Package Insert: Information for the Patient

Teva Bupropion 150 mg Modified Release Tablets EFG

Bupropion Hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for 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 package insert. 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 bupropion or any of the other ingredients in this medication (listed in section 6)

•If you are taking other medications that contain bupropion

•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 a program to stop drinking

•If you have a serious liver disease

•If you have stopped taking sedatives or plan to stop taking them while taking this medication

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

If you are in any of these situations, inform your doctor immediately anddo not takethis medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bupropion.

Children and adolescents

This medication 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 this medication:

•If you consume a lot of alcohol regularly

•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.

Bupropion Teva may 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 mentioned above. If you have a seizure during treatment, stop taking this medication. Do not take more and visit 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 inherited condition that affects heart rhythm) or if you have had a heart attack 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 risk of adverse effects is higher.

If you are in any of the situations mentioned above, consult your doctor before taking this medication. Your doctor 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 work, which is usually two weeks, but sometimes it may be longer.

It is likely that this will happen:

•If you have had thoughts of suicide or self-harm before

•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 who were being treated with some antidepressant.

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 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 concerned about changes in your behavior.

Taking Bupropión Teva with other medications

If you are taking or have taken antidepressant medications calledmonoamine oxidase inhibitors(MAOIs) in the last 14 days, inform your doctor and do not take this medication (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, herbal remedies or vitamins, even those purchased without a prescription. The doctor may change your bupropion dose or suggest a change in other medications.

Some medications should not be taken together with this medication. Some may increase the risk of seizures or convulsions. Others may increase the risk of other adverse effects. The following are some examples, although the list is not exhaustive.

You may be more likely to have 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 painkiller

•If you have been taking sedatives, or if you plan to stop taking them while taking bupropion (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 taking quinolone antibiotics

•If you are taking certain antihistamines that can cause drowsiness

•If you are taking medications to treat diabetes.

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

You may be more likely to have other adverse effects:

•If you are taking other medications for depression (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, duloxetine, desipramine or imipramine) or other mental illnesses (such as clozapine, risperidone, thioridazine or olanzapine).Bupropión Teva may 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 bupropion (carbamazepine, phenytoin, valproate)

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

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

•If you are taking a 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 this medication.

Bupropión may be less effective

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

If you are in this situation, inform your doctor. Your doctor will check if this medication is working properly for you. You may need to increase the dose or change to another treatment for your depression.

You should not increase the dose of this medication unless your doctor advises you to, as this may increase the risk of adverse effects, even seizures.

Bupropión may make other medications less effective:

•If you are taking tamoxifen used to treat cancer.

If you are in this situation, inform your doctor. You may need to change your treatment for depression.

•If you are taking digoxin for the heart.

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

Use of Bupropión Teva with alcohol

Alcohol may affect the way bupropion 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 this medication. Your doctor may recommend that you do not drink alcohol (beer, wine, spirits) or that you drink very small amounts while taking this medication. But if you currently consume a lot of alcohol, do not stop suddenly, as you may be at risk of having a seizure.

Consult your doctor about alcohol consumptionbefore starting your treatment with this medication.

Effect on urine tests

This medication 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 this medication.

Pregnancy and breastfeeding

Do not take this medication 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 this medication may pass into breast milk.

Driving and operating machinery

Do not drive or operate tools or machines if this medication makes you dizzy or drowsy.

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. In case of doubt, consult your doctor or pharmacist again.

You may need to wait some time before noticing an improvement. The medication takes time to exert its full effect, which can be weeks or months. When you start feeling better, your doctor will be able to advise you to continue your bupropion treatment to prevent depression from recurring.

What dose to take

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

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

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

The tablet is covered with a film that releases the medication slowly in your body. Sometimes you may notice that a kind of tablet appears 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, because if you do this, there is a risk of overdose due to the fact that the drug will be released very quickly in your body. This will increase the likelihood of adverse effects, including seizures.

Some people may maintain the 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 this medication. It may take several weeks or months before you notice any improvement. Discuss your symptoms with your doctor regularly so that they can decide on the duration of treatment. When you start feeling better, your doctor may recommend continuing treatment with bupropion to prevent symptoms of depression from recurring.

If you take more Bupropión Teva than you should

If you take too many tablets, you may increase the risk of suffering epileptic seizures or convulsions.Do not delay.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 Bupropión 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 compensate for the missed doses.

If you interrupt treatment with Bupropión Teva

Do not interrupt treatment with this medication or reduce the dose without having consulted your doctor first.

If you have any other questions about the use of 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

Approximately 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 than usual of experiencing seizures. If you have any doubts, ask your doctor.

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

•Swelling of eyelids, lips, or tongue.

•Muscle or joint pain.

•Syncope or fainting.

?If you experience any signs of an allergic reactionconsult 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-like skin rash 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 flares, skin rash, or lesions (especially in sun-exposed areas) while taking this medication, 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 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).
• Unsteadiness, tremor, weakness, fatigue, chest pain.
• Feeling anxious or agitated.
• Abdominal pain or digestive discomfort (constipation), taste alterations, loss of appetite (anorexia).
• Increased blood pressure, sometimes severe, flushing.
• Sound of ringing in the ears, visual disturbances.

Rare:may affect up to 1 in 100 people.

• Feeling depressed (see section 2 "Be especially 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.

• Convulsions.

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

• Palpitations, fainting.
• Widening of blood vessels, drop in blood pressure when standing, causing dizziness, confusion, or fainting.
• Muscle contractions, muscle stiffness, coordination problems, walking or coordination difficulties.
• Feeling anxious, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss.
• Yellowing 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.
• 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).

Unknown frequency:cannot be estimated from available data

• Suicidal thoughts or attempts during treatment with this medication 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 red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).
• Decreased sodium levels 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, coordination problems, 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 Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 CAD. The expiration date is the last day of the month indicated.

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

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.

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

Composition ofBupropión Teva

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

The other components are:

• tablet core::hydroxypropyl cellulose (E463) (contains silicon dioxide), microcrystalline cellulose silicified, stearic acid, magnesium stearate, purified water
• 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 contents of the packaging

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

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

Only some sizes of packaging may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Responsible manufacturer:

Teva Nederland B.V.

Swensweg 5

Haarlem

2031 GA

Netherlands

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa

2600

Bulgaria

For more information about this medicine, 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)

Last review date of thisleaflet:October 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/