MOREME 300 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. MOREME, 150 mg, modified-release tablets
3. MOREME, 300 mg, modified-release tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is MOREME and what is it used for
5. Important information before taking MOREME
   1. When not to take MOREME
   2. Warnings and precautions
   3. Brugada syndrome
   4. Children and adolescents
   5. Adults
   6. You should inform your doctor before starting to take MOREME:
   7. Suicidal thoughts and worsening of depression symptoms
   8. MOREME and other medicines
   9. You should tell your doctor or pharmacist about all medicines you are taking now or
   10. Seizures may occur more frequently than usual:
   11. The likelihood of other side effects may increase:
   12. MOREME may be less effective:
   13. MOREME may reduce the effectiveness of certain medicines
   14. MOREME and alcohol
   15. Effect on urine test results
   16. Pregnancy and breastfeeding
   17. Driving and using machines
6. How to take MOREME
   1. What dose to take
   2. How long to take MOREME
   3. How to take MOREME
   4. Taking a higher dose of MOREME than recommended
   5. Missing a dose of MOREME
   6. Stopping treatment with MOREME
7. Possible side effects
   1. Serious side effects
   2. Seizures or convulsions
   3. Allergic reactions
   4. Toxic epidermal necrolysis or worsening of lupus symptoms
   5. Acute generalized exanthematous pustulosis
   6. Other side effects
   7. Frequency not known (frequency cannot be estimated from the available data):
   8. Reporting side effects
8. How to store MOREME
9. Contents of the pack and other information
   1. What MOREME contains
   2. What MOREME looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

MOREME, 150 mg, modified-release tablets

MOREME, 300 mg, modified-release tablets

Bupropion hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is MOREME and what is it used for

MOREME is a prescription-only medicine used to treat depression. It works with chemicals in the brain called norepinephrineand dopamine.

2. Important information before taking MOREME

When not to take MOREME

• if you are allergic to bupropion or any of the other ingredients of this medicine (listed in section 6),
• if you are taking any other medicines containing bupropion,
• if you have epilepsy or have had seizures,
• if you have had or have eating disorders (such as bulimia or anorexia),
• if you have a brain tumor,
• if you are an alcoholic who has just stopped drinking or plans to do so,
• if you have severe liver disease,
• if you have recently stopped taking sedatives or plan to do so while taking MOREME (see also "When not to take MOREME" in section 2),
• if you are taking or have taken in the last two weeks medicines called monoamine oxidase inhibitors(MAOIs).

If any of the above situations apply to you, you should contact your doctor immediately and not take MOREME.

Warnings and precautions

Before starting to take MOREME, you should discuss it with your doctor or pharmacist.

Brugada syndrome

• if you have been diagnosed with Brugada syndrome (a rare, genetically determined disease affecting heart rhythm) or if there have been cases of cardiac arrest or sudden death in your family history.

Children and adolescents

MOREME is not recommended for the treatment of children under 18 years of age.
In children under 18 years of age treated with antidepressants, there is an increased risk of
suicidal thoughts and behaviors.

Adults

You should inform your doctor before starting to take MOREME:

• if you regularly drink large amounts of alcohol,
• if you have diabetes and are taking insulin or oral antidiabetic medicines,
• if you have had a serious head injury or head trauma in the past.

MOREME may cause seizures in about 1 in 1000 patients. The risk of this side effect is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures. If you have any doubts, you should contact your doctor.
If you experience a seizure, you should contact your doctor. Do not take MOREME againand contact your doctor.

• If you have bipolar disorder (severe mood swings), as MOREME may trigger an episode of this condition,
• If you are taking other medicines used to treat depression, taking them together with MOREME may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "MOREME and other medicines" in this section),
• If you have liver or kidney disease, as you may be more likely to experience side effects.

If any of the above situations apply to you, you should contact your doctor again before starting to take MOREME. Your doctor may decide to monitor your therapy closely or recommend a different treatment.

Suicidal thoughts and worsening of depression symptoms

In patients with depression, suicidal thoughts or behaviors may sometimes occur. Such behaviors may worsen when the patient first starts taking antidepressants, as it may take some time, usually about two weeks, but sometimes longer, for these medicines to start working.
Such thoughts may occur more frequently:

• if you have had suicidal thoughts or self-harm thoughts before.
• if you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults (under 25 years of age) with mental disorders who were treated with antidepressants. If you experience suicidal thoughts or self-harm thoughts at any time, you should contact your doctor immediately or go to the hospital.

It may be helpful to inform a relative or friend that you have depression and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse or if they are worried about changes in your behavior.

MOREME and other medicines

If you are currently taking or have taken in the last 14 days other antidepressant medicines called monoamine oxidase inhibitors(MAOIs), you should contact your doctor and not take MOREME(see also "When not to take MOREME" in section 2).

You should tell your doctor or pharmacist about all medicines you are taking now or

recently, as well as those you plan to take, including herbal medicines or vitamins, including those available without a prescription. Your doctor may change the dose of MOREME, recommend a change in dosing, or stop taking other medicines.
Some medicines should not be taken with MOREME. Some of them may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side effects. Examples of such medicines are listed below, but this is not an exhaustive list.

Seizures may occur more frequently than usual:

• if you are taking other antidepressant or antipsychotic medicines,
• if you are taking theophylline, an asthma or lung disease medicine,
• if you are taking tramadol, a strong pain reliever,
• if you have recently taken or are currently taking sedatives or if you plan to stop taking them while taking MOREME (see also "When not to take MOREME" in section 2),
• if you are taking antimalarial medicines (such as mefloquine or chloroquine),
• if you are taking stimulants or other medicines that control weight or appetite,
• if you are taking steroids (orally or by injection),
• if you are taking antibiotics called quinolones,
• if you are taking certain types of antihistamines that can cause drowsiness,
• if you are taking antidiabetic medicines.

If any of the above situations apply to you, you should contact your doctor immediately before starting to take MOREME. Your doctor will assess the risk and benefits of taking MOREME.

The likelihood of other side effects may increase:

• if you are taking other antidepressant medicines (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines for other mental disorders (such as clozapine, risperidone, thioridazine, or olanzapine). MOREME may interact with medicines used to treat depression, and you may experience changes in mental state (such as agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (such as nausea, vomiting, diarrhea),
• if you are taking medicines for Parkinson's disease (levodopa, amantadine, orphenadrine),
• if you are taking medicines that affect the metabolism of MOREME (carbamazepine, phenytoin, valproic acid),
• if you are taking certain medicines for cancer (such as cyclophosphamide or ifosfamide),
• if you are taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• if you are taking beta-blockers (such as metoprolol),
• if you are taking certain medicines for irregular heart rhythm (propafenone and flecainide),
• if you are using nicotine patches as an aid to stop smoking.

If any of the above situations apply to you, you should contact your doctor immediately before starting to take MOREME.

MOREME may be less effective:

• If you are taking ritonavir or efavirenz, medicines used to treat HIV infections.

If this situation applies to you, you should inform your doctor. Your doctor will assess the effectiveness of MOREME in your case. It may be necessary to increase the dose or change the treatment of depression. You should not increase the dose of MOREME without your doctor's recommendation, as this may increase the risk of side effects, including seizures.

MOREME may reduce the effectiveness of certain medicines

• If you are taking tamoxifen, used to treat breast cancer. If this situation applies to you, you should tell your doctor. It may be necessary to change the treatment of depression.
• If you are taking digoxin due to heart problems. If this situation applies to you, you should tell your doctor. Your doctor may consider adjusting the dose of digoxin.

MOREME and alcohol

Alcohol may affect the action of MOREME and, when taken together with MOREME, may rarely cause nervousness or changes in mental state. Some patients become more sensitive to alcohol while taking MOREME. While taking MOREME, your doctor may recommend avoiding alcohol (beer, wine, vodka) or significantly reducing its consumption. If you are currently drinking large amounts of alcohol, you should not stop drinking abruptly, as this may cause a seizure.
Before starting to take MOREME, you should discuss drinking alcohol with your doctor.

Effect on urine test results

MOREME may affect the results of laboratory tests on urine to detect the presence of drugs. If you are undergoing such a test, you should inform your doctor or nurse that you are taking MOREME.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, you should not take MOREME unless your doctor recommends it. Before taking this medicine during pregnancy, you should consult your doctor or pharmacist. Some, but not all, studies suggest an increased risk of congenital defects, particularly heart defects, in children whose mothers took MOREME. It is not known whether this was due to the medicine.
The ingredients of MOREME may pass into breast milk. Before taking MOREME, you should consult your doctor or pharmacist.

Driving and using machines

If MOREME causes dizziness or a feeling of emptiness in the head, you should not drive or operate machinery.

3. How to take MOREME

This medicine should always be taken exactly as your doctor or pharmacist has told you. Your doctor will recommend a dose that is right for you. If you are not sure, you should ask your doctor or pharmacist.
Improvement in your condition may not occur until after some time. The full effect of the medicine may only be apparent after several weeks or months. Even if you start to feel better, your doctor may recommend continuing to take MOREME to prevent a relapse of depression.

What dose to take

The recommended dose for adults is one150 mg tablet once a day.
If after several weeks of treatment you do not improve, your doctor may increase the dose to 300 mg once a day.
For some patients, a dose of 150 mg once a day is sufficient throughout the treatment period. Your doctor may recommend this dosing if you have liver or kidney disease.

How long to take MOREME

Only your doctor, together with you, can decide how long to take MOREME. It may take weeks or months before any improvement is seen. You should regularly discuss your depression symptoms with your doctor to decide how long you should be treated. If you feel better, your doctor may recommend continuing to take MOREME to prevent a relapse of depression.

How to take MOREME

The recommended dose of MOREME should be taken in the morning. You should not take MOREME more than once a day.
The tablet is coated with a layer that slowly releases the medicine into the digestive tract. You may notice something in your stool that looks like a tablet. This is the empty shell that has been eliminated from the body.
MOREME tablets should be swallowed whole. You should not chew, crush, or divide them – if this happens, there is a risk of overdose due to the rapid release of the medicine into the body. This may increase the risk of side effects, including seizures.
The tablets can be taken with or without food.

Taking a higher dose of MOREME than recommended

Taking too many tablets may cause seizures or convulsions. You should not delay and contact your doctor or the nearest hospital emergency department immediately.

Missing a dose of MOREME

If you miss a dose, you should wait and take the next dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping treatment with MOREME

You should not stop taking MOREME or reduce the dose without first discussing it with your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, MOREME can cause side effects, although not everybody gets them.

Serious side effects

Seizures or convulsions

About 1 in 1000 patients taking MOREME may experience seizures (convulsions). The risk of this side effect is higher in patients who take higher doses than recommended, take certain medicines, or are at increased risk of seizures. If you have any doubts, you should contact your doctor.
If you experience a seizure, you should contact your doctor. Do not take MOREME again.

Allergic reactions

Some patients may experience allergic reactions to MOREME. These include:

• redness of the skin or rash (like a nettle rash), blisters or itchy bumps (hives) on the skin; some rashes may require hospitalization, especially if they are accompanied by pain in the mouth or eye pain,
• unusual wheezing or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• muscle or joint pain,
• fainting or brief loss of consciousness.

If you experience any symptoms of an allergic reaction, you should contact your doctor immediately. Do not take MOREME again.
Allergic reactions can last a long time. If your doctor has prescribed medicines to relieve allergic symptoms, you should take the entire course.

Toxic epidermal necrolysis or worsening of lupus symptoms

Frequency not known - frequency cannot be estimated from the available data. Lupus is an immune system disorder that affects the skin and other organs.
If you experience worsening of lupus, skin rash, or skin changes (especially in areas of skin exposed to sunlight) while taking MOREME, you should contact your doctor immediately, as it may be necessary to stop treatment.

Acute generalized exanthematous pustulosis

Frequency not known - frequency cannot be estimated from the available data. Symptoms of acute generalized exanthematous pustulosis include a skin rash with pustules and (or) blisters filled with pus.
If you experience a skin rash with pustules and (or) blisters filled with pus, you should contact your doctor immediately, as it may be necessary to stop treatment.

Other side effects

Very common side effectsmay occur in more than 1 in 10patients:

• difficulty sleeping; you should make sure that MOREME is taken in the morning,
• headache,
• dry mouth,
• nausea, vomiting.

Common side effectsmay occur in less than 1 in 10patients:

• fever, dizziness, itching, sweating, and skin rash (sometimes due to an allergic reaction),
• chills, tremors, weakness, fatigue, chest pain,
• feeling anxious or agitated,
• abdominal pain or other disorders (constipation), change in taste, loss of appetite (anorexia),
• increased blood pressure, sometimes significantly, flushing of the face,
• ringing in the ears, vision disturbances.

Uncommon side effectsmay occur in less than 1 in 100patients:

• feeling depressed (see also section 2: Warnings and precautions),
• feeling disoriented,
• difficulty concentrating,
• increased heart rate,
• weight loss.

Rare side effectsmay occur in less than 1 in 1,000patients:

• seizures.

Very rare side effectsmay occur in less than 1 in 10,000patients:

• rapid heartbeat, fainting,
• muscle tremors, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• feeling anxious, irritated, hostile, aggressive, having strange dreams, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice), which may be caused by increased liver enzyme activity, liver inflammation,
• severe allergic reactions; rash with accompanying muscle and joint pain,
• changes in blood sugar levels,
• increased or decreased urination,
• incontinence (involuntary urination, uncontrolled urine flow),
• severe skin rashes that can affect the mouth and other parts of the body and can be life-threatening,
• worsening of psoriasis (red thickening of the skin),
• feeling unreal or strange ( depersonalization), seeing or hearing things that do not exist ( hallucinations), feeling or believing in things that are not real ( delusions), exaggerated suspicion ( paranoia).

Frequency not known (frequency cannot be estimated from the available data):

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

• thoughts of self-harm or suicide while taking MOREME or soon after stopping it (see section 2 "Important information before taking MOREME"). If you have such thoughts, you should contact your doctor or go to the hospital immediately.
• loss of contact with reality and ability to think or assess the situation ( psychosis); other symptoms may include hallucinations and (or) delusions.
• stuttering.
• decreased number of red blood cells (anemia), decreased number of white blood cells (leukopenia), and decreased number of platelets (thrombocytopenia).
• low sodium levels in the blood (hyponatremia).
• changes in mental state (such as agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal disorders (such as nausea, vomiting, diarrhea) when taking MOREME with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MOREME

The medicine should be stored out of sight and reach of children.
You should not take this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What MOREME contains

The active substance of MOREME is bupropion hydrochloride.
Each modified-release tablet contains 150 mg or 300 mg of bupropion hydrochloride.
The other ingredients are:
Tablet core: povidone, cysteine hydrochloride monohydrate, colloidal silica anhydrous, glyceryl dibehenate, magnesium stearate.
Coating I: ethyl cellulose, povidone, macrogol,
Coating II: methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion containing sodium lauryl sulfate and polysorbate, colloidal silica hydrated, macrogol, triethyl citrate.
Ink: shellac, glaze, iron oxide black (E 172), and propylene glycol.

What MOREME looks like and contents of the pack

MOREME 150 mg tabletsare cream-white to light yellow, round, with the inscription "GS3" on one side of the tablet and smooth on the other side. The diameter of the tablet is about 7 mm; the thickness of the tablet is about 5 mm.
MOREME 300 mg tabletsare cream-white to light yellow, round, with the inscription "GS2" on one side of the tablet and smooth on the other side. The diameter of the tablet is about 9 mm; the thickness of the tablet is about 6 mm.
Blister pack of OPA/Aluminum/PVC/Aluminum foil, containing 30, 60, or 90 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Importer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: