)
quinidine (a medicine for heart rhythm disorders)
chlorpromazine, chlorprothixene, haloperidol (medicines for mental disorders belonging to the groups known as phenothiazines, thioxanthenes, and butyrophenones)

Inform your doctor if you are taking any of the medicines listed above, as you may already be at risk of seizures.
If you undergo urine drug screening tests, taking Brintellix may cause false positive results for methadone when certain testing methods are used, even if you are not taking methadone. If this occurs, a more specific test can be performed.

Brintellix and alcohol
It is not recommended to take Brintellix with alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Pregnancy
Brintellix must not be used during pregnancy unless your doctor has specifically advised it is absolutely necessary.
If you take medicines to treat depression, including Brintellix, during the last 3 months of pregnancy, you should be aware that the following effects may occur in your newborn baby: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, stiff or floppy muscles, overactive reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. Contact your doctor immediately if your newborn shows any of these symptoms.
Ensure that your midwife and/or doctor know that you are taking Brintellix. Medicines like Brintellix, when taken during pregnancy—particularly during the last 3 months—may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Brintellix near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Brintellix so they can advise you on appropriate measures.

Breastfeeding
Components of Brintellix are expected to pass into breast milk. Brintellix must not be taken during breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop treatment with Brintellix, based on an assessment of the benefits of breastfeeding for the child and the benefits of therapy for you.

Driving and using machines
Brintellix has no or negligible influence on the ability to drive or use machines. However, since side effects such as dizziness have been reported, caution is advised when performing such activities, especially when starting treatment with Brintellix or when changing the dose.

Brintellix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Brintellix

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Brintellix for adults under 65 years of age is 10 mg of vortioxetine taken once daily. Your doctor may increase the dose up to a maximum of 20 mg of vortioxetine per day or reduce it down to a minimum of 5 mg of vortioxetine per day, depending on your response to treatment.
For elderly patients aged 65 years and over, the initial dose is 5 mg of vortioxetine taken once daily.

Method of administration
Take one tablet with a glass of water.
The tablet may be taken with or without food.

Duration of treatment
Continue taking Brintellix for as long as your doctor recommends.
Keep taking Brintellix even if it takes some time before you start to feel better.
Treatment should be continued for at least 6 months after you have recovered.

If you take more Brintellix than you should
If you take more Brintellix than prescribed, contact your doctor or the nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Do this even if you do not have any symptoms. Signs of overdose may include dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, drowsiness, and flushing.
After taking doses many times higher than the prescribed dose, seizures and a rare condition called serotonin syndrome have been reported.

If you forget to take Brintellix
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Brintellix
Do not stop taking Brintellix without first discussing it with your doctor.
Your doctor may decide to gradually reduce the dose before stopping this treatment completely.
Some patients who have discontinued treatment with Brintellix have reported symptoms such as dizziness, headache, sensations like pins and needles or electric shocks (especially in the head), inability to sleep, feeling unwell or vomiting, anxiety, irritability or agitation, fatigue, or tremor. These symptoms may occur within the first week after stopping Brintellix.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In general, the side effects observed have been mild to moderate and occurred within the first two weeks of treatment. Reactions were usually temporary and did not lead to discontinuation of therapy.
The side effects listed below have been reported with 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 all over the body
abnormal dreams
increased sweating
indigestion

Uncommon: may affect up to 1 in 100 people

flushing
night sweats
blurred vision
involuntary shaking (tremor)

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

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

Not known: frequency cannot be estimated from the available data

low levels of sodium in the blood (symptoms may include feeling dizzy, weakness, confusion, drowsiness or increased fatigue, or feeling nauseous or vomiting; more severe symptoms include fainting, seizures or falls)
serotonin syndrome (see section 2)
allergic reactions, including severe reactions causing swelling of the face, lips, tongue and throat, difficulty breathing or swallowing and/or sudden drop in blood pressure (dizziness or feeling faint)
hives
excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal or vaginal bleeding)
skin redness
sleep disorders (insomnia)
agitation and aggressiveness. If you experience these side effects, contact your doctor (see section 2)
headache
increased levels of a hormone called prolactin in the blood
persistent restlessness leading to an urge to move (akathisia)
teeth grinding (bruxism)
inability to open the mouth (trismus)
restless legs syndrome (an urge to move the legs to relieve painful or strange sensations, often occurring at night)
abnormal milk secretion from the breast (galactorrhea)

An increased risk of bone fractures has been observed in patients taking this type of medicine.
An increased risk of sexual dysfunction has been observed with the 20 mg dose, and in some patients this side effect has been observed at lower doses.
Additional side effects in children and adolescents
Side effects observed with vortioxetine in children and adolescents were similar to those observed in adults, except for abdominal pain-related events, which were observed more frequently than in adults, and suicidal thoughts, which were observed more frequently in adolescents than in adults.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brintellix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP or Exp.) stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Brintellix contains
The active substance is vortioxetine. Each film-coated tablet contains 10 mg of vortioxetine (as hydrobromide).
The other components are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), and yellow iron oxide (E172).

Description of the appearance of Brintellix and contents of the pack
Film-coated, almond-shaped tablets, 5 x 8.4 mm, yellow in colour, marked with “TL” on one side and “10” on the other side.
Brintellix 10 mg film-coated tablets are available in blisters of 7, 14, 28, 56, 56 x 1, 98, 98 x 1, 126 (9x14), 490 (5 x (98 x 1)) tablets and in bottles containing 100 and 200 tablets.
The packs containing 56 x 1, 98 x 1 and 490 film-coated tablets are supplied in unit-dose divisible blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 535 797 9

Lietuva
H. Lundbeck A/S
Tel: +45 36301311 (Denmark)
[email protected]

България
Lundbeck Export A/S Representative Office
Tel: +359 2 962 4696

Luxembourg/Luxemburg
Lundbeck S.A.
Tél: +32 2 535 7979

Česká republika
Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600

Magyarország
Lundbeck Hungaria Kft.
Tel: +36 1 4369980

Danmark
Lundbeck Pharma A/S
Tlf: +45 4371 4270

Malta
H. Lundbeck A/S
Tel: +45 36301311

Deutschland
Lundbeck GmbH
Tel: +49 40 23649 0

Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti
Lundbeck Eesti AS
Tel: +372 605 9350

Norge
H. Lundbeck AS
Tlf: +47 91 300 800

Ελλάδα
Lundbeck Hellas S.A.
Τηλ: +30 210 610 5036

Österreich
Lundbeck Austria GmbH
Tel: +43 1 253 621 6033

España
Lundbeck España S.A.
Tel: +34 93 494 9620

Polska
Lundbeck Poland Sp. Z o.o.
Tel.: +48 22 626 93 00

France
Lundbeck SAS
Tél: +33 1 79 41 29 00

Portugal
Lundbeck Portugal Lda
Tel: +351 21 00 45 900

Hrvatska
Lundbeck Croatia d.o.o.
Tel.: +385 1 6448263

România
Lundbeck Romania SRL
Tel: +40 21319 88 26

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Slovenija
Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18

Italia
Lundbeck Italia S.p.A.
Tel: +39 02 677 4171

Suomi/Finland
Oy H. Lundbeck Ab
Puh/Tel: +358 2 276 5000

Κύπρος
Lundbeck Hellas A.E
Τηλ.: +357 22490305

Sverige
H. Lundbeck AB
Tel: +46 4069 98200

Latvija
H. Lundbeck A/S
Tel: +45 36301311 (Denmark)

United Kingdom (Northern Ireland)
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient Information Leaflet

Brintellix 15 mg film-coated tablets

Vortioxetine (Vortioxetine)
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

What Brintellix is and what it is used for
What you need to know before taking Brintellix
How to take Brintellix
Possible side effects
How to store Brintellix
Contents of the pack and other information

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 for the treatment of major depressive episodes in adults.
Brintellix has been shown to reduce the various symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced sleep), decreased appetite,
difficulty concentrating, feeling worthless, loss of interest in usual activities, and feeling slowed down.

2. What you should know before taking Brintellix

Do not take Brintellix:

if you are allergic to vortioxetine or to 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 (MAOIs) or selective MAO-A inhibitors. Ask your doctor if you are unsure.

Warnings and precautions
Talk to your doctor or pharmacist before taking Brintellix if:

you are taking medicines with a so-called serotoninergic effect such as:
tramadol and similar medicines (strong painkillers)
sumatriptan and similar medicines with active substance names ending in “triptan” used to treat migraine.

Taking these medicines together with Brintellix may increase the risk of developing Serotonin Syndrome.
This syndrome may be associated with hallucinations, involuntary muscle contractions, rapid heartbeat,
high blood pressure, fever, nausea, and diarrhea.
You have had seizures.
Your doctor will treat you cautiously if you have had previous seizures or if you have unstable seizure/epilepsy disorders. Seizures are a potential risk associated with medicines used in the treatment of depression. Treatment must be discontinued in patients who develop seizures or experience an increase in seizure frequency.
You have had manic episodes.
You have a tendency to bleed easily or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
You have low sodium levels in your blood.
You are aged 65 years or older.
You have severe kidney disease.
You have severe liver disease or a liver condition called cirrhosis.
You have or have had increased eye pressure or glaucoma. If you experience eye pain or blurred vision during treatment, contact your doctor.
If you are being treated with antidepressants, including vortioxetine, you may experience feelings of aggression, agitation, anger, and irritability. If this occurs, discuss it with your doctor.
Suicidal thoughts and worsening of your depression
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts about harming yourself or committing suicide. These thoughts may increase at the beginning of antidepressant treatment, as these medicines require time to take effect, usually 2 weeks but sometimes longer.
You are more likely to have these thoughts if:
you have previously thought about killing yourself or harming yourself
you are a young adult.
Data from clinical trials have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with antidepressants.
If at any time you experience thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. It may help to inform a family member or close friend that you are depressed or suffer from an anxiety disorder and ask them to read this leaflet.
You may ask them to monitor whether your depression or anxiety is worsening or if they are concerned about changes in your behaviour.
Children and adolescents
Brintellix must not be used in paediatric patients (under 18 years of age) as efficacy has not been demonstrated. The safety of Brintellix in children and adolescents aged between 7 and 17 years is described in section 4.
Other medicines and Brintellix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

phenelzine, iproniazide, isocarboxazide, nialamide, tranylcypromine (medicines for the treatment of depression called non-selective monoamine oxidase inhibitors, MAOIs); you must not take any of these medicines together with Brintellix. If you have used these medicines, you must wait 14 days before starting Brintellix. After stopping Brintellix, you must wait 14 days before taking these medicines.
moclobemide (a medicine for the treatment of depression)
selegiline and rasagiline (medicines for the treatment of Parkinson’s disease)
linezolid (an antibiotic)
medicines with a serotoninergic effect, e.g. tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines with active substance names ending in “triptan” 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 for the treatment of depression and mental illnesses) or tryptophan
medicines that cause low sodium levels in the blood
rifampicin (a medicine used to treat tuberculosis and other infections)
carbamazepine, phenytoin (medicines for the treatment of epilepsy and other conditions)
warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to thin the blood and medicines used to relieve pain). These may increase the tendency to bleed.

Medicines that increase the risk of seizures:

sumatriptan and similar medicines with active substance names ending in “triptan”
tramadol (a strong painkiller)
mefloquine (a medicine to prevent and treat malaria)
bupropion (a medicine for the treatment of depression and to stop smoking)
fluoxetine, paroxetine and other medicines for the treatment of depression called SSRIs/SNRIs, tricyclics
St John’s wort ( Hypericum perforatum ) (a herbal medicine for the treatment of depression)
quinidine (a medicine for the treatment of heart rhythm disorders)
chlorpromazine, chlorprothixene, haloperidol (medicines for the treatment of mental disorders belonging to the group of so-called phenothiazines, thioxanthenes, butyrophenones)

Inform your doctor if you are taking any of the above-mentioned medicines, as you need to know whether you are already at risk of seizures.
If you undergo urine testing for drug screening, taking Brintellix may cause false positive results for methadone when certain analytical methods are used, even if you are not taking methadone. If this occurs, a more specific test can be performed.
Brintellix and alcohol
It is not recommended to take Brintellix with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Brintellix must not be used during pregnancy unless your doctor has specifically indicated it is absolutely necessary.
If you take medicines to treat depression, including Brintellix, during the last 3 months of pregnancy, you should be aware that the following effects may occur in your newborn: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, rigid or floppy muscles, overactive reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. Contact your doctor immediately if your newborn shows any of these symptoms.
Ensure that your midwife and/or doctor know that you are taking Brintellix. Medicines such as Brintellix, when taken during pregnancy, particularly during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Brintellix near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Brintellix so they can advise you on appropriate measures.
Breastfeeding
Components of Brintellix are expected to pass into breast milk. Brintellix must not be taken during breastfeeding. Your doctor will decide whether you should discontinue breastfeeding or discontinue Brintellix therapy, based on an assessment of the benefits of breastfeeding for the child and the benefits of therapy for you.
Driving and using machines
Brintellix has no or negligible influence on the ability to drive or use machines. However, since side effects such as dizziness have been reported, caution is advised when performing such activities, especially when starting Brintellix therapy or changing the dose.
Brintellix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Brintellix

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

For elderly patients aged 65 years or older, the initial dose is 5 mg of vortioxetine taken once daily.

Method of administration
Take one tablet with a glass of water.
The tablet may be taken with or without food.

Duration of treatment
Continue taking Brintellix for as long as your doctor recommends.
Keep taking Brintellix even if it takes some time before you start to feel better.
Treatment should be continued for at least 6 months after you have recovered.

If you take more Brintellix than you should
If you take more Brintellix than prescribed, contact your doctor or the nearest hospital emergency department immediately. Bring the container and any remaining tablets with you. Do this even if you do not have any symptoms of discomfort. Signs of overdose may include dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, drowsiness, and flushing.
After taking doses many times higher than prescribed, seizures and a rare condition called serotonin syndrome have been reported.

If you forget to take Brintellix
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Brintellix
Do not stop taking Brintellix without first discussing it with your doctor.
Your doctor may decide to gradually reduce the dose before stopping this treatment completely.
Some patients who have discontinued Brintellix therapy have reported symptoms such as dizziness, headache, sensations like pins and needles or electric shocks (especially in the head), inability to sleep, feeling unwell or nausea, anxiety, irritability or agitation, tiredness, or tremor. These symptoms may occur within the first week after stopping Brintellix.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In general, the side effects observed have been mild to moderate and occurred within the first two weeks of treatment. Reactions were usually temporary and did not lead to discontinuation of therapy.
The side effects listed below have been reported with 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 all over the body
abnormal dreams
increased sweating
indigestion

Uncommon: may affect up to 1 in 100 people

flushing
night sweats
blurred vision
involuntary shaking (tremor)

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

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

Not known: frequency cannot be estimated from the available data

low levels of sodium in the blood (symptoms may include feeling dizzy, weak, confused, unusually sleepy or tired, or feeling sick or vomiting; more severe symptoms include fainting, seizures or falls)
serotonin syndrome (see section 2)
allergic reactions, even severe, causing swelling of the face, lips, tongue and throat, breathing or swallowing difficulties and/or sudden drop in blood pressure (dizziness or feeling faint)
hives
excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal or vaginal bleeding)
skin redness
sleep disturbances (insomnia)
agitation and aggression. If you experience these side effects, contact your doctor (see section 2)
headache
increased levels of a hormone called prolactin in the blood
constant restlessness causing an urge to move (akathisia)
teeth grinding (bruxism)
inability to open the mouth (trismus)
restless legs syndrome (urge to move the legs to relieve painful or strange sensations, often occurring at night)
abnormal milk production from the breast (galactorrhea)

An increased risk of bone fractures has been observed in patients taking this type of medicine.
An increased risk of sexual dysfunction has been observed with the 20 mg dose, and in some patients this side effect has also been observed with lower doses.

Additional side effects in children and adolescents
Side effects observed with vortioxetine in children and adolescents were similar to those observed in adults, except for abdominal pain-related events, which were observed more frequently than in adults, and suicidal thoughts, which were observed more frequently in adolescents than in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brintellix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP or Exp.) stated on the
packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Brintellix contains
The active substance is vortioxetine. Each film-coated tablet contains 15 mg of vortioxetine (as hydrobromide).
The other components are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Brintellix and package contents
Film-coated, almond-shaped tablets, 5 x 8.4 mm, orange (tablets), marked with "TL" on one side and "15" on the other side.
Brintellix 15 mg film-coated tablets are available in blisters of 14, 28, 56, 56 x 1, 98, 98 x 1, 490 (5 x (98 x 1)) tablets and in bottles of 100 and 200 tablets.
The packs of 56 x 1, 98 x 1 and 490 film-coated tablets are supplied in blisters divided into unit doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Lundbeck S.A./N.V. H. Lundbeck A/S
Tél/Tel: +32 2 535 797 9 Tel: +45 36301311(Denmark)
[email protected]