Welbox

Package leaflet: Information for the patient

Warning! Keep this leaflet. 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 this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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 affect certain chemicals in the brain—noradrenaline 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 had seizures in the past
• if the patient has or has had in the past eating disorders (e.g. bulimia or mental anorexia - anorexia nervosa)
• if the patient has a brain tumor
• 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 sedative medicines or intends to do so 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, contact the
treating physician immediately and do not take Welbox.
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Warnings and precautions
Before starting treatment with Welbox, discuss this with your doctor or pharmacist.
Brugada syndrome

• if the patient has Brugada syndrome (a rare, genetically determined condition affecting heart rhythm) or if there is a family history of cardiac arrest or sudden death.

Children and adolescents
Welbox is not recommended for use in 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
Inform your treating physician before starting treatment with Welbox:

• 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 about 1 in 1,000 patients. The occurrence of this
adverse effect is more likely in patients from the groups mentioned above.
If seizures occur during treatment, stop taking Welbox.
Do not take it again and contact your treating physician.

• If the patient has bipolar disorder (extreme mood swings), because Welbox may trigger an episode of this condition.
• If the patient is taking other antidepressants, because taking these medicines together with Welbox may lead to serotonin syndrome, a potentially life-threatening condition (see "Welbox and other medicines" in section 2).
• 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
treating physician again before starting treatment with Welbox. The doctor may decide
that therapy should be conducted under close supervision or recommend alternative treatment.
Suicidal thoughts and worsening of depressive symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. Such
behaviors may worsen when the patient first starts taking antidepressant
medicines, because it takes some time—usually about two weeks, sometimes longer—before these medicines start to work.
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 trials have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

If thoughts of self-harm or suicide ever occur, contact your treating physician 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 behavior become
concerning.
Welbox and other medicines
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Inform your doctor or pharmacist about all medicines currently or recently taken,
as well as any medicines the patient plans to take, including herbal remedies or
vitamins, even those purchased without a prescription. The doctor may adjust the dose of Welbox, recommend
changing the dosage or discontinuing other medicines being taken.
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 treating physician without taking Welbox (see also "When not to use Welbox" in section 2).
Some medicines must not be taken together with Welbox. Some of them may
increase the risk of seizures or convulsive episodes. 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, contact the treating physician
immediately before starting treatment with 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 and may cause changes in mental state (e.g. agitation, hallucinations, coma) and other adverse effects such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).
• 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 tumors (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.

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If any of the above situations apply to the patient, contact the treating physician
immediately before starting treatment with Welbox.
Welbox may be less effective:

• if the patient is taking ritonavir or efavirenz—medicines used to treat HIV infections. If this applies to the patient, inform the treating physician. The physician 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 treating physician's recommendation, 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 digoxin dose.

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 recommend abstaining from
drinking alcohol (beer, wine, spirits) or significantly reducing alcohol consumption during treatment with
Welbox. If the patient currently drinks large amounts of alcohol, do not stop drinking suddenly,
as this may trigger a seizure.
Discuss alcohol consumption with your doctor before starting treatment with Welbox.
Effect on urine tests
Welbox may affect laboratory test results for the presence of other medicines. If the patient
undergoes such a test, they should inform the doctor or nurse that they are taking Welbox.
Pregnancy, breastfeeding and effect on fertility
Do not take Welbox if the patient is pregnant, suspects she may be pregnant,
or plans to have a child, unless the doctor advises otherwise. 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
took bupropion. It is not known whether this was caused by bupropion use.
The active substance of Welbox may pass into breast milk. Before taking Welbox,
consult a doctor or pharmacist.
Driving and operating machinery
If Welbox causes dizziness or a feeling of emptiness in the head, do not drive
or operate machinery.

3. How to take Welbox

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
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It may take some time before the patient starts to feel better. The full effect of the medicine may not
become apparent until 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.
If there is no improvement after several 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 may be sufficient throughout the entire treatment period.
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 should not be taken more frequently than
once daily.
Welbox is intended for oral administration.
Tablets should be swallowed whole. They must not be chewed, crushed, or split – doing so may result
in overdose due to rapid release of the medicine into the body. This may increase the risk of adverse
reactions, 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 resembling a tablet in the stool. This is the empty coating that 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 recommended
Taking too many tablets may cause seizures or a seizure attack. Immediate contact must be made with
a doctor or the nearest hospital emergency department without delay.
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 taking Welbox or reduce the dose without first consulting the treating doctor.
If there are any further doubts 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 experiences them.

Seizures or convulsions

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

If a seizure occurs, contact your doctor immediately.
Do not take these tablets again.

Allergic reactions

Some patients may experience allergic reactions to Welbox. These include:

• skin redness or rash (such as maculopapular rash), blisters, or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if mouth pain or eye pain also occurs
• 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 these tablets again.
Allergic reactions may persist for 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 changes (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 of anxiety or agitation
• abdominal pain or other gastrointestinal complaints (constipation), altered taste sensation, loss of appetite (anorexia)
• increased blood pressure, sometimes significantly, 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, subsection "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
• 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 often 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)
• feeling of unreality or detachment (depersonalization), seeing or hearing things that are not real (hallucinations), experiencing or believing in unreal things (delusions), excessive suspiciousness (paranoia)
• drop in blood pressure upon standing up quickly (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 based on available data):

• thoughts of self-harm or suicide during treatment with bupropion or shortly after treatment has ended (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 contact 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 (hyponatremia)
• serotonin syndrome: changes in mental status (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 together 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 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.

5. How to store Welbox

Keep this medicine out of the sight and reach of children.
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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.
There are no special requirements regarding storage temperature. Store in the original packaging to protect from light and moisture. After first opening: Store below 25°C. Use within 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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:
  • tablet core: hydroxypropyl cellulose, microcrystalline cellulose silicon dioxide, stearic acid, magnesium stearate
  • tablet coating: ethyl cellulose, hydroxypropyl cellulose, titanium dioxide (E 171), triethyl citrate, copolymer of methacrylic acid and methyl methacrylate (1:1), 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 entity or parallel importer.
Responsible entity in the Czech Republic, country of export:
+pharma arzneimittel gmbh, Hafnerstrasse 211, 8054 Graz, Austria
Manufacturer:
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str, Dupnitsa 2600, Bulgaria
Genericon Pharma GmbH., Hafnerstrasse 211, 8054 Graz, Austria
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorisation number in the Czech Republic, country of export: 30/429/18-C
Parallel import authorisation number: 145/23
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