Vellbutrin Xr

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Wellbutrin XR

150 mg, modified-release tablets

Bupropion hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.

In case of any further doubts, you should consult a 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.

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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. Package contents 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 acts on the chemicals in the brain called norepinephrineand dopamine.

2. Important information before taking Wellbutrin XR

When not to take Wellbutrin XR:

• If the patient is allergicto bupropion or any of the other ingredients of this medicine (listed in section 6),
• If the patient is taking any other medicines containing bupropion,
• If the patient has epilepsy or has had seizures,
• If the patient has or has hadeating disorders(such as bulimia or anorexia nervosa),
• If the patient has a brain tumor,
• If the patient is an alcohol addict, has recently stopped drinking alcohol or intends to do so,
• If the patient has severe liver disease,
• If the patient has recently stopped taking sedativesor intends to do so while taking Wellbutrin XR (see also: "When not to take Wellbutrin XR", in section 2),
• If the patient is taking or has takenantidepressant medicinescalled monoamine oxidase inhibitors (MAOIs)within the last two weeks.

If any of the above situations apply to the patient, they should contact their doctor immediately without taking Wellbutrin XR.

Warnings and precautions

Before starting to take Wellbutrin XR, the patient should discuss it with their doctor or pharmacist.

Children and adolescents

Wellbutrin XR is not recommended 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

The patient should inform their doctor before starting to take Wellbutrin XR:

• If the patient regularly drinks large amounts of alcohol,
• If the patient has diabetesand is taking insulin or oral antidiabetic medicines,
• If the patient has had a serious head injury or head traumain the past.

Wellbutrin XR may cause seizures in about 1 in 1000 patients. The occurrence of this side effect is more likely in patients with the above-mentioned conditions.
If seizures occur during treatment, the patient should stop taking Wellbutrin XR.
The patient should not take any more of this medicine and should contact their doctorimmediately.

• If the patient has bipolar disorder(severe mood swings), as Wellbutrin XR may trigger an episode of this condition,
• If the patient is taking other medicines used to treat depression, as concurrent use of these medicines with Wellbutrin XR may lead to the occurrence of serotonin syndrome, a potentially life-threatening condition (see "Wellbutrin XR and other medicines" in this section).
• If the patient has liver or kidney disease, as they may be more likely to experience side effects.

If any of the above situations apply to the patient, they should contact their doctor before starting to take Wellbutrin XR. The doctor may decide to monitor the patient 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 the patient has had suicidal thoughts or self-harm thoughts before.

If the patient is 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.
In case of suicidal thoughts or self-harm thoughts, the patient should immediately contact their doctor or go to the hospital.
It may be helpful to inform a relative or friendthat the patient has depression, and ask them to read this leaflet. The patient may ask them to tell them if they notice that their depression is getting worse or if changes in their behavior become worrying.

Wellbutrin XR and other medicines

If the patient is currently taking or has taken within the last 14 days other antidepressant medicines calledmonoamine oxidase inhibitors (MAOIs), they should contact their doctor without taking Wellbutrin XR(see also: "When not to take Wellbutrin XR", in section 2).

The patient should tell their doctor or pharmacist about all medicines they are currently taking or

have recently taken, as well as those they plan to take, including herbal medicines or vitamins, including those available without a prescription. The doctor may change the dose of Wellbutrin XR, recommend a change in dosing, or discontinue other medicines being taken.
Some medicines should not be taken at the same time as 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 the patient is taking other antidepressant or antipsychotic medicines,
• If the patient is taking theophylline, a medicine for asthma or lung disease,
• If the patient is taking tramadol, a strong pain reliever,
• If the patient has recently stopped taking or is currently taking sedativesor if they intend to stop taking them while taking Wellbutrin XR (see also: "When not to take Wellbutrin XR", in section 2),
• If the patient is taking antimalarial medicines(such as mefloquine or chloroquine),
• If the patient is taking stimulants or other medicines that control weight or appetite,
• If the patient is taking steroids (orally or by injection),
• If the patient is taking antibiotics called quinolones,
• If the patient is taking certain types of antihistamine medicines that can cause drowsiness,
• If the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, they should contact their doctor immediately before starting to take Wellbutrin XR. The doctor will assess the risk and benefits of using Wellbutrin XR.

The risk of other side effects may increase:

• If the patient is taking other antidepressant medicines(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 medicines used to treat depression, and the patient 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

exacerbation of reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (e.g., nausea, vomiting, diarrhea).

• If the patient is taking medicines used to treat Parkinson's disease(levodopa, amantadine, orphenadrine),
• If the patient is taking medicines that affect the metabolism of Wellbutrin XR(carbamazepine, phenytoin, valproic acid),
• If the patient is taking certain medicines used to treat cancer(such as cyclophosphamide or ifosfamide),
• If the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• If the patient is taking beta-blockers(such as metoprolol),
• If the patient is taking certain medicines used to treat irregular heart rhythm(propafenone and flecainide),
• If the patient is using nicotine patches as an aid to quit smoking.

If any of the above situations apply to the patient, they should contact their doctor immediately before starting to take Wellbutrin XR.

Wellbutrin XR may be less effective:

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

Wellbutrin XR may reduce the effectiveness of certain medicines:

• If the patient is taking tamoxifen, used to treat breast cancer. If this situation applies to the patient, they should tell their doctor. It may be necessary to change the treatment for depression.
• If the patient is taking digoxin for heart problems. If this situation applies to the patient, they should tell their doctor. The doctor may consider adjusting the dose of digoxin.

Wellbutrin XR and 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. The doctor may recommend abstaining from alcohol (beer, wine, spirits) or significantly reducing its consumption while taking Wellbutrin XR. If the patient is currently drinking large amounts of alcohol, they should not stop drinking suddenly, as this may cause a seizure.
The patient should discuss drinking alcohol with their doctorbefore starting to take Wellbutrin XR.

Effect on urine tests

Wellbutrin XR may affect the results of laboratory tests for the presence of other medicines. If the patient is undergoing such a test, they should inform their doctor or nurse that they are taking Wellbutrin XR.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should not take Wellbutrin XR unless their doctor recommends it. Before using this medicine during pregnancy, the patient should consult their doctor or pharmacist. Some, but not all, studies suggest an increased risk of congenital defects, particularly heart defects, in children whose mothers used Wellbutrin XR. It is not known whether this was caused by the use of this medicine.
The ingredients of Wellbutrin XR may pass into breast milk. Before using Wellbutrin XR, the patient should consult their doctor or pharmacist.

Driving and using machines

If Wellbutrin XR causes dizziness or a feeling of emptiness in the head, the patient should not drive vehicles or operate machines.

3. How to take Wellbutrin XR

This medicine should always be taken as directed by the doctor or pharmacist. The doctor will recommend a dose individually for the patient. In case of doubts, the patient should consult their doctor or pharmacist.
Improvement in the patient's condition may occur only after some time. The full effect of the medicine may only become apparent after several weeks or months. Even if the patient starts to feel better, the doctor may recommend continuing to take Wellbutrin XR to prevent a relapse of depression.
Wellbutrin XR is available in a dose of 150 mg and 300 mg.
What dose to take
Usually, the recommended dose for adults is one150 mg tablet once a day.
The doctor may recommend increasing the dose to 300 mg once a day, if after several weeks of treatment, the patient does not show improvement.

The dose of Wellbutrin XR should be taken in the morning. The patient should 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. The patient may notice something in their stool that looks like a tablet. This is the empty shell that has been eliminated from the body.

Wellbutrin XR tablets should be swallowed whole.

The patient should 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. The doctor may recommend this dosing if the patient has liver or kidney disease.
How long to take the treatment

Only the doctor, together with the patient, can decide how long to take the treatment with Wellbutrin XR.

It may take weeks or monthsbefore any improvement is observed. The patient should regularly consult their doctor to assess their depressive symptoms, so that it can be decided how long they should be treated. If the patient feels better, the doctor may recommend continuing to take 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. The patient should contact their doctor or the nearest hospital emergency department immediately.

Missing a dose of Wellbutrin XR

In case of a missed dose, the patient should wait and take the next dose at the usual time. The patient should not take a double doseto make up for the missed dose.

Stopping treatment with Wellbutrin XR

The patient should not stoptaking Wellbutrin XR or reduce the dose without first discussing it with their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Serious side effects Seizures or convulsions

About 1 in 1000 patients taking Wellbutrin XR may experience seizures (convulsions). The likelihood of this happening is higher if the patient takes higher doses than recommended, takes certain medicines, or is at increased risk of seizures.
In case of doubts, the patient should consult their doctor.
If the patient experiences a seizure, they should contact their doctor.
The patient should 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 there is also pain in the mouth 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 the patient experiences any symptoms of an allergic reaction, they should contact their doctor immediately.
The patient should not take any more of this medicine.

Allergic reactions can last a long time.

If the doctor has prescribed medicines to relieve allergic symptoms, the patient should take the entire course.
Systemic lupus erythematosus or worsening of lupus symptoms
Frequency not known - frequency cannot be estimated from the available data from patients 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 in areas of the skin exposed to sunlight) while taking Wellbutrin XR, the patient should contact their 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 patients taking Wellbutrin XR. 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, the patient should contact their doctor immediately,

as it may be necessary to stop the treatment.

Other side effects

Very common side effects

May affect more than 1 in 10patients:

• difficulty sleeping; the patient should make sure that Wellbutrin XR is taken in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

Common side effects

May affect up to 1 in 10patients:

• 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 disorders (constipation), change in taste, loss of appetite (anorexia),
• increased blood pressure, sometimes significantly, flushing of the face,
• ringing in the ears, vision disturbances.

Uncommon side effects

May affect up to 1 in 100patients:

• feeling depressed (see also section 2: "Warnings and precautions"),
• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare side effects

May affect up to 1 in 1,000patients:

• seizures.

Very rare side effects

May affect up to 1 in 10,000patients:

• rapid heartbeat, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, walking problems 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 may involve the mouth and other parts of the body and may be life-threatening,
• worsening of psoriasis (red thickening of the skin),
• 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 patients, 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 the patient has such thoughts, they should contact their 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.
• stuttering.
• decreased red blood cell count (anemia), decreased white blood cell count (leukopenia), and decreased platelet count (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

exacerbation of reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (e.g., nausea, vomiting, diarrhea) when taking Wellbutrin XR with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Wellbutrin XR

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The medicine should be stored in its original packaging to protect it from light and moisture.
The bottle contains a small, tightly closed desiccant with activated carbon and silica gel, which helps keep the tablets dry. The desiccant should be left in the bottle.
The patient should not swallow it.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Wellbutrin XR contains

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

What Wellbutrin XR looks like and contents of the pack

Wellbutrin XR 150 mg tabletsare cream-white to light yellow, round, with the inscription "GS 5FV 150" in black on one side of the tablet, and the other side is smooth. The tablets are available in white polyethylene bottles of 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque – Miraflores
1495-131 Algés
Portugal

Manufacturer:

Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,
23843 Bad Oldesloe, Germany
Glaxo Wellcome S.A., Avenida de Extremadura 3,
09400 Aranda de Duero, Burgos, Spain

Parallel importer:

ProCarePlus Pharma S.A.
ul. Bobrzyńskiego 14
30-348 Kraków

Repackaged by:

CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Chemiczno-Farmaceutyczna Spółdzielnia Pracy "ESPEFA"
ul. Juliusza Lea 208
30-133 Kraków
MEDICOFARMA S.A.

ul. Sokołowska 9 lok. U19
01-142 Warszawa
Marketing authorization number in Portugal, the country of export: 5015565

Parallel import authorization number: 248/22

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.
Date of leaflet approval: 07.06.2022
[Information about the trademark]