PIXIGAN 150 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Pixigan, 150 mg, Modified Release Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Pixigan and what is it used for
4. Important information before taking Pixigan
   1. When not to take Pixigan
   2. Warnings and precautions
   3. Brugada Syndrome
   4. Children and adolescents
   5. Adults
   6. Suicidal thoughts and worsening of depression
   7. Pixigan and other medications
   8. If you are currently taking or have taken within the last 14 days other antidepressant medications called monoamine oxidase inhibitors (MAOIs), consult your doctor without taking Pixigan
   9. Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take,
   10. Seizures may occur more frequently than usual if you take:
   11. The risk of other side effects may increase if you take:
   12. Pixigan may reduce the effectiveness of certain medications if you take:
   13. Pixigan and alcohol
   14. Effect on urine tests
   15. Pregnancy and breastfeeding
   16. Driving and using machines
5. How to take Pixigan
   1. The dose should be taken in the morning. Do not take Pixigan more than once a day.
   2. How long to take the treatment
   3. Only your doctor, together with you, can decide how long to take Pixigan.
   4. Taking a higher dose of Pixigan than recommended
   5. Missing a dose of Pixigan
   6. Stopping treatment with Pixigan
6. Possible side effects
   1. Serious side effects
   2. Seizures
   3. If you experience a seizure, consult your doctor.
   4. Do not take any more tablets.
   5. Allergic reactions
   6. If you experience any symptoms of an allergic reaction, consult your doctor immediately. Do not take any more of the medication.
   7. If you experience worsening of lupus symptoms, skin rash, or skin changes (especially in areas of skin exposed to sunlight) while taking Pixigan, consult your doctor immediately, as
   8. If you experience a skin rash with pustules/blisters filled with pus, consult your doctor immediately, as
   9. Other side effects
   10. Reporting side effects
7. How to store Pixigan
8. Contents of the pack and other information
   1. What Pixigan contains
   2. What Pixigan looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. For further information, contact your local representative of the marketing authorization holder:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Pixigan, 150 mg, Modified Release Tablets

Bupropion Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Leaflet

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

1. What is Pixigan and what is it used for

Pixigan contains the active substance bupropion hydrochloride.
Pixigan is a prescription-only medication used to treat depression. It works with chemicals in the brain called noradrenaline and dopamine.

2. Important information before taking Pixigan

When not to take Pixigan

• if you are allergic to bupropion or any of the other ingredients of this medication (listed in section 6),
• if you are taking any other medications containing bupropion,
• if you have epilepsy or have had seizures,
• if you have had or currently have eating disorders (such as bulimia or anorexia),
• if you have a brain tumor,
• if you are an alcoholic who has just stopped drinking or plans to do so,
• if you have severe liver disease,
• if you have recently stopped taking sedatives or plan to do so while taking Pixigan,
• if you are taking or have taken within the last two weeks medications called monoamine oxidase inhibitors (MAOIs). If any of the above situations apply to you,do not take Pixigan and consult your doctor immediately.

Warnings and precautions

Tell your doctor or pharmacist before starting Pixigan.

Brugada Syndrome

If you have Brugada Syndrome (a rare, genetically determined disease affecting heart rhythm) or if there is a history of cardiac arrest or sudden death in your family.

Children and adolescents

Pixigan is not indicated for the treatment of children under 18 years of age.
In children under 18 years of age treated with antidepressants, there is an increased risk of suicidal thoughts and behaviors.

Adults

Tell your doctor before starting Pixigan:

• if you regularly drink large amounts of alcohol,
• if you have diabetes and are taking insulin or oral hypoglycemic medications,
• if you have had a severe head injury or brain trauma.
• Bupropion may cause seizures in about 1 in 1000 patients. The risk of this side effect is higher in patients with a history of certain conditions. If seizures occur during treatment, stop taking Pixigan and consult your doctor.
• if you have bipolar disorder (severe mood swings), as Pixigan may trigger an episode of this condition,
• if you are taking other medications for depression, as taking them together with Pixigan may lead to a condition called serotonin syndrome, a potentially life-threatening condition (see "Pixigan and other medications" in this section),
• if you have liver or kidney disease, as you may be more likely to experience side effects.

If any of the above situations apply to you, consult your doctor before starting Pixigan. Your doctor may decide to monitor you closely or recommend alternative treatment.

Suicidal thoughts and worsening of depression

In patients with depression, suicidal thoughts or behaviors may occur. These thoughts may worsen when starting antidepressant medication, as it may take some time (usually about two weeks, but sometimes longer) for the medication to start working.

• if you have had suicidal thoughts or self-harm in the past.
• if you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults (under 25 years of age) with mental disorders treated with antidepressants. If you experience suicidal thoughts or self-harm, seek medical attention immediately.

It may be helpful to inform a relative or friend that you have depression and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse or if they notice any changes in your behavior that worry them.

Pixigan and other medications

If you are currently taking or have taken within the last 14 days other antidepressant medications called monoamine oxidase inhibitors (MAOIs), consult your doctor without taking Pixigan

(see also "When not to take Pixigan" in section 2).

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take,

including herbal remedies or vitamins, including those available without a prescription.Your doctor may adjust the dose of Pixigan, recommend a change in dosing, or discontinue other medications you are taking.
Certain medications should not be taken with Pixigan.Some medications may increase the risk of seizures or other side effects. Examples of such medications are listed below, but this is not an exhaustive list.

Seizures may occur more frequently than usual if you take:

• other antidepressant or antipsychotic medications,
• theophylline, a medication for asthma or lung disease,
• tramadol, a strong pain reliever,
• sedatives, or if you plan to stop taking them while taking Pixigan (see also "When not to take Pixigan"),
• antimalarial medications(such as mefloquine or chloroquine),
• stimulants or other medications that control weight or appetite,
• steroids (oral or injectable),
• quinolone antibiotics,
• certain types of antihistamines that may cause drowsiness,
• antidiabetic medications.If any of the above situations apply to you,consult your doctor before starting Pixigan. Your doctor will assess the risks and benefits of taking Pixigan.

The risk of other side effects may increase if you take:

• other antidepressant medications(such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medications for other mental disorders (such as clozapine, risperidone, thioridazine, or olanzapine). Pixigan may interact with antidepressants and you may experience changes in mental state (e.g., agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea),
• medications for Parkinson's disease(levodopa, amantadine, orphenadrine),
• medications that affect bupropion metabolism(carbamazepine, phenytoin, valproic acid),
• medications for cancer treatment(such as cyclophosphamide or ifosfamide),
• ticlopidine or clopidogrel, mainly used to prevent stroke,
• beta-blockers(such as metoprolol),
• medications for irregular heart rhythm(propafenone and flecainide),
• nicotine patches, used to help quit smoking.If any of the above situations apply to you,consult your doctor before starting Pixigan.

Pixigan may be less effective if you are taking ritonavir or efavirenz, medications used to treat HIV infection. If this applies to you, inform your doctor. Your doctor will assess the effectiveness of Pixigan in your case. It may be necessary to increase the dose or change the treatment for depression. Do not increase the dose of Pixigan without consulting your doctor, as this may increase the risk of side effects, including seizures.

Pixigan may reduce the effectiveness of certain medications if you take:

• tamoxifen, used to treat breast cancer. If this applies to you,tell your doctor. It may be necessary to change the treatment for depression.
• digoxin for heart conditions.If this applies to you,tell your doctor. Your doctor may consider adjusting the dose of digoxin.

Pixigan and alcohol

Alcohol may affect the action of Pixigan and their concurrent use may, although rarely, cause nervousness or changes in mental state. Some patients become more sensitive to alcohol while taking Pixigan. Your doctor may advise you to avoid drinking alcohol (beer, wine, spirits) or to significantly reduce its consumption while taking Pixigan.
Discuss drinking alcohol with your doctorbefore starting Pixigan.

Effect on urine tests

Pixigan may affect the results of laboratory tests for other medications. If you are undergoing such a test, inform your doctor or nurse that you are taking Pixigan.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, do not take Pixigan unless your doctor advises you to do so. Before taking this medication during pregnancy, consult your doctor or pharmacist. Some studies suggest an increased risk of birth defects, particularly heart defects, in children whose mothers took Pixigan. It is not known if this is due to the medication itself.
The ingredients of Pixigan may pass into breast milk. Before taking Pixigan, consult your doctor or pharmacist.

Driving and using machines

If Pixigan causes dizziness or a feeling of emptiness in the head, do not drive or operate any tools or machines.

3. How to take Pixigan

Always take this medication exactly as your doctor has told you. These are the usual doses, but your doctor may recommend a different dose for you.
In case of doubt, consult your doctor or pharmacist.
Improvement in your condition may not occur immediately.The full effect of the medication may only become apparent after several weeks or months. Even if you start to feel better, your doctor may recommend continuing to take Pixigan to prevent a relapse of depression.
What dose to take
The usual recommended dose for adults is one150 mg tablet once a day.
Your doctor may recommend increasing the dose to 300 mgonce a day if you do not improve after several weeks of treatment.

The dose should be taken in the morning. Do not take Pixigan more than once a day.

The tablet is coated with a layer that slowly releases the medication into the digestive tract. You may notice something in your stool that looks like a tablet. This is the empty shell that has been eliminated from the body.
Tablets should be swallowed whole.Do not chew, crush, or divide them – if this happens, there is a risk of overdose due to the rapid release of the active substance into the body. This may increase the risk of side effects, including seizures.
For some patients, a dose of 150 mg once a dayis sufficient for the entire treatment period. Your doctor may recommend this dosing if you have liver or kidney disease.

How long to take the treatment

Only your doctor, together with you, can decide how long to take Pixigan.

It may take weeks or months before any improvement is seen.
You should regularly discuss your symptoms with your doctor to decide how long you should be treated. If you feel better, your doctor may recommend continuing to take Pixigan to prevent a relapse of depression.

Taking a higher dose of Pixigan than recommended

Taking too many tablets may cause a seizure. Do not delay.Consult your doctor or the nearest hospital emergency department immediately.

Missing a dose of Pixigan

If you miss a dose, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Pixigan

Do not stop treatment with Pixigan or reduce the dose without first discussing it with your doctor.
In case of any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Pixigan can cause side effects, although not everybody gets them.

Serious side effects

Seizures

About 1 in 1000 patients taking Pixigan may experience seizures. The risk of this side effect is higher in patients taking higher doses than recommended, taking certain medications, or being in a group with an increased risk of seizures. In case of doubt, consult your doctor.

If you experience a seizure, consult your doctor.

Do not take any more tablets.

Allergic reactions

Some patients may experience allergic reactions to Pixigan. These include:

• skin redness or rash (like a nettle rash), blisters or itchy bumps (hives) on the skin; some rashes may require hospitalization, especially if they are accompanied by mouth pain or eye pain,
• unusual wheezing or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• muscle or joint pain,
• fainting or brief loss of consciousness.

If you experience any symptoms of an allergic reaction, consult your doctor immediately. Do not take any more of the medication.

Allergic reactions can last a long time. If your doctor has prescribed medications to alleviate allergic symptoms, take the entire course.
Systemic lupus erythematosus or worsening of lupus symptoms(frequency not known - frequency cannot be estimated from the available data)
Systemic lupus erythematosus is an immune system disorder that affects the skin and other organs.

If you experience worsening of lupus symptoms, skin rash, or skin changes (especially in areas of skin exposed to sunlight) while taking Pixigan, consult your doctor immediately, as

it may be necessary to stop the treatment.
Acute generalized exanthematous pustulosis(frequency not known - frequency cannot be estimated from the available data)
Symptoms of acute generalized exanthematous pustulosis include a skin rash with pustules and (or) blisters filled with pus.

If you experience a skin rash with pustules/blisters filled with pus, consult your doctor immediately, as

it may be necessary to stop the treatment.

Other side effects

Very common(may affect more than 1 in 10 people):

• difficulty sleeping; make sure to take Pixigan in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

Common(may affect up to 1 in 10 people):

• fever, dizziness, itching, sweating, and skin rash (sometimes due to an allergic reaction),
• chills, tremors, weakness, fatigue, chest pain,
• feeling anxious or agitated,
• abdominal pain or other discomfort (constipation), change in taste, loss of appetite (anorexia),
• increased blood pressure, sometimes significantly, flushing of the face,
• ringing in the ears, vision disturbances.

Uncommon(may affect up to 1 in 100 people):

• feeling depressed (see also section 2 "Suicidal thoughts and worsening of depression"),
• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss.

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

• seizures.

Very rare(may affect up to 1 in 10,000 people):

• rapid heartbeat, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• feeling anxious, irritated, hostile, aggressive, unusual dreams, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice), which may be caused by increased liver enzyme activity, liver inflammation,
• severe allergic reactions; rash with accompanying muscle and joint pain,
• changes in blood sugar levels,
• urinating more or less often than usual,
• incontinence (involuntary urination),
• severe skin rashes that may involve the mouth and other parts of the body and may be life-threatening,
• worsening of psoriasis (red thickening of the skin),
• unusual hair loss or thinning (alopecia),
• feeling unreal or detached (depersonalization), seeing or hearing things that do not exist (hallucinations), believing in things that are not real (delusions), exaggerated suspiciousness (paranoia).

Frequency not known(frequency cannot be estimated from the available data):

• thoughts of self-harm or suicide during treatment with Pixigan or soon after stopping it (see section 2 "Important information before taking Pixigan"). If you have such thoughts, consult your doctor or go to the hospital immediately.
• loss of contact with reality and ability to think or assess the situation (psychosis); other symptoms may include hallucinations and (or) delusions.
• sudden and intense anxiety (panic attack).
• stuttering.
• decreased number of red blood cells (anemia), decreased number of white blood cells (leukopenia), and decreased number of platelets (thrombocytopenia).
• low sodium levels in the blood (hyponatremia).
• changes in mental state (e.g., agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea) when taking Pixigan with medications used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Pixigan

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.
No special precautions for storage are necessary.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pixigan contains

The active substance of Pixigan is bupropion hydrochloride.
Each modified-release tablet contains 150 mg of bupropion hydrochloride.
The other ingredients are:
Core:
Povidone K90
Cysteine hydrochloride monohydrate
Glycerol dibehenate
Colloidal silica anhydrous
Magnesium stearate
Coating:
Methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%
Ethylcellulose
Colloidal silica hydrated
Povidone K90
Macrogol 1450
Triethyl citrate
Ink:
Shellac
Iron oxide black (E 172)
Propylene glycol

What Pixigan looks like and contents of the pack

Pixigan is a modified-release tablet.
White to light yellow round tablets with black printing "GS3" on one side, smooth on the other side, with a diameter of about 7 mm and a thickness of about 5 mm.
Packaged in blisters of OPA/Aluminum/PVC/Aluminum foil in a carton.
Package sizes: 30 and 90 modified-release tablets
Not all pack sizes may be marketed

Marketing authorization holder and manufacturer

Marketing authorization holder:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer/Importer:
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona,
Spain

For further information, contact your local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00

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

Denmark: Bupropion hydrochloride Zentiva
Poland: Pixigan
Portugal: Bupropiom Zentiva
Sweden: Bupropion Zentiva
Germany: Bupropion Zentiva 150 mg Tablets mit veränderter Wirkstofffreisetzung
Norway: Bupropion hydrochloride Zentiva
Italy: Bupropione Zentiva Italia
(logo of the marketing authorization holder)
Date of last revision of the leaflet:October 2024