Mizhaten 45 mg

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Mirzaten 45 mg

coated tablets
Mirtazapine hemihydrate

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be passed on 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 side effects 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 45 mg and what is it used for
• 2. Important information before taking Mirzaten 45 mg
• 3. How to take Mirzaten 45 mg
• 4. Possible side effects
• 5. How to store Mirzaten 45 mg
• 6. Package contents and other information

1. What is Mirzaten 45 mg and what is it used for

Mirzaten 45 mg belongs to a group of medicines known as antidepressants.
Mirzaten 45 mg is indicated for the treatment of depression.
Mirzaten 45 mg 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 a doctor. More information is provided in section 3, "When can an improvement in well-being be expected?"

2. Important information before taking Mirzaten 45 mg

When not to take Mirzaten 45 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, before taking Mirzaten 45 mg, the patient should contact their doctor 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 45 mg, the patient should discuss it with their doctor or pharmacist.

Before starting Mirzaten 45 mg, the patient should tell their doctor

If they have ever experienced a severe skin rash or peeling of the skin, blistering, or ulcers in the mouth after taking mirtazapine or other medicines.

Children and adolescents

Mirzaten 45 mg should not normally be used 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 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 45 mg to patients of this age if they consider it to be in their best interest. If the doctor has prescribed Mirzaten 45 mg to a patient under 18 years of age and any doubts arise, the patient should consult the doctor. In the case of patients under 18 years of age taking Mirzaten 45 mg, the doctor should be informed if any of the above symptoms develop or worsen. The long-term effects of Mirzaten 45 mg 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, a significant increase in body weight 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 after about 2 weeks, sometimes later. These symptoms are more likely in:

• patients who have previously experienced 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 are being treated with antidepressants. If thoughts of self-harm or suicidal thoughts occur, the patient should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friendsabout the depression and ask them to read this leaflet. The patient may ask them to inform them if they notice that the depression or anxiety has worsened or if there are any worrying changes in behavior.

Particular caution should be exercised when taking Mirzaten 45 mg:

• If the following diseases occur or have occurred. The patient should inform their doctor about the occurrence of the following diseases before starting treatment with Mirzaten 45 mg, if they have not already done so:
• -epileptic seizures. If seizures occur or their frequency increases during treatment, Mirzaten 45 mg should be discontinued and the doctor should be contacted immediately;
• -liver disease, including jaundice. If jaundice occurs, Mirzaten 45 mg should be discontinued and the doctor should be 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, they should discontinue Mirzaten 45 mg and contact their doctor immediately;
• -diabetes(it may be necessary to change the dose of insulin or other antidiabetic medicines);
• -eye diseases, such as increased intraocular pressure (glaucoma);
• -difficulty urinating, which may be caused by an enlarged prostate;
• certain heart diseasesthat can cause changes in heart rhythm, recent myocardial infarction, heart failure, or the use of certain medicines that can cause heart rhythm disturbances.
• If symptoms of infection occur, such as unexplained high fever, sore throat, and ulcers in the mouth. Mirzaten 45 mg should be discontinued and the doctor should be consulted immediately, who will order a blood test. In rare cases, these symptoms may be a sign of disturbances in blood cell production by the bone marrow. Although rare, these symptoms usually occur within 4-6 weeks of treatment.
• Elderly patients may be more susceptible to the side 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 mirtazapine. If any of the symptoms of these serious skin reactions occur, the patient should stop taking the medicine and seek medical attention immediately.
• If the patient has ever experienced a serious skin reaction, they should not restart treatment with mirtazapine.

Mirzaten 45 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Mirzaten 45 mg should not be takenin combination with:

• -monoamine oxidase inhibitors (MAOIs)or within 2 weeks of stopping their use. Mirzaten 45 mg should not be started until 2 weeks after stopping MAOIs. MAOIs include, for example, moclobemide and tranylcypromine (antidepressants), selegiline (used to treat Parkinson's disease).

Caution should be exercisedwhen taking Mirzaten 45 mg 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 levels of methemoglobin in the blood), and preparations containing St. John's wort (Hypericum perforatum)(herbal preparations used to treat depression). In patients taking only Mirzaten 45 mg or in combination with these medicines, serotonin syndrome can very rarely occur. Some of its symptoms include sudden fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, chills, increased reflexes, anxiety, mood changes, loss of consciousness. The patient should contact their doctor immediately if several of these symptoms occur at the same time.
• -the antidepressant nefazodone. It may increase the level of Mirzaten 45 mg in the blood. The patient should inform their doctor about taking this medicine. It may be necessary to reduce the dose of Mirzaten 45 mg, and after stopping nefazodone, increase the dose of Mirzaten 45 mg.
• -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 45 mg in combination with these medicines may increase the sedation caused by these medicines.
• -medicines used to treat infections, such as antibacterial agents (e.g., erythromycin), antifungal agents (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). If these medicines are started at the same time as Mirzaten 45 mg, the level of Mirzaten 45 mg in the blood may increase. The patient should inform their doctor about taking these medicines. It may be necessary to reduce the dose of Mirzaten 45 mg, and after stopping these medicines, increase the dose of Mirzaten 45 mg.
• -antiepileptic medicines, such as carbamazepine and phenytoin;
• -medicines used to treat tuberculosis, such as rifampicin. In combination with Mirzaten 45 mg, these medicines may decrease its level in the blood. The patient should inform their doctor about taking these medicines. It may be necessary to increase the dose of Mirzaten 45 mg, and after stopping these medicines, decrease the dose of Mirzaten 45 mg.

Mirzaten 45 mg in combination with these medicines may:

• -anticoagulants, such as warfarin. Mirzaten 45 mg may enhance the effect of warfarin. The patient should inform their doctor about taking these medicines. In the case of combination therapy with Mirzaten 45 mg, it is recommended to monitor blood parameters.
• -medicines that may affect heart rhythm, such as certain antibiotics and antipsychotic medicines.

Taking Mirzaten 45 mg with food, drink, and alcohol

Drinking alcohol while taking Mirzaten 45 mg may cause drowsiness.
It is best to avoid consuming alcohol during treatment with Mirzaten 45 mg.
Mirzaten 45 mg 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 the use of Mirzaten 45 mg in pregnant women does not indicate an increased risk. However, caution should be exercised when using this medicine during pregnancy.
If Mirzaten 45 mg is taken during pregnancy or shortly before birth, it is recommended to monitor the newborn for possible side effects.
Taking similar medicines during pregnancy (such as selective serotonin reuptake inhibitors (SSRIs)) may increase the risk of severe complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and cyanosis. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.

Driving and using machines

Mirzaten 45 mg may reduce alertness and ability to concentrate. During treatment with Mirzaten 45 mg, the patient should avoid performing potentially hazardous activities that require continuous attention, such as driving or operating machinery. If the doctor has prescribed Mirzaten 45 mg to a person under 18 years of age, before participating in traffic (e.g., cycling), the patient should check whether the medicine affects their alertness and ability to concentrate.

Mirzaten 45 mg contains lactose monohydrate and sodium

Lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact 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 45 mg

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

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 45 mg

Mirzaten 45 mg should be taken every day at the same time, preferably in a single dose in the evening, before going to bed. The doctor may, however, recommend taking the medicine in two divided doses throughout 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. 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 45 mg with the doctor during the first few weeks of treatment.
After 2 to 4 weeks of taking Mirzaten 45 mg, the patient should discuss with their doctor 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 patient should again discuss the treatment effects with their doctor.
Treatment should be continued until the symptoms have completely disappeared, which usually takes 4 to 6 months.

Taking a higher dose of Mirzaten 45 mg than recommended

If the patient (or someone else) has taken a higher dose of Mirzaten 45 mg than recommended, they should immediately contact their doctor.
The most likely symptoms of an overdose of Mirzaten 45 mg (without other medicines and without alcohol) are: drowsiness, 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 45 mg

If the patient forgets to take a dose of the medicine that is taken once a day:

• they should not take a double dose to make up for the missed dose; they should continue treatment by taking the next dose at the usual time the next day. If the medicine is taken twice a day:
• if they forget to take the morning dose, they should take it together with the evening dose;
• if they forget to take the evening dose, they should not take it together with the morning dose; they should skip it and continue treatment by taking the usual morning and evening doses;
• if they forget to take both doses, they should not try to make up for them; they should skip them. The next day, they should continue treatment by taking the usual morning and evening doses.

Stopping treatment with Mirzaten 45 mg

The patient should only stop taking Mirzaten 45 mg under the strict guidance of their doctor.
The patient should not stop taking the medicine too early, as this may cause the illness to recur. If there is an improvement, the patient should discuss it with their doctor, who will inform them when they can stop treatment. Suddenly stopping treatment with Mirzaten 45 mg, even if the symptoms of depression have disappeared, may cause nausea, dizziness, agitation, or anxiety and headache. These symptoms will not occur during gradual withdrawal of the medicine. The doctor will inform the patient how to gradually reduce the dose of the medicine.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Mirzaten 45 mg can cause side effects, although not everybody gets them.

If any of the following serious side effects occur, the patient should stop taking mirtazapine and contact their doctor 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 problems (jaundice)

Side effects with 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 disorders (bone marrow suppression). Some patients may become less resistant to infections because mirtazapine can cause a temporary decrease in the number of white blood cells (granulocytopenia). Rarely, mirtazapine can also cause a decrease in the number of red and white blood cells and platelets (aplastic anemia, thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).
• seizures (convulsions)
• a combination of symptoms such as unexplained high fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, chills, 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 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 drowsiness
• 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
• vivid dreams
• disorientation
• feeling anxious
• sleep disturbances
• memory disturbances, which usually resolve after stopping treatment

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

• unusual skin sensations, such as 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 with unknown frequency(frequency cannot be estimated from the available data):

• unusual sensations in the mouth (oral paresthesia)
• swelling of the mouth
• generalized swelling (generalized edema)
• localized swelling
• low sodium levels in the blood (hyponatremia)
• inappropriate secretion of antidiuretic hormone
• 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 urine or urine discoloration (rhabdomyolysis)
• increased prolactin levels in the blood (hyperprolactinemia, including symptoms such as breast enlargement and/or milk secretion from the nipples)
• prolonged painful erection

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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Mirzaten 45 mg

The medicine should be stored out of sight and reach of children.
Mirzaten 45 mg should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Mirzaten 45 mg contains

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

What Mirzaten 45 mg looks like and what the package contains

Mirzaten 45 mg: white, oval, biconvex coated tablets.
Packaging: 30, 60, or 90 coated tablets in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 30/082/05-C

Parallel import authorization number: 46/13

This medicine is authorized in the Member States of the European Economic Area under the following names:

Approval date of the leaflet: 13.01.2023

[Information about the trademark]