BUPROPION SANDOZ 300 mg EXTENDED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Bupropion Sandoz 300 mg prolonged-release tablets EFG

bupropion, hydrochloride

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Bupropion Sandoz is a medicine for the treatment of depression. It works on certain substances in the brain called noradrenaline and dopamine, which are related to depression.

2. What you need to know before you take Bupropion Sandoz

Do not takeBupropion Sandoz:

• if you are allergicto the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you are takingother medicines that contain bupropion,
• if you have been diagnosed with epilepsyor have a history of seizures,
• if you have a brain tumor,
• if you have undergone sudden withdrawal from alcoholorany medicine that is associated with a risk of withdrawal, in particular:

• medicines to calm, induce sleep or relax muscles with active substance names that end in "azepam",
• or similar sedatives,

• if you have a severe long-term liver diseasemarked by degeneration and thickening of liver tissue,
• if you have an eating disorderor have had one, such as bulimiaor anorexia nervosa,
• if you have takenor have been taking other medicines for treating depression called monoamine oxidase inhibitors.

At least 14 days should pass between the interruption of the administration of certain monoamine oxidase inhibitors (called irreversible monoamine oxidase inhibitors) and treatment with bupropion. For some monoamine oxidase inhibitors (called reversible monoamine oxidase inhibitors), a period of 24 hours is considered sufficient. In case of doubt, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take bupropion if:

• you regularly drink a lot of alcohol.
• See previous section "Do not take Bupropion Sandoz" if you have undergone sudden withdrawal from alcohol.
• you have diabetes that is being treated with insulin or oral tablets,
• you have suffered a severe head injury,
• you suffer from extreme mood swings or mental problems.

Before treatment, patients should be monitored due to the risk of disorders with episodes of excitement or agitation of the mood.

• if you are taking other medicines for depression, the use of these medicines together with bupropion may cause serotonin syndrome, a potentially fatal disease (see "Other medicines and Bupropion Sandoz" in this section),
• you have mild to moderate kidney or liver dysfunction.

Patient with liver or kidney dysfunction will be monitored by the doctor for possible side effects. Do not use bupropion if you have severe liver disease that appears in the sixth point of "Do not take Bupropion Sandoz".

• you require a urine test.

Tell your doctor that you are taking bupropion as it may interfere with urine tests to detect other medicines,

• - if you have a condition called Brugada syndrome (a rare hereditary syndrome that affects heart rhythm) or if there has been a cardiac arrest or sudden death in your family.

A reference blood pressure should be obtained at the start of treatment and monitored thereafter, especially in patients with pre-existing hypertension.

It has been observed that bupropion can cause seizures. This adverse effect is more likely to occur in people:

• affected by a disease that appears in the first three points "Warnings and precautions" in section 2 or
• who take a medicine that appears in the second of the twelve points "Other medicines and Bupropion Sandoz" in section 2.

The existence of risk factors should be assessed in all patients. Stop taking Bupropion Sandoz and inform your doctorif you suffer seizures during treatment.

Thoughts of self-harmor suicide are related to depression. These can increase at the start of treatment with medicines for treating depression, as they take time to work. Normally it is about two weeks, but sometimes it can be longer.

It is likely to happen to you if:

• you have previously had these thoughts,
• you are a young adult.

There are studies that show an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were being treated with some antidepressant.

If you have thoughts of self-harm or suicide at any time, consult your doctor or go to the hospital immediately. Talk to a close family member or friend about your depression and ask them to read this leaflet. Ask them to tell you if they think your depression is getting worse or if there are changes in your behavior.

Children under 18 years

Bupropion is not recommended for this age group. In children, there is a higher risk of thoughts and attempts of suicide when they are being treated with antidepressants.

Other medicines and Bupropion Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines may affect or may be affected by bupropion, although the list is not complete. Tell your doctor if you are taking any of these medicines so that your treatment can be modified if necessary:

• certain medicines for the treatment of depression or Parkinson's disease called monoamine oxidase inhibitors. Consider the last point of the section "Do not take Bupropion Sandoz" in section 2.
• medicines for the treatment of depression, such as amitriptyline, fluoxetine, paroxetine, dosulepin, desipramine, imipramine, citalopram, escitalopram, venlafaxine or medicines for the treatment of mental illnesses, such as clozapine, risperidone, thioridazine, olanzapine. Bupropion may interact with medicines used for the treatment of 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 and exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
• theophylline: a medicine for the treatment of asthma and other respiratory diseases
• tramadol: a medicine for the treatment of pain
• sedatives

Consider the fifth point of "Do not take Bupropion Sandoz" in section 2 if you intend to stop taking sedatives.

• medicines for preventing and treating malaria, such as mefloquine, chloroquine
• stimulantsor other medicines for controlling weight or appetite
• corticosteroids, administered orally or by injection
• medicines for the treatment of bacterial infectionswith active substance names that end in "oxacino"
• antihistaminesthat can cause drowsiness: used for the treatment of allergies, sleep disorders or colds; or to prevent and treat nausea and vomiting
• medicines for the treatment of diabetes
• levodopa, amantadine: medicines for the treatment of Parkinson's disease,
• orphenadrine: a medicine for the treatment of painful muscle tension
• carbamazepine, phenytoin, valproate: medicines for treating epilepsy and certain pain conditions
• certain medicines for the treatment of cancer, such as cyclophosphamide, ifosfamide,
• ticlopidine, clopidogrel: medicines for inhibiting blood coagulation
• medicines for the treatment of high blood pressure, heart or other diseases, with active substance names that end in "lol", such as metoprolol
• propafenone, flecainide: medicines for the treatment of heart rhythm disorders
• nicotine patches: medicines for quitting smoking
• ritonavir, efavirenz: medicines for the treatment of HIV infection
• tamoxifen: a medicine for the treatment of breast cancer

Tell your doctor if you are taking tamoxifen, as it may be necessary to change to another treatment for depression.

• digoxin, a medicine for the heart

Tell your doctor if you are taking digoxin, as it may be necessary to adjust the dose.

• metamizole, a medicine for fever, severe and acute pain and chronic pain.

Use of Bupropion Sandoz andalcohol

It is not recommendedto consume alcohol while taking bupropion. However, if you currently drink a lot of alcohol, do not stop suddenly, as you may be at risk of having a seizure.

Talk to your doctor about alcohol consumption and abstinence before taking bupropion.

Pregnancy andbreast-feeding

Do not take bupropionif you are pregnant, think you may be pregnant or plan to become pregnant unless your doctor prescribes itSome studies have reported an increased risk of birth defects, particularly heart defects, in babies whose mothers were taking bupropion. It is not known if this is due to the use of bupropion.

The components of bupropion may pass into breast milk. Consult your doctor or pharmacist if you are breast-feeding before taking bupropion.

Driving and using machines

Be cautious before driving or using machines until you are completely sure that bupropion does not affect your ability negatively.

Bupropion Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Bupropion Sandoz

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

One 150 mg tablet once a day.

Your doctor may increase the dose to300 mg once a day if your depression does not improve after several weeks.

Patients with kidney or liver impairment

The recommended dose is one 150 mg tablet once a day if you have mild to moderate kidney or liver impairment.

Do not use bupropion if you have severe liver disease that appears in the sixth point "Do not take Bupropion Sandoz" in section 2.

Method of administration

Take the tablets whole, in the morning with a glass of water. The tablets can be taken with or without food.

Do not chew, crush or divide the tablets, because if you do this, there is a risk of overdose due to the medicine being released very quickly in your body. This increases the likelihood of having side effects, including seizures.

The tablet is coated with a film that slowly releases the medicine in your body. Sometimes you may notice that a kind of tablet appears in the stool. This is the empty coating film that has passed through your body.

Duration of treatment

Your doctor will indicate the duration of treatment with bupropion.

It may take several weeks or months before you start to feel better or have the full effect.

Although you may start to feel better, your doctor may recommend continuing treatment with bupropion to prevent the symptoms of depression from returning.

If you take more Bupropion Sandoz than you should

If you take more tablets than indicated, contact your doctor immediately or go to the nearest hospital, as this may increase the risk of having seizures or convulsions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bupropion Sandoz

If you forget to take a dose, wait and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Bupropion Sandoz

Do not stop taking bupropion or reduce the dose without your doctor's approval.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Inform your doctor immediately if you experience any of the following adverse effects.

Epileptic Seizures or Convulsions

Approximately 1 in every 1,000 people taking bupropion are at risk of suffering an epileptic seizure (a seizure or convulsion). This risk is higher if you take more tablets than you should, if you are taking certain medications, or if you have a higher than usual risk of suffering seizures. If you have any doubts, ask your doctor.

Consult your doctor if you suffer an epileptic seizure.Do not take any more tablets.

Allergic Reactions

Some people may have allergic reactions to bupropion. These include:

• redness or skin rash (urticaria), blisters, or hives on the skin.

Some skin rashes may require hospitalization, especially if they are accompanied by swelling of the mouth and eyes.

• abnormal appearance of "wheezing" in the chest or difficulty breathing,
• swelling of eyelids, lips, or tongue,
• muscle or joint pain,
• fainting or loss of consciousness.

Consult your doctor immediately if you suffer an allergic reaction.Do not take any more tablets.

Allergic reactions can last for quite some time. If your doctor prescribes any medication for this, make sure to complete the treatment.

Lupus Skin Rash or Worsening of Lupus Symptoms

Frequency not known: cannot be estimated from the available data in people taking bupropion.

Lupus is a disorder of the immune system that affects the skin and other organs. If you experience lupus outbreaks, skin rash, or lesions (especially in sun-exposed areas) while taking bupropion, contact your doctor immediately, as it may be necessary to interrupt treatment.

Other Adverse Effects

Very Common Adverse Effects:may affect more than 1 in 10 people:

• difficulty sleeping. Make sure to take bupropion in the morning.
• headache,
• dry mouth,
• dizziness and vomiting.

Common Adverse Effects: may affect up to 1 in 10 people:

• fever, dizziness, itching, sweating, and skin rash (sometimes due to allergic reactions),
• instability, tremors, weakness, fatigue, chest pain,
• feeling anxious or agitated,
• stomach pain or digestive discomfort (constipation), taste disturbances, loss of appetite (anorexia),
• increased blood pressure (sometimes severe), flushing,
• ringing in the ears, vision disturbances.

Uncommon Adverse Effects: may affect up to 1 in 100 people:

• feeling depressed (see also section 2 "Special Warnings and Precautions for Use", in "Thoughts of Suicide and Worsening of Depression"),
• confusion,
• difficulty concentrating,
• accelerated heart rate,
• weight loss.

Rare Adverse Effects: may affect up to 1 in 1,000 people:

• seizures.

Very Rare Adverse Effects: may affect up to 1 in 10,000 people:

• palpitations, fainting,
• muscle contractions, muscle stiffness, uncontrolled movements, walking or coordination problems,
• feeling of restlessness, irritability, hostility, aggression, nightmares, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice) that may be associated with an increase in liver enzymes, hepatitis,
• severe allergic reactions; skin rash accompanied by joint and muscle pain,
• changes in blood sugar levels,
• increased or decreased frequency of urination, urinary incontinence,
• severe skin rashes that can affect the mouth or other parts of the body and can be life-threatening,
• worsening of psoriasis (thickening or redness of the skin),
• feelings of feeling unreal or strange (depersonalization); seeing or hearing things that do not exist (hallucinations); feeling or believing unrealistic things (delusions); severe distrust (paranoia),
• dizziness when standing up due to low blood pressure (postural hypotension).

Other Adverse Effects

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 bupropion or shortly after stopping treatment (see section 2, "What you need to know before taking Bupropion Sandoz"). 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,
• stuttering,
• reduction in the number of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia),
• decrease in sodium levels in the blood (hyponatremia),
• changes in mental status (e.g., agitation, hallucinations, coma) and other effects, such as body temperature above 38 °C, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal disorders (e.g., nausea, vomiting, diarrhea), while taking bupropion with medications used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Bupropion Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bupropion Sandoz

• The active ingredient is bupropion hydrochloride.

Each modified-release tablet contains 300 mg of bupropion hydrochloride.

• The other ingredients are: povidone, L-cysteine hydrochloride monohydrate, colloidal anhydrous silica, glyceryl dibehenate, magnesium stearate, ethylcellulose, hydrated colloidal silica, methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, macrogol, triethyl citrate, shellac, iron oxide black (E172), propylene glycol, 28% ammonium hydroxide.

Appearance and Package Contents

White-cream to light yellow, round tablets (approximately 9.3 mm in diameter), marked with "GS2" on one side and smooth on the other.

Package sizes: 10, 30, 60, or 90 modified-release tablets in OPA/Al/PVC-Al blisters.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

Ljubljana 1526,

Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Bupropion - 1 A Pharma 300 mg Tabletten mit veränderter Wirkstofffreisetzung

Belgium: Bupropion Sandoz 300mg tabletten met gereguleerde afgifte

Slovenia: Nordobux 300 mg tablete s prirejenim sprošcanjem

Finland: Bupropion Sandoz 300 mg depottabletti

Netherlands: Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte

Sweden: Bupropion Sandoz

Spain: Bupropión Sandoz 300 mg comprimidos de liberación modificada EFG

Date of the last revision of this leaflet:March 2023.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/