Vortioxetine Viatris: detailed information

Patient Information Leaflet

Vortioxetina Viatris 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
vortioxetine
Please read all of this leaflet carefully before you start 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 yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Vortioxetina Viatris is and what it is used for
What you need to know before taking Vortioxetina Viatris
How to take Vortioxetina Viatris
Possible side effects
How to store Vortioxetina Viatris
Package contents and other information

1. What Vortioxetina Viatris is and what it is used for

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

2. What you need to know before taking Vortioxetine Viatris

Do not take Vortioxetine Viatris

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 Viatris if:

you are taking medicines with a so-called serotoninergic 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 Viatris 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 diarrhoea.
you have had seizures (epileptic fits). Your doctor will treat you with caution if you have had previous seizures or if you have unstable seizure/epilepsy disorders. Seizures are a potential risk associated with medicines used in the treatment of depression. Treatment must be discontinued in patients who develop seizures or experience an increase in seizure frequency.
you have had manic episodes.
you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
you have low levels of sodium in your blood.
you are aged 65 years or older.
you have severe kidney disease.
you have severe liver disease or a liver condition called cirrhosis.
you have or have had increased intraocular pressure or glaucoma. If you experience eye pain or blurred vision during treatment, contact your doctor.

When 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 sometimes think about harming yourself or committing suicide. These
thoughts may increase at the beginning of treatment with antidepressants, as these medicines
require time to become effective, usually 2 weeks but sometimes longer.
You are more likely to have these thoughts if:

you have previously thought about killing yourself or harming yourself
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 hospital immediately. It may help to tell a relative 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 Viatris in children and adolescents aged between 7 and 17 years is described in section 4.
Other medicines and Vortioxetine Viatris
Tell 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, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines for the treatment of depression known as non-selective monoamine oxidase inhibitors, MAOIs); you must not take any of these medicines together with Vortioxetine Viatris. If you have taken these medicines, you must wait 14 days before starting Vortioxetine Viatris. After stopping Vortioxetine Viatris, you must wait 14 days before taking these medicines.
moclobemide (a medicine for the treatment of depression)
selegiline and rasagiline (medicines for the treatment of Parkinson’s disease)
linezolid (an antibiotic)
medicines with a serotoninergic effect, 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 Viatris may increase the risk of serotonin syndrome (see section Warnings and precautions)
lithium (a medicine for the treatment of 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 for the treatment of epilepsy and other conditions)
warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to make the blood thinner 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 to prevent and treat malaria)
bupropion (a medicine for the treatment of depression and to stop smoking)
fluoxetine, paroxetine and other medicines for the treatment of depression called SSRIs/SNRIs, tricyclics
St John’s wort (Hypericum perforatum) (a herbal medicine for the treatment of depression)
quinidine (a medicine for the treatment of heart rhythm disorders)
chlorpromazine, chlorprothixene, haloperidol (medicines for the treatment of mental disorders belonging to the group of so-called phenothiazines, thioxanthene, butyrophenones).

Inform your doctor if you are taking any of the medicines listed above, as you need to know whether you are already at risk of seizures.
If you undergo urine testing for drug screening, taking Vortioxetine Viatris may cause false positive results for methadone when certain analytical methods are used, even if you are not taking methadone. If this occurs, a more specific test can be performed.
Vortioxetine Viatris and alcohol
It is not recommended to take Vortioxetine Viatris with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Vortioxetine Viatris must not be used during pregnancy unless your doctor has determined it is absolutely necessary.
If you take medicines to treat depression, including Vortioxetine Viatris, during the last 3 months of your pregnancy, you should be aware that the following effects may occur in your newborn baby:
breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, stiff or floppy muscles, overactive reflexes, tremors, nervousness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. Contact your doctor immediately if your newborn shows any of these symptoms.
Ensure that your midwife and/or doctor know that you are taking Vortioxetine Viatris. When taken during pregnancy, particularly during the last 3 months, medicines like Vortioxetine Viatris 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 Vortioxetine Viatris close to 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 Vortioxetine Viatris so they can advise you on what to do.
Breastfeeding
It is expected that components of Vortioxetine Viatris pass into breast milk. Vortioxetine Viatris must not be taken during breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop treatment with Vortioxetine Viatris, based on an assessment of the benefits of breastfeeding for the child and the benefits of therapy for you.
Driving and using machines
Vortioxetine Viatris does not affect or has a negligible effect on the ability to drive or use machines. However, as side effects such as dizziness have been reported, caution is advised when performing these activities, especially when starting treatment with Vortioxetine Viatris or when changing the dose.
Vortioxetine Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Vortioxetina Viatris

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Vortioxetina Viatris for adults under 65 years of age is 10 mg of vortioxetina taken as a single daily dose. Your doctor may increase the dose up to a maximum of 20 mg of vortioxetina per day or reduce it down to a minimum of 5 mg of vortioxetina per day, depending on your response to treatment.
For elderly patients aged 65 years or older, the initial dose is 5 mg of vortioxetina taken as a single daily dose.

Method of administration
Take one tablet with a glass of water.
The tablet can be taken with or without food.

Duration of treatment
Continue taking Vortioxetina Viatris for as long as your doctor recommends.
Keep taking Vortioxetina Viatris 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 feel well again.

If you take more Vortioxetina Viatris than you should
If you take more Vortioxetina Viatris 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 may include dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, drowsiness, and flushing.
Following ingestion of doses several times higher than the prescribed dose, seizures (epileptic fits) and a rare condition called serotonin syndrome have been reported.

If you forget to take Vortioxetina Viatris
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 Vortioxetina Viatris
Do not stop taking Vortioxetina Viatris without first discussing it with your doctor.
Your doctor may decide to gradually reduce the dose before stopping treatment completely.
Some patients who have discontinued treatment with Vortioxetina Viatris have reported symptoms such as dizziness, headache, sensations like pins and needles or electric shocks (especially in the head), difficulty sleeping, feeling unwell or nausea, anxiety, irritability or agitation, tiredness, or tremor. These symptoms may occur within the first week after stopping Vortioxetina Viatris.

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 all over the body
abnormal dreams
increased sweating
indigestion

Uncommon: may affect up to 1 in 100 people

flushing
night sweats
blurred vision
involuntary shaking (tremor)

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 dizziness, weakness, confusion, drowsiness or increased fatigue, 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 (dizziness or feeling faint)
hives
excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal or vaginal bleeding)
rash
sleep disturbances (insomnia)
agitation and aggression. 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 (an urge to move the legs to relieve painful or strange sensations, often occurring at night)
abnormal milk secretion 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 been observed at 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 observed more frequently than in adults, and suicidal thoughts, which were observed 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 . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vortioxetine Viatris

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, bottle or blister after "EXP" or "Scad.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Viatris contains

The active substance is vortioxetine. Each film-coated tablet contains 5 mg, 10 mg, 15 mg or 20 mg of vortioxetine (as hydrobromide).
The other components in Vortioxetine Viatris 5 mg film-coated tablets are: mannitol, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol and red iron oxide (E172).
The other components in Vortioxetine Viatris 10 mg film-coated tablets are: mannitol, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol and yellow iron oxide (E172).
The other components in Vortioxetine Viatris 20 mg film-coated tablets are: mannitol, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol and red iron oxide (E172).

Description of the appearance of Vortioxetine Viatris and package contents
Vortioxetine Viatris 5 mg are oval-shaped, pink, film-coated tablets, marked with “5” on one side and plain on the other side.
Vortioxetine Viatris 10 mg are oval-shaped, yellow, film-coated tablets, marked with “10” on one side and plain on the other side.
Vortioxetine Viatris 20 mg are oval-shaped, red, film-coated tablets, marked with “20” on one side and plain on the other side.

Vortioxetine Viatris 5 mg film-coated tablets are available in:

blister packs containing 28, 30 or 56 tablets
unit-dose divisible blister packs containing 14 × 1, 28 × 1 or 30 × 1 tablets.

Vortioxetine Viatris 10 mg and 20 mg film-coated tablets are available in:

blister packs containing 28, 30, 56 or 98 tablets
unit-dose divisible blister packs containing 28 × 1 or 30 × 1 tablets.

Vortioxetine Viatris 5 mg, 10 mg and 20 mg film-coated tablets are also available in:

bottles with a screw cap and silica gel as desiccant, containing 100 tablets. Do not ingest the desiccant.

Marketing Authorization Holder
Mylan S.p.A
Via Vittor Pisani, 20
20124 Milano, Italy

Manufacturer
ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95,
Pikermi Attiki, 19009,
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Czech Republic and Slovak Republic: Vortioxetin Viatris
Denmark, Finland, Iceland, Norway, the Netherlands and Sweden: Vortioxetine Viatris
France: VORTIOXETINE VIATRIS
Italy and Spain: Vortioxetina Viatris
Portugal: Vortioxetina Mylan