Prospect: information for the patient

Bupropion Teva 300 mg modified-release tablets EFG

Hidrocloruro de bupropión

Read this prospect carefully before starting to use this medication, as it contains important information for you

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, 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 not listed in this prospect. See section 4.

6. Contents of the pack and additional information

Bupropión Teva is a medication prescribed by your doctorfor the treatment of depression. It is believed to act on certain substances in the brain callednoradrenalineanddopamine.

Do not take Bupropión Teva:

•if you are allergic to bupropión or any of the other components of this medication (listed in section 6)

•if you are taking other medications that contain bupropión

•if you have been diagnosed with epilepsy or have a history of seizures

•if you have or have had an eating disorder (such as bulimia or anorexia nervosa)

•if you have a brain tumor

•if you consume large amounts of alcohol and are starting or planning to start alcohol withdrawal

•if you have severe liver disease

•if you have stopped taking sedatives or plan to stop taking them while taking Bupropión Teva

•if you are taking or have taken, within the last 14 days, other medications for depression called monoamine oxidase inhibitors (MAOIs).

If you are in any of these situations, inform your doctor immediately anddo not take Bupropión Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bupropión Teva.

Children and adolescents

Bupropión Teva is not recommended for the treatment of children under 18 years of age.

In patients under 18 years of age, there is a higher risk of suicidal thoughts and attempts when taking antidepressants.

Adults

Inform your doctor before starting to take Bupropión Teva:

•if you consume a lot of alcohol

•if you have diabetes 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 Bupropión Teva can cause seizures (convulsions) in approximately 1 in 1,000 people. This adverse effect is more likely to occur in people who are in the situations listed above. If you experience a seizure while taking Bupropión Teva, stop taking it. Do not take more and visit your doctor.

•if you have bipolar disorder (very pronounced mood swings), Bupropión Teva may cause episodes of this disease

•if you have a condition called Brugada syndrome (a rare hereditary condition that affects heart rhythm) or if you have had a cardiac arrest or sudden death in your family

•if you are taking other medications for depression, the use of these medications with Bupropión Teva may cause serotonin syndrome, a potentially fatal condition (see "Other medications and Bupropión Teva" in this section)

•if you have any liver or kidney disease, the likelihood of experiencing adverse effects is higher.

If you are in any of the situations listed above, consult your doctor before taking Bupropión Teva, who may decide to monitor you more closely or recommend another treatment.

Suicidal thoughts and worsening of depression

If you are depressed, you may have thoughts of harming yourself or committing suicide. These may increase at the beginning of treatment with antidepressants, as all these medications take time to take effect, which is usually around two weeks, but sometimes it can be longer.

It is likely that this will 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 an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders being treated with some antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to the 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 can also ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Other medications and Bupropión Teva

If you are taking or have taken monoamine oxidase inhibitors (MAOIs) within the last 14 daysinform your doctor and do not take Bupropión Teva(see also "Do not take Bupropión Teva" in section 2).

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including herbal remedies or vitamins, even those purchased without a prescription. The doctor may change your Bupropión Teva dose or suggest a change in other medications.

Some medications should not be taken with Bupropión Teva.Some of them may increase the likelihood of experiencing seizures or convulsions. Others may increase the risk of other adverse effects. The following are some examples, although the list is not exhaustive.

It may increase the likelihood of experiencing seizures

•if you are taking other medications 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 analgesic

•if you have been taking sedatives, or if you plan to stop taking them while taking Bupropión Teva (see also "Do not take Bupropión Teva" in section 2)

•if you are taking medications to treat malaria (such as mefloquine or chloroquine)

•if you are taking stimulants or other medications to control your weight or appetite

•if you are taking steroids (oral or injectable)

•if you are using quinolone antibiotics

•if you are using certain antihistamines that may cause drowsiness

•if you are taking medications to treat diabetes.

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

It may increase the likelihood of experiencing other adverse effects

•if you are taking other medications for depression (amitriptiline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepine, desipramine, or imipramine) or other mental illnesses (clozapine, risperidone, thioridazine, or olanzapine). Bupropión Tevamay interact with some medications used to treat depression and may experience changes in mental state (such as agitation, hallucinations, coma) and other adverse effects such as high body temperature, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea)

•if you are taking medications for Parkinson's disease (levodopa, amantadine, or orphenadrine)

•if you are taking medications that affect your body's ability to eliminate bupropión (carbamazepine, phenytoin, valproate)

•if you are taking some medications used to treat cancer (such as cyclophosphamide or ifosfamide)

•if you are taking ticlopidine or clopidogrel, used mainly to prevent stroke

•if you are taking any beta-blocker (such as metoprolol)

•if you are taking medications to treat arrhythmias of the heart (propafenone or flecainide)

•if you are using nicotine patches to help you quit smoking.

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

Bupropión Teva may be less effective

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

Inform your doctor if you are in this situation. Your doctor will check if Bupropión Teva is working properly for you. You may need to increase your dose or change to another treatment for your depression. Do not increase your Bupropión Teva dose without consulting your doctor, as this may increase the risk of experiencing adverse effects, including seizures.

Bupropión Teva may make other medications less effective

•if you are taking tamoxifen used to treat cancer.

Inform your doctor if you are in this situation. You may need to change your treatment for depression.

•if you are taking digoxin for the heart.

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

Use of Bupropión Teva and alcohol

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

Consult your doctor about alcohol consumption before starting your treatment with Bupropión Teva.

Effect on urine tests

Bupropión Teva may interfere with some urine tests used to detect other medications or substances. If you need a urine test, inform your doctor or the hospital that you are taking Bupropión Teva.

Pregnancy and breastfeeding

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

The components of Bupropión Teva may pass into breast milk. Consult your doctor or pharmacist before taking Bupropión Teva.

Driving and operating machinery

Do not drive or operate tools or machines if Bupropión Teva makes you dizzy or drowsy.

Bupropion Teva contains sodium

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

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

You may need to wait a while before you start noticing an improvement. The medication takes time to fully exert its action, which can be weeks or months. When you start feeling better, your doctor can advise you to continue your Bupropion Teva treatment to prevent depression from recurring.

What dose to take

Bupropion Teva is only available in 300 mg doses. For a 150 mg dose, use an 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 feeling an improvement, your doctor may increase the dose to 300 mg per day.

Take the Bupropion Teva tablets in the morning. Do not take Bupropion Teva more than once a day.

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 intestine.

Swallow the tablets whole. Do not chew, crush, or divide them, as this can increase the risk of overdose due to the rapid release of the medication in your body, increasing the likelihood of adverse effects, including seizures.

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

Treatment duration

Only you and your doctor can decide on the duration of treatment with Bupropion Teva. You may need several weeks or months to notice any improvement. Discuss your symptoms regularly with your doctor to decide on the treatment duration. When you start feeling better, your doctor may recommend continuing treatment with Bupropion Teva to prevent depression symptoms from recurring.

If you take more Bupropion Teva than you should

If you take too many tablets, you may increase the risk of seizures or convulsions.

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

If you forget to take Bupropion Teva

If you forget to take a dose, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Bupropion Teva

Do not interrupt treatment with Bupropion Teva or reduce the dose without consulting your doctor first.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Inform your doctor immediately if you notice any of the following severe side effects:

• Seizures or convulsions

About 1 in 1,000 people who take Bupropion Teva have a risk of experiencing 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 experiencing seizures than usual. If you have any doubts, ask your doctor.

?If you experience a 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 "pops" in the chest or difficulty breathing.

•Swelling of the eyelids, lips, or tongue.

•Muscle or joint pain.

•Fainting or dizziness.

?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.

• Skin rash due to lupus or worsening of lupus symptoms

Unknown frequency (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 exposed areas) while taking Bupropion Teva, contact your doctor immediately, as it may be necessary to discontinue treatment.

• Acute generalized exanthematous pustulosis (AGEP)

Unknown frequency (frequency cannot be estimated from available data).

AGEP symptoms include a rash with pus-filled blisters.

?If you experience a rash with pus-filled blisters, contact your doctor immediately, as it may be necessary to discontinue treatment.

Other side 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, tremors, weakness, fatigue, chest pain.

•Feeling anxious or agitated.

•Stomach pain or digestive discomfort (constipation), taste alterations, loss of appetite (anorexia).

•Increased blood pressure sometimes severe, flushing.

•Feeling of hearing bells, visual disturbances.

Uncommon:may affect up to 1 in 100 people.

•Feeling depressed (see section 2 "Be careful with 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.

• Enlargement of blood vessels, decrease in blood pressure when standing that causes dizziness, confusion, or fainting.

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

•Feeling anxious, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss.

•Yellow discoloration of the skin or white 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 may be life-threatening.

•Worsening of psoriasis (thickened, red skin plaques).

• Unusual hair loss or thinning (alopecia).

•Feeling unreal or strange (derealization); seeing or hearing things that do not exist (hallucinations); feeling or believing things that are not real (delusions); severe distrust (paranoia).

Frequency not known: cannot be estimated from available data

•Suicidal thoughts or suicidal behavior during treatment with Bupropion Teva or shortly after discontinuing treatment (see section 2, "What you need to know before starting Bupropion Teva"). If you experience 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 intense fear (panic attack).

•Stammering.

•Reduction in the number of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).

•Decrease in sodium in the blood (hyponatremia).

• Changes in mental state (e.g. agitation, hallucinations, coma) and other side effects such as high body temperature, 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 of 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 the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CADor EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofBupropion Teva

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

The other components are:

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

Coating film: 100 mPas ethylcellulose, 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 package

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 pre-cut single-dose blisters of OPA/Alu/PVC-Alu containing 30 x 1 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible 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, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible 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 with 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 mgtablete sprirejenim sproščanjem

Spain:Bupropión Teva 300 mg comprimidos de liberación modificada EFG

Norway:Bupropion hydrochloride Teva

Sweden:Bupropion Teva

Last review date of thisleaflet: November 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83663/P_83663.html

QR+URL