Vellbutrin Xr

Leaflet accompanying the packaging: information for the user

Wellbutrin XR, 150 mg, tablets with modified release

Wellbutrin XR, 300 mg, tablets with modified release

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 them, even if their symptoms are the same as yours.
• 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 Wellbutrin XR and what is it used for
• 2. Important information before taking Wellbutrin XR
• 3. How to take Wellbutrin XR
• 4. Possible side effects
• 5. How to store Wellbutrin XR
• 6. Contents of the packaging and other information

1. What is Wellbutrin XR and what is it used for

Wellbutrin XR is a prescription-only medicine used to treat depression. It works by interacting with chemicals in the brain called norepinephrineand dopamine.

2. Important information before taking Wellbutrin XR

When not to take Wellbutrin XR:

• If you are allergicto 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 or have hadeating disorders(such as bulimia or anorexia),
• If you have a brain tumor,
• If you are an alcoholicwho has just stopped drinking or plans to do so,
• If you have severe liver disease,
• If you have recently stopped taking sedativesor plan to do so while taking Wellbutrin XR (see also "When not to take Wellbutrin XR" in section 2),
• If you are taking or have takenmonoamine oxidase inhibitors (MAOIs)in the last two weeks. If any of these situations apply to you, do not take Wellbutrin XR without consulting your doctor.

Warnings and precautions

Before starting to take Wellbutrin XR, 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 is a history of cardiac arrest or sudden death in your family.

Children and adolescents

Wellbutrin XR 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 treatment with Wellbutrin

XR:

• If you regularly drink large amounts of alcohol,
• If you have diabetesand are taking insulin or oral antidiabetic medicines,
• If you have had a serious head injury or head traumain the past. Wellbutrin XR may cause seizures in about 1 in 1000 patients. The risk of this side effect is higher in patients with the above conditions. If seizures occur during treatment, discontinue Wellbutrin XR.

Do not take more of this medicine and consult your doctor.

• If you have bipolar disorder(extreme mood swings), as Wellbutrin XR may trigger an episode of this condition
• If you are taking other medicines for depression,taking them with Wellbutrin XR may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Wellbutrin XR and other medicines" 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 treatment with Wellbutrin XR. Your doctor may decide to monitor your treatment closely or recommend alternative treatment.

Suicidal thoughts and worsening of depressive symptoms

In patients with depression, suicidal thoughts or behaviors may sometimes occur. Such
behaviors may worsen when the patient first starts taking antidepressants, as it takes some time, usually about two
weeks, but sometimes longer, for these medicines to start working.
Such thoughts may occur more frequently:

• If you have had suicidal thoughts or self-harm thoughts 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 who were treated with antidepressants. If you ever have thoughts of self-harm or suicide, 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.

Wellbutrin XR and other medicines If you are currently taking or have taken in the last 14 days other antidepressants called

monoamine oxidase inhibitors (MAOIs), do not take Wellbutrin XR without consulting your doctor (see also "When not to take Wellbutrin XR" in section 2).

Tell your doctor or pharmacist about all medicines you are taking now or

recently, and about those you plan to take,including herbal medicines or vitamins, including those available without a prescription. Your doctor may change the dose of Wellbutrin XR, recommend a change in dosing, or discontinue other medicines you are taking.
Some medicines must not be taken with Wellbutrin XR.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.

Seizures may occur more frequently than usual:

• If you are taking other antidepressants or medicines for mental disorders,
• 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 stopped taking sedativesor plan to do so while taking Wellbutrin XR (see also "When not to take Wellbutrin XR" in section 2),
• If you are taking antimalarial medicines(such as mefloquine or chloroquine),
• If you are taking stimulants or other medicines that control weight or appetite,
• If you are taking steroids(orally or by injection),
• If you are taking quinolone antibiotics,
• 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 before starting treatment with Wellbutrin XR. Your doctor will assess the risk and benefits of using Wellbutrin XR.

It may increase the likelihood of other side effects:

• If you are taking other antidepressants(such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines for other mental disorders (such as clozapine, risperidone, thioridazine, or olanzapine). Wellbutrin XR may interact with antidepressants and you may experience changes in mental state (e.g., excitement, 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 (e.g., nausea, vomiting, diarrhea),
• If you are taking medicines for Parkinson's disease(levodopa, amantadine, orphenadrine),
• If you are taking medicines that affect the metabolism of Wellbutrin XR(carbamazepine, phenytoin, valproic acid),
• If you are taking certain medicines for cancer(such as cyclophosphamide or ifosfamide),
• If you are taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• If you are taking beta-blockers(such as metoprolol),
• If you are taking certain medicines for irregular heart rhythm(propafenone and flecainide),
• If you are using nicotine patches, as an aid to smoking cessation.If any of the above situations apply to you, consult your doctor before starting treatment with Wellbutrin XR.

Wellbutrin XR may be less effective

• If you are taking ritonavir or efavirenz, medicines used to treat HIV infection. If this situation applies to you, inform your doctor. Your doctor will assess the effectiveness of Wellbutrin XR in you. It may be necessary to increase the dose or change the treatment for depression. Do not increasethe dose of Wellbutrin XR without your doctor's recommendation, as this may increase the risk of side effects, including seizures.

Wellbutrin XR may reduce the effectiveness of some medicines

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

Wellbutrin XR with alcohol

Alcohol may affect the action of Wellbutrin XR, and their concurrent use may, although rarely, cause nervousness or changes in mental state. Some patients become more sensitive to alcohol while taking Wellbutrin XR. Your doctor may recommend avoiding alcohol (beer, wine, spirits) or significantly reducing its consumption while taking Wellbutrin XR. If you are currently drinking large amounts of alcohol, do not stop suddenly, as this may cause a seizure.
Discuss drinking alcohol with your doctorbefore starting treatment with Wellbutrin XR.

Effect on urine tests

Wellbutrin XR 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 Wellbutrin XR.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, do not take Wellbutrin XR unless your doctor recommends it. Before taking this medicine during pregnancy, consult your doctor or pharmacist. Some, but not all, studies suggest an increased risk of birth defects, particularly heart defects, in children whose mothers took Wellbutrin XR. It is not known if this was caused by the use of this medicine.
The ingredients of Wellbutrin XR may pass into breast milk. Before taking Wellbutrin XR, consult your doctor or pharmacist.

Driving and using machines

If Wellbutrin XR causes dizziness or a feeling of emptiness in the head, do not drive or operate machinery.

3. How to take Wellbutrin XR

Always take this medicine exactly as your doctor or pharmacist has told you. Your doctor will recommend a dose tailored to your needs. If you are unsure, ask your doctor or pharmacist.
Improvement in your condition may not occur immediately.The full effect of the medicine may only become apparent after several weeks or months. Even if you start to feel better, your doctor may recommend continuing treatment with Wellbutrin XR 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 mg once a day,if after several weeks of treatment, you do not show improvement.

The dose of Wellbutrin XR should be taken in the morning. Do not take Wellbutrin

XR 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 by the body.
Wellbutrin XR 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 medicine into the body. This may increase the risk of side effects, including seizures.
For some patients, a dose of 150 mg once a day is sufficientthroughout the treatment period. Your doctor may recommend this dosage 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 the treatment with

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

Taking a higher dose of Wellbutrin XR than recommended

Taking too many tablets may cause seizures or convulsions. Do not delay.Contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of Wellbutrin XR

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 Wellbutrin XR

Do notstop treatment with Wellbutrin XR or reduce the dose without first discussing it with your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects Seizures or convulsions

About 1 in 1000 patients taking Wellbutrin XR may experience seizures (convulsions). The risk of this side effect is higher in patients taking higher doses than recommended, taking certain medicines, or being in a group at increased risk of seizures. If you are unsure, consult your doctor.
If you experience a seizurecontact your doctor.

Do not take any more of this medicine.

Allergic reactions
Some patients may experience allergic reactions to Wellbutrin XR. These include:

• redness of the skin or rash (like a nettle rash), blisters or itchy bumps (hives) on the skin; some rashes may require hospitalization, especially if they also cause pain in the mouth or eyes,
• 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 reactioncontact your doctor immediately. Do not take any more of this medicine.Allergic reactions can last a long time.If your doctor has prescribed medicines to relieve allergic symptoms, take the entire course.

Discoid lupus erythematosus or worsening of lupus symptoms
Frequency not known - frequency cannot be estimated from the available data from people taking Wellbutrin XR. Lupus is an immune system disorder that affects the skin and other organs.

In case of worsening of lupus, skin rash, or skin changes (especially on sun-exposed areas) while taking Wellbutrin XR, contact 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 from people taking Wellbutrin XR. Symptoms of acute generalized exanthematous pustulosis include a rash with pustules/blisters filled with pus.

In case of a rash with pustules/blisters filled with pus, contact your doctor immediately, as it may be necessary to stop the treatment.

Other side effects

Very common side effects

May affect more than 1 in 10people:

• difficulty sleeping. Make sure to take Wellbutrin XR in the morning.
• headache,
• dry mouth,
• nausea, vomiting.

Common side effects

May affect up to 1 in 10people:

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

Uncommon side effects

May affect up to 1 in 100people:
feeling depressed (see also section 2 "Important information before taking Wellbutrin XR" under 'Suicidal thoughts and worsening of depressive symptoms') ,

• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare side effects

May affect up to 1 in 1,000people:

• seizures.

Very rare side effects

May affect up to 1 in 10,000people:

• rapid heartbeat, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, walking or coordination problems,
• feeling restless, 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, 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, uncontrolled urine flow),
• severe skin rashes that can affect the mouth and other parts of the body and can be life-threatening,
• worsening of psoriasis (red thickening of the skin),
• unusual hair loss ( 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).

Frequency not known

Other side effects have occurred in a small number of people, but their exact frequency is unknown:

• thoughts of self-harm or suicide while taking Wellbutrin XR or soon after stopping it (see section 2 "Important information before taking Wellbutrin XR"). If you have such thoughts, contact 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.
• feeling 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., excitement, 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 (e.g., nausea, vomiting, diarrhea) when taking Wellbutrin XR with antidepressants (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 Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Wellbutrin XR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from moisture and light. The bottle contains a small, tightly closed desiccant with activated carbon and silicon dioxide, which helps to keep the tablets dry. Leave the desiccant in the bottle. Do not swallow it.
Medicines should 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. Contents of the packaging and other information

What Wellbutrin XR contains

The active substance of Wellbutrin XR is bupropion hydrochloride. Each tablet contains 150 or 300 mg of bupropion hydrochloride.
The other ingredients are:
Tablet core:
Polyvinyl alcohol
Glycerol dibehenate
Coating:
Ink:
Opacode S-1-17823
Lacquer (20% esterified), iron oxide black (E-172), and ammonium hydroxide (28%).

What Wellbutrin XR looks like and contents of the pack

Wellbutrin XR 150 mg tablets are cream-white to light yellow, round, with the inscription "GS 5FV 150" in black on one side of the tablet, the other side is smooth. The tablets are available in white polyethylene bottles of 7, 30, 90, or 90 (3x30) tablets.
Wellbutrin XR 300 mg tablets are cream-white to light yellow, round, with the inscription "GS 5YZ 300" in black on one side of the tablet, the other side is smooth. The tablets are available in white polyethylene bottles of 7, 30, 90, or 90 (3x30) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain
Aspen Bad Oldesloe GmbH
Industriestr. 32-36
23843 Bad Oldesloe
Germany
Manufacturer:

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

Wellbutrin XR: Austria, Belgium, Cyprus, Greece, Luxembourg, Malta, Poland, Portugal, Slovenia,
Netherlands.
Wellbutrin: Italy.
Elontril: Czech Republic, Estonia, Germany, Hungary, Italy, Lithuania, Portugal, Romania, Slovakia, Spain,
Netherlands.
Wellbutrin Retard: Iceland, Norway.
Voxra: Finland, Sweden.
To obtain more detailed information, contact the local representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Phone: +48 22 576 9000

Date of last revision of the leaflet: January 2025