Banavin

Leaflet included in the packaging: information for the user

Banavin, 5 mg, coated tablets

Banavin, 10 mg, coated tablets

Banavin, 15 mg, coated tablets

Banavin, 20 mg, coated tablets

Vortioxetine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you only. You should not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any undesirable effects occur, including any undesirable effects not mentioned in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Banavin and what is it used for
• 2. Important information before taking Banavin
• 3. How to take Banavin
• 4. Possible side effects
• 5. How to store Banavin
• 6. Contents of the packaging and other information

1. What is Banavin and what is it used for

Banavin 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.
It has been shown that vortioxetine alleviates many symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced sleep), decreased appetite, concentration difficulties, feelings of worthlessness, loss of interest in performing favorite activities, and feelings of slowing down.

2. Important information before taking Banavin

When not to take Banavin:

Warnings and precautions

Before starting to take Banavin, you should talk to your doctor or pharmacist:

• tramadol and similar medicines (strong painkillers).
• sumatriptan and similar medicines whose active substance names end with "triptan" (used to treat migraines).

Taking these medicines together with Banavin may increase the risk of serotonin syndrome. This syndrome can be accompanied by hallucinations, involuntary muscle contractions, accelerated heart rate, high blood pressure, fever, nausea, and diarrhea;

Patients taking antidepressant medicines, including vortioxetine, may also experience feelings of aggression, agitation, anger, and irritability. In such a situation, you should talk to your doctor.

Suicidal thoughts and depression worsening

In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm may sometimes occur. These thoughts may worsen after starting to take antidepressant medicines, because all these medicines start to work only after some time, usually after two weeks, and sometimes later.
The occurrence of suicidal thoughts is more likely 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 illnesses 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 the depression or anxiety disorder has worsened or if there are any 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. The safety of vortioxetine in children and adolescents aged 7 to 17 years is described in section 4.

Banavin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about medicines you plan to take.
You should 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 should not take any of these medicines with Banavin. If you have taken any of these medicines, you must wait 14 days before starting to take Banavin. After stopping treatment with Banavin, you should wait 14 days before taking any of these medicines.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines containing the active substance name ending with "triptan".
• tramadol (strong painkiller).
• mefloquine (medicine used to prevent and treat malaria).
• bupropion (medicine used to treat depression, and also used by people who want to quit smoking).
• fluoxetine, paroxetine, and other medicines used to treat depression, known as SSRI/SNRI, tricyclic medicines.
• St. John's Wort (Hypericum perforatum) (medicine used to treat depression).
• quinidine (medicine used to treat heart rhythm disorders).
• chlorpromazine, chlorprothixene, haloperidol (medicines used to treat mental disorders belonging to the group of medicines called phenothiazines, thioxanthenes, butyrophenones).

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

Drug tests

If a patient is taking Banavin 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 a situation, a more specific test can be performed.

Taking Banavin with alcohol

Concomitant use of this medicine and alcohol is not recommended.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.

Pregnancy

The medicine should not be used during pregnancy, unless the doctor considers it absolutely necessary.
Women who have taken antidepressant medicines, including Banavin, during the last three months of pregnancy, should be aware of the risk of the following symptoms in the newborn: breathing difficulties, bluish skin color, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, jitteriness, irritability, lethargy, constant crying, sleepiness, or sleep disturbances. If the newborn experiences any of these symptoms, you should immediately contact your doctor.
You should inform your obstetrician and/or doctor about taking Banavin. Medicines like Banavin used during pregnancy, especially during the last three months, may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN), which causes the baby to breathe rapidly and have a bluish skin color. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, you should immediately tell your obstetrician and/or doctor.
Taking this medicine at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if there is a history of bleeding disorders. If you are taking this medicine, you should inform your doctor or obstetrician so that they can provide you with appropriate advice.

Breastfeeding

It is expected that the components of the medicine will pass into breast milk. You should not take Banavin while breastfeeding. Your doctor will decide whether you 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

The medicine has no or negligible influence on the ability to drive and use machines. However, caution is recommended when performing these activities after starting treatment with Banavin or after changing the dose, as undesirable effects such as dizziness have been reported.

Banavin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Banavin

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
The recommended dose of Banavin is 10 mg of vortioxetine once daily in adults under 65 years of age. Your doctor may increase the dose of Banavin up to a maximum of 20 mg of vortioxetine once daily or decrease it to a minimum dose of 5 mg of vortioxetine once daily, depending on the patient's response to treatment.

Use in elderly patients

For people 65 years of age or older, the initial dose is 5 mg of vortioxetine once daily.

Method of administration

You should 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 in different pharmaceutical forms may be available on the market.

Duration of treatment

You should take the medicine for as long as your doctor has prescribed.
You should continue to take the medicine 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 Banavin than recommended

If you have taken more than the prescribed dose of Banavin, you should immediately contact your doctor or go to the emergency room of the nearest hospital. You should take the packaging and any remaining tablets with you. You should do this even if you do not feel any discomfort. Symptoms of overdose may include dizziness, nausea, diarrhea, discomfort in the stomach, sweating all over the body, sleepiness, and hot flashes.
After taking doses several times higher than the recommended dose, seizures and rarely occurring serotonin syndrome have been reported.

Missing a dose of Banavin

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

Stopping treatment with Banavin

You should not stop taking Banavin without consulting your doctor.
Your doctor may decide to reduce the dose before finally 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), difficulty sleeping, nausea or vomiting, feelings of anxiety, irritability, or agitation, and feelings of fatigue or restlessness occurred. These symptoms may occur within the first week after stopping treatment with the medicine.
In case of any further doubts related to the use of this medicine, you should 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 usually 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 have been 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
• sweating all over the body
• strange dreams
• excessive sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

• hot flashes
• night sweats
• blurred vision
• involuntary tremors

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

• increased pupil size (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, sleepiness, 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 facial swelling, lip, tongue, or throat swelling, and difficulty breathing or swallowing, as well as 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, 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 teeth (bruxism)
• inability to open the mouth (lockjaw/trismus)
• restless legs syndrome (an urge to move the legs to stop unpleasant or painful sensations, often occurring at night)
• abnormal milk secretion from the breasts (galactorrhea)

In patients taking medicines of this type, an increased risk of fractures has been observed.
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 observed more frequently in adolescents than in adults.

Reporting side effects

If you experience any side effects, including any side effects not mentioned in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Thanks to reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Banavin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Banavin contains

Banavin 5 mg coated tablets

• The active substance of the medicine is vortioxetine.
• Each coated tablet contains 5 mg of vortioxetine (in the form of bromohydrate). The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, and magnesium stearate in the tablet core, and hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide red (E172) in the tablet coating.

Banavin 10 mg coated tablets

• The active substance of the medicine is vortioxetine. Each coated tablet contains 10 mg of vortioxetine (in the form of bromohydrate).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, and magnesium stearate in the tablet core, and hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide yellow (E172) in the tablet coating.

Banavin 15 mg coated tablets

• The active substance of the medicine is vortioxetine. Each coated tablet contains 15 mg of vortioxetine (in the form of bromohydrate).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, and magnesium stearate in the tablet core, and hypromellose, macrogol 400, titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172) in the tablet coating.

Banavin 20 mg coated tablets

• The active substance of the medicine is vortioxetine. Each coated tablet contains 20 mg of vortioxetine (in the form of bromohydrate)
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, and magnesium stearate in the tablet core, and hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide red (E172) in the tablet coating.

What Banavin looks like and contents of the packaging

What Banavin looks like and contents of the packaging

Banavin 5 mg coated tablets

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

Banavin 10 mg coated tablets

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

Banavin 15 mg coated tablets

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

Banavin 20 mg coated tablets

Dark red, oval (17 mm x 8 mm), biconvex coated tablets with "20" engraved on one side of the tablet.
Banavin coated tablets are available in a cardboard box containing transparent PVC/PVDC/Aluminum blisters.
Packaging sizes are 28 or 98 coated tablets.
Not all packaging sizes may be marketed.

Marketing authorization holder:

Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

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

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

CZ: Banavin

HU: Banavin

For more information about this medicine, you should contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]
Fax: +48 (22) 755 96 24

Date of last revision of the leaflet: