Auromirta Oro

Leaflet accompanying the packaging: patient information

AuroMirta ORO, 15 mg, orally disintegrating tablets

AuroMirta ORO, 30 mg, orally disintegrating tablets

AuroMirta ORO, 45 mg, orally disintegrating tablets

Mirtazapine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness 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 is AuroMirta ORO and what is it used for
• 2. Important information before taking AuroMirta ORO
• 3. How to take AuroMirta ORO
• 4. Possible side effects
• 5. How to store AuroMirta ORO
• 6. Contents of the packaging and other information

1. What is AuroMirta ORO and what is it used for

AuroMirta ORO is one of a group of medicines called antidepressants.
AuroMirta ORO is used to treat depression in adults.
It usually takes 1 to 2 weeks before the treatment with AuroMirta ORO starts to work.
After 2 to 4 weeks, the patient may start to feel better. If the patient does not feel better or feels worse after 2-4 weeks, they should consult their doctor immediately. More information can be found in section 3 "When can improvement in well-being be expected".

2. Important information before taking AuroMirta ORO

Do not take AuroMirta ORO - OR - consult your doctor before taking AuroMirta ORO:

• if the patient is allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, the patient should immediately discuss this with their doctor before taking AuroMirta ORO.
• if the patient is taking or has recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
• if the patient has ever experienced severe skin rash or blistering of the skin, peeling, and (or) mouth sores after taking AuroMirta ORO or other medicines.

Special caution should be exercised when taking AuroMirta ORO:

In connection with the use of AuroMirta ORO, severe skin reactions have been reported, including Stevens-Johnson syndrome (ang. Stevens-Johnson syndrome, SJS), toxic epidermal necrolysis (ang. toxic epidermal necrolysis, TEN), and drug reaction with eosinophilia and systemic symptoms (ang. drug reaction with eosinophilia and systemic symptoms, DRESS). The patient should stop taking the medicine and seek medical help immediately if they experience any of the symptoms listed in section 4.

• 4.

If the patient has ever experienced a severe skin reaction, they should not restart treatment with AuroMirta ORO.

Warnings and precautions

Before starting to take AuroMirta ORO, the patient should discuss this with their doctor or pharmacist.

Children and adolescents

Mirtazapine is not usually given to children and adolescents under 18 years of age, as it has not been shown to be effective in this age group. It should also be noted that in patients under 18 years of age, the risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger), increases when taking this type of medicine. Nevertheless, the doctor may prescribe AuroMirta ORO to patients under 18 years of age if they consider it beneficial for them. If the doctor has prescribed AuroMirta ORO to a patient under 18 years of age and the patient wants to discuss this, they should consult their doctor. The patient should inform their doctor if any of the above symptoms occur or worsen while taking AuroMirta ORO in patients under 18 years of age. Additionally, the long-term safety effects of taking AuroMirta ORO on growth, maturation, and cognitive and behavioral development in this age group have not yet been demonstrated. Furthermore, in this age group, significant weight gain during treatment with AuroMirta ORO has been observed more frequently compared to adults.

Suicidal thoughts and worsening of depression

If the patient has depression, they may sometimes have thoughts of self-harm or suicide. These thoughts may be intensified after starting to take antidepressant medicines, as these medicines take time to work, usually about two weeks, and sometimes longer.
The patient may be particularly at risk:

• if they have had suicidal thoughts or self-harm in the past.
• if they are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressant medication. If the patient thinks about self-harm or suicide at any time, they should contact their doctor or go to the hospital immediately.

It may be helpful to inform a relative or close friend about the depression and ask them to read this leaflet. The patient can also ask them to tell them if they notice that the depression is getting worse or if there are changes in behavior.
Special caution should also be exercised when taking AuroMirta ORO:

• if the patient has or has ever had any of the following conditions: Before taking AuroMirta ORO, the patient should inform their doctor about the following conditions, if they have not already done so.
• seizures (epilepsy). If seizures occur or become more frequent, the patient should stop taking AuroMirta ORO and consult their doctor immediately;
• liver disease, including jaundice. If jaundice occurs, the patient should stop taking AuroMirta ORO and consult their doctor immediately;
• kidney disease;
• heart disease or low blood pressure;
• schizophrenia. If psychotic symptoms, such as paranoid thoughts, become more frequent or severe, the patient should consult their doctor immediately;
• manic depression (alternating periods of excitement/hyperactivity and low mood). If the patient feels excessive excitement or agitation, they should stop taking AuroMirta ORO and consult their doctor immediately;
• diabetes (the dose of insulin or other antidiabetic medicines may need to be adjusted);
• eye diseases, such as increased eye pressure (glaucoma);
• urination difficulties, which may be caused by an enlarged prostate;
• certain heart diseases that can change the heart rhythm, recent heart attack, heart failure, or taking certain medicines that can affect the heart rhythm.
• if infection symptoms occur, such as unexplained high fever, sore throat, and mouth sores. The patient should stop taking AuroMirta ORO and consult their doctor immediately for a blood test. In rare cases, these symptoms may be signs of blood cell production disorders in the bone marrow. Although these symptoms are rare, they most often occur within 4-6 weeks of treatment.
• if the patient is elderly. The patient may be more sensitive to the side effects of antidepressant medicines.

AuroMirta ORO 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.
AuroMirta ORO should not be taken in combination with:

• monoamine oxidase inhibitors (MAOIs). AuroMirta ORO should not be taken for two weeks after stopping MAOIs. If AuroMirta ORO treatment is stopped, MAOIs should not be taken for the next two weeks. Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressant medicines), and selegiline (used in Parkinson's disease).

Caution should be exercised when taking AuroMirta ORO in combination with:

• antidepressant medicines, such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraines), tramadol (a pain reliever), linezolid (an antibiotic), lithium (used to treat certain mental disorders), methylene blue (used to treat high levels of methemoglobin in the blood), and St. John's Wort (Hypericum perforatum) (a herbal remedy for depression). In very rare cases, AuroMirta ORO alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome are: unexplained fever, sweating, rapid heartbeat, diarrhea, (uncontrolled) muscle contractions, shivering, overreactivity, restlessness, mood changes, and loss of consciousness. If a combination of these symptoms occurs, the patient should consult their doctor immediately.
• nefazodone, an antidepressant medicine. It may increase the amount of AuroMirta ORO in the blood. The patient should inform their doctor if they are taking this medicine. It may be necessary to reduce the dose of AuroMirta ORO or, if nefazodone is stopped, to increase the dose of AuroMirta ORO again.
• anxiety or insomnia medicines, such as benzodiazepines.
• schizophrenia medicines, such as olanzapine.
• allergy medicines, such as cetirizine.
• strong pain relievers, such as morphine. In combination with these medicines, AuroMirta ORO may increase the drowsiness caused by these medicines.
• infection medicines; medicines used to treat bacterial infections (such as erythromycin), medicines used to treat fungal infections (such as ketoconazole), and medicines used to treat

HIV/AIDS (such as HIV protease inhibitors) and medicines used to treat stomach ulcers (such as cimetidine).
In combination with AuroMirta ORO, these medicines may increase the concentration of AuroMirta ORO in the blood. The patient should inform their doctor if they are taking these medicines. It may be necessary to reduce the dose of AuroMirta ORO or, after stopping these medicines, to increase the dose of AuroMirta ORO again.

• antiepileptic medicines, such as carbamazepine and phenytoin.
• antituberculosis medicines, such as rifampicin. In combination with AuroMirta ORO, these medicines may decrease the concentration of AuroMirta ORO in the blood. The patient should inform their doctor if they are taking these medicines. It may be necessary to increase the dose of AuroMirta ORO or, after stopping these medicines, to decrease the dose of AuroMirta ORO again.
• blood clot prevention medicines, such as warfarin. AuroMirta ORO may increase the effect of warfarin. The patient should inform their doctor if they are taking this medicine. If taken together, it is recommended that the doctor closely monitor blood parameters.
• medicines that can affect heart rhythm, such as certain antibiotics and certain antipsychotic medicines.

AuroMirta ORO with food and alcohol

The patient may feel drowsy if they consume alcohol while taking AuroMirta ORO.
The patient should not consume alcohol.
AuroMirta ORO can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Limited experience with the use of AuroMirta ORO in pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.
If AuroMirta ORO is used until delivery or shortly before delivery, the baby should be monitored for possible side effects.
Taking AuroMirta ORO during pregnancy, like other similar medicines (SSRIs), may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually occur within the first 24 hours after birth. In such a case, the patient should contact the midwife and/or doctor immediately.

Driving and using machines

Mirtazapine may affect concentration or attention. Before driving or using machines, the patient should make sure that it does not affect these skills. If the doctor has prescribed AuroMirta ORO to a patient under 18 years of age, the patient should make sure before driving (e.g., a bicycle) that the medicine does not affect concentration and attention on the road.
AuroMirta ORO contains aspartame,a source of phenylalanine. It may be harmful to people with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take AuroMirta ORO

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dosage

The usual starting dose is 15 mg or 30 mg per day. The doctor may recommend increasing the dose after a few days to the amount that is best for the patient (from 15 mg to 45 mg per day). The dose is usually the same for all age groups. However, if the patient is elderly or has kidney or liver disease, the doctor may adjust the dose.

When to take AuroMirta ORO

AuroMirta ORO should be taken every day at the same time.
It is best to take AuroMirta ORO in a single dose before going to bed. However, the doctor may recommend dividing the dose of AuroMirta ORO - once in the morning and once in the evening before going to bed.
The larger dose should be taken before going to bed.
Orally disintegrating tablets should be taken as follows:
Tablets should be taken orally.

1. Do not crush the orally disintegrating tablet

To prevent crushing the orally disintegrating tablet, do not press on the blister pocket (Figure A).

Figure A

2. Tear off one tablet pocket

Each blister contains six pockets that are separated by perforations. The patient should tear off one tablet pocket along the broken lines (Fig. 1).

Fig. 1

3. Open the packaging

Carefully remove the foil covering, starting from the corner, as indicated by the arrow (Fig. 2 and 3)

Fig. 2

Fig. 3

4. Remove the orally disintegrating tablet

Remove the orally disintegrating tablet with dry hands and place it on the tongue (Fig. 4).

Fig. 4
The tablet dissolves quickly and can be swallowed without drinking water.

When can improvement in well-being be expected?

Usually, AuroMirta ORO starts to work after 1 to 2 weeks, and after 2 to 4 weeks, the patient may start to feel better. It is essential to discuss the effect of AuroMirta ORO with the doctor within the first few weeks of treatment:
2-4 weeks after starting to take AuroMirta ORO, the patient should discuss the effect of the medicine with their doctor.
If the patient still does not feel better, the doctor may prescribe a higher dose. In such a case, the patient should discuss this with their doctor again after another 2-4 weeks. AuroMirta ORO is usually taken for 4 to 6 months, until the symptoms of depression disappear.

Taking a higher than recommended dose of AuroMirta ORO.

If the patient or someone else has taken too much AuroMirta ORO, they should contact their doctor immediately. The most likely symptoms of AuroMirta ORO overdose (without other medicines or alcohol) are drowsiness, disorientation, and rapid heartbeat. Symptoms of possible overdose may include changes in heart rate (fast, irregular heartbeat) and (or) fainting, which can be symptoms of a life-threatening condition called torsade de pointes.

Missing a dose of AuroMirta ORO

If the patient is supposed to take a dose once a day

• The patient should not take a double dose to make up for the missed dose. The next dose should be taken at the usual time.

If the patient is supposed to take a dose twice a day

• If the patient forgot to take the morning dose, they should take it together with the evening dose.
• If the patient forgot to take the evening dose, they should not take it with the next morning dose; they should skip it and continue taking the usual doses in the morning and evening.
• If the patient forgot to take both doses, they should not take the missed doses. They should skip both doses and continue the usual schedule the next day with doses in the morning and evening.

Stopping treatment with AuroMirta ORO

The patient should stop taking AuroMirta ORO after consulting their doctor.
If the patient stops taking the medicine too early, depression may return. When the patient feels better, they should discuss this with their doctor. The doctor will decide when to stop treatment.
The patient should not suddenly stop taking AuroMirta ORO, even if the depression has lifted. If the patient suddenly stops taking AuroMirta ORO, they may experience nausea, dizziness, restlessness, or anxiety, and headaches.
These symptoms can be avoided by gradually stopping the treatment. The doctor will tell the patient how to gradually reduce the dose.
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, AuroMirta ORO can cause side effects, although not everybody gets them.

In case of any of the following serious side effects, the patient should stop taking AuroMirta ORO and consult their doctor immediately:

Uncommon(may affect less than 1 in 100 people):

• feeling excited or emotionally unbalanced (mania).

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

• yellowing of the eyes or skin; this may indicate liver function disorders (jaundice).

Unknown(frequency cannot be estimated from the available data):

• infection symptoms, such as sudden unexplained high fever, sore throat, and mouth sores (agranulocytosis). In rare cases, mirtazapine may cause blood cell production disorders (bone marrow suppression). Some people may become less resistant to infections, as mirtazapine may cause a temporary lack of white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a lack of red and white blood cells, as well as platelets (aplastic anemia), a lack of platelets (thrombocytopenia), or an increased number of white blood cells (eosinophilia);
• seizure (convulsions);
• a combination of symptoms, such as unexplained fever, sweating, rapid heartbeat, diarrhea, (uncontrolled) muscle contractions, shivering, overreactivity, restlessness, mood changes, and loss of consciousness. In very rare cases, these may be symptoms of serotonin syndrome;
• thoughts of self-harm or suicide;
• red spots on the torso in a target shape or round, often with blisters in the center, peeling of the skin, mouth sores, and ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Other possible side effects of mirtazapine are:

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

• increased appetite and weight gain;
• feeling drowsy or sleepy;
• headache;
• dry mouth.

Common(may affect less than 1 in 10 people):

• lethargy;
• dizziness;
• tremors;
• nausea;
• diarrhea;
• vomiting;
• constipation;
• rash or pustular rash;
• joint pain (arthralgia) or muscle pain (myalgia);
• back pain;
• dizziness or fainting when standing up quickly (orthostatic hypotension);
• swelling (usually in the ankles or feet) due to fluid retention (edema);
• fatigue;
• vivid dreams;
• confusion;
• feeling anxious;
• sleep problems;
• memory problems, which in most cases disappeared after stopping treatment.

Uncommon(may affect less than 1 in 100 people):

• abnormal sensation on the skin, e.g., burning, tingling, itching, or numbness (paresthesia);
• restless legs;
• fainting;
• numbness in the mouth (oral hypoaesthesia);
• low blood pressure;
• nightmares;
• feeling agitated;
• hallucinations;
• feeling the need to move.

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

• muscle twitching or contractions (myoclonus);
• aggression;
• abdominal pain and nausea: this may indicate pancreatitis.

Unknown(frequency cannot be estimated from the available data):

• abnormal sensations in the mouth (oral paresthesia);
• mouth swelling;
• swelling throughout the body (generalized edema);
• localized swelling;
• hyponatremia;
• inappropriate antidiuretic hormone secretion;
• severe skin reactions (bullous dermatitis, erythema multiforme);
• sleepwalking (somnambulism);
• speech disorders;
• increased creatine kinase levels in the blood;
• urination difficulties (urinary retention);
• muscle pain, stiffness, and (or) weakness, darkening or discoloration of urine (rhabdomyolysis).

Additional side effects in children and adolescents

In children under 18 years of age, the following adverse events have been commonly observed in clinical trials: significant weight gain, itchy skin rash (hives), and increased triglyceride levels in the blood.

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 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store AuroMirta ORO

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
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 AuroMirta ORO contains

• Each orally disintegrating tablet contains 15 mg of mirtazapine. Each orally disintegrating tablet contains 30 mg of mirtazapine. Each orally disintegrating tablet contains 45 mg of mirtazapine.
• Other ingredients are: crospovidone (type B), mannitol, microcrystalline cellulose, aspartame, colloidal anhydrous silica, magnesium stearate, strawberry-guarana flavor (maltodextrin, propylene glycol, artificial flavorings, and acetic acid) and mint flavor (artificial flavorings, cornstarch).

What AuroMirta ORO looks like and contents of the pack

AuroMirta ORO, 15 mg, orally disintegrating tablets
White, round orally disintegrating tablets with "36" embossed on one side and "A" on the other side, and with a round edge embossed.
AuroMirta ORO, 30 mg, orally disintegrating tablets
White, round orally disintegrating tablets with "37" embossed on one side and "A" on the other side, and with a round edge embossed.
AuroMirta ORO, 45 mg, orally disintegrating tablets
White, round orally disintegrating tablets with "38" embossed on one side and "A" on the other side, and with a round edge embossed.
Single-dose blisters with foil Polyamide/Aluminum/PVC/Paper/Polyester/Aluminum, in a cardboard box.
Pack sizes:
15 mg:6 x 1 and 30 x 1 orally disintegrating tablet.
30 mg and 45 mg:30 x 1 orally disintegrating tablet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João De Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Mirtazapine Aurovitas
Malta:
Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg orodispersible tablets
Poland:
AuroMirta ORO
Spain:
MIRTAZAPINA AUROVITAS 15 mg/ 30 mg/ 45 mg comprimidos bucodispersables
Portugal:
Mirtazapina Aurovitas

Date of last revision of the leaflet: 12/2021