Bupropione Zentiva Italia: detailed information

Patient Information Leaflet

Bupropione Zentiva Italia 150 mg modified-release tablets

Equivalent medicine
Please read all of this leaflet carefully before 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Bupropione Zentiva Italia is and what it is used for
What you need to know before taking Bupropione Zentiva Italia
How to take Bupropione Zentiva Italia
Possible side effects
How to store Bupropione Zentiva Italia
Contents of the pack and other information

1. What Bupropione Zentiva Italia is and what it is used for

Bupropione Zentiva Italia contains the active substance called bupropion hydrochloride.
Bupropione Zentiva Italia is a medicine prescribed by a doctor to treat depression. It is thought to
interact with certain chemical substances in the brain called noradrenaline and dopamine.

2. What you should know before taking Bupropione Zentiva Italia

Do not take Bupropione Zentiva Italia:

if you are allergic to bupropion or 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 previously had seizures (seizure attacks).
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 Zentiva Italia.
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 Zentiva Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bupropione Zentiva Italia.
Brugada syndrome
If you have a condition called Brugada syndrome (a rare inherited disorder 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 Zentiva Italia. Stop taking Bupropione Zentiva Italia and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.
Children and adolescents
Bupropione Zentiva Italia is not recommended for the treatment of patients under 18 years of age.
There is an increased risk of suicidal thoughts and behaviors in patients under 18 years of age treated with antidepressants.
Adults
Your doctor should know before you take Bupropione Zentiva Italia

if you regularly drink large amounts of alcohol;
if you have diabetes for which you use insulin or tablets;
if you have had a serious head injury or previous head trauma;
Bupropion has been shown to cause seizures in about 1 in 1,000 people. This side effect is more likely to occur in individuals described above. If you have a seizure during treatment, you must stop taking Bupropione Zentiva Italia. Stop taking it immediately and contact your doctor.
if you have bipolar disorder (extreme mood swings), as Bupropione Zentiva Italia may trigger an episode of this illness;
if you are taking other medicines for depression, using these medicines together with Bupropione Zentiva Italia may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Bupropione Zentiva Italia” 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 them again with your doctor before taking Bupropione Zentiva Italia. Your doctor may want to pay special attention to your treatment or recommend a different 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 trials have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant. If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go immediately to hospital.

It may be helpful to inform a family member or friend that you are depressed and ask them to read this leaflet. You may ask them whether they think your depression is worsening or if they are concerned about changes in your behavior.
Other medicines and Bupropione Zentiva Italia
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 Zentiva Italia (see also “Do not take Bupropione Zentiva Italia”).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, herbal products, or vitamins, even those without a prescription. Your doctor may adjust your dose of Bupropione Zentiva Italia or recommend changes to your other medicines.
Some medicines should not be taken together with Bupropione Zentiva Italia. 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 take:

other medicines for depression or other mental illnesses;
theophylline for asthma or lung diseases;
tramadol, a strong painkiller;
sedatives, or if you are about to discontinue them while taking Bupropione Zentiva Italia (see also “Do not take Bupropione Zentiva Italia”);
medicines for malaria (such as mefloquine or chloroquine);
stimulants or other medicines to control weight or appetite;
steroids (by mouth or injection);
antibiotics called quinolones;
certain types of antihistamines that may cause drowsiness;
medicines for diabetes.

If any of the above apply to you, speak to your doctor immediately before taking Bupropione Zentiva Italia. Your doctor will evaluate the benefits and risks of taking Bupropione Zentiva Italia.
There may be a higher than usual risk of other side effects if you take:

other medicines for depression (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine, or imipramine) or for other mental illnesses (such as clozapine, risperidone, thioridazine, or olanzapine). Bupropione Zentiva Italia may 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, unstable blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
medicines for Parkinson’s disease (levodopa, amantadine, or orphenadrine).
medicines that affect the body’s ability to eliminate bupropion (carbamazepine, phenytoin, valproate).
certain medicines used to treat cancer (such as cyclophosphamide, ifosfamide).
ticlopidine or clopidogrel, mainly used to prevent stroke.
certain beta-blockers (such as metoprolol).
certain medicines for irregular heart rhythm (propafenone or flecainide).
nicotine patches to help you stop smoking.

If any of the above apply to you, speak to your doctor immediately before taking Bupropione Zentiva Italia.
Bupropione Zentiva Italia may be less effective if you take ritonavir or efavirenz, medicines used to treat HIV infection. If this applies to you, speak to your doctor. Your doctor will monitor how Bupropione Zentiva Italia is working for you. It may be necessary to increase the dose or switch to another treatment for depression. Do not increase the dose of Bupropione Zentiva Italia without medical advice, as this may increase the risk of side effects, including seizures.
Bupropione Zentiva Italia may make other medicines less effective if you take:

tamoxifen used to treat breast cancer. If this applies to you, inform your doctor, as it may be necessary to switch to another medicine for the treatment of depression.
digoxin for heart conditions. If this applies to you, inform your doctor, as they may consider adjusting the dose of digoxin.

Bupropione Zentiva Italia and alcohol
Alcohol may alter the way Bupropione Zentiva Italia works, and when used together, it may rarely affect your nerves and mental state. Some people find they are more sensitive to alcohol when taking Bupropione Zentiva Italia. Your doctor may advise you not to drink alcohol (beer, wine, or spirits) while taking Bupropione Zentiva Italia, or to drink only minimal amounts. However, if you currently drink heavily, do not stop abruptly: this may put you at risk of having seizures.
Talk to your doctor about alcohol consumption before starting Bupropione Zentiva Italia.
Effect on urine tests
Bupropione Zentiva Italia may interfere with certain urine tests used to detect other substances. If you need a urine test, inform your doctor or hospital that you are taking Bupropione Zentiva Italia.
Pregnancy and breastfeeding
Do not take Bupropione Zentiva Italia if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, unless your doctor recommends it. Consult your doctor or pharmacist 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 Zentiva Italia during pregnancy. It is not known whether these are due to the use of Bupropione Zentiva Italia.
Bupropion may pass into breast milk.
You should consult your doctor or pharmacist before taking Bupropione Zentiva Italia.
Driving and using machines
If Bupropione Zentiva Italia causes you dizziness or a feeling of lightheadedness, do not drive or operate any tools or machinery.

3. How to take Bupropione Zentiva Italia

Take this medicine exactly as directed by your doctor or pharmacist. These are the usual doses, but your doctor's advice is specific to you.
If you have any doubts, consult your doctor or pharmacist.
It may take some time before you start to feel better. It takes time for the medicine to have its full effect, sometimes weeks or months. When you start to feel better, your doctor may advise you to continue taking Bupropione Zentiva Italia to prevent depression from returning.

How much to take
The usual recommended dose for adults is one 150 mg tablet per day.
Your doctor may increase your dose to 300 mg per day if depression does not improve after several weeks.
Take your dose in the morning. Do not take Bupropione Zentiva Italia 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, as the medicine would be released into your body too quickly. This increases the likelihood of experiencing side effects, including seizures (convulsions).
Some people continue taking one 150 mg tablet per day throughout treatment. Your doctor may have prescribed this dosage if you have liver or kidney problems.

How long to take it
Only you and your doctor can decide how long to take Bupropione Zentiva Italia. Several weeks or months of treatment may be needed before improvement is seen. Regularly discuss your symptoms with your doctor to determine how long you should continue treatment. When you start to feel better, your doctor may advise you to keep taking Bupropione Zentiva Italia to prevent depression from coming back.

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

If you forget to take Bupropione Zentiva Italia
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 Zentiva Italia
Do not stop taking Bupropione Zentiva Italia or reduce the dose without first talking to your doctor.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Seizures or epileptic fits
Approximately 1 in 1,000 people taking Bupropione Zentiva Italia are at risk of seizures (epileptic fits). The likelihood of this happening is higher if you take too much, if you are taking certain other 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 to Bupropione Zentiva Italia. These include:

red 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 loss of consciousness.
→ If you experience any signs of an allergic reaction, contact a doctor immediately. Do not take any more tablets.
Allergic reactions may last a long time. If your doctor prescribes treatment to relieve allergy symptoms, make sure you complete the full course of treatment.

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

very rare (may affect up to 1 in 10,000 people): Flat red spots resembling targets or circular rashes on the trunk, often with blisters in the center, peeling of the skin, mouth, throat, nose, genital, or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
frequency not known (frequency cannot be estimated from available data):
blistering and skin peeling over large areas of skin occur in a severe form of serious skin reaction (toxic epidermal necrolysis).
widespread rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Onset of this syndrome is usually delayed (2–6 weeks after starting treatment).
widespread, red, scaly rash with pustules under the skin and blisters, accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis).

Lupus rash or worsening of lupus symptoms (frequency not known – cannot be determined from available data)
Lupus is an immune system disorder affecting the skin and other organs.
→ If you experience lupus flare-ups, skin rashes, or lesions (especially in sun-exposed areas) while taking Bupropione Zentiva Italia, contact your doctor immediately, as it may be necessary to discontinue treatment.
Other side effects
Very common: (may affect more than 1 in 10 people)

difficulty sleeping. Make sure to take Bupropione Zentiva Italia 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).
jerking movements, tremors, weakness, fatigue, chest pain.
feelings of anxiety or restlessness.
stomach ache or other disturbances (constipation), changes in taste, loss of appetite (anorexia).
sometimes severe increase in blood pressure, hot flushes.
ringing in the ears, vision disturbances.

Uncommon: (may affect up to 1 in 100 people)

feeling depressed (see also “Suicidal thoughts and worsening of depression” in Section 2, Warnings and precautions).
confusion.
difficulty concentrating.
increased heart rate.
weight loss.

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

seizures.

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

palpitations, fainting.
muscle contractions, 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 caused by increased liver enzymes, hepatitis.
severe allergic reactions; rash associated with muscle and joint pain.
changes in blood sugar levels.
urinating more or less than usual.
urinary incontinence (involuntary urination, urine leakage).
worsening of psoriasis (thickened, red skin patches).
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 suspiciousness (paranoia).

Not known: (frequency cannot be determined from available data)

thoughts of self-harm or suicide during treatment with Bupropione Zentiva Italia or immediately after stopping treatment (see Section 2, “What you need to know before taking Bupropione Zentiva Italia”). If you have such thoughts, contact your doctor or go directly to hospital.
loss of contact with reality and inability to think or judge clearly (psychosis); other symptoms may include hallucinations and/or delusions.
sudden and intense fear (panic attack).
stuttering.
reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia), and reduced number of platelets (thrombocytopenia).
reduced sodium levels 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 Bupropione Zentiva Italia together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of side effects
If you experience any side effects, 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 Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the date stated on the pack after EXP. The expiration date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Zentiva Italia contains

The active substance is bupropion hydrochloride. Each modified-release tablet contains 150 mg of bupropion hydrochloride.
The other components are:
Tablet core: povidone K90, cetyl alcohol, glyceryl dibehenate, anhydrous colloidal silica, magnesium stearate.
Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, ethylcellulose, hydrated colloidal silica, povidone K90, macrogol 1450, triethyl citrate.
Printing ink: shellac, black iron oxide (E 172), propylene glycol (E1520).

Description of the appearance of Bupropione Zentiva Italia and contents of the pack
Bupropione Zentiva Italia is a modified-release tablet.
Round tablet, white-cream to pale yellow in colour, printed with "GS3" in black ink on one side and smooth on the other, with a diameter of approximately 7 mm and a thickness of approximately 5 mm.
Packaged in OPA/Al/PVC-Al blisters.
Pack sizes: 30 and 90 modified-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia Srl – Via P. Paleocapa 7 - 20121 Milan, Italy.
Manufacturer:
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona, Spain

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Germany, Sweden: Bupropion Zentiva
Denmark, Norway: Bupropion hydrochloride Zentiva
Italy: Bupropione Zentiva Italia
Poland: Pixigan
Portugal: Bupropiom Zentiva