Wellbutrin xr

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Wellbutrin XR, 150 mg, modified-release tablets
Bupropioni hydrochloridum
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. This medicine may harm others, even if their symptoms are the same.
• If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 by affecting
certain 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 had seizures,
• if the patient has or has previously had eating disorders (e.g. bulimia or mental 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, 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 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, stop taking Wellbutrin XR. Do not take more of this medicine and contact your doctor.

• If the patient has bipolar disorder (extreme mood swings), because Wellbutrin XR may trigger an episode of this disorder.
  • 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 doctor again before starting treatment with Wellbutrin XR. The doctor may decide that treatment should be closely monitored 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, as it takes time for these medicines 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 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 you 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 at the same time as 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 antidepressant medicines or medicines used to treat mental illnesses,
• 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 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 effects 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 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 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 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 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 digoxin dose.
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 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 suddenly stop drinking, 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 other drugs. If the patient undergoes such a test, they 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 baby, do not take Wellbutrin XR unless advised by a doctor. Consult a 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.
The ingredients 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 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 150 mg and 300 mg strengths.
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 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 no improvement is observed after several weeks of treatment.
The dose of Wellbutrin XR should be taken in the morning. Do not take Wellbutrin XR
more often than once daily.
The tablet is coated with a special film that slowly releases the medicine into the gastrointestinal tract. You may notice something that looks like a tablet in your stool. This is the empty shell that has been eliminated from the body.
Wellbutrin XR tablets must be swallowed whole. Do not chew, crush, or divide them – doing so may lead to overdose due to 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 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 doctor to determine the appropriate duration of treatment. If you start to feel better, your doctor may still 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 immediately or go 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 doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Seizures or convulsions

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 doctor.

• If a seizure occurs, contact your doctor 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 be prolonged. If your doctor has prescribed medication 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 changes occur (especially on areas of skin exposed to sunlight) while taking Wellbutrin XR, contact your doctor immediately, as discontinuation of treatment may be necessary.

Other adverse effects

Very common adverse 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 adverse 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,
• feeling of anxiety or agitation,
• abdominal pain or other gastrointestinal disturbances (constipation), altered taste perception, loss of appetite (anorexia),
• increased blood pressure (sometimes significantly), facial flushing,
• ringing in the ears, visual disturbances.

Uncommon adverse effects
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 effects
May occur in up to 1 in 1,000 patients:

• seizures.

Very rare adverse effects
May occur in up to 1 in 10,000 patients:

• palpitations, fainting,
• muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• feeling 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, 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),
• feeling 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 unknown

Other adverse 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 it (see section 2 "Important information before taking Wellbutrin XR"). If you have such thoughts, contact your doctor or go immediately to a hospital,
• loss of contact with reality and loss of thinking or judgment ability (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 symptoms (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 effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.

Adverse 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 adverse effects helps provide more information on the safety of the medicine.

5. How to store Wellbutrin XR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. 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 canister with activated carbon and silica gel, which helps keep the tablets dry. Leave the desiccant canister inside 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 package and other information

What the medicine 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), iron oxide black (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, printed with "GS 5FV 150" in black on one side of the tablet, the other side smooth. The tablets are available in white, opaque HDPE bottles containing 30 tablets.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Austria, country of export:
GlaxoSmithKline Pharma GmbH
Wagenseilgasse 3
Euro Plaza/Building I/4th Floor, 1120 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, 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 Austria, country of export: 1-26840
Parallel Import Authorisation Number: 69/20
This medicinal product is authorised for marketing 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.