Wellbutrin xr

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Wellbutrin XR (Elontril), 300 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 the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• 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 side effects, 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. 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 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 on 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 experienced seizures,
• 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 who abuses alcohol has recently stopped drinking alcohol or intends to do so,
• if the patient has severe liver disease,
• if the patient has recently stopped taking sedatives or intends to do so during treatment with Wellbutrin XR,
• if the patient is taking or has taken within the last two weeks medicines for depression called 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, inform the doctor.

Children and adolescents
Wellbutrin XR is not recommended for use in children under 18 years of age. In children and adolescents under 18 years of age treated with antidepressant medicines, there is an increased risk of suicidal thoughts and suicidal behaviour.

Adults
The patient should inform their 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 had a serious head injury or head trauma.

Wellbutrin XR may cause seizures in approximately 1 in 1,000 patients. The likelihood of this adverse effect is higher in patients from the groups listed above. If seizures occur during treatment, stop taking Wellbutrin XR immediately. Do not take more of this medicine and contact your doctor.

• If the patient has bipolar disorder (extreme mood swings), because Wellbutrin XR may trigger an episode of this condition,
• If the patient is taking other medicines used to treat depression, 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, because adverse effects may be 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 closely monitored or recommend alternative therapy.

Suicidal thoughts and worsening of depression symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. These behaviours may worsen when the patient first starts taking antidepressant medicines, as it takes time for these medicines to take effect—usually about two weeks, but sometimes longer. Such thoughts may be more common:

• 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 the patient ever experiences thoughts of self-harm or suicide, contact the 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 notice that the patient's depression worsens 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 antidepressant medicines called monoamine oxidase inhibitors (MAOIs), contact the doctor without taking Wellbutrin XR (see also: When not to take Wellbutrin XR, in section 2).

Tell the doctor or pharmacist about all medicines the patient is currently taking or
has recently taken, as well as any medicines the patient plans 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 together with Wellbutrin XR. Some of these
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 stopped or is currently taking sedatives 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 stimulants or other medicines used to control body weight or appetite,
• if the patient is taking steroids (oral or injectable),
• if the patient is taking antibiotics called 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 the 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, coma), 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),
• if the patient is taking certain medicines for irregular heartbeat (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 the 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 infection. 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 treatment for depression. Do not increase the dose of Wellbutrin XR without the doctor's advice, 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 treatment for depression.
• 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 dose of digoxin.

Wellbutrin XR and alcohol
Alcohol may affect the action of Wellbutrin XR and taking them together may, although
rarely, cause nervousness or changes in mental state. Some patients may become more
sensitive to alcohol while taking Wellbutrin XR. The doctor may recommend avoiding
alcohol (beer, wine, spirits) or significantly reducing alcohol consumption during treatment
with Wellbutrin XR. If the patient currently drinks large amounts of alcohol, do not stop
drinking suddenly, as this may trigger a seizure.
Talk to the doctor about alcohol consumption before starting treatment with
Wellbutrin XR.

Effect on urine tests
Wellbutrin XR may affect laboratory test results for the presence of other drugs. If
the patient is undergoing such a test, he or she should inform the doctor or nurse that
Wellbutrin XR is being taken.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child,
Wellbutrin XR should not be taken unless otherwise advised by the doctor. Consult the 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.

Components of Wellbutrin XR may pass into breast milk. Consult the doctor or pharmacist before using Wellbutrin XR.

Driving and operating machinery
If Wellbutrin XR causes dizziness or a feeling of emptiness in the head, the patient should 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 your doctor or pharmacist. Your doctor will
prescribe an individual dose for you. If in doubt, consult your doctor or pharmacist.
Improvement in how the patient feels may take some time. The full effect of the medicine may
only become apparent after several weeks or months. Even when the patient starts to feel better,
the treating doctor may recommend continuing treatment with Wellbutrin XR to prevent
recurrence of depression.
What dose should be taken
The usual recommended dose for adults is one 150 mg tablet once daily.
Your treating doctor may recommend increasing the dose to 300 mg once daily if there is no
improvement after several weeks of treatment.
The dose of 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 in the stool that looks like a tablet. This is the empty shell that has
been excreted from 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 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 may be sufficient for the entire duration of
treatment. Your treating doctor may recommend this dosage if the patient has liver or kidney
disease.
How long to continue treatment
Only the doctor 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 treating doctor so that a
decision can be made regarding the duration of treatment. If the patient feels better, the treating
doctor 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 your doctor
or the nearest hospital emergency department immediately.
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 a missed dose.
Stopping treatment with Wellbutrin XR
Do not stop taking Wellbutrin XR or reduce the dose without first discussing it with your
treating doctor.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

• 6 -

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions

Seizures or seizure attacks
Seizures (seizure attacks or convulsions) may occur in approximately 1 in 1,000 patients taking Wellbutrin XR. The likelihood of seizures is higher in patients who take higher than recommended doses, are taking certain other medications, or belong to a group at increased risk of seizures. If in doubt, contact your physician.

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

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

• skin redness or rash (such as erythematous rash), blisters, or itchy skin lesions (urticaria); some rashes may require hospitalization, especially if accompanied by mouth pain or eye pain,

• unusual wheezing or breathing difficulties,

• 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 physician immediately. Do not take any more of the medicine. Allergic reactions may persist for a long time. If your physician has prescribed medications to relieve allergic symptoms, complete the full course of treatment.

Lupus-like skin rash or worsening of lupus symptoms
Frequency unknown – frequency cannot be estimated based on available data from patients taking Wellbutrin XR. Lupus is an autoimmune disorder affecting the skin and other organs.

• If lupus symptoms worsen, or if a skin rash or skin lesions occur (especially on areas of skin exposed to sunlight) while taking Wellbutrin XR, contact your physician immediately, as treatment discontinuation may be necessary.

Acute generalized exanthematous pustulosis
Frequency unknown – frequency cannot be estimated based on available data from patients taking Wellbutrin XR. Symptoms of acute generalized exanthematous pustulosis include a skin rash with pustules/blisters filled with pus.

• If a skin rash with pustules/blisters filled with pus occurs, contact your physician immediately, as treatment discontinuation may be necessary.

Other adverse reactions

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

• difficulty sleeping. 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,
• feelings of anxiety or agitation,
• abdominal pain or other gastrointestinal disturbances (constipation), altered taste perception, loss of appetite (anorexia),
• increased blood pressure (sometimes significantly), facial flushing,
• ringing in the ears, vision disturbances.

Uncommon adverse reactions
May occur in up to 1 in 100 patients:

• feelings of depression (see also section 2: "Important information before taking Wellbutrin XR" under "Suicidal thoughts and worsening of depression symptoms"),
• feelings 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, involuntary movements, problems with walking or coordination,
• feelings 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 or 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),
• feelings of unreality or detachment (depersonalization), seeing or hearing things that are not there (hallucinations), experiencing or believing in unreal things (delusions), excessive suspiciousness (paranoia).

Frequency unknown
Other adverse reactions have 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 physician or go to hospital immediately.
• loss of contact with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and/or delusions.
• sudden and intense feelings of fear (panic attack).
• stuttering.
• reduced number of red blood cells (anaemia), reduced number of white blood cells (leukopenia), and reduced number of platelets (thrombocytopenia).
• low sodium levels in the blood (hyponatremia).
• changes in mental status (e.g. agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (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 physician or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the 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 canister with 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 in use. This will help protect the environment.

6. Contents of the pack and other information

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

• 9 - Coating composition:

Ink:
Opacode S-1-17823
Shellac (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, printed with "GS 5YZ 300" in black on one side of the tablet, the other side being smooth. The tablets are supplied in white, opaque HDPE bottles containing a desiccant with activated carbon/silica gel combination and a sealing membrane, with child-resistant closure, each containing 30 tablets, packed in a cardboard box.
For more 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
Marketing authorisation number in Spain, the country of export: 658761.4
Parallel import licence number: 426/24

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