Velbox

Package Leaflet: Information for the Patient

Welbox, 150 mg, Modified Release Tablets

Bupropion Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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 pack and other information

1. What is Welbox and what is it used for

Welbox is a medication used for depression, available by prescription only. It is believed to affect certain substances in the brain - norepinephrineand dopamine.

2. Important information before taking Welbox

When not to take Welbox

• if the patient is allergic to bupropion or any of the other ingredientsof this medication (listed in section 6)
• if the patient is taking any other medications containing bupropion
• if the patient has epilepsy or has had seizures in the past
• if the patient has or has hadeating disorders(such as bulimia or anorexia nervosa)
• if the patient has a brain tumor
• if the patient is an alcoholic who has just stopped drinking or plans to do so
• if the patient has severe liver disease
• if the patient has recently stopped taking sedativesor plans to do so while taking Welbox
• if the patient is taking or has takenantidepressant medications called monoamine oxidase inhibitors (MAOIs)within the last 14 days. If any of the above situations apply to the patient, they should contact their doctor immediately and not take Welbox.

Warnings and precautions

Before starting to take Welbox, the patient should discuss the following with their doctor or pharmacist:

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

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 medications
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 with the conditions mentioned above.
If seizures occur during treatment, Welbox should be discontinued.

Do not take it anymore and contact your 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 medications together with Welbox may lead to serotonin syndrome, a potentially life-threatening condition (see "Welbox and other medications" 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

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 or longer) for these medications to start working.
Such thoughts may occur more frequently:

• if the patient has had suicidal thoughts or self-harm in the past
• 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. If suicidal thoughts or self-harm occur, the patient should contact their doctor immediately 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 changes in their behavior that are causing concern.

Welbox and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including herbal remedies or vitamins, including those bought without a prescription. The doctor may change the dose of Welbox, recommend a change in dosing, or discontinue other medications being taken.
If the patient is currently taking or has takenother antidepressant medications called monoamine oxidase inhibitors (MAOIs)within the last 14 days, they should contact their doctor before taking Welbox(see also "When not to take Welbox" in section 2).
Some medications should not be taken with Welbox.Some of them may increase the risk of seizures or convulsions. Other medications may increase the risk of other side effects. Examples of such medications are listed below, but this is not an exhaustive list.

Seizures may occur more frequently than usual:

if the patient is taking other antidepressants or medications for mental disorders
if the patient is taking theophylline - a medication for asthma or lung disease
if the patient is taking tramadol - a strong pain reliever
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 medications (such as mefloquine or chloroquine)
if the patient is taking stimulants or other medications that control 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 medications.
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 risk 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 medications for other mental disorders (such as clozapine, risperidone, thioridazine, or olanzapine). Welbox may interact with some medications used to treat depression and may cause changes in mental status (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 medications for Parkinson's disease (levodopa, amantadine, orphenadrine)
if the patient is taking medications that affect the metabolism of Welbox (carbamazepine, phenytoin, valproic acid)
if the patient is taking certain medications for 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 medications for irregular heart rhythm (propafenone or 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:

if the patient is taking ritonavir or efavirenz - medications 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 for depression.
The patient should not increase the dose of Welbox without their doctor's recommendation, as this may increase the risk of side effects, including seizures.

Welbox may reduce the effectiveness of other medications:

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 for 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 status. 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 medications. If the patient is undergoing such a test, they should inform their doctor or nurse that they are taking Welbox.

Pregnancy, breastfeeding, and fertility

The patient should not take Welbox if they are pregnant, think they may be pregnant, or plan to have a baby, unless their doctor recommends it. Before taking any medication during pregnancy, the patient should consult their doctor or pharmacist. Some 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 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 medication should always be taken as directed by the doctor or pharmacist. The doctor will recommend a dose individually for the patient. If the patient has any doubts, they should ask their doctor or pharmacist.
It may take some time before the patient feels better. The full effect of the medication may only be apparent after several weeks or months. If the patient feels better, their doctor may recommend continuing to take Welbox to prevent a relapse of depression.
What dose to take
Usually, the recommended dose for adults is one 150 mg tablet once a day.
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 for the entire treatment period.
The doctor may recommend this dosing if the patient has liver or kidney disorders.
The dose of Welbox should be taken in the morning. The patient should not take Welbox more than once a day.
Welbox is intended for oral use.
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 medication 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 medication 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 a relapse of depression.

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 treatment with Welbox or reduce the dose without first discussing it with their doctor.
If the patient has any further doubts about taking this medication, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medications, Welbox can cause side effects, although not everybody gets them.

Serious side effects Seizures or convulsions

About 1 in 1000 patients taking bupropion may experience seizures (convulsions). The risk of this side effect is higher in patients who take higher doses than recommended, take certain other medications, or are at increased risk of seizures. If the patient has any doubts, they should contact their doctor.
If a seizure occurs, the patient should contact their doctor.

Do not take the tablets anymore. 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 eyes
unusual wheezing or difficulty breathing
swelling of the eyelids, lips, or tongue
muscle or joint pain
collapse or brief loss of consciousness.
If the patient experiences any symptoms of an allergic reaction, they should contact their doctor immediately. Do not take the tablets anymore.
Allergic reactions can last a long time.If the doctor has prescribed medications to relieve allergic symptoms, the patient should take the entire course.
Discoid lupus erythematosus or worsening of lupus symptoms
Frequency cannot be estimated from the available data from people taking bupropion.
Lupus is an immune system disorder that affects the skin and other organs.
If the patient experiences worsening of lupus, 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.
Acute generalized exanthematous pustulosis (AGEP)
Frequency unknown - frequency cannot be estimated from the available data from people taking bupropion.
AGEP symptoms include a skin rash with pustules/blisters filled with pus.
If the patient experiences a skin rash with pustules/blisters filled with pus, 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 to take the medication 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 "Suicidal thoughts and worsening of depression")
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 difficulties or coordination problems
feeling anxious, irritated, hostile, aggressive, having 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
increased or decreased urination
incontinence (involuntary urination, uncontrolled urine flow)
severe skin reactions 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 suspiciousness (paranoia)
drop in blood pressure when standing up (orthostatic hypotension).
Frequency not known(frequency cannot be estimated from the available data)
Other side effects have occurred in a small number of patients, but the exact frequency is not known
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 immediately or go to the hospital
loss of contact with reality and ability to think or assess the situation (psychosis); other symptoms may include hallucinations and/or delusions
feeling of sudden and intense anxiety (panic attack)
stuttering
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 status (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 antidepressants (such as paroxetine, citalopram, escitalopram, fluoxetine, venlafaxine).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Welbox

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

6. Contents of the pack 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:
• tablet core:hydroxypropylcellulose (470 cps), microcrystalline cellulose silanized, stearic acid, magnesium stearate
• tablet coating: Opadry white 29A18501 (ethylcellulose, hydroxypropylcellulose, titanium dioxide (E 171)), triethyl citrate, methacrylic acid, and ethyl acrylate copolymer (1:1), talc

What Welbox looks like and contents of the pack

Cream-white to light yellow, round, biconvex tablets with a diameter of about 8.1 mm.
Welbox is available in containers containing 7, 30, 60, or 90 tablets.
The container also contains a desiccant capsule that protects the tablets from moisture. The patient should not swallow the capsule.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+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.
Hafnerstrasse 211
8054 Graz
Austria
To obtain information on the names of this medication under which it has been authorized in other European Economic Area countries or to obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the leaflet:January 2024