Mizhaten

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Mirzaten, 45 mg, coated tablets

Mirtazapine

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Mirzaten and what is it 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 is Mirzaten and what is it used for

Mirzaten belongs to a group of medicines known as antidepressants.
Mirzaten is indicated for the treatment of depression.
Mirzaten starts working after 1-2 weeks of treatment, and after 2-4 weeks, an improvement in well-being may occur. If after 2-4 weeks of treatment, there is no improvement or the patient feels worse, they should consult their doctor. More information is provided in section 3, "When can an improvement in well-being be expected?"

2. Important information before taking Mirzaten

When not to take 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, before taking Mirzaten, the doctor should be contacted as soon as possible.
• If the patient is currently taking or has taken in the recent past (within the last 2 weeks) monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Before starting treatment with Mirzaten, the doctor or pharmacist should be consulted.

Before starting Mirzaten, the doctor should be informed if:

The patient has ever experienced severe skin rash or peeling of the skin, blistering, or ulcers in the mouth after taking mirtazapine or other medicines.

Children and adolescents

Mirzaten is not usually given to children and adolescents under 18 years of age because its efficacy has not been established. It should also be noted that in patients under 18 years of age, there is a higher risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger), when they take medicines of this class. Nevertheless, the doctor may prescribe Mirzaten to patients of this age if they consider it to be in their best interest. If the doctor has prescribed Mirzaten to a patient under 18 years of age and any doubts arise, the doctor should be consulted. In patients under 18 years of age taking Mirzaten, the doctor should be informed if any of the above symptoms develop or worsen. The long-term effects of Mirzaten on safety, including growth, maturation, and cognitive development in this age group, have not been established. Additionally, during treatment with mirtazapine in this age group, significant weight gain is more frequently observed than in adults.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working only after about 2 weeks, sometimes later. The above symptoms are more likely in:

• patients who have previously had thoughts of self-harm or suicide;
• young adult patients. Data from clinical trials show an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants. If thoughts of self-harm or suicidal thoughts occur, the doctor or hospital should be contacted immediately. It may be helpful to inform relatives or friendsabout the depression and ask them to read this leaflet. The patient may ask to be informed when they notice that the depression or anxiety has worsened or worrying changes in behavior have occurred.

Special caution should be exercised when taking Mirzaten:

• If the following diseases occur or have occurred. The doctor should be informed about the occurrence of the following diseases before starting treatment with Mirzaten, if the patient has not done so before:
• epileptic seizures. If seizures occur or their frequency increases during treatment, Mirzaten should be discontinued and the doctor contacted immediately;
• liver disease, including jaundice. If jaundice occurs, Mirzaten should be discontinued and the doctor contacted immediately;
• kidney disease;
• heart diseaseor low blood pressure;
• schizophrenia. The doctor should be contacted immediately if such mental disorders as paranoid thoughts worsen or increase in frequency;
• manic depression(alternating periods of elevated mood/excitement and depression). If the patient feels excessively excited, Mirzaten should be discontinued and the doctor contacted immediately;
• diabetes(may require a change in insulin or other antidiabetic medication dose);
• eye disease, such as increased intraocular pressure (glaucoma);
• difficulty urinating, which may be caused by an enlarged prostate;
• certain heart rhythm disordersthat can cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medications that can cause heart rhythm disorders.
• If symptoms of infection occur, such as unexplained high fever, sore throat, and ulcers in the mouth. Mirzaten should be discontinued and the doctor consulted immediately, who will order a blood test. In rare cases, these symptoms may be a sign of disorders of blood cell production by the bone marrow. Although rare, these symptoms usually occur within 4-6 weeks of treatment.

• Elderly patients may be more sensitive to the side effects of antidepressants.
• Severe 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. If any of the symptoms of these severe skin reactions occur, treatment should be discontinued and medical help sought immediately.
• If a serious skin reaction has occurred, mirtazapine should not be restarted.

Mirzaten and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Mirzaten should not be takenin combination with:

• monoamine oxidase inhibitors (MAOIs)or within 2 weeks of stopping their use. Mirzaten should not be started until 2 weeks after stopping MAOIs. MAOIs include, for example, moclobemide and tranylcypromine (antidepressants), selegiline (used in the treatment of Parkinson's disease).

Caution should be exercisedwhen taking Mirzaten in combination with:

• other antidepressants, such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraines), buprenorphine(used to treat pain or opioid addiction), tramadol(a pain reliever), linezolid(an antibiotic), lithium salts(used to treat certain mental disorders), methylene blue(used to lower high methemoglobin levels in the blood), and preparations containing St. John's Wort (Hypericum perforatum)(herbal preparations used to treat depression). In patients taking only Mirzaten or in combination with these medicines, serotonin syndrome, a rare but potentially life-threatening condition, can occur. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, increased reflexes, anxiety, mood changes, loss of consciousness, and increased salivation. If several of these symptoms occur, the doctor should be contacted immediately.
• the antidepressant nefazodone. It may increase the level of Mirzaten in the blood. The doctor should be informed about the use of this medicine. It may be necessary to reduce the dose of Mirzaten, 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 the sleepiness they cause.
• medicines used to treat infections, such as antibiotics (e.g., erythromycin), antifungals (e.g., ketoconazole), and medicines used to treat HIV/AIDS (e.g., HIV protease inhibitors), and medicines used to treat stomach ulcers(e.g., cimetidine). When these medicines are started in combination with Mirzaten, the level of Mirzaten in the blood may increase. The doctor should be informed about the use of these medicines. It may be necessary to reduce the dose of Mirzaten, 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.

When taken with Mirzaten, these medicines may decrease its level in the blood. The doctor should be informed about the use of these medicines. It may be necessary to increase the dose of Mirzaten, and after stopping these medicines, the dose of Mirzaten may need to be decreased.

• anticoagulants, such as warfarin. Mirzaten may enhance the effect of warfarin. The doctor should be informed about the use of these medicines. When treating with Mirzaten in combination with warfarin, it is recommended to monitor blood parameters.
• 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 sleepiness.
It is best to avoid drinking alcohol during treatment with Mirzaten.
Mirzaten can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Limited experience with Mirzaten in pregnant women does not indicate an increased risk. However, caution should be exercised when taking this medicine during pregnancy.
If Mirzaten is taken during pregnancy or shortly before delivery, the newborn should be monitored for possible side 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), characterized by rapid breathing and bluish skin. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, the doctor or midwife should be contacted immediately.

Driving and using machines

Mirzaten may reduce alertness and concentration. During treatment with Mirzaten, potentially hazardous activities that require continuous attention, such as driving or operating machinery, should be avoided. If the doctor has prescribed Mirzaten to a person under 18 years of age, before participating in traffic (e.g., cycling), it should be checked whether the medicine affects alertness and concentration.

Mirzaten contains lactose monohydrate and sodium

Lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium

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

3. How to take Mirzaten

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Mirzaten is available in the following strengths: 30 mg, 45 mg.

Dosage

The recommended initial dose is 15 mg or 30 mg per day.After a few days of treatment, the doctor may recommend increasing the dose to the most suitable for the patient (from 15 to 45 mg per day).
Usually, the same dose of the medicine is used in patients of different ages. However, elderly patients or patients with kidney or liver disease may be prescribed a different dose by their doctor.

When to take Mirzaten

Mirzaten should be taken daily at the same time, preferably in a single dose in the evening, before bedtime. However, the doctor may recommend taking the medicine in two divided doses per day - one dose in the morning and one in the evening before sleep.
The larger dose should be taken in the evening, before bedtime.
The tablets should be taken orally. The tablets should not be chewed. The tablets should be swallowed, washed down with water or juice.

When can an improvement in well-being be expected

Usually, the medicine starts working after 1 to 2 weeks of treatment, and after 2 to 4 weeks, an improvement in well-being may occur.
It is essential to discuss the effects of Mirzaten with the doctor during the first few weeks of treatment.
After 2 to 4 weeks from the start of Mirzaten treatment, the doctor should be consulted to discuss how the medicine is working.
If there is no adequate clinical response, the doctor may increase the dose. After another 2 to 4 weeks, the treatment effects should be discussed with the doctor again.
Treatment should be continued until the symptoms have completely disappeared, which usually takes 4 to 6 months.

Overdose of Mirzaten

In case of taking a higher dose of Mirzaten than recommended, the doctor should be contacted immediately.
The most likely symptoms of Mirzaten overdose (without other medicines and without alcohol) are: sleepiness, disorientation, and rapid heart rate.Overdose symptoms may include changes in heart rhythm (rapid heart rate, irregular heart rhythm) and (or) fainting. These may be symptoms of life-threatening ventricular arrhythmias, known as "torsade de pointes".

Missing a dose of Mirzaten

In case of forgetting to take a dose that is taken once a day:

• a double dose should not be taken to make up for the missed dose. Treatment should be continued by taking the next dose at the usual time the next day.

If the medicine is taken twice a day:

• if the morning dose is missed - it should be taken together with the evening dose;
• if the evening dose is missed - it should not be taken together with the morning dose; treatment should be continued by taking the usual morning and evening doses;
• if both doses are missed - they should not be taken; the next day, treatment should be continued by taking the usual morning and evening doses.

Stopping Mirzaten treatment

Mirzaten treatment should only be stopped strictly according to the doctor's instructions.
Treatment should not be stopped too early, as this may cause the illness to recur. If an improvement occurs, this should be discussed with the doctor, who will inform when treatment can be stopped. Suddenly stopping Mirzaten treatment, even if the symptoms of depression have disappeared, may cause nausea, dizziness, agitation, or anxiety and headache. These symptoms will not occur during gradual discontinuation of the medicine. The doctor will inform how to gradually reduce the dose of Mirzaten.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Mirzaten can cause side effects, although not everybody gets them.

If any of the following serious side effects occur, Mirzaten should be discontinued and the doctor contacted immediately:

Uncommon side effects(may affect up to 1 in 100 people):

• feeling of excitement or agitation (mania).

Rare side effects(may affect up to 1 in 1,000 people):

• yellowing of the eyes or skin; this may indicate liver function disorders (jaundice).

Side effects of unknown frequency(frequency cannot be estimated from the available data):

• infection symptoms, such as sudden unexplained high fever, sore throat, and ulcers in the mouth (agranulocytosis). Mirtazapine can rarely cause blood cell production disorders (bone marrow suppression). Some patients may become less resistant to infections because mirtazapine can cause temporary decreases in white blood cell count (granulocytopenia). Rarely, mirtazapine can also cause decreases in red blood cell, white blood cell, and platelet counts (aplastic anemia, thrombocytopenia), or increases in white blood cell count (eosinophilia).
• seizures (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, shivering, increased reflexes, anxiety, mood changes, loss of consciousness, and increased salivation. In very rare cases, these may be symptoms of serotonin syndrome.
• thoughts of self-harm or suicide
• severe skin reactions:
• red spots on the torso in a target shape or round, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of 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 side effects:

Very common side effects(may affect more than 1 in 10 people):

• increased appetite and weight gain
• calmness or sleepiness
• headache
• dry mouth.

Common side effects(may affect up to 1 in 10 people):

• lethargy
• dizziness
• seizures or tremors
• nausea
• diarrhea
• vomiting
• constipation
• rash or skin eruptions
• joint or muscle pain
• back pain
• dizziness or fainting when changing body position quickly (orthostatic hypotension)
• swelling (usually of the ankles or feet) due to fluid retention in the body
• fatigue
• intensive dreaming
• disorientation
• feeling of anxiety
• sleep disturbances
• memory disorders, which in most cases disappeared after stopping treatment.

Uncommon side effects(may affect up to 1 in 100 people):

• unusual skin sensations, e.g., burning, tingling, or numbness (paresthesia)
• restless legs syndrome
• fainting
• feeling of numbness in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• agitation
• hallucinations
• urgent need to move.

Rare side effects(may affect up to 1 in 1,000 people):

• muscle twitching or contractions (clonic muscle spasms)
• aggressive behavior
• abdominal pain and nausea, which may indicate pancreatitis.

Side effects of unknown frequency(frequency cannot be estimated from the available data):

• unusual sensations in the mouth (oral paresthesia)
• swelling of the mouth
• generalized swelling
• local swelling
• low sodium levels in the blood (hyponatremia)
• inappropriate antidiuretic hormone secretion
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disorders
• increased creatine kinase levels in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness, and (or) weakness, darker or paler urine (rhabdomyolysis)
• increased prolactin levels in the blood (hyperprolactinemia, including symptoms such as breast enlargement and (or) milk secretion from the nipples)
• prolonged painful erections.

Additional side effects in children and adolescents

In clinical trials in children under 18 years of age, the following side effects were more frequently observed: significant weight gain, hives, and increased triglyceride levels in the blood.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of this medicine.

5. How to store Mirzaten

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mirzaten contains

• The active substance of Mirzaten is mirtazapine. Each coated tablet contains 45 mg of mirtazapine in the form of mirtazapine hemihydrate.
• The other ingredients of the medicine are: cellulose (lactose monohydrate, cellulose, powder), sodium carboxymethyl cellulose (type A), cornstarch, silicon dioxide, magnesium stearate; Coating:hypromellose, titanium dioxide (E 171), talc, macrogol 6000. See section 2 "Mirzaten contains lactose monohydrate and sodium".

What Mirzaten looks like and contents of the pack

Mirzaten, 45 mg, is a white, oval, biconvex coated tablet.

Packaging

Available packaging: 30, 60, or 90 coated tablets in PVC/PVDC/Al blisters, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in the Czech Republic, 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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:30/082/05-C
Parallel import authorization number:394/13

Date of leaflet approval: 23.05.2023

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