ELONTRIL 300 mg MODIFIED-RELEASE TABLETS

2. What you need to know before you take Elontril

Do not take Elontril

• if you are allergicto 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 suffer from, or have suffered from, any eating disorder(e.g. bulimia or anorexia nervosa)
• if you have a brain tumor
• if you drink a lot of alcoholand 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 Elontril
• if you are taking, or have taken in the last two weeks,other medicines for depressioncalled monoamine oxidase inhibitors(MAOIs).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Elontril.

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

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

In patients under 18 years, there is an increased risk of suicidal thoughts and attempts when treated with antidepressants.

Adults

Tell your doctor before starting Elontril:

• if you regularly 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.

It has been observed that Elontril 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 Elontril, stop taking Elontril. Do not take it again and see your doctor.

• if you have bipolar disorder(severe mood swings), Elontril may cause episodes of this illness
• if you are taking other medicines for depression,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 any liver or kidney disease, the likelihood of side effects is higher.

If you are in any of the situations mentioned above, talk to your doctor before taking Elontril, 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 or killing yourself. These may increase at the start of treatment with antidepressants, as all these medicines take time to work, usually around two weeks, but sometimes longer.

This is more likely to happen:

• if you have previously had thoughts of killing or harming yourself
• 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 antidepressants.

If you have thoughts of killing or harming yourself at any time, talk to your doctor or go to the hospital immediately.

It may be helpful for you to tell a relative 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 worried about changes in your behavior.

Other medicines and Elontril

Stop taking Elontril and tell your doctor if you are taking or have taken in the last two weeksantidepressant medicines called monoamine oxidase inhibitors(MAOIs) (see also section 2 "Do not take Elontril").

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

Some medicines interact with Elontril.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 possibility of having seizures

• if you take other medicines for depression or other mental illnesses
• if you take theophyllineused 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 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 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 Elontril. Your doctor will assess the risks and benefits of taking Elontril.

May increase the possibility 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). Elontril may interact with some medicines used to treat depression and may cause 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, 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 Elontril(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 rhythm disorders(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 Elontril.

Elontril 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 Elontril is working properly in you. You may need to increase the dose or change to another treatment for your depression. Do not increasethe dose of Elontril unless your doctor advises you to, as this may increase the risk of having side effects, including seizures.

Elontril may make other medicines less effective

• if you take tamoxifen used to treat cancer.

Tell your doctor if you are in this situation.You may need 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.

Using Elontril and alcohol

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

Ask your doctor about drinking alcoholbefore starting 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, tell your doctor or 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 for you. 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 Elontril. It is not known if this is due to the use of Elontril.

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

Driving and using machines

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

3. How to take Elontril

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. The recommended doses are listed below, but your doctor will advise you on the dose suitable 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 taking Elontril to prevent depression from coming back.

What dose to take

The usual 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 Elontril tablets in the morning. Do not take Elontril more than once a day.

The tablet is covered by a film that slowly releases the medicine 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 there is a risk of overdose due to the rapid release of the medicine in your body, increasing the likelihood of side 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.

Duration of treatment

Talk to your doctor, who will indicate the duration of treatment with Elontril. 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 advise you to continue taking Elontril to prevent the symptoms of depression from coming back.

If you take more Elontril 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 your doctor prescribed, you may increase the risk of having 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 make upfor forgotten doses.

If you stop taking Elontril

Do notstop taking Elontril or reduce the dose without talking to your doctor first.

If you have any other 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 Elontril 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 suffer an epileptic 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 "wheezing" in the chest or difficulty breathing.
• Swelling of eyelids, lips, or tongue.
• Pain in muscles or joints.
• Fainting or loss of consciousness.

• Consult your doctor if you suffer 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 with the available data from people taking Elontril. Lupus is a disorder of the immune system that affects the skin and other organs.

• If you experience aworsening 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.

Acute Generalized Exanthematous Pustulosis (AGEP)

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

The symptoms of AGEP include a rash with pus-filled blisters/grains.

• If you experience a rash with pus-filled blisters/grains, contact your doctor immediately, as it may be necessary to interrupt treatment.

Other Adverse Effects

Very Common Adverse Effects

These may affect more than 1 in every 10 people:

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

Common Adverse Effects

These may affect up to 1 in every 10 people:

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

Uncommon Adverse Effects

These may affect up to 1 in every 100 people:

• Feeling depressed (see also section 2 "Special warnings and precautions for use" in "Suicidal thoughts and worsening of depression")
• Confusion
• Difficulty concentrating
• Accelerated heart rate
• Weight loss.

Rare Adverse Effects

These may affect up to 1 in every 1,000 people:

• Convulsions.

Very Rare Adverse Effects

These may affect up to 1 in every 10,000 people:

• Palpitations, fainting
• Muscle spasms, 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 the whites 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
• 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 reddening of the skin)
• Loss or unusual thinning of hair (alopecia)
• Feeling of being unreal or strange (depersonalization); seeing or hearing things that do not exist (hallucinations); feeling or believing unrealistic things (delusional ideas); severe distrust (paranoia).

Unknown Frequency

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 Elontril or shortly after stopping treatment (see section 2, "What you need to know before taking Elontril"). If you have 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 illusions
• Sudden feeling of intense fear (panic attack)
• Stuttering
• Decrease in red blood cells (anemia), white blood cells (leukopenia), and platelets (thrombocytopenia)
• Decrease in sodium levels in the blood (hyponatremia)

• 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) while taking Elontril with other medications used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Elontril

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated 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 containing activated carbon and silica gel to keep the tablets dry. Keep the container inside the bottle. Do not swallow.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, 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 ofElontril

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

The other ingredients are:

Core of the tablet:Poly(vinyl alcohol), dibehenate of glycerol.

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

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

Appearance of the Product and Package Contents

Elontril 300 mg tablets are white-cream to light yellow, round tablets, 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

This medicine is authorized in the Member States of the European Economic Area under 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.

Date of the last revision of thisleaflet:March 2024

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