Mirtor

Patient Information Leaflet

Warning! Keep this leaflet! The packaging information in a foreign language.
Mirtor
30 mg, orodispersible tablets
Mirtazapine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this 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 to treat depression in adults.
Mirtor starts to work after 1–2 weeks of treatment, and improvement in well-being usually occurs after 2–4 weeks. If there is no improvement after 2–4 weeks of treatment, or if the patient feels worse, medical advice should be sought. Further 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 taking or has recently taken (within the last 2 weeks) 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 developed severe skin rash, skin peeling, blisters and/or mouth ulcers after taking Mirtor.

Children and adolescents
Mirtor is generally not recommended for use in children and adolescents under 18 years of age, as its effectiveness has not been established in this age group. It should also be noted that patients under 18 years of age have a higher risk of experiencing adverse effects such as suicidal attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger) when taking medicines of this class. Nevertheless, a doctor may prescribe Mirtor to patients under 18 years of age 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 if any of the symptoms mentioned 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 observed 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 behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually start to work only after about 2 weeks, sometimes later. The above symptoms are more likely in:

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

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

Special caution should also be exercised when using Mirtor:

• If the patient has or has ever had any of the following conditions: (Inform the doctor about any of the following diseases before starting treatment with Mirtor, if not already done.)
• epileptic seizures. If seizures occur or their frequency increases during treatment, discontinue the medicine and contact a doctor immediately;
• liver disease, including jaundice. If jaundice occurs, discontinue the medicine and contact a doctor immediately;
• kidney disease;
• heart disease or low blood pressure;
• schizophrenia. Contact a 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 feelings of excessive excitement occur, discontinue the medicine and contact a doctor immediately;
• diabetes (a change in insulin or other antidiabetic medication dosage may be necessary);
• eye diseases, such as increased intraocular pressure (glaucoma);
• difficulty in passing urine, which may be due to prostate enlargement;
• certain types of heart disorders, which may cause changes in heart rhythm, recent heart attack, heart failure, or use of certain medicines that may cause heart rhythm disturbances.
• If symptoms of infection occur, such as fever of unknown origin, sore throat, or mouth ulcers, discontinue the medicine, consult a doctor immediately, and have a blood count performed. In rare cases, these symptoms may indicate bone marrow suppression affecting blood cell production. These symptoms are rare and usually occur after 4–6 weeks of treatment.
• Elderly patients are often more sensitive, particularly to the adverse effects of antidepressant medicines.
• Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during mirtazapine treatment. If the patient notices any of the symptoms described in section 4 related to these severe skin reactions, treatment with Mirtor must be stopped immediately and medical advice sought. Mirtazapine treatment should not be restarted if the patient has previously experienced any severe skin reactions.

Mirtor 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 the patient plans to take.

Do not take Mirtor in combination with:

• monoamine oxidase inhibitors (MAOIs), or within 2 weeks of stopping MAOIs. MAOIs should not be started within 2 weeks of stopping Mirtor. MAOIs include moclobemide, tranylcypromine (antidepressants), and selegiline (used in the treatment of Parkinson's disease). Exercise caution when using Mirtor 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) (herbal remedies used to treat depression). Serotonin syndrome, although very rare, may occur in patients taking only Mirtor or in combination with these medicines. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhoea, uncontrolled muscle spasms, chills, increased reflexes, restlessness, mood changes, and loss of consciousness. Contact a doctor immediately if several of these symptoms occur simultaneously.
• nefazodone, an antidepressant. It may increase the blood concentration of Mirtor. Inform the doctor if this medicine is being taken. A reduction in the dose of Mirtor may be necessary, and after stopping nefazodone, the dose of Mirtor 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 in combination with these medicines, may enhance 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 these medicines are being taken. A reduction in the dose of Mirtor may be necessary, and after stopping these medicines, the dose of Mirtor 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 these medicines are being taken. An increase in the dose of Mirtor may be necessary, and after stopping these medicines, the dose of Mirtor may need to be reduced.
• anticoagulants, such as warfarin. Mirtor may enhance the effect of warfarin. Inform the doctor if these medicines are being taken. 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, food, and alcohol
Drinking alcohol while taking Mirtor may cause drowsiness. It is best to avoid alcohol consumption during treatment with Mirtor.
Mirtor may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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, newborns should be monitored for possible adverse effects.
Similar medicines (selective 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 baby.
These symptoms usually occur within the first day of the baby's life. If this happens, 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 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 and alertness before the patient participates in traffic (e.g., when cycling).

Mirtor contains aspartame (E 951), 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 the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Mirtor is available in strengths of 15 mg, 30 mg, and 45 mg.
Dosage
The recommended starting dose is 15 or 30 mg once daily. After a few days of treatment, your doctor may recommend increasing the dose to the most appropriate level for the patient (from 15 to 45 mg once daily). 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 dose in the evening 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
2. Detach the blister pocket with the tablet
Each blister pack contains 6 pockets with tablets, separated by perforated lines. Bend the blister pack and detach one pocket along the perforated line (Figure 1).

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

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

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 be noticed 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:

• After 2 to 4 weeks of 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 treatment outcomes 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. Expected signs of overdose with Mirtor (without other medicines and without alcohol) include drowsiness, disorientation, and rapid heartbeat. Symptoms of overdose may include changes in heart rhythm (increased heart rate, irregular heartbeat) and/or fainting. These may be signs of life-threatening ventricular arrhythmias known as "torsade de pointes".

Missed dose of Mirtor
If you forget to take your dose and the medicine is to 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 the missed dose. Continue treatment by taking the usual morning and evening doses;
• If you forget both doses, do not try to make them up—skip them. The next day, continue treatment 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 tapered. Your doctor will advise how to gradually reduce the dose of the medicine.
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 severe adverse reactions occur, treatment with mirtazapine must be discontinued and immediate medical advice should be sought.
Uncommon (may occur in up to 1 in 100 people):

• 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 function disorders (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 individuals, reduced resistance to infections may occur, as mirtazapine may cause transient reduction in white blood cell count (granulocytopenia). In rare cases, mirtazapine may cause reduced numbers of white and red blood cells and platelets (aplastic anaemia), reduced platelet count (thrombocytopenia), or increased white blood cell count (eosinophilia)
• Seizures (convulsions)
• Combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, (involuntary) muscle contractions, chills, exaggerated 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 affect more than 1 in 10 people):

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

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

• Lethargy
• Dizziness
• Tremors or shaking
• 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, which in most cases resolve after discontinuation of treatment

Uncommon (may affect 1 in 100 people):

• Abnormal skin sensations such as burning, stinging, tingling, or prickling (paraesthesia)
• Restless legs syndrome
• Fainting
• Oral numbness (oral paraesthesia)
• Low blood pressure
• Nightmares
• Agitation
• Hallucinations
• Urgent need for movement

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

• Muscle twitching or contractions (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
• Generalised body swelling (generalised oedema)
• Localised swelling
• Low sodium levels in the blood
• Inappropriate antidiuretic hormone secretion
• Severe skin reactions (bullous dermatitis, erythema multiforme)
• Sleepwalking (somnambulism)
• Speech disturbances
• Elevated blood creatine kinase levels
• Difficulty urinating (urinary retention)
• Muscle pain, stiffness, and (or) weakness
• Darkening or discolouration of urine (rhabdomyolysis)
• Increased blood prolactin levels (hyperprolactinaemia, including symptoms of breast enlargement and/or milk discharge from 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 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.
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.
No special storage conditions apply.
Do not use this medicine if you notice any discoloration 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. This will help protect the environment.

6. Contents of the package and other information

What Mirtor contains

• The active substance is mirtazapine. Each orodispersible tablet contains 30 mg of mirtazapine.
• Other ingredients are: crospovidone, 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 with "37" on one side and "A" on the other side.
30 or 90 tablets in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Orion Corporation, Orionintie 1/A, FI-02200 Espoo, Finland
Manufacturer:
Orion Corporation Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland
Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 30/415/06-C
Parallel Import Authorisation Number: 265/22