Wellbutrin xr

Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Wellbutrin XR (Elontril)
300 mg, modified-release tablets
Bupropioni hydrochloridum
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 for 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, pharmacist, or nurse. 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 sedatives or intends to stop 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.

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 if there is a family history of cardiac arrest or sudden death.

Children and adolescents
Wellbutrin XR is not recommended for use in 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 had a serious head injury or 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 listed above. If seizures occur during treatment, discontinue use of Wellbutrin XR immediately. Do not take any more of this medicine and contact your 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 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 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 depressive 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 work—usually about two weeks, but sometimes longer.
Such thoughts may be more common:

• if the patient has 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 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 the patient if they believe the patient's depression is worsening or if changes in behaviour become concerning.
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 currently being taken, recently taken, or planned for use, including herbal remedies or vitamins, even those available without a prescription. The doctor may adjust the dose of Wellbutrin XR, recommend changes in dosing, or discontinue other medicines.
Some medicines must not be taken at the same time as Wellbutrin XR. Some of these may increase the risk of seizures or convulsions. Others 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 antidepressants or medicines used to treat mental illnesses,
• 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 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 stimulant medicines or other medicines used to 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 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 antidepressants (such as: amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or medicines for other psychiatric conditions (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, 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 β-blockers (such as metoprolol),
• 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 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 applies to the patient, inform the doctor. The doctor will evaluate the effectiveness of Wellbutrin XR in the patient. It may be necessary to increase the dose or change the method of treating 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 applies to the patient, inform the doctor. It may be necessary to change the method of treating depression.
• If the patient is taking digoxin for heart problems. If this 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 become more sensitive to alcohol while taking Wellbutrin XR. The doctor may advise abstaining from 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 suddenly stop drinking, 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, they should inform the doctor or nurse that they are taking Wellbutrin XR.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, do not take Wellbutrin XR unless 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 due to the use of this medicine.
The ingredients of Wellbutrin XR may pass into breast milk. Consult a doctor or pharmacist before using Wellbutrin XR.
Driving and using machines
If Wellbutrin XR causes dizziness or a feeling of emptiness in the head, do not drive or operate machinery.

3. How to take Wellbutrin XR

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. The prescribing doctor will determine the dose individually for each patient. If in doubt, consult your doctor or pharmacist.
Wellbutrin XR is available in the following strengths: 150 mg, 300 mg.
Improvement in the patient's well-being may only occur after some time. The full effect of the medicine may not become apparent until several weeks or months have passed. Even if the patient begins to feel better, the prescribing doctor may recommend continuing treatment with Wellbutrin XR to prevent recurrence of depression.

What doses should be taken
The usual recommended dose for adults is one 150 mg tablet once daily.
The prescribing doctor 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 daily.
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 eliminated 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 throughout the entire treatment period. The prescribing 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 prescribing doctor to determine the appropriate duration of treatment. If the patient feels better, the 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 episode. 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 prescribing doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

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 fits) 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 medicines, or belonging to a group at increased risk of seizures. If in doubt, consult your doctor.

→ If a seizure occurs, contact your doctor immediately. 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 erythema multiforme), 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 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 doctor immediately. Do not take any more of the medicine. Allergic reactions may last a long time. If your doctor has prescribed medication to relieve allergic symptoms, take the full course as directed.

Drug-induced lupus erythematosus 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 develop (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 (AGEP)
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 develops, 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 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 complaints (constipation), altered taste sensation, loss of appetite (anorexia),
• increased blood pressure (sometimes marked), facial flushing,
• ringing in the ears, visual 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, uncontrolled movements, problems with walking or coordination,
• 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 patches),
• unusual hair loss or thinning (alopecia),
• feelings 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 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 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.
• sudden and intense 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 state (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 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, pharmacist, or nurse.
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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Wellbutrin XR

Keep the medicine out of 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 packaging to protect from light and moisture.
The bottle contains a small, tightly sealed desiccant made of activated carbon 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, glyceryl dibehenate.
Coating composition:

Ink: Opacode S-1-17823
shellac (20% esterified), black iron oxide (E 172) and concentrated ammonium hydroxide.
What Wellbutrin XR looks like and what the pack contains
Modified-release tablets are cream-white to light yellow in colour, round, printed with "GS 5YZ 300" in black on one side of the tablet, the other side smooth. The tablets are available in white, opaque HDPE bottles containing 30 tablets, in a cardboard carton.
For more detailed information, please contact the responsible party or parallel importer.
Responsible entity in Slovakia, country of export:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero, Burgos
Spain
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorisation number in Slovakia, country of export: 30/0042/07-S
Parallel import authorisation number: 39/26
This medicinal product is authorised for sale 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.