Elontril 300 mg comprimidos de liberacion modificada

Prospecto:Information for the User

Elontril 300 mg Modified Release Tablets

bupropion hydrochloride

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey do not appear in this prospectus. See section 4.

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

Do not take Elontril

• if you are allergicto bupropion or any of the other ingredients in 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(such as bulimia or anorexia nervosa)
• if you have a brain tumor
• if you drink large amounts of alcoholand are starting or planning to start a program to stop drinking
• if you have a serious liver disease
• if you have stopped taking sleeping pillsor plan to stop taking them whileyou are taking Elontril
• if you have taken,in the last two weeks,other antidepressant medicinescalledmonoamine oxidase inhibitors(MAOIs).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Elontril.

Brugada Syndrome

- if you have a condition called Brugada Syndrome (a rare inherited disorder that affects heart rhythm) or if you have had a heart attack or sudden death in your family.

Children and adolescents

Elontril 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 Elontril:

• if you drink a lot of alcohol
• if you have diabetesthat 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.

Elontril has been observed to cause seizures (convulsions) in approximately 1 in 10,000 people. This adverse effect is more likely to occur in people who are in the situations mentioned above. If you have a seizure while taking Elontril,stop taking Elontril. Do not take it again and see your doctor.

• if you have bipolar disorder(extreme mood swings), Elontril may cause episodes of this condition
• if you are taking other antidepressant medicines,the use of these medicines with Elontril may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Elontril” in this section)
• if you have 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 Elontril, 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 suicide. These may increase at the beginning of treatment with antidepressants, as all these medicines take time to work, usually two weeks, but sometimes 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 suicide at any time,see 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 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 Elontril

Stop taking Elontril and inform your doctorif you are taking or have taken antidepressant medicines calledmonoamine oxidase inhibitors(MAOIs) in the last two weeks (see also section 2 “Do not take Elontril”).

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medicine,vitamins or herbal remedies, even those bought without a prescription. Your doctor may change your Elontril dose or suggest a change in other medicines.

Some medicines interact with Elontril.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.

It may increase the risk of seizures

• if you take other antidepressant medicines or other mental health medicines
• if you take theophyllineused to treat asthma or other lung diseases
• if you take tramadol,a strong painkiller
• if you have been taking sedatives,or if you are planning to stop taking them while you are taking Elontril (see also section 2 “Do not take Elontril”)
• 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 corticosteroids (oral or injectable)
• if you use quinolone antibiotics
• if you use certain antihistamines that can cause drowsiness
• if you use medicines to treat diabetes.

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

It may increase the risk of other adverse effects

• if you take other antidepressant medicines(amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, duloxetine, desipramine, or imipramine) or other mental health medicines (clozapine, risperidone, thioridazine, or olanzapine). Elontril may interact with some medicines used to treat depression and may cause 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 take antiparkinsonian medicines(levodopa, amantadine, or orphenadrine)
• if you take medicines that affect your body's ability to eliminate Elontril(carbamazepine, phenytoin, or valproate)
• if you take some medicines used to treat cancer(such as cyclophosphamide or ifosfamide)
• if you take ticlopidine or clopidogrel, used mainly to prevent stroke
• if you take beta-blockers (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,inform your doctor immediately before taking Elontril.

Elontril may be less effective

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

Inform your doctor if you are taking any of these medicines.Your doctor will check if Elontril is working properly for you. You may need to increase your dose or change to another treatment for your depression.Do not increaseyour Elontril dose unless your doctor advises you to, as this may increase the risk of adverse effects, including seizures.

Elontril may make other medicines less effective

• if you take 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 take digoxin for your heart.

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

Use of Elontril and alcohol

Alcohol may affect the way Elontril 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 Elontril. Your doctor may recommend that you do not drink alcohol (beer, wine, spirits) or drink very small amounts while taking Elontril. 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 consumptionbefore starting your treatment with Elontril.

Effect on urine tests

Elontril 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 Elontril.

Pregnancy and breastfeeding

Do not take Elontril 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 Elontril. It is not known if this is due to the use of Elontril.

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

Driving and operating machinery

Do not drive or operate tools or machinery if Elontril makes you dizzy or drowsy.

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 will be able to advise you to continue your treatment with Elontril to prevent depression from recurring.

What dose to take

The usual recommended dose in adults isone150 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 Elontril tablets in the morning. Do not take Elontril 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 the tablets, as this may 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 tabletper day throughout 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 with Elontril.You may need several weeks or months to 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 Elontril to prevent depression symptoms from recurring.

If you take more Elontril than you should

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediatelyor 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 experiencing seizures or convulsions.

If you forget to take Elontril

If you forget to take a dose, wait and take the next dose at the usual time.

Do not take a double dose to compensatefor the missed doses.

If you interrupt treatment with Elontril

Do notinterrupt treatment with Elontril 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 medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Seizures or convulsions

About 1 in 1,000 people who take Elontril have a risk of having a seizure (a fit or convulsion). This risk is higher if you take more tablets than you should, if you are taking certain medicines, or if you have a higher than usual risk of having fits. If you have any doubts, ask your doctor.

• Consult your doctorif you have a seizure and do not take any more tablets.

Allergic reactions

Some people may have allergic reactions to Elontril, including:

• Redness or skin rash (urticaria), 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 "pops" in the chest or difficulty breathing.
• Swelling of eyelids, lips, or tongue.
• Muscle or joint pain.
• Syncope or fainting.

• Consult your doctorif you have an allergic reaction and do not take any more tablets.

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

Systemic lupus erythematosus or worsening of lupus symptoms

Unknown frequency: the frequency cannot be estimated with the available data from people taking Elontril. Lupus is an autoimmune disorder that affects the skin and other organs.

• If you experience anexacerbation of lupus, skin rash or lesions (particularly in sun-exposed areas) while taking Elontril, contact your doctor immediately, as it may be necessary to interrupt treatment.

Generalized Acute Exanthematous Pustulosis (GPE)

Unknown frequency: the frequency cannot be estimated with the available data from people taking Elontril.

The symptoms of GPE 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 interrupt treatment.

Other side effects

Very common side effects

Thesemay affect more than 1 in 10 people:

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

Common side effects

Thesemay affectup 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
• Stomach pain or digestive discomfort (constipation), taste disturbances, loss of appetite (anorexia)
• Increased blood pressure (sometimes severe), flushing
• Feeling of hearing bells, visual disturbances.

Uncommon side effects

Thesemay affectup to 1 in 100 people:

• Feeling depressed (see section 2 "Be careful with Elontril" in "Suicidal thoughts and worsening of depression")
• Confusion
• Difficulty concentrating
• Increased heart rate
• Weight loss.

Rare side effects

Thesemay affectup to 1 in 10,000 people:

• Convulsions.

Very rare side effects

Thesemay affectup to 1 in 100,000 people:

• Palpitations, fainting
• Muscle spasms, muscle stiffness, coordination problems, walking or coordination difficulties
• Feeling anxious, irritability, hostility, aggression, nightmares, tingling or numbness, memory loss
• Yellowing of the skin or white of the eyes (jaundice) that may be associated with increased 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 eruptions that can affect the mouth or other parts of the body and can be life-threatening
• Worsening of psoriasis (plaques of thickened or inflamed skin)
• Unusual hair loss (alopecia)
• Feeling unreal or strange (depersonalization); seeing or hearing things that do not exist (hallucinations); feeling or believing things that are not real (delusions); severe distrust (paranoia).

Unknown frequency

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

• Thoughts of self-harm or suicide during treatment with Elontril or shortly after stopping treatment (see section 2, "What you need to know before starting to take Elontril"). If you have these thoughts,contact your doctor or go to the hospital immediately
• Loss of contact with reality and unable to think or judge clearly (psychosis); other symptoms may include hallucinations and/or illusions
• Sudden intense fear (panic attack)
• Stammering
• Reduction in the number of red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia)
• Decreased sodium in the blood (hypontremia)

• Changes in mental state (e.g. agitation, hallucinations, coma) and other side effects such as high body temperature (above 38°C), increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, coordination problems, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) while taking Elontril with other medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting 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 usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture and light. The bottle contains a small sealed container with activated charcoal and silica gel to keep the tablets dry. Keep the container inside the bottle. Do not ingest.

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 at 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 of Elontril

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

The other components are:

Tablet core:Polysorbate (vinyl alcohol), dibehenate of glycerol.

Coating:Ethylcellulose, povidone K-90, macrogol 1450, dispersion of copolymer of methacrylic acid and ethyl acrylate, silicon dioxide, triethyl citrate.

Printing ink:Shellac Glaze, iron oxide black (E172) and ammonium hydroxide.

Appearance of the product and contents of the packaging

Elontril 300 mg tablets are white-cream to light yellow, round, with one face marked with “GS 5YZ 300” in black ink and the other smooth. They are available in white polyethylene bottles containing 7, 30, 90 or 90 (3 x 30) tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

This medicine is authorized in the member states of the European Economic Area with the following names:

Wellbutrin XR: Austria, Belgium, Cyprus, Greece, Luxembourg, Malta, Poland, Portugal, Slovenia, Netherlands.

Wellbutrin: Italy.

Elontril: Czech Republic, Estonia, Germany, Hungary, Italy, Lithuania, Portugal, Romania, Slovakia, Spain, Netherlands.

Wellbutrin Retard: Iceland, Norway.

Voxra: Finland, Sweden.

Last review date of this prospectus:March 2024

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