Mirzaten 30 mg

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Mirzaten 30 mg, coated tablets
Mirtazapine
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are similar.
• 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

1. What Mirzaten 30 mg is and what it is used for
2. What you need to know 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, 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 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 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 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 oral 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 established. 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 (mainly aggression, defiant 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. The following factors increase the likelihood of such symptoms:

• 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 being treated with antidepressants.

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 close friends about the depression and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening of depression or anxiety, or concerning changes in behaviour.

Use Mirzaten 30 mg with special 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 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 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 30 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 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 cardiac arrhythmias.
• If symptoms of infection occur, such as unexplained fever, sore throat, or oral 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. 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 in connection with these serious skin reactions.
• If the patient has ever had a serious skin reaction, re-initiation of mirtazapine treatment should not be attempted.

Mirzaten 30 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 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 MAO inhibitors. MAO inhibitors include, for example, moclobemide and tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson’s disease).

Use with caution when Mirzaten 30 mg is used 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 (an analgesic), linezolid (an antibiotic), lithium salts (used in the treatment of certain psychiatric disorders), methylene blue (used to reduce high methemoglobin levels in blood), and St. John’s wort ( Hypericum perforatum ) preparations (herbal remedies used for depression). The serotonin syndrome, although very rare, may occur in patients taking Mirzaten 30 mg alone or in combination with these medicines. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhoea, involuntary muscle contractions, chills, increased reflexes, restlessness, mood changes, and loss of consciousness. Contact a doctor immediately if several of these symptoms occur simultaneously.

• The antidepressant nefazodone. It may increase the blood concentration of Mirzaten 30 mg. Inform your 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 started concurrently with Mirzaten 30 mg, the blood concentration of Mirzaten 30 mg may increase. Inform your doctor if these medicines are being taken. 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 these medicines are being taken. A dose increase of Mirzaten 30 mg may be necessary, and after stopping these medicines, the dose of Mirzaten 30 mg may need to be decreased.

• Anticoagulant medicines, such as warfarin. Mirzaten 30 mg may enhance the effect of warfarin. Inform your doctor if these medicines are being taken. Monitoring of blood parameters is recommended when Mirzaten 30 mg is used concomitantly.

• Medicines that may affect heart rhythm, such as certain antibiotics and antipsychotics.

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 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 is planning to have a child, she should consult her 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 characterized 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 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
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 exactly as directed by the doctor. In case of any doubts, consult
your doctor or pharmacist.
The following are available on the market: Mirzaten 15 mg, Mirzaten 30 mg, Mirzaten 45 mg.
Dosage
The recommended starting dose is 15 mg or 30 mg once daily. After several days of treatment, the 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 for patients of different ages. 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 evening dose
before going to bed. However, the 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.
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 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, you should discuss with the doctor how the medicine is affecting you.
If there is no adequate clinical response, the doctor may increase the dose. After another 2 to 4 weeks, you should
again discuss the treatment outcomes with the doctor.
Treatment should be continued until symptoms have completely subsided, which usually takes
4 to 6 months.
Taking a higher than recommended dose of Mirzaten 30 mg
If a patient (or anyone else) takes more than the recommended dose of Mirzaten 30 mg, seek medical advice
immediately.
The most likely symptoms of overdose with Mirzaten 30 mg (without other medicines and without alcohol) are:
drowsiness, disorientation, and rapid heartbeat. 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 30 mg
If you forget to take your medicine when it is prescribed 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 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 the next day; skip the missed dose; continue treatment by taking the usual morning and evening doses;
• if you forget both doses—do not try to make them up; skip both doses. Continue treatment the next day by taking the usual morning and evening doses.

Stopping Mirzaten 30 mg
You should stop taking Mirzaten 30 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 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 can be avoided by gradually tapering the dose. Your doctor will advise 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 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 agitation or excitement (mania).

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

• yellowing 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 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, target-shaped spots on the trunk or circular rashes, often with blisters in the centre, peeling of the skin, mouth ulcers, ulcers in the throat, nose, genital area 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,
• 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 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 (paraesthesiae),
• 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 contractions (clonic muscle spasms),
• 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) muscle 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 adverse reactions 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 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 packaging. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
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 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 (anhydrous lactose – 75%, cellulose, powder – 25%), sodium carboxymethyl starch (type A), pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate; film-coating ingredients: hypromellose, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172), talc, macrogol 6000. See section 2 "Mirzaten 30 mg contains monohydrate lactose and sodium".

What Mirzaten 30 mg looks like and contents of the pack
Orange-brown, oval, biconvex coated tablets with a score line on one side.
Packaging: 30 film-coated tablets in blisters packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Romania, the 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
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Romania, the country of export: 11667/2019/01
Parallel import authorisation number: 137/18
This medicinal product is authorised in the European Economic Area countries under the following names: