Wellbutrin xr

Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Wellbutrin XR
150 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, as you may need to read it again.
• 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. It may harm them, 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.

Leaflet 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 acts 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 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 misusing alcohol and 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 for depression 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.
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
The patient should inform the 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 belonging to the groups mentioned above. If seizures occur
during treatment, discontinue the use of Wellbutrin XR. Do not take any more of this medicine and contact the 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 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
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 about self-harm or suicide. These
behaviours may worsen when the patient first starts taking antidepressant medicines, because 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 has 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 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 (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 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 changing the dosage, 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 antidepressants 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 used to control 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 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 ß-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 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 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 situation 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 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 advise avoiding 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 the 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 drugs. If the patient is undergoing such a test, he or she 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 have a child, do not
take Wellbutrin XR 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.
Components 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.

3. How to take Wellbutrin XR

This medicine should always be taken exactly as recommended 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 condition 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 doses 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 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 coating 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 for 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 months before any improvement is observed.
The patient should regularly discuss depressive symptoms with the treating doctor to determine the
appropriate 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 convulsions. 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 consulting 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 convulsive seizures
Seizures (convulsive seizures or convulsions) 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, contact your treating physician.
→ If a convulsive seizure occurs, contact your treating physician immediately. Do not take this medicine again.
Allergic reactions
Some patients may experience allergic reactions to Wellbutrin XR. These include:

• skin redness or rash (such as erythematous rash), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if mouth pain or eye pain also occur,
• 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 this medicine again. Allergic reactions may persist for a long time. If your doctor has prescribed medications to relieve allergic symptoms, complete the full course of treatment.

Drug-induced 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,
• 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,
• 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, scaly patches on the skin),
• unusual hair loss or thinning (alopecia),
• feelings of unreality or detachment (depersonalization), seeing or hearing things that are not real (hallucinations), believing in or experiencing unreal things (delusions), exaggerated 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 the patient has such thoughts, contact a doctor or go immediately to a hospital.
• Loss of touch with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and/or delusions.
• 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 status (e.g. agitation, hallucinations, stupor), 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 symptoms occur, including any adverse symptoms 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 to provide more information on the safety of this medicine.

5. How to store Wellbutrin XR

Keep this 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 charcoal and silica gel, which helps maintain tablet dryness. The desiccant should remain 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 150 mg of bupropion
hydrochloride.
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 contents of the pack
Wellbutrin XR 150 mg tablets are cream-white to light yellow in colour, round, with a black "GS5FV" imprint on one side of the tablet, the other side smooth. The tablets are available in white polyethylene bottles containing 30 tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Netherlands, country of export:
GlaxoSmithKline BV
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort
The Netherlands
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 the Netherlands, country of export: RVG 33668
Parallel Import Licence number: 170/20
This medicinal product is authorised for sale in the European Economic Area under the
following brand names:
Wellbutrin XR: Austria, Belgium, Cyprus, Greece, Luxembourg, Malta, Poland, Portugal, Slovenia,
the Netherlands.
Wellbutrin: Italy.
Elontril: Czech Republic, Estonia, Germany, Hungary, Italy, Lithuania, Portugal, Romania, Slovakia, Spain, the Netherlands.
Wellbutrin Retard: Iceland, Norway.
Voxra: Finland, Sweden