Mirzaten

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Mirzaten 30 mg (Mirzaten), 30 mg, film-coated tablets
Mirtazapinum
Mirzaten 30 mg and Mirzaten are different brand names for the same medicine.
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, 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.

Contents of the leaflet:

1. What Mirzaten 30 mg is and what it is used for
2. Important information before taking Mirzaten 30 mg
3. How to take Mirzaten 30 mg
4. Possible side effects
5. How to store Mirzaten 30 mg
6. Contents of the pack and other information

1. What Mirzaten 30 mg is and what it is used for

Mirzaten 30 mg belongs to a group of medicines known as antidepressants.
Mirzaten 30 mg is indicated for the treatment of depression.
The effect of Mirzaten 30 mg begins after 1-2 weeks of treatment, and improvement in well-being may occur after 2-4 weeks. If no improvement occurs after 2-4 weeks of treatment, or if the patient feels worse, consult your doctor. Further information is provided in section 3 under "When to expect improvement in well-being".

2. Important information before using Mirzaten 30 mg

When not to use Mirzaten 30 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 30 mg.
• 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 30 mg, discuss this with your doctor or pharmacist.
Before starting to take Mirzaten 30 mg, tell your doctor if the patient has ever experienced
severe skin rash or skin peeling, blistering, or mouth ulcers after taking mirtazapine or other
medicinal products.

Children and adolescents
Mirzaten 30 mg is generally not recommended for use in children and adolescents under 18 years
of age, as its efficacy 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 suicide attempts, suicidal thoughts,
and hostility (mainly aggression, oppositional behaviors, and anger) when taking medicines of this
class. Nevertheless, a doctor may prescribe Mirzaten 30 mg to patients in this age group if they
consider it to be in their best interest. If Mirzaten 30 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 30 mg, inform the doctor immediately if any of the symptoms listed above
develop or worsen. The long-term impact of Mirzaten 30 mg on safety regarding growth, puberty,
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
behaviors may worsen at the beginning of treatment with antidepressants, as these medicines
usually start to work only after about 2 weeks, sometimes later. The following 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. Contact a doctor immediately or go to hospital if thoughts of self-harm or suicidal thoughts occur. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening depression or anxiety, or concerning changes in behavior.

Take particular care when using Mirzaten 30 mg:

• 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 30 mg, if not already done:
• Epileptic seizures. If seizures occur or their frequency increases during treatment, discontinue Mirzaten 30 mg and contact your doctor immediately;
• Liver disorders, including jaundice. If jaundice occurs, discontinue Mirzaten 30 mg 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 a feeling of excessive excitement occurs, discontinue Mirzaten 30 mg and contact your doctor immediately;
• Diabetes (a change in insulin or other antidiabetic medicine dosage may be necessary);
• Eye disorders, 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 30 mg and consult a doctor immediately, who will order a blood count. In rare
cases, these symptoms may indicate bone marrow suppression affecting blood cell production.
Although rare, these symptoms most commonly occur after 4–6 weeks of 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 mirtazapine treatment if the patient has ever experienced a serious skin reaction.

Mirzaten 30 mg and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be
used.
Do not use Mirzaten 30 mg in combination with:

• Monoamine oxidase inhibitors (MAOIs) or within two weeks after stopping their use. Do not start Mirzaten 30 mg until at least two weeks after stopping MAOIs. MAO inhibitors include, for example, moclobemide and tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson’s disease).

Exercise caution when using Mirzaten 30 mg in combination with:

• Other antidepressants, such as SSRIs (selective serotonin reuptake inhibitors), venlafaxine, 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 St. John’s wort (Hypericum perforatum) (herbal remedies used to treat depression). In patients taking Mirzaten 30 mg alone or in combination with these medicines, serotonin syndrome may very rarely occur. Some symptoms include sudden fever, sweating, increased heart rate, diarrhea, involuntary muscle contractions, chills, increased reflexes, restlessness, mood changes, and loss of consciousness. Contact a doctor immediately if several of these symptoms occur simultaneously.
• Nefazodone, another antidepressant. It may increase the blood concentration of Mirzaten 30 mg. Inform your doctor if you are taking this medicine. A dose reduction of Mirzaten 30 mg may be necessary, and after stopping nefazodone, the dose of Mirzaten 30 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 30 mg 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). When these medicines are taken concurrently with Mirzaten 30 mg, the blood concentration of Mirzaten 30 mg may increase. Inform your doctor if you are taking these medicines. A dose reduction of Mirzaten 30 mg may be necessary, and after stopping these medicines, the dose of Mirzaten 30 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 30 mg, these medicines may reduce its blood concentration. Inform your doctor if you are taking these medicines. An increase in the dose of Mirzaten 30 mg may be necessary, and after stopping these medicines, the dose of Mirzaten 30 mg may need to be reduced.
• Anticoagulant medicines, such as warfarin. Mirzaten 30 mg 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 30 mg.
• Medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Use of Mirzaten 30 mg with food, drink, and alcohol
Drinking alcohol while taking Mirzaten 30 mg may cause drowsiness.
It is best to avoid alcohol consumption during treatment with Mirzaten 30 mg.
Mirzaten 30 mg can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
Limited experience with the use of Mirzaten 30 mg in pregnant women does not indicate an
increased risk. However, caution should be exercised when using this medicine during pregnancy.
If Mirzaten 30 mg 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 24 hours after birth.
If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.

Driving and operating machinery
Mirzaten 30 mg may reduce alertness and the ability to concentrate. During treatment with
Mirzaten 30 mg, avoid potentially dangerous activities requiring sustained attention, such as
driving vehicles or operating machinery. If Mirzaten 30 mg 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 30 mg contains lactose and sodium
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is considered “sodium-free”.

3. How to use Mirzaten 30 mg

This medicine should always be taken as directed by the doctor. In case of any doubts, consult a doctor or pharmacist.
Available in the market are: Mirzaten 30 mg and Mirzaten 45 mg.
Dosage
The recommended starting dose is 15 mg or 30 mg once daily. After several days of treatment, the doctor may decide to increase the dose to the most appropriate level for the patient (from 15 to 45 mg per day).
Usually, the same dose is used for patients of different ages. However, the doctor may recommend a different dose for elderly patients or patients with kidney or liver disease.
When to take Mirzaten 30 mg
Mirzaten 30 mg should be taken every day at the same time, preferably as a single evening dose before going to bed. However, the doctor may recommend taking the medicine in two divided doses during the day—one in the morning and one in the evening before bedtime.
The larger dose should be taken in the evening, before going to rest.
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
Usually, the medicine starts working 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 30 mg with the doctor during the first few weeks of treatment.
After 2 to 4 weeks from the start of taking Mirzaten 30 mg, the patient should discuss with the doctor how the medicine is affecting them.
If there is no adequate clinical response, the doctor may increase the dose. After another 2 to 4 weeks, the treatment outcomes should be reviewed again with the 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 30 mg
If the patient (or anyone else) takes more than the recommended dose of Mirzaten 30 mg, seek immediate medical advice from a doctor.
The most likely symptoms of overdose with Mirzaten 30 mg (without other medicines and without alcohol) are: drowsiness, disorientation, and increased heart rate. Symptoms of overdose may include changes in heart rhythm (accelerated heartbeat, irregular heart rhythm) and/or fainting. These may be signs of life-threatening ventricular arrhythmias known as “torsade de pointes”.
Missing a dose of Mirzaten 30 mg
If a dose is forgotten and the medicine is 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 following day.

If the medicine is taken twice daily:

• if the morning dose is forgotten, take it together with the evening dose;
• if the evening dose is forgotten, do not take it together with the morning dose; skip the missed dose; continue treatment by taking the usual morning and evening doses;
• if both doses are forgotten, do not attempt to make them up—skip both doses. The next day, continue treatment by taking the usual morning and evening doses.

Stopping Mirzaten 30 mg treatment
Mirzaten 30 mg should only be discontinued strictly according to the 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 the doctor, who will advise when treatment may be stopped.
Suddenly stopping treatment with Mirzaten 30 mg, even if depressive symptoms have resolved, may cause nausea, dizziness, agitation, anxiety, and headache. These symptoms do not occur when the medicine is gradually withdrawn. The doctor will advise how to gradually reduce the dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

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

• feeling of excitement or agitation (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 of 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 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 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 (convulsions);
• 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 rash on the trunk in the shape of a target or circular, often with blisters in the centre, peeling of the skin, mouth ulcers, in the 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 enlarged 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;
• convulsions or tremor;
• 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 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, 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 reactions (may occur in up to 1 in 1000 people):

• muscle twitching or cramps (clonic muscle spasms);
• aggressive behaviour;
• upper abdominal pain and nausea, which may indicate pancreatitis.

Adverse reactions of unknown frequency (frequency cannot be estimated from available data):

• abnormal 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 blood prolactin levels (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: significant weight gain, urticaria and increased blood triglyceride levels.
Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 to provide more information on the safety of the medicine.

5. How to store Mirzaten 30 mg

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

6. Contents of the package and other information

What Mirzaten 30 mg contains

• The active substance is mirtazapine. Each coated tablet contains 30 mg of mirtazapine in the form of mirtazapine hemihydrate.
• Other components of the medicine are: cellactose (monohydrate lactose, cellulose, powder), sodium carboxymethyl starch (type A), pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate; coating components: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), talc, macrogol 6000. See section 2 "Mirzaten 30 mg contains lactose and sodium".

What Mirzaten 30 mg looks like and contents of the pack
Mirzaten 30 mg: orange-brown, oval, biconvex coated tablets with a score line on one side.
Packaging
30 coated tablets in PVC/PVDC/Al blisters, in a cardboard box.
For more detailed 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in the Czech Republic, country of export: 30/081/05-C
Parallel import authorisation number: 401/14