Vellbutrin Xr

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Wellbutrin XR (Elontril), 300 mg, modified-release tablets

Bupropion hydrochloride
Wellbutrin XR and Elontril are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Wellbutrin XR and what is it 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 is Wellbutrin XR and what is it used for

Wellbutrin XR is a prescription-only medicine used to treat depression. It works with
chemical substances in the brain called norepinephrineand dopamine.

2. Important information before taking Wellbutrin XR

When not to take Wellbutrin XR:

• If you are allergicto bupropion or any of the other ingredients of this medicine (listed in section 6),
• If you are taking any other medicines containing bupropion,
• If you have epilepsy or have had seizures,
• If you have or have hadeating disorders(such as bulimia or anorexia nervosa),
• If you have a brain tumor,
• If you are an alcoholicwho has just stopped drinking or plans to do so,
• If you have severe liver disease,
• If you have recently stopped taking sedativesor plan to do so while taking Wellbutrin XR (see also When not to take Wellbutrin XRin section 2),
• If you are taking or have takenmonoamine oxidase inhibitors (MAOIs)in the last two weeks.

If any of the above situations apply to you, you should contact your doctor immediately and not take Wellbutrin XR.

Warnings and precautions

Before starting to take Wellbutrin XR, you should discuss it with your doctor or pharmacist.

Children and adolescents

Wellbutrin XR is not recommended for children under 18 years of age.
In children under 18 years of age treated with antidepressants, there is an increased risk of
suicidal thoughts and behaviors.

Adults

You should inform your doctor before starting to take Wellbutrin XR:

if you:

• regularly drink large amounts of alcohol,
• have diabetesand are taking insulin or oral antidiabetic medicines,
• have had a serious head injury or brain injuryin the past.

Wellbutrin XR may cause seizures in about 1 in 1000 patients. The occurrence of this side effect is more likely in patients with the conditions listed above. If seizures occur during treatment, you should stop taking Wellbutrin XR and not take it again and contact your doctor.
You should not take more of this medicine and you should contact your doctor.

• If you have bipolar disorder(severe mood swings), as Wellbutrin XR may trigger an episode of this condition.
• If you are taking other medicines used to treat depression, taking them together with Wellbutrin XR may lead to the occurrence of serotonin syndrome, a potentially life-threatening condition (see "Wellbutrin XR and other medicines" in this section).
• If you have liver or kidney disease,as you may be more likely to experience side effects. If any of the above situations apply to you, you should contact your doctor before starting to take Wellbutrin XR. Your doctor may decide to monitor your treatment closely or recommend a different treatment.

Suicidal thoughts and worsening of depression

In patients with depression, suicidal thoughts or behaviors may sometimes occur. Such behaviors may worsen when the patient first starts taking antidepressants, as it takes some time, usually about two weeks, but sometimes longer, for these medicines to start working.
Such thoughts may occur more frequently:

• if you have had suicidal thoughts or self-harm before;
• if you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults (under 25 years of age) with mental disorders who were treated with antidepressants. If you ever have thoughts of self-harm or suicide, you should contact your doctor immediately or go to the hospital.

It may be helpful to inform a relative or friendthat you have depression, and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse or if they are worried about changes in your behavior.

Wellbutrin XR and other medicines

If you are currently taking or have taken monoamine oxidase inhibitors (MAOIs)in the last 14 days, you should contact your doctor before taking Wellbutrin XR (see also When not to take Wellbutrin XRin section 2).

You should tell your doctor or pharmacist about all medicines you are taking now or
recently, and about any medicines you plan to take,including herbal medicines or vitamins, including those available without a prescription. Your doctor may change the dose of Wellbutrin XR, recommend a change in dosage, or stop taking other medicines.
Some medicines cannot be taken with Wellbutrin XR.Some of them may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side effects. Examples of such medicines are listed below, but this is not a complete list.

Seizures may occur more frequently than usual:

• if you are taking other antidepressants or medicines used to treat mental disorders,
• if you are taking theophylline, a medicine for asthma or lung disease,
• if you are taking tramadol, a strong painkiller,
• if you have recently stopped taking sedativesor plan to stop taking them while taking Wellbutrin XR (see also When not to take Wellbutrin XRin section 2),
• if you are taking antimalarial medicines(such as mefloquine or chloroquine),
• if you are taking stimulants or other medicines that control body weight or appetite,
• if you are taking steroids (orally or by injection),
• if you are taking antibiotics called quinolones,
• if you are taking certain types of antihistamines that can cause drowsiness,
• if you are taking antidiabetic medicines.

If any of the above situations apply to you, you should contact your doctor immediately before starting to take Wellbutrin XR. Your doctor will assess the risk and benefits of taking Wellbutrin XR.

It may increase the risk of other side effects:

• if you are taking other antidepressants(such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines used to treat other mental disorders (such as clozapine, risperidone, thioridazine, or olanzapine). Wellbutrin XR may interact with medicines used to treat depression, and you may experience changes in mental state (such as agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (such as nausea, vomiting, diarrhea),
• if you are taking medicines used to treat Parkinson's disease(levodopa, amantadine, orphenadrine),
• if you are taking medicines that affect the metabolism of Wellbutrin XR(carbamazepine, phenytoin, valproic acid),
• if you are taking certain medicines used to treat cancer(such as cyclophosphamide or ifosfamide),
• if you are taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• if you are taking beta-blockers(such as metoprolol),
• if you are taking certain medicines used to treat irregular heart rhythm(propafenone and flecainide),
• if you are using nicotine patches, as an aid to stop smoking.

If any of the above situations apply to you, you should contact your doctor immediately before starting to take Wellbutrin XR.

Wellbutrin XR may be less effective:

• If you are taking ritonavir or efavirenz, medicines used to treat HIV infection.

If this situation applies to you, you should inform your doctor. Your doctor will assess the effectiveness of Wellbutrin XR in you. It may be necessary to increase the dose or change the treatment of depression. You should not increasethe dose of Wellbutrin XR without your doctor's recommendation, as this may increase the risk of side effects, including seizures.

Wellbutrin XR may reduce the effectiveness of some medicines

If you are taking tamoxifen, used to treat breast cancer.

If this situation applies to you,you should tell your doctor. It may be necessary to change the treatment of depression.

If you are taking digoxin for heart problems.

If this situation applies to you,you should tell your doctor. Your doctor may consider adjusting the dose of digoxin.

Wellbutrin XR with 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. Your doctor may recommend avoiding alcohol (beer, wine, spirits) or significantly reducing its consumption while taking Wellbutrin XR. If you are currently drinking large amounts of alcohol, you should not stop drinking suddenly, as this may cause a seizure.
You should discuss drinking alcohol with your doctorbefore starting to take Wellbutrin XR.

Effect on urine tests

Wellbutrin XR may affect the results of laboratory tests for the presence of other medicines. If you are undergoing such a test, you should inform your doctor or nurse that you are taking Wellbutrin XR.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, you should not take Wellbutrin XR unless your doctor recommends it. Before taking this medicine during pregnancy, you should consult your doctor or pharmacist. Some, but not all, studies suggest an increased risk of birth defects, particularly heart defects, in children whose mothers took Wellbutrin XR. It is not known if this was caused by the use of this medicine.
The ingredients of Wellbutrin XR may pass into breast milk. Before taking Wellbutrin XR, you should consult your doctor or pharmacist.

Driving and using machines

If Wellbutrin XR causes dizziness or a feeling of emptiness in the head, you should not drive or operate machinery.

3. How to take Wellbutrin XR

This medicine should always be taken exactly as your doctor or pharmacist has told you.Your doctor will recommend a dose that is right for you. If you are unsure, you should ask your doctor or pharmacist.
Wellbutrin XR is available in 150 mg and 300 mg doses.
Improvement in your condition may not occur until after some time.The full effect of the medicine may not be apparent until after several weeks or months. Even if you start to feel better, your doctor may recommend continuing to take Wellbutrin XR to prevent a relapse of depression.
What dose to take
Normally, the recommended dose for adults is one150 mg tablet once a day.
Your doctor may recommend increasing the dose to 300 mg once a day,if after several weeks of treatment, you do not show improvement.

The dose of Wellbutrin XR should be taken in the morning. You should not take Wellbutrin XR more than once a day.

The tablet is coated with a shell that slowly releases the medicine into the digestive 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.You should not chew, crush, or divide them – if this happens, there is a risk of overdose, due to the rapid release of the medicine into the body. This may increase the risk of side effects, including seizures.

For some patients, a dose of 150 mg once a day is sufficientthroughout the treatment period. Your doctor may recommend this dosage if you have liver or kidney disease.
How long to take the treatment

Only your doctor, together with you, can decide how long to take the treatment with Wellbutrin XR.

It may take weeks or monthsbefore any improvement is seen. You should regularly discuss your symptoms of depression with your doctor, so that it can be decided how long you should be treated. If you feel better, your doctor may recommend continuing to take Wellbutrin XR to prevent a relapse of depression.

Taking a higher dose of Wellbutrin XR than recommended

Taking too many tablets may cause seizures or convulsions. Do not delay.You should contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of Wellbutrin XR

If you miss a dose, you should wait and take the next dose at the usual time. You should not take a double dose
to make up for a missed dose.

Stopping treatment with Wellbutrin XR

You should not stoptreatment with Wellbutrin XR or reduce the dose without first discussing it with your doctor.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects Seizures or convulsions

About 1 in 1000 patients taking Wellbutrin XR may experience seizures (convulsions). The risk of this is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures. If you are unsure, you should contact your doctor.

• If you experience a seizureyou should contact your doctor. You should not take the medicine again. Allergic reactionsSome patients may experience allergic reactions to Wellbutrin XR. These include:
• redness of the skin or rash (like a nettle rash), blisters or itchy bumps (hives) on the skin; some rashes may require hospitalization, especially if they occur with mouth ulcers or eye pain,
• unusual wheezing or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• muscle or joint pain,
• fainting or brief loss of consciousness.
• If you experience any symptoms of an allergic reactionyou should contact your doctor immediately. You should not take the medicine again.Allergic reactions can last a long time.If your doctor has prescribed medicines to relieve allergy symptoms, you should take the whole course. Systemic lupus erythematosus or worsening of lupus symptomsFrequency not known - frequency cannot be estimated from the available data from people taking Wellbutrin XR. Lupus is an immune system disorder that affects the skin and other organs.
• If you experience worsening of lupus, rash, or skin lesions (especially on sun-exposed areas) while taking Wellbutrin XR, you should contact your doctor immediately,
  as it may be necessary to stop the treatment.
  Acute generalized exanthematous pustulosis
  Frequency not known - frequency cannot be estimated from the available data from people taking Wellbutrin XR. Symptoms of acute generalized exanthematous pustulosis include a rash with pus-filled blisters.
  • If you experience a rash with pus-filled blisters, you should contact your doctor immediately, as it may be necessary to stop the treatment.

  Other side effects

  Very common side effects

  May affect more than 1 in 10people:

  • difficulty sleeping; you should make sure that Wellbutrin XR is taken in the morning,
  • headache,
  • dry mouth,
  • nausea, vomiting.

  Common side effects

  May affect up to 1 in 10people:

  • fever, dizziness, itching, sweating, and rash (sometimes due to an allergic reaction),
  • chills, tremors, weakness, fatigue,
  • feeling anxious or agitated,
  • abdominal pain or other gastrointestinal disorders (constipation), changes in taste, loss of appetite (anorexia),
  • increased blood pressure, sometimes significantly, flushing,
  • ringing in the ears, vision disturbances.

  Uncommon side effects

  May affect up to 1 in 100people:

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

  Rare side effects

  May affect up to 1 in 1000people:

  • seizures.

  Very rare side effects

  May affect up to 1 in 10,000people:

  • rapid heartbeat, fainting,
  • muscle tremors, muscle stiffness, uncontrolled movements, problems with walking or coordination,
  • feeling restless, irritated, hostile, aggressive, strange dreams, tingling or numbness, memory loss,
  • yellowing of the skin or whites of the eyes ( jaundice), which may be caused by increased liver enzyme activity, liver inflammation,
  • severe allergic reactions; rash with accompanying muscle and joint pain,
  • changes in blood sugar levels,
  • passing urine more or less often than usual,
  • incontinence (involuntary urination, uncontrolled urine flow),
  • severe skin rashes that can cover the mouth and other parts of the body and can be life-threatening,
  • worsening of psoriasis (red thickening of the skin),
  • feeling unreal or strange ( depersonalization), seeing or hearing things that do not exist ( hallucinations), feeling or believing in things that are not real ( delusions), exaggerated 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 while taking Wellbutrin XR or shortly after stopping it (see section 2 "Important information before taking Wellbutrin XR"). If you have such thoughts, you should contact your doctor or go to the hospital immediately,
  • loss of contact with reality and ability to think or assess the situation ( psychosis); other symptoms may include hallucinations and (or) delusions,
  • stuttering,
  • reduced number of red blood cells (anemia), reduced number of white blood cells (leukopenia), and reduced number of platelets (thrombocytopenia),
  • low sodium levels in the blood (hyponatremia),
  • changes in mental state (such as agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (such as nausea, vomiting, diarrhea) when taking Wellbutrin XR with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

  Reporting side effects

  If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.
  Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Wellbutrin XR

  The medicine should be stored out of sight and reach of children.
  You should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
  Store in the original packaging to protect from light and moisture.
  The bottle contains a small, tightly closed desiccant with activated carbon and silica gel, which helps keep the tablets dry. The desiccant should be left in the bottle.
  Do not swallow it.
  Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the pack and other information

  What Wellbutrin XR contains

  The active substance of the medicine is bupropion hydrochloride. Each tablet contains 300 mg of bupropion hydrochloride.
  The other ingredients are:
  Tablet core:
  Polyvinyl alcohol
  Glycerol dibehenate
  Coating:
  Ink:
  Opacode S-1-17823
  Shellac 45% (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 tabletsare cream-white to light yellow, round, with the inscription "GS 5YZ 300" in black on one side of the tablet, the other side is smooth. The tablets are available in white, non-transparent HDPE bottles of 30 tablets.
  For more detailed information, you should contact the marketing authorization holder or the parallel importer.

  Marketing authorization holder in the Czech Republic, the country of export:

  GlaxoSmithKline (Ireland) Limited
  12 Riverwalk
  Citywest Business Campus
  Dublin 24, Ireland

  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.

  Inner coating:	Outer coating:
  Ethylcellulose	Polyethylene glycol 1450
  Povidone K 90	Methacrylic acid and ethyl acrylate copolymer (1:1), dispersion
  Polyethylene glycol 1450	Silica, colloidal, anhydrous
  	Triethyl citrate

  ul. Strumykowa 28/11
  03-138 Warsaw

  Repackaged by:

  InPharm Sp. z o.o. Services sp. k.
  ul. Chełmżyńska 249
  04-458 Warsaw
  Marketing authorization number in the Czech Republic, the country of export:30/207/07-C

  Parallel import authorization number: 257/22

  This medicinal product is authorized in the Member States of the European Economic Area 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.
  Date of leaflet approval: 23.06.2022
  [Information about the trademark]