Mizhaten Q-tab

Leaflet accompanying the packaging: patient information

Mirzaten Q-Tab, 15 mg, orally disintegrating tablets

Mirzaten Q-Tab, 30 mg, orally disintegrating tablets

Mirzaten Q-Tab, 45 mg, orally disintegrating tablets

mirtazapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Mirzaten Q-Tab and what is it used for
• 2. Important information before taking Mirzaten Q-Tab
• 3. How to take Mirzaten Q-Tab
• 4. Possible side effects
• 5. How to store Mirzaten Q-Tab
• 6. Contents of the packaging and other information

1. What is Mirzaten Q-Tab and what is it used for

Mirzaten Q-Tab belongs to a group of medicines known as antidepressants.
Mirzaten Q-Tab is indicated for the treatment of depression in adults.
The medicine Mirzaten Q-Tab starts working after 1-2 weeks of use, 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 under
“When can an improvement in well-being be expected”.

2. Important information before taking Mirzaten Q-Tab

When not to take Mirzaten Q-Tab

• If the patient is allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). In such a case, before taking Mirzaten Q-Tab, the patient should contact their doctor as soon as possible.
• 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 Mirzaten Q-Tab, the patient should discuss it with their doctor or pharmacist.

Before starting Mirzaten Q-Tab, the patient should tell their doctor:

If they have ever experienced a severe skin rash or peeling of the skin, blistering, or changes in the mouth
after taking mirtazapine or other medicines.

Children and adolescents

Mirzaten Q-Tab is not usually given to children and adolescents under 18 years of age, as its
efficacy has not been established. It should also be noted that in patients under 18 years of age, there is a
higher risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression,
rebellious behavior, and anger), when they take medicines of this class. Nevertheless, the doctor may
prescribe Mirzaten Q-Tab to patients of this age if they consider it to be in their best interest. If the doctor has
prescribed Mirzaten Q-Tab to a patient under 18 years of age and any doubts arise, the patient should
consult the doctor. In the case of patients under 18 years of age taking Mirzaten Q-Tab, the doctor should
be informed if any of the above symptoms develop or worsen. The long-term effects of Mirzaten Q-Tab on
the safety of growth, maturation, and cognitive development in this age group have not been established
yet. Additionally, during the use of mirtazapine in this age group, a significant increase in body weight is more
often observed than in adults.

Suicidal thoughts and depression worsening

Patients 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 medicines usually start
working 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 behavior in people under 25 with mental disorders who were treated with antidepressants. If thoughts of self-harm or suicidal thoughts occur, the patient should immediately contact their doctor or go to the hospital.

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 worrying changes in behavior.
The patient should be particularly careful when taking Mirzaten Q-Tab:

• if they have or have ever had the following diseases. The patient should inform their doctor about the presence of these diseases before starting treatment with Mirzaten Q-Tab, if they have not already done so:
• -epileptic seizures. If epileptic seizures occur or their frequency increases during treatment, Mirzaten Q-Tab should be discontinued and the patient should contact their doctor immediately;
• -liver disease, including jaundice. If jaundice occurs, Mirzaten Q-Tab should be discontinued and the patient should contact their doctor immediately;
• -kidney disease;
• -heart diseaseor low blood pressure;
• -schizophrenia. The patient should contact their doctor immediately if such mental disorders as paranoid thoughts worsen or increase in frequency;
• -manic depression(alternating periods of elevated mood/excitement and depression). If the patient feels excessively excited, they should discontinue Mirzaten Q-Tab and contact their doctor immediately;
• -diabetes(it may be necessary to change the dose of insulin or other antidiabetic medicines);
• -eye diseases, such as increased intraocular pressure (glaucoma);
• -urination difficulties, which may be caused by an enlarged prostate;
• certain heart rhythm disorders that can cause a change in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medicines that can disrupt heart rhythm.
• if symptoms of infection occur, such as unexplained fever, sore throat, and mouth ulcers. Mirzaten Q-Tab should be discontinued and the patient should consult their doctor immediately, who will order a blood morphology test. In rare cases, these symptoms may be a sign of blood cell production disorders in the bone marrow. Although rare, these symptoms usually occur after 4-6 weeks of treatment.
• elderly patients may be more susceptible to the side effects of antidepressants.
• During the use of mirtazapine, serious skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The patient should discontinue the medicine and seek medical help immediately if they experience any of the symptoms listed in section 4 related to these serious skin reactions.
• If the patient has ever experienced a serious skin reaction, they should not restart treatment with mirtazapine.

Mirzaten Q-Tab and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or
have recently taken, as well as any medicines they plan to take.
Mirzaten Q-Tab should not be usedin combination with:

• -monoamine oxidase inhibitors (MAOIs), or within 2 weeks of stopping their use. The patient should not start taking Mirzaten Q-Tab within 2 weeks of stopping MAOIs. MAOIs include, for example, moclobemide and tranylcypromine (antidepressants), and selegiline (used to treat Parkinson's disease).

The patient should be cautiouswhen taking Mirzaten Q-Tab in combination with:

• -other antidepressants, such as SSRIs(selective serotonin reuptake inhibitors), venlafaxine, and L-tryptophan or triptans(used to treat migraines), buprenorphine(used to treat pain or opioid addiction), tramadol(a pain reliever), linezolid(an antibiotic), lithium salts(used to treat certain mental disorders), methylene blue(used to lower high methemoglobin levels in the blood), and products containing St. John's wort (Hypericum perforatum)(herbal products used to treat depression). In patients taking only Mirzaten Q-Tab or in combination therapy with these medicines, serotonin syndrome can very rarely occur. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, and loss of consciousness. The patient should contact their doctor immediately if they experience several of these symptoms at the same time;
• -the antidepressant nefazodone. It may increase the level of Mirzaten Q-Tab in the blood. The patient should inform their doctor if they are taking this medicine. It may be necessary to reduce the dose of Mirzaten Q-Tab and, after stopping nefazodone, increase the dose of Mirzaten Q-Tab;
• -medicines used to treat anxiety or 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; Mirzaten Q-Tab in combination with these medicines may increase the drowsiness caused by these medicines.
• -medicines used to treat infections,such as antibacterial agents (e.g., erythromycin), antifungal agents (e.g., ketoconazole), and medicines used to treat HIV/AIDS (e.g., HIV protease inhibitors) and medicines used to treat stomach ulcers (e.g., cimetidine).

If the patient starts taking these medicines with Mirzaten Q-Tab, the level of Mirzaten Q-Tab in the blood may increase. The patient should inform their doctor if they are taking these medicines. It may be necessary to reduce the dose of Mirzaten Q-Tab and, after stopping these medicines, increase the dose of Mirzaten Q-Tab.

• -antiepileptic drugs,such as carbamazepine and phenytoin;
• -medicines used to treat tuberculosis,such as rifampicin; In combination with Mirzaten Q-Tab, these medicines may decrease its level in the blood. The patient should inform their doctor if they are taking these medicines. It may be necessary to increase the dose of Mirzaten Q-Tab and, after stopping these medicines, decrease the dose of Mirzaten Q-Tab.
• -anticoagulant medicines,such as warfarin; Mirzaten Q-Tab may enhance the effect of warfarin. The patient should inform their doctor if they are taking these medicines. In the case of combination therapy with Mirzaten Q-Tab, it is recommended to monitor blood parameters.
• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Mirzaten Q-Tab with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or are planning to have a baby,
they should ask their doctor or pharmacist for advice before taking this medicine.
Limited experience with the use of Mirzaten Q-Tab in pregnant women does not indicate an increased risk.
However, caution should be exercised when using this medicine during pregnancy.
If Mirzaten Q-Tab is taken during pregnancy or shortly before birth, it is recommended to monitor the newborn for possible side effects.
Taking similar medicines during pregnancy [such as selective serotonin reuptake inhibitors (SSRIs)] may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish discoloration. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, the patient should contact their doctor and/or midwife immediately.

Driving and using machines

Mirzaten Q-Tab may reduce alertness and ability to concentrate. During treatment with Mirzaten Q-Tab,
the patient should avoid performing potentially hazardous tasks that require continuous attention, such as
driving vehicles or operating machines. If the doctor has prescribed Mirzaten Q-Tab to a person under 18 years
of age, before participating in traffic (e.g., cycling), the patient should check if the medicine affects their
alertness and ability to concentrate.

Mirzaten Q-Tab contains lactose, sorbitol, and aspartame.

This medicine contains lactose. If the patient has intolerance to certain sugars, they should consult their
doctor before taking this medicine.
This medicine contains sorbitol.
Mirzaten Q-Tab, 15 mg, orally disintegrating tablets contain 4.9-13.8 mg of sorbitol per tablet.
Mirzaten Q-Tab, 30 mg, orally disintegrating tablets contain 9.9-27.7 mg of sorbitol per tablet.
Mirzaten Q-Tab, 45 mg, orally disintegrating tablets contain 14.8-41.5 mg of sorbitol per tablet.
This medicine contains aspartame.
Mirzaten Q-Tab, 15 mg, orally disintegrating tablets contain 1.6 mg of aspartame per tablet.
Mirzaten Q-Tab, 30 mg, orally disintegrating tablets contain 3.2 mg of aspartame per tablet.
Mirzaten Q-Tab, 45 mg, orally disintegrating tablets contain 4.8 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a
rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

3. How to take Mirzaten Q-Tab

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

Dosage

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

When to take Mirzaten Q-Tab

Mirzaten Q-Tab should be taken every day at the same time, preferably in a single dose in the evening,
before going to bed. The doctor may, however, recommend taking the medicine in two divided doses
throughout the day - one dose in the morning and one in the evening before bedtime. The larger dose
should be taken in the evening, before going to bed.

Information on taking orally disintegrating tablets:

Mirzaten Q-Tab tablets should be taken orally.
The tablets are fragile. Do not push them through the blister, as this may damage them. To remove a tablet
from the packaging, the patient should:

• 1. Hold the edge of the blister and separate one square of the blister by gently tearing it off at the perforation.
• 2. Pull the marked edge of the foil and completely remove it.
• 3. Remove the tablet from the hand.
• 4. Place the tablet on the tongue immediately after removing it from the packaging.

The tablet will dissolve quickly after being placed on the tongue. The dissolved tablet can be swallowed,
with or without water. The mouth should be empty before placing the tablet on the tongue.

When can an improvement in well-being be expected

Usually, the medicine starts working 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 Mirzaten Q-Tab with the doctor during the first few weeks of treatment.
After 2 to 4 weeks from the start of Mirzaten Q-Tab 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 the symptoms have completely disappeared, which usually takes 4 to 6
months.

Taking a higher dose of Mirzaten Q-Tab than recommended

If the patient (or anyone else) has taken a higher dose of Mirzaten Q-Tab than recommended, they
should immediately contact their doctor.
The most likely symptoms of Mirzaten Q-Tab overdose (without other medicines and without alcohol) are:
drowsiness, disorientation, and rapid heartbeat.The symptoms of overdose may include changes in heart rhythm (rapid heartbeat, irregular heart rhythm) and/or fainting. These may be symptoms of life-threatening ventricular arrhythmias, known as "torsade de pointes".

Missing a dose of Mirzaten Q-Tab

The patient should not take a double dose to make up for a missed dose.
In case of forgetting to take the medicine, which is taken once a day:

• the missed dose should not be taken. The patient should skip it and continue treatment by taking the next dose at the usual time the next day. However, if the medicine 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 by taking the usual morning and evening doses;
• if the patient forgets to take both doses, they should not try to make them up. The patient should skip them and continue treatment by taking the usual morning and evening doses the next day.

Stopping treatment with Mirzaten Q-Tab

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

4. Possible side effects

Like all medicines, Mirzaten Q-Tab can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking mirtazapine and contact their doctor immediately: Uncommon side effects (may affect up to 1 in 100 people):

• feeling of excitement or agitation (mania)

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

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

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• infection symptoms, such as sudden high fever of unknown cause, sore throat, and mouth ulcers (agranulocytosis). Rarely, mirtazapine may cause blood cell production disorders in the bone marrow. Some patients may become less resistant to infections, as mirtazapine may cause a temporary decrease in the number of white blood cells (granulocytopenia). Rarely, mirtazapine may also cause a decrease in the number of red blood cells, white blood cells, and platelets (aplastic anemia), a decrease in platelets (thrombocytopenia), or an increase in 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, and loss of consciousness. In very rare cases, these may be symptoms of serotonin syndrome.
• thoughts of self-harm or suicide
• severe skin reactions:
• red spots on the torso in a target shape or round, often with blisters in the center, peeling of the skin, mouth ulcers, genital ulcers, and eye ulcers. The occurrence of such serious rashes may be 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 side effects: Very common side effects (may affect more than 1 in 10 people):

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

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

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

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

• unusual skin sensations, e.g., burning, tingling, or numbness (paresthesia)
• restless legs syndrome
• fainting
• feeling of numbness in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• urgent need to move

Rare side effects(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

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• unusual sensations in the mouth (oral paresthesia)
• mouth swelling
• generalized swelling (generalized edema)
• localized swelling
• low sodium levels in the blood (hyponatremia)
• inappropriate antidiuretic hormone secretion
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking
• speech disturbances
• increased creatine kinase levels in the blood
• urination difficulties (urinary retention)
• muscle pain, stiffness, and/or weakness, darker or paler urine (rhabdomyolysis)
• high prolactin levels in the blood (hyperprolactinemia, including symptoms such as breast enlargement and/or milk secretion from the nipples)
• prolonged painful erection

Additional side effects in children and adolescents

In clinical trials in children under 18 years of age, the following side effects were more frequently observed:
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 the leaflet, they should tell their
doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring
of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 to gather more information on the safety of the medicine.

5. How to store Mirzaten Q-Tab

The medicine should be stored in a place inaccessible to children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to
the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their
pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Mirzaten Q-Tab contains

• The active substance of the medicine is mirtazapine. Each orally disintegrating tablet contains 15 mg, 30 mg, or 45 mg of mirtazapine.
• The other ingredients are: lactose monohydrate, ethylcellulose, mannitol (E 421), sorbitol (E 420), crospovidone, colloidal silicon dioxide, orange flavor (containing maltodextrin, modified cornstarch), aspartame (E 951), magnesium stearate. See section 2 "Mirzaten Q-Tab contains lactose, sorbitol, and aspartame."

What Mirzaten Q-Tab looks like and contents of the pack

The orally disintegrating tablets are white, round, and biconvex.
Packaging: 30 orally disintegrating tablets in a perforated blister pack, in a cardboard box.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

For more information about this medicine, the patient should contact their local representative of the
marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500.
Date of last revision of the leaflet:20.01.2022