Pixigan

Leaflet accompanying the packaging: patient information

Pixigan, 300 mg, modified-release tablets

Bupropion hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any 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 and is a medicine prescribed by a doctor to treat depression. It is believed to interact with chemicals in the brain called norepinephrineand 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 medicine (listed in section 6),
• if you are taking any other medicines containing bupropion,
• if you have epilepsy or have had seizures,
• if you have had or have eating disorders (such as bulimia or anorexia),
• if you have a brain tumor,
• if you are an alcoholic who has just stopped or plans to stop drinking alcohol,
• if you have severe liver disease,
• if you have recently stopped taking sedatives or plan to stop taking them while taking Pixigan (see also "When not to take Pixigan" above),
• if you are taking or have taken in the last 14 days medicines for depression 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

Before starting to take Pixigan, discuss it with your doctor or pharmacist.

Brugada syndrome

• if you have been diagnosed with Brugada syndrome (a rare, genetically determined disease affecting heart rhythm) or if there have been cases of cardiac arrest or sudden death in your family history.

Children and adolescents

Pixigan is not recommended for 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

You should inform your doctor before starting to take Pixigan:

• if you regularly drink large amounts of alcohol,
• if you have diabetes and are taking insulin or oral hypoglycemic agents,
• if you have had a severe head injury or brain damage. It has been shown that bupropion can cause seizures in about 1 in 1000 people. The occurrence of this side effect is more likely in patients with the above-mentioned conditions. If seizures occur during treatment, discontinue Pixigan and consult your doctor.
• if you have bipolar affective disorder (extreme mood swings), as bupropion may trigger an episode of this disease,
• if you are taking other antidepressants, as concurrent use of these medicines with Pixigan may lead to the occurrence of serotonin syndrome, a potentially life-threatening condition (see "Pixigan and other medicines" in this section).
• if you have liver or kidney disease, as they may be more likely to experience side effects.

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

Suicidal thoughts and worsening of depressive symptoms

Depressed patients may sometimes experience suicidal thoughts or behaviors.
They may worsen when the patient first starts taking antidepressants,
as all these medicines usually start working after about 2 weeks, but sometimes longer.
It is more likely that such thoughts may occur:

• if you have had suicidal thoughts or self-harm before.
• 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 at any time, contact your doctor immediately or go to the hospital.

It may be helpful to inform a relative or friendthat 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 are concerned about changes in your behavior.

Pixigan and other medicines

If you are currently taking or have taken other antidepressants called monoamine oxidase inhibitors(MAOIs) in the last 14 days, contact your doctor without taking Pixigan(see also "When not to take Pixigan" above).
Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, including herbal medicines or vitamins, including those bought without a prescription. Your doctor may change the dose of Pixigan or recommend changing other medicines you are taking.
Some medicines cannot be taken at the same time as Pixigan. Some of them may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side effects. Examples of such medicines are listed below, but this is not an exhaustive list.

The risk of seizures may be higher than usual:

• if you are taking other antidepressants or other medicines used to treat mental illnesses,
• if you are taking theophylline, a medicine for asthma or lung disease,
• if you are taking tramadol, a strong pain reliever,
• if you have recently taken or are currently taking sedativesor if you plan to stop taking them while taking Pixigan (see also "When not to take Pixigan" above),
• if you are taking antimalarial medicines(such as mefloquine or chloroquine),
• if you are taking stimulants or other medicines that control body weight or appetite,
• if you are taking steroids(orally or by injection),
• if you are taking antibiotics called quinolones,
• if you are taking certain types of antihistamines that can cause drowsiness,
• if you are taking antidiabetic medicines.

If any of the above situations apply to you, consult your doctor immediately before starting to take Pixigan. Your doctor will assess the risk and benefits of using Pixigan.

The risk of other side effects may increase if:

• you are taking other antidepressants(such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines for other mental illnesses (such as clozapine, risperidone, thioridazine, or olanzapine). Pixigan may interact with medicines used to treat depression, and you may experience changes in mental state (such as 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 disorders (such as nausea, vomiting, diarrhea).
• you are taking medicines used to treat Parkinson's disease(levodopa, amantadine, orphenadrine),
• you are taking medicines that affect bupropion metabolism(carbamazepine, phenytoin, valproic acid),
• you are taking certain anticancer medicines(such as cyclophosphamide or ifosfamide),
• you are taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• you are taking beta-blockers(such as metoprolol),
• you are taking certain medicines for irregular heart rhythm(propafenone and flecainide),
• you are using nicotine patches to help you quit smoking.

If any of the above situations apply to you, consult your doctor immediately before starting to take Pixigan.

Pixigan may be less effective if:

• you are taking ritonavir or efavirenz, medicines used to treat HIV infections.

If any of the above situations apply to you, inform your doctor. Your doctor will assess the effectiveness of Pixigan in you. It may be necessary to increase the dose or change the treatment of depression. Do not increase the doseof Pixigan without consulting your doctor, as this may increase the risk of side effects, including seizures.

Pixigan may reduce the effectiveness of some medicines if:

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

Pixigan with alcohol

Alcohol may affect the action of bupropion, and when taken together, it may rarely cause nervousness or changes in mental state. Some patients become more sensitive to alcohol while taking Pixigan. Your doctor may recommend avoiding alcohol (beer, wine, spirits) or significantly reducing its consumption while taking Pixigan. If you are currently drinking large amounts of alcohol, do not stop suddenly, as this may cause a seizure. Talk to your doctor about drinking alcoholbefore starting to take Pixigan.

Effect on urine tests

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

Pregnancy, breastfeeding, and fertility

Do not take Pixigan during pregnancy, if you suspect you are pregnant, or if you plan to become pregnant, unless your doctor recommends it.
Before taking any medicine during pregnancy, consult your doctor or pharmacist.
Some, but not all, studies suggest an increased risk of congenital malformations, particularly heart defects, in children whose mothers took Pixigan. It is not known whether this was due to the medicine 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 drowsiness, do not drive or operate machinery.

Pixigan contains sodium

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

3. How to take Pixigan

Always take this medicine exactly as your doctor or pharmacist has told you.
Your doctor will recommend a dose individually for you. If you are unsure, ask your doctor or pharmacist.
Improvement in your condition may take some time. The full effect of the medicine may only become apparent after a few 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
Usually, the recommended dose for adults only 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 a few weeks of treatment.

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

The tablet is coated with a shell that slowly releases the medicine 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.
Swallow Pixigan tablets whole. Do not chew, crush, or divide them – if this happens, there is a risk of overdose due to the rapid release of the medicine 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 throughout the treatment period. Your doctor may recommend this dosage if you have liver or kidney disease.
How long to take

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

Pixigan.It may take a few weeks or months before an 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 increase the risk of a seizure. Do not delay. Contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of Pixigan

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

Stopping treatment with Pixigan

Do not stop taking Pixigan or reduce the dose without consulting your doctor first.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

Seizures

About 1 in 1000 patients taking bupropion may experience seizures or convulsions. The risk of this event is higher in patients taking higher doses than recommended, taking certain medicines, or being at increased risk of seizures. If you experience a seizure, contact your doctor. Do not take any more tablets.

Allergic reactions

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

• Redness of the skin or rash (like hives), 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, contact your doctor immediately. Do not take any more tablets. Allergic reactionscan last a long time.If your doctor has prescribed medicines to relieve allergic symptoms, take the full course.
Stevens-Johnson syndrome or worsening of symptoms(unknown) - frequency cannot be estimated from the available data.
Stevens-Johnson syndrome is a disorder of the immune system that affects the skin and other organs.

In case of worsening of Stevens-Johnson syndrome, skin rash, or skin changes (especially in areas of skin exposed to sunlight) while taking Pixigan, contact your doctor immediately, as

it may be necessary to discontinue treatment.
Acute generalized exanthematous pustulosis(unknown) frequency cannot be estimated from the available data.
Symptoms of acute generalized exanthematous pustulosis include a skin rash with pustules/blisters filled with pus.

In case of a skin rash with pustules/blisters filled with pus, contact your doctor immediately, as

it may be necessary to discontinue treatment.

Other side effects

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

• Difficulty sleeping. Pixigan should be taken in the morning.
• Headache.
• Dry mouth.
• Nausea, vomiting.

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

• 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 disorders (constipation), change in taste, loss of appetite (anorexia).
• Increased blood pressure (sometimes significant), flushing.
• Ringing in the ears, vision disturbances.

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

• Feeling depressed (see also section 2 "Warnings and precautions" in "Suicidal thoughts and worsening of depressive symptoms").
• Feeling disoriented.
• Difficulty concentrating.
• Increased heart rate.
• Weight loss.

Rare(may affect up to 1 in 1000patients):

• Seizures.

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

• Heart palpitations, fainting.
• Tremors, muscle stiffness, uncontrolled movements, walking or coordination problems.
• Feeling anxious, irritated, hostile, aggressive, having strange 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, hepatitis.
• Severe allergic reactions; rash with accompanying muscle or joint pain.
• Changes in blood sugar levels.
• Urinating more or less often than usual.
• Urinary incontinence (involuntary urination, uncontrolled urine flow).
• Severe skin rashes that may affect the mouth and other parts of the body and may be life-threatening.
• Worsening of psoriasis (thickening of red skin patches).
• Unusual hair loss or thinning (alopecia).
• Feeling unreal or strange (depersonalization), seeing or hearing things that do not exist (hallucinations), feeling or believing in things that are not real (delusions), exaggerated suspiciousness (paranoia).

Unknown(frequency cannot be estimated from the available data):

• Thoughts of self-harm or suicide during treatment with Pixigan or soon after its completion (see section 2 "Important information before taking Pixigan"). If you have such thoughts, contact your doctor or go to the hospital immediately.
• Losing touch with reality and the ability to think clearly or assess the situation (psychosis); other symptoms may include hallucinations and (or) delusions.
• Sudden and intense anxiety (panic attack).
• Stuttering.
• Decreased red blood cell count (anemia), decreased white blood cell count (leukopenia), and decreased platelet count (thrombocytopenia).
• Decreased sodium levels in the blood (hyponatremia).
• Changes in mental state (such as 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 disorders (such as nausea, vomiting, diarrhea) when taking Pixigan with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 medicine.

5. How to store Pixigan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines 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 tablet contains 300 mg of bupropion hydrochloride.
• The other ingredients are: Tablet core: povidone, cysteine hydrochloride monohydrate, colloidal silica, anhydrous, glycerol dibehenate, magnesium stearate. Tablet coating: ethylcellulose, povidone, methacrylic acid, and ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, colloidal silica, hydrated, triethyl citrate. Ink: shellac, iron oxide black (E 172), propylene glycol.

What Pixigan looks like and contents of the pack

Pixigan 300 mg tablets are round, white to light yellow tablets with "GS2" printed on one side and smooth on the other. The tablet diameter is approximately 9 mm.
Blister packs of OPA/Aluminum/PVC-Aluminum containing 7, 30, 60, and 90 modified-release tablets, in a cardboard box. Also available in a perforated blister pack of OPA/Aluminum/PVC-Aluminum, divisible into single doses, containing 30×1 tablet of modified release, in a cardboard box. 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:
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain

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

Poland: Pixigan
Portugal: Bupropiom Zentiva
Germany: Bupropion Zentiva 300 mg Tablets with modified release
Norway: Bupropion hydrochloride Zentiva
Sweden: Bupropion Zentiva
Italy: Bupropione Zentiva
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:October 2024