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

Vortioxetine

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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Vortioxetine Stada is and what it is used for
• 2. Before you take 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 improve several symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced sleep), reduced appetite, difficulties in concentrating, feelings of worthlessness, loss of interest in activities that you normally enjoy, and feeling slowed down.

2. Before you take Vortioxetine Stada

Do not take Vortioxetine Stada:

• 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 called non-selective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors. If in doubt, ask your doctor.

Warnings and precautions

Before taking Vortioxetine Stada, tell your doctor or pharmacist:

• if you are taking medicines with serotonergic effects, 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 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 you have had seizures (epileptic fits). Treatment will be carried out with caution if you have had seizures or if you currently have uncontrolled seizures/epilepsy. The use of antidepressant medicines carries a risk of seizures. Treatment should be discontinued in any patient who develops seizures for the first time or whose seizure frequency increases;
• if you have had mania;
• if you have a tendency to bleed or bruise easily, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you have low sodium levels in your blood;
• if you are 65 years of age or older;
• if you have severe kidney disease;
• if you have severe liver disease or liver disease called cirrhosis;
• if you currently have or have had increased pressure in the eye or glaucoma. If you experience eye pain and blurred vision during treatment, 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 become more severe when antidepressant medicines are started, as these medicines may take some time to start working, usually about two weeks, and sometimes longer.
Suicidal thoughts are more likely to occur if:

• you have had thoughts of self-harm or suicide 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 psychiatric disorders treated with antidepressant medicines.
If you ever have thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately. It may be helpful to tell relatives or friends that you are depressed or have anxiety disorders and ask them to read this leaflet. You can ask them to tell you if they notice that your depression or anxiety is getting worse or if you are behaving in a way that is unusual for you.

Children and adolescents

Vortioxetine should not be used in children and adolescents under the age of 18 years due to a lack of data on safety and efficacy. The safety of Vortioxetine Stada in children and adolescents aged 7 to 17 years is described in section 4.

Vortioxetine Stada with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, 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, called non-selective monoamine oxidase inhibitors); you must not take any of these medicines with Vortioxetine Stada. If you have taken any of these medicines, you must wait 14 days before starting to take Vortioxetine Stada. After stopping treatment with Vortioxetine Stada, 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 serotonergic effects, 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 Stada may increase the risk of serotonin syndrome (see section "Warnings and precautions").
• lithium (a medicine used to treat depression and other mental disorders) or tryptophan.
• medicines that lower sodium levels in the blood.
• rifampicin (an antibiotic used to treat tuberculosis and other infections).
• carbamazepine, phenytoin (medicines used to treat epilepsy and other conditions).
• warfarin, dipyridamole, phenprocoumon, some antipsychotic medicines, phenothiazines, tricyclic antidepressants, acetylsalicylic acid 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, called SSRIs/SNRIs, tricyclic antidepressants.
• 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 a group of medicines called phenothiazines, thioxanthenes, 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.

Tests for the presence of medicines

If you are taking Vortioxetine Stada 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 Stada 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

This medicine should not be used during pregnancy unless your 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 following symptoms in the newborn: difficulty breathing, blue discoloration of the skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, trembling, shaking, irritability, lethargy, constant crying, and sleep disturbances. If your baby experiences any of these symptoms, you should contact your doctor immediately.
Tell your midwife and/or doctor that you are taking Vortioxetine Stada.
Medicines like Vortioxetine Stada taken during pregnancy, especially in the last three months, may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, you should tell your midwife and/or doctor immediately.
Taking this medicine at the end of pregnancy may increase the risk of severe bleeding from the vagina, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you are taking this medicine, you should tell your doctor or midwife so that they can give you appropriate advice.

Breastfeeding

It is expected that the ingredients of this medicine will pass into breast milk. You should not take Vortioxetine Stada while breastfeeding. Your doctor will decide whether you should stop breastfeeding or stop taking this medicine, considering the benefit of breastfeeding to the baby and the benefit of treatment to the mother.

Driving and using machines

This medicine 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 Stada or after 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

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 Stada is 10 mg of vortioxetine per day in one 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.

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

Swallow one tablet with a glass of water.
The tablet can be taken with or without food.
If you are unable to swallow the tablet whole, other forms of vortioxetine may be available on the market.

Duration of treatment

Take this medicine for as long as your doctor has prescribed it.
Continue to take this medicine even if you do not feel better immediately.
Treatment should be continued for at least 6 months after you feel better.

Taking a higher dose of Vortioxetine Stada than prescribed

If you have taken more Vortioxetine Stada than you should, contact your doctor or go to the hospital immediately. Bring the medicine pack and any remaining tablets with you. Do so even if you feel well, as you may not notice any signs of discomfort. Symptoms of overdose include 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 condition 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 forgotten dose.

Stopping treatment with Vortioxetine Stada

Do not stop taking Vortioxetine Stada 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, the following symptoms have occurred: dizziness, headache, tingling sensations (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. These symptoms usually occur within the first week after stopping treatment with this medicine.
If you have any further questions on the use of this medicine, ask 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 during the first two weeks of treatment. Reactions were usually transient and did not lead to discontinuation of treatment.
The following side effects 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

• 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, confusion, sleepiness, severe tiredness, nausea, or vomiting; more severe symptoms include fainting, seizures, or falls)
• serotonin syndrome (see section 2)
• severe allergic reactions, which can be serious, 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
• unexplained or excessive bleeding (including bruising, nosebleeds, gastrointestinal bleeding, and vaginal bleeding)
• rash
• sleep disturbances (insomnia)
• agitation and aggression. If you experience these side effects, you should talk to your doctor (see section 2)
• headache
• increased levels of a hormone called prolactin in the blood
• restless legs (akathisia)
• grinding of the teeth (bruxism)
• inability to open the mouth (trismus)
• restless legs syndrome (an irresistible urge to move the legs, usually due to uncomfortable or unpleasant sensations in the legs, often occurring in the evening)

Patients taking medicines like Vortioxetine Stada have reported an increased risk of bone fractures.
There have been reports of increased risk of sexual dysfunction at a dose of 20 mg, and some patients have experienced this side effect 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the national reporting system via 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
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 Stada

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 packaging 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 Stada contains

Vortioxetine Stada, 5 mg, film-coated tablets

• The active substance is vortioxetine. Each film-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 mPa.s), macrogol 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 bromohydrate).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethylcellulose (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPa.s), macrogol 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 bromohydrate).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethylcellulose (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPa.s), macrogol 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 bromohydrate).
• The other ingredients are mannitol, microcrystalline cellulose (PH 101), hydroxypropylcellulose, sodium carboxymethylcellulose (type A), magnesium stearate in the tablet core, hypromellose 2910 (6 mPa.s), 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 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 boxes containing blisters of PVC/PVDC/Aluminum.
Pack sizes: 14, 28, 56, and 98 film-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, please 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
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
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
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
Spain
Vortioxetina STADA 5 mg film-coated tablets
Vortioxetina STADA 10 mg film-coated tablets
Vortioxetina STADA 15 mg film-coated tablets
Vortioxetina STADA 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

Date of last revision of the leaflet: