Bupropion Cinfa 150 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bupropion cinfa 150 mg modified-release tablets EFG

bupropion hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to other people even if they have the same symptoms as you, because 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 cinfa is and what it is used for
2. What you need to know before taking Bupropion cinfa
3. How to take Bupropion cinfa
4. Possible side effects
5. How to store Bupropion cinfa
6. Contents of the pack and other information

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

Bupropion cinfa 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 cinfa

Do not take Bupropion cinfa

• 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 sleeping medications or are about to stop them while taking bupropion
• if you are taking, or have taken within the last two weeks, 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.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Bupropion cinfa.

Brugada syndrome

If you have a condition called Brugada syndrome (a rare inherited disorder affecting heart rhythm), or if there has been cardiac arrest or sudden death in your family.

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.

Children and adolescents

Bupropion is not recommended for use in children and adolescents 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:

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

Seizures (epileptic fits) have been observed in approximately 1 in 1,000 people taking bupropion. This adverse effect is more likely to occur in individuals who are in the situations listed above. If you experience a seizure while taking bupropion, stop treatment with bupropion. Do not take it again and see your doctor.

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

If you are in any of the above situations, consult your doctor before taking bupropion, who 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 thoughts of suicide or self-harm
• if you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age being treated with antidepressants.

If at any time you have thoughts of harming yourself or committing suicide, 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 or have anxiety disorders, and ask them to read this leaflet. You may also ask them to inform you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Other medicines and Bupropion cinfa

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

Stop taking bupropion and inform your doctor if you are taking or have taken antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) within the last two weeks (see also section 2 “Do not take Bupropion cinfa”).

Some medicines interact with bupropion. Some may increase the risk of seizures or convulsions, while others may increase the risk of other adverse effects. Listed below are some examples, although the list is not complete:

May increase the risk of 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 sedative medicines, or are about to stop taking them while on bupropion (see also section 2 “Do not take Bupropion cinfa”)
• if you take medicines for malaria (such as mefloquine or chloroquine)
• if you take stimulants or other medicines to control your weight or appetite
• if you use corticosteroids (oral or injectable)
• if you use antibiotics known as quinolones
• if you use certain antihistamines that may cause drowsiness
• if you use medicines to treat diabetes.

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

May increase the risk of other adverse 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 may interact with some antidepressants 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 take antiparkinsonian medicines (levodopa, amantadine, or orphenadrine)
• if you take medicines that affect your body's ability to eliminate bupropion (carbamazepine, phenytoin, valproate)
• if you take certain medicines used to treat cancer (such as cyclophosphamide or ifosfamide)
• if you take ticlopidine or clopidogrel, mainly used to prevent stroke
• if you take a beta-blocker medicine (metoprolol)
• if you take medicines for heart arrhythmias (propafenone, flecainide)
• if you use nicotine patches to help you quit smoking.

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

Bupropion may be less effective

• if you take ritonavir or efavirenz, medicines used to treat HIV infection (AIDS).

Inform your doctor if you are taking any of these medicines. Your doctor will check whether bupropion is working adequately for you. It may be necessary to increase the dose or switch to another treatment for your depression. You must not increase the dose of bupropion 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 take tamoxifen used for cancer treatment.

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

• if you take digoxin for heart problems

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

Taking Bupropion cinfa 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 during treatment with bupropion. Your doctor may advise you not to drink alcohol (beer, wine, spirits) or to drink only very small amounts while taking bupropion. If you currently consume large amounts of alcohol, do not stop abruptly, as you may be at risk of experiencing a seizure.

Consult your doctor about alcohol consumption before starting treatment with bupropion.

Effect on urine tests

Bupropion may interfere with certain urine tests used to detect other medicines or substances. If you need a urine test, inform your doctor or hospital that you are taking bupropion.

Pregnancy and breastfeeding

Do not take bupropion if you are pregnant, think you might 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. It is not known whether this is due to bupropion use.

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

Driving and using machines

Do not drive or operate tools or machinery if bupropion causes you dizziness or drowsiness.

Bupropion cinfa contains sodium.

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

3. How to take Bupropion cinfa

Follow exactly the instructions for using this medicine as given 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.

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.

When you start 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 bupropion tablets in the morning. Do not take bupropion more than once a day.

The tablet is coated with a film that slowly releases the medicine into your body. Occasionally, you may notice a tablet-like substance in your stools. This is the empty coating that has passed through your intestine.

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

Some people may maintain the 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

Consult your doctor, who will determine, in agreement with you, the duration of treatment with bupropion. It may take several weeks or months before you notice any improvement. Keep your doctor regularly informed about your symptoms so that they can decide on the appropriate duration of treatment. Even if you start to feel better, your doctor may recommend continuing bupropion treatment to prevent the return of depressive symptoms.

If you take more Bupropion cinfa than you should

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, stating the medicine and the amount ingested.

If you take more tablets than prescribed by your doctor, your risk of experiencing epileptic seizures or convulsions may increase.

If you forget to take Bupropion cinfa

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 missed doses.

If you stop taking Bupropion cinfa

Do not stop treatment with bupropion 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

Seizures or convulsions

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

Contact your doctor if you experience a seizure and do not take any more tablets.

Allergic reactions

Some people may experience 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.

Contact your doctor if you experience an allergic reaction and do not take any more tablets.

Allergic reactions can last for a prolonged period. If your doctor prescribes any medication for this, make sure you complete the full course of treatment.

Severe skin reactions:

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

• Very rare frequency: Flat, red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Frequency not known: Large areas with blisters and extensive skin peeling, 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, AGEP).

Cutaneous lupus erythematosus or worsening of lupus symptoms

Frequency not known: frequency cannot be estimated from available data in people taking bupropion.

Lupus is an immune system disorder that affects the skin and other organs. If you experience a lupus flare-up, skin rash, or lesions (especially in sun-exposed areas) while taking bupropion, contact your doctor immediately, as treatment interruption may be necessary.

Acute Generalized Exanthematous Pustulosis (AGEP)

Frequency not known: frequency cannot be estimated from available data in people taking bupropion.

Symptoms of AGEP include a rash with pus-filled bumps or blisters. If you develop a rash with pus-filled bumps or blisters, contact your doctor immediately, as treatment interruption may be necessary.

Other adverse effects

Very common adverse effects (may affect more than 1 in 10 patients):

• Difficulty sleeping. Make sure to take bupropion in the morning.
• Headache.
• Dry mouth.
• Nausea, vomiting.

Common adverse effects (may affect up to 1 in 10 patients):

• 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), changes in taste sensation, loss of appetite (anorexia).
• Increased blood pressure (sometimes severe), flushing.
• Sensation of ringing in the ears, vision disturbances.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Feeling depressed (see also section 2 “Warnings and precautions. Suicidal thoughts and worsening of depression”).
• Confusion.
• Difficulty concentrating.
• Increased heart rate.
• Weight loss.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Seizures.

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• Palpitations, fainting.
• Muscle contractions, muscle stiffness, lack of coordination in movement, difficulty walking or coordination problems.
• Restlessness, irritability, hostility, aggression, nightmares, tingling or numbness, memory loss.
• Yellowing of the skin or whites of the eyes (jaundice), which may be associated with elevated liver enzymes and 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 (plaques of thickened or reddened skin).
• Unusual hair loss or thinning (alopecia).
• Feelings of unreality or strangeness (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):

Other adverse effects have occurred in a small number of people, but their exact frequency is unknown:

• Thoughts of self-harm or suicide during treatment with bupropion or shortly after stopping treatment (see section 2, “What you need to know before starting Bupropión cinfa”). If you have such thoughts, contact your doctor or go immediately to a hospital.
• Loss of touch with reality and inability to think or judge clearly (psychosis); other symptoms may include hallucinations and/or illusions.
• Sudden intense fear (panic attack).
• Stuttering.
• Decreased number of 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 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 together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of adverse effects

If you experience any type of 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 cinfa

Keep this medicine out of 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 store above 25°C.

Keep in the original packaging to protect from light and moisture.

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. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bupropion cinfa

• The active substance is bupropion hydrochloride. Each modified-release tablet contains 150 mg of bupropion hydrochloride.
• The other components are:
  • Tablet core: povidone, hydrochloric acid, stearic fumarate and sodium
  • Coating: ethylcellulose, hydroxypropylcellulose, methacrylic acid and ethyl acrylate copolymer (1:1) type A, anhydrous colloidal silica, macrogol 1500, triethyl citrate, and Opadry clear YS-1-7006 (hypromellose, macrogol 400 and macrogol 8000).

Appearance of the product and contents of the pack

White to pale yellow, round, biconvex tablets.

Presented in opaque white bottles closed with a child-resistant screw cap containing silica gel.

Each bottle contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: January 2026

Detailed 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81595/P_81595.html

QR code: https://cima.aemps.es/cima/dochtml/p/81595/P_81595.html