Wellbutrin xr

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging is in a foreign language.
Wellbutrin XR, 300 mg, modified-release tablets
Bupropion hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• 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 pass it on to 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. 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 norepinephrine 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 had in the past eating disorders (e.g. bulimia or psychological anorexia - 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 do so,
• 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 (MAO inhibitors).

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.
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
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 1000 patients. The occurrence
of this adverse effect is more likely in patients from the groups listed above. If seizures occur during treatment,
treatment with Wellbutrin XR should be discontinued. 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 condition.
• If the patient is taking other medicines used to treat depression, concomitant use of these medicines with Wellbutrin XR may lead to the development 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 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 therapy should be conducted under close supervision or recommend alternative treatment.
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, because it takes time for these medicines to start working—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 trials 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 him or her if they notice that the patient's depression worsens 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
known as monoamine oxidase inhibitors (MAO inhibitors), contact the doctor without taking Wellbutrin XR (see also: When not to take Wellbutrin XR, in section 2).
Tell your doctor or pharmacist about all medicines currently taken or 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 convulsive episodes. 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 antidepressants or medicines used to treat mental illnesses,
• if the patient is taking theophylline, a medicine for asthma or lung diseases,
• 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 used to control body weight or appetite,
• if the patient is taking steroids (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 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 antidepressant medicines, 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 stiffness, 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 infections.

If this situation 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 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 in the treatment of 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 due to 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 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 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 your 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 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 is planning to have a child, do not take Wellbutrin XR unless otherwise advised by the doctor. Consult your doctor or pharmacist before using this medicine during pregnancy. Some, but not all, studies indicate 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 your 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.

3. How to take Wellbutrin XR

This medicine should always be taken according to the instructions given by your doctor or pharmacist. Your doctor will prescribe an individual dose tailored to the patient. If in doubt, consult your doctor or pharmacist.
Wellbutrin XR is available in strengths of 150 mg and 300 mg.
Improvement in the patient's well-being may take some time. The full effect of the medicine may not become apparent until 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 a recurrence of depression.

What doses should be taken
The usual recommended dose for adults is one 150 mg tablet once daily.
Your 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 daily.
The tablet is coated with a special layer that slowly releases the active substance into the gastrointestinal tract. The patient may notice in the stool something that looks like a tablet. This is the empty shell that has been expelled from the body.
Wellbutrin XR tablets should be swallowed whole. Do not chew, crush, or divide them – doing so may lead to 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. Your doctor may recommend this dosage if the patient has liver or kidney disease.

How long to continue treatment
Only your doctor, together with the patient, can decide how long treatment with Wellbutrin XR should continue. It may take weeks or even months before any improvement is observed. The patient should regularly discuss depressive symptoms with the treating doctor to determine the appropriate duration of treatment. Even if the patient feels better, the treating doctor may recommend continuing treatment with Wellbutrin XR to prevent a relapse 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 the 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 doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects

Seizures or convulsions
Seizures (convulsions or fits) may occur in approximately 1 in 1000 patients taking Wellbutrin XR. The likelihood is higher in patients taking higher than recommended doses, taking certain other medicines, or who are in 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 may include:

• skin redness or rash (such as erythema multiforme), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if there is also 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 be prolonged. If your doctor has prescribed medication to relieve allergic symptoms, complete the full course of treatment.

Drug-induced lupus 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 changes (especially in areas of skin exposed to sunlight) occur 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 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 side effects

Very common side effects
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 side effects
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 sensation, loss of appetite (anorexia),
• increased blood pressure (sometimes significant), facial flushing,
• ringing in the ears, visual disturbances.

Uncommon side effects
May occur in up to 1 in 100 patients:

• feelings of depression (see also section 2: Warnings and precautions),
• feelings of disorientation,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare side effects
May occur in up to 1 in 1000 patients:

• seizures.

Very rare side effects
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 lesions),
• feelings of unreality or detachment (depersonalization), seeing or hearing things that are not there (hallucinations), believing in or experiencing things that are not real (delusions), excessive 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 during treatment with Wellbutrin XR or shortly after stopping (see section 2 “Important information before taking Wellbutrin XR”). If you have such thoughts, contact your doctor or go to hospital immediately,
• loss of touch with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and (or) delusions,
• 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 (hyponatraemia),
• 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 side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects 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 side effects 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 packaging 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. Such measures 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), 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 in colour, round, with the black imprint "GS 5YZ 300" on one side of the tablet, the other side being smooth. The tablets are available in white, opaque HDPE bottles containing 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Austria, the country of export:
GlaxoSmithKline Pharma GmbH
Wienerbergstraße 7
1100 Vienna, Austria
Manufacturer:
Aspen Bad Oldesloe GmbH
Bad Oldesloe
Germany
Glaxo Wellcome S.A.
Aranda de Duero (Burgos)
Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Austria, the country of export: 1-26841
Parallel import authorisation number: 467/21
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.