Bupropion Doc Generici

Patient Information Leaflet: Information for the User

BUPROPIONE DOC 150 mg modified-release tablets

Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 BUPROPIONE DOC is and what it is used for

BUPROPIONE DOC is a medicine prescribed by a doctor to treat depression. It is believed to
interact with certain chemical substances in the brain called noradrenaline and dopamine, which are associated
with depression.

2. What you should know before taking BUPROPIONE DOC

Do not take BUPROPIONE DOC

• if you are allergic to bupropion or to 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 tumour
• 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 DOC
• 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 DOC.
Warnings and precautions
Talk to your doctor or pharmacist before taking BUPROPIONE DOC.
Children and adolescents
BUPROPIONE DOC is not recommended for the treatment of patients under 18 years of age.
There is an increased risk of suicidal thoughts and behaviours in patients under 18 years of age treated with antidepressants.
Before you take BUPROPIONE DOC, your doctor needs to know:

• if you regularly drink large amounts of alcohol
• if you have diabetes for which you use insulin or tablets
• if you have previously had a serious head injury or cranial trauma
• 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.

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 DOC. Do not take it again and contact your doctor.

• if you have bipolar disorder (extreme mood changes), as BUPROPIONE DOC could trigger an episode of this condition
• if you are taking other medicines for depression, using 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 experience side effects

If any of the above apply to you, speak again with your doctor before taking BUPROPIONE DOC. Your doctor may need to take special care in treating you or recommend another treatment.
Talk to your doctor if you have heart disease or high blood pressure. Blood pressure should be checked before starting treatment.
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 behaviour 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.

You may find it helpful to tell a relative or friend that you suffer from depression and ask them to read this leaflet. You may ask them whether they think your depression is getting worse, or if they are concerned about changes in your behaviour.
Severe skin reactions
Severe 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 DOC. Stop taking BUPROPIONE DOC and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions, described in section 4.
Other medicines and BUPROPIONE DOC
If you are taking or have taken other antidepressants called monoamine oxidase inhibitors (MAOIs) within the last 14 days, speak to your doctor without taking BUPROPIONE DOC (see also “Do not take BUPROPIONE DOC” in section 2).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, herbal products or vitamins, even those not requiring a prescription. Your doctor may adjust the dose of BUPROPIONE DOC, or advise you to change your other medicines.
Some medicines must not be taken with BUPROPIONE DOC. Some may increase the likelihood 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
• if you are taking theophylline for asthma or lung diseases
• if you are taking tramadol, a strong painkiller
• if you have taken sedatives, or if you are about to discontinue them while taking BUPROPIONE DOC (see also “Do not take BUPROPIONE DOC” in section 2)
• if you are taking antimalarial medicines (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 injection)
• if you are taking antibiotics called quinolones
• if you are taking certain types of antihistamines that may cause drowsiness
• if you are taking medicines for diabetes. If any of these apply to you, speak to your doctor immediately before taking BUPROPIONE DOC. Your 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 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 DOC can interact with some medicines used for depression and you may experience changes in mental state (e.g. agitation, hallucinations, coma), and other effects such as fever 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).
• if you are taking medicines for Parkinson’s disease (levodopa, amantadine or orphenadrine)
• if you are taking medicines that affect your body’s ability to eliminate BUPROPIONE DOC (carbamazepine, phenytoin, valproate)
• if you are taking certain medicines used to treat tumours (such as cyclophosphamide, ifosfamide)
• if you are taking ticlopidine or clopidogrel, mainly used to prevent stroke
• if you are taking certain beta-blockers (such as metoprolol)
• if you are taking certain medicines for irregular heart rhythm (propafenone or flecainide)
• if you are using nicotine patches to help you stop smoking. If any of these apply to you, speak to your doctor immediately before taking BUPROPIONE DOC.

BUPROPIONE DOC 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 DOC 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 DOC without medical 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, inform your doctor. It may be necessary to use another treatment for depression.
• if 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 DOC and alcohol
Alcohol may alter the way BUPROPIONE DOC works and, when used together, may rarely affect nerves or mental state. Some people find they are more sensitive to alcohol when taking BUPROPIONE DOC. Your doctor may advise you not to drink alcohol (beer, wine or spirits) while taking BUPROPIONE DOC or to drink only minimal amounts. However, if you currently drink heavily, do not stop abruptly: this may put you at risk of seizures.
Talk to your doctor about alcohol consumption before starting to take BUPROPIONE DOC.
Effects on urine tests
BUPROPIONE DOC may interfere with certain urine tests used to detect other medicines. If you need to have a urine test, tell your doctor or hospital staff that you are taking BUPROPIONE DOC.
Pregnancy and breastfeeding
Do not take BUPROPIONE DOC if you are pregnant, suspect you may be pregnant, or are planning to become pregnant, 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, particularly heart defects, in children whose mothers took bupropion. It is not known whether these were due to bupropion use.
The active substance in BUPROPIONE DOC may 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 operate any tools or machinery.

3. How to take BUPROPIONE DOC

Take this medicine exactly as directed by your doctor or pharmacist. 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 DOC to prevent depression from returning.

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 depression does not improve after a few weeks.
Take your dose of BUPROPIONE DOC in the morning. Do not take BUPROPIONE DOC more than once a day.
BUPROPIONE DOC is for oral use.
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 split 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 side effects, including seizures.
BUPROPIONE DOC may be taken with or without food.
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.

How long to take it
Only you and your doctor can decide how long to take BUPROPIONE DOC. Several weeks or months of treatment may be needed 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 advise you to keep taking BUPROPIONE DOC to prevent depression from returning.

If you take more BUPROPIONE DOC than you should
If you take too many tablets, your risk of seizures or convulsions may increase. Do not delay. Contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to take BUPROPIONE DOC
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 DOC
Do not stop taking BUPROPIONE DOC or reduce the dose without first talking to your doctor.
If you have any questions 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.

Serious side effects

Contact your doctor immediately if you experience any of the following serious side effects:

Seizures or epileptic fits

Approximately 1 in 1,000 people taking BUPROPIONE DOC may have seizures (epileptic fits or epileptic attacks). The risk is higher if you take too high a dose, if you are taking certain other medicines, or if you already have an increased risk of seizures. If you are concerned, 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 skin rash (like 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 fainting

If you experience any sign of an allergic reaction, contact a doctor immediately. Do not take any more tablets.

Allergic reactions may last for 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 frequency: 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: Blisters and skin peeling over large areas of skin occur in a severe form of serious skin reaction (toxic epidermal necrolysis).
• Frequency not known: 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).
• Frequency not known: Extensive, 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 estimated based on available data in people taking BUPROPIONE DOC.

Lupus is an immune system disorder affecting the skin and other organs. If you experience lupus flare-ups, rash, or skin lesions (especially in sun-exposed areas) while taking BUPROPIONE DOC, contact your doctor immediately, as treatment may need to be discontinued.

Other side effects

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

• Difficulty sleeping. Make sure to 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 sensation, sweating, and skin rash (sometimes due to an allergic reaction)
• Twitching, tremors, weakness, fatigue, chest pain
• Feelings of anxiety or restlessness
• Stomach ache or other gastrointestinal disturbances (constipation), changes in taste, 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”, under “Suicidal thoughts and worsening of depression”)
• Confusion
• Difficulty concentrating
• Increased heart rate
• 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, dizziness
• Muscle contractions, muscle stiffness, uncontrolled movements, problems with walking or coordination
• Feelings of agitation, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss
• Yellowing of the skin or whites of the eyes (jaundice), which may be due to 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 thoughts or beliefs in things that are not real (delusions); severe suspiciousness (paranoia)
• Drop in blood pressure upon standing suddenly (postural hypotension)

Frequency not known

Other side effects have occurred in a small number of people, but their exact frequency is unknown (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 taking BUPROPIONE DOC”). If you have these thoughts, contact your doctor or go directly to hospital
• Loss of touch with reality and inability to think or judge clearly (psychosis); other symptoms may include hallucinations and/or delusions
• Sudden, intense feeling of fear (panic attack)
• Stuttering
• Changes in mental state (e.g. agitation, hallucinations, coma) and other symptoms such as fever 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), when taking BUPROPIONE DOC together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine)
• Decreased number of red blood cells (anaemia), decreased number of white blood cells (leucopenia), and decreased number of platelets (thrombocytopenia)
• Decreased sodium levels in the blood (hyponatraemia)

Reporting of side effects

If you experience any side effect, 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 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 stated on the pack after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture and light.
After first opening: do not store above 25°C. Use within 3 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BUPROPIONE DOC contains
The active substance is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride.
The other components are:
tablet core: hydroxypropylcellulose, silicified microcrystalline cellulose, stearic acid, magnesium stearate
tablet coating: ethylcellulose, hydroxypropylcellulose, titanium dioxide (E171), triethyl citrate, methacrylic acid-ethyl acrylate copolymer, talc

Description of the appearance of BUPROPIONE DOC and package contents
BUPROPIONE DOC tablets are white-cream to light yellow, round, biconvex, approximately 8.1 mm in diameter.

Pack sizes
BUPROPIONE DOC is available in containers of 30 tablets.
The tablet container contains a desiccant capsule to keep the tablets dry. Do not swallow the capsule.

Marketing Authorization Holder
DOC Generici S.r.l
Via Turati 40
20121 Milan
Italy

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