Wellbutrin xr

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Wellbutrin XR (Elontril), 150 mg, modified-release tablets
Bupropion hydrochloride
Wellbutrin XR and Elontril are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Wellbutrin XR is and what it is used for
2. What you need to know before taking Wellbutrin XR
3. How to take Wellbutrin XR
4. Possible side effects
5. How to store Wellbutrin XR
6. Contents of the pack and other information

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

Wellbutrin XR is a prescription medicine used to treat depression. It works by affecting chemical substances in the brain called noradrenaline and dopamine.

2. Important information before taking Wellbutrin XR

When not to take Wellbutrin XR:

• if the patient is allergic to 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 in the past,

• if the patient has or has previously had eating disorders (e.g. bulimia or anorexia nervosa),

• if the patient has a brain tumour,

• if the patient is an alcohol abuser who has recently stopped drinking alcohol or intends to stop,

• if the patient has severe liver disease,

• if the patient has recently stopped taking sedative medicines or intends to do so during treatment with Wellbutrin XR,

• if the patient is taking or has taken within the last two weeks medicines antidepressants known as monoamine oxidase inhibitors (MAOIs). If any of the above situations apply to the patient, contact the doctor immediately and do not take Wellbutrin XR.

• 2 - Warnings and precautions Before starting treatment with Wellbutrin XR, discuss this with your doctor or pharmacist. Brugada syndrome if the patient has been diagnosed with Brugada syndrome (a rare, genetically determined condition affecting heart rhythm) or has a family history of cardiac arrest or sudden death. 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 antidepressant medicines, there is an increased risk of suicidal thoughts and behaviours. Adults Inform your doctor before starting treatment with Wellbutrin XR:

• if the patient regularly drinks large amounts of alcohol,

• if the patient has diabetes and is using insulin or oral antidiabetic medicines,

• if the patient has previously suffered a serious head injury or head trauma. Wellbutrin XR may cause seizures in approximately 1 in 1000 patients. The occurrence of this adverse effect is more likely in patients from the groups mentioned above. If seizures occur during treatment, discontinue use of Wellbutrin XR. Do not take more of this medicine and contact your doctor immediately.

• if the patient has bipolar disorder (extreme mood swings), because Wellbutrin XR may trigger an episode of this disorder,

• if the patient is taking other medicines used to treat depression, as concomitant use of these medicines with Wellbutrin XR may lead to 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 adverse effects are more likely to occur. If any of the above situations apply to the patient, contact the doctor again before starting treatment with Wellbutrin XR. The doctor may decide that treatment should be administered under close supervision or recommend alternative therapy. Suicidal thoughts and worsening of depressive symptoms Patients with depression may sometimes experience thoughts of self-harm or suicide. These behaviours may worsen when patients first start taking antidepressant medicines, as it takes time for these medicines to work, usually about two weeks, but sometimes longer. Such thoughts may occur more frequently:

• If the patient previously had suicidal thoughts or thoughts of self-harm.

• If the patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults (under 25 years of age) with psychiatric disorders who were treated with antidepressant medicines. If thoughts of self-harm or suicide ever occur, contact your doctor immediately or go to hospital.

It may be helpful to inform a relative or friend that the patient has depression,
and ask them to read this leaflet. The patient may ask them to inform him or her
if they believe the patient's depression is worsening or if changes in behaviour
become concerning.

• 3 - Wellbutrin XR and other medicines If the patient is currently taking or has taken within the last fourteen days other medicines antidepressants known as monoamine oxidase inhibitors (MAOIs), contact your doctor without taking Wellbutrin XR (see also: When not to take Wellbutrin XR, in section 2).

Tell your doctor or pharmacist about all medicines you are currently taking or
have recently taken, as well as any medicines you plan to take, including herbal remedies or
vitamins, even those available without a prescription. The doctor may adjust the dose of Wellbutrin XR,
recommend changing the dosing regimen, or discontinuation of other medicines.
Some medicines must 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 adverse effects. Examples of such medicines are listed below, but this is not
a complete list.
Seizures may occur more frequently than usual:

• if the patient is taking other antidepressant medicines or medicines used to treat psychiatric disorders,
• 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 taken or is currently taking sedative medicines or intends to stop taking them during treatment with 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 stimulant medicines or other medicines that control body weight or appetite,
• if the patient is taking corticosteroids (orally or by injection),
• if the patient is taking antibiotics known as quinolones,
• if the patient is taking certain types of antihistamines that may cause drowsiness,
• if the patient is taking antidiabetic medicines. If any of the above situations apply to the patient, contact your doctor immediately before starting treatment with Wellbutrin XR. The doctor will assess the risks and benefits of using Wellbutrin XR.

The likelihood of other adverse effects may increase:

• if the patient is taking other antidepressant medicines (such as: amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or medicines for other psychiatric 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, stupor), and other symptoms such as: body temperature above 38°C, rapid heartbeat, unstable blood pressure and increased reflexes, muscle rigidity, lack of coordination and (or) gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea),
• 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 malignant tumours (such as: cyclophosphamide, ifosfamide),
• if the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• if the patient is taking ß-blockers (such as metoprolol),
• 4 -
• if the patient is taking certain medicines for 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, contact your doctor immediately before starting treatment with 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, inform the doctor. The doctor will assess the effectiveness of Wellbutrin XR in the patient. It may be necessary to increase the dose or change the method of depression treatment. Do not increase the dose of Wellbutrin XR without the doctor's recommendation, as this may increase the risk of adverse 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, inform the doctor. It may be necessary to change the method of depression treatment.
• If the patient is taking digoxin for heart problems. If this situation applies to the patient, inform the doctor. The doctor may consider adjusting the digoxin dose.

Wellbutrin XR and alcohol
Alcohol may affect the action of Wellbutrin XR and taking them together may, although
rarely, cause nervousness or alter 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 currently drinks large amounts of alcohol, do not stop
drinking suddenly, as this may trigger a seizure.
Talk to your doctor about drinking alcohol before starting treatment with
Wellbutrin XR.
Effect on urine tests
Wellbutrin XR may affect laboratory test results for the presence of other medicines. If
the patient undergoes such a test, he or she should inform the doctor or nurse that
he or she is taking Wellbutrin XR.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant,
Wellbutrin XR should not be taken unless otherwise advised by a doctor. Consult a doctor or pharmacist
before using this medicine during pregnancy. Some, but not all, studies
suggest an increased risk of congenital malformations, particularly heart defects, in children whose mothers
took Wellbutrin XR. It is not known whether this was caused by taking this medicine.
The ingredients of Wellbutrin XR may pass into breast milk. Consult a doctor or pharmacist
before using Wellbutrin XR.
Driving and operating machinery
If Wellbutrin XR causes dizziness or a feeling of emptiness in the head, do not drive
or operate machinery.

• 5 -

3. How to take Wellbutrin XR

Wellbutrin XR is available in the following strengths: 150 mg and 300 mg.
This medicine should always be taken as directed by the physician or pharmacist. The prescribing
physician determines the dose individually for each patient. If in doubt, consult the physician or
pharmacist.
Improvement in the patient's well-being may occur only after some time. The full effect of the
medicine may become apparent only after several weeks or months. Even when the patient starts
feeling better, the prescribing physician may recommend continuing treatment with Wellbutrin XR
to prevent recurrence of depression.
What doses should be taken
The usual dose for adults is one 150 mg tablet once daily.
The prescribing physician may increase the dose to 300 mg once daily if there is no improvement
after several weeks of treatment.
Wellbutrin XR should be taken in the morning. Do not take Wellbutrin XR more than once a day.
The tablet has a coating that slowly releases the medicine into the gastrointestinal tract. The patient
may notice something that looks like a tablet in the stool. This is the empty shell that has been
eliminated from the body.
Wellbutrin XR tablets should be swallowed whole. Do not chew, crush, or

divide the tablets—if this happens, there is a risk of overdose due to too rapid release of the medicine
into the body. This may increase the risk of adverse effects, including seizures.
For some patients, a dose of 150 mg once daily is sufficient throughout the entire treatment
period. The prescribing physician may recommend this dosage if the patient has liver or kidney
disease.
How long to continue treatment
Only the physician together with the patient can decide how long treatment with Wellbutrin XR
should continue. It may take weeks or months before any improvement is observed.
The patient should regularly discuss depressive symptoms with the prescribing physician so that a
decision can be made regarding the duration of treatment. If the patient feels better, the prescribing
physician may recommend continuing treatment with Wellbutrin XR to prevent recurrence of
depression.
Taking more than the recommended dose of Wellbutrin XR
Taking too many tablets may cause seizures or a seizure attack. Do not delay. Contact a physician
immediately or go to the nearest hospital emergency department.
Missing a dose of Wellbutrin XR
If a dose is missed, 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 not stop taking Wellbutrin XR or reduce the dose without first discussing it with the prescribing
physician.
If there are any further questions about the use of this medicine, consult the physician or pharmacist.

• 6 -

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Seizures or convulsions
Seizures (convulsions or seizures) may occur in approximately 1 in 1,000 patients taking Wellbutrin XR. The likelihood is higher in patients taking higher than recommended doses, taking certain other medications, or belonging to a group at increased risk of seizures. If in doubt, contact your doctor.

• If a seizure occurs, contact your doctor. Do not take any more of the medicine.

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

• skin redness or rash (such as maculopapular rash), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if accompanied by mouth pain or eye pain,
• unusual wheezing or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• muscle or joint pain,
• collapse or brief loss of consciousness.
• If any symptoms of an allergic reaction occur, contact your doctor immediately. Do not take any more of the medicine. Allergic reactions may persist for a long time. If your doctor has prescribed medications to relieve allergic symptoms, complete the full course of treatment.
  Lupus erythematosus or worsening of lupus symptoms
  Frequency unknown – frequency cannot be determined from available data in patients taking Wellbutrin XR. Lupus is an autoimmune disorder affecting the skin and other organs.
• If lupus flares, skin rash, or skin lesions occur (especially on areas of skin exposed to sunlight) during treatment with Wellbutrin XR, contact your doctor immediately, as discontinuation of treatment may be necessary.
  Acute generalized exanthematous pustulosis
  Frequency unknown – frequency cannot be determined from available data in patients taking Wellbutrin XR. Symptoms of acute generalized exanthematous pustulosis include skin rash with pustules/blisters filled with pus.
• If a skin rash with pustules/blisters filled with pus occurs, contact your doctor immediately, as discontinuation of treatment may be necessary.

Other adverse reactions
Very common adverse reactions
May occur in more than 1 in 10 patients:

• difficulty falling asleep. Ensure that Wellbutrin XR is taken in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

Common adverse reactions
May occur in up to 1 in 10 patients:

• fever, dizziness, itching, sweating, skin rash (sometimes due to allergic reaction),
• chills, tremors, weakness, fatigue, chest pain,
• feeling of anxiety or agitation,
• abdominal pain or other gastrointestinal disturbances (constipation), altered taste sensation, loss of appetite (anorexia),
• increased blood pressure (sometimes significantly), facial flushing,
• ringing in the ears, visual disturbances.

Uncommon adverse reactions
May occur in up to 1 in 100 patients:
feeling of depression (see also section 2: Important information before taking Wellbutrin XR, under ‘Suicidal thoughts and worsening of depression symptoms’),

• feeling of disorientation,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare adverse reactions
May occur in up to 1 in 1,000 patients:

• seizures.

Very rare adverse reactions
May occur in up to 1 in 10,000 patients:

• palpitations, fainting,
• muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• feeling of restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice), which may be due to increased liver enzyme activity, hepatitis,
• severe allergic reactions; rash accompanied by muscle and joint pain,
• changes in blood sugar levels,
• urinating more or less frequently than usual,
• urinary incontinence (involuntary urination, uncontrolled leakage of urine),
• severe skin rashes, which may involve the mouth and other body parts and may be life-threatening,
• worsening of psoriasis (red, thickened skin lesions),
• unusual hair loss or thinning (alopecia),
• feeling of unreality or detachment (depersonalization), seeing or hearing things that are not real (hallucinations), experiencing or believing in unreal things (delusions), excessive suspiciousness (paranoia).

Frequency unknown
Other adverse reactions occurred in a small number of patients, but their exact frequency is unknown:

• thoughts of self-harm or suicide during treatment with Wellbutrin XR or shortly after stopping it (see section 2 “Important information before taking Wellbutrin XR”). If such thoughts occur, contact your doctor or go to the hospital immediately.
• loss of contact with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and/or delusions.
• feeling of sudden and intense fear (panic attack).
• stuttering.
• decreased number of red blood cells (anaemia), 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, increased reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea) when taking Wellbutrin XR together with medicines used to treat depression (such as: paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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. Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Wellbutrin XR

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in the original container to protect from light and moisture. The bottle contains a small, tightly sealed desiccant made of activated charcoal and silica gel, which helps keep the tablets dry. Leave the desiccant in the bottle. Do not swallow it.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Wellbutrin XR contains
The active substance is bupropion hydrochloride. Each tablet contains 150 mg of bupropion
hydrochloride.
The other ingredients are:
Tablet core:
Polyvinyl alcohol
Glyceryl dibehenate

• 9 - Composition of the coating:

Ink:
Opacode S-1-17823
Shellac (20% esterified), iron oxide black (E 172) and concentrated ammonium hydroxide.
What Wellbutrin XR looks like and what the pack contains
Wellbutrin XR 150 mg tablets are cream-white to light yellow, round, printed with
"GS 5FV 150" in black on one side of the tablet, the other side smooth. The tablets are supplied in
white, opaque HDPE bottles containing a moisture-absorbing agent composed of activated carbon/silica gel and a sealing membrane, with a child-resistant closure, containing 30 tablets, packed in a cardboard box.
For further detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation 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 in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Spanish Marketing Authorisation Number (country of export): 658760.7
Parallel Import Licence Number: 425/24

• 10 - This medicinal product is authorised for marketing in the European Economic Area countries 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.