Bupropion Teva 300 mg modified-release tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Bupropion Teva 300 mg modified-release tablets EFG

Bupropion hydrochloride

Read this entire leaflet carefully before you start using 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 work 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 drink 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 them while taking Bupropion Teva
• if you are taking or have taken, within the last 14 days, other antidepressant medicines known as monoamine oxidase inhibitors (MAOIs).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Bupropion Teva.

Children and adolescents

Bupropion Teva 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 suicide attempts when being treated with antidepressants.

Adults

Tell your doctor before starting Bupropion Teva:

• if you regularly drink large amounts of alcohol
• if you have diabetes being treated with insulin or tablets
• if you have suffered a serious head injury or have had a head trauma in the past.

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 while taking Bupropion Teva, stop treatment immediately. Do not take any more and see your doctor.

• if you have bipolar disorder (extreme mood swings), Bupropion Teva 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, as using these 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, the likelihood of experiencing adverse effects is higher.

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

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase at the beginning of antidepressant treatment, as all these medicines take some 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 behavior in adults under 25 years of age with psychiatric disorders who are being treated with antidepressants.

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

It may be helpful for you to explain to 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 behavior.

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). Discontinue use of bupropion and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Other medicines and Bupropion Teva

If you are taking or have taken antidepressant medicines known asmonoamine oxidase inhibitors (MAOIs) within the last 14 days**, inform your doctor and do not take Bupropion Teva** (see also “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 the dose of Bupropion Teva or recommend changes to your other medicines.

Some medicines should not be taken with Bupropion Teva. Some of these 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 exhaustive.

May increase the risk of seizures

• if you are taking other medicines for depression or 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 if you are about to stop them while taking Bupropion Teva (see also “Do not take Bupropion Teva” in section 2)
• if you are taking medicines for 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 known as quinolones
• if you are using certain antihistamines that may cause drowsiness
• if you are using medicines for diabetes.

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

May increase the risk of other adverse effects

• if you are taking other medicines for depression (amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or other mental illnesses (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 rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
• 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 or 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 for 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 Bupropion Teva.

Bupropion Teva may be less effective

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

Inform your doctor if you are in this situation. Your doctor will check whether Bupropion Teva 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 Bupropion Teva unless advised by your doctor, as this may increase the risk of adverse effects, including seizures.

Bupropion Teva may make other medicines less effective

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

Inform your doctor if you are in this situation. It may be necessary to change your treatment for depression.

• if you are taking digoxin for heart conditions.

Inform your doctor if you are in this situation. Your doctor may consider adjusting the dose of digoxin.

Use of Bupropion Teva and alcohol

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

Talk to your doctor about alcohol consumption before starting treatment with Bupropion Teva.

Effect on urine tests

Bupropion Teva 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 Bupropion Teva.

Pregnancy and breastfeeding

Do not take Bupropion Teva 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.

Components of Bupropion Teva may pass into breast milk. Consult your doctor or pharmacist before taking Bupropion Teva.

Driving and using machines

Do not drive or operate tools or machinery if Bupropion Teva causes you to feel dizzy or lightheaded.

Bupropion Teva contains sodium

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

3. How to take Bupropion Teva

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. The recommended doses are listed below, but your doctor will advise you on the dose appropriate 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 treatment with Bupropion Teva to prevent depression from returning.

What dose to take

Bupropion Teva is only available in 300 mg strength. For the 150 mg dose, use another alternative product available on the market.

The usual recommended dose in adults is one 150 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 Bupropion Teva tablets in the morning. Do not take Bupropion Teva more than once a day.

The tablet is film-coated and releases the medicine slowly into your body. Sometimes 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 cause an overdose due to rapid release of the drug into your body, increasing 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 how long treatment with Bupropion Teva should last. It may take several weeks or months before you notice any improvement. Regularly discuss your symptoms with your doctor so they can determine the appropriate duration of treatment. When you start to feel better, your doctor may recommend continuing treatment with Bupropion Teva to prevent symptoms of depression from reappearing.

If you take more Bupropion Teva than you should

If you take too many tablets, your risk of experiencing epileptic fits or seizures may increase.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to an emergency department, 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 the 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 Bupropion Teva 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

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

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

• Frequency not known: Large areas with blistering and extensive peeling of the skin, 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 typically 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 having 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-normal risk of seizures. If you have any doubts, ask 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 Teva, including:

• Redness or skin rash (urticaria) and skin welts.
• Unusual "wheezing" in the chest or difficulty breathing.
• Swelling of the eyelids, lips, or tongue.
• Pain in muscles or joints.
• Fainting or collapse.

?If you experience 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 medication to treat allergy symptoms, make sure you complete the full course of treatment.

• Skin rash due to lupus 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 Bupropion Teva, contact your doctor immediately, as treatment may need to be discontinued.

Other adverse effects

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

• Difficulty sleeping. Make sure to take Bupropion Teva 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).
• Unsteadiness, 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.
• Ringing in the ears, visual disturbances.

Uncommon: may affect up to 1 in 100 people.

• Feeling depressed (see also section 2 “Special warnings about Bupropion Teva, Suicidal thoughts, and worsening of depression”).
• Feeling confused.
• 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.

• Dilation of blood vessels, drop in blood pressure upon standing causing dizziness, lightheadedness, or fainting.

• Muscle contractions, muscle stiffness, lack of coordination of movements, difficulty walking or coordination problems.

• Feelings of 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 together 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 (thickened, red skin patches).

  • Unusual hair loss or thinning (alopecia).

• Feeling detached or unreal (depersonalization); seeing or hearing things that are not there (hallucinations); believing or thinking unreal things (delusional ideas); severe distrust (paranoia).

Frequency not known: cannot be estimated from available data

• Thoughts of harming yourself or of suicide during treatment with Bupropion Teva or shortly after stopping treatment (see section 2, “What you need to know before starting 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.

• Decrease 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 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, diarrhoea) 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: 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 container, after CAD or EXP. The expiry date refers to 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 Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. 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 300 mg of bupropion hydrochloride.

The other components are:

Tablet core: povidone, monohydrate of cysteine hydrochloride, anhydrous colloidal silica, glycerol dibehenate, magnesium stearate (E 470b).

Film coating: ethylcellulose 100 mPas, povidone, macrogol, copolymer of methacrylic acid and ethyl acrylate (1:1) containing sodium lauryl sulfate and polysorbate 80, hydrated colloidal silica, triethyl citrate.

Printing ink: shellac, iron oxide black (E172) and propylene glycol.

Appearance of the product and contents of the pack

Bupropion Teva 300 mg is a white-cream to light yellow, round tablet, marked with "GS2" on one side and the other side smooth.

The tablet diameter is approximately 9.3 mm.

Blister packs made of OPA/Alu/PVC-Alu containing 7, 10, 30, 60 and 90 tablets. Also available in single-dose precut blisters of OPA/Alu/PVC-Alu containing 30 x 1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

Local representative:

Teva Pharma S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer:

LABORATORI FUNDACIÓ DAU

c/ c, 12-14

Pol. Ind. Zona Franca

08040 Barcelona

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria: Bupropion ratiopharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung

Germany: Bupropion-ratiopharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung

The Netherlands: Bupropion HCl retard Teva 300 mg, tabletten met gereguleerde afgifte

Slovenia: Bupropion Teva 300 mg tablete sproščevanjem načrtovanim sproščanjem

Spain: Bupropión Teva 300 mg comprimidos de liberación modificada EFG

Norway: Bupropion hydrochloride Teva

Sweden: Bupropion Teva

Date of the most recent review of this package leaflet: April 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83663/P_83663.html

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