AUROMIRTA ORO

Package leaflet: Information for the patient

AuroMirta ORO, 15 mg, orodispersible tablets
AuroMirta ORO, 30 mg, orodispersible tablets
AuroMirta ORO, 45 mg, orodispersible tablets
Mirtazapinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet to read again if necessary.
• If you have any doubts, 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 other people, even if their symptoms are the same.
• If the patient experiences 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 AuroMirta ORO is and what it is 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 pack and other information

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

AuroMirta ORO belongs to a group of medicines called antidepressants.
AuroMirta ORO is used to treat depression in adults.
It usually takes 1 to 2 weeks before treatment with AuroMirta ORO starts to show effects.
After 2 to 4 weeks, the patient may begin to feel better. If the patient does not feel better, or feels worse after 2–4 weeks, medical advice should be sought immediately. Further information can be found in section 3 "When to expect improvement in well-being".

2. Important information before taking AuroMirta ORO

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

• if the patient is allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, talk to your doctor immediately before taking AuroMirta ORO.
• if the patient is currently taking or has recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
• if severe skin rash, skin peeling, blistering, and/or mouth ulcers have ever occurred in the patient after taking AuroMirta ORO or other medicinal products.

Exercise special caution when using AuroMirta ORO:
Serious skin reactions have been reported with the use of AuroMirta ORO, including
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with
eosinophilia and systemic symptoms (DRESS). Treatment must be discontinued and immediate
medical help sought if any of the symptoms listed in section 4 occur in connection with these
serious skin reactions.
If the patient has ever experienced a serious skin reaction, re-initiation of treatment with AuroMirta
ORO should not be undertaken.
Warnings and precautions
Before starting AuroMirta ORO, discuss this with your doctor or pharmacist.
Children and adolescents
Mirtazapine is generally not recommended for use in children and adolescents under 18 years of
age, as efficacy has not been demonstrated in this age group. It should also be noted that in patients
under 18 years of age, there is an increased risk of adverse reactions such as suicidal behaviour,
suicidal thoughts, and hostility (mainly aggression, oppositional behaviours, and anger) during
treatment with this type of medicine. Nevertheless, your doctor may prescribe AuroMirta ORO to
patients under 18 years of age if they consider it beneficial. If your doctor has prescribed AuroMirta
ORO to a patient under 18 years of age and the patient wishes to discuss this, advice should be sought
from the doctor. Inform the doctor if any of the above-mentioned symptoms occur or worsen during
treatment with AuroMirta ORO in patients under 18 years of age. Furthermore, the long-term safety
effects of AuroMirta ORO on growth, puberty, and cognitive and behavioural development in this
age group have not yet been established. In addition, a more pronounced weight gain has been
observed in this age group during treatment with AuroMirta ORO compared to adults.
Suicidal thoughts and worsening of depression
If the patient has depression, they may sometimes experience thoughts of self-harm or suicide. These
may increase when starting 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 previously had thoughts of suicide or self-harm.
• if they are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant medicine. If the patient ever has thoughts of self-harm or suicide at any time, they should contact their doctor immediately or go to a hospital.

It may be helpful to inform a relative or close friend about the depression and ask them to read this
leaflet. You may also ask them to inform you if they notice worsening depression or changes in
behaviour.
Exercise particular caution when using AuroMirta ORO:

• if the patient has or has ever had any of the following conditions: Before taking AuroMirta ORO, inform your doctor about the following conditions if not already done.
  • seizures (epilepsy). If seizures occur or become more frequent, discontinue AuroMirta ORO and contact your doctor immediately;
  • liver disease, including jaundice. If jaundice occurs, discontinue AuroMirta ORO and contact your doctor immediately;
  • kidney disease;
  • heart disease or low blood pressure;
• schizophrenia. If psychotic symptoms such as paranoid thoughts become more frequent or severe, contact your doctor immediately;
• manic depression (alternating periods of excitement/hyperactivity and low mood). If the patient feels excessive excitement or agitation, discontinue taking AuroMirta ORO and contact their doctor immediately;
• diabetes (adjustment of insulin or other antidiabetic medicines may be necessary);
• eye disorders such as increased intraocular pressure (glaucoma);
• difficulty in passing urine, which may be due to an enlarged prostate;
• certain types of heart disease that may affect heart rhythm, recent heart attack, heart failure, or use of certain medicines that may affect heart rhythm.
  • if symptoms of infection occur, such as unexplained high fever, sore throat, and mouth ulcers. Discontinue AuroMirta ORO and consult your doctor immediately for blood tests. In rare cases, these symptoms may indicate bone marrow suppression affecting blood cell production. Although these symptoms are rare, they most commonly occur after 4–6 weeks of treatment.
  • if the patient is elderly. The patient may be more sensitive to the adverse effects of antidepressant medicines.

AuroMirta ORO and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines they plan to take.
Do not take AuroMirta ORO together with:

• monoamine oxidase inhibitors (MAOIs). Do not take AuroMirta ORO for two weeks after stopping MAOIs. If AuroMirta ORO is discontinued, do not take MAOIs for the next two weeks. Examples of MAOIs include moclobemide, tranylcypromine (both antidepressants), and selegiline (used in Parkinson’s disease).

Exercise caution when taking AuroMirta ORO together with:

• antidepressants such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraine), tramadol (a painkiller), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), methylene blue (used to treat high methemoglobin levels in 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 known as serotonin syndrome. Symptoms may include unexplained fever, sweating, rapid heartbeat, diarrhoea, involuntary muscle contractions, shivering, hyperreflexia, restlessness, mood changes, and loss of consciousness. If such symptoms occur, contact your doctor immediately.

• nefazodone, an antidepressant. This may increase the amount of AuroMirta ORO in the blood. Inform your doctor if the patient is taking this medicine. It may be necessary to reduce the dose of AuroMirta ORO or, if nefazodone is discontinued, to increase the dose of AuroMirta ORO again.

• medicines for anxiety or insomnia, such as benzodiazepines.

• medicines used in schizophrenia, such as olanzapine.

• antihistamines, such as cetirizine.

• strong painkillers, such as morphine. In combination with these medicines, AuroMirta ORO may increase drowsiness caused by them.

• medicines for infections; antibacterial agents (such as erythromycin), antifungal agents (such as ketoconazole), medicines used in the treatment of HIV/AIDS (such as HIV protease inhibitors), and medicines used to treat stomach ulcers (such as cimetidine).
  When used with AuroMirta ORO, these medicines may increase the blood concentration of AuroMirta ORO. Inform your doctor if the patient is 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 blood concentration of AuroMirta ORO. Inform your doctor if the patient is taking these medicines. It may be necessary to increase the dose of AuroMirta ORO or, after stopping these medicines, to reduce the dose of AuroMirta ORO again.

• anticoagulant medicines such as warfarin. AuroMirta ORO may enhance the effect of warfarin. Inform your doctor if the patient is taking this medicine. Close monitoring of blood parameters by the doctor is recommended when used concomitantly.

• medicines that may affect heart rhythm, such as certain antibiotics and certain antipsychotic medicines.

AuroMirta ORO with food and alcohol
The patient may feel drowsy if alcohol is consumed while taking AuroMirta ORO.
Do not drink alcohol.
AuroMirta ORO can be taken with or without food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
Limited experience with AuroMirta ORO in pregnant women does not indicate an increased risk.
However, caution should be exercised during pregnancy.
If AuroMirta ORO is used until delivery or shortly before delivery, the newborn should be monitored
for possible adverse effects.
Use during pregnancy of 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 bluish. These symptoms usually occur within the first 24 hours after birth.
In such cases, contact the midwife and/or doctor immediately.
Driving and using machines
Mirtazapine may affect concentration or attention. Before driving or operating machinery, ensure
that it does not impair these abilities. If the doctor has prescribed AuroMirta ORO to a patient under
18 years of age, ensure before driving (e.g. a bicycle) that the medicine does not affect concentration
and attention while 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 improper excretion.

3. How to use AuroMirta ORO

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dosage
The usual starting dose is 15 mg or 30 mg once daily. Your doctor may decide to increase the dose after a few days to the amount that is best suited for you (from 15 mg to 45 mg once daily). The dose is usually the same for all age groups. However, if you are elderly or have kidney or liver disease, your 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 as a single dose before going to bed. However, your doctor may advise splitting the dose of AuroMirta ORO into two doses – one in the morning and one in the evening before going to bed. The larger dose should be taken in the evening before bedtime.

Orally disintegrating tablets should be taken as follows:
The tablets are for oral use.

1. Do not crush the orally disintegrating tablet
To avoid crushing the orally disintegrating tablet, do not press on the blister pack (Figure A).

Figure A

2. Detach one blister
Each blister pack contains six blisters separated by perforations. Detach one blister along the dotted lines (Fig. 1).

Fig. 1

3. Open the packaging
Carefully peel off the foil cover, starting from the corner as indicated by the arrow (Figs. 2 and 3).

Fig. 2

Fig. 3

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

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

When to expect improvement in well-being
AuroMirta ORO usually starts working after 1 to 2 weeks, and you may begin to feel better after 2 to 4 weeks. It is important to discuss the effect of AuroMirta ORO with your doctor during the first few weeks of treatment:
2–4 weeks after starting AuroMirta ORO, talk to your doctor about how the medicine is affecting you.
If you still do not feel better, your doctor may prescribe a higher dose. In such a case, you should talk to your doctor again after another 2–4 weeks. AuroMirta ORO is usually taken for 4 to 6 months, until depressive symptoms have disappeared.

Taking more AuroMirta ORO than recommended
If you or someone else has taken too much AuroMirta ORO, contact a doctor immediately. The most likely symptoms of overdose (without other medicines or alcohol) are drowsiness, confusion, and rapid heartbeat. Symptoms of possible overdose may include changes in heart rate (fast, irregular heartbeat) and/or fainting, which could be signs of a life-threatening condition called torsade de pointes.

Missed dose of AuroMirta ORO
If you are taking the medicine once daily:

• Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

If you are taking the medicine twice daily:

• If you forget the morning dose, take it together with the evening dose.
• If you miss the evening dose, do not take it together with the next morning dose; skip the missed dose and continue taking your doses in the morning and evening as usual.
• If you forget both doses, do not take the missed doses. Skip both doses and continue with your normal dosing schedule the next day, taking doses in the morning and evening.

Stopping AuroMirta ORO
You should stop taking AuroMirta ORO only after consulting your doctor.
If you stop taking the medicine too early, depression may return. When you start feeling better, talk to your doctor. Your doctor will decide when it is appropriate to stop treatment.
Do not suddenly stop taking AuroMirta ORO, even if your depression has improved. If you suddenly stop taking AuroMirta ORO, you may experience nausea, dizziness, agitation or anxiety, and headaches.
These symptoms can be avoided by gradually discontinuing the medicine. Your doctor will advise you on how to gradually reduce the dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur,
discontinue use of AuroMirta ORO immediately and consult a doctor without delay:
Uncommon (may affect less than 1 in 100 people):

• feeling of excitement or emotional imbalance (mania).

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

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

Not known (frequency cannot be estimated from available data):

• signs of infection such as sudden unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disorders in blood cell production (bone marrow suppression). Some individuals may become more susceptible to infections due to mirtazapine-induced transient deficiency of white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause deficiency of red and white blood cells as well as platelets (aplastic anaemia), deficiency of platelets (thrombocytopenia), or increased number of white blood cells (eosinophilia);
• seizure (convulsion);
• combination of symptoms such as unexplained fever, sweating, rapid heartbeat, diarrhoea, (involuntary) muscle contractions, chills, exaggerated reflexes, restlessness, mood changes, loss of consciousness, and increased salivation. In very rare cases, these may be symptoms of serotonin syndrome;
• thoughts of self-harm or suicide;
• red, target-shaped or circular skin rashes, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. Such severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other possible adverse reactions associated with mirtazapine include:
Very common (may affect more than 1 in 10 people):

• increased appetite and weight gain;
• feeling of drowsiness or somnolence;
• headache;
• dry mouth.

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

• lethargy;
• dizziness;
• tremor;
• nausea;
• diarrhoea;
• vomiting;
• constipation;
• rash or urticaria;
• joint pain (arthralgia) or muscle pain (myalgia);
• back pain;
• dizziness or fainting upon sudden standing (orthostatic hypotension);
• swelling (usually in ankles or feet) due to fluid retention (oedema);
• fatigue;
• vivid dreams;
• confusion;
• feeling of anxiety;
• sleep problems;
• memory problems, which in most cases resolved after discontinuation of treatment.

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

• abnormal skin sensations, e.g. burning, pricking, tickling or tingling (paraesthesiae);
• restless legs;
• fainting;
• numbness sensation in the mouth (oral hypoesthesia);
• low blood pressure;
• nightmares;
• feeling of agitation;
• hallucinations;
• feeling of an urge to move.

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

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

Not known (frequency cannot be estimated from available data):

• abnormal sensations in the mouth (oral paraesthesia);
• swelling of the mouth;
• swelling throughout the body (generalised oedema);
• localized oedema;
• hyponatraemia;
• inappropriate antidiuretic hormone secretion;
• severe skin reactions (bullous dermatitis, erythema multiforme);
• sleepwalking (somnambulism);
• speech disorder;
• elevated creatine kinase levels in blood;
• difficulty in urination (urinary retention);
• muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis).

Additional adverse reactions in children and adolescents
In clinical trials, the following adverse events were commonly observed in children under 18 years of age: significant weight gain, itchy skin rash (urticaria), and increased blood triglyceride levels.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 provide more information on the safety of this medicine.

5. How to store AuroMirta ORO

Keep out of 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 stated month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the
environment.

6. Contents of the pack and other information

What AuroMirta ORO contains

• Each orodispersible tablet contains 15 mg of mirtazapine. Each orodispersible tablet contains 30 mg of mirtazapine. Each orodispersible tablet contains 45 mg of mirtazapine.
• The other ingredients are: crospovidone (type B), mannitol, microcrystalline cellulose, aspartame, colloidal anhydrous silica, magnesium stearate, strawberry-guarana flavour (maltodextrin, propylene glycol, artificial flavouring substances, acetic acid) and mint flavour (artificial flavouring substances, corn starch).

What AuroMirta ORO looks like and contents of the pack
AuroMirta ORO, 15 mg, orodispersible tablets
White, round orodispersible tablets, embossed on one side with the number "36" and on the reverse side with the letter "A", with a circular rim imprinted.
AuroMirta ORO, 30 mg, orodispersible tablets
White, round orodispersible tablets, embossed on one side with the number "37" and on the reverse side with the letter "A", with a circular rim imprinted.
AuroMirta ORO, 45 mg, orodispersible tablets
White, round orodispersible tablets, embossed on one side with the number "38" and on the reverse side with the letter "A", with a circular rim imprinted.
Single-dose blisters made of Polyamide/Aluminium/PVC/Paper/Polyester/Aluminium, packed in a cardboard box.
Pack sizes:
15 mg: 6 x 1 and 30 x 1 orodispersible tablet.
30 mg and 45 mg: 30 x 1 orodispersible tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lokal 27
01-909 Warszawa
Poland

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 medicinal product is authorised in the European Economic Area countries 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