Mirtor

Leaflet accompanying the packaging: patient information

Mirtor, 15 mg, orally disintegrating tablets

Mirtor, 30 mg, orally disintegrating tablets

Mirtor, 45 mg, orally disintegrating tablets

Mirtazapine

It is essential to carefully read the contents of the leaflet before taking the medication, as it contains important information for the patient.

• The leaflet should be kept to be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Mirtor and what is it used for
• 2. Important information before taking Mirtor
• 3. How to take Mirtor
• 4. Possible side effects
• 5. How to store Mirtor
• 6. Package contents and other information

1. What is Mirtor and what is it used for

Mirtor belongs to a group of medications known as antidepressants.
Mirtor is used to treat depression in adults.
Mirtor starts working after 1-2 weeks of treatment, and after 2-4 weeks, there is an improvement
in well-being. If after 2-4 weeks of treatment, there is no improvement or the patient feels worse, they should
consult a doctor. More information is provided in section 3, "When can improvement in well-being be expected".

2. Important information before taking Mirtor

When not to take Mirtor:

• if the patient is allergic to mirtazapine or any other ingredient of this medication (listed in section 6). In such a case, the patient should contact their doctor as soon as possible before taking Mirtor.
• if the patient is currently taking or has taken in the recent past (within the last 2 weeks) monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Before starting treatment with Mirtor, the patient should discuss it with their doctor or pharmacist.

Before starting treatment with Mirtor, the patient should tell their doctor:

If the patient has ever experienced a severe skin rash or skin peeling, blisters, and (or) mouth sores after taking Mirtor.

Children and adolescents

Mirtor should not be used in children and adolescents under 18 years of age, as its effectiveness has not been established in this age group. Additionally, patients under 18 years of age are at a higher risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger), when taking medications of this class. However, the doctor may prescribe Mirtor to patients in this age group if they consider it to be in the patient's best interest. If the doctor prescribes Mirtor to a patient under 18 years of age, and any concerns arise, the patient should consult their doctor. In patients under 18 years of age taking Mirtor, the doctor should be informed if any of the above symptoms develop or worsen. The long-term effects of Mirtor on safety related to growth, maturation, and cognitive development in this age group have not been established. Furthermore, in this age group, after taking mirtazapine, significant weight gain has been reported more frequently than in adult patients.

Suicidal thoughts and depression worsening

Patient with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medications usually start working after about 2 weeks, sometimes later.
These 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 behavior in people under 25 years of age with mental disorders treated with antidepressants. The patient should immediately contact their doctor or go to the hospital if they experience thoughts of self-harm or suicidal thoughts.

It may be helpful to inform relatives or friendsabout the depression and ask them to read this leaflet. The patient may ask them to inform them if they notice that the depression or anxiety has worsened or if there are any worrying changes in behavior.
Also, the patient should be cautious when taking Mirtor

• If they have or have ever had: (The patient should inform their doctor about the presence of the following diseases before starting treatment with Mirtor, if they have not already done so.)
• seizures. If seizures occur or their frequency increases during treatment, the medication should be discontinued, and the patient should immediately contact their doctor;
• liver disease, including jaundice. If jaundice occurs, the medication should be discontinued, and the patient should immediately contact their doctor;
• kidney disease;
• heart diseaseor low blood pressure;
• schizophrenia. The patient should immediately contact their doctor if such psychotic disorders as paranoid symptoms worsen or increase in frequency;
• manic depression(alternating periods of elevated mood/excitement and depression). If the patient feels excessively excited, the medication should be discontinued, and the patient should immediately contact their doctor;
• diabetes(may require a change in insulin or other hypoglycemic medication dosage);
• eye disease, such as increased intraocular pressure (glaucoma);
• urination difficulties, which may be due to prostate enlargement;
• certain heart conditionsthat can cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medications that can cause changes in heart rhythm.
• If infection symptoms occur, such as unexplained fever, sore throat, mouth sores, the medication should be discontinued, and the patient should immediately consult their doctor and have a blood morphology test. In rare cases, these symptoms may be a sign of bone marrow disorders. These symptoms are rare and usually occur after 4-6 weeks of treatment.
• Patient in old age are often more sensitive, especially to the side effects of antidepressants.
• Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with mirtazapine. If the patient notices any of the symptoms described in section 4 related to these severe skin reactions, they should immediately stop taking the medication and consult their doctor. If the patient has ever experienced severe skin reactions in the past, they should not restart treatment with mirtazapine.

stopping the medication and consulting a doctor.

Mirtor and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Mirtor should not be takenin combination with:

• monoamine oxidase inhibitors (MAOIs), nor before 2 weeks have passed since the last dose of MAOI. The patient should not start taking MAOIs before 2 weeks have passed since the last dose of Mirtor. MAOIs include moclobemide, tranylcypromine (antidepressants), and selegiline (used to treat Parkinson's disease).

The patient should be cautiouswhen taking Mirtor in combination with:

• other antidepressants, such as SSRIs, venlafaxine, and L-tryptophan or triptans(used to treat migraines), tramadol(a pain reliever), buprenorphine, linezolid(an antibiotic), lithium salts(used to treat certain psychiatric disorders), methylene blue(used to reduce high methemoglobin levels in the blood) and preparations containing St. John's wort (Hypericum perforatum)(herbal preparations used to treat depression). In patients taking only Mirtor or in combination with these medications, serotonin syndrome may rarely occur. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, loss of consciousness, and increased salivation. The patient should immediately contact their doctor if they experience several of these symptoms at the same time.
• the antidepressant nefazodone. It may increase the level of Mirtor in the blood. The patient should inform their doctor about taking this medication. It may be necessary to reduce the dose of Mirtor, and after stopping nefazodone, the dose of Mirtor may need to be increased.
• medications used to treat anxiety and insomnia, such as benzodiazepines;
• medications used to treat schizophrenia, such as olanzapine;
• medications used to treat allergies, such as cetirizine;
• medications used to treat severe pain, such as morphine. Mirtor in combination with these medications may increase drowsiness.
• medications used to treat infections, such as antibacterial agents (erythromycin), antifungal agents (such as ketoconazole), and medications used to treat HIV/AIDS (such as HIV protease inhibitors), as well as medications used to treat stomach ulcers (such as cimetidine). If these medications are started simultaneously with Mirtor, the level of Mirtor in the blood may increase. The patient should inform their doctor about taking these medications. It may be necessary to reduce the dose of Mirtor, and after stopping these medications, the dose of Mirtor may need to be increased.
• antiepileptic medications, such as carbamazepine and phenytoin;
• medications used to treat tuberculosis, such as rifampicin. When taken with Mirtor, these medications may decrease the level of Mirtor in the blood. The patient should inform their doctor about taking these medications. It may be necessary to increase the dose of Mirtor, and after stopping these medications, the dose of Mirtor may need to be decreased.
• anticoagulant medications, such as warfarin. Mirtor may enhance the effect of warfarin. The patient should inform their doctor about taking these medications. When taking Mirtor in combination with these medications, it is recommended to monitor blood tests.
• medications that may affect heart rhythm, such as certain antibiotics and antipsychotic medications.

Mirtor with food and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Limited experience with the use of Mirtor in pregnant women does not indicate an increased risk. However, caution should be exercised when using the medication during pregnancy.
If Mirtor is taken during pregnancy or shortly before delivery, it is recommended to monitor the newborn for possible side effects.
Similar medications (from the class of serotonin reuptake inhibitors - SSRIs) taken by pregnant women may increase the risk of a severe disease in the child, called persistent pulmonary hypertension of the newborn (PPHN),
causing rapid breathing and blue discoloration of the child's skin. These symptoms usually occur in the first day of life. If this happens, the patient should immediately contact their midwife and (or) doctor.

Driving and operating machinery

Mirtor may reduce alertness and concentration. During treatment with Mirtor, the patient should avoid performing potentially hazardous tasks that require continuous attention, such as driving vehicles or operating machinery. If the doctor prescribes Mirtor to a patient under 18 years of age, the patient should ensure that the medication does not impair their concentration and alertness before participating in traffic (e.g., cycling).

Mirtor contains aspartame, a source of phenylalanine

This medication contains aspartame, which is a source of phenylalanine. Each 15 mg orally disintegrating tablet contains 3 mg of aspartame. Each 30 mg orally disintegrating tablet contains 6 mg of aspartame. Each 45 mg orally disintegrating tablet contains 9 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 its improper excretion.

3. How to take Mirtor

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

The recommended initial dose is 15 or 30 mg per day.After a few days of treatment, the doctor may recommend increasing the dose to the most suitable for the patient (from 15 to 45 mg per day). Usually, the same dose of the medication is used in patients of different ages. However, the doctor may recommend a different dose of Mirtor for elderly patients or patients with kidney and liver disease.

When to take Mirtor

Mirtor should be taken daily at the same time, preferably in a single dose in the evening, before bedtime. However, the doctor may recommend taking two divided doses a day

• one in the morning and one in the evening before sleep. The larger dose should be taken in the evening, before bedtime.

Information about taking orally disintegrating tablets:

Mirtor tablets should be taken orally.
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. Tear off the blister pack

Each blister pack contains 6 pockets with tablets, separated by a perforated line. The patient should bend the blister pack and tear off one pocket along the perforated line (Figure 1).

Figure 1

3. Tear off the foil

Carefully tear off the covering 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 dry hands from the packaging and place it on the tongue.
(Figure 4).

Figure 4

The tablet disintegrates quickly and can be swallowed without water.

When can improvement in well-being be expected

The first signs of the medication's effect can be expected after 1-2 weeks of treatment, and after 2-4 weeks, there may be an improvement
in well-being.
It is essential to discuss the effects of Mirtor with the doctor during the first few weeks of treatment:

• After 2 to 4 weeks from the start of Mirtor treatment, the patient should discuss the treatment effects with their doctor. If there is no adequate clinical response, the doctor may increase the dose. After another 2 to 4 weeks, the patient should again discuss the treatment effects with their doctor. Treatment should be continued until complete remission of symptoms, which usually takes 4 to 6 months.

Taking a higher dose of Mirtor than recommended

If the patient or anyone else takes a higher dose of Mirtor than recommended, they should immediately consult their doctor.
Expected signs of Mirtor overdose (without other medications and without alcohol) include drowsiness,
disorientation, and rapid heart rate.Overdose symptoms may include changes in heart rhythm (rapid heart rate, irregular heart rhythm) and (or) fainting. These may be symptoms of life-threatening ventricular arrhythmias, known as "torsades de pointes".

Missing a dose of Mirtor

If the patient forgets to take a dose that is taken once a day

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

If the medication is taken twice a day

• if the patient forgets to take the morning dose, they should take it together with the evening dose;
• if the patient forgets to take the evening dose, they should not take it together with the morning dose; they should skip it and continue treatment, taking the usual morning and evening doses;
• if the patient forgets to take both doses, they should not try to make up for them; they should skip them. The next day, the patient should continue treatment, taking the usual morning and evening doses.

Stopping treatment with Mirtor

The patient should only stop taking Mirtor under the strict guidance of their doctor.
The patient should not stop taking the medication too early, as it may cause the disease to recur.
If there is an improvement, the patient should discuss it with their doctor. The doctor will inform them when they can stop treatment.
Suddenly stopping treatment with Mirtor, even if the symptoms of depression have disappeared, may cause nausea, dizziness, agitation, or anxiety and headache. These symptoms will not occur during gradual discontinuation of the medication. The doctor will inform the patient how to gradually reduce the dose.
If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Mirtor can cause side effects, although not everyone will experience them.

In case of any of the following serious side effects, the patient should stop taking Mirtor and immediately consult their doctor.

Uncommon(may affect up to 1 in 100 people):

• increased mood and increased mental activity (mania)

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

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

Frequency not known(frequency cannot be estimated from the available data):

• signs of infection, such as sudden and unexplained high fever, sore throat, and mouth sores (agranulocytosis). In rare cases, mirtazapine may cause blood disorders (bone marrow suppression). In some people, it may cause a temporary decrease in the number of white blood cells (granulocytopenia). In rare cases, mirtazapine may cause a decrease in the number of white blood cells, red blood cells, and platelets (aplastic anemia), a decrease in platelet count (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia)
• seizures (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, loss of consciousness, and increased salivation. In very rare cases, these symptoms may indicate the development of serotonin syndrome
• thoughts of self-harm or suicidal thoughts
• severe skin reactions:
• red spots resembling a target or round spots, often with central blisters on the torso, skin peeling, mouth sores, and genital and eye lesions. The occurrence of such severe skin rashes is often 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 include:

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

• increased appetite and weight gain
• calmness or drowsiness
• headache
• dry mouth

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

• lethargy
• dizziness
• seizures or tremors
• nausea
• diarrhea
• vomiting
• constipation
• rash or skin eruptions
• joint pain, muscle pain
• back pain
• dizziness or fainting when changing body position quickly (orthostatic hypotension)
• swelling (usually of the ankles or feet) due to fluid accumulation (edema)
• fatigue
• vivid dreams
• disorientation
• feeling anxious
• sleep disturbances
• memory disturbances, which usually resolve after stopping treatment

Uncommon(may affect up to 1 in 100 people):

• abnormal skin sensations, such as burning, tingling, or numbness (paresthesia)
• restless legs syndrome
• fainting
• numbness in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• urge to move

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

• muscle twitching or spasms (clonic muscle spasms)
• aggressive behavior
• abdominal pain and nausea, which may indicate pancreatitis

Frequency not known(frequency cannot be estimated from the available data):

• abnormal sensations in the mouth (oral paresthesia)
• mouth swelling
• generalized swelling
• localized swelling
• low sodium levels in the blood
• improper secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disturbances
• increased creatine kinase levels in the blood
• urination difficulties (urinary retention)
• muscle pain, stiffness, and (or) weakness
• darkening or discoloration of urine (rhabdomyolysis)
• increased prolactin levels in the blood (hyperprolactinemia, including breast enlargement and (or) milk secretion from the nipples)
• prolonged or painful erection

Additional side effects in children and adolescents

The following side effects were commonly observed in clinical trials with children under 18 years of age: significant weight gain, hives, and increased triglyceride levels in the blood.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Mirtor

The medication should be stored out of sight and reach of children.
The patient should not use this medication after the expiration date stated on the carton.
The expiration date refers to the last day of the specified month.
No special storage precautions are required.
The patient should not use this medication if they notice any discoloration or other signs of deterioration.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Mirtor contains

• The active substance of Mirtor is mirtazapine. Each orally disintegrating tablet contains 15 mg, 30 mg, or 45 mg of mirtazapine.
• Other ingredients of the medication are crospovidone, mannitol, microcrystalline cellulose, aspartame, strawberry-guarana flavor, peppermint flavor, anhydrous colloidal silica, and magnesium stearate.

What Mirtor looks like and what the package contains

15 mg orally disintegrating tablet:
white, round, marked with "36" on one side and
"A" on the other side.
30 mg orally disintegrating tablet:
white, round, marked with "37" on one side and
"A" on the other side.
45 mg orally disintegrating tablet:
white, round, marked with "38" on one side and
"A" on the other side.
30 (5x6) or 90 (15x6) tablets in the package. Not all pack sizes may be available.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
kontakt@orionpharma.info.pl
Date of last update of the leaflet:07.10.2021