BUPROPION CINFA 150 mg EXTENDED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Bupropion Cinfa 150 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

1. What Bupropion Cinfa is and what it is used for
2. What you need to know before you take Bupropion Cinfa
3. How to take Bupropion Cinfa
4. Possible side effects
5. Storage of 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 thought to work on certain substances in the brain called noradrenaline and dopamine.

2. What you need to know before you take Bupropion Cinfa

Do not take Bupropion Cinfa

• 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 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 sedatives, or are going to stop taking them while taking bupropion (see also section 2 "Do not take Bupropion Cinfa")
• if you are taking, or have taken in the last two weeks, other medicines for depression called monoamine oxidase inhibitors (MAOIs).

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

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 condition that affects heart rhythm) or if there has been a cardiac arrest or sudden death in your family.

Children and adolescents

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

In patients under 18 years of age, there is a greater risk of suicidal thoughts and attempts when being treated with antidepressants.

Adults

Tell your doctor before starting to take bupropion:

• if you regularly drink a lot of alcohol
• if you have diabetes that is being treated with insulin or oral tablets
• if you have had a severe head injury or have had a head trauma in the past.

It has been observed that bupropion can cause epileptic seizures (convulsions) in approximately 1 in 1,000 people. This side effect is more likely to occur in people who are in the situations mentioned above. If you have a seizure while taking bupropion, stop your treatment with bupropion immediately. Do not take it again and visit your doctor.

• if you have bipolar disorder (very pronounced mood swings), bupropion may cause episodes of this illness
• if you are taking other medicines for depression, the use of these medicines together with bupropion may cause serotonin syndrome, a potentially life-threatening condition (see also the section "Other medicines and Bupropion Cinfa")
• if you have any liver or kidney disease, the likelihood of having side effects is higher.

If you are in any of the situations mentioned above, talk to your doctor before taking bupropion, 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 yourself or committing suicide. These can increase at the start of treatment with antidepressants, as all these medicines take time to work, which is usually a few weeks, but sometimes 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 of age with psychiatric disorders who were being treated with some antidepressant.

If you have thoughts of self-harm or suicide at any time, talk to 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 or have anxiety disorders, and ask them to read this leaflet. You can also ask them to tell 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, vitamins, or herbal remedies, even those bought without a prescription. Your doctor may change the dose of bupropion or suggest a change in the other medicines.

Stop your treatment with bupropion and tell your doctor if you are taking, or have taken in the last two weeks, antidepressant medicines called monoamine oxidase inhibitors (MAOIs) (see also section 2 "Do not take Bupropion Cinfa").

Some medicines interact with bupropion. Some of them can increase the likelihood of having seizures or convulsions, and others can increase the risk of having other side effects. The following are some examples, although the list is not complete:

May increase the likelihood 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 pain reliever
• if you have been taking sedatives, or if you are going to stop taking them while taking bupropion (see also section 2 "Do not take Bupropion Cinfa")
• 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 use oral or injectable corticosteroids
• 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. Your doctor will assess the risks and benefits of taking bupropion.

May increase the likelihood 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 may interact with some medicines used to treat depression and may experience changes in mental status (e.g. agitation, hallucinations, coma) and other side effects, such as body temperature above 38 °C, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, 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 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 (metoprolol)
• if you take medicines to treat heart arrhythmias (propafenone, flecainide)
• if you use nicotine patches to help you quit smoking.

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

Bupropion may be less effective

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

Tell your doctor if you are taking any of these medicines. Your doctor will check if bupropion is working properly in you. It may be necessary to increase the dose or change to another treatment for your depression. Do not increasethe dose of bupropion unless your doctor advises you to, as this may increase the risk of having side effects, including seizures.

Bupropion 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.

Taking Bupropion Cinfa with alcohol

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

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

Effect on urine tests

Bupropion 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.

Pregnancy and breastfeeding

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

The components of bupropion may pass into breast milk. Talk to your doctor or pharmacist before taking bupropion.

Driving and using machines

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

Bupropion Cinfa contains sodium.

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

3. How to take Bupropion Cinfa

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 appropriate dose 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 treatment with bupropion to prevent depression from coming back.

What dose to take

The normal recommended dose in adults is one150 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 the bupropion tablets in the morning. Do not take bupropion more than once a day.

The tablet is covered by a film that releases the medicine slowly in your body. Sometimes you may notice that a kind of tablet appears in your stool. This is the empty film coating that has passed through your intestine.

Swallow the tablets whole. Do not chew, crush, or divide them, as this can lead to an overdose due to the medicine being released too quickly in your body, increasing the risk of having side 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.

Duration of treatment

Talk to your doctor, who will indicate the duration of treatment with bupropion according to you. It may take several weeks or months before you notice any improvement. Keep your doctor informed about your symptoms so that they can decide on the duration of treatment. Although you may start to feel better, your doctor may recommend continuing treatment with bupropion to prevent the symptoms of depression from coming back.

If you take more Bupropion Cinfa than you should

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, phone 91 562 04 20, indicating the medicine and the amount taken.

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

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 forgotten doses.

If you stop taking Bupropion Cinfa

Do not stop taking 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 all people suffer from them.

Severe Adverse Effects

Epileptic Seizures or Convulsions

Approximately 1 in every 1,000 people taking bupropion 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 seizures. If you have any doubts, ask your doctor.

Consult your doctor if you have an epileptic seizure and do not take any more tablets.

Allergic Reactions

Some people may have allergic reactions to bupropion, including:

• Redness or skin rash (hives), blisters, or hives on the skin. Some skin rashes may require hospitalization, especially if they are accompanied by swelling of the mouth and eyes.
• Abnormal appearance of "wheezing" in the chest or difficulty breathing.
• Swelling of the eyelids, lips, or tongue.
• Pain in muscles or joints.
• Fainting or fainting spells.

Consult your doctor if you have an allergic reaction and do not take any more tablets.

Allergic reactions can last for a long time. If your doctor prescribes any medication for this, make sure to complete the treatment.

Cutaneous Lupus Erythematosus or Worsening of Lupus Symptoms

Unknown frequency: the frequency cannot be estimated from the available data in people taking bupropion.

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

Acute Generalized Exanthematous Pustulosis (AGEP)

Unknown frequency: the frequency cannot be estimated from the available data in people taking bupropion.

The symptoms of AGEP include a rash with pus-filled blisters or pustules. If you experience a rash with pus-filled blisters or pustules, contact your doctor immediately, as it may be necessary to interrupt treatment.

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).
• Instability, tremors, weakness, fatigue, chest pain.
• Feeling anxious or agitated.
• Stomach pain or digestive discomfort (constipation), taste disturbances, loss of appetite (anorexia).
• Increased blood pressure (sometimes severe), flushing.
• Ringling 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.
• Accelerated 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, walking or coordination problems.
• Feeling of restlessness, irritability, hostility, aggression, nightmares, 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 along with 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 (thickening or redness of the skin).
• Loss or unusual thinning of hair (alopecia).
• Feeling of not being real or strange (dissociation); seeing or hearing things that do not exist (hallucinations); feeling or believing unrealistic things (delusional ideas); severe distrust (paranoia).

Unknown Frequency(cannot be estimated from the 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 taking Bupropion cinfa").If you have these thoughts, contact your doctor or go to the hospital immediately.
• Losing touch with reality and being unable to think or judge clearly (psychosis); other symptoms may include hallucinations and/or illusions.
• Sudden feeling of intense fear (panic attack).
• Stuttering.
• Decrease in the number of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia).
• Decrease in sodium levels in the blood (hyponatremia).
• Changes in mental state (such as agitation, hallucinations, coma) and other effects, such as body temperature above 38 °C, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea), while taking bupropion along with medications used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's pharmacovigilance system: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Bupropion cinfa

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. The expiration 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 should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. 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 cinfa

• The active ingredient is bupropion hydrochloride. Each modified-release tablet contains 150 mg of bupropion hydrochloride.
• The other ingredients are:
• • Core of the tablet: povidone, hydrochloric acid, stearic acid, and sodium
  • Coating: ethylcellulose, hydroxypropylcellulose, methacrylic acid copolymer and ethyl acrylate (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 Package Contents

White to light yellow, round, and biconvex tablets.

Presented in white opaque bottles 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 Last Revision of this Leaflet:November 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81595/P_81595.html

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