Mirzaten 45 mg

Package leaflet: Information for the patient

Mirzaten, 30 mg, film-coated tablets
Mirzaten, 45 mg, film-coated tablets
Mirtazapinum hemihydratum
Please read this leaflet carefully before taking this medicine because 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. It may harm other people, 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 is and what it is used for
2. Important information before taking Mirzaten
3. How to take Mirzaten
4. Possible side effects
5. How to store Mirzaten
6. Contents of the pack and other information

1. What Mirzaten is and what it is used for

Mirzaten belongs to a group of medicines known as antidepressants.
Mirzaten is indicated for the treatment of depression.
The effect of Mirzaten 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

When not to use Mirzaten

• 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 taking Mirzaten.
• 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, discuss this with your doctor or pharmacist.
Before starting to take Mirzaten, tell your doctor if the patient has ever experienced, after taking mirtazapine or other medicinal products,
severe skin rash, skin peeling, blistering, or mouth ulcers.

Children and adolescents
Mirzaten 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 (mainly aggression, oppositional behaviour, and anger) when taking medicines of this class. Nevertheless, a doctor may prescribe Mirzaten to patients in this age group if they consider it to be in their best interest. If Mirzaten has been prescribed to a patient under 18 years of age and any doubts arise, consult the prescribing doctor. In patients under 18 years of age taking Mirzaten, inform the doctor immediately if any of the symptoms listed above develop or worsen. The long-term impact of Mirzaten 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 start to work only after about 2 weeks, sometimes later. The above 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 are treated with antidepressants. Contact a doctor immediately or go to hospital if suicidal thoughts or thoughts of self-harm 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 required when using Mirzaten:

• If the patient has or has previously had any of the following conditions. Inform the doctor about the presence of any of the following conditions before starting treatment with Mirzaten, if not already done:
• Epileptic seizures. If seizures occur or their frequency increases during treatment, Mirzaten should be discontinued and the doctor contacted immediately;
• Liver diseases, including jaundice. If jaundice occurs, Mirzaten should be discontinued and the doctor contacted immediately;
• Kidney diseases;
• Heart diseases or low blood pressure;
• Schizophrenia. Contact the 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 and contact the 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 heart conditions 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 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 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. 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.
• Mirtazapine treatment should not be restarted if the patient has ever experienced a serious skin reaction.

Mirzaten 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 take Mirzaten in combination with:

• Monoamine oxidase inhibitors (MAOIs) or within 2 weeks after stopping them. Do not start taking Mirzaten within 2 weeks after stopping MAOIs. MAOIs include, for example, moclobemide and tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson's disease).

Exercise caution when using Mirzaten 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 preparations (herbal remedies used for depression). Very rarely, serotonin syndrome may occur in patients taking Mirzaten alone or in combination with these medicines. Some symptoms include sudden fever, sweating, increased heart rate, diarrhoea, uncontrolled muscle spasms, shivering, increased 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. Inform the doctor if this medicine is being taken. A dose reduction of Mirzaten may be necessary, and after stopping nefazodone, the dose of Mirzaten 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 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 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, the blood concentration of Mirzaten may increase. Inform the doctor if these medicines are being taken. A dose reduction of Mirzaten may be necessary, and after stopping these medicines, the dose of Mirzaten may need to be increased.
• Antiepileptic medicines, such as carbamazepine and phenytoin;
• Medicines used to treat tuberculosis, such as rifampicin. In combination with Mirzaten, these medicines may reduce its blood concentration. Inform the doctor if these medicines are being taken. An increase in the dose of Mirzaten may be necessary, and after stopping these medicines, the dose of Mirzaten may need to be reduced.
• Anticoagulant medicines, such as warfarin. Mirzaten may enhance the effect of warfarin. Inform the doctor if these medicines are being taken. Monitoring of blood parameters is recommended during combined treatment with Mirzaten.
• Medicines that may affect heart rhythm, such as certain antibiotics and antipsychotics.

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

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

Driving and using machines
Mirzaten may reduce alertness and the ability to concentrate. While being treated with Mirzaten, avoid potentially dangerous activities requiring sustained attention, such as driving or operating machinery. If Mirzaten 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 the ability to concentrate.

Mirzaten contains lactose and sodium

Lactose
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., it is considered "sodium-free".

3. How to use Mirzaten

This medicine should always be used exactly as your doctor has told you. 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, your doctor may decide to increase the dose to the most appropriate level for you (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 patients with kidney or liver disease.
When to take Mirzaten
Mirzaten 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 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 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 with your doctor during the first few weeks of treatment.
After 2 to 4 weeks of starting Mirzaten, 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 discuss the treatment outcomes with your doctor.
Treatment should be continued until symptoms have completely resolved, which usually takes about 4 to 6 months.
Taking more Mirzaten than recommended
If you (or anyone else) take more Mirzaten than recommended, seek medical advice immediately.
The most likely symptoms of Mirzaten overdose (without other medicines or alcohol) are: drowsiness, disorientation, and rapid heartbeat. Overdose symptoms 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".
If you forget to take Mirzaten
If you forget to take your dose and you are taking the medicine 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 you are taking the medicine 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 both doses. The next day, continue treatment by taking the usual morning and evening doses.

Stopping Mirzaten
You should stop taking Mirzaten 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 you when treatment can be stopped.
Suddenly stopping treatment with Mirzaten, 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 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 effects

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

• feelings of agitation or excitement (mania)

Rare adverse effects (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 effects with 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 (agranulocyt游戏副本

5. How to store Mirzaten

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Mirzaten contains

• The active substance is mirtazapine hemihydrate. Each coated tablet contains 30 mg or 45 mg of mirtazapine hemihydrate.
• Other ingredients are: Mirzaten 30 mg: cellactose (α-lactose monohydrate - 75%, microcrystalline cellulose - 25%), sodium carboxymethyl starch (type A), pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate; film-coating composition: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), talc, polyethylene glycol 6000. See section 2, "Mirzaten contains lactose and sodium". Mirzaten 45 mg: cellactose (α-lactose monohydrate - 75%, microcrystalline cellulose - 25%), sodium carboxymethyl starch (type A), pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate; film-coating composition: hypromellose, titanium dioxide (E 171), talc, polyethylene glycol 6000. See section 2, "Mirzaten contains lactose and sodium".

What Mirzaten looks like and contents of the pack
Mirzaten 30 mg: orange-brown, oval, biconvex coated tablets with a score line on one side
Mirzaten 45 mg: white, oval, biconvex coated tablets
Pack sizes: 30, 60 or 90 coated tablets in blister packs contained in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500