Bupropion cinfa 150 mg comprimidos de liberacion modificada efg

Package Leaflet: Information for the User

Bupropion cinfa 150 mg Modified Release EFG Tablets

bupropion hydrochloride

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Bupropión cinfa is a prescription medication prescribed by your doctor for the treatment of depression. It is believed to act on certain substances in the brain callednoradrenaline and dopamine.

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 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 (for example, bulimia or anorexia nervosa)
• if you have a brain tumor
• if you drink large amounts of alcohol and are starting or planning to start alcohol withdrawal
• if you have a serious liver disease
• if you have stopped taking sleeping pills or are planning to stop taking them while taking bupropion
• 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 take bupropion.

Warnings and precautions

Consult 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 the heart rhythm) or if you have had a heart attack 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 higher risk of thoughts and attempts of suicide when taking antidepressants.

Adults

Inform your doctor before starting to take bupropion:

• if you 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.

Bupropion has been observed to 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 have a seizure while taking bupropion, stop taking bupropion and do not take it again. Visit your doctor.

• if you have bipolar disorder (very pronounced mood swings), bupropion may cause episodes of this disease
• if you are taking other medicines for depression, the use of these medicines with bupropion may cause serotonin syndrome, a potentially fatal condition (see also the section “Other medicines and Bupropion cinfa”)
• if you have any liver or kidney disease, the risk of adverse effects is higher.

If you are in any of these situations, consult your doctor before taking bupropion. Your doctor may decide to monitor you more closely or recommend another treatment for your depression.

Thoughts of suicide and worsening of your depression

If you are depressed, you may have thoughts of harming yourself or suicidal thoughts. These may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, which is usually two weeks, but sometimes it may be longer. This is likely to 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 of age with psychiatric illnesses who were being treated with some antidepressant.

If you have thoughts of harming yourself or suicidal thoughts 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 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

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

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

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

May increase the risk of seizures

• if you are taking other medicines 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 are planning to stop taking them while taking bupropion (see also the section 2 “Do not take Bupropion cinfa”)
• if you are taking medicines to treat malaria (such as mefloquine or chloroquine)
• if you are taking stimulants or other medicines to control your weight or appetite
• if you are using corticosteroids (oral or injectable)
• if you are using quinolone antibiotics
• if you are using certain antihistamines that may cause drowsiness
• if you are taking 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 taking bupropion.

May increase the risk of other adverse effects

• if you are taking other medicines for depression (amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, duloxetine, 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 state (e.g., agitation, hallucinations, coma) and other adverse effects, such as high body temperature, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
• if you are taking antiparkinsonian medicines (levodopa, amantadine, or orphenadrine)
• if you are taking medicines that affect your body's ability to eliminate bupropion (carbamazepine, phenytoin, valproate)
• if you are taking some medicines 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 beta-blockers (metoprolol)
• if you are taking medicines to treat heart arrhythmias (propafenone, 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 bupropion.

Bupropion may be less effective

• if you are taking ritonavir or efavirenz, medicines to treat HIV (AIDS).

Inform your doctor if you are taking any of these medicines. Your doctor will check if bupropion is working properly for you. You may need to increase your dose or change to another treatment for your depression. Do not increase your bupropion dose without consulting your doctor, as this may increase the risk of adverse effects, including seizures.

Bupropion may make other medicines 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 your heart

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

Taking Bupropion cinfa with alcohol

Alcohol may affect the way bupropion works and, when taken together, may rarely affect your nerves or mental state. Some people have noticed that they are more sensitive to alcohol during treatment with bupropion. Your doctor may recommend that you do not drink alcohol (beer, wine, spirits) or that you 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.

Consult your doctor about alcohol consumption before starting your 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, inform your doctor or the 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. Consult 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. Consult your doctor or pharmacist before taking bupropion.

Driving and operating machinery

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

Bupropion cinfa contains sodium.

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

Follow exactly the administration instructions of this medication 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 a while before you start 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 may 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 feeling 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 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 may increase the risk of overdose due to 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 dayfor the entire treatment. Your doctor may prescribe this dose in patients with liver or kidney problems.

Treatment duration

Consult with your doctor, who will advise you on the duration of treatment withbupropion. It may take several weeks or months before you notice any improvement. Keep your doctor informed regularly about your symptoms so they can decide on the duration of treatment. Although you may start feeling better, your doctor may recommend continuing treatment with bupropion to prevent symptoms of depression from recurring.

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 room or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot 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 compensate for the missed doses.

If you interrupt treatment with Bupropion cinfa

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Severe side effects

Seizures or convulsions

Approximately 1 in 1,000 people who take bupropion 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. If you have any doubts, ask your doctor.

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

Allergic reactions

Some people may have allergic reactions to bupropion, including:

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

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

Systemic lupus erythematosus or worsening of lupus symptoms

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

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

Generalized Acute Pustular Exanthema (PEGA)

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

The symptoms of PEGA 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 side effects(may affect more than 1 in 10 patients):

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

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

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

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

Unknown frequency(cannot be estimated from the available data):

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

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 store at a temperature above 25°C.

Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and themedications that you no longer need at the SIGREcollection point of the pharmacy. Ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Bupropion cinfa

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

Appearance of the product and content of the packaging

White to light yellowish round, biconvex tablets.

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

Each bottle contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:November 2024

Detailed information about this medication 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 medication by scanning with your smartphone the QR code included in the leaflet and 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 to:https://cima.aemps.es/cima/dochtml/p/81595/P_81595.html