Oribion

Package leaflet: Information for the patient

Oribion, 150 mg, modified-release tablets
Bupropioni hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your 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. Contents of the pack and other information

1. What Oribion is and what it is used for

Oribion is a prescription medicine used to treat depression. It is believed to affect certain substances in the brain—noradrenaline and dopamine.

2. Important information before taking Oribion

When not to take Oribion:

• 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 in the past
• if the patient has or has had in the past eating disorders (e.g. bulimia or anorexia nervosa)
• if the patient has a brain tumour
• if the patient who abuses alcohol has recently stopped drinking or intends to do so
• if the patient has severe liver disease
• if the patient has recently stopped taking sedative medicines or intends to do so during treatment with Oribion
• if the patient is taking or has taken within the last 14 days antidepressant medicines known as monoamine oxidase inhibitors (MAOIs).

If any of the above situations apply to the patient, immediate contact should be made
with a doctor and Oribion must not be taken.
Warnings and precautions
Before starting treatment with Oribion, discuss this with your doctor or pharmacist.
Brugada syndrome
If the patient has a condition called Brugada syndrome (a rare, inherited disorder affecting
heart rhythm), or if there has been sudden cardiac arrest or sudden death in the family.
Children and adolescents
Oribion is not recommended for use in children under 18 years of age. In children under 18 years of age 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 Oribion:

• if the patient regularly drinks large amounts of alcohol
• if the patient has diabetes and is using insulin or oral antidiabetic medicines
• if the patient has had a serious head injury or other head trauma Oribion may cause seizures in about 1 in 1000 people. The occurrence of this adverse effect is more likely in patients from the groups listed above. If seizures occur during treatment, Oribion must be discontinued. Do not take any more of this medicine and contact your doctor.
• if the patient has bipolar disorder (extreme mood swings), because Oribion may trigger an episode of this illness.
• if the patient is taking other medicines used to treat depression, because taking these medicines together with Oribion may lead to serotonin syndrome, a potentially life-threatening condition (see "Oribion with other medicines" in this section of the leaflet).
• if the patient has liver or kidney disease, because adverse effects 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 Oribion. 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 after starting antidepressant treatment for the first time, as it may take some time before these medicines begin to work. This is usually about two weeks, although sometimes longer.
Such thoughts may be more common:

• if the patient 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, immediate contact should be made
with their doctor or go to hospital.
It may be helpful for the patient to inform a family member or friend that they have depression and ask them to read this leaflet. The patient may ask them to inform the patient if they notice worsening depression or concerning changes in behaviour.
Oribion 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 (MAOIs), the patient should contact their doctor without taking Oribion (see also: "When not to use Oribion", in section 2).
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, and any medicines the patient plans to take, including herbal, vitamin supplements and over-the-counter medicines. The doctor may adjust the dose of Oribion or recommend changing the dose of another medicine the patient is taking.
Some medicines must not be taken at the same time as Oribion. Some of these may increase the risk of seizures or convulsions. Other medicines may increase the risk of other adverse 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 medicines or medicines used to treat other psychiatric disorders
• if the patient is taking theophylline used for asthma or lung diseases
• if the patient is taking tramadol, a strong painkiller
• if the patient has previously taken sedative medicines or intends to stop taking them during treatment with Oribion (see also "When not to use Oribion", in section 2)
• if the patient is taking antimalarial medicines (such as mefloquine or chloroquine)
• if the patient is taking stimulant medicines or other weight-loss or appetite-suppressant medicines
• 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 antihistamines which may cause drowsiness
• if the patient is taking antidiabetic medicines.

If any of the above situations apply to the patient, the patient should immediately discuss this
with their doctor before starting treatment with Oribion. The doctor will assess the risks and benefits of using Oribion.
Other adverse effects may occur more frequently than usual:

• if the patient is taking other antidepressant medicines (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or medicines used for other psychiatric 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 (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle stiffness, lack of coordination and (or) gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
• 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, 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 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, the patient should immediately discuss this
with their doctor before starting treatment with Oribion.
Oribion 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, the patient 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 method of treating depression. Do not increase the dose of Oribion without the doctor's advice, as this may increase the risk of adverse effects, including seizures.
Oribion may reduce the effectiveness of certain medicines:

• if the patient is taking tamoxifen, used to treat breast cancer. If this situation applies to the patient, inform the doctor. It may be necessary to change the method of treating depression.
• if the patient is taking digoxin, used for heart conditions. If this situation applies to the patient, inform the doctor. It may be necessary to adjust the dose of digoxin.

Oribion and alcohol
Alcohol may affect the action of Oribion, and taking them together may, although rarely,
cause nervousness or changes in mental state. Some patients may notice they are more sensitive to alcohol while taking Oribion. The doctor may advise avoiding alcohol (beer, wine, spirits) while taking Oribion, or significantly reducing alcohol intake.
If the patient currently drinks significant amounts of alcohol, do not suddenly stop drinking, as this may cause seizures.
Discuss alcohol consumption with your doctor before starting treatment with Oribion.
Effect on urine tests
Oribion may affect laboratory test results detecting the presence of other drugs.
If the patient undergoes such tests, they should inform the doctor or hospital staff that they are taking Oribion.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should not take this medicine unless her doctor decides otherwise. Consult a doctor or pharmacist before taking this medicine. Results of some, although not all, studies suggest an increased risk of birth defects, particularly heart defects in babies whose mothers took bupropion. It is not known whether this was caused by taking Oribion.
The ingredients of Oribion may pass into breast milk. Consult a doctor or pharmacist before taking Oribion during breastfeeding.
Driving and operating machinery
If Oribion causes dizziness or a feeling of emptiness in the head, do not drive or operate machinery.
Excipients
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to take Oribion

This medicine should always be taken according to the doctor's or pharmacist's instructions. The treating physician will determine the dose individually for each patient. If in doubt, consult your doctor or pharmacist.
Improvement in the patient's well-being may only occur after some time. The full effect of the medicine may take several weeks or months to appear. Even when the patient starts to feel better, the treating physician may recommend continuing treatment with Oribion to prevent recurrence of depression.

What dose of the medicine should be used?
The usual recommended dose for adults is one 150 mg tablet once daily.
The treating physician may recommend increasing the dose to 300 mg once daily if there is no improvement after several weeks of treatment.
The dose of Oribion should be taken in the morning. Do not take Oribion more than once daily.
The tablet has a coating that slowly releases the active substance into the gastrointestinal tract. The patient may notice something resembling a tablet in the stool. This is the empty coating shell, which has been eliminated from the body.
Oribion tablets should be swallowed whole. Do not chew, crush, or divide them – doing so may lead to overdose due to rapid release of the active substance into the body. This may increase the risk of adverse effects, including seizures.

For some patients, a dose of 150 mg once daily may be sufficient throughout the entire treatment period. The treating physician may recommend this dose in patients with liver or kidney disease.

How long should treatment last?
Only the doctor, together with the patient, can decide how long treatment with Oribion should continue. It may take weeks or months before any improvement is observed. The patient should regularly discuss symptoms of depression with the treating physician to determine the appropriate duration of treatment. If the patient feels better, the treating physician may still recommend continuing Oribion to prevent recurrence of depression.

Taking more than the recommended dose of Oribion
Taking too many tablets may cause seizures or convulsive fits. Do not delay – contact your treating physician or the nearest hospital emergency department immediately.

Missing a dose of Oribion
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 tablet.

Stopping treatment with Oribion
Do not stop taking Oribion or reduce the dose without first consulting your treating physician.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Seizures or convulsions
Seizures (convulsions or epileptic fits) may occur in approximately 1 in 1,000 patients taking Oribion.
The likelihood of this occurring is higher in patients taking higher than recommended doses, taking certain other medications, or belonging to a group at increased risk of seizures.
If in doubt, consult your treating physician.
If seizures occur, contact your treating physician immediately. Do not take the medicine again.
Allergic reactions
Some patients may experience allergic reactions to Oribion. These may include:

• skin redness or rash (such as hives), 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 the medicine again.
Allergic reactions may persist for a long time. If your doctor has prescribed medications to relieve allergic symptoms, complete the full recommended course of treatment.
Lupus-like skin rash or worsening of lupus symptoms
Frequency unknown – frequency cannot be determined from available data in individuals taking Oribion.
Lupus is an autoimmune disorder affecting the skin and other organs. If the patient develops a flare-up of lupus symptoms, skin rash, or skin changes (especially in sun-exposed areas) while taking Oribion, contact a doctor immediately, as discontinuation of treatment may be necessary.
Acute Generalized Exanthematous Pustulosis (AGEP)
Unknown frequency – frequency cannot be determined from available data in individuals taking Oribion.
AGEP symptoms include a pustular rash and (or) small pus-filled blisters.
If the patient develops a rash with pustules and (or) small pus-filled blisters, contact a doctor immediately, as discontinuation of treatment may be necessary.
Other adverse reactions
Very common ( may occur in more than 1 in 10 people ):

• difficulty falling asleep; remember to take Oribion in the morning
• headache
• dry mouth
• nausea, vomiting.

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

• fever, dizziness, itching, sweating, skin rash (sometimes due to allergic reaction)
• chills, tremors, weakness, fatigue, chest pain
• feeling anxious or agitated
• 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 ( may occur in up to 1 in 100 people ):

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

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

• seizures.

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

• palpitations, fainting
• muscle twitching, muscle stiffness, uncontrolled movements, difficulty walking or coordination
• feelings of anxiety, 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 rashes, which may involve the mouth or other body parts and which may be life-threatening
• exacerbation of psoriasis (red, thickened skin lesions)
• unusual hair loss or thinning ( alopecia )
• 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).

Unknown ( frequency cannot be determined from available data ):
Other adverse reactions have occurred in a small number of patients, the exact frequency of which is unknown:

• thoughts of self-harm or suicide during treatment with Oribion or shortly after stopping it (see section 2 "Important information before taking Oribion"). If
  the patient has such thoughts, contact a doctor or go to the hospital immediately;

• loss of touch with reality and impaired thinking or judgment ( psychosis ); other symptoms may include hallucinations and (or) delusions

• sudden and intense feeling of fear ( 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)

• changes in mental state (e.g. agitation, hallucinations, coma) and other symptoms such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and (or) gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) when Oribion is used concomitantly with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

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

5. How to store Oribion

Keep the medicine out of the 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 stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Oribion contains

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

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

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]