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

Vortioxetine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Irsamla and what is it used for
• 2. Important information 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 is Irsamla and what is it used for

Irsamla contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.
The medicine is used to treat major depressive episodes in adults.
Vortioxetine has been shown to improve many of the symptoms of depression, including sadness, inner restlessness (feeling anxious), sleep disturbances (less sleep), decreased appetite, difficulty concentrating, feelings of worthlessness, loss of interest in activities, and feelings of slowing down.

2. Important information before taking Irsamla

When not to take Irsamla:

• 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, called non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. If in doubt, ask your doctor.

Warnings and precautions

Before starting treatment with Irsamla, tell your doctor or pharmacist:

• if you are taking medicines with so-called serotonergic effects, such as:
• tramadol and similar medicines (strong painkillers).
• sumatriptan and similar medicines whose active substance names end in "triptan" (used to treat migraines). Taking these medicines with Irsamla may increase the risk of serotonin syndrome. This syndrome can be associated with hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhea.
• if you have had seizures (epileptic fits). Treatment will be carried out with caution if you have had seizures or if you currently have uncontrolled seizures/epilepsy. The use of antidepressant medicines carries a risk of seizures. Treatment should be discontinued in any patient who develops seizures for the first time or whose seizure frequency increases.
• if you have had mania.
• if you have a tendency to bleed or bruise easily, or if you are pregnant (see 'Pregnancy and breast-feeding' below).
• if you have low sodium levels in your blood.
• if you are 65 or older.
• if you have severe kidney disease.
• if you have severe liver disease or liver disease called cirrhosis.
• if you have or have had increased pressure in the eye or glaucoma. If you experience eye pain or blurred vision during treatment, you should see a doctor.

Patient taking antidepressant medicines, including vortioxetine, may also experience feelings of aggression, agitation, anger, and irritability. In such cases, you should talk to your doctor.

Suicidal thoughts and worsening of depression

In patients with depression and/or anxiety disorders, suicidal thoughts or thoughts of self-harm may sometimes occur. These thoughts may worsen after starting treatment with antidepressant medicines, as all these medicines take time to start working, usually after two weeks, and sometimes later.
Suicidal thoughts are more likely to occur if:

• you have had suicidal thoughts or self-harm in the past.
• you are a young adult.

Information from clinical trials indicates an increased risk of suicidal behavior in adults under 25 years of age with mental health disorders treated with antidepressant medicines.
If you have ever had suicidal thoughts or self-harm, you should contact your doctor immediately or go to the hospital. It may be helpful to inform your relatives or friends about your depression or anxiety disorders and ask them to read this leaflet. You may ask them to tell you if they notice that your depression or anxiety disorders have worsened or if you have any worrying changes in your behavior.

Children and adolescents

Vortioxetine should not be used in children and adolescents under 18 years of age, due to lack of demonstrated efficacy in this age group. 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 the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Tell your doctor if you are taking any of the following medicines:

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines used to treat depression, called non-selective monoamine oxidase inhibitors); you must not take any of these medicines at the same time as Irsamla. If you have taken any of these medicines, you must wait 14 days before you can start taking Irsamla. After stopping treatment with Irsamla, you must wait 14 days before you can start taking any of these medicines.

those medicines that increase the risk of seizures:

• sumatriptan and similar medicines whose active substance names end in "triptan" (used to treat migraines).
• tramadol (strong painkiller).
• mefloquine (medicine used to prevent and treat malaria).
• bupropion (medicine used to treat depression and also to help people stop smoking).
• fluoxetine, paroxetine, and other medicines used to treat depression, called SSRIs/SNRIs, tricyclic antidepressants.
• St. John's Wort (Hypericum perforatum) (herbal medicine used to treat depression).
• quinidine (medicine used to treat heart rhythm disorders).
• chlorpromazine, chlorprothixene, haloperidol (medicines used to treat mental disorders, belonging to a group of medicines called phenothiazines, thioxanthenes, butyrophenones).

Tell your doctor if you are taking any of the above medicines, as your doctor should know that you are already at risk of seizures.

Drug tests

If you are having a urine test for drugs, taking Irsamla may cause a positive result for methadone, even if you are not taking methadone. In such cases, a more specific test can be performed.

Taking Irsamla with alcohol

It is not recommended to take this medicine with alcohol.

Pregnancy and breast-feeding

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

Irsamla should not be used during pregnancy unless your doctor considers it absolutely necessary.
If you are taking antidepressant medicines, including Irsamla, during the last 3 months of pregnancy, your newborn baby may have the following symptoms: difficulty breathing, blue discoloration of the skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, restlessness, lethargy, constant crying, and sleep disturbances. If your baby experiences any of these symptoms, you should contact your doctor immediately. You should inform your midwife and/or doctor that you are taking Irsamla. Medicines like Irsamla, 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), which causes rapid breathing and blue discoloration of the skin. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, you should contact your midwife and/or doctor immediately.
Taking this medicine at the end of pregnancy may increase the risk of severe bleeding from the birth canal immediately after birth, especially if you have a history of bleeding disorders. If you are taking Irsamla, your midwife or doctor should be aware of this so that they can give you appropriate advice.

Breast-feeding

It is assumed that the ingredients of this medicine pass into breast milk. Irsamla should not be used during breast-feeding. Your doctor will decide whether you should stop breast-feeding or stop taking this medicine, considering the benefit of breast-feeding to the baby and the benefit of treatment to the mother.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines. However, it is recommended to exercise caution when performing these activities after starting treatment with Irsamla or after changing the dose, as side effects such as dizziness have been reported.

Irsamla contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially 'sodium-free'.

3. How to take Irsamla

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Irsamla for adults under 65 years of age is 10 mg of vortioxetine once daily. Depending on your response to treatment, your doctor may increase the dose to a maximum of 20 mg of vortioxetine once daily or decrease it to a minimum of 5 mg of vortioxetine once daily.

Use in elderly patients

In elderly patients, 65 years of age 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.
For patients who are unable to swallow the tablet whole, other medicines containing vortioxetine in a different pharmaceutical form are available on the market.

Duration of treatment

Take the medicine for as long as your doctor recommends.
Continue to take Irsamla even if you do not feel better for some time.
Treatment should be continued for at least 6 months after you feel better.

Taking a higher dose of Irsamla than prescribed

If you have taken more Irsamla than prescribed, contact your doctor or go to the emergency department of your nearest hospital immediately. Take the medicine pack and any remaining tablets with you. Do this even if you do not feel any discomfort. Symptoms of overdose are dizziness, nausea, diarrhea, discomfort in the stomach, itching all over the body, sleepiness, and hot flashes.
After taking doses several times higher than the recommended dose, seizures and a rare condition called serotonin syndrome have been reported.

Forgetting to take a dose of Irsamla

Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Irsamla

Do not stop taking Irsamla without talking to your doctor.
Your doctor may decide to gradually reduce the dose before stopping treatment with this medicine.
Some patients who stopped taking the medicine experienced side effects such as dizziness, headache, tingling sensations like pins and needles or electric shock-like sensations (especially in the head), insomnia, nausea, or vomiting, restlessness, irritability, or agitation, fatigue, or tremors. These side effects may occur within the first week after stopping treatment.
If you have any further questions about 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 observed side effects were generally mild or moderate and occurred during the first two weeks of treatment. The reactions were usually transient and did not lead to discontinuation of treatment.
The following side effects were 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

• diarrhea, constipation, vomiting
• dizziness
• itching all over the body
• strange dreams
• excessive sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

• hot flashes
• night sweats
• blurred vision
• involuntary tremors

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, sleepiness, or severe fatigue, nausea, or vomiting; more severe symptoms are fainting, seizures, or falls)
• serotonin syndrome (see section 2.)
• allergic reactions, which can be serious, causing swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, and/or a sudden drop in blood pressure (causing dizziness or fainting)
• hives
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding, or bleeding from the birth canal)
• rash
• sleep disturbances (insomnia)
• agitation or aggression. If you experience such side effects, you should contact your doctor (see section 2.)
• headache
• increased levels of a hormone called prolactin in the blood
• constant need to move (akathisia)
• grinding of the teeth (bruxism)
• inability to open the mouth (trismus)
• restless legs syndrome (an urge to move the legs to stop unpleasant sensations, often occurring at night)
• abnormal milk secretion from the breasts (galactorrhoea)

In patients taking medicines like Irsamla, an increased risk of bone fractures has been observed.
At a dose of 20 mg, an increased risk of sexual dysfunction has been reported, and some patients experienced such side effects at lower doses.

Additional side effects in children and adolescents

The side 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 side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 month stated.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater 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 cellulose, and magnesium stearate in the tablet core, and 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 cellulose, and magnesium stearate in the tablet core, and 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 cellulose, and magnesium stearate in the tablet core, and 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 cellulose, and magnesium stearate in the tablet core, and 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 '5' engraved on one side.
Irsamla 10 mg film-coated tablets
Yellow, oval (13 mm x 6 mm), biconvex film-coated tablet with '10' engraved on one side.
Irsamla 15 mg film-coated tablets
Light orange, oval (15 mm x 7 mm), biconvex film-coated tablet with '15' engraved on one side.
Irsamla 20 mg film-coated tablets
Dark red, oval (17 mm x 8 mm), biconvex film-coated tablet with '20' engraved on one side.
Irsamla film-coated tablets are available in cardboard boxes containing transparent blisters with PVC/PVDC/Aluminum.
Pack sizes: 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization 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 medicine is authorized 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
To obtain more detailed information on this medicine, contact your local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the package leaflet: