Mizhaten Q-tab

Leaflet attached to 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

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your 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 as yours.
• 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 their doctor. More information is provided in section 3 in the "When can you expect an improvement in your well-being" section.

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 there are any doubts, the patient should consult their 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 safety regarding growth, maturation, and cognitive development in this age group have not been established either. Additionally, during the use of mirtazapine in this age group, a significant increase in body weight is more frequently 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 had 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 are being 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 any 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 following diseases before starting treatment with Mirzaten Q-Tab, if they have not already done so:
• -epileptic seizures. If seizures occur or their frequency increases during treatment, Mirzaten Q-Tab should be discontinued and the doctor should be contacted immediately;
• -liver disease, including jaundice. If jaundice occurs, Mirzaten Q-Tab should be discontinued and the doctor should be contacted immediately;
• -kidney disease;
• -heart diseaseor low blood pressure;
• -schizophrenia. The doctor should be contacted 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 diseases that can cause a change in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medicines that can cause a disturbance in heart rhythm.
• if infection symptoms occur, such as unexplained high fever, sore throat, and mouth ulcers. Mirzaten Q-Tab should be discontinued and the doctor should be consulted immediately, who will order a blood morphology test. In rare cases, these symptoms may be a sign of disorders in blood cell production by the bone marrow. Although rare, these symptoms usually occur after 4-6 weeks of treatment.
• elderly patients may be more sensitive 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 use of the medicine should be discontinued and medical help should be sought immediately if any of the symptoms listed in section 4 occur in relation 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 the 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. Mirzaten Q-Tab should not be started until 2 weeks after stopping MAOIs. MAOIs include, for example, moclobemide and tranylcypromine (antidepressants), and selegiline (used to treat Parkinson's disease).

Caution should be exercisedwhen 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 painkiller), 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 several of these symptoms occur 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 at the same time as 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 consult their doctor or pharmacist 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, called 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 immediately contact their doctor and/or midwife.

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 or operating machinery. 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 contact 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 excretion.

3. How to take Mirzaten Q-Tab

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they 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 in 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. However, the doctor may recommend taking the medicine in two divided doses during 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.
Mirzaten Q-Tab tablets are fragile. They should not be pressed out of 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, once placed on the tongue, dissolves quickly. The dissolved tablet can be swallowed with or without water.
The mouth should be empty before placing the tablet on the tongue.

When can you expect an improvement in your well-being

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 an overdose of Mirzaten Q-Tab (without other medicines and without alcohol) are: drowsiness, disorientation, and rapid heart rate.The symptoms of an overdose of Mirzaten Q-Tab 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 "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.
If the medicine is to be taken once a day:

• the patient should not take the missed dose. They should skip it and continue treatment by taking the next dose at the usual time the next day. However, if the medicine is to be taken twice a day:
• if the patient misses the morning dose, they should take it together with the evening dose;
• if the patient misses 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 misses both doses, they should not try to make up for them; they should skip them. The next day, the patient should continue treatment by taking the usual morning and evening doses.

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 disease to recur. If there is an improvement, the patient should discuss it with their doctor, who will inform them when they can stop treatment. Suddenly stopping treatment with Mirzaten Q-Tab, even if the symptoms of depression have disappeared, 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 of the medicine.
If the patient has any further doubts about taking 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 excited or agitated (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 unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). Rarely, mirtazapine may cause blood cell production disorders (bone marrow suppression). 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 high fever, sweating, rapid heart rate, diarrhea, (uncontrolled) muscle spasms, chills, increased reflexes, anxiety, mood changes, and loss of consciousness and increased salivation. 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 skin 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 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 anxious
• 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, such as burning, tingling, or numbness (paresthesia)
• restless legs syndrome
• fainting
• feeling numb in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• urge 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 disorders
• 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 this 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:
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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Mirzaten Q-Tab

The medicine should be stored in a place inaccessible to children.
The medicine should not be used after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the specified 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 unused medicines. 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 silica, anhydrous, 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 on this medicine, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500.
Date of last revision of the leaflet:20.01.2022