Bupropion Sandoz

Patient Information Leaflet

Bupropione Sandoz 150 mg modified-release tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bupropione Sandoz is used to treat depression. It acts on certain chemical substances in the brain called noradrenaline and dopamine, which are associated with depression.

2. What you should know before taking Bupropion Sandoz

Do not take Bupropion Sandoz
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 suffer from epilepsy or have previously had seizures
• you have a brain tumour
• you are about to stop alcohol or any medicine known to be associated with a risk of withdrawal symptoms, particularly
  • sedatives, sleep-inducing medicines or muscle relaxants whose active substance names end in "azepam"
  • or similar sedatives
• you have a severe chronic liver disease characterised by degeneration and thickening of liver tissue
• you have or have had an eating disorder, such as bulimia or anorexia nervosa
• you are taking or have taken other medicines for depression called monoamine oxidase inhibitors (MAOIs). A minimum interval of 14 days is required after stopping certain monoamine oxidase inhibitors (called irreversible monoamine oxidase inhibitors) before starting Bupropion Sandoz. For some other monoamine oxidase inhibitors (called reversible inhibitors of monoamine oxidase), a 24-hour interval may be sufficient. Please consult your doctor.

Warnings and precautions
Talk to your doctor before taking Bupropion Sandoz if:

• you regularly drink large amounts of alcohol. Refer to the previous section: "Do not take Bupropion Sandoz" if you are about to stop alcohol abruptly.
• you have diabetes requiring treatment with insulin or tablets
• you have previously had a severe head injury or cranial trauma. Bupropion Sandoz has been shown to cause seizures in approximately 1 in 1,000 people. This adverse effect is more likely to occur in individuals described above. If you experience a seizure during treatment, stop taking Bupropion Sandoz immediately. Discontinue treatment immediately and contact your doctor.
• you suffer from extreme mood swings (bipolar disorder) or mental health problems, as Bupropion Sandoz could trigger an episode of this condition
• before treatment, patients should be assessed for the risk of disorders associated with episodes of excitement or agitation.
• you are taking other medicines for depression; using these medicines together with Bupropion Sandoz may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Bupropion Sandoz" in this section)
• you have reduced kidney function or mild to moderate liver impairment. Patients with impaired liver or kidney function will be monitored by the doctor for the occurrence of any adverse effects. Do not use Bupropion Sandoz if you have the severe liver disease mentioned in the sixth point under "Do not take Bupropion Sandoz".
• you are due to undergo a urine test. Inform your doctor that you are taking Bupropion Sandoz, as it may interfere with certain urine tests used to detect other medicines.
• 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.

If any of the above apply to you, discuss them again with your doctor before taking
Bupropion Sandoz. Your doctor may wish to pay special attention to your treatment
or recommend an alternative therapy.
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 generalised exanthematous pustulosis (AGEP), have been reported in association with
Bupropion Sandoz. Stop taking Bupropion Sandoz and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.
Bupropion Sandoz has been shown to cause seizures. This adverse effect is more likely to occur in people:

• affected by any of the conditions listed in the first three points under "Warnings and precautions" in section 2, or
• taking any of the medicines listed from the second to the twelfth point under "Other medicines and Bupropion Sandoz" in section 2.
  All patients should be evaluated for existing risk factors. Stop taking Bupropion Sandoz and contact your doctor if seizures occur during treatment.

Thoughts of self-harm or suicide are associated with depression. These thoughts may increase at the beginning of treatment, as antidepressant medicines take time to work, usually about two weeks, but sometimes longer.
You are more likely to have these thoughts if:

• you have previously had similar thoughts
• you are a young adult. Clinical studies show an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders being treated with an antidepressant medicine.

Contact your doctor or go to hospital immediately if you have thoughts of self-harm or suicide. Tell a relative or friend that you suffer from depression and ask them to read this leaflet. Ask them to inform you if they think your depression is worsening or if they notice any changes in your behaviour.
Children under 18 years of age
Bupropion Sandoz is not recommended in this age group. There is an increased risk of suicidal thoughts and behaviour in children taking medicines for the treatment of depression.
Other medicines and Bupropion Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
The following medicines may affect or be affected by Bupropion Sandoz, but this is not a complete list. Inform your doctor if you are taking any of these medicines so that your treatment can be adjusted if necessary:

• certain medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs). See the last point under "Do not take Bupropion Sandoz" in section 2.
• medicines for depression, such as amitriptyline, fluoxetine, paroxetine, dosulepin, desipramine, imipramine, citalopram, escitalopram, venlafaxine, or medicines for mental illnesses, such as clozapine, risperidone, thioridazine, olanzapine. Bupropion Sandoz 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, diarrhoea)
• if you are taking other medicines for depression or other mental illnesses
• theophylline: a medicine used to treat asthma and other respiratory diseases
• tramadol: a medicine used to treat pain
• sedatives. If you intend to stop taking sedatives, refer to the fifth point under "Do not take Bupropion Sandoz" in section 2.
• medicines to prevent and treat malaria, such as mefloquine, chloroquine
• stimulants or other medicines to control weight or appetite
• steroids, administered orally or by injection
• antibiotics whose active substance names end in "oxacin"
• antihistamines that may cause drowsiness: used to treat allergies, sleep disorders or colds; or to prevent and treat nausea and vomiting
• medicines for diabetes
• levodopa, amantadine: medicines for Parkinson’s disease
• orphenadrine: a medicine for painful muscle tension
• carbamazepine, phenytoin, valproate: medicines for epilepsy and certain pain-related conditions, which affect the body’s ability to eliminate Bupropion Sandoz
• some medicines for cancer, such as cyclophosphamide, ifosfamide
• ticlopidine, clopidogrel: medicines to inhibit blood clotting, mainly used to prevent stroke
• medicines for high blood pressure, heart conditions or other diseases, whose active substance names end in "lol", such as metoprolol, beta-blockers
• propafenone, flecainide: medicines for heart rhythm disorders
• nicotine patches: medicines to stop smoking
• ritonavir, efavirenz: medicines for HIV infection. If this applies to you, discuss it with your doctor. Your doctor will check how Bupropion Sandoz affects you. It may be necessary to increase the dose or switch to another treatment for depression. Do not increase the dose of Bupropion Sandoz without medical advice, as this may increase the risk of adverse effects, including seizures.
• tamoxifen: a medicine for breast cancer. Inform your doctor if you are taking tamoxifen, as it may be necessary to switch to another treatment for depression.
• digoxin, a heart medicine

Inform your doctor if you are taking digoxin, as your dose may need adjustment.
metamizole, a medicine for acute, chronic or severe fever and pain
If any of the above apply to you, discuss them with your doctor immediately before
taking Bupropion Sandoz.
Your doctor will assess the benefits and risks of taking Bupropion Sandoz.
Bupropion Sandoz and alcohol
Consumption of alcohol (beer, wine or spirits) is not recommended during treatment with
Bupropion Sandoz. Alcohol may alter the way Bupropion Sandoz works, and when used together may rarely affect your nerves and mental state. Some people find they are more sensitive to alcohol (beer, wine or spirits) when taking Bupropion Sandoz.
However, if you currently drink heavily, do not stop abruptly, as this may put you at risk of seizures.
Talk to your doctor about your alcohol consumption and its discontinuation before starting Bupropion Sandoz.
Pregnancy and breastfeeding
Do not take Bupropion Sandoz if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, unless your doctor recommends it. Ask your doctor or pharmacist for advice before taking this medicine. Some studies have reported an increased risk of birth defects, particularly heart defects, in children whose mothers took Bupropion Sandoz. It is not known whether these are due to the use of Bupropion Sandoz.
The components of Bupropion Sandoz pass into breast milk. If you are breastfeeding, consult your doctor or pharmacist before taking Bupropion Sandoz.
Driving and using machines
Bupropion Sandoz may cause dizziness or drowsiness; therefore do not drive or operate
machinery or tools.
Bupropion Sandoz contains sodium
This medicinal product contains less than 1 mmol (23 mg) of sodium per modified-release tablet, i.e. it is essentially "sodium-free".

3. How to take Bupropione Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
One 150 mg tablet once daily.
Your doctor may increase your dose to 300 mg once daily if depression does not improve after several weeks.
Patients with impaired liver or kidney function
The recommended dose is one 150 mg tablet once daily in case of reduced kidney function or mild to moderate liver impairment.
Do not take Bupropione Sandoz if you have severe liver disease as mentioned in section 2 under "Do not take Bupropione Sandoz".
Method of administration
Swallow the tablets whole in the morning with a glass of water. Tablets may be taken with or without food. Do not take Bupropione Sandoz more than once daily.
The tablet is coated with a special film that slowly releases the active substance into the body. You may notice something in your stools that looks like a tablet. This is the empty coating that has passed through the body.
Do not chew, crush, or split the tablets, as this could cause an overdose, since the medicine would be released too quickly. This increases the risk of side effects, including seizures (convulsions).

Duration of treatment
Your doctor will decide how long you should take Bupropione Sandoz.
It may take some time before you start to feel better and the medicine reaches its full effect—sometimes weeks or months. 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 continue taking Bupropione Sandoz to prevent depression from returning.
If you take more Bupropione Sandoz than you should
Contact your doctor immediately or go to the nearest emergency room in case of overdose, as this may increase the risk of seizures.
If you forget to take Bupropione Sandoz
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 Sandoz
Do not stop taking Bupropione Sandoz or reduce the dose without first talking to your doctor.
If you have any questions about how to use 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 seizure attacks
Approximately 1 in 1,000 people taking Bupropione Sandoz is at risk of seizures (seizure attacks or epileptic seizures). The likelihood of this happening is higher if you take too much, if you are taking certain other medicines, or if you have a higher than usual risk of seizures. If you are concerned, speak with 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 experience allergic reactions to bupropion. These include:

• Reddened skin or skin rash (similar to hives) and itchy blisters (urticaria) on the skin.
• Unusual shortness of breath 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 your 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.

Serious 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: Widespread, red, scaly rash with pus-filled bumps 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
Not known – frequency cannot be determined from available data in the population taking Bupropione Sandoz.
Lupus is an autoimmune disease affecting the skin and other organs. If you experience lupus flare-ups, skin rashes, or lesions (especially in areas of the body exposed to sunlight) while taking Bupropione Sandoz, contact your doctor immediately, as treatment discontinuation may be necessary.

Acute Generalized Exanthematous Pustulosis (AGEP)
Not known – frequency cannot be determined from available data in people taking Bupropione Sandoz. Symptoms of AGEP include skin rash with pus-filled pimples/blisters.
If you develop a skin rash with pus-filled pimples/blisters, contact your doctor immediately, as treatment discontinuation may be necessary.

Other side effects

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

• Difficulty sleeping. Make sure to take Bupropione Sandoz in the morning
• Headache
• Dry mouth
• Feeling unwell, vomiting

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

• Fever, dizziness, itching, sweating, and skin rash (sometimes due to an allergic reaction)
• Twitching, tremors, weakness, fatigue, chest pain
• Feelings of anxiety or agitation
• Stomach ache or other disturbances (constipation), changes in taste, loss of appetite (anorexia)
• Increase in blood pressure, sometimes severe, hot flushes
• Ringing in the ears, vision disturbances

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

• Feelings of depression (see also section 2 “Warnings and precautions”, under “Thoughts of harming yourself or of suicide”)
• Confusion
• Difficulty concentrating
• Increased heart rate
• Weight loss

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

• Epileptic seizures

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

• 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, 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 skin patches)
• Unusual hair loss or thinning (alopecia)
• Feelings of unreality or detachment ( depersonalization ); seeing or hearing things that are not real ( hallucinations ); believing in things that are not real ( delusions ); severe suspiciousness ( paranoia )
• Dizziness upon standing due to low blood pressure (postural hypotension)

Side effects not known: frequency cannot be determined from available data

• Decreased sodium levels in the blood (hyponatremia)
• Thoughts of harming yourself or of suicide while taking Bupropione Sandoz or immediately after stopping treatment (see section 2, “What you should know before taking Bupropione Sandoz”). 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
• Reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia), and reduced number of platelets (thrombocytopenia)
• 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) during co-administration of medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine)

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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after "Exp". The
expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture and light.
Do not dispose of any medicine 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 Sandoz contains

• The active substance is bupropion hydrochloride. Each modified-release tablet contains 150 mg of bupropion hydrochloride.
• The other components are povidone, hydrochloric acid, sodium stearate fumarate, ethylcellulose, hydroxypropylcellulose, methacrylic acid-ethyl acrylate copolymer (1:1) Type A, anhydrous colloidal silica, macrogol 1500, triethyl citrate, hypromellose, macrogol 400, macrogol 8000.

Description of the appearance of Bupropione Sandoz and contents of the pack
White to light yellow, round, biconvex tablets, smooth on both sides.
The modified-release tablets are packed in a white opaque plastic bottle closed with a child-resistant screw cap. The bottle contains two sachets, which must not be ingested: one containing silica gel and activated charcoal granules, and one containing silica gel and oxygen absorber granules.
Pack sizes:
10, 30, 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d., Verovškova ulica 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
LEK S.A, ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania

This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria Bupropion 1A Pharma 150 mg - Tablette mit veränderter Wirkstofffreisetzung
Bupropion 1A Pharma 300 mg - Tablette mit veränderter Wirkstofffreisetzung
Germany Bupropionhydrochlorid HEXAL 150 mg Tabletten mit veränderter Wirkstofffreisetzung
Bupropionhydrochlorid HEXAL 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Italy Bupropione Sandoz
Netherlands Bupropion HCl Sandoz 150 mg, tabletten met gereguleerde afgifte
Bupropion HCl Sandoz 300 mg, tabletten met gereguleerde afgifte