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
Vortioxetinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Vortioxetine Viatris Pharma is and what it is used for
2. What you need to know 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 Vortioxetine Viatris Pharma is and what it is 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 (reduced amount of sleep), decreased appetite, difficulty concentrating, feelings of worthlessness, loss of interest in performing usual activities, and feelings of sluggishness.

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 medicines for depression known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. If in doubt, consult a doctor.

Warnings and precautions
Before starting treatment with Vortioxetine Viatris Pharma, talk to a doctor or pharmacist if the patient:

• is 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 Viatris Pharma may increase the risk of developing serotonin syndrome. This syndrome may present with hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea and diarrhoea;
• has experienced seizures (epileptic fits). Treatment will be conducted with caution if the patient has had seizures or currently has unstable seizures/epilepsy. Treatment with antidepressants carries a risk of seizures. Treatment should be discontinued in any patient in whom seizures occur for the first time or increase in frequency;
• has experienced mania;
• has a tendency to bleeding or bruising, or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”);
• has low sodium levels in the blood;
• is 65 years of age or older;
• has severe kidney disease;
• has severe liver disease or liver disease known as cirrhosis;
• currently has or has previously had increased pressure in the eye or glaucoma. If eye pain or blurred vision occurs during treatment, contact a doctor.

Patients taking antidepressants, including vortioxetine, may also experience feelings of aggression, agitation, anger and irritability. In such a case, consult a doctor.
Suicidal thoughts and worsening of depression
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or suicide. These thoughts may intensify after starting treatment with antidepressants, as all these medicines take some time to take effect, usually about two weeks, and sometimes longer.
The occurrence of suicidal thoughts is more likely if:

• the patient has previously experienced thoughts of self-harm or suicide;
• the patient is a young adult.

Clinical data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants.
If the patient ever experiences thoughts of self-harm or suicide, they should contact a doctor immediately or go to hospital. It may be helpful to inform family members 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 worsening of depression or anxiety or concerning changes in the patient’s behaviour.
Children and adolescents
Vortioxetine Viatris Pharma should not be used in children and adolescents (under 18 years of age) due to 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 and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

• phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines used to treat depression, known as non-selective monoamine oxidase inhibitors); none of these medicines should be used together with Vortioxetine Viatris Pharma. If the patient has taken any of these medicines, they must wait 14 days before starting Vortioxetine Viatris Pharma. After stopping treatment with Vortioxetine Viatris Pharma, wait 14 days before starting 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);
• serotonergic medicines, e.g. tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines whose active substance names end in “triptans” (used to treat migraine). 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 psychiatric 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 conditions);
• warfarin, dipyridamole, phenprocoumon, some antipsychotics, phenothiazines, tricyclic antidepressants, low-dose acetylsalicylic acid and non-steroidal anti-inflammatory drugs (blood-thinning medicines and medicines used to relieve pain). These may increase the tendency to bleed.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines containing an active substance with a name ending in “triptan”;
• tramadol (a strong painkiller);
• mefloquine (a medicine used for prevention and treatment of malaria);
• bupropion (a medicine used to treat depression and also in people quitting smoking);
• fluoxetine, paroxetine and other medicines used to treat depression, known as SSRIs/SNRIs, tricyclic medicines;
• St John’s wort (Hypericum perforatum) (a herbal remedy used to treat depression);
• quinidine (a medicine used to treat heart rhythm disorders);
• chlorpromazine, chlorprothixene, haloperidol (medicines used in psychiatric disorders belonging to groups called phenothiazines, thioxanthenes, butyrophenones).

Inform the treating doctor about taking any of the above-mentioned medicines, as the treating doctor should be aware that the patient is already at risk of seizures.
If urine screening tests are performed 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
Concomitant use of this medicine and alcohol is not recommended.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before taking this medicine.
Pregnancy
Vortioxetine Viatris Pharma should not be used during pregnancy unless the 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 newborn experiencing the following symptoms: breathing difficulties, bluish skin colour, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels, muscle stiffness or floppiness, exaggerated reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleep disturbances. If any of these symptoms occur in the newborn, contact a doctor immediately.
Inform the midwife and (or) doctor about taking Vortioxetine Viatris Pharma. Medicines such as Vortioxetine Viatris Pharma used during pregnancy, especially during the last three months, may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN), causing rapid breathing and bluish skin in the child. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, inform the midwife and (or) doctor immediately.
Taking Vortioxetine Viatris Pharma towards the end of pregnancy may increase the risk of severe vaginal bleeding occurring shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Vortioxetine Viatris Pharma, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
It is expected that components of Vortioxetine Viatris Pharma will pass into breast milk. Vortioxetine Viatris Pharma should not be used during breastfeeding. The doctor will decide whether the patient should discontinue breastfeeding or stop taking Vortioxetine Viatris Pharma, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and using machines
Vortioxetine Viatris Pharma has no effect or negligible effect 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 a dose change, as adverse 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, meaning the medicine is considered “sodium-free”.

3. How to take Vortioxetine Viatris Pharma

This medicine should always be taken as directed by the physician. In case of any doubts, consult
your doctor or pharmacist.

The recommended dose of Vortioxetine Viatris Pharma is 10 mg of vortioxetine as a single daily dose
in adults under 65 years of age. Your doctor may increase the dose up to a maximum of
20 mg vortioxetine per day or reduce it to the minimum dose of 5 mg vortioxetine per day,
depending on the patient's response to treatment.

For patients aged 65 years 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 may be taken with or without food.

Duration of treatment
Continue taking Vortioxetine Viatris Pharma for as long as your doctor recommends.
Continue taking Vortioxetine Viatris Pharma even if you do not feel improvement for some time.
Treatment should be continued for at least 6 months after you start feeling better.

If you take more Vortioxetine Viatris Pharma than prescribed
If you have taken more than the prescribed dose of Vortioxetine Viatris Pharma, contact your doctor immediately or go to the nearest hospital emergency department.
Take the medicine packaging and any remaining tablets with you. Do this even if no discomfort symptoms are present. Symptoms of overdose may include dizziness, nausea, diarrhoea, stomach discomfort, itching of the whole body, drowsiness, and facial flushing.
Seizures and a rare condition called serotonin syndrome have been reported after ingestion of doses several times higher than the recommended dose.

If you miss a dose of Vortioxetine Viatris Pharma
Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

Stopping Vortioxetine Viatris Pharma
Do not stop taking Vortioxetine Viatris Pharma without consulting your doctor.
Your doctor may decide to gradually reduce the dose before completely stopping this medicine.
Some patients who stopped taking Vortioxetine Viatris Pharma experienced symptoms such as dizziness, headache, prickling or tingling sensations like pins and needles or electric shocks (especially in the head), inability to sleep, nausea or vomiting, feelings of anxiety, irritability or agitation, fatigue, or tremor.
These symptoms may occur within the first week after stopping Vortioxetine Viatris Pharma.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Observed adverse reactions were generally mild to moderate and occurred during the first two weeks of treatment. Reactions were usually transient and did not lead to discontinuation of treatment.

The adverse reactions listed below have been reported at 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;
• unusual dreams;
• excessive sweating;
• indigestion.

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

• flushing of the face;
• night sweats;
• blurred vision;
• involuntary muscle twitching;
• hallucinations (seeing, hearing or feeling things that are not there).

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

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

Frequency not known (frequency cannot be estimated from the available data):

• low levels of sodium in the blood (symptoms may include dizziness, weakness, confusion, drowsiness, severe fatigue, nausea or vomiting; more serious symptoms include fainting, seizures or falls);
• serotonin syndrome (see section 2);
• allergic reactions, which may be severe, causing swelling of the face, lips, tongue or throat, difficulty breathing or swallowing and/or sudden drop in blood pressure (causing dizziness or a feeling of emptiness in the head);
• urticaria;
• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding and vaginal bleeding);
• rash;
• sleep problems (insomnia);
• restlessness and aggression. If any of these adverse reactions occur, contact your doctor (see section 2).
• headache;
• increased levels of a hormone called prolactin in the blood;
• constant need for movement (akathisia);
• teeth grinding (bruxism);
• inability to open the mouth (trismus);
• restless legs syndrome (an urge to move the legs to prevent painful or strange sensations, often occurring at night);
• milky discharge from the breasts (galactorrhoea).

In patients taking medicines of this type, an increased risk of bone fractures has been observed.
An increased risk of sexual dysfunction has been reported at a dose of 20 mg, and in some patients, this adverse reaction was observed even after administration of lower doses.

Additional adverse reactions in children and adolescents
Adverse reactions with vortioxetine in children and adolescents were similar to those observed in adults, except for abdominal pain events, which were reported more frequently than in adults, and suicidal thoughts, which occurred more frequently in adolescents than in adults.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions 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 stated on the carton or
blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such 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 carboxymethyl starch (type A), hydroxypropylcellulose, magnesium stearate, 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 carboxymethyl starch (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 carboxymethyl starch (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 carboxymethyl starch (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 plain on the other side.
Vortioxetine Viatris Pharma 10 mg are yellow, oval film-coated tablets, with the number “10” embossed on one side and plain on the other side.
Vortioxetine Viatris Pharma 15 mg are orange, round film-coated tablets, with the number “15” embossed on one side and plain on the other side.
Vortioxetine Viatris Pharma 20 mg are red, oval film-coated tablets, with the number “20” embossed on one side and plain on the other side.

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

• packs containing 28 or 56 film-coated tablets in blisters.
• packs containing 14 x 1 or 28 x 1 film-coated tablets in perforated blister strips, divided into single doses.

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

• packs containing 28 or 56 film-coated tablets in blisters.
• packs containing 28 x 1 film-coated tablets in perforated blister strips, divided into single doses.

Not all pack sizes may be marketed.

Marketing Authorisation 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, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00

This medicinal product is authorised in the European Economic Area under the following names:
Croatia, Hungary and the Netherlands: VORTIOXETINE VIATRIS PHARMA
Greece: Vortioxetine/ Viatris
Poland: Vortioxetine Viatris Pharma
Portugal: Vortioxetina Anova