Welbox

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Welbox (Bupropion +pharma)
150 mg, modified-release tablets
Bupropioni hydrochloridum
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, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 packaging 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 – which are 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 currently has or has previously had eating disorders (e.g. bulimia or mental anorexia - anorexia nervosa);
• if the patient has a brain tumour;
• 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 medicines called monoamine oxidase inhibitors (MAOIs).

If any of the above situations apply to the patient, you should contact
your doctor immediately
and do not take Welbox.
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 under 18 years of age treated with antidepressant medicines, there is an increased risk of suicidal thoughts and behaviours.
Adults
You should inform your doctor 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 1000 patients. The occurrence of this adverse effect is more likely in patients belonging to the groups listed above.
If seizures occur during treatment, treatment with Welbox should be discontinued.
Do not take it again and contact your doctor immediately.
If the patient has bipolar disorder (extreme mood swings), because Welbox may trigger an episode of this condition.
If the patient is taking other antidepressant medicines, because using 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 to occur.
If any of the above situations apply to the patient, contact your doctor again before starting treatment with Welbox. Your doctor may decide that treatment should be carried out under close supervision or recommend alternative treatment.
Suicidal thoughts and worsening of depression symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. These behaviours may worsen when the patient first starts taking antidepressant medicines, because it takes time before these medicines start to work, usually about two weeks, sometimes longer.
Such thoughts may be more common:

• if the patient 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 antidepressant medicines.
• If you ever experience thoughts of self-harm or suicide, contact your doctor 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 behaviour become concerning.
Welbox and other medicines
Tell your doctor or pharmacist about all medicines currently being taken 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 dosing regimen, or discontinuing other medicines.
If the patient is currently taking or has taken within the last fourteen days other antidepressant medicines called monoamine oxidase inhibitors (MAOIs), contact your 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 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 antidepressant medicines or medicines used to treat psychiatric conditions;
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 called 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 your doctor 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 antidepressant medicines (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 lead to 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, 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, contact your doctor 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 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 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 in the treatment of 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 changes in mental state. Some patients become more sensitive to alcohol while taking bupropion. The doctor may recommend abstaining from 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.
Talk to your doctor about drinking alcohol before starting treatment with 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 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 using 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 as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
It may take some time before the patient starts to feel better. Full effect of the medicine may
only become apparent after several weeks or months. If the patient feels better, the treating
physician 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 physician 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 physician 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 than once
daily.
Welbox is intended for oral use.
Tablets should be swallowed whole. They should not be chewed, crushed, or divided – doing so may lead to
danger 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 is coated with a membrane 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 membrane
that has been excreted from the body.
How long to continue treatment
Only the physician 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 physician to determine how long treatment should last. If the patient feels better,
the treating physician may recommend continuing Welbox treatment 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 physician or
the nearest hospital emergency department immediately.
Missing a dose of Welbox
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 discussing it with the treating physician.
If there are any further doubts regarding the use of this medicine, consult the physician 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 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 erythematous rash), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if there is also mouth pain or eye pain;
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 erythematosus skin rash or worsening of lupus symptoms
Frequency cannot be determined from available data in patients taking bupropion.
Lupus is an immune system 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 treatment discontinuation 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 discomfort (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, section "Suicidal thoughts and worsening of depression 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, aggressiveness, 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, liver inflammation;
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 body parts and may be life-threatening;
worsening of psoriasis (red, thickened skin patches);
feelings 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 sudden standing (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 treatment has ended (see section 2 "Important information before taking Welbox").
If such thoughts occur, contact your 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 (hyponatremia);
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 or pharmacist. 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 sight and reach of children.
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.
No special temperature storage conditions apply.
Store in the original packaging to protect from moisture and light.
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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Welbox contains

• The active substance is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride.
• 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 7, 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 Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in the Czech Republic, country of export: 30/429/18-C
Parallel Import Licence Number: 424/22