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
mirtazapine
Please read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 no improvement occurs after 2-4 weeks of treatment, or if the patient feels worse, medical advice should be sought. Further information is provided in section 3, under "When to expect improvement in well-being".

2. Important information before 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
severe skin rash, skin peeling, blistering, or mouth lesions after taking mirtazapine or other medicinal products.

Children and adolescents
Mirzaten Q-Tab should generally not be used 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 behaviour, suicidal thoughts, and hostility (particularly aggression, oppositional 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 their 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. If a patient under 18 years of age is taking Mirzaten Q-Tab, inform the doctor immediately if any of the above-mentioned symptoms 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 take about 2 weeks, or sometimes longer, to start working. 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 behaviour in individuals under 25 years of age with psychiatric disorders who are treated with antidepressant medicines. Contact your doctor immediately or go to hospital if you experience thoughts of self-harm or suicidal thoughts.

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

Use Mirzaten Q-Tab with particular caution:

• If any of the following conditions are present or have occurred in the past. Inform your doctor about any of the following conditions before starting treatment with Mirzaten Q-Tab, if not already done:
• Epilepsy. If seizures occur or their frequency increases during treatment, discontinue Mirzaten Q-Tab and contact your doctor immediately;
• Liver disorders, including jaundice. If jaundice occurs, discontinue Mirzaten Q-Tab and contact your doctor immediately;
• Kidney disorders;
• Heart disorders 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 disorders, such as increased intraocular pressure (glaucoma);
• Difficulty in passing urine, which may be caused by benign prostatic hyperplasia;
• Certain heart disorders that may cause changes in heart rhythm, recent heart attack, heart failure, or use of certain medicines that may cause heart rhythm disturbances.
• If symptoms of infection occur, such as unexplained fever, sore throat, or mouth ulcers. Discontinue Mirzaten Q-Tab and consult your doctor immediately, who will order a blood count. In rare cases, these symptoms may indicate impaired blood cell production in the bone marrow. 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 the use of mirtazapine. Discontinue the medicine and seek immediate medical help if any of the symptoms listed in section 4 occur in connection with 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 taken, recently taken, or planned to be taken.

Do not use Mirzaten Q-Tab in combination with:

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

Exercise caution when using Mirzaten Q-Tab in combination 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 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 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, or 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, 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 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 concurrently 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 reduced.
• 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 combination therapy 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 consuming alcohol during treatment with Mirzaten Q-Tab.
Mirzaten Q-Tab can be taken regardless of meals.

Pregnancy, breastfeeding and fertility
If pregnant, breastfeeding, suspecting pregnancy, or planning 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 manifests as rapid breathing and cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.

Driving and operating machinery
Mirzaten Q-Tab may reduce alertness and the ability to concentrate. During treatment with Mirzaten Q-Tab, avoid performing potentially dangerous tasks requiring constant 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 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 for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

3. How to use Mirzaten Q-Tab

This medicine should always be used as directed 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).
Usually, 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 sleep. 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. 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 your tongue immediately after removing it from the packaging.

After placement on the tongue, the tablet dissolves quickly. 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 working 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, the treatment effects should be reviewed again 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, confusion, and increased heart rate. Overdose symptoms 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 and it is prescribed once daily:

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

If the medicine is prescribed 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. Continue treatment the next day 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 symptoms of depression have resolved, may cause nausea, dizziness, agitation or anxiety, and headache. These symptoms can be avoided by gradually tapering off the medicine. Your doctor will advise you on how to gradually reduce the dose.
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 whites of the eyes or skin; this may indicate liver problems (jaundice)

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

• signs of infection such as sudden high fever of unknown cause, sore throat and mouth ulcers (agranulocytosis). Rarely, mirtazapine may cause disorders in blood cell production (bone marrow suppression). Some patients may become less resistant to infections because mirtazapine may cause transient reduction in white blood cells (granulocytopenia). Rarely, mirtazapine may also cause 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 centre, 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 fever 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 upon sudden change in body position (orthostatic hypotension)
• swelling (usually of the 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 contractions (clonic muscle jerks)
• aggressive behaviour
• upper abdominal pain and nausea which may indicate pancreatitis

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

• unnatural sensations in the mouth (oral paraesthesia)
• swelling of the mouth
• body swelling (generalised oedema)
• localised swelling
• low sodium levels in the blood (hyponatraemia)
• inappropriate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking
• speech disorders
• increased blood creatine kinase levels
• difficulty in passing urine (urinary retention)
• muscle pain, stiffness and (or) muscle weakness, darker or discoloured urine (rhabdomyolysis)
• elevated levels of prolactin hormone in the blood (hyperprolactinaemia, including symptoms such as enlarged breasts and/or milk discharge from 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, inform 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 authorisation holder.
Reporting adverse effects helps provide more information on the safety of this 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 on the blister. 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: lactose monohydrate, ethylcellulose, mannitol (E 421), sorbitol (E 420), crospovidone, colloidal hydrated silica, orange flavour (containing maltodextrin, modified corn 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 European Economic Area and the United Kingdom (Northern Ireland) under the following names:

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