WELBOX

Patient Information Leaflet

Welbox, 150 mg, modified-release tablets
Bupropioni hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm others, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Welbox is and what it is used for
2. What you need to know 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 prescription medicine used to treat depression. It is thought to work by affecting certain chemicals in the brain – noradrenaline and dopamine.

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 has or has previously had eating disorders (e.g. bulimia or 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 antidepressant medicines known as monoamine oxidase inhibitors (MAOIs). If any of the above situations apply to the patient, contact the doctor immediately and do not take Welbox.

Warnings and precautions
Before starting treatment with Welbox, discuss this with your doctor or pharmacist:

• 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.

Serious skin reactions
Serious skin reactions have been reported with the use of Welbox, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient develops symptoms indicating serious skin reactions listed in section 4, treatment with Welbox must be stopped immediately and the doctor should be contacted without delay.
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 behaviours.
Adults
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 approximately 1 in 1,000 patients. The occurrence of this adverse effect is more likely in patients belonging to the groups mentioned above. If seizures occur during treatment, Welbox must 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 concomitant use of these medicines 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 the doctor again before starting Welbox. The doctor may decide that treatment should be closely monitored 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 for these medicines to take effect—usually about two weeks, and 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 antidepressants. If thoughts of self-harm or suicide ever occur, contact the 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 him or her if they notice worsening of depression or if changes in behaviour become concerning.
Welbox and other medicines
Tell your doctor or pharmacist about all medicines currently 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 discontinuation of other medicines.
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 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 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 sedative medicines or intends to discontinue 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 used to control 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 doctor immediately before starting 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 conditions (such as clozapine, risperidone, thioridazine or olanzapine). Welbox may interact with some medicines used to treat depression, leading 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 the doctor immediately before starting Welbox.

Welbox may be less effective:

• if the patient is taking ritonavir or efavirenz—medicines used to treat HIV infection. 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 treatment for depression. Do not increase the dose of Welbox without the doctor's advice, 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 treatment for 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 may become more sensitive to alcohol while taking bupropion. The doctor may advise avoiding 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 suddenly, as this may trigger a seizure.
Talk to your doctor about alcohol consumption before starting Welbox.
Effect on urine tests
Welbox may affect laboratory test results for other drugs. If the patient undergoes such a test, he or she should inform the doctor or nurse that Welbox is being taken.
Pregnancy, breastfeeding and fertility
Do not take Welbox if the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, unless advised otherwise by a doctor. Consult a doctor or pharmacist before taking any medicine during pregnancy. 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 due to bupropion use.
The active substance of Welbox may pass into breast milk. Consult a doctor or pharmacist before taking Welbox.
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 recommended by the doctor or pharmacist. The treating physician will individually determine the dose for the patient. If in doubt, consult the doctor or pharmacist.
It may take some time before the patient starts to feel better. The full effect of the medicine may not become apparent until several weeks or months have passed. 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 frequently than once daily.
Welbox is intended for oral administration.
Tablets should be swallowed whole. Do not chew, crush, or divide them – if this occurs, there is a risk 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 has a coating that slowly releases the medicine into the gastrointestinal tract. The patient may notice in the stool something that looks like a tablet. This is the empty shell that has been eliminated 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 physician 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. Do not delay – contact a doctor or go to the nearest hospital emergency department immediately.

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 a missed dose.

Stopping Welbox treatment
Do not stop treatment with 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 doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
Seizures or epileptic seizures
Seizures (epileptic seizures or convulsions) may occur in approximately 1 in 1,000 patients taking bupropion. The likelihood is higher in patients receiving higher than recommended doses, taking certain other medicines, or belonging to a group at increased risk of seizures. If in doubt, consult your treating physician.
If a seizure occurs, contact your treating physician.
Do not take these tablets again.
Allergic reactions
Some patients may experience allergic reactions to Welbox. These include:

• skin redness or rash (such as erythema multiforme) and itchy lumps (urticaria) on the skin
• unusual wheezing or breathing difficulties
• 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 be prolonged. 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 from available data in individuals taking bupropion.
Lupus is an immunological 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.
Severe skin reactions
If any of the following symptoms occur, discontinue bupropion and seek immediate medical attention:

• Very rare: red, flat, target-like or circular spots on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Frequency unknown: extensive areas of blisters and widespread skin peeling, occurring in the severe form of the skin reaction described above (toxic epidermal necrolysis).
• Frequency unknown: widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Symptoms of DRESS syndrome are usually delayed in onset (occurring 2–6 weeks after starting treatment).
• Frequency unknown: red, peeling, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis).

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

• difficulty sleeping; 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, and skin rash (sometimes due to allergic reaction)
• chills, tremors, weakness, fatigue, chest pain
• feelings of anxiety or agitation
• abdominal pain or other gastrointestinal disturbances (constipation), altered taste perception, loss of appetite (anorexia)
• increased blood pressure, sometimes significantly, facial flushing
• ringing in the ears, vision disturbances.

Uncommon (may affect up to 1 in 100 patients)

• feelings of depression (see also section 2 “Suicidal thoughts and worsening of depressive symptoms”)
• feelings 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
• feelings of 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, hepatitis
• 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)
• worsening of psoriasis (red, thickened skin patches)
• unusual hair loss or thinning (alopecia)
• 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 standing up suddenly (orthostatic hypotension).

Frequency unknown (frequency cannot be determined from available data)
Other adverse effects occurred in a small number of patients, although the exact frequency is not known:

• thoughts of self-harm or suicide during treatment with bupropion or shortly after stopping treatment (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 touch with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and/or delusions
• sudden and intense feeling of fear (panic attack)
• stuttering
• 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 (hyponatraemia)
• Serotonin syndrome: changes in mental status (e.g. agitation, hallucinations, coma) and other adverse effects such as body temperature above 38°C, rapid heart rate, unstable blood pressure, exaggerated reflex responses, 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Welbox

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging following "EXP". 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 moisture and light.
After first opening: do not store above 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 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: hydroxypropylcellulose (470 cps), microcrystalline cellulose silicon dioxide, 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 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 desiccant must not be ingested.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria
Manufacturer/Importer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria
For information on the names under which this medicine is authorised in the Member States of the European Economic Area, or for any further information, please contact the representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel. +48 12 262 32 36
e-mail: [email protected]