Vortioxetine Viatris Pharma

Package Leaflet: Information for the Patient

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

• You should keep this leaflet, so you can read it again if you need to.
• 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 improves several symptoms of depression, including sadness,
inner restlessness (feeling anxious), sleep disturbances (less sleep), reduced appetite,
difficulties concentrating, feeling of worthlessness, loss of interest in activities you used to enjoy, feeling slowed down.

2. Important information before taking Vortioxetine Viatris Pharma

When not to take Vortioxetine Viatris Pharma

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

Warnings and precautions

Before starting to take Vortioxetine Viatris Pharma, tell your doctor or pharmacist 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 with "triptan" (used to treat migraine). Taking these medicines 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 done with caution if you have had seizures or if you currently have uncontrolled seizures/epilepsy. The use of antidepressants carries a risk of seizures. Treatment should be discontinued in any patient who develops seizures or has an increase in seizure frequency;
• have had mania;
• have a tendency to bleed or bruise, or if you are 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, you should contact your doctor.

Patient taking antidepressants, 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 the use of antidepressants, as all these medicines start working only after some time, 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.

Clinical trial data indicate an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressants.
If you ever have thoughts of self-harm or suicide, you should immediately contact your doctor 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 can ask them to tell you if they notice that your depression or anxiety disorders have worsened or if there are worrying changes in your 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 demonstrated efficacy. The safety of Vortioxetine Viatris Pharma in children and adolescents aged 7 to 17 years is described in section 4.

Vortioxetine Viatris Pharma with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as 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, known as non-selective monoamine oxidase inhibitors); you must not take any of these medicines with Vortioxetine Viatris Pharma. If you have taken any of these medicines, you must wait 14 days before starting to take Vortioxetine Viatris Pharma. After stopping treatment with Vortioxetine Viatris Pharma, you must 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 (an antibiotic);
• medicines with a serotonergic effect, such as tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines whose active substance names end with "triptan" (used to treat migraine). Taking these medicines 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 (an antibiotic used to treat tuberculosis and other infections);
• carbamazepine, phenytoin (medicines used to treat epilepsy and other conditions);
• warfarin, dipyridamole, phenprocoumon, certain antipsychotic medicines, phenothiazines, tricyclic antidepressants, aspirin in low doses, and non-steroidal anti-inflammatory medicines (blood thinners and painkillers). They may increase the risk of bleeding.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines whose active substance names end with "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 SSRIs/SNRIs, tricyclic antidepressants;
• St. John's Wort (Hypericum perforatum) (a medicine used to treat depression);
• quinidine (a medicine used to treat irregular heart rhythms);
• chlorpromazine, chlorprothixene, haloperidol (medicines used to treat mental disorders, belonging to the group of medicines known as phenothiazines, thioxanthenes, and 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.
If you are taking Vortioxetine Viatris Pharma and a urine screening test is performed, a positive result for methadone may occur with certain analytical methods, even if you are not taking methadone. In such cases, 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Vortioxetine Viatris Pharma should not be used during pregnancy unless your doctor considers it absolutely necessary.
Women who have taken antidepressants, including Vortioxetine Viatris Pharma, during the last three months of pregnancy 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, you should contact your doctor immediately.
Tell your midwife and/or doctor that you are taking Vortioxetine Viatris Pharma. Medicines like Vortioxetine Viatris Pharma taken during pregnancy, especially during the last three months, may increase the risk of a serious condition 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, you should immediately tell your midwife and/or doctor.
Taking Vortioxetine Viatris Pharma at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Vortioxetine Viatris Pharma, you should inform your doctor or midwife so that they can give you appropriate advice.

Breastfeeding

It is expected that the ingredients of Vortioxetine Viatris Pharma will pass into breast milk. You should not take Vortioxetine Viatris Pharma while breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop taking Vortioxetine Viatris Pharma, considering the benefit of breastfeeding for your baby and the benefit of treatment for you.

Driving and using machines

Vortioxetine Viatris Pharma 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 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 it is essentially "sodium-free".

3. How to take Vortioxetine Viatris Pharma

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 Vortioxetine Viatris Pharma is 10 mg of vortioxetine in a single daily dose for adults under 65 years of age. Your doctor may increase the dose to a maximum of 20 mg of vortioxetine per day or decrease it to a minimum of 5 mg of vortioxetine per day, depending on your response to treatment.
For people 65 years of age or older, the starting 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.

Duration of treatment

Take Vortioxetine Viatris Pharma for as long as your doctor has prescribed.
Continue to take Vortioxetine Viatris Pharma 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 Vortioxetine Viatris Pharma than prescribed

If you have taken more Vortioxetine Viatris Pharma than prescribed, contact your doctor or go to the emergency department of your nearest hospital immediately. Take the medicine package and any remaining tablets with you. Do this even if you do not feel any discomfort. Symptoms of overdose are dizziness, nausea, diarrhea, stomach discomfort, 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 condition called serotonin syndrome have been reported.

Missing a dose of Vortioxetine Viatris Pharma

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

Stopping treatment with Vortioxetine Viatris Pharma

Do not stop taking Vortioxetine Viatris Pharma without talking to your doctor.
Your doctor may decide to gradually reduce the dose before stopping treatment with this medicine.
In some patients who stopped taking Vortioxetine Viatris Pharma, symptoms such as dizziness, headache, tingling or numbness (like "pins and needles"), or a feeling like an electric shock (especially in the head), insomnia, nausea, or vomiting, restlessness, irritability, or agitation, feeling tired or trembling have occurred. These symptoms may occur within the first week after stopping treatment with Vortioxetine Viatris Pharma.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vortioxetine Viatris Pharma can cause side effects, although not everybody gets them.
The observed side effects were generally 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 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;
• abnormal dreams;
• excessive sweating;
• indigestion.

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

• flushing;
• night sweats;
• blurred vision;
• involuntary muscle contractions.

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, 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 feeling faint);
• hives;
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding, and vaginal bleeding);
• rash;
• sleep disturbances (insomnia);
• agitation and aggression. If you experience these 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 (lockjaw/trismus);
• restless legs syndrome (an irresistible urge to move the legs, often accompanied by uncomfortable or unpleasant sensations, usually occurring in the evening);
• abnormal milk secretion from the breasts (galactorrhoea).

Patient taking medicines of this type have reported an increased risk of bone fractures.
Increased risk of sexual dysfunction 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 reported more frequently in adolescents than in adults.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Vortioxetine Viatris Pharma

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 and blister 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 Vortioxetine Viatris Pharma 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 ingredients in 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 in 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 in 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 in 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 is a pink, oval, film-coated tablet with "5" engraved on one side and smooth on the other side.
Vortioxetine Viatris Pharma 10 mg is a yellow, oval, film-coated tablet with "10" engraved on one side and smooth on the other side.
Vortioxetine Viatris Pharma 15 mg is an orange, round, film-coated tablet with "15" engraved on one side and smooth on the other side.
Vortioxetine Viatris Pharma 20 mg is a red, oval, film-coated tablet with "20" engraved 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
For further information about this medicine, contact the 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 package leaflet:

Croatia, Hungary, and the Netherlands
Greece
Poland