Elontril 300 mg modified-release tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the user

Elontril 300 mg modified-release tablets

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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Elontril is and what it is used for
2. What you need to know before taking Elontril
3. How to take Elontril
4. Possible adverse effects
5. How to store Elontril
6. Contents of the pack and other information

1. What Elontril is and what it is used for

Elontril 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 Elontril

Do not take Elontril

• if you are allergic to bupropion or to any of the other components 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 currently have or have had an eating disorder (for example, bulimia or anorexia nervosa)
• if you have a brain tumour
• 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 medicines, or are about to stop them while taking Elontril
• 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 Elontril.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Elontril.

Brugada syndrome

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

Children and adolescents

Elontril is not recommended for use in children 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 Elontril:

• if you regularly drink 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 had a previous head trauma.

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

• if you have bipolar disorder (extreme mood swings), Elontril may trigger episodes of this illness
• if you are taking other antidepressant medicines, using these together 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 experiencing adverse effects is higher.

If you are in any of the situations listed above, consult your doctor before taking Elontril. Your doctor may decide to monitor you more closely or recommend an alternative treatment.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or of 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 behaviour in psychiatric patients under 25 years of age being treated with antidepressants.

If you have any thoughts of harming yourself or of suicide at any time, contact your doctor or go to 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 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 behaviour.

Other medicines and Elontril

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

Tell 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 need to adjust the dose of Elontril or suggest a change in your other medicines.

Some medicines interact with Elontril. Some may increase the risk of seizures or convulsions, and others may increase the risk of other adverse effects. Listed below are some examples, although the list is not exhaustive.

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 if you are about to stop taking them while on 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 (orally or by injection)
• if you use antibiotics called 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 Elontril. Your doctor will assess the risks and benefits of you taking Elontril.

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). Elontril may interact with some antidepressant medicines 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, diarrhoea)
• 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 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 stop 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 used to treat HIV infection (AIDS).

Tell your doctor if you are taking any of these medicines. Your doctor will check whether Elontril is working properly for you. It may be necessary to increase the dose or switch to another treatment for your depression. Do not increase the dose of Elontril unless advised by your doctor, 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.

Tell 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.

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

Taking Elontril with alcohol

Alcohol may affect how Elontril works, and when taken together, it may rarely affect your nerves or mental state. Some people have noticed increased sensitivity to alcohol while taking Elontril. Your doctor may advise you not to drink alcohol (beer, wine, spirits) or to drink only very small amounts while taking Elontril. If you currently drink large amounts 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 Elontril.

Effect on urine tests

Elontril may interfere with certain urine tests used to detect drugs or other substances. If you need a urine test, inform 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 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 Elontril. It is not known whether this is due to the use of Elontril.

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

Driving and using machines

Do not drive or operate tools or machinery if Elontril causes you to feel dizzy or drowsy.

3. How to take Elontril

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. The recommended doses are provided 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 exert its full effect, which may take weeks or months. Once you begin to feel better, your doctor may advise you to continue your Elontril 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 Elontril tablets in the morning. Do not take Elontril more than once a day.

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

Swallow the tablets whole. Do not chew, crush, or divide them, as doing so may lead to overdose due to rapid release of the drug 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 the treatment duration with Elontril in agreement with you. It may take several weeks or months before you notice any improvement. Keep your doctor regularly informed about your symptoms so they can decide on the appropriate treatment duration. Even if you start to feel better, your doctor may recommend continuing Elontril treatment to prevent depression symptoms from returning.

If you take more Elontril 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, indicating 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 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 up for missed doses.

If you stop taking Elontril

Do not stop taking Elontril 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 experiences them.

Serious adverse effects

Seizures or convulsions

Approximately 1 in every 1,000 people taking Elontril is 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 medicines, or if you already have a higher-than-normal risk of seizures. If you have any doubts, ask your doctor.

• Contact your doctor if you have a seizure, and do not take any more tablets.

Allergic reactions

Some people may experience allergic reactions to Elontril, including:

• Skin redness or rash (urticaria), blisters, or hives.

• Some skin rashes may require hospitalization, especially if accompanied by swelling of the mouth and eyes.

• Unusual "whistling" sounds in the chest or difficulty breathing.

• Swelling of the eyelids, lips, or tongue.

• Muscle or joint pain.

• Fainting or syncope.

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

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

Cutaneous lupus erythematosus or worsening of lupus symptoms

Frequency not known: frequency cannot be estimated from the available data in people taking Elontril. Lupus is an immune system disorder that affects the skin and other organs.

• If you experience a lupus flare-up, skin rash, or lesions (particularly in sun-exposed areas) while taking Elontril, contact your doctor immediately, as treatment interruption may be necessary.

Acute Generalized Exanthematous Pustulosis (AGEP)

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

Symptoms of AGEP include a rash with pus-filled pimples/blisters.

• If you develop a rash with pus-filled pimples or blisters, contact your doctor immediately, as treatment interruption may be necessary.

Other adverse effects

Very common adverse effects

These may affect more than 1 in 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 10 people:

• Fever, dizziness, itching, sweating, skin rash (sometimes due to allergic reactions).
• Instability, tremor, weakness, fatigue, chest pain.
• Feeling anxious or restless.
• Stomach pain or digestive discomfort (constipation), changes in taste sensation, loss of appetite (anorexia).
• Increased blood pressure (sometimes severe), flushing.
• Ringing in the ears (tinnitus), visual disturbances.

Uncommon adverse effects

These may affect up to 1 in 100 people:

• Feeling depressed (see also section 2 “Take special care with Elontril” under “Suicidal thoughts and worsening of depression”).
• Confusion.
• Difficulty concentrating.
• Increased heart rate.
• Weight loss.

Rare adverse effects

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

• Seizures.

Very rare adverse effects

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

• Palpitations, fainting.
• Muscle spasms, muscle stiffness, lack of motor coordination, 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, 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).
• Severe skin rashes that may affect the mouth or other body parts and may be life-threatening.
• 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 there (hallucinations); believing or thinking unreal things (delusional ideas); severe distrust (paranoia).

Frequency not known

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 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 delusions.
• Sudden intense fear (panic attack).
• Stuttering.
• Reduction in the number of red blood cells (anaemia), white blood cells (leucopenia), and platelets (thrombocytopenia).
• Low sodium levels in the blood (hyponatraemia).
• Changes in mental status (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, diarrhoea) while taking Elontril together with other medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of adverse effects

If you experience any 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: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging. The expiry date refers to 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 holding activated charcoal and silica gel to keep the tablets dry. Keep this container inside the bottle. Do not swallow.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Elontril

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

The other components are:

Tablet core: Poly (vinyl alcohol), glycerol dibehenate.

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

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

Appearance of the product and contents of the container

Elontril 300 mg tablets are white-cream to light yellow, round tablets, marked with “GS 5YZ 300” in black ink on one side and smooth on the other. 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

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

Wellbutrin: Italy.

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

Wellbutrin Retard: Iceland, Norway.

Voxra: Finland, Sweden.

Date of latest revision of the package leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/