Bupropion Sandoz 300 mg modified-release tablets EFG

Package Leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bupropion Sandoz 300 mg prolonged-release tablets EFG

bupropion hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Bupropion Sandoz is a medicine used to treat 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 taking Bupropion Sandoz

Do not take Bupropion Sandoz:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),

• if you are taking other medicines containing bupropion,

• if you have been diagnosed with epilepsy or have a history of seizures,

• if you have a brain tumor,

• if you have undergone alcohol withdrawal treatment or withdrawal from any medication associated with withdrawal risk, particularly:

• medicines to calm, induce sleep, or relax muscles with active substance names ending in "azepam",

• or similar sedatives,

• if you have a severe, long-standing liver disease characterized by degeneration and thickening of liver tissue,

• if you have an eating disorder or have had one, such as bulimia or anorexia nervosa,

• if you have taken or have been taking other antidepressant medicines called monoamine oxidase inhibitors (MAOIs).

At least 14 days must pass between stopping certain monoamine oxidase inhibitors (called irreversible MAOIs) and starting treatment with bupropion. For some monoamine oxidase inhibitors (called reversible inhibitors), a 24-hour interval is considered sufficient. If in doubt, consult your doctor.

Warnings and precautions

Talk to your doctor before starting bupropion if:

• you regularly drink large amounts of alcohol.
• See previous section “Do not take Bupropion Sandoz” if you have undergone abrupt alcohol withdrawal.
• you have diabetes being treated with insulin or oral tablets,
• you have suffered a serious head injury or have a history of head trauma. Bupropion has been shown to cause seizures (convulsions) in 1 out of every 1000 people. This side effect is more likely in individuals in the groups mentioned above. If you have a seizure during treatment, you must stop taking bupropion. Do not take further doses and consult your doctor.
• you suffer from mood swings (bipolar disorder) or mental health problems, as bupropion could trigger an episode of this condition. Before treatment, patients should be monitored due to the risk of disorders involving episodes of elevated or agitated mood.

Before treatment, patients should be monitored due to the risk of disorders involving episodes of elevated or agitated mood.

• you are taking other antidepressant medicines, as using these together with bupropion may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Bupropion Sandoz” in this section),
• you have mild to moderate kidney or liver dysfunction.

Patients with hepatic or renal dysfunction will be monitored by the doctor for possible side effects. Do not use bupropion if you have the severe liver disease listed in the sixth point under "Do not take Bupropion Sandoz".

• you require a urine test.

Inform your doctor that you are taking bupropion, as it may interfere with urine tests used to detect other drugs.

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

Serious skin reactions

Serious skin reactions have been reported with bupropion, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using bupropion and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

If any of the above situations apply to you, talk to your doctor again before taking bupropion. Your doctor may decide to monitor you more closely or recommend an alternative treatment.

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

Bupropion has been observed to cause seizures. This adverse effect is more likely to occur in people:

• affected by a condition listed in the first three points under "Warnings and precautions" in section 2, or
• taking a medicine listed in the second of the twelve points under "Other medicines and Bupropion Sandoz" in section 2.

Risk factors should be assessed in all patients. Stop taking Bupropion Sandoz and inform your doctor if you experience seizures during treatment.

Thoughts of self-harm or suicide are associated with depression. These may increase at the beginning of treatment with antidepressant medicines, as they take time to work—usually about two weeks, but sometimes longer.

You are more likely to experience this if:

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

Studies have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age who are being treated with antidepressants.

If you have thoughts of harming yourself or suicide at any time, contact your doctor or go to hospital immediately. Talk to a close family member or friend about your depression and ask them to read this leaflet. Ask them to inform you if they think your depression is worsening or if there are changes in your behavior.

Children under 18 years

Bupropion is not recommended for this age group. In children, there is an increased risk of suicidal thoughts and attempts when treated with antidepressants.

Other medicines and Bupropion Sandoz

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

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

• certain medicines for treating depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs). Refer to the last point in the section "Do not take Bupropion Sandoz" in section 2.
• medicines for treating depression, such as amitriptyline, fluoxetine, paroxetine, dosulepin, desipramine, imipramine, citalopram, escitalopram, venlafaxine, or medicines for treating mental illnesses, such as clozapine, risperidone, thioridazine, olanzapine. Bupropion may interact with 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, diarrhea).
• 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

Refer to the fifth point under "Do not take Bupropion Sandoz" in section 2 if you plan to stop taking sedatives.

• medicines for preventing and treating malaria, such as mefloquine, chloroquine,
• stimulants or other medicines used to control weight or appetite,
• steroids, administered orally or by injection,
• medicines for treating a bacterial infection with active substance names ending 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 treating diabetes,
• levodopa, amantadine: medicines used to treat Parkinson’s disease,
• orphenadrine: a medicine used to treat painful muscle tension,
• carbamazepine, phenytoin, valproate: medicines used to treat epilepsy and certain pain conditions,
• medicines that affect the body’s ability to break down bupropion,
• certain medicines for treating cancer, such as cyclophosphamide, ifosfamide,
• ticlopidine, clopidogrel: medicines used to inhibit blood clotting, mainly used to prevent stroke,
• medicines for treating high blood pressure, heart conditions, or other diseases, with active substance names ending in "lol", such as metoprolol, beta-blockers,
• propafenone, flecainide: medicines used to treat heart rhythm disorders,
• nicotine patches: medicines used to stop smoking,
• ritonavir, efavirenz: medicines used to treat HIV infection,
• Inform your doctor if you are taking any of these medicines. Your doctor will check whether bupropion is working properly. It may be necessary to increase the dose or switch to another treatment for your depression. Do not increase the dose of bupropion unless advised by your doctor, as this may increase the risk of adverse effects, including seizures.
• tamoxifen: a medicine used to treat breast cancer.

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

• digoxin, a medicine for the heart.

Inform your doctor if you are taking digoxin, as dose adjustment may be necessary.

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

If any of these situations apply, speak to your doctor immediately before taking bupropion. Your doctor will evaluate the benefits and risks of taking bupropion.

Taking Bupropion Sandoz with alcohol

Alcohol consumption (beer, wine, or spirits) is not recommended while taking bupropion. Alcohol may affect how bupropion works, and when used together, it may rarely affect your nerves or mental state. Some people report being more sensitive to alcohol while taking bupropion.

If you currently consume large amounts of alcohol, do not stop abruptly, as you may be at risk of experiencing a seizure.

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

Pregnancy and breastfeeding

Do not take bupropion if you are pregnant, think you may be pregnant, or plan to become pregnant unless prescribed by your doctor. Consult your doctor or pharmacist before using this medicine. Some studies have reported an increased risk of birth defects, particularly heart defects, in babies whose mothers took bupropion during pregnancy. It is not known whether this is due to bupropion use.

Components of bupropion may pass into breast milk. Consult your doctor or pharmacist if you are breastfeeding before taking bupropion.

Driving and using machines

Exercise caution before driving or operating machinery until you are fully certain that bupropion does not negatively affect your ability.

If bupropion causes dizziness or fainting, do not drive or operate tools or machinery.

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 instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

One 150 mg tablet once daily.

Your doctor may increase the dose to 300 mg once daily if your depression does not improve after several weeks.

Patients with renal or hepatic impairment

The recommended dose is one 150 mg tablet once daily if you have mild to moderate renal or hepatic impairment.

Do not use bupropion if you have severe liver disease as stated in point six "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 may be taken with or without food. Do not take bupropion more than once a day.

Do not chew, crush, or divide the tablets, because doing so may lead to overdose, as the medicine would be released too quickly into your body. This increases the risk of adverse effects, including seizures (convulsions).

The tablet is film-coated to release the medicine slowly into your body. Occasionally, you may notice a tablet-like shell in your stools. This is the empty film coating that has passed through your body.

Duration of treatment

Your doctor will determine how long you should take bupropion.

It may take several weeks or months before you start to feel better or achieve the full effect. Speak regularly with your doctor about your symptoms to determine how long you should continue treatment.

Even if you start to feel better, your doctor may recommend continuing treatment with bupropion to prevent the return of depressive symptoms.

If you take more Bupropion Sandoz than you should

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

You may also contact your pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bupropion Sandoz

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

If you stop taking Bupropion Sandoz

Do not stop treatment with bupropion or reduce the dose without approval from your doctor.

If you have any further 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 everyone will experience them.

Serious adverse effects

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

Seizures or convulsions

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

Consult your doctor if you have a seizure. Do not take any more tablets.

Allergic reactions

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

• redness or skin rash (urticaria) and hives on the skin,
• unusual wheezing in the chest or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• pain in muscles or joints,
• fainting or collapse.

Contact your doctor immediately if you experience an allergic reaction. Do not take any more tablets.

Allergic reactions can last a long time. If your doctor prescribes any medication for this, make sure you complete the full course of treatment.

Severe skin reactions

Stop taking bupropion and seek medical attention immediately if you notice any of the following symptoms:

• Very rare: Flat, red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Frequency not known: Large areas with blisters and extensive skin peeling, occurring as a severe form of the serious skin reaction described above (toxic epidermal necrolysis).
• Frequency not known: Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The onset of this syndrome is usually delayed (between 2 and 6 weeks after starting treatment).
• Frequency not known: A widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Skin rash due to lupus or worsening of lupus symptoms

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

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

Acute Generalized Exanthematous Pustulosis (AGEP)

Frequency not known: cannot be estimated from the available data in people taking bupropion. Symptoms of AGEP include a rash with pus-filled bumps or blisters.

If you develop a rash with pus-filled bumps or blisters, contact your doctor immediately, as it may be necessary to stop 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),
• unsteadiness, tremor, weakness, fatigue, chest pain,
• feeling anxious or agitated,
• stomach pain or digestive discomfort (constipation), changes in taste, loss of appetite (anorexia),
• increased blood pressure (sometimes severe), flushing,
• sensation of ringing in the ears, visual disturbances.

Uncommon adverse effects: may affect up to 1 in 100 people:

• feeling depressed (see also section 2 “Take special care with Bupropion Sandoz”, under “suicidal thoughts and worsening of your depression”),
• confusion,
• difficulty concentrating,
• rapid heartbeat,
• 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, problems walking or with coordination,
• feeling restless, irritability, hostility, aggression, nightmares, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice) which may be associated with increased liver enzymes, hepatitis,
• severe allergic reactions; skin rash along with joint and muscle pain,
• changes in blood sugar levels,
• increased or decreased frequency of urination, urinary incontinence (involuntary urination, urine leakage),
• worsening of psoriasis (plaques of thickening or redness of the skin),
• unusual hair loss or thinning (alopecia),
• feelings of unreality or strangeness (depersonalization); seeing or hearing things that are not there (hallucinations); believing or thinking unreal things (illusions); severe distrust (paranoia),
• dizziness upon standing 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 starting to take Bupropion Sandoz”). If you have these thoughts, contact your doctor or go immediately to a hospital,
• loss of touch with reality and inability to think or judge clearly (psychosis); other symptoms may include hallucinations and/or illusions,
• sudden and intense fear (panic attack),
• stuttering,
• reduction in the number of red blood cells (anaemia), white blood cells (leucopenia), and platelets (thrombocytopenia),
• low sodium levels in the blood (hyponatraemia),
• 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 disturbances (e.g., nausea, vomiting, diarrhoea) while taking bupropion together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister after CAD/EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bupropion Sandoz

• The active substance is bupropion hydrochloride.

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

• The other components are: povidone, monohydrate cysteine hydrochloride, anhydrous colloidal silica, glycerol dibehenate, magnesium stearate, ethylcellulose, hydrated colloidal silica, copolymer of methacrylic acid and ethyl acrylate (1:1), sodium lauryl sulfate, polysorbate 80, macrogol, triethyl citrate, shellac, black iron oxide (E 172), propylene glycol and 28% ammonium hydroxide.

Nature of the product and pack sizes

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

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 medicinal product is authorised in the European Economic Area member states 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 most recent revision of this leaflet: 03/2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).