ELONTRIL 150 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. ELONTRIL 150 mg modified-release tablets, 300 mg modified-release tablets
   1. What is Elontril and what is it used for
   2. What you need to know before taking Elontril
   3. How to take Elontril
   4. Possible side effects
   5. How to store Elontril
   6. Contents of the pack and other information

ELONTRIL 150 mg modified-release tablets, 300 mg modified-release tablets

bupropione cloridrato

Read this leaflet carefully before taking this medicinebecause it contains important
information for you.

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Elontril and what is it used for

Elontril is a medicine prescribed by your doctor to treat depression. It is believed to interact with
chemicals in the brain called noradrenalineand dopamine.

2. What you need to know before taking 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 any other medicine containing bupropion
• If you have been diagnosed with epilepsy or have had seizures in the past
• If you have, or have had, eating disorders(for example, bulimia or anorexia nervosa)
• If you have a brain tumor
• If you are a heavy habitual drinkerwho has just stopped or is about to stop drinking
• If you have severe liver problems
• If you have recently stopped taking sedatives, or if you are about to stop taking them while taking Elontril
• If you are taking or have taken other medicines for depressioncalled monoamine oxidase inhibitors(MAOIs) in the last 14 days. If any of the above applies to you, tell your doctor immediately, without taking Elontril.

Warnings and precautions
Talk to your doctor or pharmacist before taking Elontril.

Children and adolescents
Elontril is not recommended for the treatment of patients under the age of 18.
There is an increased risk of thoughts and behaviors related to suicide in patients under 18
years of age treated with antidepressants.

Adults
Before you take Elontril, your doctor needs to know:

• If you regularly drink a large amount of alcohol
• If you have diabetesfor which you use insulin or tablets
• If you have had a severe head injury or have had a head trauma in the pastElontril has been shown to cause seizures in about 1 in 1000 people. This side effect is more likely to occur in the individuals described above. If you have a seizure during treatment you should stop taking Elontril. Stop taking it immediately andsee your doctor.
• If you suffer from bipolar disorder(extreme mood swings), as Elontril may trigger an episode of this illness
• If you are taking other medicines for depression, the use of these medicines together with Elontril can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Elontril” in this section)
• If you have liver or kidney problems, you are more likely to have side effects. If any of the above applies to you, tell your doctor again before taking Elontril. Your doctor may want to pay particular attention to your therapy or recommend another treatment.

Thoughts of suicide and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or of taking your own life. These thoughts may
be more frequent when you first start taking antidepressants, as all these medicines
take time to work, generally about two weeks, but sometimes longer.
You may be more likely to have these thoughts:

• if you have had thoughts of taking your own life or harming yourself in the past
• if you are a young adult. Data from clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who have been treated with an antidepressant. At any time you have thoughts of harming yourself or of taking your own life, contact your doctor or goimmediately to hospital.

You may find it helpful to tell a relative or friend that you are depressed, and ask them to read
concerned about changes in your behavior.

Other medicines and Elontril
If you are taking or have taken other antidepressantscalledmonoamine oxidase inhibitors(MAOIs) in the
last 14 days, tell your doctor without taking Elontril(see also “Do not take Elontril” in
section 2).

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, herbal remedies or vitamins, even those available without a prescription. Your
doctor may adjust your dose of Elontril, or advise you to change other medicines.

Some medicines must not be taken with Elontril. Some may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side effects. Some
examples are listed below, but the list is not exhaustive.

There may be a higher chance of seizures than usual…

• If you are taking other medicines for depression or for other mental illnesses
• If you are taking theophyllinefor asthma or lung disease
• If you are taking tramadol, a strong painkiller
• If you have taken sedatives, or if you are about to stop taking them while taking Elontril (see also “Do not take Elontril” in section 2)
• If you are taking medicines against malaria(such as mefloquine or chloroquine)
• If you are taking stimulants or other medicines to control weight or appetite
• If you are taking steroids(by mouth or by injection)
• If you are taking antibiotics called quinolones
• If you are taking some types of antihistamines that can cause drowsiness
• If you are taking medicines for diabetes.If any of the above applies to you, tell your doctor immediately, before taking Elontril. Your doctor will assess the benefits and risks of taking Elontril.

There may be a higher chance of other side effects than usual…

• Ifyou are taking other medicines for depression(such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or for other mental illnesses (such as clozapine, risperidone, thioridazine or olanzapine). Elontril can interact with some medicines used to treat depression and you may experience changes in mental state (e.g. agitation, hallucinations, coma) and other effects, such as a 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 are taking medicines for Parkinson's disease(levodopa, amantadine or orphenadrine)
• If you are taking medicines that affect the body's ability to eliminate Elontril(carbamazepine, phenytoin, valproate)
• If you are taking some medicines used to treat cancer(such as cyclophosphamide, ifosfamide)
• If you are taking ticlopidine or clopidogrel, used mainly to prevent stroke
• If you are taking some beta-blockers(such as metoprolol)
• If you are taking some medicines for irregular heartbeat(propafenone or flecainide)
• If you are using nicotine patches to help you quit smoking.If any of the above applies to you, tell your doctor immediately, before taking Elontril.

Elontril may be less effective

• If you are taking ritonavir or efavirenz, medicines for the treatment of HIV infection. If this applies to you, tell your doctor. Your doctor will check how Elontril is working for you. It may be necessary to increase the dose or switch to another treatment for depression. Do not increasethe dose of Elontril without your doctor's advice, as this may increase the risk of side effects including seizures.

Elontrilmay make other medicines less effective

• If you are taking tamoxifen used to treat breast cancerIf this applies to you, tell your doctor. It may be necessary to use another treatment for depression.
• If you are taking digoxin for the heartIf this applies to you,tell your doctor. Your doctor may consider adjusting the dose of digoxin.

Elontril and alcohol
Alcohol can alter the way Elontril works and when used together can rarely alter your nerves and
mental state. Some people find they are more sensitive to alcohol when taking Elontril. Your
doctor may suggest you do not drink alcohol (beer, wine or spirits) while taking Elontril or try to
drink in moderation. But if you currently drink a lot, do not stop suddenly: this could put you at
risk of having seizures.

Talk to your doctor about your alcohol consumption, before starting to take Elontril .
Effects on urine testing
Elontril can interfere with some urine tests used to detect other drugs. If you require
a urine test, tell your doctor or the hospital that you are taking Elontril.

Pregnancy and breastfeeding
Do not take Elontril if you are pregnant, suspect you are pregnant or are planning to become
pregnant, unless your doctor recommends it. Ask your doctor or pharmacist for advice before taking this
medicine. Some, but not all studies have reported an increased risk of birth defects, in
particular heart defects, in children whose mothers took Elontril. It is not known whether these are due
to the use of Elontril.
The components of Elontril pass into breast milk. You should ask your doctor or pharmacist before
taking Elontril.

Driving and using machines
If Elontril makes you feel dizzy or lightheaded, do not drive or use any
tools or machinery.

3. How to take Elontril

Take this medicine following exactly the instructions of your doctor or pharmacist. These are the usual doses, but your doctor's instructions are specifically for you. If you have any doubts, ask your doctor or pharmacist.

It may take some time before you feel better.It takes time before the medicine has a full effect, sometimes weeks or months. When you start to feel better, your doctor may advise you to continue taking Elontril to prevent the depression from returning.

How much to take
The recommended dose is usually one150 mg tablet per day, for adults only.

Your doctor may increase your dose to 300 mgper day if your depression does not improve after several weeks.

Take your dose of Elontril tablets in the morning. Do not take Elontril more than once a day.
The tablet is coated with a coating that slowly releases the medicine into your body. You may notice something in your stool that looks like a tablet. This is the empty coating being eliminated from your body.

Swallow the tablets whole.Do not chew, crush, or divide them - if you do, there is a risk of overdose, as the medicine would be released into your body too quickly. This would make side effects, including seizures, more likely.

Some people continue to take one 150 mg tabletper day during the entire treatment. Your doctor may have prescribed this dosage if you have liver or kidney problems.

How long you need to take it
Only you and your doctor can decide how long to take Elontril.It may take weeks or months of treatment to see an improvement. Talk to your doctor regularly about your symptoms to decide how long you should take it. When you start to feel better, your doctor may advise you to continue taking Elontril to prevent the depression from returning.

If you take more Elontril than you should
If you take too many tablets, it may increase the risk of seizures or convulsions. Do not waste time.Ask your doctor what to do or go immediately to the emergency room of the nearest hospital.

If you forget to take Elontril
If you miss a dose, wait and take the next tablet at the usual time. Do not take a double doseto make up for a forgotten tablet.

If you stop taking Elontril
Donot stop taking Elontril or reduce the dose without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects
Convulsions or seizures
About 1 in 1,000 people taking Elontril are at risk of convulsions (seizures or epileptic fits). The chance of this happening is higher if you take too much, if you are taking certain medicines,
or if you are more likely to have convulsions. If you are worried, talk to your doctor.

If you have a seizure,tell your doctor as soon as you feel better. Do not take any more tablets.

Allergic reactions
Some people may have allergic reactions to Elontril. These include

• Red or rashy skin (like hives), itchy blisters or bubbles (urticaria) on the skin. Some rashes may require hospital treatment, especially if you have irritation to your mouth or eyes
• Unusual wheezing or difficulty breathing
• Swelling of the eyelids, lips or tongue
• Muscle or joint pain
• Collapse or loss of consciousness If you experience any signs of an allergic reactioncontact a doctor immediately. Do nottake any more tablets.Allergic reactions can last a long time. If your doctor prescribes something to relieve allergy symptoms, make sure to complete the treatment.

Lupus rash or worsening of lupus symptoms
Not known – the frequency cannot be estimated on the basis of the available data in people taking
Elontril
Lupus is a condition affecting the immune system that affects the skin and other organs.

If you develop a flare-up of lupus, skin rash or lesions (especially on areas exposed to the
sun) while taking Elontril, see your doctor immediately, as you may
need to stop treatment
Acute Generalized Exanthematous Pustulosis (AGEP)
Not known – the frequency cannot be estimated on the basis of the available data in people taking
Elontril.
Symptoms of AGEP include skin rash with pustules/blisters filled with pus.

If you develop a skin rash with pustules/blisters filled with pus, see your doctor immediately,
as you may need to stop treatment.
Other side effects
Very common side effects
These may affect more than 1 in 10 people:

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

Common side effects
These may affect up to 1 in 10 people:

• Fever, dizziness, itching, sweating and rash (sometimes due to an allergic reaction)
• Shaking, tremors, weakness, fatigue, chest pain
• Feeling anxious or agitated
• Stomach pain or other disturbances (constipation), changes in the taste of foods, loss of appetite (anorexia)
• Sometimes severe increase in blood pressure, flushing (sudden redness)
• Ringing in the ears, visual disturbances

Uncommon side effects
These may affect up to 1 in 100 people:

• Feeling depressed (see also “Thoughts of self-harm and worsening of depression” in “Warnings and precautions” in Paragraph 2)
• Feeling confused
• Difficulty concentrating
• Increased heart rate
• Weight loss

Rare side effects
These may affect up to 1 in 1,000 people:

• Convulsions

Very rare side effects
These may affect up to 1 in 10,000 people:

• Palpitations, fainting
• Muscle contractions, muscle stiffness, uncontrolled movements, problems walking or coordinating
• Feeling agitated, irritated, hostile, aggressive, strange dreams, tingling or numbness, memory loss
• Yellowing of the skin or whites of the eyes (jaundice) which may be caused by increased liver enzymes, hepatitis
• Severe allergic reactions; rash associated with muscle and joint pain
• Changes in blood sugar levels
• Urinating more or less than usual
• Urinary incontinence (involuntary urination, leakage of urine)
• Severe skin rashes that can affect the mouth or other parts of the body and can be life-threatening
• Worsening of psoriasis (thickened, red patches of skin)
• Feeling unreal or detached (depersonalization); seeing or hearing things that are not there (hallucinations); feeling or believing in things that are not real (delusions); severe suspicion (paranoia)

Frequency not known
Other side effects have been reported in a small number of people, but their exact frequency is not
known:

• thoughts of self-harm or suicide during treatment with Elontril or immediately after stopping treatment (see paragraph 2, “What you need to know before you take Elontril”). If you have these thoughts, contact your doctor or go to hospital immediately
• loss of contact with reality and inability to think or judge clearly (psychosis); other symptoms may include hallucinations and/or delusions
• stammering
• reduced number of red blood cells (anemia), reduced number of white blood cells (leukopenia) and reduced number of platelets (thrombocytopenia)
• reduced level of sodium in the blood (hyponatremia)
• changes in mental status (e.g. agitation, hallucinations, coma) and other effects, such as a 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), while taking Elontril together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine and venlafaxine).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Elontril

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture and light. The bottle
contains a small sealed container containing charcoal and silica gel to keep the tablets
dry. Leave the container in the bottle. Do not ingest it.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Elontril contains
The active ingredient is bupropion hydrochloride. Each tablet contains 150 mg or 300 mg of bupropion
hydrochloride.
The other ingredients are:
tablet core: polyvinyl alcohol, glyceryl dibehenate
tablet coating: ethylcellulose, povidone K-90, macrogol 1450, ethyl acrylate methyl methacrylate copolymer dispersion, silicon dioxide, triethyl citrate.
Ink: shellac fixing agent, black iron oxide (E172) and ammonium hydroxide.

Description of the appearance of Elontril and contents of the pack
Elontril 150 mg tablets are round, from off-white to pale yellow in colour, imprinted with
black ink on one side with “GS 5FV 150” and without impressions on the other side. They are available in white
polyethylene bottles containing 7, 30 or 90 (3x30) tablets.
Elontril 300 mg tablets are round, from off-white to pale yellow in colour, imprinted with
black ink on one side with “GS 5YZ 300” and without impressions on the other side. They are available in white
polyethylene bottles containing 7, 30 or 90 (3x30) tablets.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Elontril is:
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy

Sales concessionaire:
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 - 40133 Bologna - Italy
The manufacturer of Elontril is: Aspen Bad Oldesloe GmbH - Industriestrasse 32-36, 23843 Bad Oldesloe,
Germany or Glaxo Wellcome S.A. Avenida de Extremadura, 3 - 09400 Aranda de Duero, Burgos,
Spain

This medicinal product is authorised 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