Wellbutrin xr

Patient Information Leaflet

Warning! Please keep this leaflet. 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 using this 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 give it to others. This medicine may harm others, 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 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 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 do so during treatment with Wellbutrin XR,
• if the patient is taking or has taken within the last two weeks medicines for depression 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.
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 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 had a serious head injury or head trauma.

Wellbutrin XR may cause seizures in approximately 1 in 1,000 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. Do not take 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, concomitant use of these medicines with Wellbutrin XR may lead to serotonin syndrome, a potentially life-threatening condition (see "Wellbutrin XR with 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
treating doctor again before starting treatment with Wellbutrin XR. The doctor may
decide that treatment should be conducted 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 before these medicines begin to work, 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 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 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.
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 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 currently taken or
taken recently, 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 at the same time as 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 psychiatric disorders,
• 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 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 that 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
treating 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 disorders (such as: clozapine, risperidone, thioridazine or olanzapine). Wellbutrin XR may interact with antidepressants 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
treating 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 assess 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 alter mental state. Some patients may become more
sensitive to alcohol while taking Wellbutrin XR. The doctor may advise avoiding
alcohol (beer, wine, spirits) or significantly reducing its 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.
Discuss alcohol consumption with your doctor 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
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 the doctor advises otherwise. Before using this
medicine during pregnancy, consult a doctor or pharmacist. Some, but not all, studies
suggest an increased risk of congenital malformations, particularly heart defects, in children whose mothers
used Wellbutrin XR. It is not known whether this was caused by the use of this
medicine.
Components of Wellbutrin XR may pass into breast milk. Before using Wellbutrin
XR, consult a doctor or pharmacist.
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 exactly as prescribed by your doctor or pharmacist. Your 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 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 doctor may increase 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 film that slowly releases the medicine into the gastrointestinal tract. You may notice something in your 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 – doing so may lead to 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 treating doctor may recommend this dosage if you have liver or kidney disease.

How long to continue treatment
Only your doctor, together with you, can decide how long treatment with Wellbutrin XR should continue. It may take weeks or even months before any improvement is observed. You should regularly discuss your depressive symptoms with your treating doctor so that decisions about the duration of treatment can be made. If you start to feel better, your doctor may still recommend continuing treatment with Wellbutrin XR to prevent relapse of depression.

Taking more than the recommended dose of Wellbutrin XR
Taking too many tablets may cause seizures or convulsions. Do not delay. Contact your doctor or go immediately to the nearest hospital emergency department.

Missing a dose of Wellbutrin XR
If you miss a dose, wait and take the next dose at your 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.

4. Possible adverse reactions

Like all medicines, 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 1000 patients taking Wellbutrin XR. The likelihood is higher in patients taking higher than recommended doses, those taking certain other medicines, or those in a group at increased risk of seizures. If in doubt, contact 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 maculopapular rash), 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 last a long time. If your doctor has prescribed medicines to relieve allergic symptoms, complete the full course of treatment.

Drug-induced lupus erythematosus or worsening of lupus symptoms
Frequency unknown – frequency cannot be estimated from the 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 (particularly in 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 from the 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 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 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 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 areas on the skin),
• 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 not known
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 (see section 2 "Important information before taking Wellbutrin XR"). If the patient has such thoughts, contact a doctor 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 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, Poland, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to 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 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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
Modified-release tablets are cream-white to pale yellow, round, with a black "GS 5YZ 300" imprint on one side of the tablet, the other side smooth. Tablets are available in white, opaque HDPE bottles containing a desiccant and a sealing membrane, with child-resistant closure, each containing 30 tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Portugal, country of export:
BIAL – Portela & Cª, S.A.
Av. da Siderurgia Nacional
4745-457 S. Mamede do Coronado
Portugal
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
Marketing Authorisation Number in Portugal, country of export: 5015672
Parallel Import Licence Number: 202/24
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.