Mirzaten 30 mg

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Mirzaten 30 mg
film-coated tablets
Mirtazapinum
Please read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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.
Mirzaten 30 mg begins 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 you feel worse, you should 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, 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 effectiveness has not been proven. It is also important to be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicidal behaviour, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, 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 concerns 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, 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 antidepressant treatment, as these medicines usually take about 2 weeks, or sometimes longer, to start working. 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 a doctor immediately 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/her if they notice worsening depression or anxiety, or any disturbing changes in behaviour.

Take special care when using Mirzaten 30 mg

• If the patient has or has ever had any of the following conditions. Inform the doctor about these conditions before starting Mirzaten 30 mg if not already done:

• Epileptic seizures. If seizures occur or their frequency increases during treatment, discontinue Mirzaten 30 mg and contact a doctor immediately;

• Liver disorders, including jaundice. If jaundice occurs, discontinue Mirzaten 30 mg and contact a doctor immediately;

• Kidney disorders;

• Heart disorders or low blood pressure;

• Schizophrenia. Contact a 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 30 mg and contact a 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 urinating, which may be caused by benign prostatic hyperplasia;

• Certain 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 signs of infection occur, such as unexplained fever, sore throat, or mouth ulcers. Discontinue Mirzaten 30 mg and consult a doctor immediately, who may 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.

• Do not restart mirtazapine treatment if the patient has ever had a serious skin reaction.

Mirzaten 30 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not use Mirzaten 30 mg in combination with:

• Monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping them. Do not start Mirzaten 30 mg within 2 weeks of stopping MAOIs. MAOIs 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 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 St. John's wort (Hypericum perforatum) (herbal preparations used to treat depression). Serotonin syndrome, although very rare, may occur in patients taking Mirzaten 30 mg alone or in combination with these medicines. Some symptoms include sudden fever, sweating, increased heart rate, diarrhoea, muscle spasms (involuntary), shivering, increased reflexes, restlessness, mood changes, and loss of consciousness. Contact a doctor immediately if several of these symptoms occur together.
• The antidepressant nefazodone, which may increase the blood concentration of Mirzaten 30 mg. Inform the doctor if this medicine is being taken. 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 the drowsiness caused by them.
• Medicines used to treat infections, such as antibacterial agents (e.g., erythromycin), antifungal agents (e.g., ketoconazole), medicines used in the treatment of HIV/AIDS (such as HIV protease inhibitors), and medicines used to treat stomach ulcers (e.g., cimetidine). When these medicines are taken together with Mirzaten 30 mg, the blood concentration of Mirzaten 30 mg may increase. Inform the doctor if these medicines are being taken. A dose reduction of Mirzaten 30 mg may be necessary, and after stopping treatment with 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 the doctor if these medicines are being taken. An increase in the dose of Mirzaten 30 mg may be necessary, and after stopping treatment with 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 the doctor if these medicines are being taken. Monitoring of blood clotting parameters is recommended during combined treatment with Mirzaten 30 mg.
• Medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 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 characterised by 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 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 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 monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Mirzaten 30 mg contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Mirzaten 30 mg

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.

Dosage
The recommended starting dose is 15 mg or 30 mg once daily. After a few days of treatment, the doctor may recommend increasing the dose to the most appropriate level for the patient (from 15 to 45 mg daily).
Generally, the same dose is used in patients of all age groups. However, for elderly patients or patients with kidney or liver disease, the doctor may prescribe a different dose.

When to take Mirzaten 30 mg
Mirzaten 30 mg should be taken every day at the same time, preferably as a single dose in the evening before going to bed. However, the doctor may advise 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.
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 30 mg with the doctor during the first few weeks of treatment.
After 2 to 4 weeks of starting Mirzaten 30 mg, discuss with the doctor how the medicine is affecting the patient.
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 4 to 6 months.

Taking more than the recommended dose of Mirzaten 30 mg
If a patient (or anyone else) takes more than the recommended dose of Mirzaten 30 mg, seek immediate medical advice.
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 heartbeat) and/or fainting. These may be signs of life-threatening ventricular arrhythmias known as "torsade de pointes".

Missed dose of Mirzaten 30 mg
If a dose is missed 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 missed, take it together with the evening dose;
• If the evening dose is missed, do not take it together with the morning dose the next day—skip the missed dose; continue treatment by taking the usual morning and evening doses;
• If both doses are missed, 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
Stop taking Mirzaten 30 mg only 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 can be discontinued.
Suddenly stopping treatment with Mirzaten 30 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. The doctor will advise 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 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
and contact your doctor immediately:
Uncommon adverse reactions (may affect up to 1 in 100 people):

• feeling of excitement or agitation (mania)

Rare adverse reactions (may affect up to 1 in 1,000 people):

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

Adverse reactions of 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 (convulsions)
• a combination of symptoms such as fever of unknown cause, sweating, increased heart rate, diarrhoea, (uncontrolled) muscle spasms, chills, exaggerated 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 or circular rashes on the trunk, often with blisters in the centre, peeling of the skin, mouth, throat, nose, genital or eye ulcers. Such severe 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 reactions:
Very common adverse reactions (may affect more than 1 in 10 people):

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

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

• lethargy
• dizziness
• tremors 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 impairment, which in most cases resolved after discontinuation of treatment

Uncommon adverse reactions (may affect up to 1 in 100 people):

• unusual skin sensations, such as burning, stinging or tingling (paraesthesiae)
• 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 affect up to 1 in 1,000 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 determined 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: 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the container. 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 you no longer use. This will help protect the environment.

6. Package contents 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 are: cellactose (monohydrate lactose – 75%, microcrystalline cellulose – 25%), sodium carboxymethyl starch (type A), pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate; coating composition: hypromellose, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), talc, macrogol 6000.

What Mirzaten 30 mg looks like and contents of the pack
Orange-brown, oval, biconvex coated tablets with a division line on one side.
Pack sizes: 30, 60 or 90 coated tablets in blisters made of PVC/PVDC/Aluminium, packed in a cardboard box.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Marketing authorisation numbers in Romania, country of export: 11667/2019/01
11667/2019/02
11667/2019/03
Parallel import licence number: 202/18
This medicinal product is authorised in the European Economic Area countries under the following names: