Mirzaten 30 mg

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Mirzaten 30 mg, film-coated tablets
Mirtazapinum
Please read this leaflet carefully before taking 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 doubts, 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 another person, 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 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, medical advice should be sought. More information is provided in section 3, under "When can improvement in well-being be expected?"

2. 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 immediately before taking Mirzaten 30 mg.
• If the patient is currently or has 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 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 effects 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 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 above-mentioned symptoms 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 treatment with antidepressants, as these medicines usually take about 2 weeks, 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 were treated with antidepressants. 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 concerning changes in behaviour.

Special caution is advised when using Mirzaten 30 mg:

• 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 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 diseases, including jaundice. If jaundice occurs, discontinue Mirzaten 30 mg and contact your doctor immediately;
• Kidney diseases;
• Heart diseases or low blood pressure;
• Schizophrenia. Contact your doctor immediately if psychiatric disturbances 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 diseases, 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 specific medicines that may cause heart rhythm disturbances.
• If signs 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 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 antidepressants.
• 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 attention if any of the symptoms listed in section 4 occur in connection with these serious skin reactions.
• If the patient has ever experienced a serious skin reaction, re-initiation of mirtazapine treatment should not be attempted.

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

• Monoamine oxidase inhibitors (MAOIs) or within two weeks after stopping them. Do not start taking Mirzaten 30 mg within two weeks after 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 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 the blood), and St. John's wort herbal preparations (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 of its symptoms include sudden fever, sweating, increased heart rate, diarrhoea, (uncontrolled) muscle spasms, chills, exaggerated reflexes, restlessness, mood changes, or 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 you are taking this medicine. A dose reduction of Mirzaten 30 mg may be necessary, and after stopping nefazodone treatment, 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), and 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 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 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 your doctor if you are taking these medicines. A dose increase of Mirzaten 30 mg may be necessary, and after stopping treatment with 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 you are taking these medicines. Monitoring of blood parameters is recommended during concomitant 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 consumption during treatment with Mirzaten 30 mg.
Mirzaten 30 mg may be taken independently of meals.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, 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 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 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 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 monohydrate and sodium
Lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
Sodium
This 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 30 mg

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Mirzaten 30 mg is available in the following strengths: 30 mg, 45 mg.
Dosage
The recommended starting dose is 15 mg or 30 mg once daily. After several days of treatment, your doctor may decide to increase the dose to the most appropriate level for the patient (from 15 mg to 45 mg once daily).
Usually, the same dose is used in patients of different ages. However, your doctor may prescribe a different dose for elderly patients or for 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 dose in the evening before going to bed. However, your doctor may advise taking the medicine in two divided doses during the day – one dose in the morning and one in the evening before bedtime.
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 whole 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 your doctor during the first few weeks of treatment.
After 2 to 4 weeks of starting Mirzaten 30 mg, you should 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, you should again review the treatment effects with your doctor.
Treatment should be continued until symptoms have completely resolved, which usually takes 4 to 6 months.
Taking more Mirzaten 30 mg than prescribed
If a patient (or anyone else) takes more than the prescribed 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 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 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 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 try to make them up; skip them. The next day, continue treatment 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 stopped.
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. 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 reactions

Like any medicine, 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 occur in up to 1 in 100 people):

• feeling of agitation or excitement (mania).

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

• yellowing of the whites of the eyes or skin; this may indicate liver dysfunction (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 a reduction in red blood cells and white blood cells as well as platelets (aplastic anaemia), low platelet count (thrombocytopenia), or increased white blood cell count (eosinophilia).
• seizures (convulsions);
• combination of symptoms such as fever of unknown cause, sweating, increased heart rate, diarrhoea, (involuntary) 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 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 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;
• convulsions or tremor;
• nausea;
• diarrhoea;
• vomiting;
• constipation;
• rash or skin eruptions;
• joint pain or muscle pain;
• back pain;
• dizziness or fainting when changing body position suddenly (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;
• 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 1,000 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):

• 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) muscle weakness, darker or discoloured urine (rhabdomyolysis);
• increased levels of prolactin hormone 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 adverse reactions 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 apply.
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 packaging 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: cellactose (lactose monohydrate - 75%, microcrystalline cellulose - 25%), sodium carboxymethyl starch (type A), pregelatinized maize starch, colloidal anhydrous silica, magnesium stearate; film-coating ingredients: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), talc, macrogol 6000.

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, 60 or 90 coated tablets in PVC-PVDC/Al 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation numbers in Romania, the country of export: 11667/2019/01
11667/2019/02
11667/2019/03
Parallel import authorisation number: 212/19
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names: