Irsamla

Package leaflet: Information for the patient

Irsamla, 5 mg, film-coated tablets
Irsamla, 10 mg, film-coated tablets
Irsamla, 15 mg, film-coated tablets
Irsamla, 20 mg, film-coated tablets
Vortioxetinum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Irsamla is and what it is used for
2. What you need to know before taking Irsamla
3. How to take Irsamla
4. Possible side effects
5. How to store Irsamla
6. Contents of the pack and other information

1. What Irsamla is and what it is used for

Irsamla contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.
Irsamla is used to treat major depressive episodes in adults.
Vortioxetine has been shown to relieve many symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced amount of sleep), decreased appetite, difficulty concentrating, feelings of worthlessness, loss of interest in performing favourite activities, and sensation of slowing down.

2. Important information before taking Irsamla

When not to take Irsamla:

• if the patient is allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6.).
• if the patient is taking other antidepressant medicines called non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. If in doubt, consult a doctor.

Warnings and precautions
Before starting treatment with Irsamla, talk to your doctor or pharmacist:

• if the patient is taking medicines with so-called serotonergic activity, such as:
  • tramadol and similar medicines (strong painkillers).
• sumatriptan and similar medicines whose active substance names end in "triptan" (used to treat migraine). Taking these medicines together with Irsamla may increase the risk of serotonin syndrome. This syndrome may involve hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhoea.
  • if the patient has had seizures (epileptic fits). Treatment will be carried out with caution if the patient has experienced seizures or if unstable seizures/epilepsy are currently present. Treatment with antidepressant medicines carries a risk of seizures. Treatment should be discontinued in any patient who experiences seizures for the first time or whose seizure frequency increases.
  • if the patient has had mania.
  • if the patient has a tendency to bleeding or bruising, or if the patient is pregnant (see 'Pregnancy and breastfeeding' below).
  • if the patient has low sodium levels in the blood.
  • if the patient is 65 years of age or older.
  • if the patient has severe kidney disease.
  • if the patient has severe liver disease or liver disease known as cirrhosis.
  • if the patient has or has previously had increased pressure in the eye or glaucoma. If eye pain or blurred vision occurs during treatment, consult a doctor.

Patients taking antidepressant medicines, including vortioxetine, may also experience
feelings of aggression, agitation, anger, and irritability. In such a situation, consult your doctor.
Suicidal thoughts and worsening of depression
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of
self-harm or suicide. These thoughts may intensify after starting treatment with
antidepressant medicines, as all these medicines take some time to become effective, usually about two weeks, and sometimes longer.
The occurrence of suicidal thoughts is more likely if:

• the patient has previously experienced thoughts of self-harm or suicide.
• the patient is a young adult.

Clinical trial data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressant medicines.
If the patient ever experiences thoughts of self-harm or suicide, they should contact their doctor immediately or go to hospital. It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask these people to inform them if they notice that depression or anxiety disorders worsen or if there are worrying changes in the patient's behaviour.
Children and adolescents
Vortioxetine should not be used in children and adolescents (under 18 years of age) due to lack of demonstrated efficacy. The safety of vortioxetine in children and adolescents aged 7 to 17 years is described in section 4.
Irsamla and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tell your doctor if the patient is taking any of the following medicines:

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines used to treat depression, called non-selective monoamine oxidase inhibitors); none of these medicines should be taken together with Irsamla. If the patient has taken any of

these medicines, they must wait 14 days before starting treatment with Irsamla. After stopping treatment with Irsamla, wait 14 days before starting any of these medicines.

• moclobemide (a medicine used to treat depression).
• selegiline, rasagiline (medicines used to treat Parkinson's disease).
• linezolid (a medicine used to treat bacterial infections).
• serotonergic medicines, e.g. tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines whose active substance names end in "triptan" (used to treat migraine). Taking these medicines together with Irsamla may increase the risk of serotonin syndrome (see section Warnings and precautions).
• lithium (a medicine used to treat depression and psychiatric disorders) or tryptophan.
• medicines that reduce sodium levels.
• rifampicin (a medicine used to treat tuberculosis and other infections).
• carbamazepine, phenytoin (medicines used to treat epilepsy and other conditions).
• warfarin, dipyridamole, phenprocoumon, certain antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (medicines that 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 containing an active substance with a name ending in "triptan".
• tramadol (a strong painkiller).
• mefloquine (a medicine used for malaria prevention and treatment).
• bupropion (a medicine used to treat depression and in people quitting smoking).
• fluoxetine, paroxetine, and other medicines used to treat depression, known as SSRIs/SNRIs, tricyclic antidepressants.
• St John's wort ( Hypericum perforatum ) (a herbal remedy used to treat depression).
• quinidine (a medicine used to treat heart rhythm disorders).
• chlorpromazine, chlorprothixene, haloperidol (medicines used in psychiatric disorders belonging to groups called phenothiazines, thioxanthenes, butyrophenones).

Inform your treating doctor if you are taking any of the above-mentioned medicines, as your doctor should be aware that you are already at risk of seizures.
Drug screening tests
If the patient undergoes a drug screening test for narcotics in urine, taking Irsamla may cause a positive test result for methadone, even if the patient is not taking methadone. In such a case, a different, more specific test can be performed.
Taking Irsamla with alcohol
Combining this medicine with alcohol is not recommended.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Pregnancy
Irsamla should not be used during pregnancy unless the doctor considers it absolutely necessary.
If the patient takes medicines used to treat depression, including Irsamla, during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature changes, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, shakiness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If any of these symptoms occur in the newborn, contact a doctor immediately.
Inform the midwife and/or doctor about taking Irsamla. Medicines such as Irsamla used during pregnancy, especially during the last 3 months of pregnancy, may increase the risk of a serious condition in the child called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and bluish skin in the child. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, inform the midwife and/or doctor immediately.
Taking this medicine towards the end of pregnancy may increase the risk of severe bleeding from the birth canal immediately after delivery, especially if the patient has a history of blood clotting disorders.
If the patient is taking Irsamla, her midwife or doctor should be aware so they can provide appropriate advice.
Breastfeeding
It is believed that the components of this medicine pass into breast milk. Irsamla should not be used during breastfeeding. The doctor will decide whether the patient should stop breastfeeding or stop taking the medicine, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive and use machines. However, caution is advised when performing these activities after starting treatment with Irsamla or after a dose change, as adverse effects such as dizziness have been reported.
Irsamla contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to take Irsamla

Take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose of Irsamla in adults under 65 years of age is 10 mg of vortioxetine once daily. Depending on the patient's response to treatment, the doctor may increase this dose to a maximum of 20 mg vortioxetine per day or reduce it to a minimum of 5 mg vortioxetine per day.

Use in elderly patients
For elderly patients aged 65 years or older, the starting dose is 5 mg of vortioxetine once daily.

Method of administration
Take one tablet with a glass of water.
The tablet may be taken with or without food.
For patients who are unable to swallow the tablet whole, other medicines containing vortioxetine in a more suitable pharmaceutical form are available on the market.

Duration of treatment
Continue taking the medicine for as long as your doctor recommends.
Keep taking Irsamla even if you do not feel better for some time.
Treatment should continue for at least 6 months after you start feeling better.

If you take more Irsamla than you should
If you have taken more Irsamla than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Bring the medicine packaging and any remaining tablets with you. Do this even if you do not have any symptoms of discomfort. Symptoms of overdose may include dizziness, nausea, diarrhoea, stomach discomfort, itching of the whole body, drowsiness, and hot flushes.
Seizures and a rare condition called serotonin syndrome have been reported after ingestion of doses several times higher than the recommended dose.

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

Stopping Irsamla
Do not stop taking Irsamla without consulting your doctor.
Your doctor may decide to gradually reduce the dose before stopping the medicine completely.
Some patients who stopped taking Irsamla experienced symptoms such as dizziness, headache, prickling or tingling sensations, electric shock-like feelings (especially in the head), difficulty sleeping, nausea or vomiting, restlessness, irritability or agitation, fatigue, or tremor. These symptoms may occur within the first week after stopping the medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The observed adverse effects were generally mild or moderate in severity and occurred
during the first two weeks of treatment. Reactions were usually transient and did not lead to
discontinuation of treatment.
The adverse 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 of the skin
• unusual dreams
• excessive sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

• hot flushes
• night sweats
• blurred vision
• involuntary muscle twitching

Rare: may affect up to 1 in 1000 people

• dilated pupils (pupil dilation), 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 (symptoms may include: dizziness, weakness, confusion, drowsiness or severe fatigue, nausea or vomiting; more severe symptoms include fainting, seizures or falls)
• serotonin syndrome (see section 2.)
• allergic reactions, which may be serious and cause swelling of the face, lips, tongue or throat, difficulty breathing or swallowing and/or sudden drop in blood pressure (causing dizziness or feeling faint)
• urticaria
• unusual or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding or genital bleeding)
• rash
• sleep problems (insomnia)
• agitation or aggression. If such adverse effects occur, contact your doctor (see section 2.)
• headache
• increased blood levels of a hormone called prolactin
• constant 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 unusual sensations, often occurring at night)
• milky nipple discharge (galactorrhea)

In patients taking this type of medicine, an increased risk of bone fractures has been observed.
With the 20 mg dose, an increased risk of sexual dysfunction has been reported, and in some
patients, such adverse effects were observed at lower doses.
Additional adverse effects in children and adolescents
Adverse effects of vortioxetine in children and adolescents were similar to those observed in adults, except for abdominal pain, which was reported more frequently in children and adolescents than in adults, and suicidal thoughts, which were observed more frequently in adolescents than in adults.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Irsamla

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 stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Irsamla contains
Irsamla 5 mg film-coated tablets

• The active substance is vortioxetine. Each film-coated tablet contains 5 mg of vortioxetine (as vortioxetine hydrobromide).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate in the tablet core; hypromellose, macrogol, titanium dioxide (E171) and iron oxide red (E172) in the tablet coating.

Irsamla 10 mg film-coated tablets

• The active substance is vortioxetine. Each film-coated tablet contains 10 mg of vortioxetine (as vortioxetine hydrobromide).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate in the tablet core; hypromellose, macrogol, titanium dioxide (E171) and iron oxide yellow (E172) in the tablet coating.

Irsamla 15 mg film-coated tablets

• The active substance is vortioxetine. Each film-coated tablet contains 15 mg of vortioxetine (as vortioxetine hydrobromide).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate in the tablet core; hypromellose, macrogol, titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172) in the tablet coating.

Irsamla 20 mg film-coated tablets

• The active substance is vortioxetine. Each film-coated tablet contains 20 mg of vortioxetine (as vortioxetine hydrobromide).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate in the tablet core; hypromellose, macrogol, titanium dioxide (E171) and iron oxide red (E172) in the tablet coating.

What Irsamla looks like and contents of the pack
Irsamla 5 mg film-coated tablets
Pink, oval (11 mm x 5 mm), biconvex film-coated tablet with the engraved mark '5' on one side.
Irsamla 10 mg film-coated tablets
Yellow, oval (13 mm x 6 mm), biconvex film-coated tablet with the engraved mark '10' on one side.
Irsamla 15 mg film-coated tablets
Light orange, oval (15 mm x 7 mm), biconvex film-coated tablet with the engraved mark '15' on one side.
Irsamla 20 mg film-coated tablets
Dark red, oval (17 mm x 8 mm), biconvex film-coated tablet with the engraved mark '20' on one side.
Irsamla film-coated tablets are available in cardboard boxes containing transparent PVC/PVDC/Aluminium blisters.
Pack sizes of 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Egis Pharmaceutical PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Importer:
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Adalvo Limited
Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings
San Gwann SGN 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Slovenia
Irsamla 5 mg filmsko obložene tablete
Irsamla 10 mg filmsko obložene tablete
Irsamla 15 mg filmsko obložene tablete
Irsamla 20 mg filmsko obložene tablete

Bulgaria
ИРСАМЛА 5 mg филмирани таблетки
Irsamla 5 mg film-coated tablets
ИРСАМЛА 10 mg филмирани таблетки
Irsamla 10 mg film-coated tablets
ИРСАМЛА 15 mg филмирани таблетки
Irsamla 15 mg film-coated tablets
ИРСАМЛА 20 mg филмирани таблетки
Irsamla 20 mg film-coated tablets

Czech Republic
Irsamla

Hungary
Irsamla 5 mg filmtabletta
Irsamla 10 mg filmtabletta
Irsamla 15 mg filmtabletta
Irsamla 20 mg filmtabletta

Latvia
Irsamla 5 mg apvalkotās tabletes
Irsamla 10 mg apvalkotās tabletes
Irsamla 15 mg apvalkotās tabletes
Irsamla 20 mg apvalkotās tabletes

Lithuania
Irsamla 5 mg plėvele dengtos tabletės
Irsamla 10 mg plėvele dengtos tabletės
Irsamla 15 mg plėvele dengtos tabletės
Irsamla 20 mg plėvele dengtos tabletės

Poland
Irsamla

Romania
Irsamla 5 mg comprimate filmate
Irsamla 10 mg comprimate filmate
Irsamla 15 mg comprimate filmate
Irsamla 20 mg comprimate filmate

Slovakia
Irsamla 5 mg filmom obalené tablety
Irsamla 10 mg filmom obalené tablety
Irsamla 15 mg filmom obalené tablety
Irsamla 20 mg filmom obalené tablety

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00