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 All of This Leaflet Carefully Before You Start Taking This Medicine.

• You should 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. Do not pass it on to others. It may harm them, even if their symptoms 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.

Contents of the Pack and Other Information

• 1. What Irsamla is and what it is used for
• 2. What you need to know before you take 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 improve several symptoms of depression, including sadness, inner tension (anxiety), sleep disturbances (less sleep), reduced appetite, difficulty concentrating, feelings of worthlessness, lack of interest in activities that you normally enjoy, and feelings of sluggishness.

2. What you need to know before you take Irsamla

Do Not 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 (MAOIs) or selective MAO-A inhibitors. If in doubt, ask your doctor.

Warnings and Precautions

Before taking Irsamla, tell your doctor or pharmacist:

• if you are taking medicines with serotonergic effects, 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 with Irsamla may increase the risk of serotonin syndrome. This syndrome can cause 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 is associated with 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 Breastfeeding" 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 eye pain or blurred vision occurs during treatment, you should see a doctor.

Patients 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 become more severe when antidepressant medicines are first started, as these medicines may take some time to start working, usually about two weeks, but sometimes longer.
Suicidal thoughts are more likely to occur if:

• you have had thoughts of self-harm or suicide before.
• you are a young adult.

Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you ever have thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately. It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and Adolescents

Vortioxetine should not be used in children and adolescents under the age of 18 years, due to a lack of data on safety and efficacy.
The safety of vortioxetine in children and adolescents under the age of 18 years has been studied in clinical trials. For more information, see section 4.

Irsamla and 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 (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 will need to wait 14 days before you can start taking Irsamla. After stopping Irsamla, you will need to wait 14 days before you can start taking any of these medicines.

if you are taking mirtazapine (a medicine used to treat depression).

• moclobemide (a medicine used to treat depression).
• selegiline, rasagiline (medicines used to treat Parkinson's disease).
• linezolid (an antibiotic).
• medicines with serotonergic effects, such as 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 with Irsamla may increase the risk of serotonin syndrome (see "Warnings and Precautions" above).
• lithium (a medicine used to treat depression and other mental health conditions) or tryptophan.
• medicines that lower sodium levels in the blood.
• rifampicin (an antibiotic used to treat tuberculosis and other infections).
• carbamazepine, phenytoin (medicines used to treat epilepsy and other conditions).
• warfarin, dipyridamole, phenprocoumon, some antipsychotic medicines, phenothiazines, tricyclic antidepressants, aspirin in low doses, and non-steroidal anti-inflammatory medicines (medicines that thin the blood and medicines used to relieve pain). These may increase the risk of bleeding.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines whose active substance names end in "-triptan".
• tramadol (a strong painkiller).
• mefloquine (a medicine used to prevent and treat malaria).
• bupropion (a medicine used to treat depression and 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) (a herbal remedy used to treat depression).
• quinidine (a medicine used to treat irregular heartbeat).
• chlorpromazine, chlorprothixene, haloperidol (medicines used to treat mental health conditions, 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 Screening 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 done.

Taking Irsamla with Alcohol

It is not recommended to drink alcohol while taking this medicine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Irsamla should not be used during pregnancy unless your doctor considers it essential.
If you are taking antidepressant medicines, including Irsamla, during the last 3 months of pregnancy, your newborn baby might have some symptoms such as difficulty breathing, bluish skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, trembling, jitteriness, irritability, lethargy, constant crying, sleepiness, and difficulty sleeping. If your baby develops any of these symptoms, you should contact your doctor or midwife/doctor immediately. You should also tell your midwife/doctor that you are taking Irsamla.
Medicines like Irsamla, taken during pregnancy, especially in the last 3 months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and may turn blue. These symptoms usually occur in the first 24 hours after birth. If such symptoms occur, you should contact your midwife/doctor immediately.
Taking this medicine at the end of pregnancy may increase the risk of heavy bleeding from the birth canal after delivery, especially if you have a history of bleeding disorders. If you are taking Irsamla, your midwife/doctor should be aware of this so that they can give you appropriate advice.

Breastfeeding

It is thought that the ingredients of this medicine pass into breast milk. Irsamla should not be used during breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop taking this medicine, taking into account the benefit of breastfeeding for your child and the benefit of therapy for you.

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 changing the dose, as dizziness has been reported.

Irsamla Contains Sodium

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

3. How to Take Irsamla

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 or older), the initial dose is 5 mg of vortioxetine once daily.

Method of Administration

Swallow 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 vortioxetine-containing medicines are available in a different pharmaceutical form.

Duration of Treatment

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

If You Take More Irsamla Than You Should

If you take more Irsamla than you should, contact your doctor or go to the hospital immediately. Take the medicine pack with you, even if it is empty. This is so the doctor knows what you have taken. Symptoms of overdose are dizziness, nausea, diarrhea, discomfort in the stomach, itching all over the body, sleepiness, and hot flushes.
After taking doses several times higher than the recommended dose, seizures and a rare condition called serotonin syndrome have been reported.

If You Forget to Take 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 first.
Your doctor may decide to gradually reduce your dose before stopping treatment completely.
Some patients who stopped taking Irsamla experienced side effects such as dizziness, headache, tingling sensations (like pins and needles) or electric shock-like sensations (especially in the head), difficulty sleeping, nausea or vomiting, feeling anxious, irritable, or agitated, feeling tired or trembling. These symptoms usually occurred within the first week after stopping treatment.
If you have any further questions on the use of this product, 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 reported were generally mild to moderate and occurred in the first two weeks of treatment. They were usually transient and did not lead to treatment discontinuation.
The following side effects have been reported:

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 flushes
• night sweats
• blurred vision
• involuntary trembling

Rare: May Affect Up to 1 in 1,000 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 tiredness, nausea, or vomiting; more severe symptoms are fainting, seizures, or falls)
• serotonin syndrome (see section 2)
• allergic reactions, which can be severe, 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
• unusual or unexplained bleeding (including bruising, nosebleeds, bleeding from the digestive tract, or bleeding from the reproductive organs)
• rash
• sleep problems (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
• a constant need to move (akathisia)
• grinding of the teeth (bruxism)
• inability to open the mouth (trismus)
• restless legs syndrome (an irresistible urge to move the legs, usually due to uncomfortable sensations, often occurring in the evening)
• abnormal milk secretion from the breasts (galactorrhoea)

In patients taking this type of medicine, 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 have 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 seen in adults, except for abdominal pain, which was reported more frequently in children and adolescents than in adults, and suicidal thoughts, which were reported more frequently in adolescents than in adults.

Reporting of Side Effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). 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 which is stated on the carton after "EXP".
The expiry date refers to the last day of that month.
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. These measures 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 of PVC/PVDC/Aluminum.
Pack sizes are 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Egis Pharmaceutical PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer:

Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

Date of Last Revision of the Leaflet: