ORIBION 150 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Oribion, 150 mg, modified-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What Oribion is and what it is used for
4. Important information before taking Oribion
   1. When not to take Oribion:
   2. Warnings and precautions
   3. Brugada syndrome
   4. Children and adolescents
   5. Adults
   6. The patient should inform their doctor before starting treatment with Oribion:
   7. Suicidal thoughts and worsening of depression
   8. Oribion and other medicines If the patient is currently taking or has taken within the last 14 days other antidepressant medicines called monoamine oxidase inhibitors (MAOIs), they should contact
   9. The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take
   10. Seizures may occur more frequently than usual:
   11. Other side effects may occur more frequently than usual:
   12. Oribion may reduce the effectiveness of some medicines:
   13. Oribion and alcohol
   14. Effect on urine tests
   15. Pregnancy and breastfeeding
   16. Driving and using machines
   17. Excipients
5. How to take Oribion
   1. The dose of Oribion should be taken in the morning. The patient should not take Oribion more than once a day.
   2. Only the doctor, together with the patient, can decide how long to take Oribion.
   3. Taking a higher dose of Oribion than recommended
   4. Missing a dose of Oribion
   5. Stopping Oribion
6. Possible side effects
   1. Severe side effects Seizures or convulsions
   2. Acute generalized exanthematous pustulosis (AGEP)
   3. If the patient experiences a rash with pustules and (or) small blisters filled with pus, they should contact their doctor immediately, as it may be necessary to stop the treatment.
   4. Other side effects
   5. Reporting side effects
7. How to store Oribion
8. Package contents and other information
   1. What Oribion contains
   2. What Oribion looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

Oribion, 150 mg, modified-release tablets

Bupropion hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 Oribion is and what it is used for
• 2. Important information before taking Oribion
• 3. How to take Oribion
• 4. Possible side effects
• 5. How to store Oribion
• 6. Package contents and other information

1. What Oribion is and what it is used for

Oribion is a prescription-only medicine used to treat depression. It is thought to affect certain substances in the brain - norepinephrineand dopamine.

2. Important information before taking Oribion

When not to take Oribion:

• to bupropion or any of the other ingredients of this medicine (listed in section 6)
• (such as bulimia or anorexia nervosa)
• who has just stopped drinking or plans to do so
• or plans to do so while taking Oribion (see also "When not to take Oribion" in section 2)
• .

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

Warnings and precautions

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

Brugada syndrome

If the patient has a condition called Brugada syndrome (a rare, inherited condition that affects the heart rhythm) or if there have been cases of cardiac arrest or sudden death in the family.

Children and adolescents

Oribion 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

The patient should inform their doctor before starting treatment with Oribion:

• and is taking insulin or oral antidiabetic medicines
• Oribion may cause seizures in about 1 in 1000 people. The risk of this side effect is higher in patients with the above conditions. If seizures occur during treatment, Oribion should be discontinued. The patient should not take the medicine again and should contact their doctor.
• (extreme mood swings), as Oribion may trigger an episode of the condition.
• , as taking these medicines together with Oribion may lead to a condition called serotonin syndrome, which can be life-threatening (see "Oribion and other medicines" in this section of the leaflet).
• , 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 again before starting to take Oribion. The doctor may decide to monitor the patient closely or recommend a different treatment.

Suicidal thoughts and worsening of depression

In patients with depression, suicidal thoughts or behaviors may sometimes occur. Such behaviors may worsen after starting to take antidepressants for the first time, as it may take some time for the medicines to start working. This is usually about two weeks, but sometimes longer.
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 suicidal thoughts or self-harm thoughts occur at any time, the patient should contact their doctor immediatelyor go to the hospital.
It may be helpful for the patient to inform someone from their family or friendsthat they have depression and ask them to read this leaflet. The patient may ask them to tell them if they think the depression is getting worse or if changes in behavior become worrying.

Oribion and other medicines If the patient is currently taking or has taken within the last 14 days other antidepressant medicines called monoamine oxidase inhibitors (MAOIs), they should contact

their doctor without taking Oribion(see also "When not to take Oribion" in section 2).

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

, including herbal, vitamin, and over-the-counter medicines. The doctor may need to change the dose of Oribion or recommend a change in the dose of another medicine the patient is taking.
Some medicines should not be taken with Oribion. Some of them may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side effects. Some examples are listed below, but this is not a complete list.

Seizures may occur more frequently than usual:

• if the patient is taking other antidepressant or antipsychotic medicines
• if the patient is taking theophyllineused in asthma or lung diseases
• if the patient is taking tramadol, a strong painkiller
• if the patient has been taking sedativesor plans to stop taking them while taking Oribion (see also "When not to take Oribion" in section 2)
• if the patient is taking antimalarial medicines(such as mefloquine or chloroquine);
• if the patient is taking stimulants or other weight loss or appetite suppressant medicines
• if the patient is taking steroids (orally or by injection)
• if the patient is taking antibiotics called quinolones
• if the patient is taking certain antihistamines that may cause drowsiness
• if the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, they should discuss it with their doctor before starting to take Oribion. The doctor will assess the risk and benefits of using Oribion.

Other side effects may occur more frequently than usual:

• if the patient is taking other antidepressant medicines(such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, or imipramine) or medicines used in other mental disorders (such as clozapine, risperidone, thioridazine, or olanzapine). Oribion may interact with some medicines used to treat depression and the patient may experience changes in mental state (such as agitation, hallucinations, or coma) and other effects, such as body temperature above 38°C, increased heart rate, unstable blood pressure, and increased reflexes, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (such as nausea, vomiting, diarrhea).
• if the patient is taking medicines used to treat Parkinson's disease(levodopa, amantadine, or orphenadrine)
• if the patient is taking medicines that affect the metabolism of Oribion in the body(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 used mainly 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 or 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 discuss it with their doctor before starting to take Oribion.
Oribion 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 Oribion in the patient. It may be necessary to increase the dose or change the treatment of depression. The patient should not increasethe dose of Oribion without the doctor's recommendation, as this may increase the risk of side effects, including seizures.

Oribion 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 of depression.
• if the patient is taking digoxin, used to treat heart conditions. If this situation applies to the patient, they should tell their doctor. It may be necessary to change the dose of digoxin.

Oribion and alcohol

Alcohol may affect the action of Oribion, and taking it together may, although rarely, cause nervousness or change the mental state. Some patients may find that they are more sensitive to alcohol while taking Oribion. The doctor may recommend not drinking alcohol (beer, wine, spirits) while taking Oribion, or significantly reducing alcohol consumption.
The patient should discuss drinking alcohol with their doctorbefore starting to take Oribion.

Effect on urine tests

Oribion may affect the results of laboratory tests that detect the presence of other medicines.
If the patient is having such tests, they should inform their doctor or hospital staff that they are taking Oribion.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should not take this medicine unless their doctor decides otherwise. Before taking this medicine, the patient should consult their doctor or pharmacist. The results of some studies, although not all, suggest an increased risk of birth defects, especially heart defects, in children whose mothers took bupropion. It is not known if this was caused by Oribion.
The ingredients of Oribion may pass into breast milk. Before taking Oribion while breastfeeding, the patient should consult their doctor or pharmacist.

Driving and using machines

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

Excipients

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Oribion

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. The doctor will recommend a dose individually for the patient. If the patient has any doubts, they should consult their doctor or pharmacist.
Improvement in the patient's condition may take some time.The full effect of the medicine may take several weeks or months. Even if the patient starts to feel better, the doctor may recommend continuing to take Oribion to prevent the depression from coming back.
What dose of Oribion to take
Usually, the recommended dose for adults is one150 mg tablet once a day.
The doctor may recommend increasing the dose to 300 mgonce a day if the patient does not improve after several weeks of treatment.

The dose of Oribion should be taken in the morning. The patient should not take Oribion more than once a day.

The tablet is coated with a layer 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.
The tablets should be swallowed whole. They should not be chewed, crushed, or divided - if this is done, there is a risk of overdose due to the rapid release of the active substance in the body. This may increase the risk of side effects, including seizures.
For some patients, a dose of 150 mg once a dayis sufficient for the entire treatment period.
The doctor may recommend this dosage in cases of liver or kidney disease.
How long to take Oribion

Only the doctor, together with the patient, can decide how long to take Oribion.

It may take weeks or months before any improvement is seen.
The patient should regularly discuss their symptoms with their doctor to decide how long they should be treated. If the patient feels better, the doctor may recommend continuing to take Oribion to prevent the depression from coming back.

Taking a higher dose of Oribion than recommended

Taking too many tablets may cause seizures or convulsions. The patient should not delayand should contact their doctor or the nearest hospital emergency department immediately.

Missing a dose of Oribion

If the patient misses a dose, they should wait and take it at the usual time. The patient should not take a double doseto make up for the missed tablet.

Stopping Oribion

The patient should not stoptaking Oribion or reduce the dose without first discussing it with their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Severe side effects Seizures or convulsions

About 1 in 1000 patients taking Oribion may experience seizures (convulsions or seizures).
The likelihood of this is higher in patients who take higher doses than recommended, take certain other medicines, or are in a group with an increased risk of seizures.
If the patient has any doubts, they should consult their doctor.
If seizures occur, the patient should contact their doctor. The patient should not take Oribion again.
Allergic reactions
Some patients may experience allergic reactions to Oribion. These include:

• redness of the skin or rash (like hives), 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
• collapse or brief loss of consciousness.

If the patient experiences any symptoms of an allergic reaction, they should contact their doctor immediately. The patient should not take Oribion again.
Allergic reactions can last a long time.If the doctor has prescribed medicines to relieve allergic symptoms, the patient should complete the full course of treatment.
Systemic lupus erythematosus-like rash or worsening of lupus symptoms
Frequency not known - frequency cannot be estimated from the available data on people taking Oribion.
Systemic lupus erythematosus is an immune system disorder that affects the skin and other organs. If the patient experiences worsening of lupus symptoms, skin rash, or skin changes (especially on sun-exposed areas) while taking Oribion, they should contact their doctor immediately, as it may be necessary to stop the treatment.

Acute generalized exanthematous pustulosis (AGEP)

Unknown - frequency cannot be estimated from the available data on people taking Oribion.
AGEP symptoms include a rash with pustules and (or) small blisters filled with pus.

If the patient experiences a rash with pustules and (or) small blisters filled with pus, they should contact their doctor immediately, as it may be necessary to stop the treatment.

Other side effects

Very common ( may affect more than 1 in 10 people):

• difficulty sleeping; the patient should remember to take Oribion in the morning
• headache
• dry mouth
• feeling of nausea, vomiting.

Common ( may affect up to 1 in 10 people):

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

Uncommon ( may affect up to 1 in 100 people):

• feeling of depression (see also section 2: "Warnings and precautions" under "Suicidal thoughts and worsening of depression")
• feeling of disorientation
• difficulty concentrating
• increased heart rate
• weight loss.

Rare ( may affect up to 1 in 1,000 people):

• seizures.

Very rare ( may affect up to 1 in 10,000 people):

• heart palpitations, fainting
• muscle tremors, muscle stiffness, uncontrolled movements, difficulty walking or coordinating
• feeling of anxiety, irritation, hostility, aggression, 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, hepatitis
• severe allergic reactions, rash with accompanying muscle and joint pain
• changes in blood sugar levels
• urinating more or less often than usual
• incontinence (involuntary urination, uncontrolled urine flow)
• severe skin rashes that may involve the mouth or other parts of the body and may be life-threatening
• worsening of psoriasis (red thickening of the skin)
• unusual hair loss ( alopecia)
• feeling of unreality or strangeness ( depersonalization), seeing or hearing things that do not exist ( hallucinations), feeling or believing in things that are not real ( delusions), exaggerated suspiciousness (paranoia).

Unknown ( frequency cannot be estimated from the available data):
A small number of patients have experienced other side effects, the exact frequency of which is unknown:

• thoughts of self-harm or suicide while taking Oribion or soon after stopping it (see section 2 "Important information before taking Oribion"). 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

• feeling of sudden and intense anxiety ( panic attack)
• stuttering
• decreased number of red blood cells (anemia), decreased number of white blood cells (leukopenia), and decreased number of platelets (thrombocytopenia)
• decreased sodium levels in the blood (hyponatremia)

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,
Al. Jerozolimskie 181 C, 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 collected on the safety of the medicine.

5. How to store Oribion

The medicine should be stored out of 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.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Oribion contains

• The active substance of Oribion is bupropion hydrochloride. Each tablet contains 150 mg of bupropion hydrochloride.
• Other ingredients: Tablet core:povidone, hydrochloric acid, sodium stearyl fumarate. Coating:ethyl cellulose, hydroxypropyl cellulose, methacrylic acid, and ethyl acrylate copolymer (1:1), colloidal silica, macrogol, triethyl citrate, hypromellose.

What Oribion looks like and what the package contains

White to light yellow, round, biconvex tablets, smooth on both sides. The diameter of the tablet is 7.4 mm.
The tablets are packaged in HDPE bottles containing 30 or 90 tablets, with a desiccant container and an oxygen absorber, with a child-resistant closure and a tamper-evident seal.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the leaflet:11.2024