Velbox

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Welbox (Bupropion +pharma)

150 mg, tablets with modified release

Bupropion hydrochloride
Welbox and Bupropion +pharma are different trade names for the same medicine.

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Welbox and what is it 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 packaging and other information

1. What is Welbox and what is it used for

Welbox is a medicine used in depression, available by prescription only. It is believed to affect certain substances in the brain - noradrenaline and dopamine, which are related to depression.

2. Important information before taking Welbox

When not to take 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 eating disorders (such as bulimia or anorexia nervosa)
• if the patient has a brain tumor
• if the patient is an alcohol addict who has just stopped drinking or plans to do so
• if the patient has severe liver disease
• if the patient has recently stopped taking sedatives or plans to do so while taking Welbox
• if the patient is taking or has taken in the last 14 days other antidepressant medicines called monoamine oxidase inhibitors (MAOIs).

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

Before starting to take Welbox, the patient should discuss it with their doctor or pharmacist.

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

The patient should inform their doctor before starting treatment with Welbox:

• if they regularly drink large amounts of alcohol
• if they have diabetes and are taking insulin or oral hypoglycemic agents
• if they have had a serious head injury or brain trauma in the past.

Bupropion may cause seizures in about 1 in 1000 patients. The occurrence of this side effect is more likely in patients who take higher doses than recommended, take certain other medicines, or are at increased risk of seizures. If in doubt, the patient should contact their doctor.
If seizures occur during treatment, Welbox should be discontinued.

The patient should not take it anymore and should contact their doctor.

• If the patient has bipolar disorder (severe mood swings), as Welbox may trigger an episode of this condition.
• If the patient is taking other antidepressants, as 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, as they may be more likely to experience side effects.

If any of the above situations apply to the patient, they should contact their doctor before starting to take Welbox. The doctor may decide to monitor the patient closely or recommend alternative treatment.

Suicidal thoughts and worsening of depression symptoms

In patients with depression, suicidal thoughts or behaviors may occur. These behaviors may worsen when the patient first starts taking antidepressants, as it may take some time, usually about two weeks, and sometimes longer, for these medicines to start working.
Such thoughts may occur more frequently:

• if the patient has had suicidal thoughts or self-harm thoughts before
• if the patient is a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders who were treated with antidepressants.

In case of suicidal thoughts or self-harm thoughts, the patient should immediately contact their doctor or go to the hospital.
It may be helpful to inform a relative or friendthat the patient has depression and ask them to read this leaflet. The patient may ask them to inform them if they notice that the patient's depression is worsening or if there are any worrying changes in their behavior.

Welbox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including herbal medicines or vitamins, including those bought without a prescription. The doctor may change the dose of Welbox, recommend a change in dosing, or stop other medicines being taken.
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If the patient is currently taking or has takenother antidepressant medicines called monoamine oxidase inhibitors(MAOIs) in the last 14 days, they should contact their doctor before taking Welbox(see also "When not to take Welbox" in section 2).
Some medicines should not be taken with Welbox. Some of them may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side 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 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 is taking sedatives or plans to stop taking them while taking Welbox (see also "When not to take Welbox" 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 called quinolones
• if the patient is taking certain types of antihistamines that can cause drowsiness
• if the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, they should contact their doctor before starting to take Welbox. The doctor will assess the risks and benefits of taking Welbox.

The risk of other side effects may increase:

• if the patient is taking other antidepressants (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines for other mental illnesses (such as clozapine, risperidone, thioridazine, or olanzapine). Welbox may interact with some medicines used to treat depression and may cause changes in mental state (such as agitation, hallucinations, coma) and other side effects, such as body temperature above 38°C, accelerated heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (such as 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 cancer (such as cyclophosphamide or ifosfamide)
• if the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke
• if the patient is taking beta-blockers (such as metoprolol)
• if the patient is taking certain medicines used to treat 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 before starting to take Welbox.

Welbox may be less effective:

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• if the patient is taking ritonavir or efavirenz - medicines used to treat HIV infection. If this situation applies to the patient, they should inform their doctor. The doctor will assess the effectiveness of Welbox in the patient. It may be necessary to increase the dose or change the treatment of depression. The dose of Welbox should not be increased without the doctor's recommendation, as this may increase the risk of side effects, including seizures.

Welbox may reduce the effectiveness of other medicines:

• if the patient is taking tamoxifen - used to treat breast cancer. If this situation applies to the patient, they should tell their doctor. It may be necessary to change the treatment of depression.
• if the patient is taking digoxin due to heart problems. If this situation applies to the patient, they should tell their 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 changes in mental state. Some patients become more sensitive to alcohol while taking bupropion. The doctor may recommend avoiding alcohol (beer, wine, vodka) or significantly reducing its consumption while taking Welbox. If the patient currently drinks large amounts of alcohol, they should not stop drinking suddenly, as this may cause a seizure.
The patient should discuss drinking alcohol with their doctorbefore starting to take Welbox.

Effect on urine tests

Welbox may affect the results of laboratory tests for the presence of other medicines. If the patient is undergoing such a test, they should inform their doctor or nurse that they are taking Welbox.

Pregnancy, breastfeeding, and fertility

Welbox should not be taken if the patient is pregnant, thinks they may be pregnant, or plans to have a baby, unless the doctor recommends otherwise. Before taking any medicine during pregnancy, the patient should consult their doctor or pharmacist. Some, but not all, studies suggest an increased risk of birth defects, particularly heart defects, in children whose mothers took bupropion. It is not known if this was caused by taking bupropion.
The active substance of Welbox may pass into breast milk. Before taking Welbox, the patient should consult their doctor or pharmacist.

Driving and using machines

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 prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
It may take some time before the patient feels better. The full effect of the medicine may only be apparent after several weeks or months. If the patient feels better, their doctor may recommend continuing to take Welbox to prevent the depression from coming back.
What dose to take
The recommended dose for adults is one 150 mg tablet once a day.
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If after several weeks of treatment the patient does not improve, their doctor may recommend increasing the dose to 300 mg once a day.
For some patients, a dose of 150 mg once a day is sufficient throughout the treatment period.
The doctor may recommend this dosing if the patient has liver or kidney problems.
The dose of Welbox should be taken in the morning. Welbox should not be taken more than once a day.
Welbox is intended for oral use.
The tablets should be swallowed whole. They should not be chewed, crushed, or divided - if this happens, there is a risk of overdose due to the rapid release of the medicine into the body. This may increase the risk of side effects, including seizures.
Welbox can be taken with or without food.
The tablet is coated with a shell that slowly releases the medicine into the digestive tract. The patient may notice something in their stool that looks like a tablet. This is the empty shell that has been eliminated from the body.
How long to take the treatment
Only the doctor, together with the patient, can decide how long to take Welbox. It may take weeks or months before any improvement is seen. The patient should regularly discuss their symptoms with their doctor to decide how long the treatment should last. If the patient feels better, their doctor may recommend continuing to take Welbox to prevent the depression from coming back.

Taking a higher dose of Welbox than recommended

Taking too many tablets may cause seizures or convulsions. The patient should not delay and should contact their doctor or the nearest hospital emergency department immediately.

Missing a dose of Welbox

If a dose is missed, the patient should wait and take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Welbox

The patient should not stop taking Welbox or reduce the dose without first discussing it with their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Welbox can cause side effects, although not everybody gets them.
Seizures or convulsions
About 1 in 1000 patients taking bupropion may experience seizures (convulsions). The risk of this is higher in patients who take higher doses than recommended, take certain other medicines, or are at increased risk of seizures. If in doubt, the patient should contact their doctor.

In case of a seizure, the patient should contact their doctor.

The patient should not take Welbox anymore.

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

• redness of the skin or rash (like a nettle rash), blisters, or itchy bumps (hives) 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
• fainting or brief loss of consciousness.

In case of any symptoms of an allergic reaction, the patient should contact their doctor immediately. The patient should not take Welbox anymore.
Allergic reactions can last a long time. If the doctor has prescribed medicines to relieve allergic symptoms, the patient should take the whole course.
Stevens-Johnson syndrome or worsening of symptoms
The frequency cannot be estimated from the available data from people taking bupropion.
Stevens-Johnson syndrome is a disorder of the immune system that affects the skin and other organs.
If the patient experiences worsening of Stevens-Johnson syndrome, skin rash, or skin changes (especially in areas of skin exposed to sunlight) while taking Welbox, they should contact their doctor immediately, as it may be necessary to stop the treatment.
Other side effects

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

• difficulty sleeping; the patient should make sure that Welbox is taken in the morning
• headache
• dry mouth
• nausea, vomiting.

Common(may affect up to 1 in 10 patients)

• fever, dizziness, itching, sweating, and skin rash (sometimes due to an allergic reaction)
• chills, tremors, weakness, fatigue, chest pain
• feeling anxious or agitated
• abdominal pain or other discomfort (constipation), change in taste, loss of appetite (anorexia)
• increased blood pressure, sometimes significantly, flushing of the face
• ringing in the ears, vision disturbances.

Uncommon(may affect up to 1 in 100 patients)

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

Rare(may affect up to 1 in 1000 patients)

• seizures.

Very rare(may affect up to 1 in 10,000 patients)

• palpitations, fainting
• muscle tremors, muscle stiffness, uncontrolled movements, walking or coordination problems

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• feeling anxious, irritated, hostile, aggressive, strange dreams, tingling or numbness, memory loss
• yellowing of the skin or whites of the eyes (jaundice), which may be caused by increased liver enzyme activity, hepatitis
• severe allergic reactions; rash with accompanying muscle and joint pain
• changes in blood sugar levels
• urinating more or less often than usual
• incontinence (involuntary urination, uncontrolled urine flow)
• severe skin rashes that can affect the mouth and other parts of the body and can be life-threatening
• worsening of psoriasis (red thickening of the skin)
• feeling unreal or strange (depersonalization), seeing or hearing things that do not exist (hallucinations), feeling or believing in things that are not real (delusions), exaggerated suspicion (paranoia)
• drop in blood pressure when standing up (orthostatic hypotension).

Other side effects

Other side effects have occurred in a small number of patients, although the exact frequency is not known (frequency cannot be estimated from the available data):

• thoughts of self-harm or suicide while taking bupropion or soon after stopping treatment (see section 2 "Important information before taking Welbox"). If the patient has such thoughts, they should contact their doctor or go to the hospital immediately
• loss of contact with reality and ability to think or assess the situation (psychosis); other symptoms may include hallucinations and/or delusions
• decreased number of red blood cells (anemia), decreased number of white blood cells (leukopenia), and decreased number of platelets (thrombocytopenia)
• low sodium levels in the blood (hyponatremia)
• serotonin syndrome: changes in mental state (such as agitation, hallucinations, coma) and other side effects, such as body temperature above 38°C, accelerated heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea) when taking Welbox with other antidepressant medicines (such as paroxetine, citalopram, escitalopram, fluoxetine, venlafaxine).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel: +48 22 49 21 301, fax: +48 22 49 21 309; website https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Welbox

The medicine should be stored out of sight and reach of children.
Welbox should not be taken after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
There are no special storage instructions. The medicine should be stored in its original packaging to protect it from moisture and light. After opening: do not store above 25°C. Use within 3 months.
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Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Welbox contains

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

What Welbox looks like and contents of the pack

Creamy-white to light yellow, round, biconvex tablets with a diameter of about 8.1 mm.
Welbox is available in containers containing 30, 60, or 90 tablets.
The container also contains a desiccant capsule that protects the tablets from moisture. The capsule should not be swallowed.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Austrian marketing authorization number: 139246

Parallel import authorization number: 134/22 Date of leaflet approval: 21.03.2022

[Information about the trademark]
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