Package Leaflet: Information for the User

Bupropion Sandoz 150 mg Modified Release Tablets EFG

bupropion, hydrochloride

Read this 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. Do 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 leaflet. 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 take Bupropión Sandoz:

• if you areallergicto bupropion or any of the other ingredients of this medicine (listed in section 6),
• if you aretakingother medicines that contain bupropion,
• if you have been diagnosed withepilepsyor have a history of seizures,
• if you have abrain tumor,
• if you have undergone arapid alcohol withdrawalorany other medication associated with a risk of withdrawal, particularly,
• sedatives, hypnotics or muscle relaxants with active ingredients that end in "azepam",
• or similar sedatives,
• if you have asevere and long-lasting liver diseasecharacterized by liver tissue degeneration and thickening,
• if you have an eating disorder or have had one, such asbulimiaoranorexia nervosa,
• if you havetakenor have been taking other antidepressant medicines 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 bupropion. 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 bupropion if:

• you drink a lot of alcohol regularly.

See the previous section “Do not take Bupropión Sandoz” if you have undergone a rapid alcohol withdrawal,

• you have diabetesthat is being treated with insulin or oral tablets,
• you have suffered a severe head injury,
• you experience mood swings or mental problems.Before treatment, patients should be monitored due to the risk of episodes of excitement or agitation of the mood,
• if you are taking other antidepressant medicines, the use of these medicines together with Bupropión Sandoz may cause serotonin syndrome, a potentially fatal disease (see “Other medicines and Bupropión Sandoz” in this section),
• you have mild to moderate liver or kidney dysfunction.

Patients with liver or kidney dysfunction will be monitored by the doctor for possible side effects. Do not use bupropion if you have the severe liver disease mentioned in point 6 of “Do not take Bupropión Sandoz”,

• you need a urine test. Inform your doctor that you are taking bupropion as it may interfere with urine tests to detect other medicines,
• Brugada syndrome. If you have a condition called Brugada syndrome (a rare inherited condition that affects heart rhythm) or if a cardiac arrest or sudden death has occurred in your family

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

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

All patients should be evaluated for the presence of risk factors.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 beginning of treatment with antidepressant 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 is information from studies showing an increased risk of suicidal behavior in people under 25 years old with psychiatric disorders who were 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

Bupropion is not recommended for this age group.

There is a higher risk of thoughts and attempts of suicide in children when they are being 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 bupropion, 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:

• certainmedicines for the treatment of depression 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 amitriptyline, fluoxetine, paroxetine, dosulepin, desipramine, imipramine, citalopram,escitalopram, venlafaxine or medicines for the treatment ofmental disorderssuch as clozapine, risperidone, thioridazine, olanzapinemay interact with medicines used to treat depression and may experience 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 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 for preventing and treating malaria, such as mefloquine, chloroquine,
• stimulantsor other medicines for controlling weight or appetite,
• steroids, administered orally or by injection,
• medicines for the treatment of a bacterial infectionwith 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 treating epilepsy and certain pain conditions,
• certain medicines for the treatment of cancer, such ascyclophosphamide,ifosfamide,
• ticlopidine,clopidogrel: medicines for inhibiting blood coagulation,
• medicinesforthe treatment ofhigh blood pressure, the heart or other diseases, with active ingredients 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,

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

• digoxin, a heart medicine.

Inform your doctor if you are taking digoxin.He may consider adjusting the dose.

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

Taking Bupropión Sandoz with alcohol

Do not recommendthe consumption of bupropion with alcohol. If you currently drink a lot of alcohol, do not stop it abruptly, as you may be at risk of having a seizure.

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

Pregnancy and breastfeeding

Do not take bupropionif 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 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 breastfeeding before taking bupropion.

Driving and using machines

Do not drive or usetools or machines if bupropion makes you dizzy or drowsy.

Bupropión Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per modified-release tablet; that is, it 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

1 tablet of 150 mg 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 1 tablet of 150 mg once a day if you have mild to moderate renal or hepatic insufficiency.

Do not use bupropion if you have severe liver disease that appears in point 6 "Do not take Bupropion Sandoz" in 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.

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

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, including seizures.

Treatment duration

Your doctor will indicate the duration of treatment with bupropion.

You may need several weeks or months before you start feeling better or have the full effect.

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

If you take more Bupropion Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you take more tablets than indicated, consult your doctor or go to the nearest hospital, this may increase the risk of suffering epileptic crises or seizures.

If you forgot 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 having consulted your doctor beforehand.

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

Like all medications, this medication may 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 having 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 risk of seizures than usual. If you have any doubts, ask your doctor.

Consult your doctorif you have a seizure.Do not take more tablets..

Allergic reactions

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

• redness or 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 the 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 a medication for this, 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 outbreaks, skin rash, or lesions (especially in sun-exposed areas) while taking Bupropion Sandoz, contact your doctor immediately, as it may be necessary to discontinue treatment.

Other side effects

Very common side 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 side effects: may 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: may affect up to 1 in 100 people:

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

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

• convulsions.

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

• palpitations, fainting,
• muscle cramps, muscle stiffness, involuntary movements, walking or coordination problems,
• feeling of restlessness, 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,
• 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).

Side effects of unknown frequency:cannot be estimated from available data:

• decreased sodium in the blood (hyponatremia).
• 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 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,
• reduction in the number of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia),
• 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 Sandoz with medications used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting 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 Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

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

Do not store above 25°C.

Store in the original packaging to protect it from light and moisture.

Medicines should not be disposed of through drains or in the trash. Deposit containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Composition of Bupropion Sandoz:

• The active ingredient is bupropion hydrochloride. Each modified-release tablet contains 150 mg of bupropion hydrochloride.

• The other components are: povidone, hydrochloric acid, sodium fumarate estearate, ethylcellulose, hydroxypropylcellulose, copolymer of methacrylic acid and ethyl acrylate (1:1) type A, anhydrous colloidal silica, macrogol 1500, triethyl citrate, hypromellose, macrogol 400, macrogol 8000.

Appearance of the product and contents of the package

White to slightly yellowish, round, rounded on the upper and lower sides, smooth on both faces.

Package sizes:

10, 30, 90 modified-release tablets.

The modified-release tablets are packaged in white opaque bottles closed with a child-resistant cap. The bottles contain two desiccant bags, which should not be ingested, one contains activated charcoal granules and silica gel, and the other contains silica gel and oxygen absorber granules.

Package sizes:

500 modified-release tablets.

The modified-release tablets are packaged in white opaque bottles. The bottles contain two desiccant bags, which should not be ingested, one contains activated charcoal granules and silica gel, and the other contains silica gel and oxygen absorber granules.

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

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D,9220

Lendava

Slovenia

or

Lek S.A

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

Last review date of thisleaflet:March 2023

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