BUPROPION TEVA 150 mg EXTENDED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Bupropion Teva 150 mg Modified 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 and other information

1. What is Bupropion Teva and what is it used for
2. What you need to know before you take Bupropion Teva
3. How to take Bupropion Teva
4. Possible side effects
5. Storing Bupropion Teva

1. Contents of the pack and other information

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

Bupropion Teva is a medicine prescribed by your doctor to treat depression. It is thought to work on certain substances in the brain called noradrenalineand dopamine.

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

Do not take Bupropion Teva

• If you are allergic to bupropion or 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 or have had any eating disorder (such as bulimia or anorexia nervosa)
• If you have a brain tumor
• If you are taking large amounts of alcohol and have started, or are about to start, alcohol withdrawal
• If you have severe liver disease
• If you have stopped taking sedatives, or are going to stop taking them while taking this medicine (see also "Do not take Bupropion Teva" in section 2)
• If you are taking or have taken other medicines for depression called monoamine oxidase inhibitors (MAOIs) in the last 14 days.

If you are in any of these situations, tell your doctor immediately and do not takethis medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take bupropion.

Children and adolescents

This medicine is not recommended for the treatment of children under 18 years of age.

In patients under 18 years of age, there is an increased risk of suicidal thoughts and attempts when they are being treated with antidepressants.

Adults

Tell your doctor before starting to take this medicine:

• If you regularly drink a lot of alcohol
• If you have diabetes that is being treated with insulin or tablets
• If you have had a severe head injury or have had a head trauma in the past.

It has been observed that Bupropion Teva can cause seizures (convulsions) in approximately 1 in 1,000 people. This side effect is more likely to occur in people who are in the situations mentioned above. If you have a seizure during treatment, stop taking this medicine. Do not take it again and see your doctor.

• If you have bipolar disorder (very pronounced mood swings), bupropion may cause episodes of this disease
• 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
• If you are taking other medicines for depression, the use of these medicines with Bupropion Teva may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Bupropion Teva" in this section)
• If you have any liver or kidney disease, the likelihood of experiencing side effects is higher.

If you are in any of the situations mentioned above, talk to your doctor before taking this medicine. Your doctor may decide to monitor you more closely or recommend another treatment.

Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. These thoughts may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks, but sometimes can be longer.

This is more likely to happen:

• If you have previously had thoughts of suicide or self-harm
• If you are a young adult. There is information from clinical trials that shows there is an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who are being treated with any antidepressant.

If you have thoughts of harming or killing yourself at any time, talk to your doctor or go to the hospital immediately.

It may be helpful for you to tell a relative or close friendthat you are depressed and ask them to read this leaflet. You can also ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Taking Bupropion Teva with other medicines

If you are taking or have taken medicines for depression called monoamine oxidase inhibitors (MAOIs) during the last 14 days, tell your doctor and do not take this medicine (see also "Do not take Bupropion Teva" in section 2).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, herbal remedies, or vitamins, including those bought without a prescription. Your doctor may change your dose of bupropion or suggest a change in the other medicines.

Some medicines must not be taken with this medicine. Some of them can increase the likelihood of having seizures or convulsions. Others can increase the risk of having other side effects. The following are some examples, although the list is not complete.

May increase the likelihood of having seizures:

• If you take other medicines for depression or other mental illnesses
• If you take theophylline, used to treat asthma or other lung diseases
• If you take tramadol, a strong painkiller
• If you have been taking sedatives, or if you are going to stop taking them while taking bupropion (see also "Do not take Bupropion Teva" in section 2)
• If you take medicines for malaria (such as mefloquine or chloroquine)
• If you take stimulants or other medicines to control your weight or appetite
• If you take steroids (by mouth or injection)
• If you use quinolone antibiotics
• If you use certain antihistamines that can cause drowsiness
• If you use medicines for diabetes.

If you are in any of these situations, tell your doctor immediately before taking this medicine. Your doctor will weigh the risks and benefits of taking this medicine.

May increase the likelihood of having other side effects:

• If you take other medicines for depression (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine, or imipramine) or other mental illnesses (such as clozapine, risperidone, thioridazine, or olanzapine). Bupropion Teva may interact with some medicines used to treat depression and may experience changes in mental status (such as agitation, hallucinations, coma) and other side effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea
• If you take medicines for Parkinson's disease (levodopa, amantadine, or orphenadrine)
• If you take medicines that affect your body's ability to eliminate bupropion (carbamazepine, phenytoin, valproate)
• If you take some medicines used to treat cancer (such as cyclophosphamide or ifosfamide)
• If you take ticlopidine or clopidogrel, mainly used to prevent stroke
• If you take any beta-blocker medicine (such as metoprolol)
• If you take medicines for heart rhythm disorders (propafenone or flecainide)
• If you use nicotine patches to help you stop smoking.

If you are in any of these situations, tell your doctor immediately before taking this medicine.

Bupropion may be less effective

• If you take ritonavir or efavirenz, medicines for HIV infection.

If you are in this situation, tell your doctor. Your doctor will check if this medicine is working properly in you. It may be necessary to increase the dose or change to another treatment for your depression.

Do not increase the dose of this medicine unless your doctor advises you to, as this may increase the risk of having side effects, including seizures.

Bupropion may make other medicines less effective:

• If you take tamoxifen used to treat cancer.

If you are in this situation, tell your doctor. It may be necessary to change your treatment for depression.

• If you take digoxin for your heart.

If you are in this situation, tell your doctor. Your doctor may consider adjusting the dose of digoxin.

Using Bupropion Teva with alcohol

Alcohol may affect how bupropion works and, when taken together, can rarely affect your nerves or mental state. Some people have noticed that they are more sensitive to alcohol during treatment with this medicine. Your doctor may advise you not to drink alcohol (beer, wine, spirits) or to drink very small amounts while taking this medicine. But 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 consumptionbefore starting treatment with this medicine.

Effect on urine tests

This medicine may interfere with some urine tests used to detect other medicines or substances. If you need a urine test, tell your doctor or hospital that you are taking this medicine.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant, think you may be pregnant, or plan to become pregnant unless your doctor prescribes it. Talk to your doctor or pharmacist before using this medicine. Some studies, not all, have reported an increased risk of birth defects, particularly heart defects, in babies whose mothers were taking Bupropion Teva. It is not known if this is due to the use of Bupropion Teva.

The components of this medicine may pass into breast milk.

Driving and using machines

Do not drive or use tools or machines if this medicine makes you feel dizzy or drowsy.

3. How to take Bupropion Teva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. The recommended doses are included below, but your doctor will advise you on the dose that is right for you. If in doubt, consult your doctor or pharmacist again.

It may take some time before you start to feel better. The medicine takes time to work fully, which can be weeks or months. When you start to feel better, your doctor may advise you to continue treatment with bupropion to prevent depression from coming back.

What dose to take

The usual recommended dose in adults is one150 mg tablet per day.

If after several weeks you do not start to feel better, your doctor may increase the dose to 300 mg per day.

Take the tablets of this medicine in the morning. Do not take this medicine more than once a day.

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

Swallow the tablets whole. Do not chew, crush, or divide them, as this can lead to an overdose due to the rapid release of the medicine in your body. This will increase the likelihood of having side effects, including seizures.

Some people may stay on a dose of one 150 mg tablet per day throughout treatment. Your doctor may prescribe this dose in patients with liver or kidney problems.

Duration of treatment

Only you and your doctor can decide the duration of treatment with this medicine. It may take several weeks or months before you notice any improvement. Discuss your symptoms with your doctor regularly so that they can decide the duration of treatment. When you start to feel better, your doctor may advise you to continue treatment with bupropion to prevent the symptoms of depression from coming back.

If you take more Bupropion Teva than you should

If you take too many tablets, you may increase the risk of having seizures or convulsions. Do not delay.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to the emergency department or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Bupropion Teva

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 missed doses.

If you stop taking Bupropion Teva

Do not stop taking this medicine or reduce the dose without first talking to your doctor.

If you have any further questions on 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 notice any of the following severe adverse effects

• Epileptic Seizures or Convulsions

Approximately 1 in every 1,000 people taking Bupropion Teva 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 convulsions. If you have any doubts, ask your doctor.

If you suffer an epileptic seizure, consult your doctor when you have recovered. Do not take any more tablets.

• Allergic Reactions

Some people may have allergic reactions to bupropion, including:

• Redness or skin rash (urticaria), blisters, or hives on the skin. Some skin rashes may require hospital treatment, especially if they are accompanied by swelling of the mouth or eyes.
• Abnormal appearance of "wheezing" in the chest or difficulty breathing.
• Swelling of eyelids, lips, or tongue.
• Pain in muscles or joints.
• Fainting or loss of consciousness.

If you have any signs of an allergic reaction, consult your doctor immediately. Do not take any more tablets.

Allergic reactions can last for a long time. If your doctor prescribes any medication to treat the symptoms of the allergy, make sure to complete the treatment.

• Lupus Skin Rash or Worsening of Lupus Symptoms

Frequency not known (frequency cannot be estimated from available data).

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 this medication, contact your doctor immediately, as it may be necessary to interrupt treatment.

Other Adverse Effects

Very Common:may affect more than 1 in 10 people.

• Difficulty sleeping. Make sure to take this medication in the morning.
• Headache.
• Dry mouth.
• Nausea, vomiting.

Common: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), alterations in taste, loss of appetite (anorexia).
• Increased blood pressure, sometimes severe, flushing.
• Sensation of hearing bells, vision disturbance.

Uncommon:may affect up to 1 in 100 people.

• Feeling depressed (see also section 2, "Special Warnings and Precautions for Use, Suicidal Thoughts and Worsening of Depression").
• Feeling confused.
• Difficulty concentrating.
• Accelerated heart rate.
• Weight loss.

Rare:may affect up to 1 in 1,000 people.

• Convulsions.

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

• Palpitations, fainting.
• Vasodilation, decrease in blood pressure when standing up, causing dizziness, drowsiness, or fainting.
• Muscle contractions, muscle stiffness, lack of coordination, walking difficulties, or coordination problems.
• Feeling of restlessness, irritability, hostility, aggression, unusual dreams, 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 (involuntary urination, loss of urine).
• Severe skin rashes that can affect the mouth or other parts of the body and can be life-threatening.
• Worsening of psoriasis (thickened red skin plaques).
• Loss or unusual thinning of hair (alopecia).
• Feeling of being unreal or strange (derealization); seeing or hearing things that do not exist (hallucinations); feeling or believing unrealistic things (delusional ideas); severe distrust (paranoia).

Frequency Not Known:cannot be estimated from available data

• Thoughts of self-harm or suicide during treatment with this medication or shortly after stopping treatment (see section 2, "What You Need to Know Before You Start Taking Bupropion Teva"). 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.
• Sudden feeling of intense fear (panic attack).
• Stuttering.
• Decrease in 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 adverse effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) while taking Bupropion Teva with other 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 medication.

5. Storage of Bupropion Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication after 3 months after the first opening.

The unopened medication does not require any special storage temperature.

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

After the first opening: Do not store at a temperature above 25°C.

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

6. Package Contents and Additional Information

Composition ofBupropion Teva

The active ingredient is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride.

The other ingredients are:

• tablet core: hydroxypropyl cellulose (E463) (contains silicon dioxide), microcrystalline cellulose, stearic acid, magnesium stearate, purified water
• coating film:ethylcellulose (E462), hydroxypropyl cellulose, titanium dioxide (E171), triethyl citrate (E1505), methacrylic acid copolymer, talc (E553b).

Appearance of the Product and Package Contents

Bupropion Teva 150 mg is a white-cream to light yellow, round, biconvex tablet, approximately 8.1 mm in diameter.

Bupropion Teva 150 mg is available in child-resistant closure bottles containing 7, 30, or 90 tablets. The bottle cap contains an integrated desiccant to keep the tablets dry.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Manufacturer:

Teva Nederland B.V.

Swensweg 5

Haarlem

2031 GA

Netherlands

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa

2600

Bulgaria

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Date of the Last Revision of thisLeaflet:October 2024

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