Package leaflet: Information for the patient

Aurorix, 150 mg, film-coated tablets
Moclobemide
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
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. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Aurorix is and what it is used for

Aurorix belongs to a group of medicines known as antidepressants and is used in the treatment of depressive disorders and social phobia. It contains the active substance moclobemide, which affects the brain's monoaminergic neurotransmitter systems—noradrenaline, dopamine, and serotonin. This action increases the levels of these neurotransmitters in the extracellular space.

2. Important Information Before Using Aurorix

When not to use Aurorix:

if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if a tumor of the adrenal gland has previously been diagnosed (the doctor may have used the term "phaeochromocytoma" or "chromaffin tumor");
in case of acute confusion (disorientation);
when taking selegiline (an antidepressant and also used in Parkinson's disease);
when taking bupropion (an antidepressant);
when using triptans for migraine headaches, e.g. sumatriptan, rizatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan, and eletriptan (triptans' effects are intensified);
when taking pethidine (a medicine used to treat moderate to severe pain) – increases the risk of serotonin syndrome (confusion, fever, chills, increased reflexes, clonic muscle seizures, diarrhea);
when taking tramadol (a medicine used to treat moderate to severe pain);
when taking any medicines containing dextromethorphan, e.g. cough medicines available without prescription;
when taking linezolid (an antibiotic used to treat severe bacterial infections);
when taking serotonin reuptake inhibitors (e.g. tricyclic antidepressants) due to the risk of serotonin syndrome;
in children.

Warnings and precautions
Before starting treatment with Aurorix, discuss this with your doctor or pharmacist.
When to exercise particular caution when taking Aurorix:

taking any medicines, including over-the-counter medicines used for coughs or colds containing ephedrine, pseudoephedrine, or phenylpropanolamine;
during concomitant administration of buprenorphine (a potent opioid analgesic) or buprenorphine with naloxone (used in opioid addiction treatment) – risk of serotonin syndrome;
concomitant use of preparations containing St. John's wort (Hypericum perforatum L.) – increases the risk of serotonin syndrome;
presence of depression with agitation in the clinical picture;
presence of bipolar affective disorder (risk of manic episodes);
presence of epilepsy;
presence of hypertension;
presence of hyperthyroidism;
presence of other psychiatric disorders, e.g. schizophrenia (Aurorix should not be used in patients with coexisting schizophrenia or schizoaffective organic disorders).

Patients with suicidal tendencies should be closely monitored at the beginning of treatment (see also section 4. "Possible side effects").
During treatment with Aurorix, hyponatremia – decreased sodium concentration in plasma – may occur.
If rash or swelling occur, which may be symptoms of hypersensitivity to Aurorix, contact your doctor immediately.

Aurorix and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Moclobemide enhances the effects of opioids (morphine, fentanyl, codeine), which may necessitate dose adjustments.
Avoid foods rich in tyramine – see section "Taking Aurorix with food and drink".
When Aurorix is taken after a meal, it causes less increase in blood pressure.
Exercise caution when using concomitantly with medicines such as cimetidine. The doctor will consider whether dose reduction is necessary.
Exercise caution when using concomitantly with medicines such as omeprazole (used in peptic ulcer disease) and antidepressants such as fluoxetine, fluvoxamine, trimipramine, and maprotiline, as moclobemide may enhance their effects when used together.
Use of medicines that increase serotonin levels, such as many antidepressants (especially in combination), should be cautious in patients receiving moclobemide. This includes the following antidepressants: venlafaxine, clomipramine, citalopram, escitalopram, paroxetine, sertraline, bupropion. In isolated cases, multiple serious symptoms such as hyperthermia (high fever), confusion, increased reflexes, and clonic muscle seizures due to enhanced serotonin activity (serotonin syndrome) have occurred. Concomitant use of Aurorix with buprenorphine and buprenorphine with naloxone increases the risk of serotonin syndrome, a potentially life-threatening condition. If symptoms suggestive of serotonin syndrome occur, contact your doctor immediately for appropriate treatment.
Concomitant use with St. John's wort (Hypericum perforatum L.) is not recommended, as it increases the risk of serotonin syndrome.
Aurorix may enhance and prolong the effects of systemically administered sympathomimetic agents such as ephedrine, pseudoephedrine, and phenylpropanolamine, which are contained in many combination cold and cough remedies.
Since sibutramine enhances the effect of Aurorix, concomitant use of these medicines is not recommended.
Concomitant use of dextropropoxyphene is not recommended, as moclobemide may enhance the effects of dextropropoxyphene.

Use of Aurorix in children
Aurorix should not be used in children.

Use of Aurorix in patients with impaired kidney and/or liver function
Patients with reduced kidney function do not require dose adjustment of Aurorix. Patients with impaired liver function may require dose reduction (depending on the degree of liver damage).

Use of Aurorix in elderly patients
Caution is advised when treating this patient group due to the risk of hyponatremia (decreased sodium concentration in plasma), likely due to inappropriate antidiuretic hormone secretion. Symptoms of hyponatremia include drowsiness, confusion (disorientation), or seizures.

Taking Aurorix with food and drink
Aurorix should be taken after completing a meal.
There are no specific dietary restrictions while taking this medicine. However, since some individuals may be particularly sensitive to tyramine, it is advisable to avoid foods containing high levels of this substance, such as aged cheeses, yeast extract, or fermented soybean products (found in some Chinese cuisine). Dietary concerns can be discussed with your doctor.
Alcohol should be avoided during treatment with Aurorix.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The safety of Aurorix during pregnancy has not been established. Therefore, the doctor should assess the benefit-risk balance of using the medicine during pregnancy.
Only a small amount of moclobemide passes into human breast milk (approximately 0.03 of the maternal dose); however, the doctor should evaluate the benefit-risk balance of continuing therapy in breastfeeding mothers.

Driving and operating machinery
There is no reason to assume that Aurorix treatment impairs the ability to perform tasks requiring full alertness (e.g. driving). However, individual patient response to the medicine should be monitored, especially during the initial phase of treatment.

Aurorix contains lactose monohydrate and sodium
This medicine contains lactose monohydrate. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to use Aurorix

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The coated tablets are for oral use.
The tablets should be taken after meals.

Usual dosage:
Adults
Depressive disorders:
The recommended dose of Aurorix is 300 mg to 600 mg daily, usually divided into 2 or 3 doses.
The initial dose is 300 mg daily and may be increased to 600 mg daily in cases of severe depression.
The dose should not be increased before the end of the first week of treatment, as the bioavailability
of moclobemide increases during this period.
The dose may be reduced depending on the individual patient's response to treatment. Aurorix
should be administered for at least 4-6 weeks to fully assess treatment efficacy.

Social phobia:
It is recommended to take 600 mg of Aurorix daily, divided into 2 doses.
The effectiveness of treatment in an individual patient can only be evaluated after 8-12 weeks of
treatment. Your doctor will consider continuing treatment, as social phobia is a chronic condition
and clinical studies have confirmed the long-term efficacy of the medicine. Patients should be
reviewed periodically to determine the need for ongoing treatment.

Elderly patients
No special dosage adjustment of Aurorix is required for elderly patients.

Children
Due to lack of clinical data, Aurorix should not be used in this patient group.

Patients with renal and/or hepatic impairment
In patients with impaired renal function, no dosage adjustment is necessary. In case of liver disease
or concomitant use of drugs that inhibit liver enzyme activity (e.g. cimetidine), the doctor may
recommend reducing the dose of Aurorix by half or to one-third.

If you feel the effect of Aurorix is too strong or too weak, consult your doctor.

Taking more Aurorix than prescribed
If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately.
Overdose of moclobemide alone causes mild and transient symptoms affecting the central nervous
system (CNS) and gastrointestinal tract. As with other antidepressants, overdose of moclobemide
together with other medicines (e.g. drugs acting on the CNS) may be life-threatening.

If you miss a dose of Aurorix
Contact your treating doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, seek immediate medical attention by contacting your doctor or going to the nearest hospital emergency department:
Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, or sometimes longer, to start working.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

the patient has previously experienced suicidal thoughts or self-harm;
the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who are being treated with antidepressants.

If a patient experiences suicidal thoughts or thoughts of self-harm, seek immediate medical attention by contacting a doctor or going to a hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for support and request them to inform the patient if they notice worsening of depression or anxiety, or concerning changes in behaviour.
High fever, confusion, increased reflexes and clonic muscle seizures
The occurrence of hyperthermia (high fever), confusion, increased reflexes and clonic muscle seizures in a patient may indicate excessive serotonin activity (serotonin syndrome). Serotonin syndrome is a potentially life-threatening condition. If symptoms suggestive of serotonin syndrome occur, contact a doctor immediately to initiate appropriate treatment.
Rash and swelling
Swelling and skin reactions such as rash, itching and urticaria may be signs of hypersensitivity to the medicine. A patient experiencing such symptoms should contact a doctor immediately.
If any of the following adverse reactions occur, contact your doctor:
If insomnia or nervousness occurs at the beginning of treatment with Aurorix, the doctor may consider reducing the dose or initiate treatment for these symptoms.
If affective disturbances or hypomania occur, or early signs of these reactions appear (such as grandiose delusions, excessive activity including verbal hyperactivity, impulsiveness), the doctor will discontinue treatment with Aurorix and replace it with another medicine.
Very common adverse reactions (may affect more than 1 in 10 people)
Sleep disturbances, dizziness, headache, dry mouth, nausea.
Common adverse reactions (may affect up to 1 in 10 people)
Restlessness, anxiety, agitation, paraesthesia (abnormal sensations such as tingling, pricking, burning), hypotension, vomiting, diarrhoea, constipation, rash, irritability.
Uncommon adverse reactions (may affect up to 1 in 100 people)
Suicidal thoughts, confusion (a syndrome of disturbed consciousness characterised by disordered thought processes, complete disorientation, anxiety, and disorganised motor agitation – these symptoms resolved after discontinuation of treatment), taste disturbances, visual disturbances, flushing (especially of the face), swelling and skin reactions such as itching and urticaria, feeling of fatigue.
Rare adverse reactions (may affect up to 1 in 1000 people)
Decreased appetite, decreased sodium concentration in blood (hyponatraemia), suicidal behaviour, hallucinations, serotonin syndrome, increased liver enzyme activity (without clinical consequences).
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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Aurorix

Keep this medicine out of sight and reach of children.
Storage – no special storage instructions apply.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Aurorix contains

The active substance is moclobemide. One coated tablet contains 150 mg of moclobemide.
The other ingredients are:
Tablet core: monohydrate lactose (see also section 2. "Aurorix contains monohydrate lactose and sodium"), maize starch, povidone, sodium carboxymethyl starch (see also section 2. "Aurorix contains monohydrate lactose and sodium"), magnesium stearate
Coating of the coated tablet: hypromellose, ethylcellulose, polyethylene glycol 6000, talc, titanium dioxide (E 171), iron oxide yellow (E 172)

What Aurorix looks like and contents of the pack
Aurorix is a light yellow, elongated coated tablet, marked with "150" on one side and a score line on the other side.
Pack sizes: 30 and 100 coated tablets.

Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Poland

Manufacturer:
MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany
Cenexi
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary

For further information about this medicinal product, please contact the Marketing Authorisation Holder's representative:
Viatris Healthcare Sp. z o.o.
Tel.: 22 546 64 00