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

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any undesirable symptoms occur, including any undesirable symptoms not listed in this leaflet, the doctor or pharmacist should be informed. 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, difficulty concentrating, feeling of worthlessness, loss of interest in performing favorite activities, and feeling of slowing down.

2. Important information before taking Banavin

When not to take Banavin:

• 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, the doctor should be consulted.

Warnings and precautions

Before starting to take Banavin, the doctor or pharmacist should be consulted:

• 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 with "triptan" (used to treat migraines).

Taking these medicines together with Banavin 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 seizures). Treatment will be carried out with caution if the patient has had seizures or currently has uncontrolled seizures/epilepsy. The use of antidepressant medicines carries a risk of seizures. Treatment should be discontinued in every 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, or if the patient is pregnant (see "Pregnancy and breastfeeding").
• if the patient has low sodium levels in the blood.
• if the patient is 65 years old 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, the doctor should be consulted.

Patients taking antidepressant medicines, including vortioxetine, may also experience feelings of aggression, agitation, anger, and irritability. In such a situation, the doctor should be consulted.

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 antidepressant treatment, as all these medicines start working 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 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

The doctor or pharmacist should be told about all medicines currently being taken by the patient, as well as any medicines the patient plans to take.
The doctor should be told 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 Banavin. If the patient has taken any of these medicines, they must wait 14 days before starting to take Banavin. After stopping treatment with Banavin, the patient should wait 14 days before starting to take 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, as well as to help people 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 known as phenothiazines, thioxanthenes, butyrophenones).

The doctor should be informed 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 taking Banavin undergoes a urine screening test, in the case of using certain analytical methods, a positive result for methadone may occur, 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 the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy

The medicine should not be taken during pregnancy unless the doctor considers it absolutely necessary.
Patient women who took 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, tremors, irritability, or excessive crying, sleepiness, or sleep disturbances. If the newborn experiences any of these symptoms, the doctor should be contacted immediately.
The patient should inform the midwife and/or doctor about taking Banavin. Medicines like Banavin taken during pregnancy, especially during 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 bluish skin color. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, the midwife and/or doctor should be informed immediately.
Taking this medicine at the end of pregnancy may increase the risk of severe postpartum hemorrhage, 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 that they can provide appropriate advice.

Breastfeeding

It is expected that the components of the medicine will pass into breast milk. Banavin 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

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 the medicine is considered "sodium-free".

3. How to take Banavin

This medicine should always be taken as directed by the doctor. In case of doubt, the doctor or pharmacist should be consulted.
The recommended dose of Banavin is 10 mg of vortioxetine once daily in adults under 65 years of age. The doctor may increase the dose of the medicine to a maximum of 20 mg of vortioxetine per day or decrease it 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 initial dose is 5 mg of vortioxetine once daily.

Method of administration

The tablet should be taken 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

The medicine should be taken for as long as the doctor recommends.
The medicine should be continued to be taken 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 Banavin than recommended

If the patient has taken more than the prescribed dose of Banavin, they should immediately contact their doctor or go to the emergency room of the nearest hospital. The patient should bring the packaging of the medicine and any remaining tablets. The patient should do this even if they do not experience any discomfort symptoms. 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

The next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping Banavin treatment

Banavin treatment should not be stopped without consulting the doctor.
The doctor may decide to reduce the dose before finally stopping the treatment.
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 agitation, and fatigue or drowsiness occurred. These symptoms may occur within the first week after stopping the treatment.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

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. 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 occur in more than 1 in 10 people

• nausea

Common: may occur in up to 1 in 10 people

• diarrhea, constipation, vomiting
• dizziness
• sweating all over the body
• strange dreams
• excessive sweating
• indigestion

Uncommon: may occur in up to 1 in 100 people

• hot flashes
• night sweats
• blurred vision
• involuntary muscle contractions

Rare: may occur in 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, 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, the doctor should be consulted (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 uncomfortable feelings, often occurring at night)
• abnormal milk secretion from the breasts (galactorrhea)

In patients taking medicines of this type, an increased risk of bone fractures has been observed.
An increased risk of sexual disturbances has been reported after a dose of 20 mg, and in some patients, this side effect has been observed after smaller 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 any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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.
The medicine should not be used 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. The pharmacist should be asked how to dispose of medicines that are no longer needed. 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 (as bromohydrate). The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, 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 (as bromohydrate).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, 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 (as bromohydrate).
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, 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 (as bromohydrate)
• The other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, 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 pack

What Banavin looks like and contents of the pack

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.
Pack sizes of 28 or 98 coated tablets.
Not all pack 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 detailed information on the medicine, please 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: