Vellbutrin Xr

Leaflet accompanying the packaging: information for the user

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

Wellbutrin XR (Elontril), 300 mg, tablets with modified release

Bupropion hydrochloride
Wellbutrin XR and Elontril are different trade names for the same medicine.

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 necessary.
• In case of any further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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. 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 affecting certain 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 addictwho has just stopped drinking or plans to do so,
• If the patient has severe liver disease,
• If the patient has recently stopped taking sedativesor plans 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 medicines called 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 and not take Wellbutrin XR.
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Warnings and precautions

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

Brugada syndrome

If the patient has 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 their family history.

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 they

• regularly drink large amounts of alcohol,
• have diabetes and are taking insulin or oral antidiabetic medicines,
• have had a serious head injury or brain trauma.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 use of Wellbutrin XR should be discontinued.

The patient should not take more of this medicine and should contact their doctor.

• If the patient has bipolar disorder(extreme 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 these medicines
may take some time to work, usually about two weeks, but sometimes longer.
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 trials have shown an increased risk of suicidal behavior in adults (under 25 years of age) with mental disorders who were treated with antidepressants. If the patient ever has thoughts of self-harm or suicide, they should contact their doctor immediately or go to the hospital.

It may be helpful for the patient to inform a relative or friendthat they have 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 are worrying.

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Wellbutrin XR and other medicines If the patient is currently taking or has taken other antidepressant medicines called monoamine oxidase inhibitors (MAOIs) within the last 14 days, 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 stop other medicines being taken.
Some medicines should 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 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 painkiller,
• If the patient has recently stopped taking or is currently taking sedativesor plans 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 body 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 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 increased 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, ifosfamide),
• If the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• If the patient is taking beta-blockers(such as metoprolol),
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• 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 stop smoking.If any of the above situations apply to the patient, they should contact their doctor 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 infections.

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 of depression. The patient should not increasethe dose of Wellbutrin XR without their 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 of 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 avoiding 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 took 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 or operate machinery.

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3. How to take Wellbutrin XR

Wellbutrin XR is available in the following doses: 150 mg and 300 mg.
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.
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 dayif the patient does not improve after several weeks of treatment.

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.They should not be chewed, crushed, or divided – 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.

Wellbutrin XR.It may take weeks or months before any improvement is observed.
The patient should regularly consult their doctor about depressive symptoms to decide 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 a convulsion. 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 dose to make up for the missed dose.

Stopping the treatment with Wellbutrin XR

The patient should notstop the treatment with 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.

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4. Possible side effects

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

Severe side effects Seizures or convulsions

In about 1 in 1000 patients taking Wellbutrin XR, seizures (convulsions) may occur. The likelihood of this happening is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures. In case of doubts, the patient should consult their doctor.

• In case of a seizurethe patient should contact their doctor.

The patient should not take any more of the medicine. Allergic reactions

In some patients, allergic reactions to Wellbutrin XR may occur. 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 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.
• In case of any symptoms of an allergic reactionthe patient should contact their doctor immediately. The patient should not take any more of the medicine.Allergic reactions can last a long time. If the doctor has prescribed medicines to relieve allergic symptoms, the patient should take the full course. Systemic lupus erythematosus or worsening of lupus symptomsFrequency 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 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 pustulosisFrequency not known - frequency cannot be estimated from the available data from people taking Wellbutrin XR. Symptoms of acute generalized exanthematous pustulosis include a skin rash with pus-filled blisters/blisters.
• In case of a skin rash with pus-filled blisters/blisters, the patient should contact their doctor immediately, as it may be necessary to stop the treatment.

Other side effects

Very common side effects

May occur in 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.
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Common side effects

May occur in 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 significantly, flushing of the face,
• ringing in the ears, vision disturbances.

Uncommon side effects

May occur in up to 1 in 100patients:
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 occur in up to 1 in 1,000patients:

• seizures.

Very rare side effects

May occur in up to 1 in 10,000patients:

• rapid heartbeat, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, walking difficulties 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, 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 leakage),
• 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 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).

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.
• feeling of sudden and intense anxiety (panic attack).
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• 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 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 Adverse Reaction Monitoring 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 or parallel importer.
Reporting side effects will help to gather more information 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 absorber with activated carbon and silica gel, which helps to keep the tablets dry. The absorber should be left in the bottle. It should not be swallowed.
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. Contents of the packaging and other information

What Wellbutrin XR contains

The active substance of Wellbutrin XR is bupropion hydrochloride. Each tablet contains 300 mg of bupropion hydrochloride.
The other ingredients are:
Tablet core:
Polyvinyl alcohol
Glycerol dibehenate

• 9 - Composition of the 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 300 mg tablets are cream-white to light yellow, round, with the inscription "GS 5YZ 300" in black on one side of the tablet, and the other side is smooth. The tablets are available in white, non-transparent HDPE bottles with a desiccant containing activated carbon/silica gel and a child-resistant closure, in a cardboard box, containing 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

GlaxoSmithKline, S.A.
P.T.M. C/Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Spain

Manufacturer:

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

Parallel importer:

Polypharm S.A.
ul. Barska 33
02-315 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Marketing authorization number in Spain, the country of export: 658761.4

Parallel import authorization number: 426/24

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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 approval of the leaflet: 03.12.2024

[Information about the trademark]