Brintellix 20 mg/ml oral drops in solution

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Brintellix 20 mg/ml oral drops solution

vortioxetine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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. 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 broad range of depressive symptoms, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced sleep), decreased appetite, difficulty concentrating, feelings of worthlessness, loss of interest in pleasurable activities, and sensation of slowness.

2. What you need to know before taking 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 or selective MAO-A inhibitors. If you have any doubts, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 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 suffer from unstable seizure disorders/epilepsy. Seizures are a potential risk with medicines used to treat depression. Treatment should be discontinued in any patient who experiences seizures or an increase in their frequency.

• you have experienced mania.

• you have a tendency to bleed or bruise easily, or if you are pregnant (see Pregnancy, breastfeeding, and fertility).

• you have low levels of sodium in the 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 being treated with antidepressants, including vortioxetine, you may also experience feelings of aggression, agitation, anger reactions, and irritability. If this occurs, you should consult your doctor.

Suicidal thoughts and worsening of your depression

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts of harming yourself or taking your own life. These thoughts may increase when you first start taking antidepressants, as all such medicines require time to become effective—usually about two weeks, although in some cases it may take longer.

You may be more likely to have these types of thoughts:

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

Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you have thoughts of harming yourself or taking your own life, contact your doctor immediately or go directly to a hospital. It may be helpful for you to inform a family member or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.

Children and adolescents

Brintellix must not be used in pediatric patients (under 18 years of age) because 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 recently taken, or might need to take any other medicines.

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

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines for treating depression known as 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 Brintellix. After stopping Brintellix, you must wait 14 days before taking any of these medicines.
• moclobemide (a medicine for treating depression).
• selegiline, rasagiline (medicines for treating Parkinson’s disease).
• linezolid (a medicine for treating bacterial infections).
• medicines with a serotonergic effect, for example, tramadol or similar medicines (strong painkillers) and sumatriptan and similar medicines with active substance names ending in “-triptan” (used to treat migraine). Taking these medicines with Brintellix may increase the risk of serotonin syndrome (see section Warnings and precautions).
• lithium (a medicine for treating depression and mental disorders) or tryptophan.
• medicines known to cause decreased sodium levels.
• rifampicin (a medicine for treating tuberculosis and other infections).
• carbamazepine, phenytoin (medicines for treating 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 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 for preventing and treating malaria).
• bupropion (a medicine for treating depression also used to help stop smoking).
• fluoxetine, paroxetine, and other medicines for treating depression called SSRIs/SNRIs, tricyclics.
• St. John’s wort (Hypericum perforatum) (a herbal medicine for treating depression).
• quinidine (a medicine for treating heart rhythm disorders).
• chlorpromazine, chlorprothixene, haloperidol (medicines for treating mental disorders belonging to the groups called phenothiazines, thioxanthenes, or butyrophenones).

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

If you undergo a urine drug test, 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.

Taking Brintellix with alcohol

Combining this medicine with alcohol is not recommended.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

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

Ensure that your midwife and/or doctor knows that you are taking Brintellix. Medicines such as Brintellix, when taken during pregnancy—especially during the last 3 months—may increase the risk of a serious condition in the baby 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 happens to your baby, contact your midwife and/or doctor immediately.

If you take Brintellix in the late 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 be aware that you are taking Brintellix so they can advise you appropriately.

Breastfeeding

It is expected that Brintellix ingredients will pass into breast milk. Brintellix must not be used during breastfeeding. Your doctor will decide whether you should discontinue breastfeeding or stop using Brintellix, taking into account the benefit of breastfeeding 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, since side effects such as dizziness have been reported, caution is advised when performing such activities, especially at the beginning of treatment with Brintellix or when changing doses.

Brintellix contains ethanol

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

The small amount of alcohol in this medicine has no noticeable effects.

3. How to take Brintellix

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 per day or reduce it 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 once daily.

5 mg corresponds to 5 drops.

10 mg corresponds to 10 drops.

15 mg corresponds to 15 drops.

20 mg corresponds to 20 drops.

Method of administration

Brintellix can be taken with or without food.

The drops may be mixed with water, juice, or other non-alcoholic beverages. Brintellix oral drops must not be mixed with other medicines.

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

Duration of treatment

Take Brintellix for as long as your doctor advises.

Continue taking Brintellix even though it may take some time before you start to feel an improvement in your condition.

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

If you take more Brintellix than you should

If you take more Brintellix than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Take the bottle and any remaining solution with you. Do this even if you do not experience any discomfort. Symptoms of overdose may include dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, drowsiness, and flushing (reddening of the skin).

After ingestion of doses several 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 forgotten doses.

If you stop taking Brintellix

Do not stop taking Brintellix without consulting your doctor.

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

Some patients who have stopped taking Brintellix have experienced symptoms such as dizziness, headache, tingling sensations, or electric shock-like sensations (especially in the head), inability to sleep, nausea or vomiting, feeling anxious, irritability or agitation, feeling tired, or tremors. These symptoms may occur during the first week after stopping Brintellix.

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

4. Possible adverse effects

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

The adverse effects observed were mostly mild or moderate and occurred during the first two weeks of treatment. These effects were generally transient and did not require discontinuation of treatment.

The following adverse 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

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

Uncommon: may affect up to 1 in 100 people

• skin flushing (redness of the skin).
• night sweats.
• blurred vision.
• involuntary tremors (shaking).
• 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 available data

• low levels of sodium in the blood (some symptoms may include feeling dizzy, weak, confused, drowsy or very tired, or having nausea or vomiting; more serious symptoms include fainting, seizures or falls).
• serotonin syndrome (see section 2).
• allergic reactions, which may 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 make you feel dizzy or lightheaded).
• hives.
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal or vaginal bleeding).
• rash.
• sleep disorders (insomnia).
• agitation and aggression. If you experience these adverse effects, contact your doctor (see section 2).
• headache.
• increase in a hormone called prolactin in the blood.
• a constant need to move (akathisia).
• teeth grinding (bruxism).
• inability to open the mouth (trismus).
• restless legs syndrome (urge to move the legs to relieve painful or unusual sensations, which often occur at night).
• abnormal milky discharge from the breast (galactorrhoea).

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

Other adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Brintellix

• The active substance 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 medicinal product and contents of the pack

Oral drops solution

Clear, almost colourless to slightly yellowish solution.

Brintellix oral drops solution is available in 20 ml amber glass bottles with screw cap and dropper (child-resistant safety closure).

Each bottle contains 15 ml of Brintellix oral drops solution.

Marketing Authorization Holder and Manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

You can request further information regarding this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent revision of this leaflet: {MM/YYYY}

Other sources of information

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