InfoCons Consumer Protection informs you – Brintellix – Package Leaflet

Before anything else

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 h ave any further questions, ask your doctor or pharmacist.
• This medicine ha s been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Brintellix is and what it is used for

Brintellix contains the active substance vortioxetine. Itbelongs to a group o f medicines called antidepressa nts.

Brintellix is used to treat major depressive episodes in a dults.

Brintellix has been shown to reduce the broad range of depressive symptoms, including sadness, inner tension (feeling anxious), sleep disturbances (reduc ed sleep), reduced appetite, di fficulty in concentrating, feelings of worthlessness, loss of in terest in favourite activities, feeling of being slowed down .

⚠️ 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 non -selective monoamine oxidase inhibitors or selective MAO -A inhibitors . Ask your doctor if you are uncertai n.

Warnings and precautions

Talk to your doctor or pharmacist before taking Brintellix if you:

• are taking medicines with a so -called serotonergic effe ct, such as :
• tramadol and similar medicines (strong painkiller s).
• sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine ). v.

77.0 REG_00028683 106Taking these medic ines together with Brintellix may increase the risk of serot onin syndrome.

This syndrome may be associated with hallucinations, involuntary twitching, accelerate d heartbeat, high blood pressur e, fever, nausea and diarrhoea.

• have had fits (seizures) .

Your doctor will treat you cautiously if you have a history of f its or have unstable fit disorders/ep ilepsy. Fits are a potential risk with medicines used to treat d epression. Treatment should be d iscontinued in any patient who develops fits or where there is a n increase in the frequency of fits.

• have had mania .
• have a tendency to bleed or bruise easily , or if you are pregnant (See ‘Pregnancy, breast – feeding and fe rtility’).
• have low sodium leve l in the blood.
• are 65 years of age or older .
• have a severe kidn ey disease.
• have a severe liver disease or a liver disease called cirrhos is.
• have or previously have had increased pressure in the eye or glaucoma. If your eyes become painful and you develop blurred vision during treatment, contact your doctor.

When you are on antidepressant treatment, including vortioxetine, yo u may also experience feelings of aggression, agitation, anger and irritability. If this occurs, you should talk to your doctor.

Thoughts of suicide and worsening of your depression If you are depressed and/or have anxiety disorders you can sometimes ha ve thoughts of harming or killing yourself. These may be increased when first starting antidepressant s, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this if you :

• have pre viously had thoughts about killing or harming yourself.
• are a young adult.

Information from clinic al trials has shown an increase d risk of suicidal behaviour in adults aged less than 25 years w ith psychiatric conditions who were treated with an antidepr essant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. Yo u may find it helpful to tell a relative or close friend that yo u 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 is gettin g worse, or if they are worried about changes in your behaviour.

Children and adolescents

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

Other medicines and Brintellix

Tellyour doctor or pharmacist if you are t aking, have recently taken or m ight take any other medicines.

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

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called non -selective monoami ne oxidase inhibitors )you must not take any of these medicines together with Brintellix. I if you have taken any of these medicines ,you will need to v.

77.0 REG_00028683 107wait 14 days before you start taking Brintellix . After stopping Brintellix ,you must allow 14 days before taking any of these m edicines.

• moclobemide ( a medicine to treat depression) .
• selegiline and rasagiline (medicine sto treat Parkinson’s disease) .
• linezolid (a medicine to treat bacterial infections ).
• medicinal produc ts with serotonergic effect e.g. tramad ol and similar medici nes (stron g painkillers) and sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). Taking these medicines together with Brintellix may increa se the risk of serotonin syndrome (see section warnings and precaution s)
• lithium (a medicine to treat depression an d mental disorders) or tryptophan .
• medicines known to cause low sodium level.
• rifampicin (a medicine to treat tuberculosis and other infections).
• carbamazepine, phenytoin (medici nes to treat ep ilepsy or other illness).
• warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose ac etylsalicylic acid and non-steroidal anti -inflammatory drugs (blood thinning medicines and medicine s used for pain re lief). These may increase bleeding -tendency .

Medicines that increase the risk of fits:

• sumatriptan and similar medicines with active subst ance names ending in “triptans” .
• tramadol (a strong painkiller) .
• mefloquine (a medicine to prevent and treat malaria ).
• bupropion (a medicine to treat depression also used to wean from smoking) .
• fluoxetine, paroxetine and other medicines to treat depressi on called SSRI/SNRIs, tricyclics .
• St John’s wort(hypericum perforatum )(a medicine to treat depres sion) .
• quinidine ( a med icine to treat heart rhythm disorders) .
• Chlorpromazine, chlorprothixene, haloperidol ( medicines to treat mental disorders and belong t o the group called phenothiazines, thioxanthenes ,butyrophenones ).

Please tell your doctor if you are taking any of the medicine sabove, since your doctor needs to know if you already are at risk for seizure.

If you are having a urine drug screen, takin g Brintellix may cause positive results for methadone when some test methods are used, even though you may not be taking methadone . If this happens, a more specific test can be performed.

Brintellix with alcohol Combining this medicine with alcohol is no t advisable.

Pregnancy ,breast -feeding and fertility If you are pregnant or breast -feeding, think you may be pregna nt or are pla nning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Brintellix should not be used during pregnancy unless the doctor says it is absolutely necessary.

If you take medicine to treat depres sion,including Brintellix,during the last 3 months of your pregnancy ,you should be aware that the following effects may be seen in your newborn baby: trou ble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, lo w blood sugar, sti ff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. Contact your doctor immediately i f your newborn baby has any of these symptoms . v.

77.0 REG_00028683 108Make sure your midw ife and/or doctor know you are on Brintellix . When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Brintellix may incr ease the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN), makin g thebaby br eathe faster and appear bluish. These symptoms usually begin 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 ne ar the end of your pregnancy th ere may be an increased risk of heavy vaginal bleeding shortly after birth, especially if y ou have a history of bleeding disor ders. Your doctor or midwife should be aware that you are taking Brintellix so they can advise you.

Breast -feeding It isexpecte d that the ingredients of Brintellix will pass into breast milk. Brintellix is not to be used during breast -feeding. Your doct or will make a deci sion on whether you should stop breast -feeding, or stop using Brintellix taking into account the b enefi t of bre ast-feeding for your child, and the benefit of therapy for you

Driving and using machines

Brintellix has no or negligible in fluence on the ability to drive and use machines . However, as adverse reactions such as diziness ha vebeen reported, cauti on is ad vised during such activities when beginning Brintellix treatment or changing the dose.

Brintellix contains ethanol

This medi cine contains 85 mg of alcohol (ethanol 96%) in each ml which is equivalent to 10.1 % v/v.

The amou nt in 1 ml of this medi cine is equivalent to less than 3 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine will not have any noticeab le effects.

💊 3. How to take Brintellix

Always take this medicine exactly as your doctor has told you. Check with y our d octor or pharmacist if you are not sure.

The recommended dose of Brintellix is 10 mgvortioxetine taken as one daily dose in adults le ss than 65 years of age . The dose may be increased by your doctor to a maximum of 20 mgvortioxetin e per day or lower ed to a minim umof 5mgvortioxetine per day depend ingon your response to treatment .

For elderly people 65 years of age or older the star ting dose is 5mg vortioxetine taken once daily.

5mgcorresponding to 5 drops.

10mgcorrespondin g to 10 drops.

15mgcorrespond ing to 15 drops.

20mgcorresponding to 20 drops.

Method of administration Brintellix can be taken with or without food.

The drops canbe mixed with water, juice or other non -alcoholic drinks .

Brintellix oral drops are not to be mixed with other medicin al products.

Turn the bottle completely upside down. If no drops come out, tap the bottle lightly to start the flow. v.

77.0 REG_00028683 Duration of treatment Take Brintellix for as long as your doctor recommends.

Continue to take Brinte llixeven if it ta kes s ome time before you feel any improvement in your condition.

Treatment should be continued for at least 6 months after you feel well a gain.

If you take more Brintellix than you should

If you take more than the prescribed dose of Brintellix , contact your doctor o r nearest hospital emergency department immediately. Have the bottle and any remaining solution available. Do this even if the re are no signs of discomfort. Overdose signs could be dizziness, nausea, diarrhoea, stomach discom fort, itching o fthe wh ole body , sleepiness and flushing.

Following intake of dosages several times higher than the prescribed dose, fits (seizures) 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 a forgotten dose.

If you stop taking Brintellix

Do not stop taking Brintellix without talking with your doctor.

Your doctor may decide to reduce your dose before you finally st op taking this med icine .

Some patients who stop taking Brintellix have experienced symptoms such as dizziness, headache, tingling feelings like pins and need les or electric shock -like feelings (particularly in the head), inability to sleep, feeling sick or vomiting, feeling anxious, irritable or agitated, feeling tired or shaking. These symptoms may occur within the first week after stopping Brintellix.

If yo u have any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. Possi ble side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects were mil d to moderate and occurred within the first two weeks of treatment. The reactions were usually temp orary and did not lead to cessation of therapy.

Side effects listed below have been reported in the following frequencies. v.

77.0 REG_00028683 110Very common: may affect more t han 1 in 10 people

• Nausea

Common: may affect up to 1 in 10 people

• diarrhoea, constipation, vomi ting
• dizziness
• itching ofthe whole body
• abnormal dreams
• increased sweatin g
• indigestion

Uncommon :may affect up to 1in100people

• flushing
• night sweats
• blurred vision
• involuntary shaking (tremor)

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

• enlarged pupils (mydriasis), which can increase the risk of glaucoma (see section 2)

Not known: frequency cannot be estimated from available data

• low levels of sodium in th e blood (the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling o r being sick; more serious symptoms are fainting, fits or falls)
• serotonin syndrome (see section 2)
• allergic reactions, that may be serious, causing swelling of the face, lips, tongue or throat, difficulties breathing or swallowing, and/or a sudden drop in blood pressure (m aking you feel dizzy or lightheaded)
• hives
• excessive or unexplained bleeding (including bruising, nose bleeding, gastrointestinal and vagin al bleeding )
• rash
• sleep disorders (insomnia)
• agitation and aggression. If you experience these sid e effects, contact your doctor (see section 2)
• headache
• increase in a hormon called prolactin in the bl ood
• a constant urge to move (akathisia)
• grinding one’s teeth (bruxism)
• inability to open your mouth (lockjaw /trismus )
• restless leg syndrome (urges to mov e the legs to stop painful or odd sensations, often occuring at night )
• abnormal milky discharge from the breast (galactorrhoea) An increased risk of bone fr actures has been observed in patients taking thistype of medicines.

An increased risk of sexual d ysfunction has bee n rep orted with the 20 mg dose, and in some patients this side effect was observed at lower doses.

Additional side effects in children and adolescents

Side effects observed with vortioxetine in children and adolescents were similar to t hose seen for adults except for abdominal pain related events that were observed more often than in adults and suicidal thoughts that were observed more ofte n in adolescents than in adults . v.

77.0 REG_00028683 111Reporting of side effects If you get any side effects, talk to your doctor or pharm acist.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. How to store Brintellix

Keep this medicine out of the sight and re ach of children.

Do not use this medicine after the e xpiry date thatis stated on the packaging after EXP. The expiry date refers to the last day of that month.

This medicin edoes not requir e any special storage conditions.

After first opening the drop s should be used within 8 weeks.

Do not throw away an y med icines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

📦 6. Contents of the pack and other information

What Brintellix contains

• The active su bstan ce is vortioxetine. Each drop of solution contains 1mgvortioxetine (as (D,L) – lactate ).
• The other ingredients are hydroxypropylbetade x, ethanol (96 percent) and purified water

What Brintellix looks like and contents of the pack

Oral drops, solution Clear, nearly colourless to yellowish solution.

Brintellix oral drops, solution, are available in 20 ml amber glass bottle including screw cap with dropper (child -resistant closure ).

Each bottle cont ains 15 ml Brintellix oral drops, solution.

Marketing Auth orisation Holder and Manufacturer H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark For any information about this medicine, please co ntact the local representative of the Marketing Authorisation H older:

Belgique/België/Belgien Lundbeck S.A./N.V.

Tél/Tel: +322535 7979Lietuva H. Lundbeck A/S Tel: +45 36301311( Danija ) [email protected] v.

77.0 REG_00028683 112България Lundbeck Export A/S Representative Office Tel: +359 2 962 4696Luxembourg/Luxemburg Lundbeck S.A.

Tél: +32 2 535 7979 Česká republika Lundbeck Česká republika s.r.o.

Tel: +420 225 275 600Magyarország Lundbeck Hungaria Kft.

Tel: +36 1 4369980 Danmark Lundbeck Pharma A/S Tlf: +45 4371 4270Malta H. Lundbeck A/S Tel: + 45 36301311 Deutschland Lundbeck GmbH Tel: +49 4023649 0Nederland Lundbeck B.V.

Tel: +31 206971901 Eesti Lundbeck Eesti AS Tel: + 372 605 9350Norge H. Lundbeck AS Tlf: +47 91 300 800 Ελλάδα Lundbeck Hellas S.A.

Τηλ: +30 2106105036Österreich Lundbeck Austria GmbH Tel:+43 1 253 621 6033 España Lundbeck España S.A.

Tel: +34 934949620Polska Lundbeck Poland Sp. z o. o.

Tel.: + 48 22 626 93 00 France Lundbeck SAS Tél: + 33 1 79 41 29 00Portugal Lundbeck Portugal Lda Tel: +351 210045900 Hrvatska Lundbeck Cro atia d.o.o.

Tel.: + 385 1 6448263România Lundbeck Romania SRL Tel: +40 21319 88 26 Ireland Lundbeck (Ireland) L imited Tel: +353 1468 9800Slovenija Lundbeck Pharm a d.o.o.

Tel.: +386 2 229 4500 Ísland Vistor hf.

Tel: +354 535 7000Slovenská republi ka Lundbeck Slovensko s.r.o.

Tel: +421 25341 42 18 Italia Lundbeck Italia S.p.A.

Tel: +39 026774171Suomi/Finland Oy H. Lundbeck Ab Puh/Tel: +358 22765000 Κύπρος Lundbeck Hellas A.E Τηλ.: +357 22490305Sverige H. Lundbeck AB Tel: +46 406998200 Latvija H. Lundbeck A/S Tel: +45 36301311(Dānija) [email protected] Kingdom (Northern Ireland) Lundbeck (Ireland) Limited Tel: +353 1468 9800 v.

77.0 REG_00028683 113This leaflet was last revised in MM/YYYY Other sour ces of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu v.

77.0 REG_00028683

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Brintellix (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/13/891).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.