Moreme

Leaflet attached to 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 for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 by affecting chemicals in the brain called noradrenalineand dopamine.

2. Important information before taking MOREME

When not to take MOREME

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

If any of the above situations apply to the patient, they should contact their doctor immediately and not take MOREME.

Warnings and precautions

Before starting to take MOREME, the patient should discuss it with their doctor or pharmacist.

Brugada syndrome

• if the patient has been diagnosed with Brugada syndrome (a rare, genetically determined disease affecting heart rhythm) or if there is a family history of cardiac arrest or sudden death.

Children and adolescents

MOREME is not recommended for 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

The patient should inform their doctor before starting to take MOREME:

• if they regularly drink large amounts of alcohol,
• if they have diabetes and are taking insulin or oral hypoglycemic agents,
• if they have had a serious head injury or brain 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 in a group at increased risk of seizures. If in doubt, the patient should contact their doctor.
If a seizure occurs, the patient should contact their doctor. They should not take MOREME againand should contact their doctor.

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

If any of the above situations apply to the patient, they should contact their doctor before starting to take MOREME. The doctor may decide to monitor the patient closely or recommend a different treatment.

Suicidal thoughts and worsening of depression symptoms

In patients with depression, suicidal thoughts or behaviors may occur. These 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 the patient has had suicidal thoughts or self-harm thoughts before.
• if the patient is 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 the patient experiences suicidal thoughts or self-harm thoughts at any time, they should contact their doctor immediately or go to the hospital.

It may be helpful to inform a relative or friend that the patient has depression and ask them to read this leaflet. The patient may ask them to tell them if they think their depression is getting worse or if they are worried about changes in their behavior.

MOREME and other medicines

If the patient is currently taking or has taken within the last 14 days other antidepressants called monoamine oxidase inhibitors (MAOIs), they should contact their doctor and not take MOREME(see also "When not to take MOREME" in section 2).

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any they plan to take,

including herbal medicines or vitamins, including those available without a prescription. The doctor may change the dose of MOREME, recommend a change in dosing, or stop other medicines being taken.
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 the patient is taking other antidepressants or medicines used to treat mental disorders,
• if the patient is taking theophylline, a medicine for asthma or lung disease,
• if the patient is taking tramadol, a strong painkiller,
• if the patient has recently taken or is currently taking sedatives or plans to stop taking them while taking MOREME (see also "When not to take MOREME" in section 2),
• if the patient is taking antimalarial medicines (such as mefloquine or chloroquine),
• if the patient is taking stimulants or other medicines that control weight or appetite,
• if the patient is taking steroids (orally or by injection),
• if the patient is taking antibiotics called quinolones,
• if the patient is taking certain types of antihistamines that can cause drowsiness,
• if the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, they should contact their doctor immediately before starting to take MOREME. The doctor will assess the risk and benefits of taking MOREME.

The risk of other side effects may increase:

• if the patient is taking other antidepressants (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines used to treat other mental disorders (such as clozapine, risperidone, thioridazine, or olanzapine). MOREME may interact with medicines used to treat depression, and the patient may experience changes in mental state (such as agitation, hallucinations, or 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 the patient is taking medicines used to treat Parkinson's disease (levodopa, amantadine, orphenadrine),
• if the patient is taking medicines that affect the metabolism of MOREME (carbamazepine, phenytoin, valproic acid),
• if the patient is taking certain medicines used to treat cancer (such as cyclophosphamide or ifosfamide),
• if the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• if the patient is taking beta-blockers (such as metoprolol),
• if the patient is taking certain medicines used to treat irregular heart rhythm (propafenone and flecainide),
• if the patient is using nicotine patches as an aid to stop smoking.

If any of the above situations apply to the patient, they should contact their doctor immediately before starting to take MOREME.

MOREME may be less effective:

• If the patient is taking ritonavir or efavirenz, medicines used to treat HIV infections.

If this situation applies to the patient, they should inform their doctor. The doctor will assess the effectiveness of MOREME in the patient. It may be necessary to increase the dose or change the treatment for depression. The patient should not increase the dose of MOREME without their doctor's recommendation, as this may increase the risk of side effects, including seizures.

MOREME may reduce the effectiveness of some medicines

• If the patient is taking tamoxifen, used to treat breast cancer. If this situation applies to the patient, they should tell their doctor. It may be necessary to change the treatment for depression.
• If the patient is taking digoxin for heart problems. If this situation applies to the patient, they should tell their doctor. The doctor may consider adjusting the dose of digoxin.

MOREME and alcohol

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

Effect on urine test results

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

Pregnancy and breastfeeding

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

Driving and using machines

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

3. How to take MOREME

This medicine should always be taken exactly as the doctor or pharmacist has told the patient. The doctor will recommend a dose individually for the patient. If the patient is unsure, they should ask their doctor or pharmacist.
Improvement in the patient's condition may take some time. The full effect of the medicine may only be apparent after several weeks or months. Even if the patient starts to feel better, their 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 the patient does not improve, the doctor may increase the dose to 300 mg once a day.
For some patients, a dose of 150 mg once a day may be sufficient throughout the treatment period. The doctor may recommend this dosing if the patient has liver or kidney disease.

How long to take the treatment

Only the doctor, together with the patient, can decide how long to take the treatment with MOREME. It may take weeks or months before any improvement is seen. The patient should regularly discuss their depression symptoms with their doctor to decide how long they should be treated. If the patient feels better, their doctor may recommend continuing to take MOREME to prevent a relapse of depression.

Method of administration

The recommended dose of MOREME should be taken in the morning. The patient should not take MOREME more than once a day.
The tablet is coated with a shell that slowly releases the medicine into the digestive tract. The patient may notice something in their stool that looks like a tablet. This is the empty shell that has been eliminated from the body.
MOREME tablets should be swallowed whole. They should not be chewed, crushed, or divided – 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. The patient should not delay and should contact their doctor or the nearest hospital emergency department immediately.

Missing a dose of MOREME

If the patient misses a dose, they should wait and take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with MOREME

The patient should not stop taking MOREME or reduce the dose without first discussing it with their doctor.
If the patient has any further questions about taking this medicine, they should ask their 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 in a group at increased risk of seizures. If in doubt, the patient should contact their doctor.
If a seizure occurs, the patient should contact their doctor. They should 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 mouth ulcers 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 the patient experiences any symptoms of an allergic reaction, they should contact their doctor immediately. They should not take MOREME again.
Allergic reactions can last a long time. If the doctor has prescribed medicines to relieve allergic symptoms, the patient should take the full course.

Stevens-Johnson syndrome or worsening of lupus

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

Acute generalized exanthematous pustulosis

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

Other side effects

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

• difficulty sleeping; the patient 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 unreal or strange (depersonalization), seeing or hearing things that do not exist (hallucinations), feeling or believing in things that are not real (delusions), exaggerated suspiciousness (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 during treatment with MOREME or soon after stopping it (see section 2 "Important information before taking MOREME"). If the patient has such thoughts, they should contact their 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, or 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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
phone: +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, more information can be gathered on the safety of this medicine.

5. How to store MOREME

The medicine should be stored out of sight and reach of children.
The patient 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 this medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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, glycerol dibehenate, magnesium stearate.
Coating I: ethylcellulose, 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. 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. The diameter of the tablet is about 9 mm; the thickness of the tablet is about 6 mm.
Blister pack with 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: