Mirzaten q-tab

Package leaflet: Information for the patient

Mirzaten Q-Tab, 15 mg, orodispersible tablets
Mirzaten Q-Tab, 30 mg, orodispersible tablets
Mirzaten Q-Tab, 45 mg, orodispersible tablets
mirtazapinum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Mirzaten Q-Tab is and what it is 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 pack and other information

1. What Mirzaten Q-Tab is and what it is 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 effect of Mirzaten Q-Tab begins after 1-2 weeks of treatment, and improvement in well-being 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. More information is provided in section 3, under "When to expect improvement in well-being".

2. Important information before using Mirzaten Q-Tab

When not to use 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, contact a doctor as soon as possible before using Mirzaten Q-Tab.
• 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 treatment with Mirzaten Q-Tab, discuss this with your doctor or pharmacist.
Before starting to take Mirzaten Q-Tab, tell your doctor:
If the patient has ever experienced, after taking mirtazapine or other medicinal products,
severe skin rash, skin peeling, blistering, or changes in the mouth.

Children and adolescents
Mirzaten Q-Tab is generally not recommended for use in children and adolescents under 18 years of age, as its effectiveness has not been proven. It should also be noted that in patients under 18 years of age, there is an increased risk of adverse reactions 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 Mirzaten Q-Tab to patients in this age group if they consider it to be in the patient's best interest. If Mirzaten Q-Tab has been prescribed to a patient under 18 years of age and any doubts arise, consult the prescribing doctor. In patients under 18 years of age taking Mirzaten Q-Tab, inform the doctor immediately if any of the symptoms listed above develop or worsen. The long-term impact of Mirzaten Q-Tab on safety regarding growth, maturation, and cognitive development in this age group has not yet been established. Additionally, during treatment with mirtazapine in this age group, significant weight gain has been observed more frequently than in adults.

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 antidepressant medicines, as these medicines usually start to work only after about 2 weeks, sometimes later. These 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 behaviour in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines. Contact your doctor immediately or go to hospital if you experience thoughts of self-harm or suicidal thoughts.

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 you if they notice worsening of depression or anxiety, or if concerning changes in behaviour occur.

Use Mirzaten Q-Tab with particular caution:

• If any of the following conditions are present or have occurred previously. Inform your doctor about any of the following conditions before starting treatment with Mirzaten Q-Tab, if not already done:
• Epileptic seizures. If seizures occur or their frequency increases during treatment, discontinue Mirzaten Q-Tab and contact your doctor immediately;
• Liver diseases, including jaundice. If jaundice occurs, discontinue Mirzaten Q-Tab and contact your doctor immediately;
• Kidney diseases;
• Heart diseases or low blood pressure;
• Schizophrenia. Contact your doctor immediately if psychiatric disorders such as paranoid thoughts worsen or increase in frequency;
• Manic depression (alternating periods of elevated mood/excitement and depression). If feelings of excessive excitement occur, discontinue Mirzaten Q-Tab and contact your 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 urination, which may be caused by benign prostatic hyperplasia;
• Certain types of heart disorders that may cause changes in heart rhythm, recent myocardial infarction, heart failure, or use of certain medicines that may cause heart rhythm disturbances.
• If symptoms of infection occur, such as unexplained fever, sore throat, or mouth ulcers. Discontinue Mirzaten Q-Tab and consult a doctor immediately, who will order a blood count. In rare cases, these symptoms may indicate bone marrow suppression. Although rare, these symptoms most commonly occur 4–6 weeks after starting treatment.
• Elderly patients may be more sensitive to the adverse effects of antidepressant medicines.
• Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with mirtazapine use. Discontinue the medicine and seek immediate medical help if any of the symptoms listed in section 4 occur due to these serious skin reactions.
• Do not restart treatment with mirtazapine if the patient has ever had a serious skin reaction to it.

Mirzaten Q-Tab and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Do not use Mirzaten Q-Tab in combination with:

• Monoamine oxidase inhibitors (MAOIs), or within two weeks after stopping them. Do not start Mirzaten Q-Tab within two weeks after stopping MAO inhibitors. MAO inhibitors include, for example, moclobemide and tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson's disease).

Use with caution when taking Mirzaten Q-Tab together with:

• Other antidepressants, such as SSRIs (selective serotonin reuptake inhibitors), venlafaxine and L-tryptophan or triptans (used to treat migraine), buprenorphine (used to treat pain or opioid dependence), tramadol (a painkiller), linezolid (an antibiotic), lithium salts (used to treat certain psychiatric disorders), methylene blue (used to reduce high methemoglobin levels in 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 with these medicines, serotonin syndrome may very rarely occur. 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 your doctor immediately if several of these symptoms occur simultaneously;
• The antidepressant nefazodone. It may increase the blood concentration of Mirzaten Q-Tab. Inform your doctor if you are taking this medicine. A dose reduction of Mirzaten Q-Tab may be necessary, and after stopping nefazodone treatment, the dose of Mirzaten Q-Tab may need to be increased;
• 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 them.
• Medicines used to treat infections, such as antibacterial agents (e.g. erythromycin), antifungal agents (e.g. ketoconazole), medicines used to treat HIV/AIDS (such as HIV protease inhibitors), and medicines used to treat stomach ulcers (e.g. cimetidine).

If these medicines are started simultaneously with Mirzaten Q-Tab, the blood concentration of Mirzaten Q-Tab may increase. Inform your doctor if you are taking these medicines. A dose reduction of Mirzaten Q-Tab may be necessary, and after stopping treatment with these medicines, the dose of Mirzaten Q-Tab may need to be increased.

• Antiepileptic medicines, such as carbamazepine and phenytoin;
• Medicines used to treat tuberculosis, such as rifampicin; In combination with Mirzaten Q-Tab, these medicines may reduce its blood concentration. Inform your doctor if you are taking these medicines. A dose increase of Mirzaten Q-Tab may be necessary, and after stopping treatment with these medicines, the dose of Mirzaten Q-Tab may need to be decreased.
• Anticoagulant medicines, such as warfarin; Mirzaten Q-Tab may enhance the effect of warfarin. Inform your doctor if you are taking these medicines. Monitoring of blood parameters is recommended during combined treatment with Mirzaten Q-Tab.
• 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 alcohol during treatment with Mirzaten Q-Tab.
Mirzaten Q-Tab can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using 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 delivery, the newborn should be monitored for possible adverse 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 cyanosis. These symptoms usually occur within the first day after birth. If such symptoms occur in the newborn, contact your doctor and/or midwife immediately.

Driving and using machines
Mirzaten Q-Tab may reduce alertness and the ability to concentrate. During treatment with Mirzaten Q-Tab, avoid performing potentially dangerous tasks requiring sustained attention, such as driving vehicles or operating machinery. If Mirzaten Q-Tab has been prescribed to a person under 18 years of age, check whether the medicine affects alertness and concentration before participating in road traffic (e.g. cycling).

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

3. How to use Mirzaten Q-Tab

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Dosage
The recommended starting dose is 15 mg or 30 mg once daily. After several days of treatment, your doctor may recommend increasing the dose to the most appropriate level for the patient (from 15 mg to 45 mg per day).
Generally, the same dose is used in patients of different ages. However, your doctor may prescribe 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 as a single dose in the evening before going to bed. However, your 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.

Instructions for taking orally disintegrating tablets:
Mirzaten Q-Tab tablets are for oral use.
Mirzaten Q-Tab tablets are delicate. Do not push them out of the blister pack, as they may be damaged in the process. To remove a tablet from the packaging:

1. Hold the edge of the blister and carefully separate one blister square by tearing at the perforation.
2. Pull the marked edge of the foil and completely peel it back.
3. Remove the tablet with your hand.
4. Place the tablet on the tongue immediately after removing it from the packaging.

After placing the tablet on the tongue, it dissolves rapidly. The dissolved tablet may be swallowed with or without water.
The mouth should be empty before placing the tablet on the tongue.

When to expect improvement in well-being
The medicine usually starts to work 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 Mirzaten Q-Tab with your doctor during the first few weeks of treatment.
After 2 to 4 weeks of starting Mirzaten Q-Tab, you should 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, you should again discuss the treatment outcomes with your doctor.
Treatment should continue until symptoms have completely resolved, which usually takes 4 to 6 months.

Taking more Mirzaten Q-Tab than recommended
If a patient (or anyone else) takes more than the recommended dose of Mirzaten Q-Tab, seek medical advice immediately.
The most likely symptoms of overdose with Mirzaten Q-Tab (without other medicines and without alcohol) are: drowsiness, disorientation, and increased heart rate. 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 Mirzaten Q-Tab
Do not take a double dose to make up for a missed dose.
If you forget to take your medicine, which is to be taken once daily:

• do not take the missed dose; skip it. Continue treatment by taking the next dose at the usual time the following day.

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 it. Continue treatment by taking the usual morning and evening doses;
• if you forget both doses, do not try to make them up; skip them. On the following day, continue treatment by taking the usual morning and evening doses.

Stopping Mirzaten Q-Tab
You should stop taking Mirzaten Q-Tab 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, who will advise when treatment can be stopped.
Suddenly stopping treatment with Mirzaten Q-Tab, even if depressive symptoms have resolved, may cause nausea, dizziness, agitation, anxiety, and headache. These symptoms can be avoided by gradually tapering the dose. Your doctor will advise you on 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following serious adverse effects occur, stop taking mirtazapine and contact your doctor immediately:
Uncommon adverse effects (may occur in up to 1 in 100 people):

• feeling of excitement or agitation (mania)

Rare adverse effects (may occur in up to 1 in 1000 people):

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

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• signs of infection such as sudden high fever of unknown cause, sore throat and mouth ulcers (agranulocytosis). Rarely, mirtazapine may cause disturbances in blood cell production (bone marrow suppression). Some patients may become less resistant to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). Rarely, mirtazapine may also cause a reduction in red blood cells and white blood cells as well as platelets (aplastic anaemia), low platelet count (thrombocytopenia), or increased number of white blood cells (eosinophilia).
• seizures (fits)
• combination of symptoms such as fever of unknown cause, sweating, increased heart rate, diarrhoea, (uncontrolled) muscle contractions, chills, increased reflexes, restlessness, mood changes, loss of consciousness and increased salivation. In very rare cases, these may be signs of serotonin syndrome.
• thoughts of self-harm or suicide
• severe skin reactions:
• red rash on the trunk in the shape of a target or circular lesions, often with blisters in the center, peeling of the skin, mouth, throat, nose, genital ulcers and eye involvement. 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 syndrome or drug hypersensitivity syndrome)

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

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

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

• lethargy
• dizziness
• tremors or shaking
• nausea
• diarrhoea
• constipation
• vomiting
• rash or skin eruptions
• joint pain or muscle pain
• back pain
• dizziness or fainting when changing body position suddenly (orthostatic hypotension)
• swelling (usually ankles or feet) due to fluid retention
• fatigue
• vivid dreams
• disorientation
• feeling of anxiety
• sleep disturbances
• memory disturbances, which in most cases resolved after discontinuation of treatment

Uncommon adverse effects (may occur in up to 1 in 100 people):

• unusual skin sensations such as burning, stinging or tingling (paraesthesia)
• restless legs syndrome
• fainting
• sensation of numbness in the mouth (oral hypoaesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• urgent need for movement

Rare adverse effects (may occur in up to 1 in 1000 people):

• muscle twitching or spasms (clonic muscle jerks)
• aggressive behaviour
• upper abdominal pain and nausea which may indicate pancreatitis

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• unnatural sensations in the mouth (oral paraesthesia)
• swelling of the mouth
• body swelling (generalized oedema)
• local swelling
• low sodium levels in the blood (hyponatraemia)
• inappropriate antidiuretic hormone secretion
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking
• speech disorders
• increased blood creatine kinase levels
• difficulty passing urine (urinary retention)
• muscle pain, stiffness and (or) muscle weakness, darker or discoloured urine (rhabdomyolysis)
• elevated blood prolactin levels (hyperprolactinaemia, including symptoms of enlarged breasts and/or milk secretion from the nipples)
• prolonged painful erection

Additional adverse effects in children and adolescents
In clinical studies in children under 18 years of age, the following adverse effects were observed more frequently: significant weight gain, urticaria and increased blood triglyceride levels.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Mirzaten Q-Tab

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Mirzaten Q-Tab contains

• The active substance is mirtazapine. Each orodispersible tablet contains 15 mg, 30 mg or 45 mg of mirtazapine.
• The other ingredients are: monohydrate lactose, ethylcellulose, mannitol (E 421), sorbitol (E 420), crospovidone, colloidal hydrated silica, orange flavour (containing maltodextrin, modified maize starch), 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
Orodispersible tablets are white, round and biconvex.
Pack: 30 orodispersible tablets in a perforated, unit-dose blister pack, in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

For more detailed information about this medicinal product, please contact
the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Tel. 22 57 37 500.