Mirzaten 45 mg

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Mirzaten 45 mg
film-coated tablets
Mirtazapine hemihydrate
Please read the entire leaflet carefully before using this 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. This 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Mirzaten 45 mg is and what it is used for
2. Important information before taking Mirzaten 45 mg
3. How to take Mirzaten 45 mg
4. Possible side effects
5. How to store Mirzaten 45 mg
6. Contents of the pack and other information

1. What Mirzaten 45 mg is and what it is used for

Mirzaten 45 mg belongs to a group of medicines known as antidepressants.
Mirzaten 45 mg is indicated for the treatment of depression.
Mirzaten 45 mg starts to work after 1-2 weeks of treatment, and improvement in well-being may occur 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. Further information is provided in section 3 under "When to expect improvement in well-being".

2. Important information before using Mirzaten 45 mg

When not to use Mirzaten 45 mg

• 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 45 mg.
• If the patient has currently or recently (within the last 2 weeks) been taking medicines from the group of monoamine oxidase inhibitors (MAOIs).

Warnings and precautions
Before starting treatment with Mirzaten 45 mg, discuss this with your doctor or pharmacist.
Before starting to take Mirzaten 45 mg, tell your doctor
if the patient has ever experienced, after taking mirtazapine or other medicinal products,
severe skin rash, skin peeling, blistering, or oral ulcers.

Children and adolescents
Mirzaten 45 mg is generally not recommended for use in children and adolescents under 18
years of age, as its efficacy has not been demonstrated. It should also be noted that in
patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviors,
and anger) when taking medicines of this class. Nevertheless, a doctor may prescribe Mirzaten 45 mg
to patients in this age group if they consider it to be in their best interest. If Mirzaten 45 mg 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 45 mg, inform the doctor immediately if any of the symptoms listed above develop or worsen. The long-term impact of Mirzaten 45 mg on safety regarding growth, maturation, and cognitive development in this age group has not yet been established. Additionally, during mirtazapine treatment 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.
Such symptoms or behaviors 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 experienced thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines. Seek immediate medical advice from a doctor or go to hospital if thoughts of self-harm or suicidal thoughts occur. 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 him or her if they notice worsening depression or anxiety, or any disturbing changes in behavior.

Special caution is required when using Mirzaten 45 mg:

• If any of the following diseases are present or have occurred in the past. Inform your doctor about any of the following conditions before starting treatment with Mirzaten 45 mg, if not already done:
• epilepsy. If seizures occur or their frequency increases during treatment, discontinue Mirzaten 45 mg and contact your doctor immediately;
• liver disorders, including jaundice. If jaundice occurs, discontinue Mirzaten 45 mg and contact your doctor immediately;
• kidney disorders;
• heart disorders or low blood pressure;
• schizophrenia. Contact your doctor immediately if psychiatric symptoms 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 45 mg 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 due to 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 oral ulcers. Discontinue Mirzaten 45 mg and consult a doctor immediately, who will order a complete blood count. In rare cases, these symptoms may indicate bone marrow suppression affecting blood cell production. 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.
• Do not restart mirtazapine treatment if the patient has ever had a serious skin reaction to it.

Mirzaten 45 mg and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not use Mirzaten 45 mg in combination with:

• monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping them. Do not start Mirzaten 45 mg within 2 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 45 mg in combination with:

• other antidepressants, such as SSRIs (selective serotonin reuptake inhibitors), venlafaxine and L-tryptophan or triptans (used to treat migraine), buprenorphine (used for 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 herbal preparations containing St. John's wort ( Hypericum perforatum ) (herbal remedies used for depression). In patients taking Mirzaten 45 mg alone or in combination with these medicines, serotonin syndrome may very rarely occur. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, 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 45 mg. Inform your doctor if you are taking this medicine. A dose reduction of Mirzaten 45 mg may be necessary, and after stopping nefazodone, the dose of Mirzaten 45 mg 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 45 mg 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), and medicines used to treat HIV/AIDS (such as HIV protease inhibitors), and medicines used to treat stomach ulcers (e.g., cimetidine). When starting concurrent administration of these medicines with Mirzaten 45 mg, the blood concentration of Mirzaten 45 mg may increase. Inform your doctor if you are taking these medicines. A dose reduction of Mirzaten 45 mg may be necessary, and after stopping these medicines, the dose of Mirzaten 45 mg may need to be increased.

• antiepileptic medicines, such as carbamazepine and phenytoin;

• medicines used to treat tuberculosis, such as rifampicin. In combination with Mirzaten 45 mg, these medicines may reduce its blood concentration. Inform your doctor if you are taking these medicines. A dose increase of Mirzaten 45 mg may be necessary, and after stopping treatment with these medicines, the dose of Mirzaten 45 mg may need to be decreased.

• anticoagulant medicines, such as warfarin. Mirzaten 45 mg 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 45 mg.

• medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Use of Mirzaten 45 mg with food, drink, and alcohol
Drinking alcohol while taking Mirzaten 45 mg may cause drowsiness.
It is best to avoid alcohol consumption during treatment with Mirzaten 45 mg.
Mirzaten 45 mg can be taken independently of meals.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Limited experience with the use of Mirzaten 45 mg in pregnant women does not indicate an increased risk. However, caution should be exercised when using this medicine during pregnancy.
If Mirzaten 45 mg is taken during pregnancy or shortly before delivery, newborns should be monitored for possible adverse effects.
Taking similar medicines during pregnancy [such as 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 45 mg may reduce alertness and the ability to concentrate. During treatment with Mirzaten 45 mg, avoid performing potentially dangerous activities requiring sustained attention, such as driving or operating machinery. If Mirzaten 45 mg has been prescribed to a person under 18 years of age, check before participating in road traffic (e.g., cycling) whether the medicine affects alertness and concentration.

Mirzaten 45 mg contains lactose monohydrate and sodium
Lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., the medicine is considered "sodium-free".

3. How to use Mirzaten 45 mg

This medicine should always be taken 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 to 45 mg per day).
Usually, the same dose is used in patients of different ages. However, your doctor may recommend a different dose for elderly patients or for patients with kidney or liver disease.
When to take Mirzaten 45 mg
Mirzaten 45 mg should be taken every day at the same time, preferably as a single evening dose before going to bed. However, your doctor may recommend taking the medicine in two divided doses during the day – one in the morning and one in the evening before sleep.
The larger dose should be taken in the evening, before going to bed.
The tablets should be taken orally. Do not chew the tablets. Swallow the tablets with water or juice.
When to expect improvement in well-being
The medicine usually starts to work after 1 to 2 weeks of treatment, and improvement in well-being may occur after 2 to 4 weeks.
It is important to discuss the effects of Mirzaten 45 mg with your doctor during the first few weeks of treatment.
After 2 to 4 weeks from starting Mirzaten 45 mg, discuss with your doctor how the medicine is affecting you.
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 be continued until symptoms have completely resolved, which usually takes about 4 to 6 months.
Taking more than the recommended dose of Mirzaten 45 mg
If a patient (or anyone else) takes more than the recommended dose of Mirzaten 45 mg, seek immediate medical advice.
The most likely symptoms of overdose with Mirzaten 45 mg (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 45 mg
If you forget to take your dose and the medicine is to be taken once daily:

• do not take a double dose to make up for the missed dose; continue treatment by taking the next dose at the usual time the next day. If, however, 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 the missed dose; continue treatment by taking the usual morning and evening doses;
• if you forget both doses – do not attempt to make them up; skip them. The next day, continue treatment by taking the usual morning and evening doses.

Stopping Mirzaten 45 mg
You should stop taking Mirzaten 45 mg 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 45 mg, even if depressive symptoms have resolved, may cause nausea, dizziness, agitation or anxiety, and headache. These symptoms do not occur when the medicine is gradually withdrawn. Your doctor will advise you on how to gradually reduce the doses.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• feeling of agitation or excitement (mania)

Rare adverse reactions (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 reactions with unknown frequency (frequency cannot be estimated from the 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 the number of white blood cells (granulocytopenia). Rarely, mirtazapine may also cause a reduction in the number of 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 spasms, 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, target-shaped spots on the trunk or circular rashes, often with blisters in the centre, peeling of the skin, mouth ulcers, sore throat, nose, genital organs and around the eyes. Such severe 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 reactions:
Very common adverse reactions (may occur in more than 1 in 10 people):

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

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

• lethargy
• dizziness
• tremor or shaking
• nausea
• diarrhoea
• vomiting
• constipation
• 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 reactions (may occur in up to 1 in 100 people):

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

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

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

Adverse reactions with unknown frequency (frequency cannot be estimated from the 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 (somnambulism)
• speech disorders
• increased blood creatine kinase levels
• difficulty in passing urine (urinary retention)
• muscle pain, stiffness and (or) weakness, darker or discoloured urine (rhabdomyolysis)
• increased prolactin hormone levels in the blood (hyperprolactinaemia, including symptoms such as breast enlargement and (or) milky discharge from the nipples)
• prolonged painful erection

Additional adverse reactions in children and adolescents
In clinical studies in children under 18 years of age, the following adverse reactions were observed more frequently: marked weight gain, urticaria and increased blood triglyceride levels.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Mirzaten 45 mg

Keep this medicine out of the sight and reach of children.
Do not use Mirzaten 45 mg after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mirzaten 45 mg contains

• The active substance is mirtazapine hemihydrate. Each coated tablet contains 45 mg of mirtazapine hemihydrate.
• Other ingredients are: cellactose (monohydrate lactose, cellulose, powder), sodium carboxymethylstarch (type A), pregelatinized maize starch, colloidal anhydrous silica, magnesium stearate; film-coating ingredients: hypromellose, titanium dioxide (E 171), talc, and macrogol 6000. See section 2 "Mirzaten 45 mg contains monohydrate lactose and sodium".

What Mirzaten 45 mg looks like and contents of the pack
Mirzaten 45 mg: white, oval, biconvex coated tablets.
Pack sizes: 30, 60 or 90 coated tablets in blisters, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in the Czech Republic, country of export: 30/082/05-C
Parallel import authorisation number: 46/13
This medicinal product is authorised for marketing in the European Economic Area under the following names: