Wellbutrin xr

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Wellbutrin XR, 150 mg, modified-release tablets
Bupropion hydrochloride
Please read the entire leaflet carefully before taking 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 pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects 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. 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 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,
• 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 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 antidepressants 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.
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
You should 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 had a serious head injury or head trauma in the past.

Wellbutrin XR may cause seizures in about 1 in 1000 patients. The occurrence of this adverse reaction is more likely in patients from the groups mentioned above. If seizures occur during treatment, stop taking Wellbutrin XR. Do not take any 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 illness.
  • 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, because adverse reactions 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 carried out 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. Such behaviours may worsen when the patient first starts taking antidepressant medicines, because it takes time before these medicines start to work, usually about two weeks, but sometimes longer.
Such thoughts may occur more frequently:

• 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 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/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 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 you are currently taking or have recently taken, as well as any medicines you plan 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 seizures. Other medicines may increase the risk of other adverse reactions. 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 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 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 your 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 reactions 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 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 and exaggerated 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 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 your 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 your 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 reactions, 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 your doctor. It may be necessary to change the method of treating depression.

• If the patient is taking digoxin due to heart problems.

If this situation applies to the patient, inform your 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 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/she should inform the doctor or nurse that he/she is taking Wellbutrin XR.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, do not take Wellbutrin XR unless advised by a doctor. Consult your 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.
The ingredients of Wellbutrin XR may pass into breast milk. Consult your 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 recommended 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 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 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.

Your prescribing 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 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 must be swallowed whole. Do not chew, crush, or divide the tablets. 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 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 even 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 prescribing 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 go to 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 prescribing doctor.

If you have any further doubts 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, taking certain other medicines, or belonging to 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 erythema multiforme), 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 any more of the medicine.

Allergic reactions may be prolonged. If your doctor has prescribed medication to relieve allergic symptoms, take the full course as directed.
Drug-induced lupus or worsening of lupus symptoms
Frequency unknown – frequency cannot be estimated from available data in patients taking Wellbutrin XR. Lupus is an immune system disorder affecting the skin and other organs.

• If lupus flare-ups, skin rash or skin changes (especially on areas of skin exposed to sunlight) occur during treatment with Wellbutrin XR, contact your doctor immediately, as treatment discontinuation may be necessary.
  Acute generalized exanthematous pustulosis
  Frequency unknown – frequency cannot be estimated 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 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,
• feeling of anxiety or agitation,
• abdominal pain or other gastrointestinal disturbances (constipation), altered taste sensation, loss of appetite (anorexia),
• increased blood pressure (sometimes significantly), facial flushing,
• ringing in the ears, visual disturbances.

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

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

Rare adverse reactions
May occur in up to 1 in 1000 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 skin patches),
• feelings of unreality or detachment ( depersonalization ), seeing or hearing things that are not real ( hallucinations ), believing in or experiencing things that are not real ( delusions ), excessive suspiciousness ( paranoia ).

Frequency unknown
Other adverse reactions have occurred in a small number of patients, but their exact frequency is unknown:

• thoughts about 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 immediately to hospital,
• loss of contact with reality and ability to think or assess situations ( 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 rigidity, lack of coordination, and/or gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea) when Wellbutrin XR is taken 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 or pharmacist. 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 the 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 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. Such measures 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 what the packaging contains
Wellbutrin XR 150 mg tablets are cream-white to light yellow in colour, round, with a black imprint "GS 5FV 150" on one side of the tablet, the other side being smooth. The tablets are available in white, opaque HDPE bottles containing 30 tablets.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, the country of export:
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Site Apollo
Avenue Pascal, 2-4-6
B-1300 Wavre, Belgium
Manufacturer:
Aspen Bad Oldesloe GmbH, Industriestraße 32-36, 23843 Bad Oldesloe, Germany
Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Belgium, the country of export: BE294226
Parallel import authorisation number: 89/20
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.