Velbox

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 side effects, including any side effects not listed in this leaflet, they should tell their 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 medicine used in depression, prescribed by a doctor. 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 ingredientsof 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 hasor has had in the past eating disorders(such as bulimia or anorexia nervosa);
• if the patient has a brain tumor;
• if the patient, who abuses alcohol,has just stopped drinking or intends to do so;
• if the patient has severe liver disease;
• if the patient has recently stopped taking sedativesor intends to do so while taking Welbox;
• if the patient is taking orhas taken in the last 14 days other antidepressant medicinescalled monoamine oxidase inhibitors(MAOIs).

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 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 the patient regularly drinks large amounts of alcohol;
if the patient has diabetes and is taking insulin or oral antidiabetic medicines;
if the patient has had a serious head injury or head 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 groups 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 (extreme mood swings), as Welbox may cause an episode of this disease.
If the patient is taking other antidepressants, as taking these medicines at the same time as 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 therapy closely or recommend other treatment.

Suicidal thoughts and worsening of depression symptoms

In patients with depression, suicidal thoughts or behaviors may sometimes occur. Such behaviors may worsen when the patient first starts taking antidepressants, as it takes 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.
• If suicidal thoughts or self-harm thoughts occur at any time, 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 changes in their behavior become worrying.

Welbox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as those they 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 taking other medicines.
If the patient is currently taking orhas taken in the last fourteen days other antidepressant medicinescalled monoamine oxidase inhibitors(MAOIs), they should contact their doctorwithout taking Welbox (see also "When not to take Welbox" in section 2).
Some medicines cannot be taken at the same time as 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 an exhaustive 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 if they intend 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 immediately before starting to take Welbox. The doctor will assess the risk and benefits of taking Welbox.

The likelihood 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 (e.g., 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 (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 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 immediately before starting to take Welbox.

Welbox may be less effective:

if the patient is taking ritonavir or efavirenz - medicines used to treat HIV infections.
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 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 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 with alcohol

Alcohol may affect the action of Welbox, and their simultaneous intake may rarely cause nervousness or change the mental state. Some patients become more sensitive to alcohol while taking bupropion. The doctor may recommend abstaining from 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

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 medicine during pregnancy, the patient should consult their doctor or pharmacist. Some, but not all, studies suggest an increased risk of congenital defects, particularly heart defects, in children whose mothers took bupropion. It is not known whether 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 medicinemay only become apparent after several weeksor months. If the patient feels better, their doctor may recommend continuing to take Welbox to prevent the recurrence 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 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. The patient should not take Welbox 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 coating 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 coating 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 recurrence of depression.

Taking a higher dose of Welbox than recommended

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

Missing a dose of Welbox

If the patient misses a dose, they 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 medicine, they 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 likelihood of this happening is higher in patients who take higher doses than recommended, take certain other medicines, or are at increased risk of seizures. In case of doubt, the patient 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 lumps (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.
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 medicines to relieve allergic symptoms, the patient should take the whole course.
Discoid lupus erythematosus or worsening of lupus symptoms
The frequency cannot be determined 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.
Other side effects
Very common(may affect more than 1 in 10 people)
difficulty sleeping; the patient should make sure to take the medicine in the morning;
headache;
dry mouth;
nausea, vomiting.
Common(may affect up to 1 in 10 people)
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 people)
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 people)
seizures.
Very rare(may affect up to 1 in 10,000 people)
heart palpitations, fainting;
muscle tremors, muscle stiffness, uncontrolled movements, walking problems or coordination;
feeling restless, 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;
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 unreal things (delusions), exaggerated suspiciousness (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 determined 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 (e.g., 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 (e.g., 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 any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: +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 collected on the safety of the medicine.

5. How to store Welbox

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage temperature recommendations.
Store in the original packaging to protect from moisture and light.
After first opening: Store at a temperature below 25°C. Use within 3 months.
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 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:hydroxypropyl cellulose, microcrystalline cellulose, stearic acid, magnesium stearate,
• tablet coating: ethyl cellulose, hydroxypropyl cellulose, titanium dioxide (E 171), triethyl citrate, methacrylic acid, and methyl methacrylate copolymer (1:1), talc.

What Welbox looks like and what the pack contains

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, which 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 the Czech Republic, the 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:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa Street 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka Street 190
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 30/429/18-C
Parallel import authorization number: 424/22
Date of leaflet approval: 09.12.2022
[Information about the trademark]