Vortioxetine stada

Package leaflet: Information for the user

Vortioxetine Stada, 5 mg, film-coated tablets
Vortioxetine Stada, 10 mg, film-coated tablets
Vortioxetine Stada, 15 mg, film-coated tablets
Vortioxetine Stada, 20 mg, film-coated tablets
Vortioxetinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• 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.

Leaflet contents

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

1. What Vortioxetine Stada is and what it is used for

Vortioxetine Stada contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.
This medicine is used to treat major depressive episodes in adults.
Vortioxetine has been shown to relieve 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 favourite activities, and feeling slowed down.

2. Important information before taking Vortioxetine Stada

When not to take Vortioxetine Stada:

• 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 Stada, talk to your doctor or pharmacist:

• if the patient is taking medicines with so-called serotonergic activity, 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 Stada may increase the risk of serotonin syndrome. This syndrome may present with hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea and diarrhoea;
• if the patient has had seizures (epileptic fits). Treatment will be carried out with caution if the patient has experienced seizures or if seizures/epilepsy are currently unstable. Treatment with antidepressants carries a risk of seizures. Treatment should be discontinued in any patient who experiences seizures for the first time or whose seizure frequency increases;
• if the patient has experienced mania;
• if the patient has a tendency to bleed or bruise easily, or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”);
• if the patient has low sodium levels in the blood;
• if the patient is 65 years of age or older;
• if the patient has severe kidney disease;
• if the patient has severe liver disease or liver disease known as cirrhosis;
• if the patient currently has or has previously had increased pressure in the eye or glaucoma. If during treatment eye pain or blurred vision occurs, contact a doctor.

Patients taking antidepressants, including vortioxetine, may also experience feelings of aggression, agitation, anger and irritability. In such cases, consult your doctor.
Suicidal thoughts and worsening of depression
Patients with depression and (or) anxiety disorders may occasionally experience thoughts of self-harm or suicide. These thoughts may intensify after starting treatment with antidepressants, as all these medicines take some time to become effective, 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 trial 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 their 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 depression or anxiety, or concerning changes in the patient’s behaviour.
Children and adolescents
Vortioxetine should not be used in children and adolescents (under 18 years of age) due to lack of demonstrated efficacy. The safety of Vortioxetine Stada in children and adolescents aged 7 to 17 years is described in section 4.
Vortioxetine Stada and other medicines
Tell your 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.
Tell your 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 must be taken together with Vortioxetine Stada. If the patient has taken any of these medicines, a 14-day interval must be observed before starting Vortioxetine Stada. After stopping treatment with Vortioxetine Stada, a 14-day interval must be observed 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 Stada 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 (medicines that 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 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 antidepressants.
• 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 known as 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.
Drug screening tests
If the patient undergoes urine drug screening while taking Vortioxetine Stada, a positive result for methadone may occur with certain analytical methods, even if the patient is not taking methadone. In such cases, a more specific test can be performed.
Use of Vortioxetine Stada 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 her doctor before taking this medicine.
Pregnancy
This medicine should not be used during pregnancy unless the doctor considers it absolutely necessary.
Women who have taken antidepressants, including Vortioxetine Stada, during the first 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, increased reflexes, tremors, shakiness, irritability, lethargy, constant crying, drowsiness and sleep difficulties. If any of these symptoms occur in the newborn, contact a doctor immediately.
Inform the midwife and (or) doctor about taking Vortioxetine Stada.
Medicines such as Vortioxetine Stada taken 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 baby. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, inform the midwife and (or) doctor immediately.
Taking this medicine towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking this medicine, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
It is expected that components of this medicine will pass into breast milk. Vortioxetine Stada should not be used during breastfeeding. The doctor will decide whether the patient should discontinue breastfeeding or stop taking this medicine, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery. However, caution is advised when performing these activities after starting treatment with Vortioxetine Stada or after changing the dose, as adverse effects such as dizziness have been reported.
Vortioxetine Stada contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Vortioxetine Stada

This medicine should always be taken exactly as directed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
The recommended dose of Vortioxetine Stada is 10 mg of vortioxetine as a single daily dose
in adults under 65 years of age. Your doctor may increase the dose of this medicine 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.
Use in elderly patients
For patients aged 65 years or older, the initial dose is 5 mg vortioxetine once daily.
Method of administration
Take one tablet with a glass of water.
The tablet may be taken with or without food.
If a patient is unable to swallow the tablet whole, other medicines containing vortioxetine in different
pharmaceutical forms may be available on the market.
Duration of treatment
You should continue taking this medicine for as long as your doctor has instructed.
Continue taking this medicine even if you do not feel improvement for some time.
Treatment should be continued for at least 6 months after you start feeling better.
Taking more Vortioxetine Stada than recommended
If you have taken more Vortioxetine Stada than prescribed, 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 you do not have any symptoms of discomfort. Symptoms of overdose include
dizziness, nausea, diarrhoea, stomach discomfort, itching of the whole body, drowsiness and facial flushing.
After ingestion of doses several times higher than recommended, seizures and a rare condition called
serotonin syndrome have been reported.
Missing a dose of Vortioxetine Stada
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Vortioxetine Stada
Do not stop taking Vortioxetine Stada without consulting your doctor.
Your doctor may decide to reduce the dose before stopping this medicine completely.
In some patients who have discontinued vortioxetine, symptoms such as dizziness, headache,
pins and needles sensation or electric shock-like feelings (especially in the head), inability to sleep,
nausea or vomiting, feeling of restlessness, irritability or agitation, feeling of fatigue or tremor have occurred.
These symptoms may occur within the first week after stopping this medicine.
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 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
• unusual dreams
• excessive sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

• flushing (redness of the face)
• night sweats
• blurred vision
• involuntary muscle tremors

Rare: may affect up to 1 in 1000 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 sodium levels 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 (hives)

• excessive or unexplained bleeding (including bruising, nosebleeds, gastrointestinal bleeding and vaginal bleeding)

• rash

• sleep problems (insomnia)

• agitation and aggression. If these adverse reactions occur, contact your doctor (see section 2)

• headache

• increased blood levels of a hormone called prolactin

• constant 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 unusual sensations, often occurring at night)

• milky discharge from the breast (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 with the 20 mg dose, and in some patients this adverse reaction was observed even with 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, which was reported more frequently than in adults, and suicidal thoughts, which were observed more frequently in adolescents than in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly via the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected. Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Vortioxetine Stada

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month. There are no special storage
instructions 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 help protect the environment.

6. Contents of the pack and other information

What Vortioxetine Stada contains
Vortioxetine Stada 5 mg, film-coated tablets

• The active substance is vortioxetine. Each film-coated tablet contains 5 mg of vortioxetine (as hydrobromide).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPa·s), polyethylene glycol 400, titanium dioxide (E171), and iron oxide red (E172) in the tablet coating.

Vortioxetine Stada 10 mg, film-coated tablets

• The active substance is vortioxetine. Each film-coated tablet contains 10 mg of vortioxetine (as hydrobromide).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPa·s), polyethylene glycol 400, titanium dioxide (E171), and iron oxide yellow (E172) in the tablet coating.

Vortioxetine Stada 15 mg, film-coated tablets

• The active substance is vortioxetine. Each film-coated tablet contains 15 mg of vortioxetine (as hydrobromide).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPa·s), polyethylene glycol 400, titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172) in the tablet coating.

Vortioxetine Stada 20 mg, film-coated tablets

• The active substance is vortioxetine. Each film-coated tablet contains 20 mg of vortioxetine (as hydrobromide).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethyl starch (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPa·s), polyethylene glycol 400, titanium dioxide (E171), and iron oxide red (E172) in the tablet coating.

What Vortioxetine Stada looks like and contents of the pack
Vortioxetine Stada 5 mg film-coated tablets
Pink, oval (11 mm x 5 mm), biconvex film-coated tablet with "5" engraved on one side.
Vortioxetine Stada 10 mg film-coated tablets
Yellow, oval (13 mm x 6 mm), biconvex film-coated tablet with "10" engraved on one side.
Vortioxetine Stada 15 mg film-coated tablets
Light orange, oval (15 mm x 7 mm), biconvex film-coated tablet with "15" engraved on one side.
Vortioxetine Stada 20 mg film-coated tablets
Dark red, oval (17 mm x 8 mm), biconvex film-coated tablet with "20" engraved on one side.

Vortioxetine Stada is available in cardboard packs containing blisters made of PVC/PVDC/Aluminum.
Pack sizes: 14, 28, 56, and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG,
Stadastrasse 2–18,
61118 Bad Vilbel,
Germany

Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
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 Ltd.
Waterford Road
Clonmel, Co. Tipperary E91 D768
Ireland

For further information, please contact the local representative of the Marketing Authorisation Holder:
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Croatia
Vortioksetin STADA 5 mg filmom obložene tablete
Vortioksetin STADA 10 mg filmom obložene tablete
Vortioksetin STADA 15 mg filmom obložene tablete
Vortioksetin STADA 20 mg filmom obložene tablete

Denmark
Vortioxetin STADA

Finland
Vortioxetine STADA 5 mg kalvopäällysteinen tabletti
Vortioxetine STADA 10 mg kalvopäällysteinen tabletti
Vortioxetine STADA 15 mg kalvopäällysteinen tabletti
Vortioxetine STADA 20 mg kalvopäällysteinen tabletti

France
VORTIOXETINE EG, 5/10/15/20 mg, comprimé pelliculé

Spain
Vortioxetina STADA 5 mg comprimidos recubiertos con película EFG
Vortioxetina STADA 10 mg comprimidos recubiertos con película EFG
Vortioxetina STADA 15 mg comprimidos recubiertos con película EFG
Vortioxetina STADA 20 mg comprimidos recubiertos con película EFG

Ireland
Vortioxetine Clonmel 5 mg film-coated tablets
Vortioxetine Clonmel 10 mg film-coated tablets
Vortioxetine Clonmel 15 mg film-coated tablets
Vortioxetine Clonmel 20 mg film-coated tablets

Iceland
Vortioxetine STADA 5 mg filmuhúðaðar töflur
Vortioxetine STADA 10 mg filmuhúðaðar töflur
Vortioxetine STADA 15 mg filmuhúðaðar töflur
Vortioxetine STADA 20 mg filmuhúðaðar töflur

Germany
Vortioxetin STADA 5 mg Filmtabletten
Vortioxetin STADA 10 mg Filmtabletten
Vortioxetin STADA 15 mg Filmtabletten
Vortioxetin STADA 20 mg Filmtabletten

Norway
Vortioxetine STADA 5 mg filmdrasjerte tabletter
Vortioxetine STADA 10 mg filmdrasjerte tabletter
Vortioxetine STADA 15 mg filmdrasjerte tabletter
Vortioxetine STADA 20 mg filmdrasjerte tabletter

Portugal
Vortioxetina STADA

Slovakia
Vortioxetín STADA 5 mg filmom obalené tablety
Vortioxetín STADA 10 mg filmom obalené tablety
Vortioxetín STADA 15 mg filmom obalené tablety
Vortioxetín STADA 20 mg filmom obalené tablety

Slovenia
Vortioksetin STADA AG 5 mg filmsko obložene tablete
Vortioksetin STADA AG 10 mg filmsko obložene tablete
Vortioksetin STADA AG 15 mg filmsko obložene tablete
Vortioksetin STADA AG 20 mg filmsko obložene tablete

Sweden
Vortioxetine STADA 5 mg filmdragerade tabletter
Vortioxetine STADA 10 mg filmdragerade tabletter
Vortioxetine STADA 15 mg filmdragerade tabletter
Vortioxetine STADA 20 mg filmdragerade tabletter

Italy
Vortioxetina EG