BUPROPION TEVA 300 mg EXTENDED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Bupropion Teva 300 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 (e.g. bulimia or anorexia nervosa)
• if you have a brain tumor
• if you drink a lot 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 about to stop taking them while taking Bupropion Teva
• if you are taking or have taken in the last 14 days other medicines for depression called monoamine oxidase inhibitors (MAOIs).

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Bupropion Teva.

Children and adolescents

Bupropion Teva is not recommended for use in children under 18 years of age.

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

Adults

Tell your doctor before you start taking Bupropion Teva:

• if you regularly drink a lot of alcohol
• if you have diabetes treated with insulin or tablets
• if you have had a severe head injury or have had a previous head trauma.

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

• if you have bipolar disorder (very pronounced mood swings), Bupropion Teva may cause episodes of this illness
• if you have a condition called Brugada syndrome (a rare inherited condition 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, using 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 having side effects is higher.

If you are in any of the above situations, talk to your doctor before taking Bupropion Teva, who 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 start 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 thoughts of killing or harming yourself
• if you are a young adult. There is information from clinical trials that shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who are being treated with some antidepressants.

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

It may be helpful for you to tell a relative or close friend that 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.

Other medicines and Bupropion Teva

If you are taking or have taken in the last 14 days medicines for depression calledmonoamine oxidase inhibitors(MAOIs), tell 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 take any other medicines, herbal remedies or vitamins, including those bought without a prescription. Your doctor may change your dose of Bupropion Teva or suggest a change in the other medicines.

Some medicines must not be taken with Bupropion Teva.Some of them can increase the chance 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 chance 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 Teva (see also "Do not take Bupropion Teva" in section 2)
• if you take medicines to treat 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 by injection)
• if you use antibiotics called quinolones
• if you use certain antihistamines that can cause drowsiness
• if you use medicines to treat diabetes.

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

May increase the chance of having other side effects

• if you take 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 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 (e.g. 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 to treat 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 Bupropion Teva.

Bupropion Teva may be less effective

• if you take ritonavir or efavirenz, medicines to treat HIV infection.

Tell your doctor if you are in this situation. Your doctor will check if Bupropion Teva 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 Bupropion Teva unless your doctor advises you to, as this may increase the risk of having side effects, including seizures.

Bupropion Teva may make other medicines less effective

• if you take tamoxifen used to treat cancer.

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

• if you take digoxin for your heart.

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

Using Bupropion Teva and alcohol

Alcohol may affect how Bupropion Teva works and, when taken together, can rarely affect your nerves or mental state. Some people have noticed that they are more sensitive to alcohol while taking Bupropion Teva. Your doctor may advise you not to drink alcohol (beer, wine, spirits) or to drink very small amounts while taking Bupropion Teva. But if you currently drink a lot of alcohol, do not stop suddenly, as you may be at risk of having a seizure.

Ask your doctor about drinking alcohol before you start taking Bupropion Teva.

Effect on urine tests

Bupropion Teva 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 Bupropion Teva.

Pregnancy and breastfeeding

Do not take Bupropion Teva if you are pregnant, think you may be pregnant or are planning to have a baby, unless your doctor prescribes it for you. Ask your doctor or pharmacist for advice before taking 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 Bupropion Teva may pass into breast milk. Ask your doctor or pharmacist for advice before taking Bupropion Teva.

Driving and using machines

Do not drive or use tools or machines if Bupropion Teva makes you feel dizzy or drowsy.

Bupropion Teva contains sodium

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

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 taking Bupropion Teva to prevent your depression from coming back.

What dose to take

Bupropion Teva is only available in 300mg doses. For a 150mg dose, use an alternative product available on the market.

The usual recommended dose in adults is one150mg tablet per day.

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

Take Bupropion Teva tablets in the morning. Do not take Bupropion Teva 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 stools. This is the empty film coating that has passed through your intestines.

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

Some people may stay on a dose of one 150mg tablet per day throughout their 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 Bupropion Teva. 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 taking Bupropion Teva to prevent your 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.

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, telephone: 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 Bupropion Teva or reduce the dose without first talking to your doctor.

If you have any further questions on the use of this product, 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 Teva, 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.

• Muscle or joint pain.

• Fainting or loss of consciousness.

If you experience 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 flare-ups, skin rash, or lesions (especially in areas exposed to the sun) while taking Bupropion Teva, contact your doctor immediately, as it may be necessary to interrupt treatment.

• Acute Generalized Exanthematous Pustulosis (AGEP)

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

AGEP symptoms include rash with pus-filled blisters/grains.

If you have a rash with pus-filled blisters/grains, 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 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).
• 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.
• Feeling of ringing in the ears, vision disturbances.

Uncommon:may affect up to 1 in 100 people.

• Feeling depressed (see also section 2, "What you need to know before taking Bupropion Teva", "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, fainting, or loss of consciousness.
• 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).
• Unusual hair loss or thinning (alopecia).

• Feeling of being unreal or strange (dissociation); 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 Bupropion Teva or shortly after stopping treatment (see section 2, "What you need to know before 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 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, 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging, after CAD or EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Bupropion Teva

The active ingredient is bupropion hydrochloride. Each tablet contains 300 mg of bupropion hydrochloride.

The other ingredients are:

Core of the tablet: povidone, cisteine hydrochloride monohydrate, anhydrous colloidal silica, dibehenate, magnesium stearate (E 470b).

Coating: ethylcellulose 100 mPas, povidone, macrogol, methacrylic acid - ethyl acrylate copolymer (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 Package Contents

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

The diameter of the tablet is approximately 9.3 mm.

OPA/Alu/PVC-Alu blisters containing 7, 10, 30, 60, and 90 tablets. Also available in precut unit-dose OPA/Alu/PVC-Alu blisters containing 30 x 1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Local Representative:

Teva Pharma S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer:

LABORATORI FUNDACIÓ DAU

c/ c, 12-14

Pol. Ind. Zona Franca

08040 Barcelona

Spain

This medicine is authorized 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

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

Slovenia: Bupropion Teva 300 mg tablete sprirejenim sprošcanjem

Spain: Bupropión Teva 300 mg comprimidos de liberación modificada EFG

Norway: Bupropion hydrochloride Teva

Sweden: Bupropion Teva

Date of the Last Revision of this Leaflet: November 2024

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

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). 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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