Mirtor

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Mirtor, 30 mg, orodispersible tablets
Mirtazapinum
Please read this leaflet carefully before taking this medicine because it contains
important information for the patient.

• Keep this leaflet in case you need to read it again.
• 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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Mirtor is and what it is used for

Mirtor belongs to a group of medicines known as antidepressants.
Mirtor is used for the treatment of depression in adults.
Mirtor begins to work after 1–2 weeks of treatment, and improvement in well-being occurs after 2–4 weeks. If there is no improvement or if the patient feels worse after 2–4 weeks of treatment, consult a doctor. More information is provided in section 3 under "When to expect improvement in well-being".

2. Important information before taking Mirtor

When not to use Mirtor:

• if the patient is allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In such a case, contact a doctor as soon as possible before taking Mirtor.
• if the patient is currently or has recently (within the last 2 weeks) been treated with medicines from the group of monoamine oxidase inhibitors (MAOIs).

Warnings and precautions
Before starting to take Mirtor, discuss this with your doctor or pharmacist.
Before starting to take Mirtor, tell your doctor:
If the patient has ever experienced severe skin rash, skin peeling, blisters, and/or
oral mucosal ulcers after taking Mirtor.

Children and adolescents
Mirtor is generally not recommended for use in children and adolescents under 18 years of age,
because its efficacy has not been demonstrated in this age group. It should also be noted that
patients under 18 years of age have a higher risk of adverse effects such as suicide attempts,
suicidal thoughts, and hostility (particularly aggression, defiant behaviors, and anger) when taking
medicines of this class. Nevertheless, a doctor may prescribe Mirtor to patients in this age group
if they consider it to be in their best interest. If a doctor has prescribed Mirtor to a patient under
18 years of age and any doubts arise, consult the prescribing doctor. If a patient under 18 years
of age is taking Mirtor, inform the doctor immediately if any of the symptoms listed above develop
or worsen. The long-term impact of Mirtor on growth, maturation, and cognitive development in
this age group has not yet been established. Additionally, in this age group, significant weight
gain has been reported more frequently after mirtazapine use than in adult patients.

Suicidal thoughts and worsening of depression
Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or
behaviors may worsen at the beginning of treatment with antidepressants, as these medicines
usually take about 2 weeks, or sometimes longer, to start working. These symptoms are more
likely in:

• patients who previously experienced thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders treated with antidepressants. Contact a doctor immediately or go to hospital if thoughts of self-harm or suicidal thoughts occur.

It may be helpful to inform family members or friends about the depression and ask them to
read this leaflet. The patient may ask them to notify him/her if they notice worsening depression
or anxiety, or concerning changes in behavior.

Special caution is also required when using Mirtor:

• If the patient has or has ever had any of the following conditions: (Inform the doctor about any of the following conditions before starting Mirtor, if not already done.)
• epileptic seizures. If seizures occur or their frequency increases during treatment, discontinue the medicine and contact the doctor immediately;
• liver diseases, including jaundice. If jaundice occurs, discontinue the medicine and contact the doctor immediately;
• kidney diseases;
• heart diseases or low blood pressure;
• schizophrenia. Contact the doctor immediately if psychotic disorders such as paranoid symptoms worsen or increase in frequency;
• manic depression (alternating periods of elevated mood/excitement and depression). If excessive excitement is felt, discontinue the medicine and contact the doctor immediately;
• diabetes (a change in insulin or other antidiabetic medication dosage may be necessary);
• eye diseases, such as increased intraocular pressure (glaucoma);
• difficulty urinating, which may be due to prostate enlargement;
• certain heart conditions that may affect heart rhythm, recent myocardial infarction, heart failure, or use of certain medications that may cause heart rhythm disturbances.
• If symptoms of infection occur, such as unexplained fever, sore throat, or oral ulcers, discontinue the medicine, consult a doctor immediately, and perform a blood count test. In rare cases, these symptoms may indicate impaired blood cell production by the bone marrow. These symptoms are rare and usually occur 4–6 weeks after starting treatment.
• Elderly patients are often more sensitive, particularly to the adverse effects of antidepressants.
• Severe skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), during mirtazapine treatment. If the patient notices any of the symptoms described in section 4 related to these severe skin reactions, stop taking the medicine immediately and consult a doctor. Do not restart mirtazapine treatment if the patient has previously experienced any severe skin reactions.

Mirtor with 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 use Mirtor in combination with:

• monoamine oxidase inhibitors (MAOIs), or within 2 weeks after stopping MAOI treatment. Do not start MAOI treatment within 2 weeks after stopping Mirtor. MAOIs include moclobemide, tranylcypromine (antidepressants), and selegiline (used in the treatment of Parkinson's disease).

Use Mirtor with caution in combination with:

• other antidepressants such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraine), tramadol (a painkiller), buprenorphine, linezolid (an antibiotic), lithium salts (used in the treatment of certain psychiatric disorders), methylene blue (used to reduce high methemoglobin levels in blood), and St. John's wort (Hypericum perforatum) preparations (herbal remedies used to treat depression). In patients taking only Mirtor or in combination with these medicines, serotonin syndrome may very rarely occur. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhea, uncontrolled muscle contractions, chills, exaggerated reflexes, restlessness, mood changes, and loss of consciousness. Contact a doctor immediately if several of these symptoms occur simultaneously.
• the antidepressant nefazodone. It may increase the blood concentration of Mirtor. Inform the doctor if taking this medicine. A dose reduction of Mirtor may be necessary, and after stopping nefazodone treatment, the Mirtor dose may need to be increased.
• medicines used to treat anxiety and insomnia, such as benzodiazepines.
• medicines used to treat schizophrenia, such as olanzapine.
• medicines used to treat allergies, such as cetirizine.
• medicines used to treat severe pain, such as morphine. Mirtor, when used with these medicines, may increase the drowsiness they cause.
• medicines used to treat infections, such as antibacterial agents (erythromycin), antifungal agents (e.g., ketoconazole), medicines used in the treatment of HIV/AIDS (such as HIV protease inhibitors), and medicines used to treat stomach ulcers (e.g., cimetidine). When these medicines are taken concurrently with Mirtor, the blood concentration of Mirtor may increase. Inform the doctor if taking these medicines. A dose reduction of Mirtor may be necessary, and after stopping treatment with these medicines, the Mirtor dose may need to be increased.
• antiepileptic medicines, such as carbamazepine and phenytoin.
• medicines used to treat tuberculosis, such as rifampicin. In combination with Mirtor, these medicines may reduce the blood concentration of Mirtor. Inform the doctor if taking these medicines. An increase in the Mirtor dose may be necessary, and after stopping treatment with these medicines, the Mirtor dose may need to be reduced.
• anticoagulant medicines, such as warfarin. Mirtor may enhance the effect of warfarin. Inform the doctor if taking these medicines. Monitoring of blood parameters is recommended when Mirtor is used in combination with warfarin.
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotics.

Mirtor with food and alcohol
Drinking alcohol while taking Mirtor may cause drowsiness. It is best to avoid alcohol consumption during Mirtor treatment.
Mirtor can be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant, 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 the use of Mirtor in pregnant women does not indicate an increased risk. However, caution should be exercised when using the medicine during pregnancy.
If Mirtor is taken during pregnancy or shortly before delivery, the newborn should be monitored for possible adverse effects.
Similar medicines (serotonin reuptake inhibitors - SSRIs) used by pregnant women may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and skin blueness in the infant. These symptoms usually occur within the first day of life. If this occurs, contact the midwife and/or doctor immediately.

Driving and operating machinery
Mirtor may reduce alertness and the ability to concentrate. While being treated with Mirtor, avoid performing potentially dangerous tasks requiring sustained attention, such as driving vehicles or operating machinery. If a doctor has prescribed Mirtor to a patient under 18 years of age, ensure that the medicine does not impair the patient's concentration or alertness before the patient participates in traffic (e.g., when cycling).

Mirtor contains aspartame, a source of phenylalanine
This medicine contains aspartame, which is a source of phenylalanine. Each 30 mg orodispersible tablet contains 6 mg of aspartame. Aspartame may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

3. How to take Mirtor

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Mirtor is available in the following doses: 15 mg, 30 mg and 45 mg.
Dosage
The recommended starting dose is 15 or 30 mg once daily. After several days of treatment, your doctor may recommend increasing the dose to the most appropriate level for the patient (from 15 to 45 mg per day). Usually, the same dose is used in patients of different ages. However, your doctor may prescribe a different dose of Mirtor for elderly patients or patients with kidney or liver disease.
When to take Mirtor
Mirtor should be taken every day at the same time, preferably as a single evening dose before going to bed. However, your doctor may recommend taking two divided doses during the day – one in the morning and one in the evening before sleep. The larger dose should be taken in the evening, before going to bed.
Instructions for taking orally disintegrating tablets:
Mirtor tablets should be taken by mouth.
1. Do not crush the orally disintegrating tablet
To avoid crushing the orally disintegrating tablet, do not press on the blister pocket containing the tablet (Figure A).
Figure A
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2. Tear off the blister pocket with the tablet
Each blister contains 6 pockets with tablets, separated by perforated lines. Bend the blister and tear off one pocket along the perforated line (Figure 1).
Figure 1

3. Peel back the foil
Carefully peel back the foil starting from the corner marked with an arrow (Figures 2 and 3).
Figure 2

Figure 3

4. Remove the orally disintegrating tablet
Remove the orally disintegrating tablet with a dry hand from the packaging and place it on the tongue (Figure 4).
Figure 4

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The tablet dissolves rapidly and can be swallowed without water.
When to expect improvement in well-being
Initial signs of the medicine's effect may appear after 1–2 weeks of treatment, and improvement in well-being may occur after 2–4 weeks.
It is important to discuss the effects of Mirtor with your doctor during the first few weeks of treatment:

• 2 to 4 weeks after starting Mirtor, discuss the treatment effects achieved so far with your doctor. If there is no adequate clinical response, your doctor may increase the dose. After another 2 to 4 weeks, discuss again with your doctor the effects achieved. Treatment should be continued until symptoms have completely resolved, which usually takes 4 to 6 months.

Taking more than the recommended dose of Mirtor
If a patient or anyone else takes more than the recommended dose of Mirtor, seek immediate medical advice from a doctor.
Expected signs of Mirtor overdose (without other medicines and without alcohol) include drowsiness,
disorientation, and rapid heartbeat. Symptoms of overdose may include changes in heart rhythm (accelerated heartbeat, irregular heart rhythm) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias known as "torsade de pointes".
If you miss a dose of Mirtor
If you forget to take a dose that should be taken once daily

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

If the medicine is to be taken twice daily

• if you forget the morning dose – take it together with the evening dose;
• if you forget the evening dose – do not take it together with the morning dose; skip that dose. Continue treatment by taking the usual morning and evening doses;
• if you forget both doses – do not try to make them up; skip both doses. Continue treatment the next day by taking the usual morning and evening doses.

Stopping Mirtor
You should stop taking Mirtor only strictly according to your doctor's instructions.
Do not stop taking the medicine too early, as this may cause the illness to return. If improvement occurs, discuss this with your doctor. Your doctor will advise when treatment can be discontinued.
Suddenly stopping treatment with Mirtor, even if depressive symptoms have resolved, may cause nausea, dizziness, agitation or anxiety, and headache. These symptoms do not occur when the medicine is gradually withdrawn. Your doctor will advise how to gradually reduce the doses of the medicine.
If you have any further doubts about using 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,
treatment with mirtazapine must be discontinued and immediate medical advice must be sought.
Uncommon (may occur in up to 1 in 100 people):
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• Elevated mood and increased mental activity (mania)

Rare (may occur in up to 1 in 1,000 people):

• Yellowing of the whites of the eyes and skin; which may indicate liver dysfunction (jaundice)

Frequency unknown (frequency cannot be estimated from available data):

• Signs of infection such as sudden and unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow suppression). In some people, there may be reduced resistance to infections, as mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine may cause a decrease in white and red blood cells and platelets (aplastic anaemia), a decrease in platelets (thrombocytopenia), or an increase in white blood cells (eosinophilia)
• Seizures (convulsions)
• Combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, (uncontrolled) muscle contractions, chills, increased reflexes, restlessness, mood changes, loss of consciousness, and excessive salivation. In very rare cases, these symptoms may indicate the development of serotonin syndrome
• Thoughts of self-harm or suicidal thoughts
• Severe skin reactions:
• Reddish, target-like or circular rashes, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital and eye ulcers. Such severe skin eruptions are often preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)

Other possible adverse reactions include:
Very common (may occur in more than 1 in 10 people):

• Increased appetite and weight gain
• Sedation or drowsiness
• Headache
• Dry mouth

Common (may occur in up to 1 in 10 people):

• Lethargy
• Dizziness
• Twitching or tremor
• Nausea
• Diarrhoea
• Vomiting
• Constipation
• Rash or skin eruptions
• Joint pain, muscle pain
• Back pain
• Dizziness or fainting upon sudden change in body position (orthostatic hypotension)
• Swelling (usually of the ankles or feet) due to fluid accumulation (oedema)
• Fatigue
• Vivid dreams
• Disorientation
• Feeling of anxiety
• Sleep disturbances
• Memory disturbances, mostly resolving after discontinuation of treatment

Uncommon (may occur in up to 1 in 100 people):
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• Abnormal skin sensations, e.g. burning, pricking, stinging, or tingling (paraesthesia)
• Restless legs syndrome
• Fainting
• Numbness or altered sensation in the mouth (oral hypoaesthesia)
• Low blood pressure
• Nightmares
• Agitation
• Hallucinations
• Urge to move

Rare (may occur in up to 1 in 1,000 people):

• Muscle twitching or cramps (clonic muscle spasms)
• Aggressive behaviour
• Abdominal pain and nausea, which may indicate pancreatitis

Frequency unknown (frequency cannot be estimated from available data):

• Abnormal sensations in the mouth (oral paraesthesia)
• Swelling of the mouth
• Swelling of the entire body (generalised oedema)
• Localised swelling
• Low sodium levels in the blood
• Inappropriate antidiuretic hormone secretion
• Severe skin reactions (bullous dermatitis, erythema multiforme)
• Sleepwalking (somnambulism)
• Speech disorders
• Increased blood creatine kinase levels
• Difficulty in passing urine (urinary retention)
• Muscle pain, stiffness, and (or) weakness
• Darkening or discolouration of urine (rhabdomyolysis)
• Increased blood prolactin levels (hyperprolactinaemia, including symptoms such as breast enlargement and/or milk discharge from the nipples)
• Prolonged or painful erection

Additional adverse reactions in children and adolescents
The following adverse reactions were commonly observed in clinical trials involving
children under 18 years of age: significant weight gain, urticaria, and increased blood triglyceride levels.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Mirtor

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
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No special storage conditions apply.
Do not use this medicine if you notice any discolouration or other signs of deterioration.
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 Mirtor contains

• The active substance is mirtazapine. Each orodispersible tablet contains 30 mg of mirtazapine.
• Other ingredients are: crospovidone (type B), mannitol (E 421), microcrystalline cellulose, aspartame (E 951), strawberry-guarana flavour, mint flavour, colloidal anhydrous silica, magnesium stearate.

What Mirtor looks like and contents of the pack
Orodispersible tablet 30 mg: white, round tablet marked “37” on one side and “A” on the other side.
30 (5x6) or 90 (15x6) tablets in PVC/PA/Al/Polyester blisters in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
Manufacturer:
Orion Corporation Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 30/415/06-C
Parallel import authorisation number: 90/23
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