Bupropion Teva 150 mg modified-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Bupropion Teva 150 mg modified-release tablets EFG

Hydrochloride bupropion

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

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

Bupropion Teva is a medicine prescribed by your doctor for the treatment of depression. It is believed to act on certain substances in the brain called noradrenaline and dopamine.

2. What you need to know before taking Bupropion Teva

Do not take Bupropion Teva

• If you are allergic to bupropion 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 or have had an eating disorder (for example, bulimia or anorexia nervosa)
• If you have a brain tumor
• If you consume 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 sedative medicines, or are about to stop taking them while on this medicine
• If you are taking or have taken other antidepressant medicines called monoamine oxidase inhibitors (MAOIs) within the last 14 days.

If you are in any of these situations, inform your doctor immediately and do not take this medicine.

Warnings and precautions

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

Children and adolescents

This medicine is not recommended for use in children under 18 years of age.

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

Adults

Tell your doctor before starting this medicine:

• If you regularly consume large amounts of alcohol
• If you have diabetes being treated with insulin or tablets
• If you have suffered a serious head injury or have previously had a head trauma.

Seizures (epileptic fits) have been observed in approximately 1 in 1,000 people taking Bupropion Teva. This adverse effect is more likely to occur in people who are in the situations listed above. If you experience a seizure during treatment, stop taking this medicine immediately. Do not take any more and see your doctor.

• If you have bipolar disorder (extreme mood swings), bupropion may trigger episodes of this illness
• If 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
• If you are taking other antidepressant medicines, using them together with Bupropion Teva may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Bupropion Teva” in this section)
• If you have liver or kidney disease, your risk of experiencing adverse effects is higher.

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

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase at the beginning of treatment with antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer.

This is more likely to happen:

• If you have previously had suicidal thoughts or thoughts of self-harm
• If you are a young adult. Clinical trial data show an increased risk of suicidal behaviour in antidepressant-treated psychiatric patients under 25 years of age.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to hospital immediately.

It may be helpful for you to tell a family member or close friend that you are depressed and ask them to read this leaflet. You may also ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behaviour.

Serious skin reactions

Serious skin reactions associated with bupropion have been reported, 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.

Taking Bupropion Teva with other medicines

If you are taking or have taken antidepressant medicines called monoamine oxidase inhibitors (MAOIs) within the last 14 days, inform your doctor and do not take this medicine (also see “Do not take Bupropion Teva” in section 2).

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, herbal remedies, or vitamins, even those obtained without a prescription. Your doctor may need to adjust your bupropion dose or suggest changes to your other medicines.

Some medicines should not be taken together with this medicine. Some of them may increase the risk of seizures or convulsions. Others may increase the risk of other adverse effects. Listed below are some examples, although the list is not complete.

The risk of seizures may increase:

• If you are taking other antidepressant medicines or medicines for other mental illnesses
• If you are taking theophylline, used to treat asthma or other lung diseases
• If you are taking tramadol, a strong painkiller
• If you have been taking sedative medicines, or are about to stop taking them while on bupropion (also see “Do not take Bupropion Teva” in section 2)
• If you are taking medicines to treat malaria (such as mefloquine or chloroquine)
• If you are taking stimulants or other medicines to control your weight or appetite
• If you are taking steroids (oral or injectable)
• If you are using antibiotics called quinolones
• If you are using certain antihistamines that may cause drowsiness
• If you are using medicines to treat diabetes.

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

The risk of other adverse effects may increase:

• If you are taking other antidepressant medicines (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or medicines for other mental illnesses (such as clozapine, risperidone, thioridazine or olanzapine). Bupropion Teva may interact with some medicines used to treat depression and you may experience changes in mental state (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, diarrhoea)
• If you are taking medicines for Parkinson’s disease (levodopa, amantadine or orphenadrine)
• If you are taking medicines that affect your body’s ability to eliminate bupropion (carbamazepine, phenytoin, valproate)
• If you are taking certain medicines used to treat cancer (such as cyclophosphamide, ifosfamide)
• If you are taking ticlopidine or clopidogrel, mainly used to prevent stroke
• If you are taking a beta-blocker medicine (such as metoprolol)
• If you are taking medicines to treat heart arrhythmias (propafenone or flecainide)
• If you are using nicotine patches to help you stop smoking.

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

Bupropion may be less effective

• If you are taking ritonavir or efavirenz, medicines used to treat HIV infection.

If you are in this situation, inform your doctor. Your doctor will check whether this medicine is working adequately for you. It may be necessary to increase the dose or switch to another treatment for your depression.

Do not increase the dose of this medicine unless advised by your doctor, as this may increase the risk of adverse effects, including seizures.

Bupropion may make other medicines less effective:

• If you are taking tamoxifen, used to treat cancer.

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

• If you are taking digoxin for heart problems.

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

Use of Bupropion Teva with alcohol

Alcohol may affect how bupropion works, and when taken together, it may rarely affect your nerves or mental state. Some people have reported being more sensitive to alcohol while taking this medicine. Your doctor may advise you not to drink alcohol (beer, wine, spirits) or to drink only very small amounts while taking this medicine. However, if you currently consume large amounts of alcohol, do not stop abruptly, as this may increase your risk of experiencing a seizure.

Talk to your doctor about alcohol consumption before starting treatment with this medicine.

Effect on urine tests

This medicine may interfere with certain urine tests used to detect other drugs or substances. If you need a urine test, inform 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 prescribed by your doctor. Consult your doctor or pharmacist before using this medicine. Some, but not all, studies have reported an increased risk of birth defects, particularly heart defects, in babies whose mothers took Bupropion Teva. It is not known whether 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 operate tools or machinery if this medicine causes you dizziness or drowsiness.

3. How to take Bupropion Teva

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

It may take some time before you start to notice an improvement. The medicine takes time to exert its full effect, which may take weeks or months. Once you begin to feel better, your doctor may advise you to continue your bupropion treatment to prevent depression from returning.

What dose to take

The usual recommended dose in adults is one 150 mg tablet per day.

If after several weeks you do not begin 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 coated with a film that slowly releases the medicine into your body. Occasionally, you may notice something resembling a tablet in your stools. This is the empty coating film that has passed through your intestine.

Swallow the tablets whole. Do not chew, crush, or divide them, as doing so may lead to overdose due to rapid release of the drug into your body. This increases the risk of adverse effects, including seizures (convulsions).

Some people may remain on a dose of one 150 mg tablet per day throughout treatment. Your doctor may prescribe this dose for 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 regularly with your doctor so they can determine the appropriate treatment duration. When you start to feel better, your doctor may recommend continuing bupropion treatment to prevent depressive symptoms from reappearing.

If you take more Bupropion Teva than you should

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

If you forget to take Bupropion Teva

If you miss a dose, wait and take the next dose at your usual time.

Do not take a double dose to make up for missed doses.

If you stop taking Bupropion Teva

Do not stop treatment with this medicine or reduce the dose without first consulting 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 notice any of the following serious adverse effects:

• Serious skin reactions Discontinue bupropion and seek immediate medical attention if you notice any of the following:

• Very rare: Reddish, flat spots on the trunk, often in the shape of targets or circles, frequently with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

• Not known frequency: Large areas with blisters and extensive skin peeling, occurring as a severe form of the serious skin reaction described above (toxic epidermal necrolysis).

• Not known frequency: 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).

• Not known frequency: 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).

• Seizures or convulsions

Approximately 1 in 1,000 people taking Bupropion Teva are at risk of experiencing a seizure (a fit or convulsion). This risk is higher if you take more tablets than prescribed, are taking certain other medicines, or have a higher-than-usual risk of seizures. If you have any doubts, consult your doctor.

?If you have a seizure, consult your doctor once you have recovered. Do not take any more tablets.

• Allergic reactions

Some people may have allergic reactions to bupropion, including:

• Skin redness or rash (urticaria) and hives.
• Unusual wheezing in the chest or difficulty breathing.
• Swelling of the eyelids, lips, or tongue.
• Pain in muscles or joints.
• Fainting or syncope.

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

Allergic reactions may last for a prolonged period. If your doctor prescribes any medication to treat allergy symptoms, make sure you complete the full course of treatment.

• Lupus rash or worsening of lupus symptoms

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

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

Other adverse effects

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

• Difficulty sleeping. Make sure to take this medicine 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, tremor, weakness, fatigue, chest pain.
• Feeling anxious or agitated.
• Stomach pain or digestive discomfort (constipation), changes in taste sensation, loss of appetite (anorexia).
• Increased blood pressure (sometimes severe), flushing.
• Ringing in the ears (tinnitus), visual disturbances.

Uncommon: may affect up to 1 in 100 people.

• Feeling depressed (see also section 2 “Take special care with Bupropion Teva, Suicidal thoughts and worsening of depression”).
• Confusion.
• Difficulty concentrating.
• Increased heart rate.
• Weight loss.

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

• Seizures.

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

• Palpitations, fainting.
• Vasodilation, drop in blood pressure upon standing causing dizziness, lightheadedness, or fainting.
• Muscle contractions, muscle stiffness, lack of motor coordination, walking or coordination problems.
• Restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss.
• Yellowing of the skin or whites of the eyes (jaundice), which may be associated with elevated liver enzymes or 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, urine leakage).
• Worsening of psoriasis (thickened, red skin patches).
• Unusual hair loss or thinning (alopecia).
• Feeling unreal or detached from oneself (depersonalization); seeing or hearing things that are not real (hallucinations); believing or thinking unreal 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 medicine or shortly after stopping treatment (see section 2, “What you need to know before starting to take Bupropion Teva”). If you have these thoughts, contact your doctor or go immediately to a hospital.
• 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.
• Decreased number of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).
• Low sodium levels in the blood (hyponatremia).
• Changes in mental state (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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) while taking Bupropion Teva together with other 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 Teva

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine more than 3 months after first opening.

For unopened medicine, no special storage temperature requirements apply.

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

After first opening: Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bupropion Teva

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

The other components are:

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

Appearance of the product and pack contents

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

Manufacturer:

Teva Nederland B.V.

Swensweg 5

Haarlem

2031 GA

The Netherlands

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa

2600

Bulgaria

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Date of the most recent revision of this leaflet: April 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/