Welbox

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Welbox (Bupropion +pharma)
150 mg, modified-release tablets
Bupropion hydrochloride
Welbox and Bupropion +pharma are different trade names for the same medicine.
Please read carefully all the information in this leaflet before taking 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 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 as yours.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Welbox is and what it is used for
2. Important information before taking Welbox
3. How to take Welbox
4. Possible side effects
5. How to store Welbox
6. Contents of the pack and other information

1. What Welbox is and what it is used for

Welbox is a medicine used in the treatment of depression, available only on prescription. It is believed to act on certain substances in the brain—norepinephrine and dopamine—whose activity is associated with depression.

2. Important information before using Welbox

When not to use Welbox

• 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 previously experienced seizures
• if the patient has or has previously had eating disorders (e.g. bulimia or 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 stop
• if the patient has severe liver disease
• if the patient has recently stopped taking sedative medicines or intends to stop during treatment with Welbox
• if the patient is taking or has taken within the last 14 days antidepressant medicines known as monoamine oxidase inhibitors (MAOIs).

If any of the above situations apply to the patient, they should contact their doctor immediately
and must not take Welbox.
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Warnings and precautions

Before starting treatment with Welbox, discuss this with your doctor or pharmacist.
Children and adolescents

Welbox is not recommended for use in children under 18 years of age.
In children and adolescents under 18 years of age being treated with antidepressants, there is an increased risk of suicidal thoughts and behaviour.
Adults

Before starting treatment with Welbox, inform your doctor:

• 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.

Bupropion may cause seizures in approximately 1 in 1000 patients. The occurrence of this adverse reaction is more likely in patients belonging to the groups listed above.
If seizures occur during treatment, Welbox must be discontinued.
The patient must not take it again and should contact their doctor immediately.

• If the patient has bipolar disorder (extreme mood swings), because Welbox may trigger an episode of this illness.
• If the patient is taking other antidepressants, because combining these medicines with Welbox may lead to serotonin syndrome, a potentially life-threatening condition (see “Welbox with other medicines” in section 2).
• 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, they should contact their doctor again before starting Welbox. The doctor may decide that treatment should be closely monitored 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 increase when the patient first starts taking antidepressant medicines, because it usually takes about two weeks, and sometimes longer, before these medicines begin to work.
Such thoughts may be more frequent:

• 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 antidepressants.

If thoughts of self-harm or suicide occur at any time, the patient should contact their doctor immediately or go to a 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 the patient if they believe the patient's depression is worsening or if changes in their behaviour become concerning.
Welbox with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal remedies or vitamins, even those purchased without a prescription. The doctor may adjust the dose of Welbox, recommend changing the dosing schedule, or discontinuing other medicines.
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If the patient is currently taking or has taken within the last fourteen days other antidepressant medicines known as monoamine oxidase inhibitors (MAOIs), the patient should contact their doctor without taking Welbox (see also “When not to use Welbox” in section 2).
Some medicines must not be taken at the same time as Welbox. 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 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 is taking sedative medicines or intends to stop taking them during treatment with Welbox (see also “When not to use Welbox” 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, they should contact their doctor immediately before starting Welbox. The doctor will assess the risks and benefits of using Welbox.
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). Welbox may interact with some medicines used to treat depression, leading to changes in mental state (e.g. agitation, hallucinations, coma) and other adverse effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (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 Welbox (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, they should contact their doctor immediately before starting Welbox.

Welbox may be less effective: Page 3 of 8

• if the patient is taking ritonavir or efavirenz – medicines used to treat HIV infection. If this applies to the patient, inform the doctor. The doctor will assess the effectiveness of Welbox in the patient. It may be necessary to increase the dose or change the method of treating depression. Do not increase the dose of Welbox without the doctor’s advice, as this may increase the risk of adverse effects, including seizures.

Welbox may reduce the effectiveness of other medicines:

• if the patient is taking tamoxifen – used to treat breast cancer. If this 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 applies to the patient, inform the doctor. The doctor may consider adjusting the dose of digoxin.

Welbox and alcohol

Alcohol may affect the action of Welbox, and taking them together may rarely cause nervousness or alter mental state. Some patients become more sensitive to alcohol while taking bupropion. The doctor may advise avoiding alcohol (beer, wine, spirits) or significantly reducing alcohol consumption during treatment with Welbox. If the patient currently drinks large amounts of alcohol, they should not stop suddenly, as this may trigger a seizure.
The patient should talk to their doctor about alcohol consumption before starting Welbox.
Effect on urine tests

Welbox may affect laboratory test results for the presence of other drugs. If the patient undergoes such a test, they should inform the doctor or nurse that they are taking Welbox.
Pregnancy, breastfeeding and fertility

Do not take Welbox if the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, unless advised otherwise by a doctor. Before taking any medicine during pregnancy, consult a doctor or pharmacist. Some, but not all, studies suggest an increased risk of congenital malformations, particularly heart defects, in children whose mothers used bupropion. It is not known whether this was due to bupropion use.
The active substance of Welbox may pass into breast milk. Consult a doctor or pharmacist before using Welbox.
Driving and operating machinery

If Welbox causes dizziness or a feeling of emptiness in the head, the patient should not drive or operate machinery.

3. How to take Welbox

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt,
consult the doctor or pharmacist.
It may take some time before the patient starts to feel better. The full effect of the medicine may only
become apparent after several weeks or months. If the patient feels better, the treating doctor may
recommend continuing treatment with Welbox to prevent recurrence of depression.

What dose should be taken
The usual recommended dose for adults is one 150 mg tablet once daily.
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If there is no improvement after a few weeks of treatment, the treating doctor may recommend
increasing the dose to 300 mg once daily.
For some patients, a dose of 150 mg once daily is sufficient for the entire duration of treatment.
The treating doctor may recommend this dosage if the patient has liver or kidney impairment.
The dose of Welbox should be taken in the morning. Welbox must not be taken more than once
daily.
Welbox is intended for oral use.
Tablets should be swallowed whole. They must not be chewed, crushed, or split—if this occurs,
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.
Welbox may be taken with or without food.
The tablet has a coating 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 coating, which has been
excreted from the body.

How long to continue treatment
Only the doctor together with the patient can decide how long Welbox treatment should continue.
It may take weeks or months before any improvement is observed. The patient should regularly
discuss symptoms with the doctor to determine how long treatment should last. If the patient feels
better, the treating doctor may recommend continuing treatment with Welbox to prevent recurrence
of depression.

Taking more Welbox than prescribed
Taking too many tablets may cause seizures or a seizure attack. Do not delay—contact a doctor or
the nearest hospital emergency department immediately.

If a dose of Welbox is missed
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 Welbox treatment
Do not stop treatment with Welbox or reduce the dose without first discussing it with the treating
doctor.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

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

Seizures or epileptic fits

Seizures (epileptic fits or convulsions) may occur in approximately 1 in 1,000 patients taking bupropion. The likelihood is higher in patients who take higher than recommended doses, are taking certain other medicines, or belong to a group at increased risk of seizures. If in doubt, contact your treating physician.

If a seizure occurs, contact your treating physician immediately.
Do not take this medication again.

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Allergic reactions

Some patients may experience allergic reactions to Welbox. 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 medication again.
Allergic reactions may last a long time. If your doctor has prescribed medications to relieve allergic symptoms, complete the full course of treatment.

Lupus-like skin rash or worsening of lupus symptoms

Frequency cannot be determined based on available data from patients taking bupropion.

Lupus is an autoimmune disorder affecting the skin and other organs. If lupus flares, skin rash, or skin lesions (especially in areas of skin exposed to sunlight) occur during treatment with Welbox, contact your doctor immediately, as discontinuation of treatment may be necessary.

Other adverse effects

Very common (may affect more than 1 in 10 patients)

• difficulty falling asleep; ensure the medicine is taken in the morning
• headache
• dry mouth
• nausea, vomiting

Common (may affect up to 1 in 10 patients)

• fever, dizziness, itching, sweating, skin rash (sometimes due to allergic reaction)
• chills, tremors, weakness, fatigue, chest pain
• feeling anxious or agitated
• abdominal pain or other gastrointestinal complaints (constipation), altered taste sensation, loss of appetite (anorexia)
• increased blood pressure, sometimes significant, facial flushing
• ringing in the ears, visual disturbances

Uncommon (may affect up to 1 in 100 patients)

• feeling of depression (see also section 2: Warnings and precautions, “Suicidal thoughts and worsening of depressive symptoms”)
• feeling of disorientation
• difficulty concentrating
• increased heart rate
• weight loss

Rare (may affect up to 1 in 1,000 patients)

• seizures

Very rare (may affect 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 parts of the body 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 things that are not real (delusions), excessive suspiciousness (paranoia)
• drop in blood pressure upon standing up suddenly (orthostatic hypotension)

Other adverse effects

Other adverse effects have occurred in a small number of patients, although the exact frequency is unknown (frequency cannot be determined from available data):

• thoughts of self-harm or suicide during treatment with bupropion or shortly after stopping treatment (see section 2 "Important information before taking Welbox"). If the patient has such thoughts, contact a doctor immediately or go to a 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)
• serotonin syndrome: changes in mental state (e.g. agitation, hallucinations, coma) and other adverse effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) when Welbox is taken with other antidepressant medicines (such as paroxetine, citalopram, escitalopram, fluoxetine, venlafaxine)

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 to provide more information on the safety of the medicine.

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5. How to store Welbox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: "EXP". The expiry date refers to the last day of the stated month.
No special temperature requirements for storage. Store in the original packaging to protect from moisture and light. After first opening: do not store at temperatures above 25°C. Use within 3 months.
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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 Welbox contains

• The active substance is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride.
• The other ingredients are:
  • hydroxypropyl cellulose, microcrystalline cellulose siliconized, stearic acid, magnesium stearate
  • tablet coating: ethyl cellulose, hydroxypropyl cellulose, titanium dioxide (E 171), triethyl citrate, copolymer of methacrylic acid and ethyl acrylate, talc.

What Welbox looks like and contents of the pack
Cream-white to light yellow, round, biconvex tablets with a diameter of approximately 8.1 mm.
The medicine is available in containers containing 30, 60 or 90 tablets.
The container also contains a desiccant capsule which protects the tablets from moisture. The capsule must not be ingested.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Austria, country of export:
+pharma arzneimittel gmbh, Hafnerstrasse 211, 8054 Graz, Austria
Manufacturer:
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria
Genericon Pharma Gesellschaft m.b.H., A-8054 Graz, Austria
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Austrian licence number, country of export: 139246
Parallel import licence number: 134/22
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