BUPROPIONE 150 mg Модифицированные Таблетки

Содержание инструкции

1. Bupropione SUN 150 mg modified-release tablets, 300 mg modified-release tablets
   1. What is Bupropione SUN and what is it used for
   2. What you need to know before you take Bupropione SUN
   3. How to take Bupropione SUN
   4. Possible side effects
   5. How to store Bupropione SUN
   6. Package contents and other information

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

bupropion hydrochloride

Generic medicine
Read 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 pass it on to others, even if their symptoms are the same as yours, as it may 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 SUN is and what it is used for
• 2. What you need to know before you take 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 is Bupropione SUN and what is it used for

Bupropione SUN is a medicine prescribed by your doctor to treat depression. It is believed to
interact with chemicals in the brain called noradrenalineand dopamine.

2. What you need to know before you take Bupropione SUN

Do not take Bupropione SUN:

• If you are allergic to bupropione or any of the other ingredients of this medicine (listed in section 6)
• If you are taking any other medicine containing bupropione
• 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 habitual drinker who 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 SUN
• If you are taking or have taken other medicines for depression called monoamine oxidaseinhibitors(MAOIs) in the last 14 days.

If any of the above applies to you, tell 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 hereditary syndrome that affects the
heart rhythm) or if there have been cases of cardiac arrest or sudden death in your family.

Children and adolescents
Bupropione SUN is not recommended for the treatment of children or adolescents under the age of 18
years.
There is an increased risk of thoughts and suicidal behavior in children and adolescents under the age of 18 treated with antidepressants.

Adults
Before you take Bupropione SUN, 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 severe head injury or have had a head trauma in the past. Bupropione SUN has been shown to cause seizures (epileptic 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, stop taking Bupropione SUN. Stop taking it immediately and see your doctor.
• If you suffer from bipolar disorder (extreme mood swings), as Bupropione SUN may trigger an episode of this illness.
• If you are taking other medicines for depression, the use of these medicines together with Bupropione SUN can 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 have side effects. If any of the above applies to you, tell your doctor again before taking Bupropione SUN. The 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 sometimes have thoughts of harming yourself or of taking your own life. These thoughts
may be more frequent the first time you 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 previously had thoughts of taking your own life or of harming yourself
• if you are a young adult. Data from clinical studies have shown an increased risk of suicidal behavior in adults under the age of 25 with psychiatric disorders who have been treated with an antidepressant. If you have thoughts of harming yourself or of taking your own life, contact your doctor or go to hospital immediately.You may find it helpful to tell a relative or friend that you are suffering from depression, and ask them

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

Other medicines and Bupropione SUN
If you are taking or have taken other antidepressants called monoamine oxidase inhibitors (MAOIs)
within the last 14 days, tell your doctor without taking Bupropione SUN (see also “Do not
take Bupropione SUN” in section 2).
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.
The doctor may adjust your dose of Bupropione SUN, or advise you to change other medicines.
Some medicines should not be taken with Bupropione SUN. 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 convulsions…

• 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 if you are about to stop them while taking Bupropione SUN (see also “Do not take Bupropione SUN” 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 by injection)
• If you take antibiotics called quinolones
• If you take some types of antihistamines that can cause drowsiness
• If you take medicines for diabetes. If any of the above applies to you, tell your doctor immediately, before taking Bupropione SUN. The doctor will assess the benefits and risks of taking this medicine.

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

• If you take other medicines for depression (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepine, desipramine or imipramine) or for other mental illnesses (such as clozapine, risperidone, thioridazine or olanzapine). Bupropione SUN 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 a temperature above 38°C, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, 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 SUN (carbamazepine, phenytoin, valproate)
• If you take some medicines used to treat cancer (such as cyclophosphamide, ifosfamide)
• If you take ticlopidine or clopidogrel, used mainly to prevent stroke
• If you take some beta-blockers (such as metoprolol)
• If you take some medicines for irregular heartbeat (propafenone or flecainide)
• If you use nicotine patches to help you quit smoking. If any of the above applies to you, tell your doctor immediately, before taking Bupropione SUN.

Bupropione SUN 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 SUN 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 SUN without your doctor's advice, 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, 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 SUN with alcohol
Alcohol can alter the way Bupropione SUN works and, when used together, can rarely
alter your nerves and mental state. Some people find they are more sensitive to alcohol when
taking Bupropione SUN. The doctor may suggest that you do not drink alcohol (beer, wine or spirits)
while taking Bupropione SUN or try to drink it 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 your alcohol consumption,before starting to take Bupropione SUN.

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

Pregnancy and breastfeeding
Do not take Bupropione SUN if you are pregnant, suspect you are pregnant or are planning a
pregnancy, unless your doctor recommends it. Ask 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 SUN. It is not known whether this is due to the use of Bupropione SUN.
The components of Bupropione SUN pass into breast milk. You should ask your doctor or
pharmacist before taking Bupropione SUN.

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

Bupropione SUN contains lactose
Bupropione SUN contains lactose (a type of sugar). If you have been diagnosed
with an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Bupropione SUN

Take this medicine following exactly the instructions of your doctor or pharmacist.
These are the usual doses, but your doctor's instructions are specifically for you. If you have doubts
consult your doctor or pharmacist.

Itmay 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 SUN, to prevent
the recurrence of depression.

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 the 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 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.
Swallow the tablets whole. Do not chew, crush or divide them, as this carries the risk
of overdose, as the medicine would be released into your body too quickly.
This would make the occurrence of side effects more likely, including seizures.
Some people continue to take one 150 mg tablet per day during the entire
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 SUN. It may take
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 SUN to prevent
the recurrence of depression.

If you take more Bupropione SUN 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 SUN
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 a forgotten 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 doubts about the use of this medicine, ask 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 convulsions
About 1 in 1,000 people taking Bupropione SUN is at risk of seizures (convulsive or epileptic seizures). The possibility of this happening is higher if you take too much, if you take certain medicines, or if you are more at risk of 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 SUN. 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 a sore mouth or eye pain
• 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 allergy symptoms, make sure to complete the treatment.

Lupus rash or worsening of lupus symptoms
Not known – the frequency cannot be defined based on available data in people taking Bupropione SUN.
Lupus is a disorder of the immune system that affects the skin and other organs.
➔ If you develop lupus flare-ups, rashes or lesions (especially on areas exposed to the sun) while taking Bupropione SUN, see your doctor immediately, as you may need to stop treatment.
Acute Generalized Exanthematous Pustulosis (AGEP)
Not known – the frequency cannot be defined based on available data in people taking Bupropione SUN.
Symptoms of AGEP include rashes with pustules/blisters filled with pus.
➔ If you have a rash with pustules/blisters filled with pus, see your doctor immediately, as you may need to stop treatment.
Other side effects
Very common side effects
These 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
These may affect up to 1 in 10 people:

• Fever, dizziness, itching, sweating and rash (sometimes due to an allergic reaction)
• 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
• Ringing in the ears, visual disturbances

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

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

Rare side effects
These may affect up to 1 in 1,000 people:

• Seizures

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

• Palpitations, fainting
• Muscle twitching, stiffness, uncontrolled movements, problems walking or coordinating
• Feeling restless, irritable, hostile, aggressive, strange dreams, tingling or numbness, memory loss
• Yellowing of the skin or whites of your 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, loss 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 skin patches)
• Feeling of unreality or detachment (depersonalization); seeing or hearing things that are not there (hallucinations); having the feeling or believing 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 unknown:

• thoughts of self-harm or suicide during treatment with Bupropione SUN or immediately after stopping treatment (see paragraph 2, “What you need to know

before taking Bupropione SUN”). If you have these thoughts, contact your doctor or go directly to the hospital

• loss of contact with reality and inability to think or judge clearly (psychosis);
• other symptoms may include hallucinations and/or delusions.
• stammering
• reduction in the number of red blood cells (anemia), reduction in the number of white blood cells (leukopenia) and reduction in the number of platelets (thrombocytopenia)
• reduction in blood sodium levels (hyponatremia)
• 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 exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea), while taking Bupropione SUN 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, 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 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 particular storage temperature.
Store in the original package to protect the medicine from moisture and light.
Do not use this medicine after the expiry date which is reported on the pack. The expiry date
refers to the last day of that month.
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. Package contents and other information

What Bupropione SUN contains
The active ingredient is bupropion hydrochloride. Each tablet contains 150 mg or 300 mg of bupropion
hydrochloride.
The other ingredients 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 hydrated colloidal silica.
Printing ink: shellac, black iron oxide (E 172), propylene glycol

Description of the appearance of Bupropione SUN and package contents
Bupropione SUN 150 mg tablets are white to pale yellow in color,
round, approximately 7.7 mm in diameter, film-coated tablets imprinted with "T" in black
ink on one side and smooth on the other side.
Bupropione SUN 300 mg tablets are white to pale yellow in color,
round, approximately 9.6 mm in diameter, film-coated tablets imprinted with "T1" in black
ink on one side and smooth on the other side.
Bupropione SUN is provided in a package containing:
Opaque white plastic bottle with a desiccant containing activated silica gel
and activated carbon. The bottle is closed with a child-resistant plastic closure
including an induction seal lining
150 mg: 30, 60, 90 tablets.
300 mg: 30, 60, 90 tablets.
Not all pack sizes may be marketed.

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

Local Representative:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milan

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

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Sweden Bupropion SUN 150 mg Modified Release Tablet
Bupropion SUN 300 mg Modified Release Tablet
Germany BUPROPION BASICS 150 mg Tablets with modified release
BUPROPION BASICS 300 mg Tablets with modified release
Spain Bupropión SUN 150 mg modified release tablets EFG
Bupropión SUN 300 mg modified release tablets EFG
Netherlands Bupropion HCl SUN 150 mg tablets with controlled release
Bupropion HCl SUN 300 mg tablets with controlled release
Italy Bupropione SUN
Poland Bucidar
Romania AXABAL 150 mg modified release tablets
AXABAL 300 mg modified release tablets