Wellbutrin xr

Package leaflet: Information for the user

Warning! Keep the 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 using the 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.
  The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed
  in this leaflet, inform your doctor or pharmacist. See section 4.
  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 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 experienced seizures,
• if the patient currently has or has had in the past 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 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 for depression known as monoamine oxidase inhibitors (MAO inhibitors).

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 use in 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 behaviour.
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 immediately.
Do not take 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 condition,
• If the patient is taking other medicines used to treat depression, as 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, as adverse effects may be more likely to occur.

If any of the above situations apply to the patient, contact
your 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 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 take effect, usually about two
weeks, but sometimes longer.
Such thoughts may occur more frequently:

• 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 occur at any time, 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 their 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 (MAO inhibitors), 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 currently being taken or recently taken, as well as any medicines the patient plans 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 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 antidepressant medicines 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 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 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 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 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 treatment for 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 treatment for 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 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 the presence of other medicines. If the patient is undergoing 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 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.
Components of Wellbutrin XR may pass into breast milk. Consult your 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 according to the instructions given by your doctor or pharmacist. Your doctor will individually determine the appropriate dose for you. If you have any doubts, consult your doctor or pharmacist.
Improvement in how you feel may take some time. The full effect of the medicine may not become apparent until after several weeks or months. Even when you begin to feel better, your doctor may recommend continuing treatment with Wellbutrin XR to prevent recurrence of depression.
Wellbutrin XR is available in 150 mg and 300 mg strengths.
What doses should be taken?
The usual recommended dose for adults is one 150 mg tablet once daily.
Your 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 has a special coating that slowly releases the medicine into the gastrointestinal tract. You may notice something in your stool that looks like a tablet. This is the empty shell, which has been eliminated from the body.
Wellbutrin XR tablets should be swallowed whole.

Do not chew, crush, or divide the tablets – 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 dosing 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 so that decisions can be made regarding the duration of your treatment. If you start feeling 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 the 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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

Serious adverse reactions

Seizures or convulsions

Seizures (convulsions or epileptic fits) 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 medications, or who belong to a group at increased risk of seizures.

If in doubt, consult your doctor.

If a seizure occurs, contact your doctor immediately.

Do not take the medicine again.

Allergic reactions

Some patients may experience allergic reactions to Wellbutrin XR. These may include:

• Skin redness or rash (such as erythema multiforme), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if there is also pain in the mouth or eye pain,
• 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 the medicine again.

Allergic reactions may persist for a long time. If your doctor has prescribed medication to relieve allergic symptoms, complete the full course of treatment.

Lupus-like skin rash or worsening of lupus symptoms

Frequency unknown – frequency cannot be estimated based on available data from 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 in 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 estimated based on available data from 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 complaints (constipation), altered taste perception, 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:

• Feelings of depression (see also section 2: "Warnings and precautions"),
• Feelings of disorientation,
• Difficulty concentrating,
• Increased heart rate,
• Weight loss.

Rare adverse reactions

May occur in up to 1 in 1,000 patients:

• Seizure attacks.

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),
• Feelings of unreality or detachment (depersonalization), seeing or hearing things that are not there (hallucinations), believing in or experiencing things that are not real (delusions), excessive 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 such thoughts occur, contact your doctor or go to hospital immediately.
• Loss of contact with reality and impaired thinking or judgment (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 (hyponatremia).
• 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 also be reported directly to the Department for 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 this medicine.

5. How to store Wellbutrin XR

Keep the 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 packaging to protect from light and moisture.
The bottle contains a small, tightly sealed desiccant canister with 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 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, round, with the black imprint “GS 5FV 150” on one side of the tablet, the other side being smooth. The tablets are available in white polyethylene bottles containing 30 tablets.
For more detailed information, please contact the responsible party or 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:
ProCarePlus Pharma S.A.
ul. Bobrzyńskiego 14
30-348 Kraków
Repackaged in:
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Chemiczno-Farmaceutyczna Spółdzielnia Pracy "ESPEFA"
ul. Juliusza Lea 208
30-133 Kraków
MEDICOFARMA S.A.
ul. Sokołowska 9 lok. U19
01-142 Warszawa
Authorisation number in Portugal, country of export: 5015565
Parallel import authorisation number: 248/22
This medicinal product is authorised for marketing in the European Economic Area member states 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.