Package leaflet: Information for the patient

MOREME, 150 mg, modified-release tablets
MOREME, 300 mg, modified-release tablets
Bupropion hydrochloride
Please read the entire leaflet carefully before 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 further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What MOREME is and what it is used for
Important information before taking MOREME
How to take MOREME
Possible side effects
How to store MOREME
Contents of the pack and other information

1. What MOREME is and what it is used for

MOREME is a prescription medicine used to treat depression. It works on chemical substances in the brain called noradrenaline and dopamine.

2. Important information before taking MOREME

When NOT to take MOREME

if the patient is allergic to bupropion or to 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 suffers from epilepsy or has had seizures,
if the patient has or has had in the past eating disorders (e.g. bulimia or psychological anorexia),
if the patient has a brain tumour,
if the patient is an alcohol abuser who has recently stopped drinking alcohol or intends to do so,
if the patient has severe liver disease,
if the patient has recently stopped taking sedatives or intends to do so during treatment with MOREME,
if the patient is taking or has taken within the last two weeks antidepressant medicines known as monoamine oxidase inhibitors (MAO inhibitors).

If any of the above situations apply to the patient, the patient should contact their doctor immediately and must not take MOREME.
Warnings and precautions
Before starting treatment with MOREME, discuss this with your doctor or pharmacist.
Brugada syndrome

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

Children and adolescents
MOREME is not recommended for use in children under 18 years of age.
In children under 18 years of age being treated with antidepressant medicines, there is an increased risk of suicidal thoughts and behaviours.
Adults
The patient should inform their doctor before starting treatment with MOREME:

if they regularly drink large amounts of alcohol,
if they have diabetes and are using insulin or oral antidiabetic medicines,
if they have previously had a serious head injury or head trauma.

MOREME may cause seizures in about 1 in 1000 patients. The occurrence of this adverse reaction is more likely in patients belonging to the groups listed above.
If seizures occur during treatment, the patient must stop taking MOREME. Do not take any more of this medicine and contact your doctor immediately.

If the patient has bipolar disorder (extreme mood swings), because MOREME may trigger an episode of this condition,
If the patient is taking other medicines used to treat depression, concomitant use of these medicines with MOREME may lead to serotonin syndrome, a potentially life-threatening condition (see “MOREME with other medicines” in this section),
If the patient has liver or kidney disease, because adverse reactions may be more likely to occur.

If any of the above situations apply to the patient, the patient should contact their doctor again before starting treatment with MOREME. The doctor may decide that treatment should be carried out under close supervision or recommend alternative treatment.
Suicidal thoughts and worsening of depression symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. These behaviours may worsen when the patient first starts taking antidepressant medicines, because it takes time before these medicines start to work, usually about two weeks, but sometimes longer.
Such thoughts may be more common:

if the patient has previously had suicidal thoughts or thoughts of self-harm,
if the patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults (under 25 years of age) with psychiatric disorders who were treated with antidepressant medicines. If the patient ever experiences thoughts of self-harm or suicide, they should contact their doctor immediately or go to 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 inform the patient if they notice worsening of depression or if changes in their behaviour become concerning.
MOREME with other medicines
If the patient is currently taking or has taken within the last fourteen days other antidepressant medicines known as monoamine oxidase inhibitors (MAO inhibitors), the patient should contact their doctor and must not take MOREME (see also: When NOT to take MOREME, section 2).
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including herbal remedies or vitamins, even those available without a prescription. The doctor may adjust the dose of MOREME, recommend changing the dosing regimen, or discontinuation of other medicines.
Some medicines must not be taken together with MOREME. Some of these may increase the risk of seizures or convulsions. Other medicines may increase the risk of other adverse reactions. Examples of such medicines are listed below, but this is not a complete list.
Seizures may occur more frequently than usual:

if the patient is taking other antidepressant medicines or medicines used to treat psychiatric disorders,
if the patient is taking theophylline, a medicine for asthma or lung diseases,
if the patient is taking tramadol, a strong painkiller,
if the patient has recently taken and/or is currently taking sedatives or intends to stop taking them during treatment with MOREME (see also When NOT to take MOREME, section 2),
if the patient is taking antimalarial medicines (such as mefloquine or chloroquine),
if the patient is taking stimulant medicines or other medicines that control body weight or appetite,
if the patient is taking steroids (orally or by injection),
if the patient is taking antibiotics known as quinolones,
if the patient is taking certain types of antihistamines that may cause drowsiness,
if the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, the patient should contact their doctor immediately before starting treatment with MOREME. The doctor will assess the risks and benefits of using MOREME.
The likelihood of other adverse reactions may increase:

if the patient is taking other antidepressant medicines (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or medicines for other psychiatric 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 (e.g. agitation, hallucinations, stupor), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure and increased reflexes, muscle rigidity, lack of coordination and (or) gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea),
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 malignant tumours (such as cyclophosphamide, ifosfamide),
if the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
if the patient is taking β-blockers (such as metoprolol),
if the patient is taking certain medicines for 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, the patient should contact their doctor immediately before starting treatment with MOREME.
MOREME may be less effective:

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

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. Do not increase the dose of MOREME without the doctor’s advice, as this may increase the risk of adverse reactions, including seizures.
MOREME may reduce the effectiveness of certain medicines

If the patient is taking tamoxifen, used to treat breast cancer. If this applies to the patient, they should inform their doctor. It may be necessary to change the treatment for depression.
If the patient is taking digoxin for heart problems. If this applies to the patient, they should inform their doctor. The 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, although rarely, cause nervousness or alter mental state. Some patients may become more sensitive to alcohol while taking MOREME. During treatment with MOREME, the doctor may advise abstaining from alcohol (beer, wine, spirits) or significantly reducing alcohol consumption. If the patient currently drinks large amounts of alcohol, they should not suddenly stop drinking, as this may trigger a seizure.
Before starting treatment with MOREME, the patient should discuss alcohol consumption with their doctor.
Effect on urine test results
MOREME may affect laboratory urine test results used to detect the presence of drugs. If the patient is undergoing such a test, they should inform the doctor or nurse that they are taking MOREME.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should not take MOREME unless advised otherwise by her doctor. During pregnancy, consult a doctor or pharmacist before taking this medicine. Some, but not all, studies suggest an increased risk of congenital malformations, particularly heart defects in children whose mothers took MOREME. It is not known whether this was caused by taking this medicine.
Components of MOREME may pass into breast milk. Consult a doctor or pharmacist before taking MOREME.
Driving and operating machinery
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 according to the doctor's or pharmacist's instructions. The treating physician determines the dose individually for each patient. If in doubt, consult your doctor or pharmacist.
Improvement in the patient's well-being may occur only after some time. The full effect of the medicine may become apparent only after several weeks or months. Even when the patient starts feeling better, the treating physician may recommend continuing treatment with MOREME to prevent recurrence of depression.

What doses should be taken
The usual recommended dose for adults is one 150 mg tablet once daily.
If there is no improvement after several weeks of treatment, the treating physician may increase the dose to 300 mg per day.
For some patients, a dose of 150 mg once daily is sufficient throughout the entire treatment period. The treating physician may recommend this dosage if the patient has liver or kidney disease.

How long to continue treatment
Only the doctor, together with the patient, can decide how long treatment with MOREME should continue. It may take weeks or even months before any improvement is observed. The patient should regularly discuss depressive symptoms with the treating physician so that decisions about the duration of treatment can be made. Even if the patient feels better, the treating physician may recommend continuing treatment with MOREME to prevent recurrence of depression.

Method of administration
The recommended dose of MOREME should be taken in the morning. MOREME must not be taken more than once a day.
The tablet has a coating that slowly releases the medicine into the gastrointestinal tract. The patient may notice something in the stool that looks like a tablet. This is the empty coating shell, which has been excreted from the body.
MOREME tablets should be swallowed whole. They must not be chewed, crushed, or divided – doing so could lead to overdose due to too rapid release of the medicine into the body. This may increase the risk of adverse effects, including seizures.
Tablets may be taken with or between meals.

Accidental overdose of MOREME
Taking too many tablets may cause seizures or convulsions. Do not delay – contact a doctor immediately or go to the nearest hospital emergency department.

Missed dose of MOREME
If a dose is missed, wait and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with MOREME
Do not stop taking MOREME or reduce the dose without first discussing it with the treating physician.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
Seizures or convulsive seizures
Seizures (convulsive seizures or convulsions) may occur in approximately 1 in 1,000 patients taking MOREME. The likelihood of this occurring is higher in patients taking higher than recommended doses, taking certain other medicines, or belonging to groups at increased risk of seizures. If in doubt, consult your doctor.
If a convulsive seizure occurs, contact your doctor immediately. Do not take any more of the medicine.
Allergic reactions
Some patients may experience allergic reactions to MOREME. These may include:

skin redness or rash (such as maculopapular rash), blisters or itchy lumps (urticaria) on the skin; some rashes may require hospitalization, especially if mouth pain or eye pain also occur,
unusual wheezing or difficulty breathing,
swelling of the eyelids, lips or tongue,
muscle or joint pain,
collapse or brief loss of consciousness.

If any symptoms of an allergic reaction occur, contact your doctor immediately. Do not take MOREME again.
Allergic reactions may last a long time. If your doctor has prescribed medication to relieve allergic symptoms, complete the full course of treatment.
Lupus-like skin rash or worsening of lupus symptoms
Frequency unknown – frequency cannot be estimated based on available data from patients taking MOREME. Lupus is an autoimmune disorder affecting the skin and other organs.
If lupus flares, skin rash, or skin changes (especially on areas of skin exposed to sunlight) occur during treatment with MOREME, contact your doctor immediately, as treatment discontinuation may be necessary.
Acute generalized exanthematous pustulosis (AGEP)
Frequency unknown – frequency cannot be estimated based on available data from patients taking MOREME. Symptoms of acute generalized exanthematous pustulosis include skin rash with pustules and/or pus-filled blisters.
If a skin rash with pustules and/or pus-filled blisters occurs, contact your doctor immediately, as treatment discontinuation may be necessary.
Other adverse effects
Very common adverse effects may occur in more than 1 in 10 patients:

difficulty sleeping; ensure that MOREME is taken in the morning,
headache,
dry mouth,
nausea, vomiting.

Common adverse effects may occur in up to 1 in 10 patients:

fever, dizziness, itching, sweating, skin rash (sometimes due to allergic reaction),
chills, tremors, weakness, fatigue, chest pain,
feeling of anxiety or agitation,
abdominal pain or other gastrointestinal complaints (constipation), altered taste sensation, loss of appetite (anorexia),
increased blood pressure (sometimes significantly), facial flushing,
ringing in the ears, visual disturbances.

Uncommon adverse effects may occur in up to 1 in 100 patients:

feeling of depression (see also section 2: Warnings and precautions),
feeling of disorientation,
difficulty concentrating,
increased heart rate,
weight loss.

Rare adverse effects may occur in up to 1 in 1,000 patients:

seizures.

Very rare adverse effects may occur in up to 1 in 10,000 patients:

palpitations, fainting,
muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination,
restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss,
yellowing of the skin or whites of the eyes (jaundice), which may be due to increased liver enzyme activity, hepatitis,
severe allergic reactions; rash accompanied by muscle and joint pain,
changes in blood sugar levels,
urinating more or less frequently than usual,
urinary incontinence (involuntary urination, uncontrolled leakage of urine),
severe skin reactions, which may involve the mouth and other body parts and may be life-threatening,
worsening of psoriasis (red, thickened skin lesions),
feelings of unreality or detachment (depersonalization), seeing or hearing things that are not real (hallucinations), experiencing or believing in unreal things (delusions), excessive suspiciousness (paranoia).

Frequency unknown (frequency cannot be estimated from available data):
Other adverse effects have occurred in a small number of patients, but their exact frequency is unknown:

thoughts about self-harm or suicide during treatment with MOREME or shortly after stopping it (see section 2 "Important information before taking MOREME"). If such thoughts occur, contact your doctor or go to hospital immediately.
loss of contact with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and/or delusions.
stuttering.
reduced number of red blood cells (anaemia), reduced number of white blood cells (leucopenia), and reduced number of platelets (thrombocytopenia).
low sodium levels in the blood (hyponatremia).
changes in mental state (e.g. agitation, hallucinations, coma), and other symptoms such as body temperature above 38°C, rapid heartbeat, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea) when MOREME is taken together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store MOREME

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What MOREME contains
The active substance in MOREME is bupropion hydrochloride.
Each modified-release tablet contains either 150 mg or 300 mg of bupropion hydrochloride.
The other ingredients are:
Tablet core: povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica, 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 hydrated silica, macrogol, triethyl citrate.
Printing ink: shellac, glaze, black iron oxide (E 172) and propylene glycol.

What MOREME looks like and contents of the pack
MOREME, 150 mg tablets are cream-white to light yellow, round tablets, printed with "GS3" on one side and smooth on the other side. The tablet diameter is approximately 7 mm; tablet thickness is approximately 5 mm.
MOREME, 300 mg tablets are cream-white to light yellow, round tablets, printed with "GS2" on one side and smooth on the other side. The tablet diameter is approximately 9 mm; tablet thickness is approximately 6 mm.
Blister pack made of OPA/Aluminium/PVC/Aluminium foil containing 30, 60 or 90 tablets, in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation 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

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