Aurorix

Leaflet attached to the packaging: patient information

Aurorix, 150 mg, coated tablets

Moclobemide

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

• Keep this leaflet, you may need to read it again.
• In case of 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Aurorix and what is it used for
• 2. Important information before taking Aurorix
• 3. How to take Aurorix
• 4. Possible side effects
• 5. How to store Aurorix
• 6. Contents of the packaging and other information

1. What is Aurorix and what is it used for

Aurorix belongs to a group of antidepressant medicines and is used to treat depressive disorders and social phobia. It contains the active substance moclobemide, which affects the brain's monoaminergic neurotransmitter system - norepinephrine, dopamine, and serotonin. This action increases the amount of these neurotransmitters in the extracellular space.

2. Important information before taking Aurorix

When not to take Aurorix:

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if a pheochromocytoma (a tumor of the adrenal gland) has been previously diagnosed;
• in case of acute confusion (disorientation);
• when taking selegiline (an antidepressant and anti-Parkinson's disease medicine);
• when taking bupropion (an antidepressant);
• when taking triptans used for migraine headaches, such as sumatriptan, rizatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan, and eletriptan (this increases the effect of triptans);
• when taking pethidine (a medicine used to treat moderate to severe pain) - this increases the risk of serotonin syndrome (confusion, fever, chills, increased reflexes, clonic muscle spasms, diarrhea);
• when taking tramadol (a medicine used to treat moderate to severe pain);
• when taking any medicines containing dextromethorphan, such as over-the-counter cough medicines;
• when taking linezolid (an antibiotic used to treat severe bacterial infections);
• when taking serotonin reuptake inhibitors (such as tricyclic antidepressants) due to the risk of serotonin syndrome;
• in children.

Warnings and precautions

Before starting Aurorix, the patient should discuss it with their doctor or pharmacist. When to be particularly cautious when taking Aurorix:

• when taking any other medicines. This includes over-the-counter medicines used to treat coughs or colds that contain ephedrine, pseudoephedrine, or phenylpropanolamine;
• when taking buprenorphine (a strong pain reliever) or buprenorphine with naloxone (for opioid addiction treatment) - this increases the risk of serotonin syndrome;
• when taking St. John's Wort (Hypericum perforatum) preparations - this increases the risk of serotonin syndrome;
• in cases of depression with agitation;
• in cases of bipolar affective disorder (risk of manic episodes);
• in cases of epilepsy;
• in cases of hypertension;
• in cases of hyperthyroidism;
• in cases of other mental illnesses, such as schizophrenia (Aurorix should not be used in patients with co-existing schizophrenia or schizoaffective organic disorders).

Patient with a history of suicidal thoughts or behavior should be closely monitored during treatment initiation (see also section 4, "Possible side effects"). During Aurorix treatment, hyponatremia (low sodium levels in the blood) may occur. If a rash or swelling occurs, which may be symptoms of hypersensitivity to Aurorix, the patient should contact their doctor immediately.

Aurorix and other medicines

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. Moclobemide increases the effect of opioids (morphine, fentanyl, codeine), which may require a change in their dosage. It is recommended to avoid foods rich in tyramine (see section "Taking Aurorix with food and drink"). When Aurorix is taken after a meal, it causes less of an increase in blood pressure. The patient should be cautious when taking medicines such as cimetidine, as the doctor may need to reduce the dose. The patient should be cautious when taking medicines such as omeprazole (used for stomach ulcers) and antidepressants like fluoxetine, fluvoxamine, trimipramine, and maprotiline, as moclobemide may increase their effect. The use of medicines that increase serotonin levels, such as many antidepressants (especially in combination), should be cautious in patients taking moclobemide. This applies to the following antidepressants: venlafaxine, clomipramine, citalopram, escitalopram, paroxetine, sertraline, and bupropion. In individual cases, serious symptoms have occurred, such as hyperthermia (high fever), confusion, increased reflexes, and clonic muscle spasms, resulting from increased serotonin effects (serotonin syndrome). Concomitant use of Aurorix and buprenorphine or buprenorphine with naloxone increases the risk of serotonin syndrome, a potentially life-threatening disease. If symptoms of serotonin syndrome occur, the patient should contact their doctor immediately, who will initiate appropriate treatment. Concomitant use with St. John's Wort (Hypericum perforatum) is not recommended, as it increases the risk of serotonin syndrome. Aurorix may increase and prolong the effect of systemically administered sympathomimetic medicines, such as ephedrine, pseudoephedrine, and phenylpropanolamine, which are found in many combination anti-cold and anti-cough medicines. Since sibutramine increases the effect of Aurorix, concomitant use of these medicines is not recommended. Concomitant use of dextropropoxyphene is not recommended, as moclobemide may increase its effect.

Using Aurorix in children

Aurorix should not be used in children.

Using Aurorix in patients with kidney or liver problems

Patients with reduced kidney function do not need to adjust the dose of Aurorix. Patients with liver problems may need to reduce the dose of Aurorix (depending on the degree of liver damage).

Using Aurorix in the elderly

During treatment of this age group, caution should be exercised due to the possibility of hyponatremia (low sodium levels in the blood), probably due to inadequate secretion of antidiuretic hormone. Symptoms of hyponatremia include drowsiness, confusion (disorientation), or seizures.

Using Aurorix with food and drink

Aurorix should be taken after a meal. There are no special dietary restrictions during treatment. However, as some people may be particularly sensitive to tyramine, it is recommended to avoid foods containing large amounts of this compound, such as mature cheeses, yeast extract, or fermented soy products (found in some Chinese dishes). The patient can discuss dietary issues with their doctor. The patient should avoid consuming alcohol during Aurorix treatment.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The safety of using Aurorix in pregnant women has not been established. Therefore, the doctor should assess the ratio of potential benefits of using the medicine during pregnancy to the risk to the fetus. Only a small amount of moclobemide passes into breast milk (about 0.03 of the dose taken by the mother), but the doctor should assess the ratio of potential benefits of continuing therapy in breastfeeding mothers to the risk to the child.

Driving and using machines

There is no reason to assume that Aurorix treatment will impair the ability to perform activities that require full alertness (e.g., driving). However, the patient's individual reaction to the medicine should be monitored, especially at the beginning of treatment.

Aurorix contains lactose and sodium

The medicine contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Aurorix

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The coated tablets are for oral use. The tablets should be taken after a meal. The usual dose is:

Adults

Depressive disorders: The recommended dose of Aurorix is 300-600 mg per day, usually in 2 or 3 divided doses. The initial dose is 300 mg per day, and in cases of severe depression, it may be increased to 600 mg per day. The dose should not be increased before the first week of treatment, as the bioavailability of moclobemide increases during this period. The dose can be reduced depending on the patient's individual response to treatment. To fully assess the effectiveness of treatment, Aurorix should be taken for at least 4-6 weeks. Social phobia: The recommended dose is 600 mg per day, in 2 divided doses. The effectiveness of treatment can be assessed after 8-12 weeks of taking the medicine. The doctor will consider the possibility of continuing treatment, as social phobia is a chronic disease, and clinical trials have confirmed the effectiveness of long-term treatment with Aurorix. Patients should be periodically examined to determine the need for further treatment.

Elderly patients

There is no need for special dosing of Aurorix in elderly patients.

Children

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

Patients with kidney or liver problems

Patients with kidney problems do not need to adjust the dose of Aurorix. In cases of liver disease or when taking medicines that inhibit liver enzyme activity (e.g., cimetidine), the doctor may recommend reducing the dose of Aurorix by half or to one-third. If the patient feels that the effect of Aurorix is too strong or too weak,they should consult their doctor.

Taking more than the recommended dose of Aurorix

In case of taking a larger dose than recommended, the patient should immediately consult their doctor or pharmacist. Overdose of moclobemide causes mild and transient symptoms from the central nervous system (CNS) and gastrointestinal tract. Like other antidepressants, overdose of moclobemide with other medicines (e.g., CNS-acting medicines) can be life-threatening.

Missing a dose of Aurorix

The patient should contact their doctor.

4. Possible side effects

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

In case of any of the following side effects, the patient should immediately contact their doctor or go to the nearest hospital emergency room:

Suicidal thoughts, worsening of depression or anxiety disorders

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after 2 weeks, sometimes later. The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• the patient has previously had suicidal thoughts or self-harm;
• the patient is a young adult; data from clinical trials indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient can ask their relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are worrying changes in behavior.

High fever, confusion, increased reflexes, and clonic muscle spasms

The occurrence of hyperthermia (high fever), confusion, increased reflexes, and clonic muscle spasms in the patient may be due to increased serotonin effects (symptoms of serotonin syndrome). Serotonin syndrome is a potentially life-threatening disease. If symptoms of serotonin syndrome occur, the patient should immediately contact their doctor to initiate appropriate treatment.

Rash and swelling

Swelling and skin reactions, such as rash, itching, and hives, may be symptoms of hypersensitivity to Aurorix. The patient should immediately contact their doctor if such symptoms occur.

In case of the following side effects, the patient should contact their doctor:

If the patient experiences insomnia or nervousness at the beginning of treatment with Aurorix, the doctor may consider reducing the dose or treating these symptoms. In cases of affective disorders or hypomania, or early symptoms of these reactions (delusions of grandeur, excessive activity, including verbal activity, impulsivity), the doctor will stop treatment with Aurorix and replace it with another medicine.

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

Sleep disorders, dizziness, headaches, dry mouth, nausea.

Common side effects (may affect up to 1 in 10 people)

Agitation, feeling of anxiety, restlessness, paresthesia (unusual sensations, e.g., tingling, prickling, burning), hypotension, vomiting, diarrhea, constipation, rash, irritability.

Uncommon side effects (may affect up to 1 in 100 people)

• Suicidal thoughts, confusion (a syndrome of consciousness disorders characterized by disorders of thought, complete disorientation, fear, uncontrolled motor agitation - resolved after discontinuation of treatment), taste disorders, vision disorders, flushing (especially of the face), swelling, and skin reactions, such as itching and hives, feeling of fatigue.

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

Decreased appetite, decreased sodium levels in the blood (hyponatremia), suicidal behavior, hallucinations, serotonin syndrome, increased liver enzyme activity (without clinical consequences).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products of 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. 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 Aurorix

Keep the medicine out of sight and reach of children. There are no special storage instructions. Do not use this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month. 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. Contents of the packaging and other information

What Aurorix contains

• The active substance of Aurorix is moclobemide. One coated tablet contains 150 mg of moclobemide.
• Other ingredients are: Core of the coated tablet:lactose monohydrate (see also section 2, "Aurorix contains lactose monohydrate and sodium"), corn starch, povidone, sodium carboxymethylcellulose (see also section 2, "Aurorix contains lactose monohydrate and sodium"), magnesium stearate Coating of the coated tablet:hypromellose, ethylcellulose, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Aurorix looks like and contents of the packaging

Aurorix is a yellow, elongated, coated tablet with the inscription "150" on one side and a notch on the other side. The packaging contains 30 and 100 coated tablets.

Marketing authorization holder:

Viatris Healthcare Sp. z o.o., ul. Postępu 21B, 02-676 Warsaw

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 more information about this medicine, please contact

the representative of the marketing authorization holder: Viatris Healthcare Sp. z o.o., tel.: 22 546 64 00

Date of last revision of the leaflet: