VORTIOXETINE EG

Patient Information Leaflet

VORTIOXETINE EG 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What VORTIOXETINE EG is and what it is used for

VORTIOXETINE EG contains the active substance vortioxetine. It belongs to a group of medicines called
antidepressants.
This medicine is used for the treatment of major depressive episodes in adults.
Vortioxetine has been shown to reduce the various symptoms of depression, including sadness, inner tension (anxious feeling), sleep disturbances (reduced sleep), decreased appetite, difficulty concentrating, feelings of worthlessness, loss of interest in usual activities, and feelings of being slowed down.

2. What you should know before taking VORTIOXETINE EG

Do not take VORTIOXETINE EG:

• if you are allergic to vortioxetine or to 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 (MAOIs) or selective MAO-A inhibitors. Ask your doctor if you are unsure.

Warnings and precautions
Talk to your doctor or pharmacist before taking VORTIOXETINE EG:

• if you are taking medicines with a so-called serotonergic effect 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 VORTIOXETINE EG may increase the risk of Serotonin Syndrome. This syndrome may be associated with hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhea.

• If you have had seizures. Your doctor will treat you cautiously if you have a history of seizures or suffer from unstable seizure disorders/epilepsy. Seizures are a potential risk associated with medicines used to treat depression. Treatment must be discontinued in patients who develop seizures or experience an increased frequency of seizures.
• If you have experienced manic episodes.
• If you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you have low levels of sodium in your blood.
• If you are aged 65 years or older.
• If you have severe kidney disease.
• If you have severe liver disease or liver disease known as cirrhosis.
• If you have or have had increased intraocular pressure or glaucoma. If you experience eye pain or blurred vision during treatment, contact your doctor.

While being treated with antidepressants, including vortioxetine, you may experience feelings of aggression, agitation, anger, and irritability. If this occurs, discuss it with your doctor.
Suicidal thoughts and worsening of your depression
If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of harming yourself or suicide. These thoughts may increase at the beginning of antidepressant treatment, as these medicines require time to take effect, usually 2 weeks but sometimes longer.
You are more likely to experience such thoughts if:

• you have previously thought about suicide or self-harm,
• you are a young adult.

Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants.
If at any time you experience thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. It may help to tell a family member or close friend that you are depressed or suffer from an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Children and adolescents
Vortioxetine must not be used in paediatric patients (under 18 years of age) as efficacy has not been demonstrated. The safety of vortioxetine in children and adolescents aged 7 to 17 years is described in section 4.
Other medicines and VORTIOXETINE EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

• phenelzine, iproniazide, isocarboxazide, nialamide, tranylcypromine (medicines used to treat depression known as non-selective monoamine oxidase inhibitors, MAOIs); you must not take any of these medicines together with VORTIOXETINE EG. If you have taken any of these medicines, you must wait 14 days before starting VORTIOXETINE EG. After stopping VORTIOXETINE EG, you must wait 14 days before taking any of these medicines;
• moclobemide (a medicine used to treat depression);
• selegiline and rasagiline (medicines used to treat Parkinson’s disease);
• linezolid (an antibiotic used to treat bacterial infections);
• medicines with serotonergic effects, 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 VORTIOXETINE EG may increase the risk of serotonin syndrome (see section Warnings and precautions);
• lithium (a medicine used to treat depression and mental illnesses) or tryptophan;
• medicines that cause low sodium levels in the blood;
• 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 used to 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 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 stop smoking);
• fluoxetine, paroxetine, and other medicines for depression known as SSRIs/SNRIs, tricyclics;
• St. John’s wort (Hypericum perforatum) (a herbal medicine used to treat depression);
• quinidine (a medicine used to treat heart rhythm disorders);
• chlorpromazine, chlorprothixene, haloperidol (medicines used to treat mental disorders belonging to the group known as phenothiazines, thioxanthenes, butyrophenones).

Inform your doctor if you are taking any of the medicines listed above, as you may already be at risk of seizures.
Drug screening tests
If you undergo urine analysis for drug screening, taking VORTIOXETINE EG may cause false positive results for methadone when certain testing methods are used, even if you do not take methadone. If this occurs, a more specific test can be performed.
VORTIOXETINE EG and alcohol
It is not recommended to take VORTIOXETINE EG with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
This medicine should not be used during pregnancy unless your doctor has determined it is absolutely necessary.
If you take medicines to treat depression, including VORTIOXETINE EG, during the last 3 months of pregnancy, 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 levels, stiff or floppy muscles, overactive reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. Contact your doctor immediately if the newborn shows any of these symptoms.
Ensure that your midwife and/or doctor know you are taking VORTIOXETINE EG. When taken during pregnancy, particularly during the last 3 months, medicines like VORTIOXETINE EG may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take this medicine near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking this medicine so they can advise you accordingly.
Breastfeeding
Components of this medicine are expected to pass into breast milk. VORTIOXETINE EG must not be taken during breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop treatment with this medicine, based on an assessment of the benefits of breastfeeding for the child and the benefits of therapy for you.
Driving and using machines
This medicine has no or negligible influence on the ability to drive or use machines. However, since adverse effects such as dizziness have been reported, caution is advised when performing such activities, especially when starting treatment with VORTIOXETINE EG or when changing the dose.
VORTIOXETINE EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take VORTIOXETINE EG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended dose of VORTIOXETINE EG for adults under 65 years of age is 10 mg of
vortioxetine taken as a single daily dose. Your doctor may increase the dose up to a maximum of
20 mg of vortioxetine per day or reduce it down to a minimum of 5 mg of vortioxetine per day, depending
on your response to treatment.
Use in elderly patients
In elderly patients aged 65 years or older, the initial dose is 5 mg of vortioxetine taken as a single daily dose.
Method of administration
Take one tablet with a glass of water.
The tablet may be taken with or without food.
If you are unable to swallow the tablet whole, other medicinal products containing vortioxetine in different pharmaceutical forms may be available on the market.
Duration of treatment
Take this medicine for as long as your doctor recommends.
Continue taking this medicine even if it takes some time before you notice an improvement in your condition.
Treatment should be continued for at least 6 months after you start feeling well again.
If you take more VORTIOXETINE EG than you should
If you take more VORTIOXETINE EG than prescribed, contact your doctor or the nearest hospital emergency department immediately. Bring the container and any remaining tablets with you. Do this even if you do not have any symptoms of discomfort. Signs of overdose include dizziness, nausea, diarrhoea, stomach discomfort, itching all over the body, drowsiness and flushing.
After taking doses several times higher than the prescribed dose, seizures (convulsions) and a rare condition called serotonin syndrome have been reported.
If you forget to take VORTIOXETINE EG
Take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking VORTIOXETINE EG
Do not stop taking VORTIOXETINE EG without first talking to your doctor.
Your doctor may decide to gradually reduce the dose before stopping this treatment completely.
Some patients who have stopped taking vortioxetine have reported symptoms such as dizziness, headache, sensations like pins and needles or electric shocks (especially in the head), inability to sleep, feeling unwell or vomiting, anxiety, irritability or agitation, tiredness or tremor. These symptoms may occur within the first week after stopping this medicine.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

In general, the side effects observed have been mild to moderate and occurred within the first two weeks of treatment. Reactions were usually temporary and did not lead to discontinuation of therapy.

The side 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;
• abnormal dreams;
• increased sweating;
• indigestion.

Uncommon: may affect up to 1 in 100 people

• flushing;
• night sweats;
• blurred vision;
• involuntary shaking (tremor);
• hallucinations (seeing, hearing or sensing things that are not really there).

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

• dilated pupils (mydriasis), which may increase the risk of glaucoma (see section 2).

Not known: frequency cannot be estimated from the available data

• low levels of sodium in the blood (symptoms may include feeling dizzy, weakness, confusion, drowsiness or increased tiredness, or feeling nauseous or vomiting; more severe symptoms include fainting, seizures or falls);
• serotonin syndrome (see section 2);
• allergic reactions, even severe ones, causing swelling of the face, lips, tongue and throat, difficulty breathing or swallowing and/or sudden drop in blood pressure (feeling dizzy or lightheaded);
• hives;
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal or vaginal bleeding);
• rash;
• sleep disturbances (insomnia);
• agitation and aggressiveness. If you experience these side effects, contact your doctor (see section 2);
• headache;
• increased levels of a hormone called prolactin in the blood;
• constant restlessness leading to an urge to move (akathisia);
• teeth grinding (bruxism);
• inability to open the mouth (trismus);
• restless legs syndrome (urge to move the legs to relieve painful or strange sensations, which often occur at night);
• abnormal milk production from the breast (galactorrhea).

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

An increased risk of sexual dysfunction has been observed with the 20 mg dose, and in some patients, this side effect has also been seen with lower doses.

Additional side effects in children and adolescents

Side effects observed with vortioxetine in children and adolescents were similar to those seen in adults, except for abdominal pain-related events, which were reported more frequently than in adults, and suicidal thoughts, which were reported more frequently in adolescents than in adults.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store VORTIOXETINE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after Exp. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VORTIOXETINE EG contains
VORTIOXETINE EG 5 mg film-coated tablets

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

VORTIOXETINE EG 10 mg film-coated tablets

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

VORTIOXETINE EG 15 mg film-coated tablets

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

VORTIOXETINE EG 20 mg film-coated tablets

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

Description of the appearance of VORTIOXETINE EG and contents of the pack
VORTIOXETINE EG 5 mg film-coated tablets
Pink, oval (11 mm x 5 mm), biconvex film-coated tablet, marked with "5" on one side.
VORTIOXETINE EG 10 mg film-coated tablets
Yellow, oval (13 mm x 6 mm), biconvex film-coated tablet, marked with "10" on one side.
VORTIOXETINE EG 15 mg film-coated tablets
Light orange, oval (15 mm x 7 mm), biconvex film-coated tablet, marked with "15" on one side.
VORTIOXETINE EG 20 mg film-coated tablets
Dark red, oval (17 mm x 8 mm), biconvex film-coated tablet, marked with "20" on one side.
VORTIOXETINE EG film-coated tablets are available in cardboard boxes containing PVC/PVdC/Al blisters.
Pack sizes of 14, 28, 56 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturers
Pharmadox Healthcare Limited, KW20A Kordin Industrial Estate, Paola PLA 3000 - Malta
Adalvo Limited, Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann, SGN 3000 - Malta
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel - Germany
Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary, E91 D768 - Ireland

This medicinal product is authorized in the European Economic Area countries under the following names:
DE Vortioxetin STADA 5 mg; 10 mg; 15 mg; 20 mg Filmtabletten
DK Vortioxetin STADA
ES Vortioxetina STADA 5 mg; 10 mg; 15 mg; 20 mg comprimidos recubiertos con pelicula EFG
FI Vortioxetine STADA 5 mg; 10 mg; 15 mg; 20 mg kalvopäällysteinen tabletti
FR VORTIOXETINE EG, 5/10/15/20 mg, comprimé pelliculé
HR Vortioksetin STADA 5 mg; 10 mg; 15 mg; 20 mg filmom obložene tablete
IT Vortioxetina EG
IE Vortioxetine Clonmel 5 mg; 10 mg; 15 mg; 20 mg film-coated tablets
IS Vortioxetine STADA 5 mg; 10 mg; 15 mg; 20 mg filmuhúðaðar töflur
NO Vortioxetine STADA 5 mg; 10 mg; 15 mg; 20 mg filmdrasjerte tabletter
PT Vortioxetina STADA
PL Vortioxetine Stada
SK Vortioxetín STADA 5 mg; 10 mg; 15 mg; 20 mg filmom obalené tablety
SE Vortioxetine STADA 5 mg; 10 mg; 15 mg; 20 mg filmdragerade tabletter
SI Vortioksetin STADA AG 5 mg; 10 mg; 15 mg; 20 mg filmsko obložene tablete