Package Insert: Information for the User

Bupropion Sandoz 300 mg Modified Release Tablets EFG

bupropion, hydrochloride

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Bupropión Sandoz is a medication for the treatment ofdepression. It acts on certain substances in the brain called noradrenaline and dopamine, which are related to depression.

Do not takeBupropión Sandoz:

• if you areallergicto the active ingredient or to any of the other components of this medicine (listed in section 6),
• if you aretakingother medicines that containbupropión,
• if you have been diagnosed withepilepsyor have a history of seizures,
• if you have abrain tumor,
• if you have undergone arapid withdrawal from alcoholorany other medication associated with a risk of withdrawal, particularly:

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

• if you have along-term severe liver diseasecharacterized by degeneration and thickening of liver tissue,
• if you have aneating disorderor have had one, such asbulimiaoranorexia nervosa,
• if you havetakenor have been taking other medicines to treat depression calledmonoamine oxidase inhibitors.

At least 14 days should elapse between the discontinuation of certain monoamine oxidase inhibitors (denominated irreversible monoamine oxidase inhibitors) and the treatment with bupropión. As for some monoamine oxidase inhibitors (denominated 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 bupropión if:

• you drink a lot of alcohol regularly.
• See the previous section “Do not take Bupropión Sandoz”if you have undergone a rapid withdrawal from alcohol.
• you have diabetesbeing treated with insulin or oral tablets,
• you have had a severe head injury,
• you experience extreme mood swings or mental problems.

Patients should be closely monitored before treatment due to the risk of episodes of excitement or agitation of mood.

• if you are taking other medicines for depression, the use of these medicines together with bupropión may cause serotonin syndrome, a potentially fatal disease (see “Other medicines and Bupropión Sandoz” in this section),
• you have mild to moderate renal or hepatic dysfunction.

Patients with liver or kidney dysfunction will be monitored by the doctor for possible side effects. Do not use bupropión if you have severe liver disease as described in point six of “Do not take Bupropión Sandoz”.

• you require a urine test.

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

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

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

Bupropión has been observed to produceseizures. This adverse effect is more likely to occur in individuals:

• affected by a disease listed in the first three points “Warnings and precautions” in section 2 or
• who are taking a medicine listed in the second of the twelve points “Other medicines and Bupropión Sandoz” in section 2.

Assess the presence of risk factors in all patients.Stop taking Bupropión Sandoz and inform your doctorif you experience seizures during treatment.

Thoughts of self-harm or suicideare associated with depression. These may increase at the start of treatment with depression medicines, as they take time to become effective. Normally, this takes about two weeks, but sometimes it may take longer.

This is more likely to happen if:

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

There are studies showing an increased risk of suicidal behavior in adults under 25 years old with psychiatric disorders being treated with some antidepressants.

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 being depressed 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

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

Other medicines and Bupropión Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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

• somemedicines for the treatment ofdepression or Parkinson's disease calledmonoamine oxidase inhibitors. Consider the last point of the section “Do not take Bupropión Sandoz” in section 2.
• medicines for the treatment of depression, such as amitriptiline, fluoxetine, paroxetine, dosulepine, desipramine, imipramine, citalopram,escitalopram, venlafaxine or medicines for the treatment ofmental illnesses,such as clozapine, risperidone, thioridazine, olanzapine. Bupropiónmay 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 and exaggerated reflexes, muscle rigidity, 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 Bupropión Sandoz” in section 2 if you intend to stop taking sedatives.

• medicines to prevent and treat malaria, such as mefloquine, chloroquine
• stimulantsor other medicines to control weight or appetite
• steroids, administered orally or by injection
• medicines for the treatment of a bacterial infectionwith names of active ingredients that end in "oxacino"
• antihistaminesthat may 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 muscle tension pain
• carbamazepine,phenytoin,valproate: medicines for the treatment of epilepsy and certain pain conditions
• some medicines for the treatment of cancer, such ascyclophosphamide,ifosfamide,
• ticlopidine,clopidogrel: medicines to inhibit blood coagulation
• medicinesforthe treatment ofhigh blood pressure, the heart or other diseases, with names of active ingredients that end in "lol", such as metoprolol
• propafenone,flecainide: medicines for the treatment of heart rhythm disorders
• nicotine patches: medicines to quit smoking
• ritonavir,efavirenz: medicines for the treatment of HIV infection
• tamoxifen: a medicine for the treatment of breast cancer

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

• digoxin, a heart medicine

Inform 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 Bupropión Sandoz andalcohol

Do not consume alcoholwhile taking bupropión. 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 withdrawal before taking bupropión.

Pregnancy andbreastfeeding

Do not take bupropiónif you are pregnant, think you may be pregnant or intend to become pregnantunless your doctor prescribes it. Some studies have reported an increased risk of birth defects, particularly heart defects, in babies whose mothers were taking bupropión. It is not known if this is due to the use of bupropión.

The components of bupropión may pass into breast milk. Consult your doctor or pharmacist if you are breastfeeding before taking bupropión.

Driving and use of machines

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

Bupropión Sandoz contains sodium

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

Follow exactly the administration instructions of this medication 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 renal or hepatic insufficiency

The recommended dose is one 150 mg tablet once a day if you have mild to moderate renal or hepatic insufficiency.

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

Form of use

Take the whole tablets 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 fact that the medication will be released very quickly in your body. This increases the likelihood of adverse effects, even seizures.

The tablet is coated with a film that releases the medication slowly 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.

Treatment duration

Your doctor will indicate the duration of treatment with bupropion.

It may take several weeks or months for you to start feeling better or to experience the full effect.

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

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 experiencing epileptic seizures or convulsions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 compensate for the missed doses.

If you interrupt treatment with Bupropion Sandoz

Do notinterrupt treatment with bupropion or reduce the dose without your doctor's approval.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

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

Seizures or convulsions

Approximately 1 in 1,000 people who take bupropion are at risk of experiencing a 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 seizures. If you have any doubts, ask your doctor.

Consult your doctorif you experience a seizure.Do not take 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 "ticks" in the chest or difficulty breathing,
• swelling of eyelids, lips, or tongue,
• muscle or joint pain,
• syncope or fainting.

Consult your doctor immediatelyif you experience an allergic reaction.Do not take more tablets..

Allergic reactions can last a long time.If your doctor prescribes you a medication for it, make sure to complete the treatment.

Skin rash due to lupus or worsening of lupus symptoms

Unknown frequency:cannot be estimated from available datain people taking bupropion.

Lupus is an autoimmune 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 discontinue treatment.

Other side effects

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

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

Common side effects: can affect up to 1 in 10 people:

• fever, dizziness, itching, sweating, and skin rash (sometimes due to allergic reactions),
• instability, tremor, weakness, fatigue, chest pain,
• feeling anxious or agitated,
• stomach pain or digestive discomfort (constipation), altered sense of taste, loss of appetite (anorexia),
• increased blood pressure (sometimes severe), flushing,
• feeling of hearing bells, visual disturbances.

Rare side effects: can affect up to 1 in 100 people:

• feeling depressed (see section 2 "Be especially careful with Bupropion Sandoz" in "suicidal thoughts and worsening of depression"),
• confusion,
• difficulty concentrating,
• rapid heartbeat,
• weight loss.

Very rare side effects:can affect up to 1 in 1,000 people:

• convulsions.

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

• palpitations, fainting,
• muscle cramps, muscle stiffness, involuntary movements, gait disturbances, or coordination problems,
• feeling of unease, irritability, hostility, aggression, nightmares, tingling or numbness, memory loss,
• yellow discoloration of the skin or white of the eyes (jaundice) that may be associated with increased 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 (plaques of thickening or redness of the skin),
• feeling unreal or strange (depersonalization); seeing or hearing things that do not exist (hallucinations); feeling or believing things that are not real (illusions); severe distrust (paranoia),
• dizziness when standing due to low blood pressure (postural hypotension).

Other side 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 discontinuing treatment (see section 2, "What you need to know before starting Bupropion Sandoz"). If you have these thoughts,contact your doctor or go to the hospital immediately,
• loss of contact with reality and unable to think or judge clearly (psychosis); other symptoms may include hallucinations and/or illusions,
• stammering,
• reduction in red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia),
• decreased sodium levels in the blood (hyponatremia),
• changes in mental state (e.g., agitation, hallucinations, coma) and other effects, such as high body temperature, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea), while taking bupropion with medications used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bupropion Sandoz

• The active ingredient is bupropion hydrochloride.

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

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicine is authorized in the member states of the European Economic Area with 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 sproščanjem

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

Last review date of this leaflet:March 2023.

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