Banavin

Package leaflet: Information for the user

Banavin, 5 mg, coated tablets
Banavin, 10 mg, coated tablets
Banavin, 15 mg, coated tablets
Banavin, 20 mg, coated tablets
Vortioxetinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Banavin is and what it is used for
Banavin contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants.
This medicine is used for the treatment of major depressive episodes in adults.
Vortioxetine has been shown to improve multiple symptoms of depression, including sadness, inner tension (feeling of anxiety), sleep disturbances (reduced amount of sleep), reduced appetite, difficulty concentrating, feelings of worthlessness, loss of interest in performing favourite activities, and feelings of slowing down.

2. What you need to know before taking Banavin

Do not take Banavin if:

• you are allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6).
• you are taking other antidepressant medicines known as non-selective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors. If in doubt, please consult your doctor.

Warnings and precautions
Before starting Banavin, talk to your doctor or pharmacist if:

• you are 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 “tryptan” (used to treat migraine).

Taking these medicines together with Banavin may increase the risk of serotonin syndrome. This syndrome may include hallucinations, involuntary muscle contractions, rapid heartbeat, high blood pressure, fever, nausea, and diarrhoea.

• you have had seizures (epileptic fits). Treatment will be carried out with caution if you have had seizures or if you currently have unstable seizures/epilepsy. Antidepressant medicines carry a risk of seizures. Treatment should be discontinued in any patient who experiences seizures for the first time or whose seizure frequency increases.
• you have experienced mania.
• you have a tendency to bleeding or bruising, or if you are pregnant (see “Pregnancy and breastfeeding”).
• you have low sodium levels in your blood.
• you are 65 years of age or older.
• you have severe kidney disease.
• you have severe liver disease or liver cirrhosis.
• you currently have or have previously had increased eye pressure or glaucoma. If you experience eye pain or blurred vision during treatment, contact your 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 sometimes experience thoughts of self-harm or suicide. These thoughts may intensify after starting antidepressant treatment, as all these medicines take time to work—usually about two weeks, and sometimes longer.

The risk of suicidal thoughts is higher if:

• you have previously had thoughts of self-harm or suicide;
• you are 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 you experience any thoughts of self-harm or suicide, contact your doctor immediately or go to hospital. It may be helpful to inform your family or friends about your depression or anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they notice that your depression or anxiety worsens or if they observe disturbing changes in your 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 in children and adolescents aged 7 to 17 years is described in section 4.

Banavin with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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); none of these medicines should be taken with Banavin. If you have taken any of these medicines, you must wait 14 days before starting Banavin. After stopping treatment with Banavin, you must wait 14 days before starting any of these medicines.

• moclobemide (a medicine used to treat depression).

• selegiline, rasagiline (medicines used to treat Parkinson’s disease).

• linezolid (an antibiotic used to treat bacterial infections).

• medicines with serotonergic activity, e.g. tramadol and similar medicines (strong painkillers), and sumatriptan and similar medicines whose active substance names end in “tryptans” (used to treat migraine). Taking these medicines together with Banavin 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 risk of bleeding.

Medicines that increase the risk of seizures:

• sumatriptan and similar medicines containing an active substance whose name ends in “tryptan”.
• 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 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 the phenothiazine, thioxanthene, and butyrophenone groups).

Tell your doctor if you are taking any of the above medicines, as your doctor needs to know that you are already at risk of seizures.

Drug screening tests
If you undergo urine drug screening while taking Banavin, certain analytical methods may give a false positive result for methadone, even if you are not taking methadone. In such cases, 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 are planning to have a baby, consult your doctor before using this medicine.

Pregnancy
This medicine should not be used during pregnancy unless your doctor considers it absolutely necessary.
Women who have taken antidepressants, 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 colour, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and sleep disturbances. If any of these symptoms occur in the newborn, contact your doctor immediately.
Inform your midwife and/or doctor that you are taking Banavin. Medicines such as Banavin used 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 the baby to breathe rapidly and have blue-tinged skin. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, inform your 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 you have a history of blood clotting disorders. If you are taking this medicine, inform your doctor or midwife so they can provide appropriate advice.

Breastfeeding
It is expected that components of the medicine will pass into breast milk. Banavin should not be used during breastfeeding. Your doctor will decide whether you should discontinue breastfeeding or discontinue/abstain from treatment with 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 negligible effect on the ability to drive and operate machinery. However, caution is advised when performing these activities after starting treatment with Banavin or after a dose change, as side effects such as dizziness have been reported.

Banavin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Banavin

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of Banavin is 10 mg of vortioxetine once daily in adults under the age of 65.
The physician may increase the dose of the medicine up to a maximum of 20 mg of vortioxetine per day or
decrease it to the minimum dose of 5 mg of 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 of vortioxetine once daily.
Method of administration
Take one tablet with a glass of water.
The tablet may 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 prescribed by the physician.
Continue taking the medicine even if the patient does not feel improvement for some time.
Treatment should be continued for at least 6 months after the patient starts feeling better.
Taking more Banavin than recommended
If the patient has taken more Banavin than prescribed, contact a doctor immediately or go to the
emergency department of the nearest hospital. Bring the medicine packaging and any remaining tablets.
Do this even if no discomfort symptoms are present. Symptoms of overdose may include dizziness, nausea,
diarrhea, stomach discomfort, itching of the entire body, drowsiness, and hot flashes.
Seizures and a rare condition called serotonin syndrome have been reported after ingestion of doses
several times higher than the recommended dose.
Missed dose of Banavin
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Banavin
Do not stop taking Banavin without consulting your doctor.
The physician may decide to gradually reduce the dose before completely discontinuing this medicine.
In some patients who stopped taking vortioxetine, symptoms such as dizziness, headache, tingling
resembling pinpricks or needles, or a sensation similar to electric shock (especially in the head),
inability to fall asleep, nausea or vomiting, restlessness, irritability or agitation, fatigue, or tremor
have occurred. These symptoms may appear within the first week after stopping the 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 experiences them.
The observed adverse reactions were generally mild to moderate and occurred within 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 whole body
• unusual dreams
• excessive sweating
• indigestion

Uncommon: may affect up to 1 in 100 people

• hot flushes
• night sweats
• blurred vision
• involuntary tremors
• hallucinations (seeing, hearing or feeling things that do not exist)

Rare: may affect up to 1 in 1,000 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
• 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 need for movement (akathisia)
• teeth grinding (bruxism)
• inability to open the mouth (trismus)
• restless legs syndrome (an urge to move the legs to prevent painful or unusual sensations, often occurring at night)
• milky discharge from the breasts (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 at a dose of 20 mg, and in some patients, this adverse reaction was observed after lower doses.
Additional adverse reactions in children and adolescents
Adverse reactions of vortioxetine in children and adolescents were similar to those observed in adults, except for abdominal pain events, which were 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 effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store the medicine Banavin

The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
No special storage instructions are required 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. This will help protect the environment.

6. Package contents and other information

What the medicine Banavin contains
Banavin 5 mg film-coated tablets

• The active substance is vortioxetine.
• Each film-coated tablet contains 5 mg of vortioxetine (as hydrobromide).
• Other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate in the tablet core, and hypromellose, polyethylene glycol 400, titanium dioxide (E171) and iron oxide red (E172) in the tablet coating.

Banavin 10 mg film-coated tablets

• The active substance is vortioxetine.
• Each film-coated tablet contains 10 mg of vortioxetine (as hydrobromide).
• Other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate in the tablet core, and hypromellose, polyethylene glycol 400, titanium dioxide (E171) and iron oxide yellow (E172) in the tablet coating.

Banavin 15 mg film-coated tablets

• The active substance is vortioxetine.
• Each film-coated tablet contains 15 mg of vortioxetine (as hydrobromide).
• Other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate in the tablet core, and hypromellose, polyethylene glycol 400, titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172) in the tablet coating.

Banavin 20 mg film-coated tablets

• The active substance is vortioxetine.
• Each film-coated tablet contains 20 mg of vortioxetine (as hydrobromide).
• Other ingredients are: mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch and magnesium stearate in the tablet core, and hypromellose, polyethylene glycol 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 film-coated tablets
Pink, oval (11 mm x 5 mm), biconvex film-coated tablets with the inscription "5" embossed on one side of the tablet.
Banavin 10 mg film-coated tablets
Yellow, oval (13 mm x 6 mm), biconvex film-coated tablets with the inscription "10" embossed on one side of the tablet.
Banavin 15 mg film-coated tablets
Light orange, oval (15 mm x 7 mm), biconvex film-coated tablets with the inscription "15" embossed on one side of the tablet.
Banavin 20 mg film-coated tablets
Dark red, oval (17 mm x 8 mm), biconvex film-coated tablets with the inscription "20" embossed on one side of the tablet.
Banavin film-coated tablets are available in cardboard packaging containing transparent PVC/PVDC/Aluminium blisters.
Pack sizes: 28, 56 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised for marketing in the European Economic Area countries under the following names:
CZ: Banavin
HU: Banavin

For further information about this medicine, please contact:
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]