BRINTELLIX 15 mg FILM-COATED TABLETS

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 monoamine oxidase inhibitors (MAOIs) or reversible MAO-A inhibitors. If in doubt, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Brintellix if:

• you are taking medicines with a serotonergic effect, such as:

tramadol and similar medicines (strong painkillers).

• sumatriptan and similar medicines, with active ingredient names ending in "-triptan" (used to treat migraine).

Taking these medicines with Brintellix may increase the risk of serotonin syndrome. This syndrome can be associated with hallucinations, involuntary jerks, 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 unstable/epileptic seizure 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 seizure frequency.

• you have had mania.

• you have a tendency to bleed or bruise easily or if you are pregnant (see "Pregnancy, breast-feeding 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 increased eye pressure or glaucoma. If you experience eye pain and blurred vision during treatment, contact your doctor.

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

Suicidal thoughts and worsening of your depression

If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as these medicines take time to start working, usually around 2 weeks, but sometimes longer.

You are more likely to have these thoughts:

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

Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 with psychiatric disorders who were treated with an antidepressant.

If at any time you 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 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 has got worse, or if they are worried about changes in your behavior.

Children and adolescents

Brintellix should not be used in patients under 18 years of age because it has not been shown to be effective. The safety of Brintellix in children and adolescents aged 7 to 17 years is described in section 4.

Taking Brintellix with other medicines

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 (non-selective monoamine oxidase inhibitors); you must not take any of these medicines with Brintellix. If you have taken any of these medicines, you must wait 14 days before starting to take Brintellix. After stopping Brintellix, you must wait 14 days before taking any of these medicines.

• moclobemide (a medicine for depression).
• selegiline, rasagiline (medicines for Parkinson's disease).
• linezolid (an antibiotic).
• medicines with a serotonergic effect, such as tramadol or similar medicines (strong painkillers) and sumatriptan and similar medicines with active ingredient names ending in "-triptan" (used to treat migraine). Taking these medicines with Brintellix may increase the risk of serotonin syndrome (see section 2).
• lithium (a medicine for depression and mental disorders) or tryptophan.
• medicines known to cause decreased sodium levels.
• rifampicin (an antibiotic for tuberculosis and other infections).
• carbamazepine, phenytoin (a medicine for epilepsy or other conditions).
• warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (anticoagulants and medicines used to relieve pain). 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 (a strong painkiller).
• mefloquine (a medicine to prevent and treat malaria).
• bupropion (a medicine for depression, also used to help stop smoking).

• fluoxetine, paroxetine, and other medicines for depression called SSRIs/SNRIs, tricyclics.
• St. John's Wort (Hypericum perforatum) (a medicine for depression).
• quinidine (a medicine for heart rhythm disorders).

• chlorpromazine, chlorprothixene, haloperidol (medicines for mental disorders belonging to the groups called phenothiazines, thioxanthenes, or butyrophenones).

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

If you are given a urine test, taking Brintellix may cause positive results for methadone when some test methods are used, even if 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, 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 your doctor considers it absolutely necessary.

If you take medicines for depression, including Brintellix, during the last 3 months of pregnancy, you should be aware that the following effects may be seen in the newborn: breathing difficulties, blue discoloration of the skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, exaggerated reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep disturbances. If your baby experiences any of these symptoms, contact your doctor immediately.

Make sure your midwife and/or doctor know you are taking Brintellix. When taken during pregnancy, especially in the last 3 months, medicines like Brintellix may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start 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 in the last trimester 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 you are taking Brintellix so they can advise you.

Breast-feeding

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

Driving and using machines

Brintellix has little or no influence on the ability to drive or use machines. However, as dizziness has been reported, caution is recommended during these activities at the start of treatment with Brintellix or when changing dose.

Brintellix contains sodium

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

3. How to take Brintellix

Follow exactly the instructions of your doctor for taking this medicine.

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

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

For elderly patients aged 65 years or older, the initial dose is 5 mg of vortioxetine 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 tells you.

Continue taking Brintellix even if it takes some time to start feeling better.

You should continue treatment for at least 6 months after you feel better.

If you take more Brintellix than you should

If you take more Brintellix than you have been prescribed, contact your doctor or go to the nearest hospital emergency department immediately. Take the pack and any remaining tablets with you. Do this even if you do not feel any symptoms. Symptoms in case of overdose are: dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, sleepiness, and flushing (redness of the skin).

After taking doses several times higher than the prescribed dose, seizures (convulsions) 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 forgotten doses.

If you stop taking Brintellix

Do not stop taking Brintellix without consulting your doctor.

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

Some patients who have stopped taking Brintellix have experienced symptoms such as dizziness, headache, sensation of tingling or sensations similar to electric shocks (mainly in the head), inability to sleep, nausea, or vomiting, anxiety, irritability, or restlessness, feeling tired or trembling. These symptoms may appear in 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.

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

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

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

• flushing (redness of the skin).
• night sweats.
• blurred vision.
• involuntary jerks (tremors).
• hallucinations (seeing, hearing, or feeling things that are not there).

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 the available data

• low sodium levels in the blood (some symptoms may be dizziness, weakness, confusion, drowsiness, or excessive tiredness, or nausea and 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 a sudden drop in blood pressure (which can make you feel dizzy or faint).

• hives.

• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding, and vaginal bleeding).
• rash.
• 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.
• a constant need to move (akathisia).
• grinding your teeth (bruxism).
• inability to open your mouth (trismus).
• restless legs syndrome (an urge to move your legs to stop unpleasant sensations, often occurring at night).

secreting milk from the breast (galactorrhea).

A higher risk of sexual dysfunction has been reported 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 medicine.

Other side effects in children and adolescents

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

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Brintellix

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Package Contents and Additional Information

Brintellix Composition

• The active ingredient is vortioxetine. Each film-coated tablet contains 15 mg of vortioxetine (as hydrobromide).

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

Product Appearance and Package Contents

Film-coated tablet (tablet), orange in color and almond-shaped (5 x 8.4 mm), engraved with "TL" on one side and "15" on the other.

Brintellix 15 mg film-coated tablets are available in blisters of 14, 28, 56, 56x1, 98, 98x1, 490 (5 x (98x1)) tablets and in packs of 100 and 200 tablets.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

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

Date of the Last Revision of this Leaflet:{MM/YYYY}

Other Sources of Information

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