Vortioxetine Stada

Leaflet accompanying the packaging: information for the user

Vortioxetine Stada, 5 mg, coated tablets

Vortioxetine Stada, 10 mg, coated tablets

Vortioxetine Stada, 15 mg, coated tablets

Vortioxetine Stada, 20 mg, 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 Stada and what is it used for
• 2. Important information 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 is Vortioxetine Stada and what is it 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 improve many symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (less sleep), reduced appetite, difficulty concentrating, feelings of worthlessness, loss of interest in performing favorite activities, and feelings of slowing 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 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 treatment with Vortioxetine Stada, talk to your doctor or pharmacist:

• if the patient is taking medicines with serotonergic activity, such as:
• tramadol and similar medicines (strong painkillers).
• sumatriptan and similar medicines whose active substance names end with "triptan" (used to treat migraines). Taking these medicines with Vortioxetine Stada 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;
• if the patient has had seizures (epileptic fits). Treatment will be carried out with caution if the patient has had seizures or if they currently have unstable 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;
• if the patient has had mania;
• if the patient has a tendency to bleed or bruise, 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 called cirrhosis;
• if the patient currently has or has had increased eye pressure or glaucoma. If eye pain and blurred vision occur during treatment, consult a doctor.

Patients taking antidepressant medicines, including vortioxetine, may also experience feelings of aggression, agitation, anger, and irritability. In such cases, consult your doctor.

Suicidal thoughts and depression worsening

In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm may occasionally occur. These thoughts may worsen after starting antidepressant treatment, 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:

• 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 disorders treated with antidepressant medicines.
If the patient has ever had suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask these people to inform them if they notice that depression or anxiety disorders have worsened or if there are worrying changes in the patient's behavior.

Children and adolescents

Vortioxetine should not be used in children and adolescents (under 18 years of age) due to the lack of demonstrated efficacy of its use. 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 taking, has recently taken, or might 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 should be taken with Vortioxetine Stada. If the patient has taken any of these medicines, they must wait 14 days before starting Vortioxetine Stada. After stopping treatment with Vortioxetine Stada, 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).
• serotonergic medicines, e.g., tramadol and similar medicines (strong painkillers) and sumatriptan and similar medicines whose active substance names end with "triptan" (used to treat migraines). Taking these medicines with Vortioxetine Stada may increase the risk of serotonin syndrome (see 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 low doses, and non-steroidal anti-inflammatory medicines (blood thinners and pain relievers). 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 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 groups of medicines known as phenothiazines, thioxanthenes, and butyrophenones).

Tell the treating doctor about taking any of the above medicines, as the doctor should know that the patient is already at risk of seizures.

Drug tests

If a patient is taking Vortioxetine Stada and a urine screening test is performed, 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.

Taking 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy

This medicine should not be used during pregnancy unless the doctor considers it absolutely necessary.
Pregnant women who took antidepressant medicines, including Vortioxetine Stada, during the first 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, tremors, shaking, irritability, lethargy, constant crying, and sleep disturbances. If the newborn experiences any of these symptoms, consult a doctor immediately.
Tell the midwife and/or doctor about taking Vortioxetine Stada.
Medicines like Vortioxetine Stada used during pregnancy, especially in the last three months, may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN), causing the baby to breathe rapidly and have a blue skin color. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, tell the midwife and/or doctor immediately.
Taking this medicine at 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, they should inform their doctor or midwife so they can provide appropriate advice.

Breastfeeding

It is expected that the ingredients of this medicine will pass into breast milk. Vortioxetine Stada should not be taken during breastfeeding. The doctor will decide whether the patient should stop breastfeeding or stop taking this medicine, considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother.

Driving and using machines

This medicine 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 Stada or changing the dose, as side effects such as dizziness have been reported.

Vortioxetine Stada contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Vortioxetine Stada

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Vortioxetine Stada 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 Stada to a maximum of 20 mg of vortioxetine per day or decrease to a minimum dose of 5 mg of vortioxetine per day, depending on the patient's response to treatment.

Use in elderly patients

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.
If the patient is unable to swallow the tablet whole, other medicines containing vortioxetine may be available in different pharmaceutical forms.

Duration of treatment

Take this medicine for as long as your doctor recommends.
Continue taking this medicine even if the patient does 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 Stada than recommended

If the patient has taken more Vortioxetine Stada than prescribed, they should immediately contact their doctor or go to the emergency department of the nearest hospital. Take the packaging and any remaining tablets with them. Do this even if there are no signs of discomfort. Symptoms of overdose are dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, drowsiness, and flushing of the face.
After taking doses several times higher than recommended, seizures and a rare disease called serotonin syndrome have been reported.

Missing a dose of Vortioxetine Stada

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

Stopping treatment with Vortioxetine Stada

Do not stop taking Vortioxetine Stada without consulting your doctor.
The doctor may decide to gradually reduce the dose before stopping treatment with this medicine.
In some patients who stopped taking vortioxetine, symptoms such as dizziness, headache, tingling like pins and needles or electric shock-like sensations (especially in the head), insomnia, nausea, or vomiting, restlessness, irritability, or excitement, and fatigue or tremors occurred. These symptoms may occur within the first week after stopping treatment with this medicine.
If you have any further questions about the use of this medicine, consult your 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 generally mild to moderate and occurred within the first two weeks of treatment. The reactions were usually transient and did not lead to treatment discontinuation.
The following side effects were 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 tremors

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, drowsiness, extreme fatigue, nausea, or vomiting; more severe 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, consult 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 (trismus)
• restless legs syndrome (an urge to move the legs to stop uncomfortable or unusual sensations, often occurring at night)

Patients 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 reported more frequently in adolescents than in adults.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Vortioxetine Stada

Keep this medicine out of the 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 month stated.
There are no special storage precautions 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. This will help protect the environment.

6. Contents of the pack and other information

What Vortioxetine Stada contains

Vortioxetine Stada, 5 mg, coated tablets

• The active substance is vortioxetine. Each coated tablet contains 5 mg of vortioxetine (as bromohydrate).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethylcellulose (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPas), macrogol 400, titanium dioxide (E171), and iron oxide red (E172) in the tablet coating.

Vortioxetine Stada, 10 mg, coated tablets

• The active substance is vortioxetine. Each coated tablet contains 10 mg of vortioxetine (as bromohydrate).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethylcellulose (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPas), macrogol 400, titanium dioxide (E171), and iron oxide yellow (E172) in the tablet coating.

Vortioxetine Stada, 15 mg, coated tablets

• The active substance is vortioxetine. Each coated tablet contains 15 mg of vortioxetine (as bromohydrate).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethylcellulose (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPas), macrogol 400, titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172) in the tablet coating.

Vortioxetine Stada, 20 mg, coated tablets

• The active substance is vortioxetine. Each coated tablet contains 20 mg of vortioxetine (as bromohydrate).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethylcellulose (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPas), macrogol 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 coated tablets

Pink, oval (11 mm x 5 mm), biconvex coated tablet with "5" engraved on one side.

Vortioxetine Stada 10 mg coated tablets

Yellow, oval (13 mm x 6 mm), biconvex coated tablet with "10" engraved on one side.

Vortioxetine Stada 15 mg coated tablets

Light orange, oval (15 mm x 7 mm), biconvex coated tablet with "15" engraved on one side.

Vortioxetine Stada 20 mg coated tablets

Dark red, oval (17 mm x 8 mm), biconvex coated tablet with "20" engraved on one side.
Vortioxetine Stada is available in cardboard boxes containing blisters of PVC/PVDC/Aluminum.
Pack sizes: 14, 28, 56, and 98 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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
To obtain more detailed information, contact the local representative of the marketing authorization holder:
STADA Pharm Sp. z o.o.
Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

This medicine is authorized in the Member States of the European Economic Area under the following names:

Croatia
Vortioksetin STADA 5 mg film-coated tablets
Vortioksetin STADA 10 mg film-coated tablets
Vortioksetin STADA 15 mg film-coated tablets
Vortioksetin STADA 20 mg film-coated tablets
Denmark
Vortioxetin STADA
Finland
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
France
VORTIOXETINE EG, 5/10/15/20 mg, film-coated tablets
Spain
Vortioxetina STADA 5 mg film-coated tablets EFG
Vortioxetina STADA 10 mg film-coated tablets EFG
Vortioxetina STADA 15 mg film-coated tablets EFG
Vortioxetina STADA 20 mg film-coated tablets 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 film-coated tablets
Vortioxetine STADA 10 mg film-coated tablets
Vortioxetine STADA 15 mg film-coated tablets
Vortioxetine STADA 20 mg film-coated tablets
Germany
Vortioxetin STADA 5 mg film-coated tablets
Vortioxetin STADA 10 mg film-coated tablets
Vortioxetin STADA 15 mg film-coated tablets
Vortioxetin STADA 20 mg film-coated tablets
Norway
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
Portugal
Vortioxetina STADA
Slovakia
Vortioxetín STADA 5 mg film-coated tablets
Vortioxetín STADA 10 mg film-coated tablets
Vortioxetín STADA 15 mg film-coated tablets
Vortioxetín STADA 20 mg film-coated tablets
Slovenia
Vortioksetin STADA AG 5 mg film-coated tablets
Vortioksetin STADA AG 10 mg film-coated tablets
Vortioksetin STADA AG 15 mg film-coated tablets
Vortioksetin STADA AG 20 mg film-coated tablets
Sweden
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
Italy
Vortioxetina EG

Date of last revision of the leaflet: