BUPROPIONE 150 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

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

Bupropione Teva 150 mg modified-release tablets

Bupropione hydrochloride
Generic medicine

Read this leaflet carefully before you start to use 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 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 Teva is and what it is used for
• 2. What you need to know before you take Bupropione Teva
• 3. How to take Bupropione Teva
• 4. Possible side effects
• 5. How to store Bupropione Teva
• 6. Contents of the pack and other information

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

Bupropione Teva 150 mg modified-release tablets contain 150 mg of bupropion and belong to
the pharmacotherapeutic category called “Other antidepressants”.
Bupropione Teva 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 Teva

Do not take Bupropione Teva

• 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 Teva
• 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 taking
Bupropione Teva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bupropione Teva.

Children and adolescents
Bupropione Teva is not recommended for the treatment of patients under the age of 18 years.
There is an increased risk of thoughts and behaviors related to suicide in the case where patients
under the age of 18 years are treated with antidepressants.

Adults
Before you take Bupropione Teva, your doctor needs to know:

• If you regularly drink a large amount of alcohol
• If you have diabetesfor which you use insulin or tablets
• If you have had a serious head injury or have had a head trauma in the past

Bupropion hydrochloride 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 should stop taking Bupropione Teva. Stop
immediately and see your doctor.

• If you suffer from bipolar disorder(extreme mood swings), as Bupropione Teva may trigger an episode of this illness
• 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 Teva. Your doctor may want to pay particular attention to your therapy or
recommend another treatment.

Thoughts of suicide and worsening of depression
If you are depressed, you may have sometimes thought about harming yourself or committing suicide. These thoughts
may increase at the beginning of treatment with antidepressants, as these medicines may
take some time before they have an effect, usually about a couple of weeks, but sometimes
even longer.
You may be more likely to have thoughts of this kind:

• if you have already thought about harming yourself or committing suicide 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. If at any time you should have self-harming or suicidal thoughts, contact your doctor or go immediately to a hospital.You may find it helpful to tell a relative or friend that you are suffering from depressionand ask them to

worsening, or if they are concerned about changes in your behavior.

Other medicines and Bupropione Teva
If you are taking or have taken other antidepressants calledmonoamine oxidase inhibitors
(MAOIs) in the last 14 days, tell your doctor without taking Bupropione Teva(see also
“Do not take Bupropione Teva” in section 2 ).

Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, herbal remedies or vitamins, even those available without
prescription. Your doctor may need to adjust your dose of Bupropione Teva, or advise you on
changing other medicines.

Some medicines must not be taken with Bupropione Teva.Some may increase the
risk of seizures or convulsions. Other medicines may increase the risk of other
side effects. Some examples are listed below, but the list is not exhaustive.

There may be a higher than usual chance of seizures:

• If you are taking other medicines for depression or for other mental illnesses
• If you are taking theophyllinefor asthma or lung disease
• If you are taking tramadol,a strong painkiller
• If you have taken sedatives, or if you are about to stop them while taking Bupropione Teva (see also “Do not take Bupropione Teva” in section 2)
• If you are taking medicines against 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 by injection)
• If you are taking antibiotics called quinolones
• If you are taking some types of antihistamines that can cause drowsiness
• If you are taking medicines for diabetes.If any of the above applies to you,tell your doctor immediately before taking Bupropione Teva. Your doctor will assess the benefits and risks of taking Bupropione Teva.

There may be a higher than usual chance of other side effects:

• If you are taking other medicines for depression(such as amitriptyline, fluoxetine, paroxetine, dosulepine, desipramine or imipramine) or for other mental illnesses (such as clozapine, risperidone, thioridazine or olanzapine).
• If you are taking medicines for Parkinson's disease(levodopa, amantadine or orphenadrine)
• If you are taking medicines that affect the body's ability to eliminate BupropioneTeva(carbamazepine, phenytoin, valproate)
• If you are taking certain medicines used to treat cancer(such as cyclophosphamide, ifosfamide)
• If you are taking ticlopidine or clopidogrel, used mainly to prevent stroke
• If you are taking some beta-blockers(such as metoprolol)
• If you are taking some medicines for irregular heartbeat(propafenone or flecainide)
• If you are using nicotine patches to help you quit smoking.If any of the above applies to you,tell your doctor immediately before taking Bupropione Teva.

Bupropione Teva may be less effective:

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

Bupropione Teva 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 switch to another treatment for depression.
• If you are taking digoxin for the heart.If this applies to you, tell your doctor. Your doctor may need to assess whether to adjust the dose of digoxin.

Bupropione Teva with alcohol
Alcohol can alter the effect of Bupropione Teva and, if taken together with the medicine, can rarely
have effects on the nervous system and mental state. Some people notice they are more
sensitive to alcohol when taking Bupropione Teva. Your doctor may suggest you do not drink alcohol
(beer, wine or spirits) while taking Bupropione Teva, or try to drink it in moderation.
But if you currently drink a lot, do not stop suddenly: this may put you at risk of having
seizures.

Talk to your doctor about alcohol consumptionbefore starting to take Bupropione Teva.

Effects on urine testing
Bupropione Teva can interfere with some urine tests used to detect other drugs. If
you need to have a urine test, tell your doctor or the hospital that you are taking Bupropione Teva.

Pregnancy and breastfeeding
Do not take Bupropione Teva 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
before using this medicine. Some, but not all studies, have reported an increased
risk of birth defects, particularly heart defects, in children whose mothers took
bupropion hydrochloride. It is not known whether this is due to the use of bupropion hydrochloride.
The components of Bupropione Teva can pass into breast milk. Consult your doctor or pharmacist
before taking Bupropione Teva.

Driving and using machines
If Bupropione Teva makes you feel dizzy or lightheaded, do not drive or use any
tools or machinery.

3. How to take Bupropione Teva

Always take this medicine exactly as your doctor or pharmacist has told you.
These are the usual doses, but your doctor will advise you on the best dosage for you. If you have any doubts
consult your doctor or pharmacist.

It may take some time before you feel better.It takes time for the medicine to have a full effect, sometimes weeks or months. When you start to
feel better, your doctor may advise you to continue taking Bupropione Teva to
prevent the depression from returning.

How much to take
The recommended dose is usually one150 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 Teva tablets in the morning. Do not take Bupropione Teva more
than once a day.
The tablet is coated with a coating that slowly releases the medicine into your body. You may
notice something in your stool that looks like a tablet. This is the empty coating being
eliminated from the body.

Swallow the tablets whole.Do not chew, crush or split them - if you do, there is a risk
of overdose, as the medicine would be released into your body too quickly.
This will more likely cause you side effects, including seizures.

Some people continue to take one 150 mg tablet a dayduring the entire
treatment. Your doctor may have prescribed this dosage for you 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 Teva.It may take weeks or months of treatment to see an 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 Teva to
prevent the depression from returning.

If you take more Bupropione Teva than you should
If you take too many tablets, it may increase your risk of seizures or fits. 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 Teva
If you miss a dose, wait and take the next tablet at your usual time.

Do not take a double doseto make up for a missed tablet.

If you stop taking Bupropione Teva
Donot stop taking Bupropione Teva 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.

Seizures or convulsive attacks
About 1 in 1,000 people taking bupropion hydrochloride is at risk of seizures (convulsive
attacks or epileptic fits). The chance of this happening increases if you take too much, if you
take certain medicines, or if you are more likely than usual to have seizures. If you are
worried, talk to your doctor.

If you have a seizure, tell your doctor as soon as you feel better. Do not take any more
tablets.
Allergic reactions
Some people may have allergic reactions to Bupropione Teva. These include

• Red or rashy skin (like hives), itchy blisters or bubbles (urticaria) on the skin. Some rashes
  may require hospital treatment, especially if you have irritation to your mouth or eyes.
• Unusual whistling 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 can last a long time.If your doctor prescribes something to relieve
the symptoms of the allergy, make sure you complete the treatment.

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

• Difficulty sleeping. Make sure you take Bupropione Teva in the morning.
• Headache
• Dry mouth
• Nausea, vomiting

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

• Fever, dizziness, itching, sweating and rash (sometimes due to an allergic reaction)
• Shocks, tremors, weakness, fatigue, chest pain
• Feeling anxious or agitated
• Stomach pain or other disorders (constipation), changes in the taste of food, loss of appetite
  (anorexia)
• Sometimes severe increase in blood pressure, flushing (sudden redness)
• 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 heartbeat
• 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, fainting
• Muscle contractions, muscle stiffness, uncontrolled movements, problems walking or with
  coordination
• Feeling agitated, irritated, hostile, aggressive, strange dreams, tingling or numbness, loss of
  memory
• 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 rashes that can affect the mouth or other parts of the body and can be life-threatening
• Worsening of psoriasis (thickened, red patches of skin)
• Feeling unreal or detached (depersonalization); seeing or hearing things that are not there
  (hallucinations); feeling or believing in things that are not real (delusions); severe
  suspiciousness (paranoia).

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

• Thoughts of self-harm or suicide during treatment with bupropion hydrochloride or immediately
  after stopping treatment (see section 2, “What you need to know before you take Bupropione
  Teva”). If you have these thoughts, contact your doctor or go straight tohospital.
• Loss of contact with reality and inability to think or judge clearly (psychosis); other
  symptoms may include hallucinations and/or delusions.
• Reduced number of red blood cells (anemia), reduced number of white blood cells (leukopenia) and
  reduced number of platelets (thrombocytopenia).
• Reduced level of sodium 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 Teva

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 packaging. The expiry date refers to the last day of the month.
Do not use after three months from first opening.
The intact medicine does not require any particular storage temperature.
Store in the original container to protect the medicine from moisture and light.
After first opening: Do not store at a temperature above 25 ºC.

Bottle
The bottle has a desiccant integrated in the cap to keep the tablets dry.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bupropione Teva contains

• The active ingredient is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride.
• The other ingredients are:
• tablet core: hydroxypropylcellulose (E463) (contains silicon dioxide), silicified microcrystalline cellulose, stearic acid, magnesium stearate, purified water tablet coating :ethylcellulose (E462), hydroxypropylcellulose, titanium dioxide (E171), triethyl citrate (E1505), methacrylic acid - ethyl acrylate copolymer, talc (E553b)

Description of the appearance of Bupropione Teva and contents of the pack
Bupropione Teva 150 mg tablets are off-white to pale yellow in colour, round,
biconvex, with a diameter of approximately 8.1 mm.
Bupropione Teva is available in child-resistant bottles containing 30 or 90 tablets

Marketing Authorisation Holder and Manufacturer
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

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