BUPROPIONE 150 mg Modified-Release Tablet

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1. BUPROPIONE DOC 150 mg modified-release tablets
   1. What is BUPROPIONE DOC and what is it used for?
   2. What you need to know before you take BUPROPIONE DOC
   3. How to take BUPROPIONE DOC
   4. Possible side effects
   5. How to store BUPROPIONE DOC
   6. Contents of the pack and other information

BUPROPIONE DOC 150 mg modified-release tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is BUPROPIONE DOC and what is it used for?

BUPROPIONE DOC contains bupropion and belongs to the pharmacotherapeutic group called: Other
antidepressants.
BUPROPIONE DOC is a medicine prescribed by your doctor to treat depression. It is believed to
interact with chemicals in the brain called norepinephrine and dopamine, which are linked
to depression.

2. What you need to know before you take BUPROPIONE DOC

Do not take BUPROPIONE DOC

• if you are allergicto 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 had seizures in the past
• 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 habitual drinkerwho has just 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 stop them while taking BUPROPIONE DOC
• if you are taking or have taken other medicines for depressioncalled monoamine oxidase inhibitors (MAOIs) in the last 14 days. If any of the above applies to you,talk to your doctor immediately, without takingBUPROPIONE DOC.

Warnings and precautions
Talk to your doctor or pharmacist before taking BUPROPIONE DOC.
Before you take BUPROPIONE DOC, your doctor needs to know:

• if you regularly drink a large amount of alcohol
• if you have diabetes for which you use insulin or tablets
• if you have had a serious head injury or have had a head trauma in the past
• if you have a condition called Brugada syndrome (a rare inherited syndrome that affects the heart rhythm) or if there have been cases of cardiac arrest or sudden death in your family.

Bupropion has been shown to cause seizures in about 1 in 1000 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 DOC. Do not take it again and see your doctor.

• if you suffer from bipolar disorder (extreme mood swings), as BUPROPIONE DOC may trigger an episode of this illness
• if you are taking other medicines for depression, the use of these medicines together with BUPROPIONE DOC may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and BUPROPIONE DOC” in this section)
• if you have liver or kidney problems, you are more likely to have side effects

If any of the above applies to you, talk to your doctor again before taking BUPROPIONE
DOC. Your doctor may want to take special care with your treatment or recommend another treatment.
Talk to your doctor if you have heart disease or high blood pressure. Blood pressure monitoring is necessary
before starting treatment.

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

• if you have had thoughts of ending your life or harming yourself in the past
• if you are a young adult. Data from clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who have been treated with an antidepressant. At any time, if you have thoughts of harming yourself or ending your life, contact your doctor or go to the hospital immediately. It may be helpful to tell a relative or friendthat you are suffering from depression and ask them to read

concerned about changes in your behavior.

Effects on urine testing
BUPROPIONE DOC may interfere with some urine tests used to detect other medicines. If
you need to have a urine test, tell your doctor or in hospital that you are taking BUPROPIONE DOC.

Children and adolescents
BUPROPIONE DOC is not recommended for the treatment of patients under the age of 18.
There is an increased risk of thoughts and behaviors related to suicide in the case of patients under the age of
18 being treated with antidepressants.

Other medicines and BUPROPIONE DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, herbal products or vitamins, even those available without a prescription. Your doctor may
adjust the dose of BUPROPIONE DOC, or advise you to change other medicines.
Some medicines must not be taken with BUPROPIONE DOC. Some may increase the
possibility of seizures or fits. Other medicines may increase the risk
of other side effects. Some examples are listed below, but the list is not exhaustive.
If you are taking or have taken other antidepressants called monoamine oxidase inhibitors (MAOIs) in the
last 14 days, talk to your doctor without taking BUPROPIONE DOC (see also “Do not take
BUPROPIONE DOC” in section 2).
There may be a higher than usual risk of seizures:

• if you take other medicines for depression or other mental illnesses
• if you take theophylline for asthma or lung disease
• if you take tramadol, a strong painkiller
• if you have stopped taking sedatives, or are about to stop them while taking BUPROPIONE DOC (see also “Do not
• take BUPROPIONE DOC” in section 2)
• if you take medicines against malaria (such as mefloquine or chloroquine)
• if you take stimulants or other medicines to control weight or appetite
• if you take steroids (by mouth or injection)
• if you take antibiotics called quinolones
• if you take certain types of antihistamines that can cause drowsiness
• if you take medicines for diabetes If any of these applies to you, tell your doctor immediately, before taking BUPROPIONE DOC. The doctor will assess the benefits and risks of taking BUPROPIONE DOC.

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 DOC may interact with some medicines used for depression and you may experience changes in mental status (e.g., agitation, hallucinations, coma), and other effects, such as a temperature above 38 °C, increased heart rate, unstable blood pressure and exaggeration of reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
• if you take medicines for Parkinson's disease (levodopa, amantadine or orphenadrine)
• if you take medicines that affect the body's ability to eliminate BUPROPIONE DOC (carbamazepine, phenytoin, valproate)
• if you take certain medicines used to treat cancer (such as cyclophosphamide, ifosfamide)
• if you take ticlopidine or clopidogrel, used mainly to prevent stroke
• if you take certain beta-blockers (such as metoprolol)
• if you take certain medicines for irregular heartbeat (propafenone or flecainide)
• if you use nicotine patches to help you quit smoking. If any of these applies to you, tell your doctor immediately, before taking BUPROPIONE DOC.

BUPROPIONE DOC may be less effective

• if you take ritonavir or efavirenz, medicines for the treatment of HIV infection. If this applies to you, tell your doctor. The doctor will check how BUPROPIONE DOC is working for you. You may need to increase the dose or switch to another treatment for depression. Do not increase the dose of BUPROPIONE DOC without your doctor's advice, as this may increase the risk of side effects including seizures.

BUPROPIONE DOC may make other medicines less effective

• if you are taking tamoxifen used to treat breast cancer If this applies to you, tell your doctor. You may need to use another treatment for depression.
• if you are taking digoxin for the heart

If this applies to you, tell your doctor. The doctor may consider adjusting the dose of digoxin.

BUPROPIONE DOC with alcohol
Alcohol can alter the way BUPROPIONE DOC works and when used together may rarely
alter the nerves or the
mental state. Some people find they are more sensitive to alcohol when taking BUPROPIONE
DOC. Your doctor
may suggest not drinking alcohol (beer, wine or spirits) while taking BUPROPIONE DOC or try to
drink in
small amounts. But if you currently drink a lot, do not stop abruptly: this may put you at risk of
having seizures.

Talk to your doctor about alcohol consumption, before starting to take BUPROPIONE DOC.

Pregnancy and breastfeeding
Do not take BUPROPIONE DOC if you are pregnant, if you suspect you are pregnant or if you 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, in
particular heart defects, in children whose mothers took bupropion. It is not known whether these are
due to the use of bupropion.
The active ingredient of BUPROPIONE DOC can pass into breast milk. You should ask your doctor
or pharmacist for advice before taking BUPROPIONE DOC.

Driving and using machines
If BUPROPIONE DOC causes dizziness or a feeling of lightheadedness, do not drive or use any
tools or
machinery.

3. How to take BUPROPIONE DOC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

How much to take
The recommended dose for adults is one 150 mg tablet per day.
Your doctor may increase the dose to 300 mg per day if your depression does not improve after a few weeks.
Some people may continue taking one 150 mg tablet per day for the entire
duration of treatment. Your doctor may have prescribed this dose if you have liver or kidney problems.
Take the dose of BUPROPIONE DOC in the morning. Do not take BUPROPIONE DOC more than once a
day.
BUPROPIONE DOC is for oral use.
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
will make it more likely that you may experience side effects, including seizures.
BUPROPIONE DOC can be taken with or without food.
The tablet is coated with a coating that slowly releases the medicine into the body. You may notice
something in your stool that looks like a tablet. This is the empty coating that is eliminated from the
body.

How long to take it
Only you and your doctor can decide how long to take BUPROPIONE DOC. It may be
necessary
weeks or months of treatment to see improvement. Talk to your doctor
regularly about your symptoms to decide how long you should take it. When you start to feel better, your doctor may
advise you to continue taking BUPROPIONE DOC to prevent the recurrence of depression.

If you take more BUPROPIONE DOC than you should
If you take too many tablets, it may increase the risk of seizures or convulsions. Do not waste time.
Ask your doctor what to do or go immediately to the emergency room of the nearest hospital.

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

If you stop taking BUPROPIONE DOC
Do not stop taking BUPROPIONE DOC or reduce the dose without first talking to your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects
Contact your doctor immediately if you notice any of the following serious side effects:
Convulsions or seizures
About 1 in 1,000 people taking BUPROPIONE DOC are at risk of convulsions (seizures or epileptic fits). The chance of this happening is higher if you take too much, if you take
certain medicines or if you are more likely than usual to have convulsions. If you are worried, talk 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 BUPROPIONE DOC. These include

• Reddened skin or rash (like hives), itchy blisters or bubbles (urticaria) on the skin. Some rashes may require hospital treatment, especially if you have irritation to the mouth or eyes
• 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 reactioncontact a doctor immediately. Do not take
any more tablets.
Allergic reactions can last a long time.If your doctor prescribes something to relieve the symptoms
of the allergy, make sure you complete the treatment.

Lupus rash or worsening of lupus symptoms
Frequency not known: cannot be estimated based on available data in people taking
BUPROPIONE DOC.
Lupus is a condition that affects the immune system and affects the skin and other organs. If you experience
flare-ups of lupus, rash or skin lesions (especially on areas exposed to the sun) while
taking BUPROPIONE DOC, contact your doctor immediately, as you may need to
stop treatment.

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

• Difficulty sleeping. Make sure you take BUPROPIONE DOC in the morning
• Headache
• Dry mouth
• Feeling unwell, vomiting

Common side effects: may affect up to 1 in 10 people

• Fever, dizziness, itching, sweating and rash (sometimes due to an allergic reaction)
• Shaking, tremors, weakness, fatigue, chest pain
• Feeling anxious or agitated
• Stomach pain or other disturbances (constipation), changes in the taste of foods, loss of appetite (anorexia)
• Sometimes severe increase in blood pressure, flushing
• Ringing in the ears, vision disturbances

Uncommon side effects: may affect up to 1 in 100 people

• Feeling depressed (see also Section 2 “Warnings and precautions”, in “Thoughts about suicide 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

• Convulsions

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

• Palpitations, fainting
• Muscle contractions, muscle stiffness, uncontrolled movements, problems walking or with coordination
• Feeling agitated, 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 muscle and joint pain
• Changes in blood sugar levels
• Urinating more or less than usual
• Urinary incontinence (involuntary urination, leakage of urine)
• Severe skin rashes that can affect the mouth or other parts of the body and can be life-threatening
• Worsening of psoriasis (thickened, reddened skin patches)
• Feeling unreal or detached (depersonalization); seeing or hearing things that are not there (hallucinations); having feelings or beliefs in things that are not real (delusions); severe suspicion (paranoia)
• Low blood pressure after getting up suddenly (postural hypotension)

Other side effects
Other side effects have been reported in a small number of people, but their exact frequency is
not known (frequency cannot be estimated based on available data):

• Thoughts of self-harm or suicide during treatment with bupropion or immediately after stopping treatment (see section 2, “What you need to know before you take BUPROPIONE DOC”). If you have these thoughts, contact your doctor or go to the hospital immediately
• Loss of contact with reality and inability to think or judge clearly (psychosis); other symptoms may include hallucinations and/or delusions
• Altered mental status (e.g., agitation, hallucinations, coma) and other effects, such as fever above 38 °C, increased heart rate, unstable blood pressure and exaggeration of reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea), when taking BUPROPIONE DOC together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine and venlafaxine).
• Reduced number of red blood cells (anemia), reduced number of white blood cells (leukopenia) and reduced number of platelets (thrombocytopenia)
• Reduced sodium levels in the blood (hyponatremia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from moisture and light.
After first opening: do not store at a temperature above 25°C. Use within 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BUPROPIONE DOC contains
The active ingredient is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride
The other ingredients are:

tablet core: hydroxypropylcellulose, silicified microcrystalline cellulose, stearic acid, magnesium
stearate

tablet coating: ethyl cellulose, hydroxypropylcellulose, titanium dioxide (E171), triethyl citrate,
acrylic acid-ethyl acrylate copolymer, talc

Description of the appearance of BUPROPIONE DOC and contents of the pack
BUPROPIONE DOC tablets are off-white to pale yellow in colour, round, biconvex,
with a diameter of approximately 8.1 mm.
Packs
BUPROPIONE DOC is available in containers of 30 tablets.
The tablet container contains a desiccant capsule to keep the tablets dry. Do not
ingest the capsule.

Marketing Authorisation Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano
Italy

Manufacturer
Balkanpharma Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Germany: Blakerti 150 mg prolonged-release tablets
Italy: BUPROPIONE DOC