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
Mirtazapine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm others, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What AuroMirta ORO is and what it is used for
2. What you need to know 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 have an effect.
After 2 to 4 weeks, you may start to feel better. If you do not feel better or if you feel worse after 2–4 weeks, contact your doctor immediately. More information can be found in section 3, "When can improvement in well-being be expected?"

2. Important information before using 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, speak 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 after taking AuroMirta ORO or other medicinal products.

Exercise special caution when using AuroMirta ORO:
Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of AuroMirta ORO. Discontinue the medicine and seek immediate medical help if any of the symptoms listed in section 4 occur.
If the patient has ever experienced a serious skin reaction, treatment with AuroMirta ORO must not be restarted.

Warnings and precautions
Discuss the use of AuroMirta ORO with your doctor or pharmacist before starting treatment.

Children and adolescents
Mirtazapine is generally not recommended for children and adolescents under 18 years of age, as efficacy has not been demonstrated in this age group. It should also be noted that patients under 18 years of age have an increased risk of experiencing adverse effects such as suicidal behaviour, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) while taking 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, significant weight gain has been observed more frequently in this age group during treatment with AuroMirta ORO compared to adults.

Suicidal thoughts and worsening depression
If the patient has depression, they may sometimes experience thoughts of self-harm or suicide. These may increase after starting antidepressant treatment, as these medicines require time to take effect, 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 data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants. If the patient ever has thoughts of self-harm or suicide, contact the doctor immediately or go to 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: Inform the doctor about the following conditions before taking AuroMirta ORO, if not already done.
  • seizures (epilepsy). If seizures occur or become more frequent, discontinue AuroMirta ORO and contact the doctor immediately;
  • liver disease, including jaundice. If jaundice occurs, discontinue AuroMirta ORO and contact the doctor immediately;
  • kidney disease;
  • heart disease or low blood pressure;
• schizophrenia. If psychotic symptoms such as paranoid thoughts become more frequent or severe, contact the 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 the doctor immediately;
• diabetes (dose adjustment of insulin or other antidiabetic medicines may be necessary);
• eye disorders such as increased intraocular pressure (glaucoma);
• difficulty in urination, 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 signs of infection occur, such as unexplained high fever, sore throat, and mouth ulcers. Discontinue AuroMirta ORO and consult the 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 appear after 4–6 weeks of treatment.
  • if the patient is elderly. The patient may be more sensitive to the adverse effects of antidepressants.

AuroMirta ORO and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Do not take AuroMirta ORO in combination 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 levels of methemoglobin 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 called serotonin syndrome. Symptoms may include unexplained fever, sweating, rapid heartbeat, diarrhoea, involuntary muscle contractions, shivering, hyperreflexia, restlessness, mood changes, and loss of consciousness. If these symptoms occur together, contact the doctor immediately.

• nefazodone, an antidepressant. It may increase the level of AuroMirta ORO in the blood. Inform the 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.

• 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.

• antibiotics used for bacterial infections (such as erythromycin), antifungals (such as ketoconazole), antivirals used in HIV/AIDS (such as HIV protease inhibitors), and medicines used for stomach ulcers (such as cimetidine).
  These medicines may increase the blood concentration of AuroMirta ORO when used together. Inform the doctor if the patient is taking any of 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.

• antiepileptic medicines, such as carbamazepine and phenytoin.

• antituberculosis medicines, such as rifampicin. These medicines may decrease the blood concentration of AuroMirta ORO. Inform the 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.

• anticoagulants, such as warfarin. AuroMirta ORO may enhance the effect of warfarin. Inform the doctor if the patient is taking this medicine. Close monitoring of blood parameters is recommended when used together.

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

AuroMirta ORO, 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 is planning 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 of similar medicines (SSRIs) during pregnancy 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 the medicine does not impair these abilities. If AuroMirta ORO has been prescribed to a patient under 18 years of age, ensure 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 improper excretion.

3. How to use AuroMirta ORO

This medicine should always be taken as directed by the 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 recommend
increasing the dose after a few days to the amount that may be best for you (from 15 mg to 45
mg per day). 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 – 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:
The tablets are taken by mouth.
1. Do not crush the orally disintegrating tablet
To prevent crushing the orally disintegrating tablet, do not press on the blister pack (Figure A).

Figure A
2. Detach one blister pack
Each blister contains six compartments separated by perforations. Detach one blister pack 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 (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 water.
When can you expect to feel better?
AuroMirta ORO usually starts working after 1 to 2 weeks, and after 2 to 4 weeks you may
start to feel better. 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 this medicine is affecting you.
If you still do not feel better, your doctor may prescribe a higher dose. In such a case,
talk to your doctor again after another 2–4 weeks. Usually, AuroMirta ORO should be taken for 4 to 6 months, until depressive symptoms disappear.
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 with AuroMirta ORO (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.
If you miss a 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 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 the normal dosing schedule the next day with morning and evening doses.

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 to feel 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 stop taking AuroMirta ORO suddenly, 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 using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following serious adverse effects occur,
treatment with AuroMirta ORO must be discontinued and immediate medical advice sought:

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

• feeling of excitement or emotional instability (mania).

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

• yellowing of the eyes or skin; this may indicate liver problems (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 disturbances in blood cell production (bone marrow suppression). Some people become more susceptible to infections because mirtazapine may cause a temporary 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 excessive salivation. In very rare cases, these may be symptoms of serotonin syndrome;
• thoughts of self-harm or suicide;
• red, target-shaped spots on the trunk or circular rashes, often with blisters in the centre, peeling skin, mouth, throat, nose, genital or eye ulcers. Such severe skin rashes 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 effects associated with mirtazapine include:

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

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

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

• lethargy;
• dizziness;
• tremor;
• nausea;
• diarrhoea;
• vomiting;
• constipation;
• rash or vesicular eruption;
• 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, such as burning, pricking, tickling or tingling (paraesthesia);
• restless legs;
• fainting;
• numbness in the mouth (oral hypoesthesia);
• low blood pressure;
• nightmares;
• feeling of restlessness;
• hallucinations;
• 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 swelling;
• hyponatraemia;
• inappropriate secretion of antidiuretic hormone;
• severe skin reactions (bullous dermatitis, erythema multiforme);
• sleepwalking (somnambulism);
• speech disorder;
• elevated blood creatine kinase levels;
• difficulty in passing urine (urinary retention);
• muscle pain, stiffness and (or) weakness, darkening or discolouration of urine (rhabdomyolysis).

Additional adverse effects in children and adolescents
In clinical trials, the following adverse events were commonly observed in children under 18 years of age: substantial weight gain, itchy skin rash (urticaria), and increased blood triglyceride levels.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to 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 apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Contents of the package 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.
• 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 code
"36" and on the other side with "A", with a circular rim imprint.
AuroMirta ORO, 30 mg, orodispersible tablets
White, round orodispersible tablets embossed on one side with the code
"37" and on the other side with "A", with a circular rim imprint.
AuroMirta ORO, 45 mg, orodispersible tablets
White, round orodispersible tablets embossed on one side with the code
"38" and on the other side with "A", with a circular rim imprint.
Single-dose blisters made of Polyamide/Aluminum/PVC/Paper/Polyester/Aluminum foil, 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 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