Vortioxetine Viatris Pharma

Leaflet accompanying the packaging: patient information

Vortioxetine Viatris Pharma, 5 mg, film-coated tablets

Vortioxetine Viatris Pharma, 10 mg, film-coated tablets

Vortioxetine Viatris Pharma, 15 mg, film-coated tablets

Vortioxetine Viatris Pharma, 20 mg, film-coated tablets

Vortioxetine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vortioxetine Viatris Pharma and what is it used for
• 2. Important information before taking Vortioxetine Viatris Pharma
• 3. How to take Vortioxetine Viatris Pharma
• 4. Possible side effects
• 5. How to store Vortioxetine Viatris Pharma
• 6. Contents of the pack and other information

1. What is Vortioxetine Viatris Pharma and what is it used for

Vortioxetine Viatris Pharma contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.
Vortioxetine Viatris Pharma is used to treat major depressive episodes in adults.
It has been shown that Vortioxetine Viatris Pharma alleviates many symptoms of depression, including sadness,
inner tension (feeling of anxiety), sleep disturbances (less sleep), decreased appetite,
difficulty concentrating, feeling of worthlessness, loss of interest in performing favorite activities, feeling of slowing down.

2. Important information before taking Vortioxetine Viatris Pharma

When not to take Vortioxetine Viatris Pharma

• 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 known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. In case of doubt, consult your doctor.

Warnings and precautions

Before starting to take Vortioxetine Viatris Pharma, the patient should talk to their doctor or pharmacist if they:

• are taking medicines with so-called serotonergic action, 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 together with Vortioxetine Viatris Pharma may increase the risk of serotonin syndrome. This syndrome can occur with hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhea;
• have had seizures (epileptic fits). Treatment will be carried out with caution if the patient has had seizures or if they currently have uncontrolled seizures/epilepsy. The use of 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;
• have experienced mania;
• have a tendency to bleed or bruise, or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility");
• have low sodium levels in the blood;
• are 65 years of age or older;
• have severe kidney disease;
• have severe liver disease or liver disease called cirrhosis;
• currently have or have had increased pressure in the eye or glaucoma. If eye pain and blurred vision occur during treatment, the patient should contact their doctor.

Patient taking antidepressant medicines, including vortioxetine, may also experience feelings of aggression, agitation, anger, and irritability. In such a situation, the patient should talk to their doctor.

Suicidal thoughts and depression worsening

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

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult.

Clinical trial data indicate an increased risk of suicidal behavior in adults under 25 years of age with mental illnesses treated with antidepressant medicines.
If the patient has ever had thoughts of self-harm or suicide, they should contact their doctor or go to the hospital immediately. It may be helpful to inform relatives 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 the depression or anxiety disorder has worsened or if there are worrying changes in the patient's behavior.

Children and adolescents

Vortioxetine Viatris Pharma should not be used in children and adolescents (under 18 years of age) due to the lack of proven efficacy of its use. The safety of Vortioxetine Viatris Pharma in children and adolescents aged 7 to 17 years is described in section 4.

Vortioxetine Viatris Pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should tell their doctor if they are taking any of the following medicines:

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines used to treat depression, known as non-selective monoamine oxidase inhibitors); these medicines should not be taken with Vortioxetine Viatris Pharma. If the patient has taken any of these medicines, they must wait 14 days before starting to take Vortioxetine Viatris Pharma. After stopping treatment with Vortioxetine Viatris Pharma, the patient should wait 14 days before taking 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);
• medicines with serotonergic action, such as tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines whose active substance names end in "triptan" (used to treat migraines). Taking these medicines together with Vortioxetine Viatris Pharma may increase the risk of serotonin syndrome (see section "Warnings and precautions");
• lithium (a medicine used to treat depression and mental disorders) or tryptophan;
• medicines that lower sodium levels;
• rifampicin (a medicine used to treat tuberculosis and other infections);
• carbamazepine, phenytoin (medicines used to treat epilepsy and other diseases);
• warfarin, dipyridamole, phenprocoumon, some antipsychotic medicines, phenothiazines, tricyclic antidepressants, acetylsalicylic acid in small doses, and non-steroidal anti-inflammatory medicines (medicines that thin the blood and medicines used to relieve pain). They 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, known as SSRI/SNRI, tricyclic medicines;
• St. John's Wort (Hypericum perforatum) (a 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 of medicines known as phenothiazines, thioxanthenes, and butyrophenones).

The patient should tell their doctor about taking any of the above medicines, as their doctor should know that the patient is already at risk of seizures.
If the patient is undergoing a urine screening test while taking Vortioxetine Viatris Pharma, a positive result for methadone may occur with certain analytical methods, even if the patient is not taking methadone. In such a case, a more specific test can be performed.

Taking Vortioxetine Viatris Pharma with alcohol

It is not recommended to take this medicine with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy

Vortioxetine Viatris Pharma should not be used during pregnancy unless the doctor considers it absolutely necessary.
Patient who have taken antidepressant medicines during the last three months of pregnancy, including Vortioxetine Viatris Pharma, should be aware of the risk of the following symptoms in the newborn:
breathing difficulties, blue discoloration of the skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, trembling, tremors, irritability, lethargy, constant crying, sleepiness, and sleep disturbances. If the newborn experiences any of these symptoms, the patient should contact their doctor immediately.
The patient should inform their midwife and/or doctor about taking Vortioxetine Viatris Pharma. Medicines like Vortioxetine Viatris Pharma used during pregnancy, especially during the last three months, may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN), causing rapid breathing and blue discoloration of the skin in the baby.
These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, the patient should tell their midwife and/or doctor immediately.
Taking Vortioxetine Viatris Pharma at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after birth, especially if the patient has a history of bleeding disorders. If the patient is taking Vortioxetine Viatris Pharma, they should inform their doctor or midwife so that they can provide appropriate advice.

Breastfeeding

It is expected that the ingredients of Vortioxetine Viatris Pharma will pass into human milk. Vortioxetine Viatris Pharma should not be used during breastfeeding. The doctor will decide whether the patient should stop breastfeeding or stop taking Vortioxetine Viatris Pharma, considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

Vortioxetine Viatris Pharma has no or negligible influence on the ability to drive and use machines. However, caution is advised when performing these activities after starting treatment with Vortioxetine Viatris Pharma or after changing the dose, as side effects such as dizziness have been reported.

Vortioxetine Viatris Pharma contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Vortioxetine Viatris Pharma

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose of Vortioxetine Viatris Pharma is 10 mg of vortioxetine in a single daily dose for adults under 65 years of age. The doctor may increase the dose of Vortioxetine Viatris Pharma to a maximum of 20 mg of vortioxetine per day or decrease it to a minimum dose of 5 mg of vortioxetine per day, depending on the patient's response to treatment.
For patients 65 years of age or older, the initial dose is 5 mg of vortioxetine once daily.

Method of administration

The patient should take one tablet, with a glass of water. The tablet can be taken with or without food.

Duration of treatment

The patient should take Vortioxetine Viatris Pharma for as long as their doctor has prescribed.
The patient should continue to take Vortioxetine Viatris Pharma even if they do not feel better for some time.
Treatment should be continued for at least 6 months after the patient feels better.

Taking a higher dose of Vortioxetine Viatris Pharma than prescribed

If the patient has taken a higher dose of Vortioxetine Viatris Pharma than prescribed, they should contact their doctor or go to the emergency department of the nearest hospital immediately. The patient should take the medicine packaging and any remaining tablets with them. The patient should do this even if they do not feel any discomfort. Symptoms of overdose are dizziness, nausea, diarrhea, discomfort in the stomach, itching all over the body, sleepiness, and flushing of the face.
After taking doses several times higher than the recommended dose, seizures and a rare disease called serotonin syndrome have been reported.

Missing a dose of Vortioxetine Viatris Pharma

The patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Vortioxetine Viatris Pharma

The patient should not stop taking Vortioxetine Viatris Pharma without consulting their doctor.
The doctor may decide to reduce the dose before finally stopping treatment with this medicine.
In some patients who stopped taking Vortioxetine Viatris Pharma, symptoms such as dizziness, headache, tingling like pins and needles or electric shock-like sensations (especially in the head), inability to sleep, nausea, or vomiting, restlessness, irritability, or agitation, feeling of tiredness or trembling have occurred.
These symptoms may occur within the first week after stopping treatment with Vortioxetine Viatris Pharma.
If the patient has any further doubts about the use of this medicine, they should consult their 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 usually mild to 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 have been reported with the following frequency.

• 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;
• abnormal dreams;
• excessive sweating;
• indigestion.

Uncommon (may affect up to 1 in 100 people):

• flushing of the face;
• 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 (frequency cannot be estimated from the available data):

• low sodium levels in the blood (symptoms may include dizziness, weakness, disorientation, sleepiness, extreme fatigue, nausea, or vomiting; more serious symptoms include 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 a feeling of emptiness in the head);
• hives;
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding, and vaginal bleeding);
• rash;
• sleep disturbances (insomnia);
• agitation and aggression. If these side effects occur, the patient should contact their 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 (lockjaw/trismus);
• restless legs syndrome (an urge to move the legs to stop unpleasant feelings, often occurring at night);
• abnormal milk secretion from the breasts (galactorrhea).

Patient taking medicines of this type have been observed to have an increased risk of bone fractures.
Increased risk of sexual disorders has been reported at a dose of 20 mg, and in some patients, this side effect has been observed 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Vortioxetine Viatris Pharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vortioxetine Viatris Pharma contains

• The active substance of the medicine is vortioxetine. Each film-coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of vortioxetine (as hydrobromide).
• The other ingredients of the 5 mg film-coated tablets are: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, magnesium stearate, and hypromellose 2910, titanium dioxide (E171), macrogol 400, and iron oxide red (E172).
• The other ingredients of the 10 mg film-coated tablets are: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, magnesium stearate, hypromellose 2910, titanium dioxide (E171), macrogol 400, and iron oxide yellow (E172).
• The other ingredients of the 15 mg film-coated tablets are: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, magnesium stearate, hypromellose 2910, titanium dioxide (E171), macrogol 400, iron oxide yellow (E172), and iron oxide red (E172).
• The other ingredients of the 20 mg film-coated tablets are: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, magnesium stearate, hypromellose 2910, titanium dioxide (E171), talc, macrogol 8000, and iron oxide red (E172).

What Vortioxetine Viatris Pharma looks like and contents of the pack

Vortioxetine Viatris Pharma 5 mg are pink, oval, film-coated tablets with the number "5" embossed on one side and smooth on the other side.
Vortioxetine Viatris Pharma 10 mg are yellow, oval, film-coated tablets with the number "10" embossed on one side and smooth on the other side.
Vortioxetine Viatris Pharma 15 mg are orange, round, film-coated tablets with the number "15" embossed on one side and smooth on the other side.
Vortioxetine Viatris Pharma 20 mg are red, oval, film-coated tablets with the number "20" embossed on one side and smooth on the other side.
Vortioxetine Viatris Pharma 5 mg film-coated tablets are available in:

• blister packs containing 28 tablets.
• perforated unit dose blister packs containing 14 x 1 or 28 x 1 tablets.

Vortioxetine Viatris Pharma 10 mg, 15 mg, and 20 mg film-coated tablets are available in:

• blister packs containing 28 tablets.
• perforated unit dose blister packs containing 28 x 1 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin
Dublin 15
Ireland

Manufacturer

ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95
190 09 Pikermi, Attiki
Greece
To obtain more detailed information on the medicine, the patient should contact their local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00

The medicine has been authorized in the Member States of the European Economic Area under the following names:

VORTIOXETINE VIATRIS PHARMA
Vortioxetine/ Viatris
Vortioxetine Viatris Pharma
Portugal
Vortioxetina Anova

Date of last revision of the leaflet:

Croatia, Hungary, and the Netherlands
Greece
Poland