Bupropion Sun

Package leaflet: Information for the user

Bupropione SUN 150 mg prolonged-release tablets, 300 mg prolonged-release tablets

bupropion hydrochloride
Generic medicine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Bupropione SUN is and what it is used for
2. What you need to know before taking Bupropione SUN
3. How to take Bupropione SUN
4. Possible side effects
5. How to store Bupropione SUN
6. Contents of the pack and other information

1. What Bupropione SUN is and what it is used for

Bupropione SUN is a medicine prescribed by a doctor to treat depression. It is believed to
interact with certain chemical substances in the brain called noradrenaline and dopamine.

2. What you should know before taking Bupropione SUN

Do not take Bupropione SUN:

• If you are allergic to bupropion or to any of the other ingredients of this medicine (listed in section 6)
• If you are taking any other medicine containing bupropion
• If you have been diagnosed with epilepsy or have a history of seizures
• If you have or have had eating disorders (for example, bulimia or anorexia nervosa)
• If you have a brain tumor
• If you are a heavy drinker who has recently stopped or is about to stop drinking
• If you have severe liver problems
• If you have recently stopped taking sedatives, or if you are about to discontinue them while taking Bupropione SUN
• If you are taking or have taken other medicines for depression called monoamine oxidase inhibitors (MAOIs) within the last 14 days.

If any of the above apply to you, speak to your doctor immediately, without taking Bupropione SUN.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bupropione SUN.
Brugada syndrome
If you have a condition called Brugada syndrome (a rare inherited condition affecting heart rhythm), or if there have been cases of cardiac arrest or sudden death in your family.
Serious skin reactions
Serious skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with Bupropione SUN.
Stop taking Bupropione SUN and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.
Children and adolescents
Bupropione SUN is not recommended for the treatment of children or adolescents under 18 years of age.
There is an increased risk of suicidal thoughts and behaviour in children and adolescents under 18 years of age treated with antidepressants.
Adults
Before you take Bupropione SUN, your doctor should know:

• If you regularly drink large amounts of alcohol
• If you have diabetes for which you use insulin or tablets
• If you have previously had a serious head injury or cranial trauma Bupropione SUN has been shown to cause seizures (epileptic fits) in approximately 1 in 1,000 people. This side effect is more likely to occur in the individuals described above. If you have a seizure during treatment, you must stop taking Bupropione SUN. Stop taking it immediately and contact your doctor.
• If you suffer from bipolar disorder (extreme mood swings), as Bupropione SUN could trigger an episode of this illness.
• If you are taking other medicines for depression, using these medicines together with Bupropione SUN may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Bupropione SUN” in this section)
• • If you have liver or kidney problems, you are more likely to experience side effects. If any of the above apply to you, discuss this again with your doctor before taking Bupropione SUN. Your doctor may wish to pay special attention to your treatment or recommend an alternative therapy.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may be more common when you first start taking antidepressants, as all these medicines take time to work, usually about two weeks, but sometimes longer.
You may be more likely to have these thoughts:

• If you have previously had thoughts of suicide or self-harm
• If you are a young adult. Data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant. If you have thoughts of harming yourself or of suicide, contact your doctor or go immediately to hospital. You may find it helpful to tell a relative or friend that you suffer from depression, and ask them to read this leaflet. You may ask them whether they think your depression is getting worse, or if they are concerned about changes in your behaviour.

Other medicines and Bupropione SUN
If you are taking or have taken other antidepressants called monoamine oxidase inhibitors (MAOIs) within the last 14 days, inform your doctor without taking Bupropione SUN (see also “Do not take Bupropione SUN” in section 2).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, herbal products or vitamins, even those not requiring a prescription. Your doctor may adjust your dose of Bupropione SUN, or recommend changing your other medicines.
Some medicines should not be taken together with Bupropione SUN. Some may increase the risk of seizures or convulsions. Others may increase the risk of other side effects. Some examples are listed below, but the list is not complete.
There may be a higher than usual risk of seizures …

• If you are taking other medicines for depression or for other mental illnesses
• If you are taking theophylline for asthma or lung disease
• If you are taking tramadol, a strong painkiller
• If you have taken sedatives, or if you are about to discontinue them while taking Bupropione SUN (see also “Do not take Bupropione SUN” in section 2)
• If you are taking medicines for malaria (such as mefloquine or chloroquine)
• If you are taking stimulants or other medicines to control weight or appetite
• If you are taking steroids (by mouth or injection)
• If you are taking antibiotics called quinolones
• If you are taking certain types of antihistamines that may cause drowsiness
• If you are taking medicines for diabetes. If any of the above apply to you, speak to your doctor immediately before taking Bupropione SUN. Your doctor will evaluate the benefits and risks of taking this medicine.

There may be a higher than usual risk of other side effects…

• If you are taking other antidepressants (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or medicines for other mental illnesses (such as clozapine, risperidone, thioridazine or olanzapine). Bupropione SUN can interact with some medicines used to treat depression and you may experience changes in mental state (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, blood pressure instability, and exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea)
• If you are taking medicines for Parkinson's disease (levodopa, amantadine or orphenadrine)
• If you are taking medicines that affect your body's ability to eliminate Bupropione SUN (carbamazepine, phenytoin, valproate)
• If you are taking certain medicines used to treat cancer (such as cyclophosphamide, ifosfamide)
• If you are taking ticlopidine or clopidogrel, mainly used to prevent stroke
• If you are taking certain beta-blockers (such as metoprolol)
• If you are taking certain medicines for irregular heart rhythm (propafenone or flecainide)
• If you are using nicotine patches to help you stop smoking. If any of the above apply to you, speak to your doctor immediately before taking Bupropione SUN.

Bupropione SUN may be less effective

• If you are taking ritonavir or efavirenz, medicines used to treat HIV infection. If this applies to you, inform your doctor. Your doctor will monitor how Bupropione SUN works for you. It may be necessary to increase the dose or switch to another treatment for depression. Do not increase the dose of Bupropione SUN without consulting your doctor, as this may increase the risk of side effects, including seizures.

Bupropione SUN may make other medicines less effective

• If you are taking tamoxifen, used to treat breast cancer. If this applies to you, inform your doctor. It may be necessary to use another treatment for depression.
• If you are taking digoxin for heart problems. If this applies to you, inform your doctor. Your doctor may consider adjusting the dose of digoxin.

Bupropione SUN and alcohol
Alcohol may alter the way Bupropione SUN works and, when used together, may rarely affect your nerves and mental state. Some people find they are more sensitive to alcohol when taking Bupropione SUN. Your doctor may advise you not to drink alcohol (beer, wine or spirits) while taking Bupropione SUN, or to drink only in minimal amounts. However, if you currently drink heavily, do not stop abruptly: this could put you at risk of having seizures.
Talk to your doctor about alcohol consumption before starting Bupropione SUN.
Effects on urine tests
Bupropione SUN may interfere with certain urine tests used to detect other drugs. If you are required to undergo a urine test, inform your doctor or hospital that you are taking Bupropione SUN.
Pregnancy and breastfeeding
Do not take Bupropione SUN if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, unless your doctor recommends it. Ask your doctor or pharmacist for advice before taking this medicine. Some, but not all, studies have reported an increased risk of birth defects, particularly heart defects, in children whose mothers took Bupropione SUN. It is not known whether these are due to the use of Bupropione SUN.
The components of Bupropione SUN pass into breast milk. You should consult your doctor or pharmacist before taking Bupropione SUN.
Driving and using machines
If Bupropione SUN causes you dizziness or a feeling of lightheadedness, do not drive or operate any tools or machinery.
Bupropione SUN contains lactose
Bupropione SUN contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Bupropione SUN

Take this medicine exactly as your doctor or pharmacist has told you.
These are the usual doses, but your doctor’s instructions are specifically for you. If you are not sure,
ask your doctor or pharmacist.
It may take some time before you start to feel better. It takes time for the medicine to have full effect,
sometimes weeks or months. When you start to feel better, your doctor may advise you to continue
taking Bupropione SUN to prevent depression from returning.

How much to take
The recommended dose is usually one 150 mg tablet per day, for adults only.
Your doctor may increase your dose to 300 mg per day if your depression does not improve after
several weeks.
Take your dose of Bupropione SUN tablets in the morning. Do not take Bupropione SUN more than
once a day.
The tablet has a coating that slowly releases the medicine into the body.
You may notice something in your stools that looks like a tablet. This is the empty coating being
eliminated from the body.
Swallow the tablets whole. Do not chew, crush, or divide them. If you do, there is a risk of overdose,
because the medicine would be released into your body too quickly. This would make side effects,
including seizures, more likely.
Some people continue taking one 150 mg tablet per day throughout their treatment. Your doctor may
have prescribed this dose if you have liver or kidney problems.

How long to take it for
Only you and your doctor can decide how long to take Bupropione SUN. It may take weeks or months
of treatment before improvement is seen. Talk regularly with your doctor about your symptoms to
decide how long you should continue treatment. When you start to feel better, your doctor may
advise you to keep taking Bupropione SUN to prevent depression from returning.

If you take more Bupropione SUN than you should
If you take too many tablets, your risk of seizures or convulsions may increase. Do not delay. Contact
your doctor immediately or go to the nearest hospital emergency department.

If you forget to take Bupropione SUN
If you miss a dose, wait and take the next tablet at your usual time. Do not take a double dose to
make up for the missed tablet.

If you stop taking Bupropione SUN
Do not stop taking Bupropione SUN or reduce the dose without first talking to your doctor.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Seizures or convulsions
Approximately 1 in 1,000 people taking Bupropione SUN are at risk of seizures (convulsive or
epileptic seizures). The likelihood of this happening is higher if you take too much, if you take certain
medicines, or if you are already at increased risk of seizures. If you are concerned, speak to your doctor.
➔ If you have a seizure, inform your doctor as soon as you feel better. Do not take any more tablets.
Allergic reactions
Some people may experience allergic reactions after taking bupropion. These include:

• Reddened skin or skin rash (similar to hives), and itchy blisters (urticaria) on the skin.
• Unusual wheezing or difficulty breathing
• Swelling of the eyelids, lips, or tongue
• Muscle or joint pain
• Collapse or fainting ➔ If you experience any signs of an allergic reaction, contact a doctor immediately. Do not take any more tablets. Allergic reactions can last a long time. If your doctor prescribes medication to relieve allergy symptoms, make sure you complete the full course of treatment.

Severe skin reactions
Stop taking bupropione and contact your doctor immediately if you notice any of the following symptoms:

• Very rare: Flat red spots resembling targets or circular lesions on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

• Frequency not known: Blisters and peeling over large areas of skin occur in a severe form of serious skin reaction (toxic epidermal necrolysis).

• Frequency not known: Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
  The onset of this syndrome is usually delayed (2–6 weeks after starting treatment).

• Frequency not known: Extensive, red, scaly rash with pustules under the skin and blisters accompanied by fever. Symptoms usually appear early in treatment (generalized pustular eruption, acute generalized exanthematous pustulosis).

Drug-induced lupus or worsening of lupus symptoms
Not known – frequency cannot be determined from available data in people taking Bupropione SUN.
Lupus is an immune system disorder that affects the skin and other organs.
➔ If you experience lupus flare-ups, skin rashes, or lesions (especially on sun-exposed areas) while taking Bupropione SUN, contact your doctor immediately, as treatment discontinuation may be necessary.

Other side effects
Very common side effects (may affect more than 1 in 10 people)

• Difficulty sleeping (make sure to take Bupropione SUN in the morning)
• Headache
• Dry mouth
• Feeling unwell, vomiting

Common side effects (may affect up to 1 in 10 people)

• Fever, dizziness, itching sensation, sweating, and skin rash (sometimes due to an allergic reaction)
• tremors, weakness, fatigue, chest pain
• Feeling anxious or restless
• Stomach pain or other gastrointestinal disturbances (constipation), changes in taste, loss of appetite (anorexia)
• Increase in blood pressure, sometimes severe, flushing
• Ringing in the ear, visual disturbances

Uncommon side effects (may affect up to 1 in 100 people)

• Feeling depressed (see also section 2, “Warnings and precautions with Bupropione SUN”, under “Suicidal thoughts and worsening of depression”)
• Feeling confused
• Difficulty concentrating
• Increased heart rate
• Weight loss

Rare side effects (may affect up to 1 in 1,000 people)

• Seizures

Very rare side effects (may affect up to 1 in 10,000 people)

• Palpitations, feeling faint
• Muscle contraction, stiffness, uncontrolled movements, problems with walking or coordination
• Feeling restless, irritable, 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 enzymes, hepatitis
• Severe allergic reactions; rash associated with joint and muscle pain
• Changes in blood sugar levels
• Urinating more or less than usual
• Urinary incontinence (involuntary urination, urine leakage)
• Worsening of psoriasis (thickened, red patches of skin)
• Feelings of unreality or detachment (depersonalization); seeing or hearing things that are not there (hallucinations); having thoughts or beliefs in things that are not real (delusions); severe suspicion (paranoia).

Frequency not known
Other side effects have occurred in a small number of people, but their exact frequency is not known:

• thoughts of self-harm or suicide during treatment with bupropion or immediately after stopping treatment (see section 2, “What you need to know before taking Bupropione SUN”). If you have these thoughts, contact your doctor or go directly to hospital
• loss of touch with reality and inability to think or judge clearly (psychosis);
  other symptoms may include hallucinations and/or delusions.
• stuttering
• reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia), and reduced number of platelets (thrombocytopenia)
• reduced level of sodium in the blood (hyponatraemia)
• changes in mental state (e.g. agitation, hallucinations, coma) and other 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), while taking bupropion together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bupropione SUN

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture and light.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bupropione SUN contains
The active substance is bupropione hydrochloride. Each tablet contains 150 mg or 300 mg of bupropione hydrochloride.
The other components are:
tablet core: hydroxypropylcellulose, glyceryl dibehenate, stearic acid.
tablet coating: hypromellose, ethylcellulose, povidone K90, lactose monohydrate, triethyl citrate, 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1), macrogol 6000 and colloidal hydrated silica.
Printing ink: shellac, iron oxide black (E 172), propylene glycol.

Description of the appearance of Bupropione SUN and package contents
Bupropione SUN 150 mg tablets are white to pale yellow, round, approximately 7.7 mm in diameter, film-coated tablets imprinted with "T" in black ink on one side and plain on the other side.
Bupropione SUN 300 mg tablets are white to pale yellow, round, approximately 9.6 mm in diameter, film-coated tablets imprinted with "T1" in black ink on one side and plain on the other side.
Bupropione SUN is supplied in the following pack sizes:
White opaque plastic bottle with a desiccant container containing activated silica gel and activated charcoal. PLEASE DO NOT EAT the contents of the desiccant container! The bottle is closed with a child-resistant plastic cap including an induction seal liner.
150 mg: 30, 60, 90 tablets.
300 mg: 30, 60, 90 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132 JH, Hoofddorp, The Netherlands

Local representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milano

Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp – The Netherlands
Terapia S.A.
124 Fabricii Street.
400635, Cluj-Napoca – Romania

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Sweden Bupropion SUN 150 mg Tablett med modifierad frisättning
Bupropion SUN 300 mg Tablett med modifierad frisättning
Germany BUPROPION BASICS 150 mg Tabletten mit veränderter Wirkstofffreisetzung
BUPROPION BASICS 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Spain Bupropión SUN 150 mg comprimidos de liberación modificada EFG
Bupropión SUN 300 mg comprimidos de liberación modificada EFG
Netherlands Bupropion HCl SUN 150 mg tabletten met gereguleerde afgifte
Bupropion HCl SUN 300 mg tabletten met gereguleerde afgifte
Italy Bupropione SUN
Poland Bucidar
Romania AXABAL 150 mg comprimate cu eliberare modificată
AXABAL 300 mg comprimate cu eliberare modificată