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
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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions 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 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 experienced 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 who abuses alcohol 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
in charge, 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
The patient should inform the doctor in charge 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 approximately 1 in 1000 patients. The occurrence
of this adverse effect is more likely in patients from the groups mentioned
above. If seizures occur during treatment, discontinue use of Wellbutrin XR. Do not take more of this medicine and contact the doctor
in charge.

• 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.

If any of the above situations apply to the patient, contact the
doctor in charge 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. Such
behaviours may worsen when the patient first starts taking antidepressant
medicines, as it takes time before these medicines start 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 the doctor in charge 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 in charge 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 purchased 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 them
may increase the risk of seizures or convulsive fits. 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 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 stimulant medicines 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
doctor in charge 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 and 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 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
doctor in charge 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 in charge. The doctor
in charge 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 recommendation, 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 alter mental state. Some patients become more
sensitive to alcohol while taking Wellbutrin XR. The doctor may advise abstaining from
drinking 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 the doctor 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 or she should inform the doctor or nurse that
Wellbutrin XR is being taken.
Pregnancy and breastfeeding
Do not take Wellbutrin XR during pregnancy, if pregnancy is suspected, or when planning a pregnancy,
unless otherwise advised by a doctor. Consult a doctor or pharmacist before taking any 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 taking 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 the doctor or pharmacist. The treating physician will individually determine the dose for the patient. If in doubt, consult the doctor or pharmacist.
Wellbutrin XR is available in 150 mg and 300 mg strengths.
Improvement in the patient's condition 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 treating physician 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.
The treating physician 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 than once daily.
The tablet is coated with a special layer that slowly releases the active substance into the gastrointestinal tract. The patient may notice something resembling a tablet in the stool. This is the empty shell that has been expelled from the body.
Wellbutrin XR tablets should be swallowed whole. Do not chew, crush, or divide the tablets – doing so may result in overdose due to rapid release of the active substance 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. The treating physician may recommend this dosing regimen 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 treating physician to determine the appropriate duration of treatment. If the patient feels better, the treating physician 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 a doctor immediately or go to the nearest hospital emergency department.

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 the treating physician.

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

4. Possible adverse effects

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

Serious adverse effects

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. Do not take any more of this medicine.

Allergic reactions
Some patients may experience allergic reactions to Wellbutrin XR. These may 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 any more of this medicine.

Allergic reactions may persist for a long time. 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 based on available data from patients taking Wellbutrin XR. Lupus is an immune system disorder affecting the skin and other organs.

• If symptoms of lupus flare-up, skin rash, or skin lesions occur (especially on areas of skin exposed to sunlight) while taking Wellbutrin XR, contact your doctor immediately, as treatment discontinuation may be necessary.

Other adverse effects

Very common adverse effects
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 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 sensation, loss of appetite (anorexia),
• increased blood pressure (sometimes significant), 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 1000 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 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 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 (see section 2 “Important information before taking Wellbutrin XR”). If such thoughts occur, contact your doctor or go immediately to hospital,
• loss of touch with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and/or delusions,
• 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 packaging. The expiry date refers to the last day of the stated month.
Store in the original container to protect from moisture and light. The bottle contains a small, tightly sealed desiccant made of activated charcoal 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 helps 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.
The other ingredients are:
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 imprint "GS 5FV 150" on one side of the tablet, the other side being smooth. The tablets are supplied in white, opaque HDPE bottles containing 30 tablets.
For further information, please contact the responsible entity or the parallel importer.
Responsible entity in Portugal, country of export:
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque - Miraflores
1495-131 Algés
Portugal
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
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorisation number in Portugal, country of export: 5015565
Parallel import authorisation number: 342/19
This medicinal product is authorised 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.