Bupropione Zentiva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Bupropione Zentiva 300 mg modified-release tablets

Generic 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 they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Bupropione Zentiva contains the active substance called bupropion and 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

Do not take Bupropione Zentiva if:

you are allergic to bupropion or to any of the other ingredients of this medicine (listed in section 6).
you are taking any other medicine containing bupropion.
you have been diagnosed with epilepsy or have previously had seizures.
you have or have had eating disorders (for example, bulimia or anorexia nervosa).
you have a brain tumor.
you are a heavy drinker who has recently stopped or is about to stop drinking.
you have severe liver problems.
you have recently stopped taking sedatives, or if you are about to discontinue them while taking Bupropione Zentiva.
you are taking or have taken within the last 14 days other medicines for depression called monoamine oxidase inhibitors (MAOIs). If any of the above apply to you, speak to your doctor immediately, without taking Bupropione Zentiva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bupropione Zentiva.
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 Zentiva. Stop taking Bupropione Zentiva 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 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 needs to know before you take Bupropione Zentiva

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 the individuals described above. If you have a seizure during treatment, you must stop taking Bupropione Zentiva. Stop taking it immediately and contact your doctor.
if you suffer from bipolar disorder (extreme mood swings), as bupropion may trigger an episode of this condition.
if you are taking other medicines for depression, using these medicines together with Bupropione Zentiva may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Bupropione Zentiva” 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 Zentiva. Your doctor may wish to pay particular 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 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 tell a relative or friend that you suffer from depression and ask them to read this leaflet. You may also ask them whether they think your depression is getting worse, or if they are concerned about changes in your behavior.

Other medicines and Bupropione Zentiva
If you are taking or have taken within the last 14 days other antidepressants called monoamine oxidase inhibitors (MAOIs), inform your doctor without taking Bupropione Zentiva (see also “Do not take Bupropione Zentiva” above).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, herbal products, or vitamins, even those not requiring a prescription. Your doctor may need to adjust your dose of Bupropione Zentiva or recommend changes to your other medicines.
Some medicines should not be taken together with Bupropione Zentiva. 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.
are taking theophylline for asthma or lung diseases.
are taking tramadol, a strong painkiller.
have taken sedatives, or are about to discontinue them while taking Bupropione Zentiva (see also “Do not take Bupropione Zentiva” above).
are taking medicines for malaria (such as mefloquine or chloroquine).
are taking stimulants or other medicines to control weight or appetite.
are taking steroids (by mouth or injection).
are taking antibiotics called quinolones.
are taking certain types of antihistamines that may cause drowsiness.
are taking medicines for diabetes.

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

are taking 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 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, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
are taking medicines for Parkinson’s disease (levodopa, amantadine or orphenadrine).
are taking medicines that affect your body’s ability to eliminate bupropion (carbamazepine, phenytoin, valproate).
are taking certain medicines used to treat cancer (such as cyclophosphamide, ifosfamide).
are taking ticlopidine or clopidogrel, mainly used to prevent stroke.
are taking certain beta-blockers (such as metoprolol).
are taking certain medicines for irregular heart rhythm (propafenone or flecainide).
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 Zentiva.

Bupropione Zentiva may be less effective if you

are taking 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 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 Zentiva without medical advice, as this may increase the risk of side effects, including seizures.

Bupropione Zentiva 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 switch to another medicine for the treatment of depression.
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 Zentiva and alcohol
Alcohol may alter the way bupropion 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 Zentiva. Your doctor may advise you not to drink alcohol (beer, wine or spirits) while taking Bupropione Zentiva, or to drink only in minimal amounts. However, if you currently drink heavily, do not stop abruptly: this could put you at risk of seizures. Talk to your doctor about alcohol consumption before starting Bupropione Zentiva.
Effects on urine tests
Bupropion 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 Zentiva.
Pregnancy and breastfeeding
Do not take Bupropione Zentiva 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 bupropion during pregnancy. It is not known whether these are due to the use of bupropion.
The components of Bupropione Zentiva pass into breast milk. You should consult your doctor or pharmacist before taking Bupropione Zentiva.
Driving and using machines
If Bupropione Zentiva causes you dizziness or a feeling of lightheadedness, do not drive or operate any tools or machinery.
Bupropione Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Bupropione Zentiva

Take this medicine exactly as instructed by your doctor or pharmacist. These are the usual doses, but your doctor’s instructions apply specifically 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 full effect, sometimes weeks or months. When you start to feel better, your doctor may advise you to continue taking Bupropione Zentiva to prevent depression from returning.

How much to take
Bupropione Zentiva is available only in the 300 mg strength. For the 150 mg dose, use other products available on the market.

The recommended dose is one 150 mg tablet per day, for adults only.

Your doctor may increase your dose to 300 mg per day if depression does not improve after several weeks.

Take your dose of Bupropione Zentiva tablets in the morning. Do not take Bupropione Zentiva 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.

Some people continue taking one 150 mg tablet per day throughout treatment. Your doctor may have prescribed this dose 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. It may take weeks or months of treatment before improvement is seen. Discuss your symptoms regularly with your doctor to determine how long you should continue treatment. When you start to feel better, your doctor may recommend continuing Bupropione Zentiva to prevent depression from returning.

If you take more Bupropione Zentiva 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
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
Do not stop taking Bupropione Zentiva 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 bupropion are at risk of seizures (epileptic fits or convulsions). 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 have allergic reactions to bupropion. These include:

Reddened skin or 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 sign 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 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 lesions on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
Frequency not known (frequency cannot be estimated from available data):
Blistering and 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). The onset of this syndrome is usually delayed (2–6 weeks after starting treatment).
Extensive, red, scaly rash with pustules under the skin and blisters, accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis).

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

Other side effects

Very common (may affect more than 1 in 10 people):

Difficulty sleeping. Make sure to take Bupropione Zentiva 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).
Shaking, 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).
Feeling confused.
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 or 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 patches of skin).
Unusual hair loss or thinning (alopecia).
Feelings of unreality or detachment (depersonalization); seeing or hearing things that are not there (hallucinations); having beliefs or thoughts that are not real (delusions); severe suspiciousness (paranoia).

Frequency not known (frequency cannot be determined from available data):

Thoughts of self-harm or suicide during treatment with Bupropione Zentiva or immediately after stopping treatment (see Section 2, “What you need to know before taking Bupropione Zentiva”). 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.
Decreased number of red blood cells (anaemia), decreased number of white blood cells (leucopenia), and decreased number of platelets (thrombocytopenia).
Low 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 together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of side effects
If you get any side effects, including ones 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

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

The active substance is bupropione hydrochloride. Each tablet contains 300 mg of bupropione hydrochloride.
The other components are: tablet core: Povidone, cisteine hydrochloride monohydrate, anhydrous colloidal silica, glycerol dibehenate, magnesium stearate (E 470b). Tablet coating: ethylcellulose, povidone, macrogol, methacrylic acid-ethyl acrylate copolymer (1:1) (sodium lauryl sulfate, polysorbate 80), hydrated colloidal silica, macrogol, triethyl citrate. Printing ink: shellac, black iron oxide (E 172), propylene glycol (E1520).

Description of the appearance of Bupropione Zentiva and contents of the pack
Bupropione Zentiva tablets are round, white-cream to pale yellow in colour, printed in black ink on one side with "GS2" and unmarked on the other side. The diameter of the tablet is approximately 9 mm.
Available in OPA/Alu/PVC-Alu blisters containing 7, 30, 60 and 90 modified-release tablets. Also available in perforated OPA/Alu/PVC-Alu single-dose blisters containing 30×1 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 Milano.
Manufacturer:
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona
08040, Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:
Germany: Bupropion Zentiva 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Italy: Bupropione Zentiva
Norway: Bupropion hydrochloride Zentiva
Poland: Pixigan
Portugal: Bupropiom Zentiva
Sweden: Bupropion Zentiva